SILICONE Personal Lubricant 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

SILICONE Personal Lubricant is a non-sterile, clear and odorless siliconebased personal lubricant for use during intimate sexual activity. This device is compatible with natural rubber latex and polyisoprene condoms. This device is not compatible with polyurethane condoms. Its formulation consists of dimethicone and dimethiconol. The product is packed into a 3.38 oz (100 mL) bottle.

AI/ML Overview

This document describes the non-clinical performance testing for the "SILICONE Personal Lubricant" device (K191654) to demonstrate its substantial equivalence to a predicate device.

Here's the breakdown of the acceptance criteria and the studies performed:

1. Table of Acceptance Criteria and Reported Device Performance

Property	Acceptance Criteria	Reported Device Performance
Viscosity (@ 25°C) per USP <912>	300-700 cps	300-700 cps (met within the specified range)
Total aerobic microbial count (TAMC) per USP <61>	< 10 CFU/g	< 10 CFU/g
Total yeast and mold count (TYMC) per USP <61>	< 10 CFU/g	< 10 CFU/g
Absence of Escherichia coli per USP <62>	Absence	Absence
Absence of Pseudomonas aeruginosa per USP <62>	Absence	Absence
Absence of Staphylococcus aureus per USP <62>	Absence	Absence
Absence of Salmonella Enterica subsp. per USP <62>	Absence	Absence
Absence of Candida albicans per USP <62>	Absence	Absence
Absence of Clostridium sporogenes per USP <62>	Absence	Absence
Absence of Bile-tolerant Gram-negative Bacteria per USP <62>	Absence	Absence
Shelf Life (Accelerated Aging Study)	Device met all specifications	Device met all specifications at baseline and throughout the proposed shelf life (18 months)
Condom Compatibility (Natural Rubber Latex)	Compatible	Compatible (with three different brands of natural rubber latex condoms)
Condom Compatibility (Polyisoprene)	Compatible	Compatible (with one brand of polyisoprene condom)
Condom Compatibility (Polyurethane)	Not Compatible (This is a negative acceptance criterion for comparison to predicate)	Not Compatible (with one brand of polyurethane condom)
Cytotoxicity (ISO 10993-5:2009)	Non-cytotoxic	Non-cytotoxic
Sensitization (ISO 10993-10:2010)	Non-sensitizing	Non-sensitizing
Vaginal Irritation (ISO 10993-10:2010)	Non-irritating	Non-irritating
Acute Systemic Toxicity (ISO 10993-11:2017)	Not systemically toxic	Not systemically toxic

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

Microbial Purity and Viscosity: The document does not specify a separate "test set" sample size for these chemical and microbiological tests. These are typically performed on representative batches of the final product. The data provenance is implied to be from the manufacturer's internal testing as part of their quality control and submission process.
Shelf Life: The sample size for the accelerated aging study is not explicitly stated. The data provenance is from the manufacturer's testing.
Condom Compatibility: The testing involved "three different brands of natural rubber latex," "one brand of polyisoprene," and "one brand of polyurethane condoms." The specific number of individual condoms tested for each brand is not provided. The data provenance is from testing performed to ASTM D7661-10.
Biocompatibility: The specific sample sizes (e.g., number of animals for irritation/sensitization, cell cultures for cytotoxicity) are not provided in this summary. The data provenance is from testing performed according to ISO 10993 standards.

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

This document describes non-clinical performance testing for a medical device (personal lubricant) rather than a diagnostic or AI-driven device. Therefore, the concept of "experts" establishing a "ground truth" for a test set in the way it applies to image interpretation or clinical diagnosis is not directly applicable here. The "ground truth" for these tests is based on established scientific methods and standards (USP, ASTM, ISO) and laboratory measurements.

4. Adjudication method for the test set

Not applicable, as this is non-clinical performance testing following standardized protocols, not human-in-the-loop diagnostic assessment.

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

Not applicable. This is not an AI-driven or diagnostic device, so MRMC studies are not relevant.

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

Not applicable. This is not an algorithm or AI device.

