Smile Makers Personal Lubricants are water-based personal lubricants for vaginal application, intended to lubricate and moisturize, 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

Smile Makers personal lubricants are water-based personal lubricants. There are three formulations, Generous Gel, Stay Silky Serum, and Little Light Liquid, that contain the same ingredients, and only differ in amounts of specific ingredients. Ingredients of the lubricants include the following: water (aqua), glycerin, propylene glycol, methyl propanediol, carbomer, sodium benzoate, sodium hydroxide, and dipotassium glycyprizate. They are compatible with natural rubber latex and polyisoprene condoms, but are not compatible with polyurethane condoms. They are provided non-sterile. The product is packaged in 30 ml transparent plastic bottles made of acrylonitrile styrene and polyethylene terephthalate. The bottle contains a pump dispenser made of polypropylene and the cap is made of an aluminum coated low density polyethylene. It is for over-the-counter use.

AI/ML Overview

This document describes the premarket notification (510(k)) for "Smile Makers Personal Lubricants." Therefore, the information provided focuses on demonstrating substantial equivalence to a predicate device, rather than a study proving the device meets acceptance criteria in the context of an AI-powered medical device study. Concepts like "acceptance criteria," "sample size for test set," "number of experts," "adjudication method," "MRMC study," "standalone performance," "ground truth," and "training set" are specific to the development and validation of AI/ML medical devices, which is not what this document addresses.

However, I can extract the closest analogous information from the provided text regarding the device specifications and the studies performed to demonstrate performance and safety in relation to these specifications and the predicate device.

Here's an interpretation based on the provided document, restructured to address your questions where possible, and noting where the information is not applicable to a traditional AI/ML device study:

Device: Smile Makers Personal Lubricants (Smile Makers Little Light Liquid, Smile Makers Stay Silky Serum, and Smile Makers Generous Gel)

Purpose of the Submission: 510(k) Premarket Notification to demonstrate substantial equivalence to a legally marketed predicate device (BioFilm, Inc. - Astroglide Sensual Strawberry, K140590).

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

The acceptance criteria here refer to the product specifications that the manufacturer sets for the lubricant. The "reported device performance" refers to the results of tests demonstrating compliance with these specifications.

Parameter	Specification (Test Method)	Reported Device Performance (Implied "Met Specification")
Appearance & Color	Clear gel, viscous, no visible foreign matter	Implied: Met specification (as concluded to be safe and effective and substantially equivalent).
Odor	Characteristic odor	Implied: Met specification.
Osmolality (10% (w/w) dilution with water)	299 – 449 mOsm/kg	Implied: Met specification.
pH (at 25 °C)	4.90 - 5.50	Implied: Met specification.
Viscosity	56,000 – 84,000 cps (Generous Gel)6,200 – 10,000 cps (Stay Silky Serum)3,700 - 5,600 cps (Little Light Liquid)	Implied: Met specification.
Total Aerobic Microbial Count (USP <61>)	<10 cfu/g	Implied: Met specification.
Total Yeast & Mold Count (USP <61>)	<10 cfu/g	Implied: Met specification.
Antimicrobial Effectiveness (USP <51>) - Bacterial (E. coli, P. aeruginosa, S. aureus)	No less than a 2.0 log reduction from the initial count at 14 days, and no increase from the 14 days' count at 28 days	Implied: Met specification.
Antimicrobial Effectiveness (USP <51>) - Fungal (C. albicans, A. brasiliensis)	No increase from the initial count at 14 and 28 days	Implied: Met specification.
Absence of Pathogenic Organisms (USP <62>) - S. aureus, P. aeruginosa, C. albicans	Absent	Implied: Met specification.
Biocompatibility	Non-cytotoxic, non-sensitizing, non-irritating, and non-systemically toxic (based on ISO 10993-5, 10993-10, 10993-11)	Tested as compliant: "The results demonstrate that the subject lubricants are non-cytotoxic, non-sensitizing, non-irritating, and non-systemically toxic."
Condom Compatibility	Compatible with natural rubber latex and polyisoprene condoms (based on ASTM D7661-10)	Tested as compliant: "was determined to be compatible with natural rubber latex and polyisoprene condoms. The subject device was determined not to be compatible with polyurethane condoms." (Note: Incompatibility with polyurethane condoms is stated as a difference from the predicate but not raising new safety/effectiveness questions, and is explicitly stated in Indications for Use).
Shelf-life	One-year shelf-life (based on real-time aging study, meeting all Table 1 specifications throughout)	Tested as compliant: "The Smile Makers Personal Lubricant has a one-year shelf-life based on the results of a real-time aging study. Testing demonstrated that the device met specifications for parameters shown in Table 1."

