INTEGRA® Wound Matrix (Macro-Channels) is indicated for the management of wounds including: partial and full-thickness wounds, pressure 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, partial thickness burns, skin tears) and draining wounds. The device is intended for one-time use.

Device Description

INTEGRA® Wound Matrix (Macro-Channels) is a collagen-glycosaminoglycan wound dressing that maintains and supports a healing environment for wound management. INTEGRA® Wound Matrix (Macro-Channels) has macro-channels to facilitate drainage of wound exudate. INTEGRA® Wound Matrix (Macro-Channels) is supplied sterile and is intended for one-time use.

AI/ML Overview

The provided text is a 510(k) Pre-market Notification document for a medical device called INTEGRA® Wound Matrix (Macro-Channels). This document focuses on demonstrating substantial equivalence to a predicate device, rather than providing a detailed study of the device's performance against specific acceptance criteria in a clinical setting in the way an AI/ML device study might.

Since this document is not for an AI/ML device, the typical metrics and study designs (like MRMC studies, standalone algorithm performance, number of experts for ground truth, sample size of a test set, etc.) are not applicable here. The device is a collagen wound dressing, meaning its evaluation relies on material properties, biocompatibility, and animal models, rather than diagnostic accuracy or human interpretation of outputs.

However, I can extract the information relevant to its acceptance criteria and the studies performed to demonstrate equivalence:

1. Table of Acceptance Criteria and Reported Device Performance:

The document doesn't present a table of specific acceptance criteria in the sense of predefined thresholds for clinical outcomes (e.g., wound closure rate) for the subject device. Instead, it focuses on demonstrating that the technological characteristics of the subject device are substantially equivalent to the predicate device, and that its performance meets general scientific and safety standards.

Here's a breakdown of the key characteristics and findings:

Characteristic/Test	Acceptance Criteria (Implied by Predicate Equivalence)	Reported Device Performance (Subject Device)
Composition	Type I Bovine Collagen - glycosaminoglycan matrix	Type I Bovine Collagen - glycosaminoglycan matrix (Identical to predicate)
Form	Sheet	Sheet (Identical to predicate)
Perforations	No (Predicate)	Yes (Subject device modification: Macro-channels to facilitate drainage)
Dimensions	2"x2", 4"x5", 4"x10", 8"x10"	2"x2", 4"x5", 4"x10", 8"x10" (Identical to predicate)
Resistance to collagenase Digestion	Optical Density Less than 0.800 absorbance unit	Optical Density Less than 0.800 absorbance unit (Matches predicate)
Endotoxin	Must be Less than 20 EU/device	Must be Less than 20 EU/device (Matches predicate)
Biocompatibility	Passes ISO 10993 tests (Cytotoxicity, Dermal Irritation, Dermal Sensitization, Acute Systemic Toxicity, Hemolysis, Sub-chronic (sub-acute) Toxicity, Genotoxicity)	Biocompatibility testing on predicate leveraged; additional chemical analysis for new manufacturing step. Passes ISO 10993 tests for cytotoxicity. (Deemed acceptable based on predicate data and additional assessment).
Anatomical Location	Wounds	Wounds (Identical to predicate)
Thickness	Approximately 0.8mm	Approximately 0.8mm (Identical to predicate)
Sterility	e-beam irradiation, 10-6 SAL, single-use only	e-beam irradiation, 10-6 SAL, single-use only (Identical to predicate)
Pore size	Not explicitly stated for predicate in table, but listed as a tested parameter for subject device	Tested to ensure specifications are met (Specific values not provided in this summary).
Collagen nativity-FTIR test of denaturing	Not explicitly stated for predicate in table, but listed as a tested parameter for subject device	Tested to ensure specifications are met (Specific values not provided in this summary).
Chondroitin-6-sulfate content	Not explicitly stated for predicate in table, but listed as a tested parameter for subject device	Tested to ensure specifications are met (Specific values not provided in this summary).
Permeability	Not explicitly stated for predicate in table, but listed as a tested parameter for subject device	Tested to ensure specifications are met (Specific values not provided in this summary).
Drapeability	Not explicitly stated for predicate in table, but listed as a tested parameter for subject device	Tested to ensure specifications are met (Specific values not provided in this summary).
Degree of cross-linking	Not explicitly stated for predicate in table, but listed as a tested parameter for subject device	Tested to ensure specifications are met (Specific values not provided in this summary).
In Vivo Safety & Effectiveness	Equivalent healing to predicate device	No significant differences in healing between the predicate and modified devices in a porcine wound healing model.

2. Sample size used for the test set and the data provenance:

Test Set Sample Size: Not specified for any of the individual tests. For the in vivo study, a "porcine wound healing model" was used, but the number of animals or wounds is not mentioned.
Data Provenance: The biocompatibility data was leveraged from the predicate device (K022127). The in vivo study was conducted, likely by the manufacturer, but country of origin is not specified. The studies are retrospective in the sense that existing data from the predicate device was largely used, and any new tests (like the in vivo porcine study) would be considered prospective for the subject device.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

Not Applicable. This is not a diagnostic device that requires expert interpretation for ground truth. The evaluation is based on material science, chemical analysis, and animal model outcomes.

