wettrust D2care is a personal lubricant for vaginal application, intended to moisturize and lubricate, to enhance the ease and comfort of intimate sexual activity and supplement the body's natural lubrication. This product is not compatible with natural rubber latex or polyurethane condoms. This product is compatible with synthetic polyisoprene condoms.

Device Description

wettrust D2care is a water-based personal lubricant that is packaged in a single use prefilled one-push syringe. The primary ingredients include water, glycerin, and hydroxethylcellulose. The device specifications include appearance, color, odor, pH, viscosity, osmolality, antimicrobial effectiveness, total aerobic microbial count, total yeast and mold count, and absence of pathogenic organisms.

AI/ML Overview

Here's an analysis of the provided text, focusing on acceptance criteria and the study data:

1. Table of Acceptance Criteria and Reported Device Performance

For the wettrust D2care personal lubricant, the acceptance criteria are generally established by compliance with various national and international standards. The document doesn't explicitly list "acceptance criteria" then "reported performance" side-by-side in a single table, but rather states that the device was tested in accordance with standards and demonstrated compliance.

Test Category	Acceptance Criteria (Standard Reference / Goal)	Reported Device Performance
Material Biocompatibility	ISO 10993-1 (Cytotoxicity, Sensitization, Irritation, Acute Systemic Toxicity)	Device demonstrated to be biocompatible.
Condom Compatibility	ASTM D7661 (with Synthetic Polyisoprene Condoms)	Device demonstrated to be compatible with synthetic polyisoprene condoms.
Antimicrobial Effectiveness	USP <51>	Device passed Antimicrobial Effectiveness Testing.
Total Aerobic Microbial Counts	USP <61>	Device passed Total Aerobic Microbial Counts.
Total Yeast and Mold Counts	USP <61>	Device passed Total Combined Yeast and Mold Counts.
Absence of Pathogenic Organisms	USP <62>	Device passed Absence of Pathogenic Organisms testing.
Shelf Life	ASTM F1980	Device meets its specifications over the duration of its proposed shelf life.
Physical/Chemical Specifications	Appearance, color, odor, pH, viscosity, osmolality (internal specs implied)	Device meets specifications. (Implied by meeting shelf-life)

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

The document provided does not specify the sample sizes used for the test sets for any of the non-clinical performance data. It mentions the types of tests and the standards they adhere to, but not the number of units/samples tested.

The data provenance is for a manufacturing company based in Korea (Wettrust Korea Co., Ltd.). The studies are non-clinical performance tests conducted to demonstrate substantial equivalence, which are typically prospective in nature for a new device.

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

This information is not applicable and not provided in the document. The studies performed are non-clinical, laboratory-based performance tests (e.g., biocompatibility, microbial counts, condom compatibility) against established standards. These types of tests do not involve human expert adjudication for a "ground truth" in the way a diagnostic AI study would. The "ground truth" here is the adherence to the methodologies and pass/fail criteria of the specified international/national standards.

4. Adjudication Method for the Test Set

This is not applicable and not provided. As mentioned above, these are non-clinical hardware/chemical performance tests, not studies requiring expert adjudication of results.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size

This is not applicable. The device is a personal lubricant, not a diagnostic imaging device or an AI-powered tool that would typically undergo an MRMC study. The studies performed are non-clinical performance and safety tests.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

This is not applicable. The device is a physical product (personal lubricant), not an algorithm or software.

7. The Type of Ground Truth Used

The "ground truth" for the non-clinical performance studies is compliance with the methodologies and acceptance criteria defined by the referenced international and national standards. For example, the "ground truth" for biocompatibility is that the device passes all tests outlined in ISO 10993-1. For condom compatibility, it's that the device meets the performance requirements specified in ASTM D7661 after exposure to synthetic polyisoprene condoms.

8. The Sample Size for the Training Set

This is not applicable as the device is a personal lubricant and not an AI/ML algorithm or software that requires a training set.

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

This is not applicable as the device is a personal lubricant and not an AI/ML algorithm or software.

Summary

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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo features the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.

December 6, 2017

Wettrust Korea Co., Ltd. % Jigar Shah Consultant mdi Consultants, Inc. 55 Northern Blvd. Great Neck, NY 11021

Re: K170797 Trade/Device Name: wettrust D2care Regulation Number: 21 CFR§ 884.5300 Regulation Name: Condom Regulatory Class: II Product Code: NUC Dated: October 24, 2017 Received: October 26, 2017

Dear Jigar Shah:

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.

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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 803); 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.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

Image /page/1/Picture/6 description: The image shows the name "Charles Viviano -S" in a large, sans-serif font. The text is black and stands out against a light background. The name is likely a person's name, with "-S" possibly indicating an initial or a designation.

