CUTICOVER SKIN BARRIER DEVICE by D & D HOLDINGS, LLC

The provided text is a 510(k) summary for the CUTICOVER™ SKIN Barrier Device (K042955). This document primarily establishes substantial equivalence to a predicate device (NUVO Barrier Film, K980117) and does not contain detailed information about a comprehensive study with specific acceptance criteria and performance metrics as typically expected for novel devices or those requiring clinical studies. The basis for clearance is that the device is identical in formulation, design, composition, indications, and packaging to a previously cleared device.

Therefore, many of the requested categories will be marked as "Not applicable" or "Not provided" because the nature of this submission does not involve a de novo study to prove device performance against acceptance criteria in the way a clinical trial or algorithm validation study would.

Here is the breakdown of the requested information based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria	Reported Device Performance
Safety: The formulation is safe for its intended use as a skin barrier. (Implied by substantial equivalence to a marketed device)	"The formulation is identical to that currently used in the marketed device, NUVO Barrier Film." (Section 10.5) This implies that the device is considered safe due to the predicate's established safety profile, not through independent performance metrics.
Effectiveness/Intended Use: The device performs as a skin barrier for protection against detrimental effects of moisture, urine, or feces. (Implied by substantial equivalence to a marketed device with the same intended use)	"CUTICOVER™ SKIN is a barrier film of identical formulation to the predicate NUVO Barrier Film device." (Section 10.3) "INDICATIONS: "CUTICOVER™ SKIN is a skin barrier for protection against the detrimental effects of moisture, urine, or feces." (Section 10.4) This indicates that the device is expected to perform effectively because it is identical to the predicate device which is already marketed for this indication. No specific performance metrics like durability, barrier efficacy, or duration of protection are reported here for the CUTICOVER™ SKIN device itself.
Basis of Substantial Equivalence: Design, composition, indications, and packaging are equivalent to currently marketed similar devices.	"The design, composition, indications and packaging are equivalent to similar devices currently marketed." (Section 10.6)

Details of the Study (or lack thereof)

This 510(k) summary primarily relies on demonstrating substantial equivalence to a predicate device, rather than providing data from a new study designed to meet specific performance acceptance criteria for the CUTICOVER™ SKIN device itself. Therefore, many of the following points are not applicable as no such detailed study is presented in the provided text.

Sample size used for the test set and the data provenance: Not applicable. No test set data is presented for CUTICOVER™ SKIN. The submission relies on the established safety and effectiveness of the predicate device.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. No new test set requiring expert ground truth establishment is described.
Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable.
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 skin barrier, not an AI-assisted diagnostic tool, so an MRMC study is irrelevant.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is not an algorithm-based device.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable to a new study for this device. The "ground truth" for clearance is the established performance and safety of the predicate device.
The sample size for the training set: Not applicable. No training set is mentioned as this is not an algorithm or a device requiring a training phase in this context.
How the ground truth for the training set was established: Not applicable.

Summary

{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

{3}------------------------------------------------

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

Regulation Number and Section

§ 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.