4. Adjudication method for the test set:

Not Applicable. No human adjudication of results in the context of interpretation of diagnostic outputs. Results are from laboratory tests and an animal study.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:

Not Applicable. This is not an AI/ML device, nor does it involve human readers or comparative effectiveness in that sense.

6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:

Not Applicable. This is not an AI/ML algorithm.

7. The type of ground truth used:

Laboratory Measurements & Animal Study Outcomes:
- Compositional analysis: Used to confirm material identity.
- Physical property measurements: (e.g., pore size, thickness, resistance to collagenase, endotoxin levels).
- Biocompatibility test results: Against ISO 10993 standards.
- Histopathological & clinical observations from porcine wound healing model: To assess safety and effectiveness in wound healing.

8. The sample size for the training set:

Not Applicable. This is not an AI/ML device that requires a training set.

9. How the ground truth for the training set was established:

Not Applicable. As there is no training set.

Summary

{0}------------------------------------------------

Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

October 8, 2021

Integra LifeSciences Corporation Nicole Kotter Manager, Regulatory Affairs 1100 Campus Road Princeton, New Jersey 08540

Re: K210128

Trade/Device Name: INTEGRA Wound Matrix (Macro-Channels) Regulatory Class: Unclassified Product Code: KGN Dated: January 15, 2021 Received: January 19, 2021

Dear Nicole Kotter:

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 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for

{1}------------------------------------------------

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,

Lixin Liu. Ph.D. Acting 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

Enclosure

{2}------------------------------------------------

Indications for Use

510(k) Number (if known)

K210128

Device Name

INTEGRA® Wound Matrix (Macro-Channels)

Indications for Use (Describe)

Type of Use (Select one or both, as applicable)

Prescription Use (Part 21 CFR 801 Subpart D)	Over-The-Counter Use (21 CFR 801 Subpart C)
------------------------------------------------------------	-----------------------------------------------------------

CONTINUE ON A SEPARATE PAGE IF NEEDED.

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."

{3}------------------------------------------------

510(K) SUMMARY

INTEGRA® Wound Matrix (Macro-Channels)

I. SUBMITTER

Submitter's name and address: Integra LifeSciences Corporation 1100 Campus Rd, Princeton, NJ 08540 USA

Contact person and telephone number: Saakshi Arora-Tice Specialist. Regulatory Affairs Telephone: 609.325.7374

Date Summary was prepared: January 14, 2021

II. DEVICE

Name of the device:	INTEGRA® Wound Matrix (Macro-Channels)
Common Name:	Collagen Wound Dressing
Classification Name:	Not Classified
Regulatory Class:	Unclassified
Product Code:	KGN

III. PREDICATE DEVICE

INTEGRA® Wound Matrix (Macro-Channels) is substantially equivalent in technological characteristics and intended use to the predicate device detailed in the following table.

510(k) Number	Product Code	Trade Name	Manufacturer
K022127	KGN	INTEGRA® WoundMatrix (also known asIntegra Matrix WoundDressing)	Integra LifeSciencesCorporation

The specific trade name AVAGEN Wound Dressing was cleared through 510(k) K022127 on September 10, 2002. Prior to official market release of AVAGEN Wound Dressing (K022127), Integra changed the product name from AVAGEN Wound Dressing to INTEGRA Matrix Wound Dressing in an effort to market a more uniform product family to consumers. The product name change from INTEGRA Matrix Wound Dressing to INTEGRA Wound Matrix was reflected in our INTEGRA Wound Matrix (Thin) 510(k) K113104 on February 9, 2012.

{4}------------------------------------------------

IV. DEVICE DESCRIPTION

V. INDICATIONS FOR USE

INTEGRA® Wound Matrix (Macro-Channels) is indicated for the management of wounds including: partial and full-thickness wounds, pressure ulcers, diabetic ulcers, chronic vascular ulcers, tunneled/undermined wounds (donor sites/grafts, post-Moh's surgery, post-laser surgery, podiatric, wound dehiscence), trauma wounds (abrasions, lacerations, partial thickness burns, skin tears) and draining wounds. The device is intended for one-time use.

VI. COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE PREDICATE DEVICE

Substantial Equivalence Comparison:

INTEGRA® Wound Matrix (Macro-Channels) is substantially equivalent in technological characteristics and intended use to the predicate device, which has been cleared under Premarket Notification 510(k) K022127. The modified device, INTEGRA® Wound Matrix (Macro-Channels), utilizes identical manufacturing processes, packaging, and sterilization as the predicate device (K022127) except for an additional process step to introduce the presence of macro-channels (small holes) in the proposed device to facilitate fluid drainage through the device post-application. Further, the following technological characteristics, e.g., pore size, collagennativity, extent of collagen cross-linking, and glycosaminoglycan content, are identical between INTEGRA® Wound Matrix (Macro-Channels) and the predicate device INTEGRA® Wound Matrix (K022127). The table below provides a comparison between the predicate and subject device.

