Play and Joy Water-Based Lubricant is a water-based personal lubricant, 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, polyurethane, and polyisoprene condoms.

Device Description

Play and Joy Water-Based Lubricant is a non-sterile, clear, semi-viscous water-based personal lubricant that provides lubrication during intimate sexual activity. The subject device is compatible with natural rubber latex, polyisoprene, and polyurethane condoms. Its formulation consists of water, xantham gum, glycerine, Chondrus crispus extract, sodium hyaluronate, saccharide isomerate, hydroxyethylcellulose, citric acid, sodium citrate, lactic acid, 1,2-pentanediol, phenoxyethanol, iodopropynyl butylcarbamate, hydroxyacetophenone, gluconolactone, and sodium benzoate. Play and Joy Water-Based Lubricant is for over-the-counter use and is provided in volumes of 50 mL and 100 mL in polyethylene tubes closed with polypropylene caps.

AI/ML Overview

The provided document is a 510(k) Summary for a medical device called "Play and Joy Water-Based Lubricant." It is a submission to the FDA demonstrating substantial equivalence to a predicate device.

This document does not contain the type of acceptance criteria and study information (such as AI performance metrics, sample sizes for test/training sets, expert qualifications, or adjudication methods) typically found for AI/ML-driven medical devices.

The product described is a personal lubricant, and the performance testing focuses on its physical characteristics, biocompatibility, and condom compatibility, not on an AI algorithm's diagnostic performance. Therefore, I cannot extract the information requested in your prompt regarding AI device acceptance criteria and study data from this document.

However, I can provide the acceptance criteria and performance data for the mechanical/physical performance of the lubricant as reported in the document:

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

Physical Specification	Acceptance Criteria (Specifications)	Reported Device Performance
Appearance	Clear, semi-viscous liquid	Clear, semi-viscous liquid
Color	Colorless	Colorless
Odor	Odorless	Odorless
PH@25° C (per USP <791>)	4.92-5.38	4.92-5.38 (within range)
Viscosity (cps, per USP <912>)	1727-3463 cps	1727-3463 cps (within range)
Specific Gravity (per USP <841>)	1.04-1.08	1.04-1.08 (within range)
Osmolality (mOsm/Kg, per USP <785>)	(944-984) mOsm/kg	(944-984) mOsm/kg (within range)
Antimicrobial effectiveness (per USP <51>)	Category 2 product: bacteria should show not less than 2.0 log reduction at 14 days and no increase from 14-day count at the 28-day count. Yeast and molds should show no increase from the initial calculated count at 14 and 28 days	Met criteria (demonstrated antimicrobial effectiveness)
Total yeast and mold count (TYMC, per USP <61>)	<10 cfu/g	<10 cfu/g (met criteria)
Total aerobic microbial count (TAMC, per USP <61>)	<100 cfu/g	<100 cfu/g (met criteria)
Absence of Pathogenic Organisms (P. aeruginosa, S. aureus, Salmonella/Shigella, E. coli, and C. albicans)	Absent	Absent (met criteria)
Biocompatibility: Cytotoxicity (ISO 10993-5:2009)	Non-cytotoxic	Non-cytotoxic
Biocompatibility: Sensitization (ISO 10993-10:2010)	Non-sensitizing	Non-sensitizing
Biocompatibility: Vaginal Irritation (ISO 10993-10:2010)	Non-irritating	Non-irritating
Biocompatibility: Acute Systemic Toxicity (ISO 10993-11:2017)	Non-systemically toxic	Non-systemically toxic
Condom Compatibility (ASTM D7661-10/(R)2017 -Standard Test Method for Determining Compatibility of Personal Lubricants with Natural Rubber Latex Condoms)	Compatible with natural rubber latex, polyisoprene, and polyurethane condoms (no detrimental effect on condom integrity/performance)	Compatible with natural rubber latex, polyisoprene, and polyurethane condoms (demonstrated compatibility)
Shelf Life (Accelerated Aging Study)	Maintain all device specifications (as listed above in Table 1) for the stated duration. The predicate had 36 months, the subject device initially aimed for this but demonstrated 6 months.	6 months (all device specifications from Table 1 met over this duration). The shelf life is reported as 6 months, which is lower than the predicate (36 months), but the document states this difference does not raise different questions of safety and effectiveness (S&E).

Regarding the other points you requested, as they relate to AI/ML device studies, the document does not contain this information because the device is a physical product (personal lubricant), not an AI/ML diagnostic or therapeutic tool.

