Playboy Premium Silicone Lubricant is indicated for penile, vaginal and/or anal 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

Playboy Premium Silicone Lubricant is a non-sterile, silicone-based personal lubricant for penile, anal, 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 device is compatible with natural rubber latex and polyisoprene condoms and is not compatible with polyurethane condoms. Its formulation consists of dimethicone. Playboy Premium Silicone Lubricant is sold as an over-the-counter (OTC) product and is provided in 88.7 mL LDPE bottles.

AI/ML Overview

The provided text describes a 510(k) submission for the "Playboy Premium Silicone Lubricant." This is a medical device approval document, not a study evaluating an AI/ML powered device. As such, the specific information requested in the prompt (acceptance criteria and a study proving an AI device meets them, including sample sizes, ground truth, expert opinions, MRMC studies, etc.) is not present in the given text.

The document focuses on demonstrating substantial equivalence to a predicate device (K-Y Silicone K173504) for a personal lubricant. It does this by comparing indications for use, technological characteristics, and non-clinical performance testing.

Here's how the available information relates to the prompt, with the understanding that it's for a traditional medical device, not an AI one:

1. A table of acceptance criteria and the reported device performance

The document provides "Device Specifications" which can be considered acceptance criteria for the physical and biological properties of the lubricant. It also implicitly reports the device performance by stating that it meets these specifications and compares them to the predicate device.

Property	Acceptance Criteria (Specification)	Reported Device Performance (Implicitly met as per submission)
Appearance	Clear, free from suspended matter and sediment	Clear, free from suspended matter and sediment
Color	Clear	Clear
Odor	Odorless	Odorless
Viscosity	315 – 385 cps	315 – 385 cps
Total Aerobic Microbial Count (TAMC)	<100 cfu/g	<100 cfu/g
Total Yeast and Mold Count (TYMC)	<10 cfu/g	<10 cfu/g
Presence of Pathogens (Pseudomonas aeruginosa)	Absent	Absent
Presence of Pathogens (Staphylococcus aureus)	Absent	Absent
Presence of Pathogens (Candida albicans)	Absent	Absent
Presence of Pathogens (Escherichia coli)	Absent	Absent
Presence of Pathogens (Salmonella)	Absent	Absent
Biocompatibility	Met ISO 10993 standards	Met ISO 10993 standards (Tested and results support)
Shelf-Life	36 months, maintaining specifications	36 months (Real-time testing demonstrated maintenance)
Condom Compatibility	Compatible with natural rubber latex and polyisoprene condoms	Compatible with natural rubber latex and polyisoprene condoms; Not compatible with polyurethane condoms

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

The document does not specify sample sizes for the non-clinical performance tests (biocompatibility, shelf-life, condom compatibility). It only states that these tests were performed according to relevant standards (e.g., ISO 10993, ASTM D7661-10(R) 2017). The data provenance is implied to be from internal testing conducted by or for Thai Nippon Rubber Industry Public Company Limited. It's a prospective evaluation for the new device.

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

This concept is not applicable to this type of device and submission. "Ground truth" established by experts is relevant to diagnostic or interpretative AI systems, which this lubricant is not. The evaluation here relies on standardized laboratory testing protocols, not expert interpretation of results.

4. Adjudication method

This is not applicable for the same reasons as point 3. Adjudication methods like 2+1 or 3+1 are used in clinical trials or studies involving human readers/interpreters to reconcile differing opinions, which is not relevant here.

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

This is not applicable as the device is a personal lubricant, not an AI-powered diagnostic or assistive tool.

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

This is not applicable as the device is a personal lubricant, not an AI algorithm.

7. The type of ground truth used

For the physical and biological properties, the "ground truth" is based on objective measurements and laboratory test results against predefined specifications from recognized standards (e.g., USP <61>, USP <62>, ISO 10993, ASTM D7661-10(R) 2017). For example, a viscosity reading of 350 cps is a measured truth, not an expert's opinion.

8. The sample size for the training set

This is not applicable. The concept of a "training set" refers to data used to train an AI model. This document describes a traditional medical device, not an AI system.

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

This is not applicable for the same reasons as point 8.

Summary

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Image /page/0/Picture/0 description: The image shows 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 is a blue square with the letters "FDA" in white, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue.

November 23, 2021

Thai Nippon Rubber Industry Public Company Limited % Kevin Walls Principal Consultant Regulatory Insight, Inc. 33 Golden Eagle Lane Littleton, CO 80127

Re: K210095

Trade/Device Name: Playboy Premium Silicone Lubricant Regulation Number: 21 CFR§ 884.5300 Regulation Name: Condom Regulatory Class: II Product Code: NUC Dated: October 23, 2021 Received: October 26, 2021

Dear Kevin Walls:

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.