Product Name	INTEGRA® Wound Matrix(predicate device)	INTEGRA® Wound Matrix(Macro-Channels)(subject device)
510(k) Number	K022127	K210128
Product Code	KGN	KGN
Indications for Use	INTEGRA® Wound Matrix isindicated for the managementof wounds including: partialand full-thickness wounds,pressure ulcers, venousulcers, diabetic ulcers,chronic vascular ulcers,tunneled/underminedwounds, surgical wounds(donor sites/grafts, post-Moh's surgery, post-laser	INTEGRA® Wound Matrix(Macro-Channels) isindicated for the managementof wounds including: partialand full-thickness wounds,pressure ulcers, venousulcers, diabetic ulcers,chronic vascular ulcers,tunneled/underminedwounds, surgical wounds(donor sites/grafts, post-Moh's surgery, post-laser
	surgery, podiatric, wounddehiscence), trauma wounds(abrasions, lacerations,second-degree burns, skintears) and draining wounds.The device is intended forone-time use.	Moh's surgery, post-lasersurgery, podiatric, wounddehiscence), trauma wounds(abrasions, lacerations, partialthickness burns, skin tears)and draining wounds. Thedevice is intended for one-time use.
Design
Physical Structure/Materials	Type I Bovine Collagen -glycosaminoglycan matrix	Type I Bovine Collagen -glycosaminoglycan matrix
Form	Sheet	Sheet
Perforations	No	Yes
Characteristics
Dimensions	2"x2" (5 cm x 5cm)4"x5" (10 cm x 12.5 cm)4"x10" (10 cm x 25 cm)8"x10" (20 cm x 25 cm)	2"x2" (5 cm x 5cm)4"x5" (10 cm x 12.5 cm)4"x10" (10 cm x 25 cm)8"x10" (20 cm x 25 cm)
Resistance to collagenaseDigestion	Optical Density Less than0.800 absorbance unit	Optical Density Less than0.800 absorbance unit
Endotoxin	Must be Less than 20EU/device	Must be Less than 20EU/device
Biocompatibility	Passes panel of ISO 10993tests: Cytotoxicity, DermalIrritation, DermalSensitization, Acute SystemicToxicity, Hemolysis, Sub-chronic (sub-acute) Toxicity,Genotoxicity	Biocompatibility testingcompleted on INTEGRA®Wound Matrix was leveragedto support INTEGRA®Wound Matrix (Macro-Channels). Passes ISO 10993tests for cytotoxicity.
Anatomical Location	Wounds	Wounds
Thickness	Approximately 0.8mm	Approximately 0.8mm
Sterility	e-beam irradiation, 10-6 SAL,single-use only	e-beam irradiation, 10-6 SAL,single-use only

{5}------------------------------------------------

VII. PERFORMANCE DATA:

INTEGRA® Wound Matrix (Macro-Channels) and INTEGRA® Wound Matrix (K022127) are comprised of identical materials and are processed and sterilized by similar methods.

Biocompatibility testing, including Cytotoxicity, Dermal Sensitization, Irritation, Acute Systemic Toxicity, Subchronic toxicity, Implantation, Genotoxicity, and Hemocompatibility tests, were conducted for the predicate device INTEGRA® Wound Matrix (K022127). All test results were acceptable. Due to the equivalent nature of the device composition, the biocompatibility testing completed on the INTEGRA® Wound Matrix (K022127) was leveraged to support the proposed device INTEGRA® Wound Matrix (Macro-Channels). In addition, the added manufacturing

{6}------------------------------------------------

process step was considered during the risk assessment for biocompatibility evaluations of the subject device, and the knowledge gaps were addressed through chemical analysis of manufacturing aids used during the process.

The proposed device is tested to ensure the following performance specifications are met: pore size, collagen nativity-FTIR test of denaturing, chondroitin-6-sulfate content, permeability, drapeability, degree of cross-linking, and bacterial endotoxin. In addition to bench performance tests, the in vivo safety and effectiveness of the INTEGRA® Wound Matrix (Macro-Channels) was assessed in a porcine wound healing model. The results of the study demonstrate that there are no significant differences in healing between the predicate and modified devices. Furthermore, the safe history of clinical use of similar collagen products, including the predicate device, manufactured, and marketed by Integra LifeSciences Corporation has been cited in this 510(k) Premarket Notification.

Conclusion:

The proposed INTEGRA® Wound Matrix (Macro-Channels) is substantially equivalent to the commercially marketed device, INTEGRA® Wound Matrix (K022127).

The modifications expressed in this 510(k) Premarket Notification do not change the intended use or fundamental scientific technology of the device and do not raise different questions of safety or effectiveness.

Regulation Number and Section

N/A