OneTouch™ Lubricant Gel is a personal lubricant, for penile and/or 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 compatible with natural rubber latex and polyisoprene condoms. This product is not compatible with polyurethane condoms.

Device Description

One Touch™ Lubricant Gels by Thai Nippon Rubber Industry Company, Ltd. ("TNR") are a line of personal lubricants, for penile and/or vaginal application, intended to moisturize and lubricate, to enhance the ease and comfort of intimate sexual activity, and supplement the body's natural lubrication. These lubricants are compatible with natural rubber latex and polyisoprene condoms, and are not a contraceptive and do not contain a spermicide. One Touch™ Lubricant Gels are made available in three (3) different versions: One Touch™ Plain, One Touch™ Flavored and One Touch™ Colored, and come packaged in either single-use disposable application film/foil sachets, or in multiple application polyethylene tubes with a flip-top closure. OneTouch™ Lubricant Gels use hydroxyethyl cellulose and refined glycerin as the lubricating agent, with the methyl paraben, propyl paraben and cremophor acting as the antiseptic and preservative additives.

AI/ML Overview

Here's an analysis of the provided text regarding the acceptance criteria and study for the OneTouch™ Lubricant Gel:

This document is a 510(k) premarket notification for a medical device, which seeks to demonstrate substantial equivalence to legally marketed predicate devices, rather than establishing de novo acceptance criteria and proving performance against them in a traditional sense. The "acceptance criteria" here largely refer to meeting recognized standards and demonstrating similar performance to the predicate devices.

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria Category	Specific Test/Standard	Reported Device Performance/Findings
Material Safety	Biocompatibility Testing (Per ISO 10993-1, specifically -5, -10, -11)	OneTouch™ Lubricant Gel passed all biocompatibility testing. (This implies it met the criteria defined by ISO 10993-1 Parts 5, 10, and 11, assessing cytotoxicity, sensitization, and irritation).
Product Compatibility	Condom Compatibility Testing (Per ASTM D7661)	OneTouch™ Lubricant Gel passed all condom compatibility testing. (This means it did not compromise the integrity or performance of natural rubber latex and polyisoprene condoms, as assessed by ASTM D7661).
Microbial Purity	Total Aerobic Microbial Counts (Per USP 37 <61>/<62>)	OneTouch™ Lubricant Gel passed all testing. (Indicates microbial counts were within acceptable limits as per USP 37).
	Total Combined Yeast and Mold Counts (Per USP 37 <61>/<62>)	OneTouch™ Lubricant Gel passed all testing. (Indicates yeast and mold counts were within acceptable limits as per USP 37).
Product Stability	Package Shelf-Life (Per ASTM F1980)	OneTouch™ Lubricant Gel successfully completed testing. (Demonstrated a shelf-life of 3 years, indicating the product maintains its properties and safety over that period when packaged). This is comparable or better than the 1-year shelf life of one predicate and equal to the 3-year shelf life of the other predicate.
Risk Management	Device Risk Analysis (Per ISO 14971)	OneTouch™ Lubricant Gel successfully completed analysis. (Implies identified risks were managed and deemed acceptable according to ISO 14971 principles).

2. Sample size used for the test set and the data provenance

The document does not specify the exact sample sizes used for each individual test (e.g., number of lubricant samples for microbial testing, number of condoms for compatibility testing, or number of batches for shelf-life testing).

The data provenance is from Thailand, as the submission sponsor, Thai Nippon Rubber Industry Co., Ltd., is located in Thailand. The studies would be considered prospective in the sense that they were conducted specifically for this submission to evaluate the OneTouch™ Lubricant Gel.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

This information is not provided in the document. The tests performed are based on established national and international standards (ISO, ASTM, USP), which have predefined methodologies and acceptance limits. The "ground truth" is therefore derived from meeting these objective, quantitative standards, rather than expert consensus on specific cases.

