[Federal Register Volume 79, Number 115 (Monday, June 16, 2014)]
[Rules and Regulations]
[Pages 34222-34224]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2014-13905]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 878

[Docket No. FDA-2014-N-0655]


Medical Devices; General and Plastic Surgery Devices; 
Classification of the Nonabsorbable Expandable Hemostatic Sponge for 
Temporary Internal Use

AGENCY: Food and Drug Administration, HHS.

ACTION: Final order.

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SUMMARY: The Food and Drug Administration (FDA) is classifying the 
nonabsorbable expandable hemostatic sponge for temporary internal use 
into class II (special controls). The special controls that will apply 
to the device are identified in this order and will be part of the 
codified language for the nonabsorbable expandable hemostatic sponge 
for temporary internal use classification. The Agency is classifying 
the device into class II (special controls) in order to provide a 
reasonable assurance of safety and effectiveness of the device.

DATES: This order is effective July 16, 2014. The classification was 
applicable April 3, 2014.

FOR FURTHER INFORMATION CONTACT: Kelley Burridge, Center for Devices 
and Radiological Health, Food and Drug Administration, 10903 New 
Hampshire Ave., Bldg. 66, Rm. G425, Silver Spring, MD 20993-0002, 301-
796-7630.

SUPPLEMENTARY INFORMATION:

I. Background

    In accordance with section 513(f)(1) of the Federal Food, Drug, and 
Cosmetic Act (the FD&C Act) (21 U.S.C. 360c(f)(1)), devices that were 
not in commercial distribution before May 28, 1976 (the date of 
enactment of the Medical Device Amendments of 1976), generally referred 
to as postamendments devices, are classified automatically by statute 
into class III without any FDA rulemaking process. These devices remain 
in class III and require premarket approval, unless and until the 
device is classified or reclassified into class I or II, or FDA issues 
an order finding the device to be substantially equivalent, in 
accordance with section 513(i) of the FD&C Act, to a predicate device 
that does not require premarket approval. The Agency determines whether 
new devices are substantially equivalent to predicate devices by means 
of premarket notification procedures in section 510(k) of the FD&C Act 
(21 U.S.C. 360(k)) and part 807 (21 CFR part 807) of the regulations.
    Section 513(f)(2) of the FD&C Act, as amended by section 607 of the 
Food and Drug Administration Safety and Innovation Act (Pub. L. 112-
144, July 9, 2012), provides two procedures by which a person may 
request FDA to classify a device under the criteria set forth in 
section 513(a)(1). Under the first procedure, the person submits a 
premarket notification under section 510(k) of the FD&C Act for a 
device that has not previously been classified and, within 30 days of 
receiving an order classifying the device into class III under section 
513(f)(1) of the FD&C Act, the person requests a classification under 
section 513(f)(2). Under the second procedure, rather than first 
submitting a premarket notification under section 510(k) of the FD&C 
Act and then a request for classification under the first procedure, 
the person determines that there is no legally marketed device upon 
which to base a determination of substantial equivalence and requests a 
classification under section 513(f)(2) of the FD&C Act. If the person 
submits a request to classify the device under this second procedure, 
FDA may decline to undertake the classification request if FDA 
identifies a legally marketed device that could provide a reasonable 
basis for review of substantial equivalence with the device or if FDA 
determines that the device submitted is not of ``low-moderate risk'' or 
that general controls would be inadequate to control the risks and 
special controls to mitigate the risks cannot be developed.
    In response to a request to classify a device under either 
procedure provided by section 513(f)(2) of the FD&C Act, FDA will 
classify the device by written order within 120 days. This 
classification will be the initial classification of the device.
    On January 30, 2013, RevMedx, Inc., submitted a request for 
classification of XSTAT under section 513(f)(2) of the FD&C Act. The 
manufacturer recommended that the device be classified into class II 
(Ref. 1).
    In accordance with section 513(f)(2) of the FD&C Act, FDA reviewed 
the request in order to classify the device under the criteria for 
classification set forth in section 513(a)(1) of the FD&C Act. FDA 
classifies devices into class II if general controls by themselves are 
insufficient to provide reasonable assurance of safety and 
effectiveness, but there is sufficient information to establish special 
controls to provide reasonable assurance of the safety and 
effectiveness of the device for its intended use. After review of the 
information submitted in the de novo request, FDA determined that the 
device can be classified into class II with the establishment of 
special controls. FDA believes these special controls, in addition to 
general controls, will provide reasonable assurance of the safety and 
effectiveness of the device.
    Therefore, on April 3, 2014, FDA issued an order to the requestor 
classifying the device into class II. FDA is codifying the 
classification of the device by adding Sec.  878.4452.
    Following the effective date of this final classification 
administrative order, any firm submitting a premarket notification 
(510(k)) for a nonabsorbable expandable hemostatic sponge for temporary 
internal use will need to comply with the special controls named in the 
final administrative order.
    The device is assigned the generic name nonabsorbable expandable 
hemostatic sponge for temporary internal use, and it is identified as a 
prescription device intended to be placed temporarily into junctional, 
non-compressible wounds, which are not amenable to tourniquet use, to 
control bleeding until surgical care is acquired. The sponges expand 
upon contact with blood to fill the wound cavity and provide a physical 
barrier and pressure that facilitates formation of a clot. The device 
consists of sterile nonabsorbable radiopaque compressed sponges and