7. The type of ground truth used

The "ground truth" for the various tests is established by:

Laboratory measurements and analytical chemistry: For properties like viscosity, appearance, color, and odor.
Microbiological testing standards (USP <61>, USP <62>): For microbial counts and absence of specific pathogens.
Accelerated aging protocols: For shelf life, confirming product specifications remain within limits over time.
ASTM D7661-10 standard: For condom compatibility, which involves physical testing of condom integrity after exposure to the lubricant.
ISO 10993 series of standards: For biocompatibility, involving in vitro (cytotoxicity) and in vivo (sensitization, irritation, acute systemic toxicity) tests.

8. The sample size for the training set

Not applicable. This document does not describe an AI or machine learning model that requires a training set.

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

Not applicable. There is no training set mentioned in this document.

Summary

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April 14, 2020

Bath Concept Cosmetics (Dongguan) Co., Ltd % Wei Zhang, Ph.D., RAC Regulatory Manager RGLM Consulting LLC 3302 171 St Pl SE Bathell, WA 98012

Re: K191654

Trade/Device Name: SILICONE Personal Lubricant Regulation Number: 21 CFR 884.5300 Regulation Name: Condom Regulatory Class: II Product Code: NUC Dated: March 10, 2020 Received: March 13, 2020

Dear Wei Zhang:

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. 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 located 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.

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

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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) for devices or postmarketing safety reporting (21 CFR 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 4, Subpart A) for combination products; 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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

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,

Monica D. Garcia, Ph.D. Acting Assistant Director DHT3B: Division of Reproductive. Gynecology and Urology Devices OHT3: Office of GastroRenal, ObGyn, General Hospital and Urology 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) K191654

Device Name SILICONE Personal Lubricant

Indications for Use (Describe)

Type of Use (Select one or both, as applicable)
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Registration (Part 21 CFR 201, Subpart D)
Over-The-Counter (Part 21 CFR 201, Subpart G)

__ Prescription Use (Part 21 CFR 801 Subpart D)

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

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510(k) Summary – K191654

SILICONE Personal Lubricant

A. General Information

Submitter	Bath Concept Cosmetics (Dongguan) Co., LtdNo.2, Dushang Industrial Zone, DaFen, WanJiangDistrict, Dongguan city, Guangdong, China
Contact Person(Preparer)	Wei Zhang, PhD RACRGLM consulting LLCRegulatory ManagerTel: 425-236-4274Email: wei@rglm-fda.com
Date prepared	April 13, 2020

B. Device

Propriety Name	SILICONE Personal Lubricant
Common Name	Personal Lubricant
Product Code	NUC (Lubricant, Personal)
Regulatory Class	II
Regulation Number	21 CFR §884.5300
Regulation Name	Condom

C. Predicate Device

Name	ONE® SILICONE Personal Lubricant
Owner	ONE®, 12 Channel Street Boston, MA 02210
510(k) number	K110690

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

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D. Description of the Device

Property	Specification
Appearance	Clear Gel
Color	Colorless
Odor	Odorless
Viscosity (@ 25°C) per USP <912>	300-700cps
Total aerobic microbial count (TAMC) per USP <61>	< 10 CFU/g
Total yeast and mold count (TYMC) per USP <61>	< 10 CFU/g
Absence of Pathogens per USP <62>
Escherichia coli	Absence
Pseudomonas aeruginosa	Absence
Staphylococcus aureus	Absence
Salmonella Enterica subsp.	Absence
Candida albicans	Absence
Clostridium sporogenes	Absence
Bile-tolerant Gram-negative Bacteria	Absence

