TearRepair is intended to be used in areas exposed to mechanical forces such as friction and shear from bedding, olothing. shoes, or any material that may damage the skin. TearRepair can also be used to irritation from moisture such as urine, feces, digestive juices, perspiration, and wound drainage. TearRepair can also help protect the skin against irritation caused by adhesive products.

Device Description

TearRepair Liguid Skin Protectant is a rapid-drying liquid barrier film for the protection of the skin. It is applied as a liquid and dries within minutes, adhering to the contours of the skin to form a transparent flexible film. TearRepair will wear off, naturally, and is provided as a singleuse, sterile device provided as Rx Only.

AI/ML Overview

The provided text describes a 510(k) premarket notification for a medical device called "TearRepair Liquid Skin Protectant." This submission seeks to demonstrate that the new device is substantially equivalent to a legally marketed predicate device, "Marathon No Sting Liquid Skin Protectant" (K133443).

However, the document does not contain the information requested in the prompt regarding acceptance criteria and a study proving the device meets those criteria, particularly for an AI/ML powered device. The "TearRepair Liquid Skin Protectant" is a physical medical device (liquid bandage) and not an AI/ML-powered device.

Therefore, I cannot extract the following information from the provided text:

A table of acceptance criteria and the reported device performance: Not applicable for this type of device in the provided text.
Sample size used for the test set and the data provenance: Not provided, as this is not an AI/ML study.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not provided, as this is not an AI/ML study.
Adjudication method for the test set: Not provided, as this is not an AI/ML study.
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, as this is not an AI/ML device.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable, as this is not an AI/ML device.
The type of ground truth used: Not applicable, as this is not an AI/ML study.
The sample size for the training set: Not applicable, as this is not an AI/ML device.
How the ground truth for the training set was established: Not applicable, as this is not an AI/ML device.

The document focuses on non-clinical bench testing and biocompatibility testing for a physical liquid skin protectant, as summarized below:

Summary of Non-Clinical Testing

The following tests were performed to demonstrate safety based on current industry standards, indicating that TearRepair is substantially equivalent to the predicate device:

Bench Testing:

Mechanical Testing/Adhesive strength testing
Heat of Polymerization
Moisture Vapor Transmission Rate
Setting Time of Liquid Skin Protectant
Applicator Functionality

Biocompatibility (ISO 10993 series):

Cytotoxicity (ISO 10993-5)
Sensitization (ISO 10993-10)
Irritation (ISO 10993-10)
Acute systemic toxicity (ISO 10993-11)
Material-mediated pyrogenicity (ISO 10993-11, USP <151>)
Subacute toxicity (ISO 10993-11)
Implantation (ISO 10993-6)

Acceptance Criteria and Reported Device Performance
The document states that "No FDA performance standards have been established for TearRepair." Therefore, while specific tests are listed, the explicit quantitative acceptance criteria and the numerical reported performance for each test are not provided in the given text. The conclusion merely states that the results "indicate that TearRepair is substantially equivalent to the predicate device" and "does not raise different questions of safety or effectiveness compared to the predicate devices."

Summary

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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

September 27, 2024

OptMed, Inc. % Allison Komiyama VP, MedTech Innovations Ram+ 2790 Mosside Blvd. Suite 800 Monroeville, Pennsylvania 15146

Re: K241916

Trade/Device Name: TearRepair Liquid Skin Protectant Regulation Number: 21 CFR 880.5090 Regulation Name: Liquid Bandage Regulatory Class: Class I, reserved Product Code: KMF Dated: June 28, 2024 Received: July 1, 2024

Dear Allison Komiyama:

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 (the 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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database available at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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.

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Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).

Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).

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 of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.