[[Page 34223]]

may include an applicator to facilitate delivery into a wound.
    FDA has identified the following risks to health associated with 
this type of device and the measures required to mitigate these risks 
in table 1:

    Table 1--Nonabsorbable Expandable Hemostatic Sponge for Temporary
               Internal Use Risks and Mitigation Measures
------------------------------------------------------------------------
             Identified risk                     Mitigation measure
------------------------------------------------------------------------
Failure to Stop Bleeding or Recurrence of  Non-Clinical Performance
 Bleeding.                                  Data.
                                           In Vivo Performance Data.
                                           Stability Assessment.
                                           Labeling.
Obstruction of Vital Organs..............  Human Factors Testing.
                                           Labeling.
Embolization.............................  In Vivo Performance Data.
Collateral Tissue Damage (e.g.,            In Vivo Performance Data.
 paralysis, nerve damage, tissue
 necrosis).
                                           Labeling.
Adverse Tissue and Allergic Reactions....  Material Characterization.
                                           Biocompatibility.
                                           In Vivo Performance Data.
                                           Labeling.
Infection (e.g., cellulitis, Toxic Shock   Sterility Testing.
 Syndrome, sepsis).
                                           Stability Assessment.
Reoperation Due to Material Retained in    Non-Clinical Performance
 Body.                                      Data.
                                           In Vivo Performance Data.
                                           Human Factors Testing.
                                           Labeling.
Sponge Deployment Failure................  Non-Clinical Performance
                                            Data.
                                           In Vivo Performance Data.
                                           Stability Assessment.
                                           Human Factors Testing.
                                           Labeling.
Improper Application Technique or Use      Human Factors Testing.
 Error.
                                           Labeling.
------------------------------------------------------------------------

    FDA believes that the following special controls, in addition to 
the general controls, address these risks to health and provide 
reasonable assurance of safety and effectiveness:
    1. Performance data must demonstrate the biocompatibility of 
patient-contacting components.
    2. Performance data must demonstrate the sterility of patient-
contacting components including endotoxin and pyrogenicity assessments.
    3. Performance data must support device stability by demonstrating 
continued sterility of the patient-contacting components of the device, 
package integrity, and device functionality over the requested shelf 
life.
    4. Assessment of material characteristics must be sufficient to 
support safety under anticipated conditions of use. Assessments must 
include the following:
     Material specifications;
     immunogenicity; and
     viral inactivation for animal-derived materials.
    5. Non-clinical performance data must demonstrate that the device 
performs as intended under anticipated conditions of use. The following 
performance characteristics must be tested:
     Absorption capacity;
     extent of swelling;
     mechanical properties;
     expansion force/pressure;
     radiopacity; and
     deployment/applicator functionality.
    6. In vivo performance data must demonstrate safe and effective use 
by verifying that the device performs as intended under anticipated 
conditions of use. Appropriate analysis/testing must demonstrate that 
the product: Controls bleeding, does not promote adverse local or 
systemic effects, and can be completely removed from the wound. The 
following performance characteristics must be tested:
     Deployment;
     control of bleeding;
     radiopacity;
     retrieval; and
     assessment of local and systemic effects.
    7. Human factors testing and analysis must validate that the device 
design and labeling are sufficient for appropriate use by emergency 
responders deploying the device as well as surgeons retrieving the 
device from wounds.
    8. Labeling must include:
     Specific instructions for deployment by emergency 
responders and retrieval by surgeons;
     warnings, cautions, and limitations needed for safe use of 
the device;
     information on how the device operates and the typical 
course of treatment;
     a detailed summary of the in vivo and human factors 
testing pertinent to use of the device;
     appropriate imaging information to ensure complete 
retrieval of device; and
     an expiration date/shelf life.
    Nonabsorbable expandable hemostatic sponges for temporary internal 
use are prescription devices restricted to patient use only upon the 
authorization of a practitioner licensed by law to administer or use 
the device. (Sec.  878.4452; see section 520(e) of the FD&C Act (21 
U.S.C. 360j(e)) and 21 CFR 801.109 (Prescription devices).) 
Prescription-use restrictions are a type of general controls as defined 
in section 513(a)(1)(A)(i) of the FD&C Act.
    Section 510(m) of the FD&C Act provides that FDA may exempt a class 
II device from the premarket notification requirements under section 
510(k) of the FD&C Act if FDA determines that premarket notification is 
not necessary to provide reasonable assurance of the safety and 
effectiveness of the device. For this type of device, FDA has 
determined that premarket notification is necessary to provide 
reasonable assurance of the safety and effectiveness of the device. 
Therefore, this device type is not exempt from premarket

[[Page 34224]]

notification requirements. Persons who intend to market this type of 
device must submit to FDA a premarket notification, prior to marketing 
the device, which contains information about the nonabsorbable 
expandable hemostatic sponge for temporary internal use they intend to 
market.

