(32 days)
Not Found
Not Found
No
The summary describes a collagen-based wound dressing and does not mention any AI or ML components or functionalities.
Yes
The device is intended for the management of various types of exudating wounds, implying it is used to treat or alleviate a medical condition.
No
The device is a wound dressing designed to manage exudating wounds by maintaining a moist environment. Its intended use and device description do not indicate any diagnostic capabilities, such as detecting, monitoring, or predicting medical conditions.
No
The device description clearly states it is a "wound dressing device" comprising collagen, indicating it is a physical, material-based product, not software.
Based on the provided information, the CollaWound™ dressing is not an IVD (In Vitro Diagnostic).
Here's why:
- IVDs are used to examine specimens from the human body. They are used to diagnose diseases, conditions, or to monitor health. Examples include blood tests, urine tests, and genetic tests.
- The CollaWound™ dressing is a wound dressing. Its intended use is for the management of wounds by providing a moist environment and potentially aiding in healing. It is applied directly to the wound site on the body.
The description clearly indicates it's a topical wound dressing and does not involve the examination of specimens from the body for diagnostic purposes.
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
KGN
Device Description
CollaWound™ dressing is a sterile, single use, disposable wound dressing device for the management of exudating wounds. It comprises collagen derived from porcine, which forms a layer of thin film to maintain 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 device.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Not Found
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
N/A
0
Attachment 9
COLLAMATRIX Inc.
1/2
510(k) summary
1. Date Prepared Jan 18, 2007
Submitter name and address 2.
MAR 0 2 2007
Collamatrix Inc. 2nd F, 360, 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 |
ડ. Device classification
Regulatory class: Product code:
Class II unelassified
KGN
6. Device description
CollaWound™ dressing is a sterile, single use, disposable wound dressing device for the management of exudating wounds. It comprises collagen derived from porcine, which forms a layer of thin film to maintain 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
KC70269
2/2
COLLAMATRIX Inc.
8. Statement of Substantial equivalence
CollaWound™ dressing is substantially equivalent in material, function, technological characteristics and intended use to its predicate.
9. Safety
Biocompatibility tests have confirmed that CollaWound™ dressing meets the reguirements 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 device.
2
DEPARTMENT OF HEALTH & HUMAN SERVICES
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 with three stripes forming its body and wing. The eagle faces left. Encircling the eagle is the text "DEPARTMENT OF HEALTH & HUMAN SERVICES. USA" in a circular arrangement.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Collamatrix Co., Inc. % Mr. Dennis J. Seah Manager 2nd F, 360, RuiGuang Road Neihu, Taipei, 114, Taiwan
MAR 0 2 2007
Re: K070269
Trade/Device Name: CollaWound™ dressing Regulatory Class: Unclassified Product Code: KGN Dated: January 19, 2007 Received: January 31, 2007
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 (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 - Mr. Dennis J. 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 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 M. Milkezon
Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
K07-0369
3 Statement of indications for use
510(k) Number (if known): .
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
Mark A. Milkersen
Division Sign-Off Division of General, Restorative, and Neurological Devices
510(k) Number K070269
X Prescription Use_ (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 OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)