(252 days)
Not Found
No
The device description and intended use focus on the physical properties of a skin protectant film. There is no mention of AI, ML, image processing, or any data-driven analytical capabilities.
No
The device is a skin protectant that forms a barrier to protect the skin from moisture, irritants, friction, and shear, rather than treating a disease or condition.
No.
The device is a skin protectant that forms a film barrier, described as a polymeric-cyanoacrylate solution. Its intended use is to protect intact or damaged skin from moisture, irritants, friction, and shear. There is no mention of the device being used to diagnose any condition or disease.
No
The device description clearly indicates it is a liquid solution that forms a film barrier on the skin, which is a physical product, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices intended to be used in vitro for the examination of specimens, including blood, tissue, and urine, derived from the human body, solely or principally for the purpose of providing information concerning a physiological state, state of health, or disease or congenital abnormality.
- Device Function: The description of Cavilon™ Advanced Skin Protectant clearly states its function is to form a physical barrier on the skin to protect it from external irritants and friction. It is applied directly to the skin and does not involve the examination of bodily specimens.
- Intended Use: The intended use is to protect intact or damaged skin, not to provide diagnostic information about a patient's health status based on analyzing samples.
Therefore, Cavilon™ Advanced Skin Protectant falls under the category of a topical skin protectant, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
Cavilon™ Advanced Skin Protectant forms a film barrier intended to protect intact or damaged skin. It is effective in conditions where skin is frequently or continuously exposed to moisture and caustic irritants such as feces, digestive fluids, wound drainage and urine. Cavilon™ Advanced Skin Protectant also can be used in areas exposed to friction and shear from bedding, clothing, shoes or any other material that would rub against the skin.
Product codes (comma separated list FDA assigned to the subject device)
KMF
Device Description
3M™ Cavilon™ Advanced Skin Protectant is a polymeric-cyanoacrylate solution intended for the protection of intact or damaged skin. Upon application to skin, the liquid dries rapidly to form a primary long-lasting waterproof, highly durable film barrier. It is elastomeric, adhering to the contours of the skin and providing a uniform film. The film is transparent and possesses good oxygen and moisture vapor permeability. The polymer-cyanoacylate is dispersed in a non-stinging solvent. The film is colorless and non-cytotoxic. The film adheres to dry, moist or wet skin surfaces and remains intact during conditions of continuous or repeated exposure to moisture or caustic irritants. It will wear off the skin and does not require removal.
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)
Biocompatibility Testing:
The biocompatibility evaluation for Cavilon™ Advanced Skin Protectant was conducted in accordance with the FDA Blue Book Memorandum #G95-1 "Use of International Standard ISO-10993, 'Biological Evaluation of Medical Devices Part 1: Evaluation of Medical Devices - Part 1: Evaluation and Testing Within a Risk Management Process," as recognized by FDA. Cavilon™ Advanced Skin Protectant is characterized as a surface contacting device for use on breached or compromised skin for periods of time greater than 30 days. The battery of testing included the following tests:
- Cytotoxicity
- Sensitization
- Irritation
- Systemic Toxicity
- Genotoxicity
Bench Testing:
Bench testing for Cavilon™ Advanced Skin Protectant was conducted in support of substantial equivalence to the predicate devices. The bench testing included the following tests:
- Elongation
- Cure and/or Dry Time
- Friction
- Moisture Vapor Transmission Rate
Clinical Studies:
Clinical testing of Cavilon™ Advanced Skin Protectant include:
- Controlled, randomized open label durability study on healthy subjects that demonstrated that Cavilon™ Advanced Skin Protectant is a durable barrier film that lasts up to 72 hours.
- Prospective, open label wash off resistance study on healthy subjects showed that the Cavilon™ Advanced Skin Protectant is similarly to Marathon® Liquid Skin Protectant with respect to the 'active' wash-off resistance and its ability to protect skin.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 880.5090 Liquid bandage.
(a)
Identification. A liquid bandage is a sterile device that is a liquid, semiliquid, or powder and liquid combination used to cover an opening in the skin or as a dressing for burns. The device is also used as a topical skin protectant.(b)
Classification. Class I (general controls). When used only as a skin protectant, the device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 880.9.
0
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular and contains the department's name around the perimeter. In the center of the logo is an abstract symbol that resembles a stylized caduceus or a family of people. The symbol is composed of three figures in profile, one behind the other.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
August 23, 2016
3M Healthcare Ms. Maria Ruiz Regulatory Affairs Specialist 3M Center 2510 Conway Avenue, Bldg. 275-5W-06 St. Paul. MN 55144
Re: K153571
Trade/Device Name: Cavilon Advanced Skin Protectant Regulation Number: 21 CFR 880.5090 Regulation Name: Liquid bandage Regulatory Class: Class I Product Code: KMF Dated: July 25, 2016 Received: July 27, 2016
Dear Ms. Ruiz:
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 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
1
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 contact the Division of Industry and Consumer Education 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. 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 Industry and Consumer Education 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,
David Krause -S
Binita S. Ashar, M.D., M.B.A., F.A.C.S. for Director Division of Surgical Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K153571
Device Name
3M™ Cavilon™ Advanced Skin Protectant
Indications for Use (Describe)
Cavilon™ Advanced Skin Protectant forms a film barrier intended to protect intact or damaged skin. It is effective in conditions where skin is frequently or continuously exposed to moisture and caustic irritants such as feces, digestive fluids, wound drainage and urine. Cavilon™ Advanced Skin Protectant also can be used in areas exposed to friction and shear from bedding, clothing, shoes or any other material that would rub against the skin.
| Type of Use (Select one or both, as applicable) |
|---|
| Prescription Use (Part 21 CFR 801 Subpart D) |
| Over-The-Counter Use (21 CFR 801 Subpart C) |
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510K SUMMARY
SUBMITTER I.
