(75 days)
Not Found
No
The provided text describes a passive wound dressing material and does not mention any computational or analytical capabilities, let alone AI/ML.
Yes
The device is intended for the management and healing of wounds, which are therapeutic applications.
No
Explanation: The provided text describes the device as a wound dressing for managing wounds, indicating its therapeutic rather than diagnostic function. It facilitates healing by providing a scaffold and covering for wounds, without mentioning any capability to identify or analyze a condition.
No
The device description clearly states it is comprised of physical materials (collagen, glycosaminoglycan, polysiloxane) and is a physical wound dressing, not software.
Based on the provided information, this device is not an In Vitro Diagnostic (IVD).
Here's why:
- Intended Use: The intended use clearly states the device is for the management of various types of wounds. This is a direct application to the body for therapeutic purposes.
- Device Description: The description details a wound dressing made of collagen, glycosaminoglycan, and silicone. This is a physical device applied externally to a wound.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens derived from the human body (like blood, urine, tissue samples, etc.) to provide information for diagnosis, monitoring, or screening.
IVDs are used in vitro (outside the body) to analyze biological samples. This device is used in vivo (on the body) for wound management.
N/A
Intended Use / Indications for Use
Bilayer Matrix Wound Dressing is indicated for the management of wounds including: partial and full thickness wounds, pressure ulcers, venous ulcers, diabetic ulcers, chronic vascular ulcers, 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, 79FRO
Device Description
Bilayer Matrix Wound Dressing is an advanced woundcare device comprised of a porous matrix of cross-linked bovine tendon collagen and glycosaminoglycan and a semipermeable polysiloxane (silicone) layer. The semi-permeable silicone membrane controls water vapor loss, provides a flexible adherent covering for the wound surface and adds increased tear strength to the device. The collagen-glycosaminoglycan 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
Biocompatibility studies have demonstrated Bilayer Matrix Wound Dressing to be noncytotoxic, non-pyrogenic, non-irritating, non-sensitizing, non-hemolytic and non-toxic.
Key Metrics
Not Found
Predicate Device(s)
K993948, K014129, K896455, K896110
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
N/A
0
Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of three parts: a symbol resembling a caduceus on the left, the letters "FDA" in a square in the middle, and the words "U.S. FOOD & DRUG ADMINISTRATION" on the right. The symbol on the left is a stylized representation of a staff with two snakes winding around it, enclosed in a circle.
November 18, 2019
Integra Lifesciences Corp. Diana Bordon Manager Of Special Projects 311 Enterprise Dr. Plainsboro, New Jersey 08536
Re: K021792
Trade/Device Name: Bilayer Matrix Wound Dressing Regulatory Class: Unclassified Product Code: KGN Dated: May 30, 2002 Received: May 31, 2002
Dear Diana Bordon:
This letter corrects our substantially equivalent letter of August 14, 2002.
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 mav, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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 warranties. 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
1
801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE(@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Kimberly Ferlin -S
Kimberly M. Ferlin, Ph.D. Assistant Director (acting) 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
Enclosure
2
Bilaver Matrix Wound Dressing 510(K) SUMMARY
Submitter's name and address:
Integra LifeSciences Corporation 311 Enterprise Drive Plainsboro, NJ 08536 USA
AUG 1 4 2002
Contact person and telephone number:
Diana M. Bordon Manager, Regulatory Affairs, (609) 275-0500
Date: May 23, 2002
Name of the device:
| Proprietary Name: | Bilayer Matrix Wound Dressing |
|---|---|
| Common Name: | Wound Dressing |
| Classification Name: | Dressing, Product Code 79FRO |
Substantial Equivalence:
Bilayer Matrix 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), Fortaderm™ Wound Dressing (K014129), VitaChoice™ Wound Dressing (K896455) and Biobrane® II Temporary Wound Dressing (K896110).
Intended Use:
Bilayer Matrix Wound Dressing is indicated for the management of wounds including: partial and full thickness wounds, pressure ulcers, venous ulcers, diabetic ulcers, chronic vascular ulcers, 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:
Bilayer Matrix Wound Dressing is an advanced woundcare device comprised of a porous matrix of cross-linked bovine tendon collagen and glycosaminoglycan and a semipermeable polysiloxane (silicone) layer. The semi-permeable silicone membrane controls water vapor loss, provides a flexible adherent covering for the wound surface and adds increased tear strength to the device. The collagen-glycosaminoglycan biodegradable matrix provides a scaffold for cellular invasion and capillary growth.
Tests and Test Results
Biocompatibility studies have demonstrated Bilayer Matrix 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 Bilayer Matrix 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.
3
Integra LifeSciences Corporation 510(k) Premarket Notification Bilayer Matrix Wound Dressing .
Confidential
INDICATIONS FOR USE
510(k) Number:
K02 1792
Page 1 of 1
Device Name: Bilayer Matrix Wound Dressing
Indications for Use:
Bilayer Matrix Wound Dressing is indicated for the management of wounds including: partial and full thickness wounds, pressure ulcers, venous ulcers, chronic vascular ulcers, surgical wounds (donor sites/grafts, post-Moh's surgery, post-laser surgery, podiatric, wound dehiscence), trauma wounds (abrasions, lacerations, sccond-degree burns, and draining wounds. The device is intended for one-time use.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHIER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
(Division Sign-Off)
Division of General, Restorative
and Neurological Devices
Prescription Usc
(Per 21 CFR 801.109)
Over-the-Counter Use
510(k) Number K071792 (Optional Format 1-2-96)