Table 1. Subject Device Specifications

E. Indications for Use

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	Subject Device	Predicate Device
Product	SILICONE Personal Lubricant	ONE® SILICONE PersonalLubricant
Sponsor	Bath Concept Cosmetics(Dongguan) Co., Ltd	ONE®
510(k) number	K191654	K110690
Regulation No.	21 CFR §884.5300	21 CFR §884.5300
Product Code	NUC	NUC
Class	II	II
Intended use	SILICONE Personal Lubricantis an over-the-counter personallubricant.	ONE® SILICONE PersonalLubricant is an over-the-counter personal lubricant.
Indications forUse	SILICONE Personal Lubricantis a personal lubricant, forpenile and/or vaginalapplication, intended tomoisturize and lubricate, toenhance the ease and comfortof intimate sexual activity andsupplement the body's naturallubrication. This product iscompatible with natural rubber	ONE® SILICONE PersonalLubricant is a personallubricant, for penile and/orvaginal application, intendedto moisturize and lubricate, toenhance the ease andcomfort of intimate sexualactivity and supplement thebody's natural lubrication.This product is compatible
	latex and polyisoprenecondoms. This product is notcompatible with polyurethanecondoms.	with natural rubber latex,polyisoprene, andpolyurethane condoms.
OTC use?	Yes	Yes
Primaryingredients	DimethiconeDimethiconol	DimethiconeDimethiconol
Targetedpopulation	Adult	Adult
Appearance	Clear	Clear
Color	Colorless	Colorless
Odor	No Odor	No Odor
Viscosity (25°C)	300-700cps	300-400 cps
Total aerobicmicrobial count(TAMC)	< 10 CFU/g	< 10 CFU/g
Total yeast andmold count(TYMC)	< 10 CFU/g	< 10 CFU/g
Absence ofpathogenicorganisms	Absence	Not provided
Application site	Penile and/or vaginal	Penile and/or vaginal
CondomCompatibility	Natural Rubber Latex andPolyisoprene	Natural Rubber Latex,Polyurethane, andPolyisoprene
Sterility	Non-sterile	Non-sterile
BiocompatibilityTests	Comply with ISO 10993biocompatibility evaluation	Comply with ISO 10993biocompatibility evaluation

F. Comparison of Intended Use and Technological Characteristics to the Predicate Device

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Shelf Life	1 year & 6 months (18 months)	1 year (12 months)
------------	-------------------------------	--------------------

The subject product and the predicate device have similar indications for use statements and have the same Intended Use.

The subject and predicate device have different technological characteristics, including different shelf-life and condom compatibility. The differences in technological characteristics described above between the subject and predicate device do not raise different questions of safety and effectiveness.

G. Summary of non-clinical performance testing:

Shelf life

SILICONE Personal Lubricant has a one-year-and-six-month (18 months) shelf life based on the results of an accelerated aging study. The results of the shelf life study demonstrated that the subject device met all device specifications at baseline and throughout the proposed shelf life.

Condom Compatibility

The compatibility of the SILICONE Personal Lubricant with male condoms was tested in accordance with ASTM D7661-10 Standard Test Method for Determining Compatibility of Personal Lubricants with Natural Rubber Latex Condoms. Condom compatibility testing was performed with three different brands of natural rubber latex, one brand of polyisoprene, and one brand of polyurethane condoms. The results indicate that SILICONE Personal Lubricant is compatible with natural rubber latex and polyisoprene condoms and is not compatible with polyurethane condoms.

Biocompatibility

The biocompatibility evaluation for the SILICONE Personal Lubricant was conducted in accordance with the FDA Guidance "Use of International Standard ISO 10993-1, 'Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process", June 2016, and

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International Standard ISO 10993-1 "Biological Evaluation of Medical Devices - Part 1: Evaluation and Testing Within a Risk Management Process," as recognized by FDA.

The evaluation included the following tests:

Cytotoxicity (ISO 10993-5:2009) .
Sensitization (ISO 10993-10:2010) .
Vaginal Irritation (ISO 10993-10:2010) .
Acute Systemic Toxicity (ISO 10993-11:2017) .

The results of this testing demonstrated that the subject lubricant is noncytotoxic, non-irritating, non-sensitizing, and not systemically toxic.

H. Conclusions

The results of the performance testing described above demonstrate that the SILICONE personal lubricant is as safe and effective as the predicate device and supports a determination of substantial equivalence.

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.