(150 days)
Not Found
No
The device description focuses on the material composition and physical properties of a collagen matrix for wound management. There is no mention of AI, ML, image processing, or any computational analysis of data. The performance studies are standard biocompatibility and material characteristic tests.
Yes
The device is intended for the management of wounds, which is a therapeutic purpose.
No
This device is a wound dressing material intended for the management and healing of wounds, not for diagnosis.
No
The device description clearly states it is a physical, biodegradable material composed of collagen, intended for wound dressing. It is a tangible product, not software.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for the management of various types of wounds. This is a therapeutic application, not a diagnostic one.
- Device Description: The device is described as a biodegradable material composed of collagen used as a wound dressing. This aligns with a therapeutic device, not a diagnostic one.
- Lack of Diagnostic Elements: There is no mention of the device being used to test samples from the human body (like blood, urine, tissue, etc.) to provide information about a disease or condition.
- Performance Studies: The performance studies focus on product characteristics and biocompatibility, which are relevant for a therapeutic device, not the analytical or clinical performance typically evaluated for an IVD.
IVD devices are specifically designed to perform tests on samples taken from the human body to diagnose, monitor, or screen for diseases or conditions. This device's function is to aid in wound healing, which is a therapeutic intervention.
N/A
Intended Use / Indications for Use
ologen™ Collagen Matrix is intended for the management of wounds including: surgical wounds, trauma wounds, second degree burns, partial and full-thickness wounds, pressure ulcers, venous ulcers, vascular ulcers, diabetic ulcers, oral wounds and sores.
Product codes (comma separated list FDA assigned to the subject device)
KGN
Device Description
ologen™ Collagen Matrix (K173223) proposed device has 9 models which differ in sizes and shapes but with the same composition. Different specifications are all intended for wound dressing. Which specification should be applied is determined by the physician according to the size, depth, location, type of wound and his/hers preference. The lists the specifications and shapes of all 9 models refer to Instruction for Use.
ologen™ Collagen Matrix is a biodegradable material composed of collagen. It is indicated for the management of wounds. ologen™ Collagen Matrix is obtained from porcine hide and the matrix structure has a porous configuration made of ≥90% cross-linked lyophilized porcine collagen and 90% collagen same as predicate device.
pH value test: The result showed that the device met our acceptance criterion of pH value 7.0±0.5.
Stability test: The results of both real time aging stability test showed that, there were no significant difference between samples, which were stored under 40 +2°C.
Biocompatibility tests & Animal Study: Pyrogen Test Collagen matrix, Implantation Study in Rabbits-Muscle-12 weeks Collagen Matrix, Hemolytic Properties Study Collagen Matrix, Cytotoxicity study for biocompatibility Collagen Matrix, Acute Systemic toxicity study in Mice Collagen Matrix, Skin sensitization Skin irritation (Intradermal reaction) Subchronic Systemic Toxicity.
Pyrogen test: Concluded that the proposed device was non-pyrogenic.
Implantation Study in Rabbits-Muscle-12 weeks: After 12-week of implantation, the device was degraded and the histopathological evaluation of the implantation site showed no irratation reaction was observed.
Hemolytic Properties Study: ologen™ Collagen Matrix extract had non-hemolytic potential in rabbit blood in vitro.
Cytotoxicity study: ologen™ Collagen Matrix had no cytotoxic effect on L929 cells under the testing condition employed.
Acute Systemic toxicity study: ologen™ Collagen Matrix had no significant evidences of systemic toxicity from the test article extracts into ICR mice.
Skin Sensitization Study: Collagen Matrix, was classified as a non-sensitizer.
Skin irritation (Intradermal reaction): Collagen Matrix, was classified as a non-irritative.
Subchronic Systemic Toxicity: The test sample exhibited no subchronic systemic toxicity.
Summary: Based on the Biocompatibility tests & Animal Study, the ologen™ Collagen Matrix was found to have a safety and effectiveness profile that is similar to the predicate device.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
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
Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo features the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.
March 2, 2018
Aeon Astron Europe B.V. Horng Lai C.E.O. J.H. Oortweg 19 Leiden, 2333 CH N1
Re: K173223 Trade/Device Name: ologen Collagen Matrix Regulatory Class: Unclassified Product Code: KGN Dated: January 25, 2018 Received: February 2, 2018
Dear Horng 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 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); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
1
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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
David Krause -S
for Binita S. Ashar, M.D., M.B.A., F.A.C.S. Director Division of Surgical Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K173223
Device Name
ologen™ Collagen Matrix
ologen™ Collagen Matrix is intended for the management of wounds including:
surgical wounds, trauma wounds, second degree burns, partial and full-thickness wounds, pressure ulcers, venous ulcers, vascular ulcers, diabetic ulcers, oral wounds and sores.