Sample size used for the test set and the data provenance: Not applicable. For physical property testing and biocompatibility, samples of the lubricant itself were tested.
Number of experts used to establish the ground truth... and qualifications: Not applicable. Performance was measured against objective chemical/physical standards and biological endpoints using validated lab tests, not expert interpretation of AI output.
Adjudication method: Not applicable.
Multi reader multi case (MRMC) comparative effectiveness study... effect size of human readers improve with AI vs without AI assistance: Not applicable.
Standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
The type of ground truth used: For physical/chemical properties, the ground truth is established by the specified reference standards (e.g., USP monographs). For biocompatibility, it's defined by the biological response as per ISO 10993 standards. For condom compatibility, it's the lack of degradation of condoms as per ASTM D7661.
The sample size for the training set: Not applicable.
How the ground truth for the training set was established: Not applicable.

Summary

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July 11, 2023

InnoveMed Bio-tech Co., Ltd. % Charles Shen Director Manton Business and Technology Services 37 Winding Ridge Oakland, NJ 07436

Re: K221137

Trade/Device Name: Play and Joy Water-Based Lubricant Regulation Number: 21 CFR§ 884.5300 Regulation Name: Condom Regulatory Class: II Product Code: NUC Dated: June 8, 2023 Received: June 9, 2023

Dear Charles 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, 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,

Monica D. Garcia -S

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) K221137

Device Name Play and Joy Water-Based Lubricant

Indications for Use (Describe)

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

| | 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 K221137 Play and Joy Water-Based Lubricant

1 Submitter Information:

InnoveMed Bio-tech Co., Ltd. 6F, No.184, Sec. 2, Chongqing N. Rd., Datang District., Taipei City 10357, Taiwan (R.O.C.) Contact person: Miss Linda Li TEL: +86-2-2552-9398-25 E-Mail: Linda(@innovemed.biz

2 Submission Correspondent:

Charles Shen Manton Business and Technology Services 37 Winding Ridge, Oakland, New Jersey 07436, USA Tel: 608-217-9358 Email: cyshen@aol.com

3 Date of Summary: July 6, 2023

4 Subject Device Information:

Proprietary Name:	Play and Joy Water-Based Lubricant
Common Name:	Personal Lubricant
Regulation Number:	21 CFR 884.5300
Regulation Name:	Condom
Product Code:	NUC (lubricant, personal)
Device Class:	Class II

5 Predicate Device Information:

K203654, Solvey Co. LLC Water-Based Lubricant

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

Device Descriptions 6

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Its formulation consists of water, xantham gum, glycerine, Chondrus crispus extract, sodium hyaluronate, saccharide isomerate, hydroxyethylcellulose, citric acid, sodium citrate, lactic acid, 1,2-pentanediol, phenoxyethanol, iodopropynyl butylcarbamate, hydroxyacetophenone, gluconolactone, and sodium benzoate.

Play and Joy Water-Based Lubricant is for over-the-counter use and is provided in volumes of 50 mL and 100 mL in polyethylene tubes closed with polypropylene caps.

Device specifications for the Play and Joy Water-Based Lubricant are listed in Table 1.

Physical Specification	Specifications
Appearance	Clear, semi-viscous liquid
Color	Colorless
Odor	Odorless
PH@25° C (per USP <791>)	4.92-5.38
Viscosity (cps, per USP <912>)	1727-3463 cps
Specific Gravity (per USP <841>)	1.04-1.08
Osmolality (mOsm/Kg, per USP <785>)	(944-984) mOsm/kg
Antimicrobial effectiveness (per USP <51>)	Category 2 product: bacteria should show notless than 2.0 log reduction at 14 days and noincrease from 14-day count at the 28-daycount. Yeast and molds should show noincrease from the initial calculated count at 14and 28 days
Total yeast and mold count (TYMC, per USP<61>)	<10 cfu/g
Total aerobic microbial count (TAMC, perUSP <61>)	<100 cfu/g
Absence of Pathogenic Organisms (P.aeruginosa, S. aureus, Salmonella/Shigella, E.coli, and C. albicans)	Absent

Table 1: Device specifications for Play and Joy Water-Based Lubricant

7 Indications for Use:

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

Table 2 below compares the intended use and technological characteristics of the subject and predicate device.

