Play & Joy InvisiLube Lubricant Capsule is a personal lubricant for over-the counter use, for vaginal application, intended to moisturize and lubricate, to enhance the ease and comfort of intimate sexual activity and supplement the body's natural lubrication. Play & Joy InvisiLube Lubricant Capsule is a non-sterile, anhydrous silicone inner component encapsulated with a gelatin shell. It is compatible with natural rubber latex, polyisoprene, and polyurethane condoms. The inner component is composed of a blend of silicone with primary ingredients: Cyclopentasiloxane, Dimethiconol, and Dimethicone. The gelatin shell is composed of gelatin, glycerin, Phatic acid, and water.

AI/ML Overview

The provided text is a 510(k) summary for a medical device called "Play & Joy InvisiLube Lubricant Capsule." This document is used to demonstrate substantial equivalence to a predicate device, not to showcase a study comparing human reader performance with and without AI assistance for tasks like image interpretation.

Therefore, the requested information regarding acceptance criteria and a study proving device performance in the context of AI assistance (e.g., sample size for test sets, data provenance, number of experts, adjudication methods, MRMC studies, standalone performance, ground truth for training/test sets) is not applicable to this specific document.

The document describes the non-clinical performance testing conducted for the Play & Joy InvisiLube Lubricant Capsule to demonstrate its safety and effectiveness relative to a predicate device. This includes:

1. A table of acceptance criteria and the reported device performance (Non-clinical Specifications):

Property	Acceptance Criteria (Specification)	Reported Device Performance (Implied to meet specification)
Appearance	Colorless	Colorless
Color	Clear	Clear
Odor	Odorless	Odorless
Viscosity	75 - 201 cps	(Tested to be within this range)
Total Aerobic Microbial Count (TAMC, per USP <61>)	<100 cfu/g	<100 cfu/g
Total Yeast and Mold Count (TYMC, per USP <61>)	<10 cfu/g	<10 cfu/g
Water Activity	<0.3 Aw	<0.3 Aw
Presence of Pathogens (per USP <62>)	Absent	Absent
- Pseudomonas aeruginosa	Absent	Absent
- Staphylococcus aureus	Absent	Absent
- Candida albicans	Absent	Absent
- Escherichia coli	Absent	Absent
- Salmonella	Absent	Absent
Biocompatibility	Non-sensitizing, Non-irritation, Not systemically toxic	Met (Results demonstrate non-sensitizing, non-irritation, and not systemically toxic)
Shelf-Life	6 months (maintains specifications)	Met (Demonstrated stability over 6 months)
Condom Compatibility	Compatible with natural rubber latex, polyisoprene, and polyurethane condoms	Met (Showed compatibility with all three types)

Regarding the other points, they are not relevant to this type of device and study:

2. Sample size used for the test set and the data provenance: Not applicable. The tests are laboratory-based performance and biocompatibility studies, not clinical studies with patient data.
3. Number of experts used to establish the ground truth... and qualifications: Not applicable. Ground truth for these tests is based on established testing standards (e.g., USP, ISO, ASTM).
4. Adjudication method: Not applicable.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done: Not applicable. This is not an AI-assisted diagnostic device.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done: Not applicable.
7. The type of ground truth used: For non-clinical tests, the "ground truth" is defined by the specific parameters and limits set by the referenced standards (e.g., sterility limits, pH ranges, cytotoxicity assays).
8. The sample size for the training set: Not applicable. This product does not involve machine learning or AI models with training sets.
9. How the ground truth for the training set was established: Not applicable.

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.

July 10, 2023

InnoveMed Bio-tech Co., Ltd. Elsa Li Regulatory Consultant 6F, No. 184, Sec. 2, Chongqing N. Rd., Datong Dist. Taipei Citv. 10357 Taiwan

Re: K220646

Trade/Device Name: Play & Joy InvisiLube Lubricant Capsule Regulation Number: 21 CFR§ 884.5300 Regulation Name: Condom Regulatory Class: II Product Code: NUC Dated: June 9, 2023 Received: June 9, 2023

Dear Elsa Li:

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) K220646

Device Name Play & Joy InvisiLube Lubricant Capsule

Indications for Use (Describe)

Play & Joy Invis Lube Lubricant Capsule is a personal lubricant for over-the counter use, for vaginal application, intended to mosturize 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, polyisoprene, and polyurethane condoms

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 K220646 Play & Joy InvisiLube Lubricant Capsule

1. Submitter Information

Applicant:	InnoveMed Bio-tech Co., Ltd.
Contact:	Linda Li,
Address:	6F, No.184, Sec. 2, Chongqing N. Rd.Datang District.,Taipei City 10357, Taiwan (R.O.C.)
Phone:	(+886-2-2552-9398-25)
Email:	Linda@innovemed.biz

2. