(279 days)
NOT FOUND
No
The device description and performance studies focus on the material properties and biological interaction of a wound matrix, with no mention of AI/ML, image processing, or data-driven analysis.
Yes.
The device is intended for the management of various wound types and provides a scaffold for cellular infiltration and vascularization, which are therapeutic actions to aid in wound healing.
No
The device is a wound matrix intended for the management and healing of wounds by providing a scaffold for cellular infiltration and vascularization, not for diagnosing conditions.
No
The device description explicitly states it is a "tailorable, porous, bioabsorbable material matrix" composed of a synthetic copolymer, indicating it is a physical material, not software.
Based on the provided information, the GORE® BIO-A® Wound Matrix is not an In Vitro Diagnostic (IVD) device.
Here's why:
- Intended Use: The intended use is for the management of wounds, which is a therapeutic application, not a diagnostic one.
- Device Description: The device is a physical matrix designed to provide a scaffold for tissue growth. It does not analyze biological samples or provide diagnostic information.
- Lack of Diagnostic Function: There is no mention of the device being used to test blood, urine, tissue, or any other biological sample to diagnose a condition or provide information about a patient's health status.
- Performance Studies: The performance studies focus on wound healing and biocompatibility, not diagnostic accuracy.
IVD devices are used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. The GORE® BIO-A® Wound Matrix does not fit this description.
N/A
Intended Use / Indications for Use
The GORE® BIO-A® Wound Matrix is intended for use in the management of wounds.
Wound types include: Partial and full-thickness wounds, pressure ulcers, diabetic ulcers, chronic vascular ulcers, tunneled/undermined wounds (donor sites/grafts, post-Mob's surgery, post laser surgery, podiatic, wound dehiscence), trauma wounds (abrasions, second degree burns, skin tears) and draining wounds.
Product codes
QSZ, FRO
Device Description
GORE® BIO-A® Wound Matrix device is a tailorable, porous, bioabsorbable material matrix that provides a scaffold for cellular infiltration and vascularization. The device permits the ingress of cells and soft tissue formation into the defect space/wound bed. GORE® BIO-A® Wound Matrix is a porous fibrous structure composed solely of a synthetic copolymer comprised of polyglycolic acid and trimethylene carbonate (PGA:TMC).
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Prescription Use (Part 21 CFR 801 Subpart D)
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies
Bench study: Testing of the GORE® BIO-A® Wound Matrix device demonstrated the performance of the GORE® BIO-A® Wound Matrix is capable of meeting intended product specifications which are similar to the predicate Gore device comprised of the same material construct.
Animal study: Testing of the GORE® BIO-A® Wound Matrix device also included biocompatibility testing in accordance with ISO 10993-1 and in vivo safety and performance studies. The performance of the GORE® BIO-A® Wound Matrix device and the collagen predicate control device was evaluated in both full and partial thickness wounds in a porcine model analysis including wound closure, macroscopic appearance, and microscopic evaluation via histological assessment. The results of the studies showed that the test and predicate control device exhibited no adverse tissue response, a similar inflammatory response, and no differences in time to wound closure. All wounds healed prior to device absorption, and the devices were no longer histologically detectable at 8 months.
Clinical: No clinical evaluations of this product have been conducted.
Key Metrics
Not Found
Predicate Device(s)
K021792, K022127, K090160, K083266
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
N/A
0
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December 15, 2022
W. L. Gore & Associates, Incorporated Barbara L. Smith, RAC Official Correspondent 301 Airport Rd. Elkton, Maryland 21921
Re: K132397
Trade/Device Name: Gore® Bio-A® Wound Matrix Regulatory Class: Unclassified Product Code: QSZ
Dear Barbara L. Smith, RAC:
The Food and Drug Administration (FDA) is sending this letter to notify you of an administrative change related to your previous substantial equivalence (SE) determination letter dated May 7, 2014. Specifically, FDA is updating this SE Letter because FDA has better categorized your device technology under product code QSZ.
Please note that the 510(k) submission was not re-reviewed. For questions regarding this letter please contact Julie Morabito, OHT4: Office of Surgical and Infection Control Devices, 240-402-3839, Julie.Morabito@fda.hhs.gov.
Sincerely,
Julie A. Morabito -S
Julie Morabito, Ph.D. Assistant Director DHT4B: Division of Infection Control and Plastic Surgery Devices OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
1
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
May 7, 2014
W.L. Gore & Associates Incorporated % Ms. Barbara L. Smith, RAC Regulatory Associate 301 Airport Road Elkton, Maryland 21921
Rc: K132397
Trade/Device Name: GORE® BIO-A™ Wound Matrix Regulatory Class: Unclassified Product Code: FRO Dated: April 2. 2014 Reccived: April 7, 2014
Dear Ms. Smith:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Mcdical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warrantics. We remind you; however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations. Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA 's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
2
Page 2 - Ms. Barbara L. Smith, RAC
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.
Sincerely yours,
Binita S. Ashar - S 2014.05.07 12:01:48 -04'00'
Binita S. Ashar, M.D., M.B.A., F.A.C.S. Acting Director Division of Surgical Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
3
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement befow.
510(k) Number (if known) K 132397
Device Name
GORE® BIO-A® Wound Matrix
Indications for Use (Describe)
The GORE® BIO-A® Wound Matrix is intended for use in the management of wounds.
