(246 days)
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.
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.
The provided text describes a 510(k) submission for a wound dressing called CollaWound™ Hydrogel. It focuses on demonstrating substantial equivalence to a predicate device and safety through biocompatibility testing. The document does not describe a study involving a "device" in the context of an AI/ML algorithm or software that would have performance metrics like accuracy, sensitivity, or specificity. Therefore, many of the requested elements for describing an AI study are not applicable to this submission.
Here's a breakdown based on the information available:
1. A table of acceptance criteria and the reported device performance
This information is not applicable as the submission is for a material-based wound dressing, not a software or AI device with performance metrics. The "acceptance criteria" here relate to meeting biocompatibility standards and demonstrating substantial equivalence.
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Meets Biocompatibility Requirements (ISO 10993/G95-1) | "Biocompatibility tests have confirmed that CollaWound™ Hydrogel meets the requirements stated in ISO 10993/G95-1." |
| Substantial Equivalence to Predicate Device | "CollaWound™ Hydrogel is substantially equivalent in material, function, technological characteristics and intended use to its predicate." |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
Not applicable. This is not an AI/ML algorithm study. The "testing" involved biocompatibility tests on the material itself.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
Not applicable.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
Not applicable.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
Not applicable. For biocompatibility, the "ground truth" is adherence to established international standards (ISO 10993/G95-1).
8. The sample size for the training set
Not applicable.
9. How the ground truth for the training set was established
Not applicable.
Summary of the Study:
The "study" described in the 510(k) summary for CollaWound™ Hydrogel primarily consists of biocompatibility testing to ensure the material is safe for its intended use, and a comparison to a legally marketed predicate device to demonstrate substantial equivalence.
- Biocompatibility Study: The submission confirms that CollaWound™ Hydrogel underwent biocompatibility tests that met the requirements of ISO 10993/G95-1. This ensures the device material does not cause adverse biological reactions when in contact with the body. Details about the specific tests performed (e.g., cytotoxicity, sensitization, irritation, etc.), the number of samples, or the outcome of individual tests are not provided in this summary.
- Substantial Equivalence Study: The core of a 510(k) submission is to demonstrate that the new device is as safe and effective as a legally marketed predicate device. The submission states that CollaWound™ Hydrogel is "substantially equivalent in material, function, technological characteristics and intended use to its predicate." The specific predicate device is not named in the provided text, but the claim of equivalence is a key finding for the FDA's approval. This often involves comparing device specifications, materials, manufacturing processes, intended uses, and any performance data if relevant.
In conclusion, the provided documentation focuses on the safety and equivalence of a physical wound dressing material, not on the performance of a digital or AI-driven diagnostic or treatment device. Therefore, the questions related to AI/ML study design are not relevant to this specific FDA submission.
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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.
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K071557
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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.
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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.
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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
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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 |
N/A