(601 days)
Not Found
No
The summary describes a barrier film with an identical formulation to a predicate device and makes no mention of AI, ML, image processing, or any related concepts.
No
The device is described as a skin barrier for protection, which is a preventive measure, not a treatment, and therefore not explicitly therapeutic.
No
The intended use describes the device as a skin barrier for protection, not for diagnosing any condition.
No
The device description explicitly states it is a "barrier film," which is a physical product, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is "a skin barrier for protection against the detrimental effects of moisture, urine, or feces." This describes a topical application for physical protection of the skin.
- Device Description: It's described as a "barrier film." This aligns with a physical barrier, not a diagnostic test.
- Lack of Diagnostic Elements: There is no mention of analyzing samples (blood, urine, tissue, etc.), detecting biomarkers, or providing diagnostic information about a disease or condition. IVDs are designed to perform tests in vitro (outside the body) on biological samples to provide information for diagnosis, monitoring, or screening.
The device's function is purely protective and applied externally to the skin. This falls under the category of a medical device, but not an IVD.
N/A
Intended Use / Indications for Use
"CUTICOVER™ SKIN is a skin barrier for protection against the detrimental effects of moisture, urine, or feces."
Product codes
KMF
Device Description
CUTICOVER™ SKIN is a barrier film of identical formulation to the predicate NUVO Barrier Film device.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
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)
Not Found
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
EXHIBIT 3 - CUTICOVER™ SKIN BARRIER DEVICE - REVISED 510(K) SUMMARY
K042955
Page 1 of 1
10.0 510(K) Summary
10.1 Device Name/Sponsor CUTICOVER™ SKIN Barrier Device D & D Holdings, LLC Contact: Robert Conway Telephone: 908-534-7714
- Predicate Device/Company Name and Addresses 10.2
000
NUVO Barrier Film (K980117) EPIKEIA, INC. 500 Sandau, Suite 200 San Antonio, TX 78216-3636
- 10.3 Description of Device CUTICOVER™ SKIN is a barrier film of identical formulation to the predicate NUVO Barrier Film device.
- 10.4 Intended Use INDICATIONS: "CUTICOVER™ SKIN is a skin barrier for protection against the detrimental effects of moisture, urine, or feces."
- 10.5 Safety The formulation is identical to that currently used in the marketed device, NUVO Barrier Film.
- 10.6 Basis of Substantial Equivalence The design, composition, indications and packaging are equivalent to similar devices currently marketed.
1
Image /page/1/Picture/1 description: The image shows the seal of the Department of Health and Human Services (HHS). The seal features a stylized caduceus, a symbol often associated with medicine and healthcare, consisting of a staff with two snakes coiled around it. The words "DEPARTMENT OF HEALTH AND HUMAN SERVICES USA" are arranged in a circular pattern around the caduceus.
JUN 19 2006
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
D&D Holdings, LLC % R.G. Conway & Associates Consulting Services, Inc. Mr. R.G. Conway President Six Edison Road White House Station, New Jersey 08889
Re: K042955
Trade/Device Name: CUTICOVER™ SKIN Barrier Device Regulatory Number: 21 CFR 880.5090 Regulatory Name: Liquid bandage Regulatorv Class: I Product Code: KMF Dated: May 17, 2006 Received: May 19, 2006
Dear Mr. Conway:
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.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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); good manufacturing practice requirements as set
2
Page 2 - Mr. R.G. Conway
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. This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at (240) 276-0115. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely vours.
Hucker Lemon no
Radiological Health
Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and
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510(K) Number (if known): K042955
Device Name: CUTICOVER™ SKIN Barrier Device
INDICATIONS FOR USE:
Skin barrier for protection against the detrimental effects of moisture, urine, or feces.
Prescription Use (Per 21 CFR 801.109) -OR-
Over-the-Counter Use
(PLEASE DO NOT WRITE BELOW THIS LINE; CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH; Office of Device Evaluation (ODE)
Hebert Turner
Division of General, Restorative, and Neurological Devices
510(k) Number K042935