Wound types include: Partial and full-thickness wounds, pressure ulcers, diabetic ulcers, chronic vascular ulcers, tunneled/undermined wounds (donor sites/grafts, post-Mob's surgery, post laser surgery, podiatic, wound dehiscence), trauma wounds (abrasions, second degree burns, skin tears) and draining wounds.
Type of Use (Select one or both, as applicable)
2 Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.
STORE CONSTITUTION CORTEDATION SECONE CONCELLERS CONCELLERS CONCELLAND CONSECTION CONSULTION CONSECTION
Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)
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This section applies only to requirements of the Paperwork Reduction Act of 1995.
*DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW."
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this Information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of Information unless it displays a currently valid OMB number."
FORM FDA 3881 (1/14)
PSC Publishing Servises (101) 441-6240
4
W. L. Gore & Associates, Inc. GORE® BIO-A® Wound Matrix Section 5. 510(k) Summary
MAY 0 7 2014 K132397 page 1 of 3
510(k) SUMMARY (Per 21CFR807.92)
Submission Information
Owner/Operator: W. L. Gore & Associates, Inc. 1505 N. Fourth Street Flagstaff, AZ 86004 USA
Regulatory Contact: W. L. Gore & Associates, Inc. 301 Airport Road Elkton, Maryland 21921 Attn: Barbara L. Smith, RAC Phone: 410-506-8189 Fax: 410-506-8221 E-mail: blsmith@wlgore.com
Date Summary Prepared
April 29, 2014
Device Names/Classification
| Trade Name: | GORE® BIO-A® Wound Matrix |
|---|---|
| Common Name: | Wound Dressing |
| Classification Name: | Unclassified |
| Product Code: | FRO (Dressing, wound, drug) |
Predicate Device
The predicate devices to which the GORE® BIO-A® Wound Matrix is being compared are:
- K021792 INTEGRA™ Bilayer Matrix Wound Dressing (FRO) .
- K022127 AVAGEN Wound Dressing (KGN) .
- K090160 SUPRATHEL® Wound & Burn Dressing (FRO) .
- K083266 GORE® BIO-A® Fistula Plug (FTL) .
GORE AND DESIGNS ARE TRADEMARKS OF W. L. GORE & ASSOCIATES, INC.
Integra is a trademark of INTEGRA Lifesciences Corporation. SUPRATHEL is a registered trademark of PolyMedics Innovations GmbH.
5
W. L. Gore & Associates, Inc. GORE® BIO-A® Wound Matrix Section 5. 510(k) Summary
Intended/Indications for Use
The GORE® BIO-A® Wound Matrix is intended for use in the management of wounds.
Wound types include: Partial and full-thickness wounds, pressure ulcers, venous ulcers, diabetic ulcers, chronic vascular ulcers, tunneled/undermined wounds, surgical wounds (donor sites/grafts, post-Moh's surgery, post laser surgery, podiatric, wound dehiscence), trauma wounds (abrasions, lacerations, second degree burns, skin tears) and draining wounds.
Device Description
GORE® BIO-A® Wound Matrix device is a tailorable, porous, bioabsorbable material matrix that provides a scaffold for cellular infiltration and vascularization. The device permits the ingress of cells and soft tissue formation into the defect space/wound bed. GORE® BIO-A® Wound Matrix is a porous fibrous structure composed solely of a synthetic copolymer comprised of polyglycolic acid and trimethylene carbonate (PGA:TMC).
Summary of Similarities and Difference in Technological Characteristics, Performance and Intended Use
The primary difference between the subject Wound Matrix device and Integra (Avagen) predicate is in the material type i.e. synthetic polymer scaffold vs. a collagen scaffold.
Performance Data / Predicate Device Comparison
Pre-Clinical
Bench study: Testing of the GORE® BIO-A® Wound Matrix device demonstrated the performance of the GORE® BIO-A® Wound Matrix is capable of meeting intended product specifications which are similar to the predicate Gore device comprised of the same material construct.
Animal study: Testing of the GORE® BIO-A® Wound Matrix device also included biocompatibility testing in accordance with ISO 10993-1 and in vivo safety and performance studies. The performance of the GORE® BIO-A® Wound Matrix device and the collagen predicate control device was evaluated in both full and partial thickness wounds in a porcine model analysis including wound closure, macroscopic appearance, and microscopic evaluation via histological assessment. The results of the studies showed that the test and predicate control device exhibited no adverse tissue response, a similar inflammatory response, and no differences in time to wound closure. All wounds healed prior to device absorption, and the devices were no longer histologically detectable at 8 months.
Gore and Designs are trademarks of W. L. Gore & Associates, Inc.
Integra is a trademark of INTEGRA Lifesciences Corporation. SUPRATHEL is a registered trademark of PolyMedics Innovations GmbH.
6
W. L. Gore & Associates, Inc. GORE® BIO-A® Wound Matrix Section 5. 510(k) Summary
Clinical
No clinical evaluations of this product have been conducted.
Conclusion
W. L. Gore & Associates concludes the GORE® BIO-A® Wound Matrix is substantially equivalent to the predicate devices based upon similarities in product indications, operation, design, materials of construction, sterilization, labeling, shelf life, and performance.
GORE AND DESIGNS ARE TRADEMARKS OF W. L. GORE & ASSOCIATES, INC.
Integra is a trademark of INTEGRA Lifesciences Corporation. SUPRATHEL is a registered trademark of PolyMedics Innovations GmbH.