(232 days)
CollaWound ART is a wound dressing intended for use as a barrier to resist microbial colonization within the dressing and reduce microbial penetration through the dressing. CollaWound ART is intended for the management of wounds including:
- partial and full thickness wounds .
- pressure ulcers .
- venous ulcers .
- diabetic ulcers .
- . chronic vascular ulcers
- tunneled/undermined wounds .
- surgical wounds (donor sites/grafts, post-Moh's surgery, post-laser surgery, . wound dehiscence)
- trauma wounds (abrasions, lacerations, second-degree burns, and skin tears) .
- draining wounds .
CollaWound ART is a wound dressing comprised of collagen and polyhexamethylene biguanide (PHMB). The collagen is prepared from pig skin. CollaWound ART absorbs wound exudates and forms gel-like structure that maintains a moist microenvironment at the wound bed and aids in granulation tissue formation and re-epithelialization. The dressing acts as a protective barrier to the invasion of foreign microorganisms. The PHMB content is intended to reduce or prevent microbial colonization or growth on the device.
Here's an analysis of the provided 510(k) summary regarding the CollaWound ART device, focusing on acceptance criteria and the supporting study, structured as requested:
Device: CollaWound ART (Antimicrobial wound dressing)
Acceptance Criteria and Device Performance:
The provided document describes biocompatibility tests and an antimicrobial effectiveness study as the basis for the device's safety and effectiveness. It states that CollaWound ART "meets the requirements stated in the FDA Blue book memorandum G95-1 and ISO 10993" for biocompatibility, and an "Antimicrobial effectiveness study" was conducted. However, specific quantitative acceptance criteria (e.g., minimum log reduction for antimicrobial effectiveness, specific thresholds for cytotoxicity) and the detailed results demonstrating the device meets these criteria are not provided in this summary.
| Acceptance Criteria Category | Specific Criteria (from document) | Reported Device Performance (from document) |
|---|---|---|
| Biocompatibility | Meets requirements stated in FDA Blue book memorandum G95-1 and ISO 10993 for: (a) Cytotoxicity (b) Irritation test (c) Sensitization (d) Systemic toxicity test (e) Genotoxicity (f) Hemocompatibility/hemolysis (g) Pyrogenic test (h) Release kinetic | "Biocompatibility tests have confirmed that CollaWound ART meets the requirements stated in the FDA Blue book memorandum G95-1 and ISO 10993." (Detailed results for each test are not provided.) |
| Antimicrobial Effectiveness | Implied to demonstrate effectiveness in reducing/preventing microbial colonization or growth on the device. | "Antimicrobial effectiveness study" was conducted. (Specific performance metrics like log reduction or percentage reduction are not provided.) |
| Substantial Equivalence | To be "similar with respect to the indication for use, technological characteristics and material" to predicate devices (FortaDerm™ Antimicrobial PHMB Wound Dressing, XCell Antimicrobial Cellulose Wound Dressing). | "The proposed device, CollaWound ART, is another PHMB-containing wound dressing that is quite similar with respect to the indication for use, technological characteristics and material to the above devices in terms of the substantial equivalency under the 510(k) regulations." |
Study Details:
The provided document is a 510(k) summary, which typically provides high-level information rather than full study reports. Consequently, many of the requested details about the study design are not explicitly stated.
-
Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
- Sample Size: Not specified for any of the studies (biocompatibility or antimicrobial effectiveness).
- Data Provenance: Not specified. It's likely these were laboratory-based studies rather than human clinical trials.
-
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- This information is not applicable and not provided. The studies mentioned (biocompatibility, antimicrobial effectiveness) are laboratory tests, not clinical evaluations requiring expert consensus on ground truth in the typical sense.
-
Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not applicable and not provided for laboratory-based studies.
-
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:
- No, a MRMC comparative effectiveness study was not done. This device is a wound dressing, not an AI-powered diagnostic tool, so such a study would not be relevant.
-
If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
- Not applicable. This device is a physical wound dressing, not an algorithm.
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The type of ground truth used (expert concensus, pathology, outcomes data, etc):
- For biocompatibility tests, the "ground truth" would be the established scientific and regulatory standards (e.g., ISO 10993 guidelines) for various biological responses (cytotoxicity, irritation, etc.).
- For the antimicrobial effectiveness study, the "ground truth" would be the laboratory-defined reduction of microbial growth or colonization under specified test conditions, based on standard microbiology testing methods.
-
The sample size for the training set:
- Not applicable. This device does not involve machine learning or AI that requires a training set.
-
How the ground truth for the training set was established:
- Not applicable, as no training set was used.
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COLLAMATRIX
510(k) summary Summary information
1. Date Prepared
August 1, 2009
Submitter name and address 2.