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

This is not applicable as this is not an AI/ML device study. The "test set" here would refer to the specific samples of lubricant used for the various physical, chemical, and biological tests. The document does not specify the exact batch sizes or numbers of samples tested for each parameter (e.g., how many bottles were tested for viscosity, how many animal subjects for biocompatibility). The studies are conducted by the manufacturer, LFBeauty (Thailand) Limited. The data provenance is from in vitro laboratory tests and in vivo animal tests, performed by or on behalf of the manufacturer, to demonstrate product specifications and safety/performance.

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

Not applicable. This is not an AI/ML device requiring human expert annotation for ground truth. Technical specifications are verified through standardized laboratory test methods (e.g., USP, ISO, ASTM).

4. Adjudication Method for the Test Set

Not applicable. Ground truth for physical/chemical/biological properties is established by defined test methods, not by human adjudication of opinions.

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-powered medical device.

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

Not applicable. This is not an AI-powered medical device.

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

The "ground truth" for the device's characteristics and performance is established through standardized laboratory testing protocols (USP, ISO, ASTM) for chemical, physical, and biological properties, and in vivo animal model biocompatibility studies. For example, pH is measured by a pH meter against calibrated standards, microbial counts are determined by microbiological culture methods, and condom compatibility is assessed by stress-strain tests per ASTM standards.

8. The sample size for the training set

Not applicable. This is not an AI/ML device.

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

Not applicable. This is not an AI/ML device.

Summary

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

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

April 25, 2019

LFBeauty (Thailand) Limited % Shelley Shen, Ph.D. Consultant PharmEng Technology 23 Lesmill Road North York, M3B 3P6 Ontario CANADA

Re: K182100

Trade/Device Name: Smile Makers Personal Lubricants (Smile Makers Little Light Liquid, Smile Makers Stay Silky Serum, and Smile Makers Generous Gel) Regulation Number: 21 CFR§ 884.5300 Regulation Name: Condom Regulatory Class: II Product Code: NUC Dated: March 19, 2019 Received: March 21, 2019

Dear Shelley Shen:

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. Iisting 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.

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

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 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.htm); good manufacturing practice requirements as set forth in the quality systems (QS) 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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm.

For comprehensive regulatory information about medical devices and radiation-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,

Michael T. Bailey -S

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

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

Indications for Use

510(k) Number (if known) K182100

Device Name

Smile Makers Personal Lubricants (Smile Light Liquid, Smile Makers Stay Silky Serum, and Smile Makers Generous 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)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

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

510(k) Summary K182100 Smile Makers Personal Lubricants

I. Submitter

LFBeauty (Thailand) Limited 21/7 Moo 6 Kookot Lamlukka Pathum Thani, Thailand 12130

Applicant

Apasara Kaewlor Senior Manager - QA & QMS LFBeauty (Thailand) Limited (662) 987 6500 Ext.315 (Phone) (662) 987 6500 Ext.185 (Fax) Apasarakaewlor@LFBeauty.com

Contact Person

Shelley Shen Consultant, PharmEng Technology 23 Lesmill Road North York, CA M3B 3P6 Ontario 14 (163) 853-922 Ext.118 (Phone) 14 (163) 853-912 (Fax) shelley.s@pharmeng.com

Date Prepared

April 24, 2019

II. Subject Device

Trade Names

Smile Makers Personal Lubricants:

Smile Makers Little Light Liquid 트
트 Smile Makers Stay Silky Serum
I Smile Makers Generous Gel

Common Name

Personal Lubricant

Classification

Regulation Name: Condom Regulation Number: 21 CFR 884.5300

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

Regulatory Class: II Product Code: NUC (lubricant, personal)

III. Predicate Device

BioFilm, Inc. - Astroglide Sensual Strawberry (K140590)

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

IV. Device Description

The product is packaged in 30 ml transparent plastic bottles made of acrylonitrile styrene and polyethylene terephthalate. The bottle contains a pump dispenser made of polypropylene and the cap is made of an aluminum coated low density polyethylene. It is for over-the-counter use.