II. Environmental Impact

    The Agency has determined under 21 CFR 25.34(b) that this action is 
of a type that does not individually or cumulatively have a significant 
effect on the human environment. Therefore, neither an environmental 
assessment nor an environmental impact statement is required.

III. Paperwork Reduction Act of 1995

    This final administrative order establishes special controls that 
refer to previously approved collections of information found in other 
FDA regulations. These collections of information are subject to review 
by the Office of Management and Budget (OMB) under the Paperwork 
Reduction Act of 1995 (44 U.S.C. 3501-3520). The collections of 
information in part 807, subpart E, regarding premarket notification 
submissions have been approved under OMB control number 0910-0120, and 
the collections of information in 21 CFR part 801, regarding labeling 
have been approved under OMB control number 0910-0485.

IV. Reference

    The following reference has been placed on display in the Division 
of Dockets Management (HFA-305), Food and Drug Administration, 5630 
Fishers Lane, Rm. 1061, Rockville, MD 20852, and may be seen by 
interested persons between 9 a.m. and 4 p.m., Monday through Friday, 
and is available electronically at http://www.regulations.gov.

    1. K130218: De novo request per 513(f)(2) of the Federal Food, 
Drug, and Cosmetic Act from RevMedx, Inc., dated January 28, 2013.

List of Subjects in 21 CFR Part 878

    Medical devices, General and plastic surgery devices.

    Therefore, under the Federal Food, Drug, and Cosmetic Act and under 
authority delegated to the Commissioner of Food and Drugs, 21 CFR part 
878 is amended as follows:

PART 878--GENERAL AND PLASTIC SURGERY DEVICES

0
1. The authority citation for 21 CFR part 878 continues to read as 
follows:

    Authority:  21 U.S.C. 351, 360, 360c, 360e, 360j, 360l, 371.


0
2. Add Sec.  878.4452 to subpart E to read as follows:


Sec.  878.4452  Nonabsorbable expandable hemostatic sponge for 
temporary internal use.

    (a) Identification. A nonabsorbable expandable hemostatic sponge 
for temporary internal use is a prescription device intended to be 
placed temporarily into junctional, non-compressible wounds, which are 
not amenable to tourniquet use, to control bleeding until surgical care 
is acquired. The sponges expand upon contact with blood to fill the 
wound cavity and provide a physical barrier and pressure that 
facilitates formation of a clot. The device consists of sterile, 
nonabsorbable radiopaque compressed sponges and may include an 
applicator to facilitate delivery into a wound.
    (b) Classification. Class II (special controls). The special 
controls for this device are:
    (1) Performance data must demonstrate the biocompatibility of 
patient-contacting components.
    (2) Performance data must demonstrate the sterility of patient-
contacting components including endotoxin and pyrogenicity assessments.
    (3) Performance data must support device stability by demonstrating 
continued sterility of the patient-contacting components of the device, 
package integrity, and device functionality over the requested shelf 
life.
    (4) Assessment of material characteristics must be sufficient to 
support safety under anticipated conditions of use. Assessments must 
include the following:
    (i) Material specifications.
    (ii) Immunogenicity.
    (iii) Viral inactivation for animal-derived materials.
    (5) Non-clinical performance data must demonstrate that the device 
performs as intended under anticipated conditions of use. The following 
performance characteristics must be tested:
    (i) Absorption capacity.
    (ii) Extent of swelling.
    (iii) Mechanical properties.
    (iv) Expansion force/pressure.
    (v) Radiopacity.
    (vi) Deployment/applicator functionality.
    (6) In vivo performance data must demonstrate safe and effective 
use by verifying that the device performs as intended under anticipated 
conditions of use. Appropriate analysis/testing must demonstrate that 
the product: Controls bleeding, does not promote adverse local or 
systemic effects, and can be completely removed from the wound. The 
following performance characteristics must be tested:
    (i) Deployment.
    (ii) Control of bleeding.
    (iii) Radiopacity.
    (iv) Retrieval.
    (v) Assessment of local and systemic effects.
    (7) Human factors testing and analysis must validate that the 
device design and labeling are sufficient for appropriate use by 
emergency responders deploying the device as well as surgeons 
retrieving the device from wounds.
    (8) Labeling must include:
    (i) Specific instructions for deployment by emergency responders 
and retrieval by surgeons.
    (ii) Warnings, cautions, and limitations needed for safe use of the 
device.
    (iii) Information on how the device operates and the typical course 
of treatment.
    (iv) A detailed summary of the in vivo and human factors testing 
pertinent to use of the device.
    (v) Appropriate imaging information to ensure complete retrieval of 
device.
    (vi) An expiration date/shelf life.

    Dated: June 10, 2014.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2014-13905 Filed 6-13-14; 8:45 am]
BILLING CODE 4164-01-P