(246 days)
IV Clear® is intended to cover and protect insertion sites, and secure devices to skin. Common applications include IV catheters, central venous lines, PICCs, suction catheters, epidural catheters, hemodialysis catheters, orthopedic pins, other intravascular catheters and percutaneous devices. IV Clear® inhibits microbial growth within the dressing and prevents external contamination.
IV Clear® is composed of a clear polyurethane film coated with a silicone adhesive containing chlorhexidine and silver salts.
This document describes the premarket notification (510(k)) for the IV Clear® Antimicrobial Clear Silicone Adhesive Dressing with Chlorhexidine and Silver. It does not contain information about acceptance criteria or a study that proves the device meets specific performance metrics in the format typically used for AI/ML device evaluations. This submission primarily focuses on establishing substantial equivalence to predicate devices based on safety and efficacy, rather than AI performance.
Therefore, many of the requested sections about AI performance studies, sample sizes for training/test sets, ground truth establishment, expert qualifications, and MRMC studies are not applicable to this 510(k) summary. I will answer the applicable questions based on the provided text.
1. A table of acceptance criteria and the reported device performance
The document does not explicitly state quantitative acceptance criteria or detailed performance metrics in a tabular format as would be expected for an AI/ML device. Instead, it lists types of performance tests conducted to demonstrate substantial equivalence for the dressing.
| Acceptance Criteria Category | Reported Device Performance / Assessment |
|---|---|
| in vitro log reduction | Performed (details not provided) |
| Biocompatibility | Confirmed in accordance with ISO 10993 (cytotoxicity, sensitization, irritation, systemic toxicity, sub-chronic toxicity) |
| Porcine wound healing | Performed (details not provided) |
| Human repeat insult patch test | Performed (details not provided) |
| Human regrowth prevention | Performed (details not provided) |
| Substantial Equivalence | Confirmed to predicate devices with regard to materials, intended use, and technological characteristics. |
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document does not provide sample sizes for any test sets in the context of an AI/ML device study. It refers to a "Porcine wound healing study," a "Human repeat insult patch test," and a "Human regrowth prevention study," but no details on sample size, data provenance, or study design (retrospective/prospective) are given for these tests. These are biological/clinical tests for a medical dressing, not data sets for AI evaluation.
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)
This information is not applicable and not present in the document. The studies referenced are for a physical medical device (dressing), not an AI/ML diagnostic or assistive device that would require expert-established ground truth for its performance evaluation.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not applicable and not present in the document. Adjudication methods are typically used when establishing ground truth for evaluating AI/ML models, which is not the context of this 510(k) summary.
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
This information is not applicable and not present in the document. This is a 510(k) for a medical dressing, not an AI/ML device, and therefore no MRMC study or AI assistance evaluation would be conducted or described.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This information is not applicable and not present in the document. This is not an AI/ML device.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)
For the studies mentioned (e.g., porcine wound healing, human repeat insult patch test, human regrowth prevention), the "ground truth" would likely be based on standard biological, clinical, or laboratory measurements and observations relevant to wound healing, skin irritation, and microbial growth inhibition. Precise details are not provided in this 510(k) summary. It would not typically involve "expert consensus" in the way it's used for image/data labeling in AI/ML.
8. The sample size for the training set
This information is not applicable and not present in the document. There is no AI/ML model for which a training set would be required.
9. How the ground truth for the training set was established
This information is not applicable and not present in the document. There is no AI/ML model for which ground truth for a training set would be established.
{0}------------------------------------------------
MAY - 4 2012
Image /page/0/Picture/1 description: The image shows the number K112549 written in black ink. Underneath the number is the fraction 1/2, also written in black ink. The handwriting appears to be somewhat cursive and slightly slanted.
Premarket Notification (510(k)) Summary
1. Sponsor information
Covalon Technologies Inc. 405 Britannia Road East, Suite #106 · Mississauga, Ontario, Canada L4Z 3E6
| Contact person: | Kim CrooksDir., Customer Operations, QA/RA |
|---|---|
| Phone number: | 1-905-568-8400 |
| Fax number: | 1-905-568-5200 |
| Date of summary: | 26 March 2012 |
2. Device name and classification
| Common Name: | Wound Dressing, Antimicrobial |
|---|---|
| Proprietary Name: | IV Clear® Antimicrobial Clear Silicone Adhesive Dressingwith 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 |
4. Indications for use
IV Clear® is intended to cover and protect insertion sites, and secure devices to skin. Common applications include IV catheters, central venous lines, PICCs, suction catheters, epidural catheters, hemodialysis catheters, orthopedic pins, other intravascular catheters and percutaneous devices. IV Clear® inhibits microbial growth within the dressing and prevents external contamination.
{1}------------------------------------------------
2/2
5. Performance testing
IV Clear® is composed of a clear polyurethane film coated with a silicone adhesive containing chlorhexidine and silver salts. The following tests were performed on IV Clear®.
- 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 "
- Human regrowth prevention study -
e Substantial equivalence
Performance testing confirmed that IV Clear is substantially equivalent to the predicate devices with regard to materials, intended use and technological characteristics, pursuant to section 510(k).
{2}------------------------------------------------
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 eagle or bird symbol, with three curved lines representing its wings or body. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the bird symbol. The logo is in black and white.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
MAY - 4 2012
Covalon Technologies, Inc. % Ms. Kim Crooks Director, Customer Operations, QA/RA 405 Britannia Road East, Suite #106 Mississauga, Ontario, Canada L4Z 3E6
Re: Ki12549
Trade/Device Name: IV Clear Antimicrobial Clear Silicone Adhesive Dressing With Chlorhexidine and Silver
Regulatory Class: Unclassified Product Code: FRO Dated: March 26, 2012 Received: March 27, 2012
Dear Ms. Crooks:
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 - Ms. Kim Crooks
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/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Einet Keith
Mark N. Melkerson Director Division of Surgical, Orthopedic and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
{4}------------------------------------------------
Indications for Use
510(k) Number: K112549
Device Name: IV Clear® Antimicrobial Clear Silicone Adhesive Dressing with Chlorhexidine and Silver
Indications for Use:
IV Clear® is intended to cover and protect insertion sites, and secure devices to skin. IV. Olear 13 michaed to 6010. and and and all enous lines, PICCs, suction catheters, epidural catheters, hemodialysis catheters, orthopedic pins, other Cathelers, epiddral catheters, nemodiaryols outhors, exclude 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 Kramer NKM
(Division Sign-Off) Division of Surgical, Orthopedic, and Restorative Devices
Page 1 of 1
510(k) Number K112549
14
N/A