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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) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatoryinformation/postmarketing-safety-reporting-combination-products); 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 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,

For Monica D. Garcia, Ph.D. 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) K210095

Device Name Playboy Premium Silicone Lubricant

Indications for Use (Describe)

Type of Use (Select one or both, as applicable)

Residential Use (Part 1 of SEE 301)	Crop Tier Certification (Part 1 of SEE 301)
-------------------------------------	---------------------------------------------

| | 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 K210095 Playboy Premium Silicone Lubricant

1. Submitter Information

Applicant:	Thai Nippon Rubber Industry Public CompanyLimited
Contact:	Tossaporn Nilkhamhang,
Address:	789/139 Moo 1 Pinthong Industrial EstateNongkham Sriracha Chonburi 20110Thailand
Phone:	(+66-38-317999)

2. Correspondent Information

Company:	Regulatory Insight
Contact:	Kevin Walls
Phone:	(720) 962-5412
Email:	kevin@reginsight.com

3. Date prepared: November 22, 2021

4. Device Information

Device Name:	Playboy Premium Silicone Lubricant
Common Name:	Personal Lubricant
Regulation Number:	21 CFR 884.5300
Regulation Name:	Condom
Product Code:	NUC (lubricant, personal)
Regulatory Class:	Class II

5. Predicate Device Information

Device Name:	K-Y Silicone
510(k) Number:	K173504
Manufacturer:	Reckitt Benckiser LLC

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

6. Device Description

Device specifications are listed in Table 1 below.

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Property	Specification
Appearance	Clear, free from suspended matter andsediment
Color	Clear
Odor	Odorless
Viscosity	315 – 385 cps
Total Aerobic Microbial Count (TAMC, perUSP <61>)	<100 cfu/g
Total Yeast and Mold Count (TYMC, perUSP <61>)	<10 cfu/g
Presence of Pathogens (per USP <62>)	Specification
Pseudomonas aeruginosa	Absent
Staphylococcus aureus	Absent
Candida albicans	Absent
Escherichia coli	Absent
Salmonella	Absent

Table 1: Device Specifications for Playboy Premium Silicone Lubricant

7. Indications for Use

8. Comparison of Intended Use and Technological Characteristics with the Predicate Device

The table below compares the intended use and technological characteristics of the subject and predicate device.

Table 2: Comparator Table for Subject and Predicate Device

	Playboy Premium SiliconeLubricantK210095Subject Device	K-Y SiliconeK173504Predicate Device
Device Classification Name	Lubricant, Personal	Lubricant, Personal
Indications for Use	Playboy Premium Silicone Lubricant isindicated for penile, vaginal and/or analapplication, intended to moisturize andlubricate, to enhance the ease andcomfort of intimate sexual activity andsupplement the body's naturallubrication. This product is compatiblewith natural rubber latex andpolyisoprene condoms. This product isnot compatible with polyurethanecondoms.	K-Y® Silicone is indicated for penile,vaginal, and/or anal application,intended to moisturize and lubricate,to enhance the ease and comfort ofintimate sexual activity andsupplement the body's naturallubrication. This product is compatiblewith natural rubber latex,polyisoprene, and polyurethanecondoms.
Base type	Silicone	Silicone

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Primary ingredients	Dimethicone	Dimethicone
Rx/OTC	OTC	OTC
Sterile	No	No
Appearance/color	Clear, free from suspended matter andsediment	Colorless
Odor	Odorless	Odorless
Viscosity	315-385 cps	80-110 cps
Total Aerobic Microbialcount (TAMC)	<100 cfu/g	<100 cfu/g
Total Yeast and Mold Count(TYMC)	<10 cfu/g	Absent
Absence of PathogenicOrganisms	Yes	Yes
Condom Compatibility	Compatible with natural rubber latex andpolyisoprene condoms	Compatible with natural rubber latex,polyisoprene, and polyurethanecondoms
Biocompatibility Tested	Yes	Yes
Shelf life	36 months	24 months

The subject and predicate device indications for use are similar and their intended uses are the same (i.e., provide lubrication during intimate sexual activity). The subject and predicate device have different technological characteristics, including appearance, viscosity, and TYMC specifications, condom compatibility, and shelf-life duration. The differences in technological characteristics between the subject and predicate devices do not raise different questions of safety and effectiveness.

9. Summary of Non-Clinical Performance Testing

Biocompatibility

Biocompatibility studies were performed in accordance with the 2020 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. " The following testing was conducted:

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 testing support the biocompatibility of the device materials.

Shelf-Life

The subject device has a shelf-life of 36 months. Results from real-time testing demonstrated that the device maintains its specifications (as shown in Table 1) over the duration of its shelf-life.

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Condom Compatibility

The compatibility of Playboy Premium Silicone Lubricant with condoms was evaluated in accordance with ASTM D7661-10(R) 2017 "Standard Test Method for Determining Compatibility of Personal Lubricants with Natural Rubber Latex Condoms." The results of this test showed Playboy Premium Silicone Lubricant to be compatible with natural rubber latex and polyisoprene condoms. Results showed Playboy Premium Silicone Lubricant not to be compatible with polyurethane condoms.

10. Conclusion

The results of the performance testing described above demonstrate that Playboy Premium Silicone 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.