(71 days)
Not Found
No
The summary describes a biological wound dressing and does not mention any computational or analytical capabilities, let alone AI/ML.
Yes.
The device is a wound dressing indicated for the management of various types of wounds, which is a therapeutic purpose.
No
The device is a wound dressing intended for the management of wounds, providing a scaffold for cellular invasion and capillary growth, rather than diagnosing a condition.
No
The device description explicitly states it is a "porous matrix of cross-linked bovine tendon collagen and glycosaminoglycan," which are physical materials, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the device is a wound dressing for the management of various types of wounds. This is a therapeutic application, not a diagnostic one.
- Device Description: The description details the composition and function of a wound dressing, which is applied externally to a wound. IVDs are typically used to examine samples from the body (like blood, urine, or tissue) to diagnose or monitor a condition.
- Lack of Diagnostic Elements: There is no mention of analyzing biological samples, detecting biomarkers, or providing diagnostic information.
Therefore, AVAGEN Wound Dressing falls under the category of a medical device used for wound management, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
AVAGEN Wound Dressing is indicated for the management of wounds including: 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, and skin tears) and draining wounds. The device is intended for one-time use.
Product codes
KGN
Device Description
AVAGEN Wound Dressing is an advanced wound dressing comprised of a porous matrix of cross-linked bovine tendon collagen and glycosaminoglycan. The biodegradable matrix provides a scaffold for cellular invasion and capillary growth.
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
Not Found
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
Biocompatibility studies have demonstrated AVAGEN Wound Dressing to be noncytotoxic, non-pyrogenic, non-irritating, non-sensitizing, non-hemolytic and non-toxic.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
N/A
0
AVAGEN Wound Dressing 510(K) SUMMARY
Submitter's name and address:
SEP 1 0 2002
Integra LifeSciences Corporation 311 Enterprise Drive Plainsboro, NJ 08536 USA
Contact person and telephone number:
Diana M. Bordon Manager, Regulatory Affairs, (609) 275-0500
June 28, 2002 Date:
Name of the device:
| Proprietary Name: | AVAGEN Wound Dressing |
|---|---|
| Common Name: | Wound Dressing |
| Classification Name: | Unclassified, (79KMF) |
Substantial Equivalence:
A VAGEN Wound Dressing is substantially equivalent in function and intended use to the following products which have been cleared to market under Premarket Notifications 510(k): Oasis™ SIS Wound Dressing II (K993948) and Fortaderm™ Wound Dressing (K014129).
Intended Use:
A VAGEN Wound Dressing is indicated for the management of wounds including: 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, and skin tears) and draining wounds. The device is intended for one-time use.
Device Description:
AVAGEN Wound Dressing is an advanced wound dressing comprised of a porous matrix of cross-linked bovine tendon collagen and glycosaminoglycan. The biodegradable matrix provides a scaffold for cellular invasion and capillary growth.
Tests and Test Results
Biocompatibility studies have demonstrated AVAGEN Wound Dressing to be noncytotoxic, non-pyrogenic, non-irritating, non-sensitizing, non-hemolytic and non-toxic.
Conclusion
Valid scientific evidence through biocompatibility and physical property testing provide reasonable assurance that AVAGEN Wound Dressing is safe and effective under the proposed conditions of use, and is, with respect to intended use and technological characteristics, substantially equivalent to the predicate devices.
1
Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized caduceus, which is a symbol of medicine, with three lines representing the three branches of government. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular fashion around the caduceus. The logo is black and white.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Judith E. O'Grady Senior Vice President, Regulatory Affairs Integra LifeSciences Corporation 311 Enterprise Drive Plainsboro, New Jersey 08536
Re: K022127
Trade/Device Name: AVAGEN Wound Dressing Regulatory Class: Unclassified Product Code: KGN Dated: June 28, 2002 Received: July 1, 2002
Dear Ms. O'Grady:
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 Medical 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.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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); 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. Judith E. O'Grady 1.1
This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 21 CFR Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4659. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely yours,
Celia M. Witten, Ph.D., M.D.
Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
3
INDICATIONS FOR USE
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Page 1 of 1
510(k) Number:
Device Name: AVAGEN Wound Dressing
Indications for Use:
AVAGEN Wound Dressing is indicated for the management of wounds including; partial and full-thickness wounds, pressure ulcers, venous 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, second-degree burns, skin tears) and draining wounds. The device is intended for one-time use.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use
(Per 21 CFR 801.109)
Or
Over-the-Counter Use
(Optional Format 1-2-96)
(Division Sign-Off)
Division of General, Restorative
and Neurological Devices
510(k) Number B0001 K022127