(53 days)
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.
SurgiClear™ is composed of a clear polyurethane film coated with a silicone adhesive containing chlorhexidine and silver salts.
This document (K121819) is a 510(k) Premarket Notification for a medical device called SurgiClear™ Antimicrobial Clear Silicone Adhesive Dressing with Chlorhexidine and Silver, submitted by Covalon Technologies Inc. in 2012.
The 510(k) summary focuses on demonstrating that the new device is "substantially equivalent" to already legally marketed predicate devices, rather than providing detailed acceptance criteria and study results in the format requested, which is more typical for AI/ML device submissions.
Here's an attempt to extract and interpret the information provided in the context of your request, with significant caveats that the level of detail is much lower than what would be expected for AI/ML performance studies:
Acceptance Criteria and Reported Device Performance
The provided document does not specify quantitative acceptance criteria in terms of performance metrics (e.g., sensitivity, specificity, accuracy) because it's a submission for a physical medical product (a wound dressing), not an AI/ML diagnostic or predictive algorithm.
Instead, the "acceptance criteria" are implied by the battery of tests performed to demonstrate safety and effectiveness for a physical device, and the "reported device performance" is that the device met these criteria, leading to a determination of substantial equivalence.
Implied "Acceptance Criteria" and "Reported Device Performance" (based on tests conducted):
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Antimicrobial Efficacy: Capable of reducing microbial growth | In vitro log reduction: Confirmed (implies positive results) |
| Biocompatibility: Non-toxic, non-sensitizing, non-irritating | Biocompatibility studies (ISO 10993): Passed (cytotoxicity, sensitization, irritation, systemic toxicity, sub-chronic toxicity) |
| Wound Healing Support: Promotes or does not hinder healing | Porcine wound healing study: Confirmed (implies positive results) |
| Human Safety (Irritation): Safe for human skin contact | Human repeat insult patch test: Confirmed (implies no significant irritation or sensitization) |
| Substantial Equivalence: Similar in materials, intended use, and technological characteristics to predicate devices | Performance testing confirmed: SurgiClear™ is substantially equivalent to predicate devices. |
Study Details (Based on available information)
Given this is a physical medical device and not an AI/ML algorithm, many of the requested points are not applicable or the information is not provided in the document.
2. Sample size used for the test set and the data provenance:
* Test Set (In vitro log reduction): Not specified. This typically involves standardized bacterial cultures.
* Test Set (Biocompatibility): Not specified. These studies typically use cell cultures (cytotoxicity), animal models (systemic toxicity, sub-chronic toxicity), and guinea pigs/rabbits (sensitization, irritation).
* Test Set (Porcine wound healing study): Not specified, but involved porcine models. Data provenance is implied as in-vivo animal study.
* Test Set (Human repeat insult patch test): Not specified, but involved human subjects. Data provenance is implied as prospective clinical study (human subjects).
* Country of Origin: Studies likely conducted in Canada or via contract research organizations for a Canadian company.
3. Number of experts used to establish the ground truth for the test set and qualifications of those experts:
* Not applicable in the AI/ML sense. Ground truth for these studies would be established by laboratory technicians, pathologists, and clinicians/toxicologists, following established scientific and regulatory protocols rather than "expert consensus" on imaging or data interpretation.
4. Adjudication method for the test set:
* Not applicable. Adjudication methods like 2+1 or 3+1 are used for human interpretation discrepancies in AI/ML studies. For these types of device tests, results are typically objective measurements or observations interpreted by trained personnel according to pre-defined criteria.
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 device is a physical wound dressing and does not involve human readers or AI assistance.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
* Not applicable. This is not an algorithm.
7. The type of ground truth used:
* In vitro log reduction: Measured bacterial count reductions.
* Biocompatibility: Histopathological findings, cytotoxicity assays, irritation scores, systemic toxicity measurements, sensitization reactions.
* Porcine wound healing study: Clinical observations of wound healing, possibly histopathology.
* Human repeat insult patch test: Clinical assessment of skin reaction (e.g., erythema, edema) by dermatologists or trained clinicians.
8. The sample size for the training set:
* Not applicable. This is a physical device, not an AI/ML algorithm requiring a training set.
9. How the ground truth for the training set was established:
* Not applicable.
Conclusion:
The provided document is a 510(k) summary for a physical medical device (wound dressing) and therefore does not contain the type of detailed information about acceptance criteria, sample sizes, expert ground truth, or study designs that would be relevant for an AI/ML medical device submission. The performance testing section mentions several standard biological and clinical studies (in vitro log reduction, biocompatibility, porcine wound healing, human repeat insult patch test) which confirmed the device's safety and effectiveness, leading to a determination of substantial equivalence to predicate devices.
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Premarket Notification (510(k)) Summary
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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 FredricManager, 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 AdhesiveDressing 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).
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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
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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
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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
N/A