(303 days)
Not Found
No
The summary describes a collagen wound dressing and its biocompatibility and performance testing. There is no mention of any computational or analytical capabilities that would suggest the use of AI or ML.
Yes
The device is a wound dressing used for treating various types of wounds, indicating it has a therapeutic purpose in aiding the healing process.
No
Explanation: The device is described as a wound dressing intended for treatment, not for diagnosing medical conditions. Its purpose is to be applied to wounds, not to identify or characterize them.
No
The device description clearly states it is a "white, porous, pliable and absorbable collagen wound dressing" fabricated from "fibrous collagen matrix," indicating it is a physical, material-based device, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the device is a wound dressing applied to the surface of the body for the management of various types of wounds. This is a topical application for therapeutic purposes.
- Device Description: The description confirms it's a physical dressing made of collagen, designed to be applied to wounds.
- Lack of Diagnostic Purpose: There is no mention of the device being used to examine specimens from the human body (like blood, urine, tissue, etc.) to provide information for diagnosis, monitoring, or screening.
- Performance Studies: The performance studies focus on biocompatibility and physical/chemical properties of the dressing, not on diagnostic accuracy or performance metrics typically associated with IVDs (like sensitivity, specificity, etc.).
IVDs are devices used in vitro (outside the body) to examine specimens to provide information about a person's health. This device is used in vivo (on the body) for wound management.
N/A
Intended Use / 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.
Product codes
KGN
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.
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
The SurgiAid Wound Dressing has been subjected to extensive Non-clinical testing to assess the biocompatibility and the performance of the device. The Biocompatibility Evaluations include: cytotoxicity, hemolysis, sensitization, intracutaneous reactivity, acute systemic toxicity, genotoxicity, implantation and pyrogenicity. That is, the SurgiAid Wound Dressing conforms to the requirements specified in ISO 10993-1:2009 series. The Pre-clinical Benchtop Type Evaluations performed contain: Physical tests, Chemical tests, and Substantial Equivalent Comparisons, in order to demonstrate the substantial equivalence between the SurgiAid Collagen Wound Dressing and predicate device, including Purity (Collagen content), Endotoxin level (Pyrogen test), Pepsin resistance, Collagenase resistance & Rehydration Test ..... etc.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
N/A
0
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. Performance
Summary: | The SurgiAid Wound Dressing has been subjected to
extensive Non-clinical testing to assess the biocompatibility
and the performance of the device. |
|---------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | The Biocompatibility Evaluations include: cytotoxicity,
hemolysis, sensitization, intracutaneous reactivity, acute
systemic toxicity, genotoxicity, implantation and
pyrogenicity. That is, the SurgiAid Wound Dressing
conforms to the requirements specified in ISO 10993-1:2009
series. |
| | The Pre-clinical Benchtop Type Evaluations performed
contain: Physical tests, Chemical tests, and Substantial
Equivalent Comparisons, in order to demonstrate the
substantial equivalence between the SurgiAid Collagen
Wound Dressing and predicate device, including Purity
(Collagen content), Endotoxin level (Pyrogen test), Pepsin resistance,
Collagenase resistance & Rehydration Test ..... etc. |
| 8. Substantial
Equivalence
Discussion | SugiAid Collagen Wound Dressing has the same general
design 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 Dressing
described in this submission is, in our opinion, substantially
equivalent to the predicate device. |
----ـــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــ - ..
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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
4
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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