Source: https://www.federalregister.gov/documents/2014/06/16/2014-13905/medical-devices-general-and-plastic-surgery-devices-classification-of-the-nonabsorbable-expandable
Timestamp: 2017-11-20 17:43:16
Document Index: 168802051

Matched Legal Cases: ['§\u2009878', '§\u2009878', 'art 807', 'art 801', '§\u2009878', '§\u2009878']

Federal Register :: Medical Devices; General and Plastic Surgery Devices; Classification of the Nonabsorbable Expandable Hemostatic Sponge for Temporary Internal Use
Medical Devices; General and Plastic Surgery Devices; Classification of the Nonabsorbable Expandable Hemostatic Sponge for Temporary Internal Use
A Rule by the Food and Drug Administration on 06/16/2014
This order is effective July 16, 2014. The classification was applicable April 3, 2014.
79 FR 34222
34222-34224 (3 pages)
Docket No. FDA-2014-N-0655
2014-13905
FDA-2014-N-0655
https://www.federalregister.gov/d/2014-13905 https://www.federalregister.gov/d/2014-13905
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.
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.
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.
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 § 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 Start Printed Page 34223may include an applicator to facilitate delivery into a wound.
Table 1—Nonabsorbable Expandable Hemostatic Sponge for Temporary Internal Use Risks and Mitigation Measures
Failure to Stop Bleeding or Recurrence of Bleeding Non-Clinical Performance Data.
In Vivo Performance Data.
Obstruction of Vital Organs Human Factors Testing.
Embolization In Vivo Performance Data.
Collateral Tissue Damage (e.g., paralysis, nerve damage, tissue necrosis) In Vivo Performance Data.
Adverse Tissue and Allergic Reactions Material Characterization.
Infection (e.g., cellulitis, Toxic Shock Syndrome, sepsis) Sterility Testing.
Reoperation Due to Material Retained in Body Non-Clinical Performance Data.
Sponge Deployment Failure Non-Clinical Performance Data.
Improper Application Technique or Use Error Human Factors Testing.
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:
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;
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:
control of bleeding;
radiopacity;
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. (§ 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 Start Printed Page 34224notification 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.
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.
1. K130218: De novo request per 513(f)(2) of the Federal Food, Drug, and Cosmetic Act from RevMedx, Inc., dated January 28, 2013.
2. Add § 878.4452 to subpart E to read as follows:
§ 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.
(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.
(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.
[FR Doc. 2014-13905 Filed 6-13-14; 8:45 am]