For Benjamin R. Fisher, Ph.D. Director Division of Reproductive, Gastro-Renal, and Urological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K170797

Device Name wettrust D2care

Indications for Use (Describe)

Type of Use (Select one or both, as applicable)
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Prescription Use (Part 21 CFR 801 Subpart D)

|X | Over-The-Counter Use (21 CFR 801 Subpart C)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

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510(k) Summary

Date Prepared: December 5, 2017

1. Company and Correspondent:

	Company
Name	Wettrust Korea Co., Ltd.
Address	312 The Prau, 27 Jeongjail-ro, Bundang-guSeongnam, Gyeonggi-do, Korea463-480
PhoneFaxContact	+82(31) 719-8394+82(31) 719-8395Sungho Lee / Director

2. Device:

Proprietary Name	wettrustD2care
Common Name	Personal Lubricant
Classification Name	Condom (21 CFR 884.5300)
Product code	NUC (lubricant, personal)
Class	II

3. Predicate Device:

Replens Long-lasting Vaginal Moisturizer (K101241) The predicate device has not been subject to a design-related recall.

4. Description:

5. Indications for use:

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6. Substantial Equivalence Discussion

The following tables outline the similarities and differences between wettrust D2care and the predicate device.

Device Name	WettrustD2care(Subject Device)	Replens Long-lasting VaginalMoisturizer(Predicate Device)
510(k)	K170797	K101241
Manufacturer	Wettrust Korea Co., Ltd.	Lil Drug Store Products, Inc.
Indications forUse statement	wettrust D2Care is a personallubricant for vaginal application,intended to moisturize and lubricate,to enhance the ease and comfort ofintimate sexual activity, andsupplement the body's naturallubrication. This product is notcompatible with natural rubber latexor polyurethane condoms. Thisproduct is compatible with syntheticpolyisoprene condoms.	Replens is a personal lubricant forvaginal application, intended tomoisturize and lubricate, to enhance theease and comfort of intimate sexualactivity and supplement the body'snatural lubrication. This product iscompatible with natural rubber latexcondoms and synthetic (polyurethaneand polyisoprene) condoms.
Ingredients	Purified waterGlycerinHydroxyethylcelluloseSodium LactateMethylparabenAloe Barbadensis Leaf JuiceButylene glycolCamellia Sinensis Leaf ExtractLactic acidChamomilla Recutita (Matricaria)Flower ExtractMorus Alba Bark ExtractDisodium EDTASodiumHyaluronate	Purified waterGlycerin MineralOilPolycarbophilCarbomer Homoploymer Type BSorbic AcidSodium Hydroxide.MethylparabenHydrogenated Palm Oil Glyceride

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CondomCompatibility	Synthetic polyisoprene condoms	Natural rubber latex condoms andsynthetic (polyurethane andpolyisoprene) condoms
Sterilization	Non-sterile	Non-sterile
Single UseApplicator	Yes	Yes

The subject and predicate device have the same intended use – supplementation of lubrication during intercourse.

The subject and predicate device have different technological characteristics, including ingredients and specifications. These differences in technological characteristics do not raise different questions of safety and effectiveness.

7. Non-Clinical Performance Data

The following tests were completed on wettrust D2care in accordance with national and international standards to support substantial equivalence to the predicate device.

. Biocompatibility (per ISO 10993-1). including cytotoxicity, sensitization, irritation, and acute systemic toxicity, demonstrating that the subject device is biocompatible
. Condom Compatibility Testing (per ASTM D7661) demonstrating that the subject device is compatible with synthetic polyisoprene condom
. Antimicrobial Effectiveness Testing (per USP <51>)
. Total Aerobic Microbial Counts (per USP <61>)
Total Combined Yeast and Mold Counts (per USP <61>
Absence of Pathogenic Organisms (per USP <62>)
. Shelf Life (per ASTM F1980) demonstrating that the subject device meets its specifications over the duration of its proposed shelf life

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8. Conclusion

The wettrust D2care is substantially equivalent to the proposed predicate device.

Regulation Number and Section

§ 884.5300 Condom.

(a)
Identification. A condom is a sheath which completely covers the penis with a closely fitting membrane. The condom is used for contraceptive and for prophylactic purposes (preventing transmission of sexually transmitted infections). The device may also be used to collect semen to aid in the diagnosis of infertility.(b)
Classification. (1) Class II (special controls) for condoms made of materials other than natural rubber latex, including natural membrane (skin) or synthetic.(2) Class II (special controls) for natural rubber latex condoms. The guidance document entitled “Class II Special Controls Guidance Document: Labeling for Natural Rubber Latex Condoms Classified Under 21 CFR 884.5300” will serve as the special control. See § 884.1(e) for the availability of this guidance document.