AONGEN COLLAGEN MATRIX

K080868 · Aeon Astron Europe B.V. · KGN · May 14, 2009 · SU

Device Facts

• Record ID: K080868
• Device Name: AONGEN COLLAGEN MATRIX
• Applicant: Aeon Astron Europe B.V.
• Product Code: KGN · SU
• Decision Date: May 14, 2009
• Decision: SESE
• Submission Type: Traditional
• Device Class: Class U
• Attributes: Therapeutic

Intended 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

Device Story

Aongen™ Collagen Matrix is a sterile, single-use, biodegradable collagen-based wound dressing. It is applied topically to the wound site to assist in management. The device functions as a physical matrix to support wound healing. It is intended for use by healthcare professionals in clinical settings for various wound types, including ulcers and surgical sites. The device provides a scaffold for tissue repair, potentially benefiting patients by facilitating the healing process of chronic or acute wounds.

Clinical Evidence

Bench testing only. Biocompatibility testing was conducted in accordance with ISO 10993 requirements to evaluate safety. No clinical trial data was provided.

Technological Characteristics

Biodegradable collagen-based matrix. Supplied sterile for single-use. Biocompatibility meets ISO 10993 standards.

Indications for Use

Indicated for management of surgical, trauma, draining, partial/full-thickness wounds, second-degree burns, pressure, venous, vascular, and diabetic ulcers, and oral wounds/sores.

Predicate Devices

• ACell™ Powder Wound Dressing (K060888)
• Collagen Topical Wound Dressing (K030921)
• Collagen Topical Wound Dressing - Ora (K040403)

Submission Summary (Full Text)

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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 : [phone] Fax : [phone]

## 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 [phone]. 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 [phone]. 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 [phone] or [phone] 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

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