All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rule"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-device-advicecomprehensive-regulatory-assistance/unique-device-identification-system-udi-system.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

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For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

Yu-chieh Chiu -S

Yu-Chieh Chiu, Ph.D. Assistant Director DHT4B: Division of Plastic and Reconstructive Surgery Devices OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K241916

Device Name TearRepair Liquid Skin Protectant

Indications for Use (Describe)

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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510(k) SUMMARY

DATE PREPARED

September 23, 2024

MANUFACTURER AND 510(k) OWNER

OptMed. Inc. 745 Fifth Ave., Suite 500 New York, New York 10151 Telephone: Official Contact: Nitasha Yajnik, Associate Director, Quality and Regulatory Assurance

REPRESENTATIVE/CONSULTANT

Allison C. Komiyama, Ph.D., RAC (RQM+) Lucie Dalet, Ph.D. (RQM+) Bhoomika Joyappa (Medical Device Academy, Inc.) Telephone: +1 (412) 816-8139 Email: akomiyama@rqmplus.com ldalet@rqmplus.com

DEVICE INFORMATION

Proprietary Name/Trade Name:	TearRepair Liquid Skin Protectant
Common Name:	Bandage, Liquid
Regulation Number:	21 CFR 880.5090
Class:	I
Product Code:	KMF
Premarket Review:	Office of Surgical and Infection Control Devices (OHT4)Infection Control and Plastic and Reconstructive SurgeryDevices (DHT4B)
Review Panel:	General & Plastic Surgery

PREDICATE DEVICE IDENTIFICATION

TearRepair is substantially equivalent to the following predicate:

510(k) Number	Predicate Device Name / Manufacturer	PrimaryPredicate
K133443	Marathon No Sting Liquid Skin Protectant/ AdvancedMedical Solutions (Plymouth) Ltd.	✓

The predicate device has not been subject to a design related recall.

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DEVICE DESCRIPTION

INDICATIONS FOR USE

TearRepair is intended to be used in areas exposed to mechanical forces such as friction and shear from bedding, clothing, shoes, or any material that may damage the skin. TearRepair can also be used to protect skin exposed to irritation from moisture such as urine, feces, digestive juices, perspiration, and wound drainage. TearRepair can also help protect the skin against irritation caused by adhesive products.

COMPARISON OF TECHNOLOGICAL CHARACTERISTICS

OptMed, Inc. believes that the TearRepair is substantially equivalent to the predicate device based on the information summarized here:

The subject device has a similar design and uses similar materials as the device cleared in K133443. The subject device has the similar intended use and similar technological characteristics to the devices cleared in K133443. The device has similar instrumentation to the device cleared in K133443. These technological characteristics have undergone testing to ensure the device is as safe and effective as the predicates.