The specifications for Smile Makers personal lubricants are listed in Table 1 below:

Parameter	Specification (Test Method)
Appearance & Color	Clear gel, viscous, no visible foreign matter
Odor	Characteristic odor
Osmolality (10% (w/w) dilution with water)	299 – 449 mOsm/kg
pH (at 25 °C)	4.90 - 5.50
Viscosity	56,000 – 84,000 cps (Generous Gel)6,200 – 10,000 cps (Stay Silky Serum)3,700 - 5,600 cps (Little Light Liquid)
Total Aerobic Microbial Count(USP <61>)	<10 cfu/g
Total Yeast & Mold Count (USP <61>)	<10 cfu/g
Antimicrobial Effectiveness(USP <51>)
Escherichia coli, Pseudomonas	No less than a 2.0 log reduction from

Table 1: Smile Makers Personal Lubricant Specifications

{5}------------------------------------------------

aeruginosa, Staphylococcusaureus	the initial count at 14 days, and noincrease from the 14 days' count at 28days
Candida albicans, A. brasiliensis	No increase from the initial count at 14and 28 days
Absence of PathogenicOrganisms (USP <62>)
Staphylococcus aureus	Absent
Pseudomonas aeruginosa	Absent
Candida albicans	Absent

V. Indications for Use Statement

Smile Makers Personal Lubricants are water-based personal lubricants for penile and/or vaginal application, intended to lubricate and moisturize, 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.

VI. Comparison of Intended Use and Technological Characteristics

Compared to Predicate
	Smile Makers PersonalLubricantsK182100Subject Device	Astroglide SensualStrawberryK140590Predicate Device
Sponsor	LFBeauty (Thailand) Ltd.	BioFilm, Inc.
Indication for Use	Smile Makers personallubricants are water-basedpersonal lubricants forpenile and/or vaginalapplication, intended tolubricate and moisturize, toenhance the ease andcomfort of intimate sexualactivity and supplement thebody's natural lubrication.This product is compatiblewith natural rubber latex andpolyisoprene condoms. Thisproduct is not compatiblewith polyurethane condoms.	Astroglide SensualStrawberry is a personallubricant for penile and/orvaginal application, intendedto moisturize and lubricate,to enhance the ease andcomfort of intimate sexualactivity and supplement thebody's natural lubrication.This product is compatiblewith natural rubber latex,polyisoprene, andpolyurethane condoms.
Water-based	Yes	Yes

Table 2: Technological Characteristics of Smile Makers Personal Lubricants Compared to Predicate

{6}------------------------------------------------

Appearance	Clear gel, viscous, no visibleforeign matter	Clear, colorless
Primary Ingredients	Water, Glycerin, PropyleneGlycol, Methyl propanediol,Carbomer, SodiumBenzoate, SodiumHydroxide, DipotassiumGlycyprizate	Not known
Provided Non-Sterile	Yes	Yes
CondomCompatibility	Natural rubber latex,Polyisoprene	Natural rubber latex,Polyisoprene, Polyurethane
BiocompatibilityTested	Yes	Yes
Antimicrobial Tested	Yes	Yes

The subject and predicate devices have the same indications for use statements with the exception of condom compatibility. The subject device is compatible with natural rubber latex and polyisoprene but not compatible with polyurethane condoms. The predicate device is compatible with natural rubber latex, polyisoprene, and polyurethane condoms. These differences do not impact the intended uses of these devices, which are the same (i.e., lubrication during intimate sexual activity).

As noted in the table above, the subject and predicate device have different formulations and condom compatibilities. The differences in technological characteristics between the subject and predicate device do not raise different questions of safety and effectiveness.

VII. Performance Data

Biocompatibility Testing

Biocompatibility studies were performed in accordance with the 2016 FDA guidance document "Use of International Standard ISO 10993-1, Biological Evaluation of Medical Devices - Part 1: Evaluation and testing within a risk management process" and ISO 10993-1: 2009 as follows:

Cytotoxicity (ISO 10993-5: 2009)
Guinea Pig Maximization Sensitization Test (ISO 10993-10: 2010)
Vaginal Irritation (ISO10993-10: 2010)
Acute Systemic Toxicity (ISO 10993-11: 2017)

The results demonstrate that the subject lubricants are non-cytotoxic, non-

{7}------------------------------------------------

sensitizing, non-irritating, and non-systemically toxic.

Condom Compatibility

The compatibility of the subject devices with natural rubber latex, polyisoprene and polyurethane condoms was evaluated in accordance with ASTM D7661-10 "Standard Test Method for Determining Compatibility of Personal Lubricants with Natural Rubber Latex Condoms" and was determined to be compatible with natural rubber latex and polyisoprene condoms. The subject device was determined not to be compatible with polyurethane condoms.

Shelf-life

The Smile Makers Personal Lubricant has a one-year shelf-life based on the results of a real-time aging study. Testing demonstrated that the device met specifications for parameters shown in Table 1.

VIII. Conclusion

The results of performance testing described above demonstrate that the Smile Makers Personal Lubricants are as safe and effective as the predicate device and support 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.