3M Company 3M Health Care 3M Center 2510 Conway Ave., Bldg 275-5W-06 St. Paul, MN 55144
| Phone: | 651-736-2733 |
|---|---|
| Fax: | 651-737-5320 |
| E-Mail: | meruiz@mmm.com |
| Contact Person: | Maria Ruiz |
| Contact Person: | Maria Ruiz |
|---|---|
| Regulatory Affairs Specialist |
Date Prepared: December 4, 2015
II. DEVICE
| Name of Device: | 3MTM Cavilon™ Advanced Skin Protectant |
|---|---|
| Common or Usual Name: | Barrier Film |
| Classification Name: | Liquid Bandage |
| Regulatory Class: | Class 1 |
| Product Code: | KMF per 21 CFR 880.5090 |
III. PREDICATE DEVICE
3MTM Cavilon™ No Sting Barrier Film (K955103) Medline® Marathon® Liquid Skin Protectant (K133443)
IV. DEVICE DESCRIPTION
3M™ Cavilon™ Advanced Skin Protectant is a polymeric-cyanoacrylate solution intended for the protection of intact or damaged skin. Upon application to skin, the liquid dries rapidly to form a primary long-lasting waterproof, highly durable film barrier. It is elastomeric, adhering to the contours of the skin and providing a uniform film. The film is transparent and possesses good oxygen and moisture vapor permeability.
4
The polymer-cyanoacylate is dispersed in a non-stinging solvent. The film is colorless and non-cytotoxic. The film adheres to dry, moist or wet skin surfaces and remains intact during conditions of continuous or repeated exposure to moisture or caustic irritants. It will wear off the skin and does not require removal.
V. INDICATIONS FOR USE
Cavilon™ Advanced Skin Protectant forms a film barrier intended to protect intact or damaged skin. It is effective in conditions where skin is frequently or continuously exposed to moisture and caustic irritants such as feces, digestive fluids, wound drainage and urine. Cavilon™ Advanced Skin Protectant also can be used in areas exposed to friction and shear from bedding, clothing, shoes or any other material that would rub against the skin.
The Indications for Use statement for Cavilon™ Advanced Skin Protectant is similar to the predicate devices. Both the Subject Device and predicate devices have the same intended use to form a liquid barrier film when applied to the skin, by providing a barrier against irritants and caustic substances (e.g., urine, fecal matter, digestive juices) and to reduce friction and shear from materials rubbing against the skin (e.g., bedsheets, clothing, shoes).
VI. COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE PREDICATE DEVICE
The technological principle for the Subject Device and the predicate devices are that they are all liquid bandages. Just like its predicate devices, Cavilon™ Advanced Skin Protectant forms a transparent and durable barrier film to protect intact or damaged skin from the caustic effects of moisture, urine or feces and friction and shear. It is applied in liguid form to the area of interest on the skin and quickly polymerizes upon contact to form the barrier film.
The Subject Device and predicate devices all have similar technological elements which include:
- Operational principle ●
- Device is transparent
- Device provided in a liquid form
- Device forms a protective barrier
- Device is elastomeric
- Device is a durable barrier ●
- Device protects from friction .
- Device is breathable ●
5
The minor differences do not raise different questions of safety and effectiveness. The following technological differences exist between the subject device and one or both of the predicate devices:
- Liquid technological components
- Monomer and/or polymer composition ●
- Device dries rapidly
- Device cures upon contact
- Delivery system ●
- Sterilization method
VII. PERFORMANCE DATA
The following performance data is provided in support of the substantial equivalence determination.
Biocompatibility Testing
The biocompatibility evaluation for Cavilon™ Advanced Skin Protectant was conducted in accordance with the FDA Blue Book Memorandum #G95-1 "Use of International Standard ISO-10993, 'Biological Evaluation of Medical Devices Part 1: Evaluation of Medical Devices - Part 1: Evaluation and Testing Within a Risk Management Process," as recognized by FDA. Cavilon™ Advanced Skin Protectant is characterized as a surface contacting device for use on breached or compromised skin for periods of time greater than 30 days. The battery of testing included the following tests:
- Cytotoxicity ●
- Sensitization
- Irritation
- Systemic Toxicity ●
- Genotoxicity ●
Bench Testing
Bench testing for Cavilon™ Advanced Skin Protectant was conducted in support of substantial equivalence to the predicate devices. The bench testing included the following tests:
- Elongation ●
- Cure and/or Dry Time ●
- Friction ●
- Moisture Vapor Transmission Rate
6
Clinical Studies
Clinical testing of Cavilon™ Advanced Skin Protectant include:
- Controlled, randomized open label durability study on healthy subjects that . demonstrated that Cavilon™ Advanced Skin Protectant is a durable barrier film that lasts up to 72 hours.
- . Prospective, open label wash off resistance study on healthy subjects showed that the Cavilon™ Advanced Skin Protectant is similarly to Marathon® Liquid Skin Protectant with respect to the 'active' wash-off resistance and its ability to protect skin.
VIII. CONCLUSIONS
3M™ Cavilon™ Advanced Skin Protectant is substantially equivalent to the predicate devices, 3MTM Cavilon™ Barrier Film (K955103) and Medline Marathon® Liquid Skin Protectant (K133443).
Cavilon™ Advanced Skin Protectant is composed of similar components and similar performance, intended use and indications for use as the predicate devices.
Based on the similarities to the predicate devices, the minor differences do not present or raise any new safety or effectiveness issues and the device is substantially equivalent to the predicates.