(176 days)
Not Found
No
The document describes a wound matrix and its physical properties and testing methods. While it mentions "Image Analysis" for pore size determination, there is no indication of AI or ML being used in this analysis or any other aspect of the device's function or manufacturing.
Yes
The device is indicated for the management of various wounds, including chronic ones, and provides a scaffold for cellular invasion and capillary growth, which are therapeutic functions for tissue repair.
No
This device is a wound matrix designed for the management and healing of wounds, acting as a scaffold for tissue growth. It does not perform diagnostic functions such as detecting, identifying, or monitoring a disease or condition.
No
The device description clearly states it is comprised of a physical matrix of collagen, glycosaminoglycan, and polysiloxane, which are hardware components. While image analysis is mentioned for quality control, the primary function and composition are physical.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the device is for the management of various types of wounds. This is a therapeutic application, not a diagnostic one. IVDs are used to examine specimens from the human body to provide information for diagnosis, monitoring, or screening.
- Device Description: The description details a wound matrix designed to provide a scaffold for healing and a protective covering. This aligns with a therapeutic device, not a diagnostic one.
- Lack of Diagnostic Function: There is no mention of the device being used to analyze biological samples or provide diagnostic information about a patient's condition. The image processing mentioned is for quality control of the device itself (pore size determination), not for analyzing patient samples.
Therefore, based on the provided text, the INTEGRA™ Meshed Bilayer Wound Matrix is a therapeutic medical device, not an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
INTEGRA™ Meshed Bilayer Wound Matrix 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 may be used in conjunction with negative pressure wound therapy. The device is intended for one-time use.
Product codes (comma separated list FDA assigned to the subject device)
KGN
Device Description
INTEGRA™ Meshed Bilayer Wound Matrix is an advanced wound care device comprised of a porous matrix of cross-linked bovine tendon collagen and glycosaminonlycan with a polysiloxane (silicone) layer. The meshed bilayer matrix allows drainage of wound exudate and provides a flexible adherent covering for the wound surface. The collagen- glycosaminoglycan biodegradable matrix provides a scaffold for cellular invasion and capillary growth.
Mentions image processing
Yes
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 testing including Cytotoxicity, Dermal Sensitization, Irritation, Acute Systemic Toxicity, Pyrogenicity and Hemolysis were conducted for the INTEGRA Bilayer Matrix Wound Dressing product, in accordance with International Standard ISO 10993-1:1992, Biological evaluation of medical devices - Part I : Guidance on selection of tests and with Good Laboratory Practices. All test results were acceptable.
In addition to biocompatibility testing, the product is tested to meet the following performance characteristics. Pore size is determined using SEM and Image Analysis to provide a pre-determined functional pore size. In order to ensure that the native helical configuration of collagen is not significantly altered in the manufacturing process, the helical content in the collagen-glycosaminoglycan sponge is evaluated using Fourier Transform Infrared (FTIR) Spectrophotometry. Chondroitin-6-sulfate (C-6-S) is quantified using visible spectroscopy. The degree of cross-linking is determined using a colorimetric assay.
Conclusion: The results of the in vitro product characterization studies, performance testing and biocompatibility data demonstrate that INTEGRA Meshed Bilayer Wound Matrix is safe and substantially equivalent to its predicate device.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
N/A
0
February 26, 2020
Image /page/0/Picture/1 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health and Human Services logo on the left and the FDA logo on the right. The FDA logo is a blue square with the letters "FDA" in white, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue.
Integra Lifesciences Corp. Diana Bordon 311 Enterprise Dr. Plainsboro, New Jersey 08536
Re: K081635
Trade/Device Name: Integra Meshed Bilayer Wound Matrix Regulatory Class: Unclassified Product Code: KGN Dated: June 6, 2008 Received: June 11, 2008
Dear Diana Bordon:
This letter corrects our substantially equivalent letter of December 04, 2008.
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. 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 mediation-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
Indications for Use
510(k) Number (if known):
KO81635
Device Name:
INTEGRA™ Meshed Bilayer Wound Matrix
Indications For Use: INTEGRA™ Meshed Bilayer Wound Matrix 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 may be used in conjunction with negative pressure wound therapy. The device is intended for one-time use.
Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
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(Division Sign-Off) | |
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Division of General, Restorative, and Neurological Devices
| 510(k) Number | K081625 |
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3
510(k) Premarket Notification
Integra™ Meshed Bilayer Wound Matrix
Integra LifeSciences Corporation
510(K) SUMMARY
INTEGRA™ Meshed Bilayer Wound Matrix
DEC 0 4 2008
Submitter's name and address:
Integra LifeSciences Corporation 311 Enterprise Drive Plainsboro, NJ 08536 USA
Contact person and telephone number:
Diana Bordon Director, Regulatory Affairs Telephone: (609) 275-0500 (609) 275-9445 Fax:
Date Summary was prepared: June 4, 2008
Name of the device:
Proprietary Name: Common Name: Classification Name: Product Code:
INTEGRATM Meshed Bilayer Wound Matrix Wound Dressing Dressing, Wound, Drug FRO
Substantial Equivalence:
INTEGRA™ Meshed Bilayer Wound Matrix is substantially equivalent in function and intended use to INTEGRAM Bilayer Matrix Wound Dressing, which has been cleared to market under Premarket Notification 510(k) K021792.
Device Description:
INTEGRA™ Meshed Bilayer Wound Matrix is an advanced wound care device comprised of a porous matrix of cross-linked bovine tendon collagen and glycosaminonlycan with a polysiloxane (silicone) layer. The meshed bilayer matrix allows drainage of wound exudate and provides a flexible adherent covering for the wound surface. The collagen- glycosaminoglycan biodegradable matrix provides a scaffold for cellular invasion and capillary growth.
Intended Use:
INTEGRA™ Meshed Bilayer Wound Matrix 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, seconddegree burns, and skin tears) and draining wounds. May be used in conjunction with negative pressure wound therapy. The device is intended for one-time use.
4
Testing and Test Results:
INTEGRA™ Meshed Bilayer Wound Matrix and INTEGRA™ Bilayer Matrix Wound Dressing (K021792) are comprised of identical materials and are processed and sterilized by identical methods. Biocompatibility testing including Cytotoxicity. Dermal Sensitization, Irritation, Acute Systemic Toxicity, Pyrogenicity and Hemolysis were conducted for the INTEGRA Bilayer Matrix Wound Dressing product, in accordance with International Standard ISO 10993-1:1992, Biological evaluation of medical devices - Part I : Guidance on selection of tests and with Good Laboratory Practices. All test results were acceptable. These test results are applicable to the meshed product because, as noted above, the dressings are comprised of the same materials.
In addition to biocompatibility testing, the product is tested to meet the following performance characteristics. Pore size is determined using SEM and Image Analysis to provide a pre-determined functional pore size. In order to ensure that the native helical configuration of collagen is not significantly altered in the manufacturing process, the helical content in the collagen-glycosaminoglycan sponge is evaluated using Fourier Transform Infrared (FTIR) Spectrophotometry. Chondroitin-6-sulfate (C-6-S) is quantified using visible spectroscopy. The degree of cross-linking is determined using a colorimetric assay.
Conclusion
The results of the in vitro product characterization studies, performance testing and biocompatibility data demonstrate that INTEGRA Meshed Bilayer Wound Matrix is safe and substantially equivalent to its predicate device.