Table 2: Intended Use and Technological Characteristics Comparison

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Characteristics	Subject device(K221137)	Predicate device(K203654)	Comparison
Device Name	Play and Joy Water-Based Lubricant	Solevy Co. LLC Water-Based Lubricant	N/A
Device Model	50 mL and 100 mL(1.7/3.4 fl. Oz)	1, 2.5, 4.5, 8, and 16 fl. oz	N/A
Manufacturer	InnoveMed Bio-techCo., Ltd	Solevy Co. LLC	N/A
Indications for Use	Play and Joy Water-BasedLubricant is a water-basedpersonal lubricant, forpenile and/or vaginalapplication, intended tolubricate and moisturize, toenhance the ease andcomfort of intimate sexualactivity and supplementthe body's naturallubrication. This product iscompatible with naturalrubber latex, polyurethane,and polyisoprenecondoms.	Solevy Co. LLC Water-Based Lubricant is awater-based personallubricant, for penileand/or vaginalapplication, intended tolubricate and moisturize,to enhance the ease andcomfort of intimate sexualactivity and supplementthe body's naturallubrication. This productis compatible with naturalrubber latex,polyurethane, andpolyisoprene condoms.	The indications foruse and intendeduse of the subjectand predicatedevices are thesame.
Base type	Water-based	Water-based	Same
Rx/OTC	OTC	OTC	Same
Sterile	No	No	Same
Ingredients	Water (Aqua)Xantham gumGlycerineChondrus crispus extractSodium hyaluronateSaccharide isomerateHydroxyethylcelluloseCitric acidSodium citrateLactic acid1,2-pentanediolPhenoxyethanolIodopropynylbutylcarbamateHydroxyacetophenoneGluconolactoneSodium benzoate	GlycerinWaterCellulose gumMethylparabenPropylparaben	Different: Thereare differences inthe subject andpredicate deviceformulations. Thesedifferences indevice formulationsdo not raisedifferent questionsof safety andeffectiveness(S&E).
Appearance	Clear, semi-viscousliquid	Clear, semi-viscousliquid	Same
Color	Colorless	Colorless	Same
Odor	Odorless	Odorless	Same
PH@25° C	4.92-5.38	6.0-7.0	Different: The pHfor the subjectdevice is lower thanthe predicatedevice. Thisdifference in pH

Viscosity	1727-3463 cps	1,200 - 1,800 cps	does not raisedifferent questionsof S&E.Different: Theviscosity range forthe subject device iswider than thepredicate device.This differencedoes not raisedifferent questionsof S&E.
Specific Gravity	1.04-1.08	1.12- 1.20	Similar
Osmolality	944-984 mOsm/kg	750 - 950 mOsm/kg	Different: Theosmolality of thesubject device ishigher than thepredicate device.This differencedoes not raisedifferent questionsof S&E.
AntimicrobialEffectiveness Testedper USP<62>	Yes	Yes	Same
Total yeast and mold(TYMC)	<10 cfu/g	<10 cfu/g	Same
Total aerobicmicrobialcount (TAMC)	<100 cfu/g	<100 cfu/g	Same
Absence of PathogenicOrganisms per USP<62>	Yes	Yes	Same
CondomCompatibility	Compatible with naturalrubber latex,polyurethane, andpolyisoprenecondoms	Compatible with naturalrubber latex,polyurethane, andpolyisoprenecondoms	Same
BiocompatibilityTested	Yes	Yes	Same
Shelf life	6 months	36 months	Different: Theshelf-life for thesubject device isless than thepredicate device.This differencedoes not raisedifferent questionsof S&E.

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The subject device and predicate device have the same indications for use and intended use. As shown in the table, there are differences in the technological characteristics of the subject and

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predicate devices, including formulation, specifications (pH, viscosity, and osmolality), and device shelf-life. These differences in technological characteristics 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 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) a.
Sensitization (ISO 10993-10:2010) b.
Vaginal Irritation (ISO 10993-10:2010) C.
Acute Systemic Toxicity (ISO 10993-11:2017) d.

The results of testing demonstrated the subject device is non-cytotoxic, non-sensitizing, nonirritating, 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/(R)2017 -Standard Test Method for Determining Compatibility of Personal Lubricants with Natural Rubber Latex Condoms. The results of testing demonstrated that the Play and Joy Water-Based Lubricant is compatible with natural rubber latex, polyisoprene, and polyurethane condoms.

Shelf Life:

The subject device has a shelf-life of 6 months based on the results of an accelerated aging study. The shelf-life study evaluated all device specifications listed in Table 1, Device Specifications. The subject device met all device specifications over the stated shelf-life duration.

10 Conclusions

The results of performance testing described above demonstrate that the Play and Joy Water-Based 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.