	Subject DeviceTearRepair Liquid SkinProtectant	Primary PredicateDeviceMarathon No Sting LiquidSkin Protectant	Comparison
Manufacturer	OptMed, Inc.	Advanced MedicalSolutions	N/A
510(k)Number	TBD	K133443	N/A
Device Image	Image: TearRepair Liquid Skin Protectant	Image: Marathon No Sting Liquid Skin Protectant	N/A
Single-Use	Yes	Yes	Equivalent
PatientPopulation	Adults over the age of 21	Unknown	Equivalent
	Subject DeviceTearRepair Liquid SkinProtectant	Primary PredicateDeviceMarathon No Sting LiquidSkin Protectant	Comparison
Indicationsfor Use	TearRepair is intended to beused in areas exposed tomechanical forces such asfriction and shear frombedding, clothing, shoes, orany material that maydamage the skin. TearRepaircan also be used to protectskin exposed to irritationfrom moisture such as urine,feces, digestive juices,perspiration, and wounddrainage. TearRepair canalso help protect the skinagainst irritation caused byadhesive products.	Marathon No Sting LiquidSkin Protectant helpsprotect skin exposed toIrritation from moisturesuch as urine, feces,digestive juices,perspiration, and wounddrainage.Marathon No StingLiquid Skin Protectantcan also be used in areasthat are exposed tofriction and shear frombedding, clothing, shoes,or any material that willrub against the skin.Marathon No StingLiquid Skin Protectanthelps protect the skinagainst Irritation causedby adhesive products.	Equivalent
Type of Use	Prescription (Rx Only)	Prescription (Rx Only)	Equivalent
OperatingPrinciple	The healthcare provideractuates the device bysqueezing the applicatorwalls, crushing the glassampoule within allowingthe adhesive to flow to theapplication tip. Theadhesive is applied as aliquid and polymerizes,adhering to the contours ofthe skin to form atransparent, flexible film.TearRepair wears offnaturally as the skinregenerates.	The adhesive is accessedby crushing the glassampoule. This isachieved by holding itvertically with the tipupper most, and then theglass ampoule is brokenby squeezing theapplicator walls betweenfinger and thumb.The adhesive isexpressed by invertingthe applicator and gentlysqueezing the applicatorbody until the adhesivewets the tip of theapplicator. The adhesive	Equivalent
	Subject DeviceTearRepair Liquid SkinProtectant	Primary PredicateDeviceMarathon No Sting LiquidSkin Protectant	Comparison
		is applied to the requiredarea as a thin film andallowed to polymerizesolid.
Monomer	Methylidene malonate	Cyanoacrylate	Similar; both aremonomer/polymermaterials; doesnot raise issues ofsafety andeffectiveness based onperformance,biocompatibility,sterilization andshelf-life testing.
Dispenser	Applicator sleevecontaining a glassampoule that, whencrushed, allows forexpressing the adhesivethrough the tip;Polyolefin/PP Molded tip	Applicator sleevecontaining a glassampoule that, whencrushed, allows forexpressing the adhesivethrough the tip; Spongeapplicator	Similar;applicator tip ofsubject device ismade of apolyolefin/PPmolded part whilethe predicatedevice has asponge applicator.Performancetesting does notraise new issuesof safety andeffectiveness.
Outer PlasticTube	Yes	Yes	Equivalent
Applicator TipShape	Domed	Deerfoot	Similar;applicatorfunctionalitytestingperformed tosupportequivalent
	Subject DeviceTearRepair Liquid SkinProtectant	Primary PredicateDeviceMarathon No Sting LiquidSkin Protectant	Comparison
			performance tothe predicate.
Adhesive	Yes	Yes	Equivalent
Stability andShelf-life	Real Time Aged Product Environmental Conditioning and Distribution Testing Product Stability Testing Package integrity	Unknown; Redacted from510(k).	Similar; testingdemonstrates thatthe device issubstantiallyequivalent topredicate
Sterilization	Gamma Irradiation	EtO	Similar; bothproducts sterilizedaccording tovalidated processes

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SUMMARY OF NON-CLINICAL TESTING

No FDA performance standards have been established for TearRepair. The following tests were performed to demonstrate safety based on current industry standards:

Bench Testing:

Mechanical Testing/Adhesive strength testing
Heat of Polymerization .
Moisture Vapor Transmission Rate .
. Setting Time of Liquid Skin Protectant
Applicator Functionality

Biocompatibility:

Cytotoxicity (ISO 10993-5)
Sensitization (ISO 10993-10) ●
Irritation (ISO 10993-10) ●
. Acute systemic toxicity (ISO 10993-11)
Material-mediated pyrogenicity (ISO 10993-11, USP <151>)
Subacute toxicity (ISO 10993-11) .
. Implantation (ISO 10993-6)

The results of these tests indicate that TearRepair is substantially equivalent to the predicate device.

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CONCLUSION

Based on the testing performed, including wound closure strength, shear strength, and tensile strength, and biocompatibility testing, it can be concluded that the subject device does not raise different questions of safety or effectiveness compared to the predicate devices. The similar indications for use, technological characteristics, and performance characteristics for the proposed TearRepair are assessed to be substantially equivalent to the predicate device.

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.