INTEGRA™ Flowable Wound Matrix 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, skin tears) and draining wounds. The device is intended for one-time use.

Device Description

INTEGRA™ Flowable Wound Matrix is an advanced wound care device comprised of granulated cross-linked bovine tendon collagen and glycosaminoglycan. The granulated collagen-glycosaminoglycan is hydrated with saline and applied in difficult to access wound sites and tunneled wounds. It provides a scaffold for cellular invasion and capillary growth. INTEGRA™ Flowable Wound Matrix is supplied sterile, in single use kits containing one syringe with granular collagen, one empty sterile syringe, one luer lock connector, and one flexible injector.

AI/ML Overview

The provided text is a 510(k) Summary for the INTEGRA™ Flowable Wound Matrix. It does not contain information about acceptance criteria or a detailed study proving the device meets specific performance criteria beyond a general statement. This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than presenting detailed clinical trial results with predefined acceptance criteria.

Therefore, most of the requested information cannot be extracted from the given document.

Here's a breakdown of what can and cannot be answered:

1. Table of acceptance criteria and the reported device performance:

Cannot be provided. The document states, "Results of physical testing, biocompatibility studies and clinician evaluation have demonstrated the collagen-glycosaminoglycan matrix in INTEGRA Flowable Wound Matrix to be safe and effective for the management of wounds." However, it does not specify what the acceptance criteria were for "safe and effective" or present quantitative performance data against those criteria.

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

Cannot be provided. The document mentions "physical testing, biocompatibility studies and clinician evaluation" but does not detail the sample sizes for these tests or the data provenance (e.g., country of origin, retrospective/prospective).

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

Cannot be provided. The document does not describe the establishment of a "ground truth" using experts for a test set. The evaluation seems to be related to general clinician feedback, not a formal expert-adjudicated performance study.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:

Cannot be provided. No information on an adjudication method is present.

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:

Cannot be provided. This device is a wound matrix, not an AI-assisted diagnostic or imaging device. Therefore, an MRMC study or AI-related effectiveness is not applicable and not mentioned.

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

Cannot be provided. This device is a physical wound matrix, not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):

Cannot be provided. The document refers to "biocompatibility studies and clinician evaluation" for demonstrating safety and effectiveness, but it doesn't define a specific 'ground truth' as would be done in a diagnostic device study (e.g., using pathology as ground truth for a cancer detection device). In the context of a wound dressing, "safety and effectiveness" would likely be based on observations of wound healing, absence of adverse reactions, and clinician satisfaction, but no specific methodology for establishing ground truth is detailed.

8. The sample size for the training set:

Cannot be provided. The device is not an AI algorithm that requires a training set.

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

Cannot be provided. Not applicable as there is no training set for an AI algorithm.

Summary based on the provided text:

The document focuses on demonstrating substantial equivalence to predicate devices (INTEGRAIM Matrix Wound Dressing K022127 and Medifi® Particles K910944) for the INTEGRA™ Flowable Wound Matrix. The testing mentioned ("physical testing, biocompatibility studies and clinician evaluation") is cited as the basis for concluding the device is "safe and effective," but not as a study designed to meet specific, quantitatively defined acceptance criteria for performance as typically seen for diagnostic devices or more complex medical technologies. The 510(k) process often relies on demonstrating that a new device is as safe and effective as an already legally marketed one, rather than requiring extensive de novo performance studies against pre-defined metrics.

Summary

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K072113 Page 1/1

510(K) SUMMARY

INTEGRA™ Flowable Wound Matrix

OCT 1 0 2007

Submitter's name and address:

Integra LifeSciences Corporation 311 Enterprise Drive Plainsboro, NJ 08536 USA

Contact person and telephone number:

Diana Bordon Manager, Regulatory Affairs Telephone: (609) 275-0500 (609) 275-9445 Fax:

Date Summary was prepared:

July 27, 2007

Name of the device:

Proprietary Name:	INTEGRA™ Flowable Wound Matrix
Common Name:	Collagen Wound Dressing
Classification Name:	Not Classified
Product Code:	KGN

Substantial Equivalence:

INTEGRA™ Flowable Wound Matrix is substantially equivalent in function and intended use to INTEGRAIM Matrix Wound Dressing (K022127) and Medifi® Particles K910944.

Device Description:

INTEGRA™ Flowable Wound Matrix is an advanced wound care device comprised of granulated cross-linked bovine tendon collagen and glycosaminoglycan. The granulated collagenglycosaminoglycan is hydrated with saline and applied in difficult to access wound sites and tunneled wounds. It provides a scaffold for cellular invasion and capillary growth. INTEGRA™ Flowable Wound Matrix is supplied sterile, in single use kits containing one syringe with granular collagen, one empty sterile syringe, one luer lock connector, and one flexible injector.

Intended Use:

INTEGRATM Flowable Wound Matrix 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, seconddegree burns, skin tears) and draining wounds. The device is intended for one-time use.

Testing and Test Results:

Results of physical testing, biocompatibility studies and clinician evaluation have demonstrated the collagen-glycosaminoglycan matrix in INTEGRA Flowable Wound Matrix to be safe and effective for the management of wounds.

Conclusion:

INTEGRA Flowable Wound Matrix is safe and effective under the proposed conditions of use and substantially equivalent to its predicate devices.

Poy.

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Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" arranged around the circumference. Inside the circle is a stylized image of an eagle with its wings spread, depicted with three curved lines representing the wings and a simple representation of the head and body.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Integra LifeSciences Corporation % Ms. Diana M. Bordon Manager, Regulatory Affairs 311 Enterprise Drive Plainsboro, New Jersey 08536

OCT ] 0 2007

Re: K072113

Trade/Device Name: INTEGRA™ Flowable Wound Matrix Regulatory Class: Unclassified Product Code: KGN Dated: July 31, 2007 Received: August 1, 2007

Dear Ms. Bordon:

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.

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Page 2 - Ms. Diana M. Bordon

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), please contact the Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely vours Mark N. Melke

Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known):

INTEGRA™ Flowable Wound Matrix Device Name:

Indications For Use: INTEGRA™ Flowable Wound Matrix 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, skin tears) and draining wounds. The device is intended for one-time use.

Prescription Use X	AND/OR	Over-The-Counter Use ______
(Part 21 CFR 801 Subpart D)		(21 CFR 807 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

(Division Sign-Off)

Concurrence of CDH: Office of Device Evaluation (ODE)

Division of General, Restorative,

and Neurological Devices

510(k) Number	K072113
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Regulation Number and Section

N/A