(246 days)
None
No
The summary describes a transparent dressing with antimicrobial properties and does not mention any AI or ML components or functionalities.
No.
The device's intended use is to cover, protect, and secure insertion sites and devices, and to inhibit microbial growth. These functions are preventative and supportive rather than treating a disease or medical condition.
No
Explanation: The device, IV Clear®, is a dressing intended to cover, protect, and secure medical devices to the skin, and to inhibit microbial growth. Its function is not to diagnose conditions or diseases.
No
The device description explicitly states it is composed of a clear polyurethane film coated with a silicone adhesive, indicating it is a physical dressing, not software.
Based on the provided information, no, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that IV Clear® is for covering and protecting insertion sites and securing devices to the skin. This is a topical application for wound care and device securement.
- Device Description: The description details a dressing with adhesive and antimicrobial agents. This aligns with a wound dressing or securement device, not a diagnostic test performed on samples outside the body.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.) or providing diagnostic information about a patient's health status. IVDs are used to diagnose diseases, monitor conditions, or screen for health issues by testing samples.
The performance studies listed (in vitro log reduction, biocompatibility, wound healing, patch tests, regrowth prevention) are typical for a wound dressing or medical device that comes into contact with the body, not for an IVD.
N/A
Intended Use / 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.
Product codes
FRO
Device Description
IV Clear® 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
Skin
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)
- 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
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Mepitac® Soft Silicone Tape (Class I)
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
N/A
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 Crooks
Dir., 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 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 |
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.
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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).
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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
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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
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