ProDerma Liquid Bandage is indicated for over-the-counter (OTC) use to cover minor cuts, scrapes and minor irritations of the skin and help protect them from infection.

Device Description

ProDerma Liquid Bandage, a formulated Cyanoacrylate adhesive, is a violet tinted, clear liquid topical bandage composed of 2-Octyl and N-Butyl Cyanoacrylate monomers, a plasticizer and D&C violet #2 pigment.

ProDerma is packaged in a single use applicator containing up to 0.5 grams of product. The single use applicator is constructed in the shape of “tear drop” with the flat bottom side made of a flexible laminated film of Pet/AL/Nitrile and a flexible laminate of either Nitrile/PE or Nitrile/PP/PE formed as a blister on the top side with a polyurethane foam sponge for applying the liquid bandage. Each applicator is individually packaged in a blister with a Tyvek backing. The applicators are packaged in a box with a quantity ranging of 6 to 24 per box depending on the customer's requirements. The applicator is opened by folding over the packet at the narrow end under the foam sponge onto itself. The liquid flows into the foam sponge and is control by the user as pressure is applied to the applicator. ProDerma is then applied to the area in need.

Applicators sterilized to a Sterilization Acceptance Level (SAL) of 10° via commercially available irradiation facilities.

AI/ML Overview

The provided text describes the 510(k) summary for the ProDerma Liquid Bandage (K063202). This document focuses on demonstrating substantial equivalence to predicate devices, rather than presenting a performance study with acceptance criteria in the way a medical AI/ML device submission would.

Therefore, the following information is not applicable or not provided in the given text:

A table of acceptance criteria and the reported device performance: This is a submission for a traditional medical device (liquid bandage) and not an AI/ML device. Performance is assessed through chemical properties and biocompatibility, not statistical metrics like sensitivity/specificity.
Sample size used for the test set and the data provenance: Not applicable for a chemical product's substantial equivalence review.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable.
Adjudication method: 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.
If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not applicable.
The type of ground truth used: For a chemical product, ground truth would relate to material properties and biological response, not diagnostic accuracy.
The sample size for the training set: Not applicable.
How the ground truth for the training set was established: Not applicable.

However, based on the provided text, we can infer some information relevant to the device's "performance" and how its safety and effectiveness were evaluated:

Acceptance Criteria (Implied by Substantial Equivalence and Testing Summary):

The acceptance criteria for a Class I general hospital device like a liquid bandage primarily revolve around:

Safety (Biocompatibility): The device must not cause adverse biological reactions when in contact with the skin.
Sterilization Efficacy: If sterilized, the process must achieve a specified sterility assurance level (SAL).
Functional Equivalence: The device must perform its intended function (forming a cover, polymerization time) similarly to its predicate devices.
Material Composition: The components should be known and similar to legally marketed devices.

Study that Proves the Device Meets the Acceptance Criteria:

The key study mentioned is the testing summary which supports the substantial equivalence claim.

Here's a breakdown based on the provided text:

1. Table of Acceptance Criteria (Implied) and Reported Device Performance:

Acceptance Criteria (Implied)	Reported Device Performance (from "Testing Summary")
Safety (Biocompatibility with human tissues)	"ProDerma - Liquid Bandage has been subjected to the appropriate biocompatibility testing in accordance with ANSI/AAMI/ISO 10993 and the results have confirmed that the product is safe for its intended use."
Sterility (Sterilization Assurance Level)	"ProDerma has also been subject to the appropriate sterilization validation testing in accordance with ANSI/AAMI/ISO 11137 & 11737 and the results have confirmed that the method of sterilization selected for ProDerma provides a SAL level 10th [presumably 10^-6] in the finished individual applicator package."
Functional Equivalence (Polymerization time)	"The polymerization or set time typically occurs within less than 2 minutes." (This is stated under "Technological Characteristics," implying it's an expected performance criterion similar to predicates).
Material Equivalence (Composition and function)	"ProDerma - Liquid Bandage is similar to the predicate devices listed in the section named 'Predicate Devices' in that all are cyanoacrylate based liquid bandages. They are manufactured in a similar manner... and blending with other ingredients and sterilized in its finished package."

2. Sample Size Used for the Test Set and the Data Provenance:

Sample Size for Test Set: Not specified in the document. Biocompatibility and sterility testing typically involve specific sample sizes dictated by the standards (ANSI/AAMI/ISO 10993, 11137, 11737) but these are not enumerated here.
Data Provenance: Not specified, but standard testing is generally conducted in controlled laboratory environments. The document does not indicate retrospective or prospective clinical data for performance evaluation in the context of human use outcomes.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts:

Not applicable / Not specified. The evaluation here relies on standardized laboratory tests and comparisons to predicate devices, not expert consensus on diagnostic interpretations.

4. Adjudication Method for the Test Set:

Not applicable / Not specified.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:

No. This type of study is relevant for diagnostic imaging or AI devices, not for a liquid bandage.

6. Standalone (Algorithm Only) Performance:

No. This is a physical medical device, not an algorithm.

7. Type of Ground Truth Used:

Biocompatibility Standards: Ground truth is established by adherence to in vitro and in vivo testing protocols defined by international standards (ANSI/AAMI/ISO 10993).
Sterilization Standards: Ground truth is established by adherence to validation protocols defined by international standards (ANSI/AAMI/ISO 11137 & 11737).
Predicate Device Characteristics: For functional aspects (like polymerization time), the "ground truth" or benchmark is the performance characteristics of the legally marketed predicate devices.