Collamatrix Inc. 1F, No.50-1, Keyan Road, Jhunan Science Park, Miaoli County, 350, Taiwan
3. Contact person
| Name: | Dennis J. N. Seah |
|---|---|
| Tel: | + 886 2 7711 3699 |
| Fax: | + 886 2 7711 3599 |
Device names 4.
| Propriety name: | CollaWound ART |
|---|---|
| Common name: | Antimicrobial wound dressing |
| Classification name: | Dressing, Wound |
5. Device classification
| Regulatory class: | Unclassified |
|---|---|
| Product code: | FRO |
6. Device description
CollaWound ART is a wound dressing comprised of collagen and polyhexamethylene biguanide (PHMB). The collagen is prepared from pig skin. CollaWound ART absorbs wound exudates and forms gel-like structure that maintains a moist microenvironment at
1F, No. 50-1, Keyan Road, Jhunan Science Park, Miaoli Country, 350, Taiwan Page 1 of 3 Tel: +886 2 7711 3699 Fax: +886 2 7711 3599
JUN 1 & 2010
K09335)
page 1/3
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K093351 page 2/3
COLLAMATRIX
the wound bed and aids in granulation tissue formation and re-epithelialization. The dressing acts as a protective barrier to the invasion of foreign microorganisms. The PHMB content is intended to reduce or prevent microbial colonization or growth on the device.
7. Intended use
CollaWound ART is a wound dressing intended for use as a barrier to resist microbial colonization within the dressing and reduce microbial penetration through the dressing. CollaWound ART will be used for the management of partial and full thickness wounds, chronic vascular ulcers, ulcers, diabetic ulcers, ulcers, venous pressure tunneled/undermined wounds, surgical wounds (donor sites/grafts, post-Moh's surgery, dehiscence), trauma wounds (abrasions, lacerations, post-laser surgery, wound second-degree bums, and skin tears) and draining wounds.
Statement of Substantial equivalence 8.
CollaWound ART is a PHMB-containing wound dressing device similar to predicate PHMB-containing devices that are previously approved by the agency and allowed for marketing towards the management of wounds.
Predicate devices are listed below
| Trade name: | FortaDermTM Antimicrobial PHMB Wound Dressing coated with 0.1% |
|---|---|
| Polyhexamethylene Biguanide Hydrochloride (PHMB) (K051647) | |
| Company: | Organogenesis Inc. |
XCell Antimicrobial Cellulose Wound Dressing (K024054) Trade name: Xylos® Corporation Company:
The proposed device, CollaWound ART, is another PHMB-containing wound dressing that is quite similar with respect to the indication for use, technological characteristics and material to the above devices in terms of the substantial equivalency under the 510(k) regulations.
9. Safety and effectiveness
Biocompatibility tests have confirmed that CollaWound ART meets the requirements
1F, No. 50-1, Keyan Road, Jhunan Science Park, Miaoli Country, 350, Taiwan Page 2 of 3 Tel: +886 2 7711 3699 Fax: +886 2 7711 3599
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K093351 page 3/3
COLLAMATRIX
stated in the FDA Blue book memorandum G95-1 and ISO 10993. The following studies were conducted:
- (a) Cytotoxicity
- (b) Irritation test
- (c) Sensitization
- (d) Systemic toxicity test
- (e) Genotoxicity
- (f) Hemocompatibility/hemolysis
- (g) Pyrogenic test
- (h) Release kinetic
- (i) Antimicrobial effectiveness study
10. Conclusion
CollaWound ART is essentially equivalent in indication for use, technological characteristics, material, safety and effectiveness to the commercially available predicate device, and therefore meets the requirements as defined in 21 CFR § 807.
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Image /page/3/Picture/0 description: The image shows the logo for the Department of Health & Human Services - USA. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized eagle or bird symbol, represented by a series of curved lines.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
JUN 1 8 2010
Collamatrix, Inc. % Mr. Dennis J.N. Seah 1F, No. 50-1, Keyan Road, Jhunan Science Park Miaoli County, 350 Taiwan
Re: K093351
Trade/Device Name: CollaWound ART Regulatory Class: Unclassified Product Code: FRO Dated: May 10, 2010 Received: May 14, 2010
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. 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 (reporting of medical device-related adverse events) (21 CFR 803); 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
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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/ReportalProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
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 (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.
Sincerely yours,
Mark N. Melkerson
Director Division of Surgical, Orthopedic and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Statement of indications for use
510(K) Number (if known):
Device Name: CollaWound ART
Indications for Use:
CollaWound ART is a wound dressing intended for use as a barrier to resist microbial colonization within the dressing and reduce microbial penetration through the dressing. CollaWound ART is intended for the management of wounds including:
- partial and full thickness wounds .
- pressure ulcers .
- venous ulcers .
- diabetic ulcers .
- . chronic vascular ulcers
- tunneled/undermined wounds .
- surgical wounds (donor sites/grafts, post-Moh's surgery, post-laser surgery, . wound dehiscence)
- trauma wounds (abrasions, lacerations, second-degree burns, and skin tears) .
- draining wounds .
Prescription Use _ X (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)
Daniel Keene for MXM
(Division Sign-Off)
Division of Surgical, Orthopedic, and Restorative Devices
510(k) Number K093351
N/A