(176 days)
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.
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.
The provided text describes a 510(k) premarket notification for the Integra™ Meshed Bilayer Wound Matrix. This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than conducting new clinical trials to establish de novo safety and efficacy. Therefore, the information typically requested in your prompt regarding acceptance criteria, specific study designs (like MRMC or standalone algorithm studies), sample sizes for test and training sets, and ground truth establishment, is generally not present in a 510(k) summary focused on material and processing equivalence.
However, I can extract the relevant information from the provided document regarding substantial equivalence and performance testing for this type of device.
Here's an analysis based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Predicate Equivalence/Performance Characteristic) | Reported Device Performance (Integra™ Meshed Bilayer Wound Matrix) |
|---|---|
| Biocompatibility: | |
| Cytotoxicity | Acceptable (based on predicate testing) |
| Dermal Sensitization | Acceptable (based on predicate testing) |
| Irritation | Acceptable (based on predicate testing) |
| Acute Systemic Toxicity | Acceptable (based on predicate testing) |
| Pyrogenicity | Acceptable (based on predicate testing) |
| Hemolysis | Acceptable (based on predicate testing) |
| Product Characterization/Performance: | |
| Pore size (pre-determined functional pore size) | Determined using SEM and Image Analysis |
| Helical content of collagen | Evaluated using Fourier Transform Infrared (FTIR) Spectrophotometry |
| Chondroitin-6-sulfate (C-6-S) quantification | Quantified using visible spectroscopy |
| Degree of cross-linking | Determined using a colorimetric assay |
2. Sample Size Used for the Test Set and Data Provenance
The document does not detail a "test set" in the context of clinical performance data for the Integra™ Meshed Bilayer Wound Matrix. The primary demonstration is that it is comprised of identical materials and processed and sterilized by identical methods as its predicate device (Integra™ Bilayer Matrix Wound Dressing, K021792).
The biocompatibility testing was performed on the predicate device (Integra™ Bilayer Matrix Wound Dressing) in accordance with International Standard ISO 10993-1:1992 and Good Laboratory Practices. The document implies the "data provenance" for these biocompatibility tests would be the lab that conducted them, likely in the country where Integra LifeSciences Corp. operates (USA, given the FDA submission). This was a retrospective application of predicate data to the new device.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
Not applicable. This type of 510(k) submission does not typically involve expert review of a "test set" in the sense of clinical images or patient outcomes for ground truth establishment. The ground truth for biocompatibility is established by standardized, objective laboratory tests.
4. Adjudication Method for the Test Set
Not applicable. There was no clinical "test set" requiring adjudication by experts.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size of How Much Human Readers Improve with AI vs. Without AI Assistance
Not applicable. This device is a wound matrix, not an AI-powered diagnostic or assistive tool. MRMC studies are not relevant to this type of medical device submission.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
Not applicable. This device is a physical wound matrix, not an algorithm.
7. The Type of Ground Truth Used
- For Biocompatibility: The "ground truth" was established by standardized laboratory test results against established biological safety guidelines (ISO 10993-1:1992) for cytotoxicity, dermal sensitization, irritation, acute systemic toxicity, pyrogenicity, and hemolysis.
- For Product Characterization: The "ground truth" for characteristics like pore size, helical content of collagen, C-6-S quantification, and degree of cross-linking was based on objective measurement techniques (SEM, Image Analysis, FTIR, visible spectroscopy, colorimetric assay) against internal specifications or established material properties.
8. The Sample Size for the Training Set
Not applicable. This device is not an AI algorithm. There is no concept of a "training set" in this context.
9. How the Ground Truth for the Training Set Was Established
Not applicable. As there is no training set, there is no ground truth for a training set to establish.
Summary of the Study:
The "study" described for the Integra™ Meshed Bilayer Wound Matrix is primarily a comparative study for substantial equivalence to a predicate device (INTEGRA™ Bilayer Matrix Wound Dressing, K021792). The key findings are:
- The new meshed device uses identical materials and undergoes identical processing and sterilization methods as the cleared predicate device.
- Biocompatibility data for the predicate device, performed according to ISO 10993-1:1992 and Good Laboratory Practices, were found to be acceptable and are considered applicable to the new meshed product due to material and process identity.
- In vitro product characterization studies were performed on the new device (e.g., pore size, collagen helical content, C-6-S quantification, cross-linking degree) to confirm its physical and chemical properties.
The conclusion is that based on the in vitro product characterization studies, performance testing, and biocompatibility data (from the predicate), the Integra™ Meshed Bilayer Wound Matrix is safe and substantially equivalent to its predicate device. This demonstrates that the new device meets the regulatory acceptance criteria for substantial equivalence, which is the primary "acceptance criterion" for a 510(k) submission.
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February 26, 2020
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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
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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
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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)
| (Division Sign-Off) | ||
|---|---|---|
| -- | --------------------------------------------------------- | -- |
Division of General, Restorative, and Neurological Devices
| 510(k) Number | K081625 |
|---|---|
| --------------- | --------- |
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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.
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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.
N/A