(303 days)
SurgiAid Collagen Wound Dressing is intended for use in patients who have surgical wounds, donor sites/grafts podiatric wounds, wound dehiscence, traumatic wounds, abrasions, lacerations, partial thickness burns or skin tears. SurgiAid Collagen Wound Dressing can be applied to wounds with depth less than 0.3 cm.
SugiAid Collagen Wound Dressing is white, porous, pliable and absorbable collagen wound dressings. It is fabricated by fibrous collagen matrix which is purified from bovine Achilles tendon. SugiAid is pliable and can be applied easily to clean wounds. The product is supplied in sterile, nonpyrogenic package, and is indicated for single use only.
The provided text describes a 510(k) summary for the "SurgiAid Collagen Wound Dressing." This document focuses on demonstrating substantial equivalence to a predicate device rather than conducting a de novo clinical study to define and meet specific acceptance criteria for performance.
Therefore, the study design elements typically associated with establishing acceptance criteria for a new AI/medical device (like sample size for test sets, ground truth methodology, MRMC studies, or standalone performance) are not applicable here. The submission's goal is to prove the new device is as safe and effective as a previously cleared device, not to prove its own independent performance against a set of statistical targets.
Here's a breakdown based on the provided text, highlighting what is (and isn't) present:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria (Demonstration of Substantial Equivalence to Predicate) | Reported Device Performance (as demonstrated by testing and comparison) |
|---|---|
| Biocompatibility: Conformance to ISO 10993-1:2009 series requirements. | Confirmed: Biocompatibility evaluations (cytotoxicity, hemolysis, sensitization, intracutaneous reactivity, acute systemic toxicity, genotoxicity, implantation, pyrogenicity) confirm conformance. |
| Similar Physical Properties: | Confirmed: Pre-clinical benchtop type evaluations including physical tests (e.g., Purity (Collagen content), Endotoxin level (Pyrogen test), Pepsin resistance, Collagenase resistance & Rehydration Test) show substantial equivalence. |
| Similar Chemical Properties: | Confirmed: Pre-clinical benchtop type evaluations including chemical tests show substantial equivalence. |
| Same Intended Use: | Confirmed: "SugiAid Collagen Wound Dressing has the same intended use." |
| Similar Operating Principle: | Confirmed: "using similar operating principle." |
| Similar Technological Characteristics: | Confirmed: "using similar technological characteristics." Bench testing demonstrates that differences do not raise new safety/effectiveness questions. |
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 submission relies on bench testing and biocompatibility assessments rather than a clinical trial with a "test set" of patient data in the typical sense for AI/diagnostic devices. The goal is to show the device itself meets material and safety standards and is similar to a predicate, not to test its performance on a dataset of clinical cases.
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. No human experts were used for "ground truth" establishment in this context, as it's a submission for a wound dressing, not an AI diagnostic device. The "ground truth" for material properties is established through standardized laboratory testing and specific ISO standards.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not Applicable. As there is no "test set" in the context of clinical image or data interpretation, no adjudication method was used.
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. This is a physical medical device (collagen wound dressing), not an AI-assisted diagnostic tool. Therefore, MRMC studies are irrelevant to this submission.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not Applicable. This is a physical medical device, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- The "ground truth" here is based on established scientific and regulatory standards for material properties, biocompatibility, and intended use. This includes:
- ISO 10993-1:2009 series for biocompatibility (cytotoxicity, hemolysis, sensitization, etc.).
- Validated laboratory methods for physical and chemical tests (Purity, Endotoxin level, Pepsin resistance, Collagenase resistance, Rehydration Test).
- Comparison to the known characteristics of the predicate device (SkinTemp, K925545).
8. The sample size for the training set
- Not Applicable. This device is not an AI algorithm that requires a "training set."
9. How the ground truth for the training set was established
- Not Applicable. No training set was used.
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510(K) SUMMARY
FEB - 2 2011
This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA and 21 CFR §807.92
| 1. Submitter's Name: | Maxigen Bioteq INC. |
|---|---|
| Address: | 17, Wuchiuan 8th Rd., Wugu Shiang Taipei, Taiwan |
| Phone: | + 886-2-2398-2345 |
| Fax: | + 886-2-5591-9522 |
| Contact: | Cinn-Jenn Wei/ President |
| 2. Device Name : | SurgiAid Collagen Wound Dressing |
|---|---|
| Trade Name: | SurgiAid Collagen Wound Dressing |
| Common Name: | Wound Dressing |
| Classification name | Collagen Wound Dressing |
| 3. DEVICE CLASS | SurgiAid Collagen Wound Dressing has been classified as |
| Regulatory Class: Unclassified | |
| Product Code: KGN | |
| Panel : General & Plastic Surgery | |
| 4. Predicate Device: | The predicate device is the |
| • SkinTemp (K925545) marketed by BIOCORE. |
- Device Description: SugiAid Collagen Wound Dressing is white, porous, pliable and absorbable collagen wound dressings. It is fabricated by fibrous collagen matrix which is purified from bovine Achilles tendon. SugiAid is pliable and can be applied easily to clean wounds. The product is supplied in sterile, nonpyrogenic package, and is indicated for single use only.