4. Adjudication method for the test set

This is not applicable as the evaluations are based on adherence to quantitative standards and laboratory test results, not subjective expert review or consensus.

5. 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

A Multi-Reader, Multi-Case (MRMC) comparative effectiveness study is not applicable to this device. This type of study is typically used for diagnostic or screening devices where human interpretation (e.g., of images) is involved, potentially with AI assistance. The OneTouch™ Lubricant Gel is a personal lubricant, and its evaluation does not involve human readers interpreting cases or AI assistance in that context.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

A standalone algorithm performance study is not applicable as this device does not involve an algorithm or AI.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

The ground truth for the performance of the OneTouch™ Lubricant Gel is based on objective measurements and adherence to established international and national standards. This includes:

Quantitative laboratory results for biocompatibility (e.g., cell viability, irritation scores), microbial counts (CFU/g), and physical properties for condom compatibility.
Conformance to specifications and acceptance limits predefined by standards such as ISO 10993-1, ASTM D7661, USP 37 <61>/<62>, ASTM F1980, and ISO 14971.

8. The sample size for the training set

This is not applicable. The OneTouch™ Lubricant Gel is a physical medical device (personal lubricant), not an AI/ML algorithm or a diagnostic tool that requires a 'training set' in the computational sense. The product formulation development might involve iterative testing, but this is not typically referred to as a "training set" in this context.

9. How the ground truth for the training set was established

This is not applicable for the reasons stated in point 8.

Summary

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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is an abstract symbol resembling a stylized caduceus or a series of human profiles facing right, rendered in a dark color.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

July 30, 2015

Thai Nippon Rubber Industry Co., Ltd. % Stuart Goldman Senior Consultant Emergo Group 816 Congress Avenue Suite 1400 Austin, Texas 78701

Re: K142790

Trade/Device Name: OneTouch Lubricant Gel Regulation Number: 21 CFR 884.5300 Regulation Name: Condom Regulatory Class: Class II Product Code: NUC Dated: June 30, 2015 Received: July 1, 2015

Dear Stuart Goldman,

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. 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 (reporting of medical device

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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.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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.

You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

Joyce M. Whang -S

for Benjamin 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) K142790

Device Name OneTouch™ Lubricant Gel

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)

PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.

FOR FDA USE ONLY

Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)

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510(k) Summary

for

OneTouch™ Lubricant Gel

1. Submission Sponsor

Thai Nippon Rubber Industry Company, Ltd. ("TNR") 789/139 Pinthong Industrial Estate, Nongkham Sriracha, Chonburi, 20110 Thailand Phone: + 66 38 317 999 Fax: + 66 38 317 950 Contact: Mr. Pisut Chanwatarungkull, Quality Management System Manager Email: pisut c@tnrcondom.com; tnrfact@tnrcondom.com

2. Submission Correspondent

Emergo Group 816 Congress Avenue, Suite 1400 Austin, TX 78701, USA Office Phone: 512.327.9997 Fax: 512.327.9998 Contact: Stuart R. Goldman, Senior Consultant, RA/QA Email: project.management@emergogroup.com

3. Date Prepared

July 30, 2015

4. Device Identification

Trade/Proprietary Name:	OneTouch™ Lubricant Gel
Common/Usual Name:	Lubricant, Personal
Classification Name:	Condom
Classification Regulation:	§884.5300
Product Code:	NUC
Device Class:	Class II
Classification Panel:	Obstetrics/Gynecology

5. Legally Marketed Predicate Device(s)

Global Protection Corp. [ONE® Oasis (K110691)] Ansell Healthcare Products [LifeStyles® Smooth™ 2-in-I Massage & Lubricant (K122476)]

6. Device Description

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polyisoprene condoms, and are not a contraceptive and do not contain a spermicide. One Touch™ Lubricant Gels are made available in three (3) different versions: One Touch™ Plain, One Touch™ Flavored and One Touch™ Colored, and come packaged in either single-use disposable application film/foil sachets, or in multiple application polyethylene tubes with a flip-top closure. OneTouch™ Lubricant Gels use hydroxyethyl cellulose and refined glycerin as the lubricating agent, with the methyl paraben, propyl paraben and cremophor acting as the antiseptic and preservative additives.

