(53 days)
No
The summary describes a wound dressing with antimicrobial properties and does not mention any computational or analytical capabilities that would suggest the use of AI/ML.
No
SurgiClear™ is a wound dressing designed to cover and protect wounds, inhibit microbial growth, and prevent external contamination. While it aids in wound management, it does not directly treat or cure a disease or condition in the way a therapeutic device would (e.g., provide therapy, stimulation, or treatment). Its function is primarily protective and preventative.
No
SurgiClear™ is a wound dressing designed to cover and protect wounds, inhibit microbial growth, and secure primary dressings. Its intended use is therapeutic and protective, not diagnostic.
No
The device description clearly states it is composed of a physical film and adhesive, indicating it is a hardware device, not software-only.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens taken from the human body (like blood, urine, tissue) to provide information about a person's health. This testing is done outside of the body (in vitro).
- SurgiClear™ Function: SurgiClear™ is a wound dressing applied directly to the body to cover and protect wounds. It works by providing a physical barrier and releasing antimicrobial agents to inhibit microbial growth on the wound surface.
The intended use and device description clearly indicate that SurgiClear™ is a topical wound care product, not a device used for testing biological samples in a laboratory setting.
N/A
Intended Use / Indications for Use
SurgiClear™ is intended to cover and protect a wound caused by percutaneous medical devices such as drains, chest tubes, orthopedic pins, fixtures, and wires.
SurgiClear™ may also be used to cover and secure primary dressing.
SurgiClear™ inhibits microbial growth within the dressing and prevents external contamination.
Product codes
FRO
Device Description
SurgiClear™ is composed of a clear polyurethane film coated with a silicone adhesive containing chlorhexidine and silver salts.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
wound caused by percutaneous medical devices such as drains, chest tubes, orthopedic pins, fixtures, and wires.
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 following tests were performed on SurgiClear™:
- In vitro log reduction
- Biocompatibility studies, including, cytotoxicity, sensitization, irritation, systemic toxicity and sub-chronic toxicity in accordance with ISO 10993
- Porcine wound healing study
- Human repeat insult patch test
Performance testing confirmed that SurgiClear™ is substantially equivalent to the predicate devices with regard to materials, intended use and technological characteristics, pursuant to section 510(k).
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
K080620, K973036, K990810, K003229
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
N/A
0
Premarket Notification (510(k)) Summary
519
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1. Sponsor information
AUG 1 3 2012 Covalon Technologies Inc. 405 Britannia Road East, Suite #106 Mississauga, Ontario, Canada L4Z 3E6
| Contact person: | Christopher Fredric
Manager, Clinical & Regulatory Affairs |
|------------------|---------------------------------------------------------------|
| Phone number: | 1-905-568-8400 x 261 |
| Fax number | 1-905-568-5200 |
| Date of summary: | 07 June 2012 |
2. Device name and classification
| Common Name: | Wound Dressing, Antimicrobial |
|---|---|
| Proprietary Name: | SurgiClear™ Antimicrobial Clear Silicone Adhesive |
| Dressing with Chlorhexidine and Silver | |
| Device Classification: | Antimicrobial Dressing, Unclassified |
| Classification Panel: | General and Plastic Surgery |
3. Predicate devices
| Manufacturer | Device | 510(k) number |
|---|---|---|
| 3M Health Care | 3M™ Tegaderm™ CHG Dressing | K080620 |
| 3M Health Care | 3M™ Tegaderm™ Transparent Dressing | K973036 |
| Maersk Medical, Ltd. | Arglaes® Film Antimicrobial Barrier Dressing | K990810 |
| Molnlycke Health Care | Mepitac® Soft Silicone Tape | Class I |
| Ethicon Inc. | BIOPATCH | K003229 |
4. Indications for use
SurgiClear™ is intended to cover and protect a wound caused by percutaneous medical devices such as drains, chest tubes, orthopedic pins, fixtures, and wires.
SurgiClear™ may also be used to cover and secure primary dressing.
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SurgiClear™ inhibits microbial growth within the dressing and prevents external contamination.
5. Performance testing
SurgiClear™ is composed of a clear polyurethane film coated with a silicone adhesive containing chlorhexidine and silver salts. The following tests were performed on SurgiClear™:
- In vitro log reduction
- Biocompatibility studies, including, cytotoxicity, sensitization, irritation, systemic toxicity and sub-chronic toxicity in accordance with ISO 10993
- Porcine wound healing study
- Human repeat insult patch test
റ Substantial equivalence
Performance testing confirmed that SurgiClear™ is substantially equivalent to the predicate devices with regard to materials, intended use and technological characteristics, pursuant to section 510(k).
2
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized graphic of an eagle or bird-like figure with three curved lines representing its wings or body. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES. USA" is arranged in a circular fashion around the graphic.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -W066-G609 Silver Spring. MD 20993-0002
AUG 1 3 2012
Covalon Technologies Incorporated % Mr. Christopher Fredric Manager, Clinical and Regulatory Affairs 405 Brittania Road East, Suite 106 Mississauga, Ontario, Canada L4Z 3E6
Re: K121819
Trade/Device Name: SurgiClear™ Antimicrobial Clear Silicone Adhesive Dressing with Chlorhexidine and Silver
Regulation Name: Wound Dressing, Antimicrobial Regulatory Class: Unclassified Product Code: FRO Dated: June 19, 2012 Received: June 21, 2012
Dear Mr. Fredric:
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
3
Page 2 - Mr. Christopher Fredric
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.
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/Resourcesfor You/Industry/default.htm.
Sincerely yours.
Sincerely yours,
Mulh A. Millam
Mark N. Melkerson Director Division of Surgical, Orthopedic and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
K121849. 26
Indications for Use
510(k) Number: K
Device Name: SurgiClear™ Antimicrobial Clear Silicone Adhesive Dressing with Chlorhexidine and Silver
Indications for Use:
SurgiClear™ is intended to cover and protect a wound caused by percutaneous medical devices such as drains, chest tubes, orthopedic pins, fixtures, and wires.
SurgiClear™ may also be used to cover and secure primary dressing.
SurgiClear™ inhibits microbial growth within the dressing and prevents external contamination.
Prescription Use × (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 Kicne for MM
(Division Sign-Off)
Division of Surgical, Orthopedic. and Restorative Devices
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510(k) Number K121819