| 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) |
|---|---|
| ------------------------------------------------- | ------------------------------------------------------------------------------------------------------------------------ |
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510(k) Summary
Date Prepared: January, 29, 2018
The 510(k) owner
Aeon Astron Europe B.V. J.H. Oortweg 19, 2333 CH. Leiden, The Netherlands Contact Person: Horng Ji Lai, C.E.O. Tel: +31.71.332.2280 Fax: +31.71.332.2281 E-mail: michael.lai(@aeonastron.com
Device Information
Proprietary Name: ologen™ Collagen Matrix Common name: Wound dressing Classification Name: Dressing, wound, collagen Product Code: KGN Device Class: Unclassified Review Panel: General & plastic surgery 510(k) Number: K173223
Predicate Device
Proprietary Name: Aongen™ Collagen Matrix; ologen™ Collagen Matrix Common name: Wound dressing Classification Name: Dressing, wound, collagen Product Code: KGN Device Class: Unclassified Review Panel: General & plastic surgery 510(k) Number: K080868 510(k) Submitter: Aeon Astron Europe B.V.
Device Description
Device Identification:
ologen™ Collagen Matrix (K173223) proposed device has 9 models which differ in sizes and shapes but with the same composition. Different specifications are all intended for wound dressing. Which specification should be applied is determined by the physician according to the size, depth, location, type of wound and his/hers preference. The lists the specifications and shapes of all 9 models refer to Instruction for Use.
4
Device Characteristics
- single-use sterile
Environment of Use: healthcare facility/hospital
Description of the Device:
ologen™ Collagen Matrix is a biodegradable material composed of collagen. It is indicated for the management of wounds. ologen™ Collagen Matrix is obtained from porcine hide and the matrix structure has a porous configuration made of ≥90% cross-linked lyophilized porcine collagen and 90% collagen same as predicate device.
pH value test
pH value test was performed for semi-product inspection. The result showed that the device met our acceptance criterion of pH value 7.0±0.5. Please note that semi-product is the unsterilized final product.
Stability test
The stability test was performed by placing samples at real time aging stability temperature limitation storage conditions (40 + 2 °C). For the real time aging stability test, the quantity of samples was randomly withdrawn for inspection at 3 time points: 0, 6 and 36 months. The results of microstructure, optical, pH value, water absorption ratio and sterility tests were recorded to determine whether the acceptability criteria were met. The results of both real time aging stability test showed that, there were no significant difference between samples, which were stored under 40 +2°C.
Biocompatibility tests & Animal Study
Pyrogen Test Collagen matrix Implantation Study in Rabbits-Muscle-12 weeks Collagen Matrix Hemolytic Properties Study Collagen Matrix Cytotoxicity study for biocompatibility Collagen Matrix Acute Systemic toxicity study in Mice Collagen Matrix Skin sensitization Skin irritation (Intradermal reaction) Subchronic Systemic Toxicity
6
Pyrogen test Collagen matrix
The pyrogen test was performed in accordance with the USP35 – NF30 (2012), Biological Tests: PYROGEN TEST. Based on the finding of the test, it was concluded that the proposed device was non-pyrogenic.
Implantation Study in Rabbits-Muscle-12 weeks Collagen Matrix
This test was conducted in accordance with ISO 10993-6. After 12-week of implantation, the device was degraded and the histopathological evaluation of the implantation site showed no irratation reaction was observed.
Hemolytic Properties Study Collagen Matrix
This test was conducted in accordance with ISO 10993-4. ologen™ Collagen Matrix extract had non-hemolytic potential in rabbit blood in vitro.
Cytotoxicity study for biocompatibility Collagen Matrix
This test was conducted in accordance with ISO 10993-5. ologen™ Collagen Matrix had no cytotoxic effect on L929 cells under the testing condition employed.
Acute Systemic toxicity study in Mice Collagen Matrix
This test was conducted in accordance with ISO 10993-11. ologen™ Collagen Matrix had no significant evidences of systemic toxicity from the test article extracts into ICR mice. All data generated from this study will provide as safety information for human exposure.
Skin Sensitization Study Guinea Pig Maximization Test Collagen Matrix
This test was conducted in accordance with ISO 10993-10. The sensitization rate in each group was calculated and determined. Collagen Matrix, was classified as a non-sensitizer.
Skin irritation (Intradermal reaction)
This test was conducted in accordance with ISO 10993-10. The irritation rate in each group was calculated and determined. Collagen Matrix, was classified as a non-irritative.
Subchronic Systemic Toxicity
This test was conducted in accordance with ISO 10993-11. The test sample exhibited no subchronic systemic toxicity.
Summary
Based on the Biocompatibility tests & Animal Study, the ologen™ Collagen Matrix was found to have a safety and effectiveness profile that is similar to the predicate device.
Conclusions
The results of the product characterization studies and biocompatibility studies demonstrate that the ologen™ Collagen Matrix is substantially equivalent to the predicate devices.