(246 days)
Not Found
Not Found
No
The summary describes a collagen-based hydrogel for wound management and does not mention any computational or analytical capabilities, let alone AI/ML.
Yes
The device is intended for the management of wounds and burns, which are therapeutic applications.
No
CollaWound™ Hydrogel is intended for wound management and treatment, not for diagnosing medical conditions.
No
The device description clearly states it is a "collagen-based emulsion/liquid formulation," which is a physical substance, not software.
Based on the provided information, 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 description states it's a collagen-based formulation for wound management. This aligns with a therapeutic device, not a diagnostic one.
- Lack of Diagnostic Elements: There is no mention of analyzing samples from the human body (like blood, urine, tissue) to provide information about a disease or condition. IVDs are designed for this purpose.
- Focus on Wound Management: The entire description revolves around treating and managing wounds, which is a direct interaction with the patient's body for therapeutic benefit.
Therefore, CollaWound™ Hydrogel is a therapeutic medical device, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
CollaWound™ Hydrogel is intended for the management of:
- Partial and full thickness wounds
- Pressure ulcers, diabetic ulcers, venous ulcers
- Surgical wounds
- First and second degree burns
- Superficial injuries, cuts, abrasions
Product codes (comma separated list FDA assigned to the subject device)
MGQ PRO, FRO
Device Description
CollaWound™ Hydrogel is a collagen-based emulsion/liquid formulation comprising collagen derived from porcine hides. It is intended for the management of partial and full thickness wounds, pressure ulcers, diabetic ulcers, venous ulcers, surgical wounds, first and second degree burns, superficial injuries, cuts and abrasions.
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™ Hydrogel is safe and substantially equivalent to its 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.
Not Found
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 2
page 1/2
COLLAMATRIX Inc.
510(k) summary
1. Date Prepared
January 28, 2008
J
2. Submitter name and address
Collamatrix Inc. 26th F, 105, section 2, DunHua South Road, Da-an District, Taipei, 106, Taiwan
3. Contact person
| Name: | Dennis J. N. Seah |
|---|---|
| Tel: | + 886 2 7711 3299 |
| Fax: | + 886 2 7711 3599 |
4. Device names
| Propriety name: | CollaWound™ Hydrogel |
|---|---|
| Common name: | Collagen hydrogel wound dressing |
| Classification name: | Dressing, wound and burn, hydrogel w/drug and/or biologic |
5. Device classification_
| Regulatory class: | Unclassified |
|---|---|
| Product code: | MGQ PRO |
6. Device description
CollaWound™ Hydrogel is a collagen-based emulsion/liquid formulation comprising collagen derived from porcine hides. It is intended for the management of partial and full thickness wounds, pressure ulcers, diabetic ulcers, venous ulcers, surgical wounds, first and second degree burns, superficial injuries, cuts and abrasions.
7. Intended use
CollaWound™ Hydrogel is intended for the management of partial and full thickness wounds, pressure ulcers, diabetic ulcers, venous ulcers, surgical wounds, first and second degree burns, superficial injuries, cuts and abrasions.
1
K071557
page 2/2
COLLAMATRIX Inc.
8. Statement of Substantial equivalence
CollaWound™ Hydrogel is substantially equivalent in material, function, technological characteristics and intended use to its predicate.
9. Safety
Biocompatibility tests have confirmed that CollaWound™ Hydrogel meets the requirements stated in ISO 10993/G95-1.
10. Conclusion
The product characterization studies and biocompatibility studies show that the CollaWound™ Hydrogel is safe and substantially equivalent to its predicate device.
2
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized caduceus symbol, which is a staff with two snakes coiled around it, representing medicine and healing. The symbol is positioned to the right of the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA", which is arranged in a circular pattern around the symbol.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
FEB -8 2008
Collamatrix Co., Inc. % Mr. Dennis J.N. Seah Quality Assurance No. 360 Ruiguang Road, 2nd Floor Neihu District, Taipei Taiwan
Re: K071557 Trade/Device Name: Collawound Hydrogel Regulatory Class: Unclassified Product Code: FRO Dated: February 3, 2008 Received: February 5, 2008
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.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 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 postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at (240) 276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at (240) 276-3464. 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 vours.
Mark N Millman
Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Attachment 7
K07-1557
3 Statement of indications for use
CollaWound™ Hydrogel is intended for the management of:
- . Partial and full thickness wounds
- Pressure ulcers, diabetic ulcers, venous ulcers
- Surgical wounds
- First and second degree burns
- Superficial injuries, cuts, abrasions ●
| 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 of Device Evaluation (ODE)
| 510(k) Number | K071557 |
|---|---|
| 3-1 | |
| 2/7/08 |