7. Indication for Use Statement

8. Substantial Equivalence Discussion

TNR has chosen two predicate devices in the 510(k) submission for their OneTouch™ Lubricant Gel, those being ONE® Oasis by Global Protection Corp. (K110691) and LifeStyles® Smooth™ 2-in-1 Massage & Lubricant by Ansell Healthcare Products (K122476).

The following table 5-1 compares OneTouch™ Lubricant Gels to the predicate devices with respect to intended use, technological characteristics and principles of operation, thus providing more detailed information regarding the basis for the determination of substantial equivalence in this 510(k) submission.

Device	OneTouch™Lubricant Gel	ONE® Oasis	LifeStyles®Smooth™2-in-1 Massage& Lubricant	Differences
510(k):	Pending	K110691	K122476	-
Manufacturer:	Thai NipponRubber IndustryCompany, Ltd.	GlobalProtection Corp.	Ansell HealthcareProducts	-
Product Code:	NUC	NUC	NUC	Same. The subjectand predicatedevices share thesame FDA productcode.
Regulation:	§884.5300	§884.5300	§884.5300	Same. The subjectand predicatedevices share thesame FDAregulation number.
Class:	II	II	II	Same. The subjectand predicatedevices share thesame FDA deviceclassification.
Prescription orOTC Use:	OTC	OTC	OTC	Same. The subjectand predicate
				devices are soldOTC.
Intended Use:	OTC personallubricant.	OTC personallubricant.	OTC personallubricant.	Same. The subjectand predicatedevices are soldOTC and intendedbe used as apersonal lubricant.
Indications forUse:	OneTouch™Lubricant Gel is apersonal lubricantfor penile and/orvaginal application,intended tomoisturize andlubricate, toenhance the easeand comfort ofintimate sexualactivity andsupplement thebody's naturallubricant. Thisproduct iscompatible withnatural rubberlatex, polyisoprene,and polyurethanecondoms.	ONE® Oasis is apersonal lubricant,for penile and/orvaginal application,intended tomoisturize andlubricate, toenhance the easeand comfort ofintimate sexualactivity andsupplement thebody's naturallubrication. Thisproduct iscompatible withnatural rubberlatex,polyisoprene, andpolyurethanecondoms.	Indications for Use:LifeStyles®Smooth™ 2-in-lMassage &Lubricant is apersonalLubricant, forpenile and/orvaginal application,intended tomoisturize andlubricate, toenhance the easeand comfort ofintimate sexualactivity andsupplement thebody's naturallubrication. Thisproduct iscompatible withnatural rubberlatex,polyurethane, andpolyisoprenecondoms.	Similar. The subjectand predicatedevices havevirtually the sameindications for use;any minor wordingdifferencesbetween them areinsignificant totheir intended useand do not affectthe safety orefficacy.
Mode ofOperation(LubricatingAgent):	hydroxyethylcellulose	hydroxyethylcellulose	hydroxyethylcellulose	Similar. The subjectand predicatedevices usehydroxyethylcellulose as themain lubricatingagent in theirproductformulation; overallingredient % mayvary.
Water BasedLubricant:	Yes	Yes	Yes	Same. The subjectand predicatedevices are water-based personallubricants.
Sterile:	No	No	No	Same. The subjectand predicatedevices are notprovided sterile or
				intended to besterilized by theuser.
Body LocationTarget Area:	for penile and/orvaginal application	for penile and/orvaginal application	for penile and/orvaginal application	Same. The subjectand predicatedevices are forpenile and/orvaginal application.
Single Use:	Yes	Yes	Yes	Same. The subjectand predicatedevices are applied,as needed, to thetarget area.
Packaging:	Single use film/foilsachets andmultiple use tubes.	Multiple use tubes.	Multiple useplastic pumpdispenser.	Similar. The subjectand predicatedevices usesomewhat differentsizes and shapes fortheir OTCpackaging, butthese differencesare minor and haveno impact on thesafety or efficacy ofthe personallubricant.
Shelf-life:	3 years	1 year	3 years	Similar. The subjectand predicatedevices have thesame or similarshelf-life for theirOTC packaging, butthese differencesare minor and haveno impact on thesafety or efficacy ofthe personallubricant.
BiocompatibilityTestingPerformed:	YesISO 10993-1(-5, -10, -11)	YesISO 10993-1(-5, -10, -11)	YesISO 10993-1(-5, -10, -11)	Same. The subjectand predicatedevices haveundergonebiocompatibility inaccordance withthe applicable partsof ISO 10993-1.
CondomCompatibilityTestingPerformed:	YesASTM D7661-10	YesASTM D7661-10	YesASTM D7661-10	Same. The subjectand predicatedevices have beentested for condomcompatibility inaccordance withASTM D7661-10.
Microbiological	Yes	Not known	Yes	Same. The subject
Examination ofNon-sterileProductsTesting:	USP 37(<61>/<62>)	USP	and one of thepredicate devices(K122476) havebeen tested formicroorganismcontamination inaccordance withthe applicable partsof the USP.

