The Aongen™ Collagen Matrix is a biodegradable material composed of collagen. It is indicated for the management of wounds. The device is supplied sterile and for single use only.

AI/ML Overview

The provided document describes a medical device called "Aongen™ Collagen Matrix," which is a wound dressing. The document is a 510(k) summary, indicating the device underwent a premarket notification process for substantial equivalence to legally marketed predicate devices.

Here's an analysis of the acceptance criteria and the study as per your request:

1. Table of Acceptance Criteria and Reported Device Performance:

Assessment Area	Acceptance Criteria	Reported Device Performance
Biocompatibility	Meets the requirements of ISO 10993 (standard for biological evaluation of medical devices).	"The results of these tests demonstrate that the Aongen™ Collagen Matrix meets the requirements of ISO 10993."
Substantial Equivalence	Demonstrates equivalence to predicate devices (ACell™ Powder Wound Dressing, Collagen Topical Wound Dressing).	"The results of the product characterization studies and biocompatibility studies demonstrate that the Aongen™ Collagen Matrix is substantially equivalent to the predicate devices."

2. Sample Size Used for the Test Set and Data Provenance:

The document does not provide specific details on the sample size used for the biocompatibility tests or product characterization studies, nor does it specify the data provenance (e.g., country of origin, retrospective or prospective). It simply states that "Tests were conducted to evaluate the biocompatibility" and refers to "product characterization studies."

This type of information is typically detailed in the full 510(k) submission, which is not fully included here. The summary provided is high-level.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts:

This information is not applicable and not provided in this document. The device is a wound dressing, and the studies mentioned are laboratory-based (biocompatibility and product characterization), not clinical studies requiring expert interpretation of results to establish ground truth in the way it's done for diagnostic AI.

4. Adjudication Method for the Test Set:

This information is not applicable and not provided. As mentioned above, the studies are laboratory-based, not clinical studies involving human readers or interpretation of complex data that would require adjudication.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size:

No, an MRMC comparative effectiveness study was not done. This type of study is typically performed for diagnostic devices where human interpretation is a key component, often comparing human performance with and without AI assistance. The Aongen™ Collagen Matrix is a wound dressing, and its evaluation focused on material properties and biological compatibility.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done:

Not applicable. This device is a physical wound dressing, not an algorithm or software. Therefore, there is no "standalone" algorithm performance to evaluate.

7. The Type of Ground Truth Used:

For the biocompatibility studies, the "ground truth" was established by compliance with the ISO 10993 standard. This standard outlines a series of tests (e.g., cytotoxicity, sensitization, irritation) and their acceptance criteria to ensure a material is biologically safe for its intended use. The results of these tests, as interpreted against the ISO 10993 requirements, formed the ground truth for biocompatibility.

For the product characterization studies (implied by "substantial equivalence"), the ground truth would typically be established by comparing the physical, chemical, and performance characteristics of the Aongen™ Collagen Matrix to those of the predicate devices. This involves material testing to ensure similar properties and performance.

8. The Sample Size for the Training Set:

This information is not applicable as the device is a physical product (wound dressing) and not an AI or machine learning model that requires a training set.

9. How the Ground Truth for the Training Set Was Established:

This information is not applicable for the same reasons as point 8.

Summary

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K080868

page 1/2

510(k) Summary

Submitter Name and Address:

1 4 2009 MAY

Aeon Astron Europe B.V. Niels Bohrweg 11-13, 2333 CA Leiden, The Netherlands

Contact Person:

ﻌﻢ

Horng Ji Lai C.E.O. Tel : +31.71.332.2280 Fax : +31.71.332.2281

Date Prepared:

February 18, 2008

Device Information:

Proprietary Name:	Aongen™ Collagen Matrix
Common Name:	Wound dressing
Classification Name:	Dressing, wound, collagen
Product Code:	KGN
Device Class:	Unclassified
Review Panel:	General & plastic surgery

Predicate Device:

Predicate #1
Proprietary Name:	ACell™ Powder Wound Dressing
Common Name:	Topical Wound Dressing
Product Code:	KGN
510(k) Number:	K060888
510(k) Submitter:	ACell, Incorporated

Predicate #2

Proprietary Name:	To be determined
Common Name:	Collagen Topical Wound Dressing
Product Code:	KGN

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K050068

510(k) Number: K030921 510(k) Submitter: Collagen Matrix, Inc.

Predicate #3
Proprietary Name:	To be determined
Common Name:	Collagen Topical Wound Dressing - Ora
Product Code:	KGN
510(k) Number:	K040403
510(k) Submitter:	Collagen Matrix, Inc.

Device Description:

The Aongen™ Collagen Matrix is a biodegradable material composed of collagen. It is indicated for the management of wounds. The device is supplied sterile and for single use only.

Indications for Use:

The Aongen™ Collagen Matrix is intended for the management of wounds including:

. surgical wounds
trauma wounds .
draining wounds .
second degree burns .
partial and full-thickness wounds ●
pressure ulcers �
venous ulcers ●
vascular ulcers .
. diabetic ulcers
. oral wounds and sores

Summary of Tests:

Tests were conducted to evaluate the biocompatibility of the Aongen™ Collagen Matrix. The results of these tests demonstrate that the Aongen™ Collagen Matrix meets the requirements of ISO 10993.

Conclusion of Tests:

The results of the product characterization studies and biocompatibility studies demonstrate that the Aongen™ Collagen Matrix is substantially equivalent to the predicate devices.

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle or bird-like symbol on the right side. To the left of the symbol, the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the symbol.

MAY 14 2009

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Public Health Service

Acon Astron Europe B. V. % Horng Ji Lai C.E.O. Niels Bohrweg 11-13 Leiden 2333 CA The Netherlands

Re: K080868

Trade/Device Name: Aongen™ Collagen Matrix Regulatory Class: Unclassified Product Code: KGN Dated: April 27, 2009 Received: May 1, 2009

Dear Horng Ji Lai:

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.

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); 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 - Horng Ji Lai

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please contact the CDRH/Office of Surveillance and Biometrics/Division of Postmarket Surveillance at (240) 276-3464. For more information regarding the reporting of adverse events, please go to http://www.fda.gov/cdrl/mdr/.

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 yours,

Mark N. Milliman

Mark N. Melkerson Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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1080868

Indications for Use

510(k) Number (if known):

K080868

Device Name: Aongen™ Collagen Matrix

Indications for Use:

The Aongen™ Collagen Matrix is intended for the management of wounds including:

. surgical wounds
trauma wounds t
draining wounds .
. second degree burns
partial and full-thickness wounds .
. pressure ulcers
. venous ulcers
vascular ulcers .
. diabetic ulcers
oral wounds and sores .

Prescription Use X (Part 21 CFR 801 Subpart D)

AND/OR

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

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

Concurrence of CDRH, C

urrence of CDRH, Office of Device Evaluation (ODE)
Division of Surgical, Orthopedic,
and Restorative Devices

510(k) Number K080668

Pagc 4-1

Regulation Number and Section

N/A