SurgiAid Collagen Wound Dressing is intended for use in 6. Intended Use: patients who have surgical wounds, donor sites/grafts podiatric wounds, wound dehiscence, traumatic wounds, abrasions, lacerations, partial thickness burns or skin tears. SurgiAid Collagen Wound Dressing can be applied to wounds with depth less than 0.3 cm."
| Product: SurgiAid Collagen Wound Dressing | ||
|---|---|---|
| Page 1 of 3 | Section 4 - 510(k) Summary | REV. [C] |
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| 7. PerformanceSummary: | The SurgiAid Wound Dressing has been subjected toextensive Non-clinical testing to assess the biocompatibilityand the performance of the device. |
|---|---|
| The Biocompatibility Evaluations include: cytotoxicity,hemolysis, sensitization, intracutaneous reactivity, acutesystemic toxicity, genotoxicity, implantation andpyrogenicity. That is, the SurgiAid Wound Dressingconforms to the requirements specified in ISO 10993-1:2009series. | |
| The Pre-clinical Benchtop Type Evaluations performedcontain: Physical tests, Chemical tests, and SubstantialEquivalent Comparisons, in order to demonstrate thesubstantial equivalence between the SurgiAid CollagenWound Dressing and predicate device, including Purity(Collagen content), Endotoxin level (Pyrogen test), Pepsin resistance,Collagenase resistance & Rehydration Test ..... etc. | |
| 8. SubstantialEquivalenceDiscussion | SugiAid Collagen Wound Dressing has the same generaldesign with the predicate devices |
| Since the Applicant has selected Legally Marketed Devices | |
| • SkinTemp (K925545) marketed by BIOCORE. | |
| The has the following similarities to the predicate device in:• having the same intended use.• using similar operating principle.• using similar technological characteristics | |
| In summary, the SugiAid Collagen Wound Dressingdescribed in this submission is, in our opinion, substantiallyequivalent to the predicate device. |
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9. Conclusions:
The SurgiAid Collagen Wound Dressing has the same intended use and technological characteristics as the SkinTemp (K925545) marketed by BIOCORE. Moreover, bench testing contained in this submission demonstrates that any differences in their technological characteristics do not raise any new questions of safety or effectiveness. Thus, the SurgiAid Collagen Wound Dressing is substantially equivalent to the predicate device.
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Image /page/3/Picture/1 description: The image is a black and white seal for the Department of Health & Human Services. The seal is circular, with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" arranged around the perimeter. In the center of the seal is a stylized caduceus symbol, featuring a staff with two snakes intertwined and a pair of wings at the top.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room W-O66-0609 Silver Spring, MD 20993-0002
Maxigen Biotech. Inc. % Harvest Consulting Group Ms. Jennifer Reich 2904 N. Boldt Avenue Flagstaff, Arizona 86001
MAR 1 6 2011
Re: K100927 Trade/Device Name: SurgiAid Collagen Wound Dressing Regulatory Class: Unclassified Product Code: KGN Dated: January 28, 2011 Received: January 31, 2011
Dear Ms. Reich:
This letter corrects our substantially equivalent letter of February 2. 2011.
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 (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 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
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Page 2 - Ms. Jennifer Reich
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.
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/ReportaProblem/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/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Azy B. R. h
Mark N. Melkerson Director Division of Surgical, Orthopedic and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
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Indications for Use
510(k) Number (if known): K100927
Device Name: SurgiAid Collagen Wound Dressing Maxigen Biotech, Inc.
Indications for Use:
SurgiAid Collagen Wound Dressing is intended for use in patients who have surgical wounds, donor sites/grafts podiatric wounds, wound dehiscence, traumatic wounds, abrasions, lacerations, partial thickness burns or skin tears. SurgiAid Collagen Wound Dressing can be applied to wounds with depth less than 0.3 cm."
Prescription Use (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
David Stone for MXU
(Division Sign-Off) Division of Surgical, Orthopedic. and Restorative Devices
510(k) Number K100927
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