(412 days)
No
The device description and performance studies focus on the material properties and biocompatibility of a collagen matrix, with no mention of AI or ML technologies.
Yes
The device is intended for the management of various wounds, which falls under the definition of a therapeutic purpose.
No
The device is described as a "biodegradable material composed of collagen" intended for wound management, which is a therapeutic function, not a diagnostic one. There is no indication of it being used to identify or analyze a medical condition.
No
The device description clearly states it is a "biodegradable material composed of collagen," indicating a physical, non-software component.
Based on the provided information, the Aongen™ Collagen Matrix is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the device is for the "management of wounds." This involves direct application to the wound for healing purposes.
- Device Description: The description confirms it's a "biodegradable material composed of collagen" for wound management.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens derived from the human body (like blood, urine, tissue samples, etc.) to provide information for diagnosis, monitoring, or screening. IVDs typically involve testing these types of samples.
The Aongen™ Collagen Matrix falls under the category of a wound dressing or wound management device, which is a different type of medical device than an IVD.
N/A
Intended Use / 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 .
Product codes
KGN
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Wounds (surgical, trauma, draining, second degree burns, partial and full-thickness, pressure ulcers, venous ulcers, vascular ulcers, diabetic ulcers, oral wounds and sores)
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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.
The results of the product characterization studies and biocompatibility studies demonstrate that the Aongen™ Collagen Matrix is substantially equivalent to the predicate devices.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
N/A
0
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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 |
1
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.
2
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.
3
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
4
1080868
Indications for Use
510(k) Number (if known):
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