(36 days)
Not Found
No
The device description and performance studies focus on the material properties and biocompatibility of a collagen wound dressing, with no mention of AI or ML.
Yes
The device is described as a wound dressing intended for the management of various types of wounds, indicating it is used to treat or alleviate a medical condition.
No
The device is a wound dressing, intended for the management of exudating wounds by creating a moist environment, which is a treatment rather than a diagnostic function.
No
The device description clearly states it is a "wound dressing device" made of "insoluble fibrous collagen," indicating it is a physical, material-based product, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the device is a wound dressing for the management of various types of wounds. This is a topical application for wound care, not a diagnostic test performed on samples taken from the body.
- Device Description: The description details a sterile, single-use wound dressing made of collagen. This aligns with a medical device used for wound management, not an IVD.
- Lack of IVD Characteristics: There is no mention of the device being used to test samples (like blood, urine, tissue, etc.) or to provide diagnostic information about a patient's health status.
IVDs are devices used to perform tests on specimens taken from the human body to provide information for the diagnosis, prevention, monitoring, treatment, or alleviation of disease. This device does not fit that description.
N/A
Intended Use / Indications for Use
CollaWound™ dressing will be used for the management of partial and full thickness wounds, pressure ulcers, venous ulcers, chronic vascular ulcers, diabetic ulcers, trauma wounds, first and second degree burns, surgical wounds and superficial injuries.
CollaWound™ dressing is intended for the management of partial and full-thickness exudating wounds including:
- Pressure ulcers
- Venous ulcers
- Vascular ulcers
- Diabetic ulcers
- Trauma wounds (abrasions, lacerations, skin tears)
- First and second degree burns
- Surgical wounds
Product codes (comma separated list FDA assigned to the subject device)
KGN, KME
Device Description
CollaWound™ dressing is a sterile, single use, disposable wound dressing device for the management of exudating wounds. It comprises insoluble fibrous collagen derived from porcine with white to off-white appearance, which forms a layer of thin film by maintaining a moist environment at the wound site.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
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)
The product characterization studies and biocompatibility studies show that the CollaWound™ dressing is safe and substantially equivalent to its predicate devices.
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.
K021637, K011026, K020732, K030921, K012990, K910944
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
Attachment 26
COLLAMATRIX Inc.
510(k) summary
-
- Date Prepared May 8, 2006
JUL - 5 2006
- Date Prepared May 8, 2006
2. Submitter name and address
Collamatrix Inc. 2nd floor, N360, RuiGuang Road, Neihu, Taipei, 114, Taiwan
3. Contact person
| Name: | Dennis J. N. Seah |
|---|---|
| Tel: | + 886 2 7720 9988 |
| Fax: | + 886 2 7720 9900 |
4. Device names
| Propriety name: | CollaWound™ dressing |
|---|---|
| Common name: | Wound dressing |
| Classification name: | Collagen wound dressing |
5. Device classification
Regulatory class: Product code:
| Unclassified |
|---|
| KGN |
| KME |
6. Device description
CollaWound™ dressing is a sterile, single use, disposable wound dressing device for the management of exudating wounds. It comprises insoluble fibrous collagen derived from porcine with white to off-white appearance, which forms a layer of thin film by maintaining a moist environment at the wound site.
7. Intended use
CollaWound™ dressing will be used for the management of partial and full thickness wounds, pressure ulcers, venous ulcers, chronic vascular ulcers, diabetic ulcers, trauma wounds, first and second degree burns, surgical wounds and superficial injuries.
1
K061474 Pag.
COLLAMATRIX Inc.
8. Statement of Substantial equivalence
CollaWound™ dressing is substantially equivalent in material, function, technological characteristics and intended use to predicate collagen-based devices that are previously approved by the agency: ACell UBM Lyophilized wound dressing (K021637), Fortaderm (K011026), SS Matrix (K020732), Collagen topical wound dressing (K030921), Collatek powder (K012990) and Medifil (K910944).
9. Safety
Biocompatibility tests have confirmed that CollaWound™dressing meets the requirements stated in ISO 10993/G95-1.
10. Conclusion
The product characterization studies and biocompatibility studies show that the CollaWound™ dressing is safe and substantially equivalent to its predicate devices.
2
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized caduceus symbol, which is a staff with two snakes coiled around it, and the words "DEPARTMENT OF HEALTH AND HUMAN SERVICES. U.S.A." arranged in a circle around the symbol. The caduceus is composed of three curved lines that resemble human profiles.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUL - 5 2006
Collamatrix Co., LTD. % Quality Assurance Mr. Dennis J. N. Seah, Manager 2nd Floor, No. 360 RuiGang Road NeiHu District Taipei China (Taiwan) 114
Re: K061474
Trade/Device Name: CollaWound™ dressing Regulation Class: Unclassified Product Code: KGN Dated: May 26, 2006 Received: May 30, 2006
Dear Mr. Seah:
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 (OS) regulation (21 CFR Part 820); and if applicable, the clectronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
3
Page 2 – Mr. Dennis J. N. Seah
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 rrumber (800) 638-2041 or (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Hulut Lemerno
Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
3 Statement of indications for use
510(k) Number (if known): KO60147
Device Name: CollaWound™ dressing
Indications for Use:
CollaWound™ dressing is intended for the management of partial and full-thickness exudating wounds including:
- Pressure ulcers
- Venous ulcers
- Vascular ulcers
- Diabetic ulcers
- Trauma wounds (abrasions, lacerations, skin tears)
- First and second degree burns
- Surgical wounds
| Prescription Use | X | AND/OR | Over-The-Counter Use | |
|---|---|---|---|---|
| (Part 21 CFR 801 Subpart D) | (21 CFR 801 Subpart C) |
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
(Division Sign-Off)
Division of General, Restorative, and Neurological Devices
Concurrence of CDRH, Office of Device Evaluation510(k) Number_Kc61474/