Table 5-1 OneTouch™ Lubricant Gels vs. Predicate Devices - Similarities and Differences

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9. Non-Clinical Performance Data

As part of demonstrating the safety and effectiveness of OneTouch™ Lubricant Gel and in showing substantial equivalence to the predicate devices, TNR completed a number of tests on their device to prove this. OneTouch™ Lubricant Gel meets all the requirements for overall design, biocompatibility, condom compatibility, microbial contamination, package shelf-life and device risk, which confirms that the outputs meets the design inputs and specifications for the device.

OneTouch™ Lubricant Gel passed all the testing in accordance with national and international standards shown below to support substantial equivalence to the predicate devices.

Biocompatibility Testing (Per ISO 10993-1) ●
Condom Compatibility Testing (Per ASTM D7661)
Total Aerobic Microbial Counts (Per USP 37 <61>/<62>)
Total Combined Yeast and Mold Counts (Per USP 37 <61>/<62>)
Package Shelf-Life (Per ASTM F1980)
Device Risk Analysis (Per ISO 14971) ●

10. Clinical Performance Data

There was no human clinical testing required to support OneTouch™ Lubricant Gel as the indications for use is equivalent to the predicate devices. These types of devices, including the predicate devices, have been on the market for many years with a proven safety and efficacy for the intended use of the device. The non-clinical testing detailed in this submission supports the substantial equivalence of OneTouch™ Lubricant Gel to the predicate devices.

11. Statement of Substantial Equivalence

By definition, a device is substantially equivalent to a predicate device when the subject device has the same intended use and the same technological characteristics as the previously cleared device, or has the same intended use and different technological characteristics, but it can be demonstrated that the new device is substantially equivalent to the predicate device, and that the new device does not raise any questions regarding its safety and effectiveness when compared to the predicate device.

OneTouch™ Lubricant Gel and the predicate devices that are the subject of this 510(k) submission, all function as a personal lubricant for penile and/or vaginal application, intended to moisturize and lubricate, to enhance the ease and comfort of intimate sexual activity and to supplement the body's natural lubricant, and are all compatible with natural

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rubber latex, polyisoprene, and polyurethane condoms, but are not a contraceptive and do not contain a spermicide.

Therefore, based on the substantial equivalence analysis described above, OneTouch™ Lubricant Gel, as designed, developed, manufactured, packaged and tested by TNR, is determined to be substantially equivalent to ONE® Oasis (K110691) and LifeStyles® Smooth™ 2-in-1 Massage & Lubricant (K122476) personal lubricants regulated by the FDA as a Class II medical device under Product Code NUC and §884.5300.

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.