8. Sample Size for the Training Set:

Not applicable / Not specified. This concept is for AI/ML models, not for a traditional medical device. There is no "training set" in the context of this 510(k) submission.

9. How the Ground Truth for the Training Set Was Established:

Not applicable / Not specified.

Summary

{0}------------------------------------------------

K063202

Procurement Technology Syrtem/.

510(k) SUMMARY ProDerma - Liquid Bandage

Submitted By:	Procurement Technology Systems, LLC2375 Hwy 101 South, Bldg AGreer, SC 29651Telephone: 864-655-3500Fax: 702-447-7243Contact Name: Bill GriswoldDate Prepared: September 9, 2006	MAY - 2 200
Device Name:	Trade Name: ProDermaCommon Name: Liquid BandageProduct Code: KMFClassification: Class ICFR Section: 880.5090
Predicate Devices:	Liquiderm™ Liquid Adhesive Bandage – K002338MFG By: Closure Medical CorporationMarketed As: Johnson & Johnson Band-Aid® Liquid Bandage
	LiquiShield™ Liquid Bandage – K031321MFG By: Medlogic Global LtdMarketed As: LiquiShield™
	DERMA+FLEX™ Gel Adhesive – K050757MFG By: Chemence Medical ProductsMarketed As: DERMA+FLEX™
Description:	ProDerma Liquid Bandage, a formulated Cyanoacrylate adhesive, is a violet tinted, clear liquid topical bandage composed of 2-Octyl and N-Butyl Cyanoacrylate monomers, a plasticizer and D&C violet #2 pigment.ProDerma is packaged in a single use applicator containing up to 0.5 grams of product. The single use applicator is constructed in the shape of “tear drop” with the flat bottom side made of a flexible laminated film of Pet/AL/Nitrile and a flexible laminate of either Nitrile/PE or Nitrile/PP/PE formed as a blister on the top side with a polyurethane foam sponge for applying the liquid bandage. Each applicator is individually packaged in a blister with a Tyvek backing. The applicators are packaged in a box with a quantity ranging of 6 to 24 per box depending on the customer's requirements. The applicator is opened by folding over the packet

{1}------------------------------------------------

KO 63202

Procurement Technology Syrtem

510(k) SUMMARY ProDerma - Liquid Bandage

at the narrow end under the foam sponge onto itself. The liquid flows into the foam sponge and is control by the user as pressure is applied to the applicator. ProDerma is then applied to the area in need.

Applicators sterilized to a Sterilization Acceptance Level (SAL) of 10° via commercially available irradiation facilities.

Indications for Use: ProDerma Liquid Bandage is indicated for Over-The-Counter (OTC) use to cover minor cuts, scrapes and minor irritations of the skin and help protect them from infection.
ProDerma should not be applied near the eyes. Do not use on Contraindications: areas that are infected or that show signs of infection or drainage. Avoid using ProDerma on major wounds that require wound closure with another device.
Technological Characteristics: ProDerma Liquid Bandage is applied to the desired area and polymerizes to form a mechanical bond with the skin. The polymerization process time varies based on the amount of ProDerma applied. The polymerization or set time typically occurs within less than 2 minutes. Once the polymerization is complete the resulting film acts as a cover allowing the wound to heal. During the healing process the polymer covering sloughs off naturally, as dead skin cells are shed and replaced with new ones.

Substantial Equivalence: ProDerma - Liquid Bandage is similar to the predicate devices listed in the section named "Predicate Devices" in that all are cyanoacrylate based liquid bandages. They are manufactured in a similar manner using synthesization and distillation methods and blending with other ingredients and sterilized in its finished package.

Testing Summary: ProDerma - Liquid Bandage has been subjected to the appropriate biocompatibility testing in accordance with ANSI/AAMI/ISO 10993 and the results have confirmed that the product is safe for its intended use. ProDerma has also been subject to the appropriate sterilization validation testing in accordance with ANSI/AAMI/ISO 11137 & 11737 and the results have confirmed that the method of sterilization selected for ProDerma provides a SAL level 10th in the finished individual applicator package.

{2}------------------------------------------------

Image /page/2/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo consists of a stylized eagle with its wings spread, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle. The eagle is black, and the text is also black.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Procurement Technology Systems, LLC % Mr. Bill Griswold P.O. Box 748 Duncan, South Carolina 29334-0748

Re: K063202

Trade/Device Name: ProDerma - Liquid Bandage Regulation Number: 21 CFR 880.5090 Regulation Name: Liquid bandage Regulatory Class: I Product Code: KMF Dated: March 20, 2007 Received: March 21, 2007

MAY - 2 2007

Dear Mr. Griswold:

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 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.

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

Page 2 - Mr. Bill Griswold

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 yours

Mark N. Molkersaan

Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

{4}------------------------------------------------

Indications for Use

510(k) Number (if known): _ K 063 202

Device Name: ProDerma - Liquid Bandage

Indications for Use:

ProDerma Liquid Bandage is indicated for over-the-counter (OTC) use to cover minor cuts, scrapes and minor irritations of the skin and help protect them from infection.

Prescription Use (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use_ X (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)

Pele m

(Division Sign-Off) Division of General, Restorative, and Neurological Devices

510(k) Number L063262

Indications for Use Statement 09-09-06

Page 1 of 1

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.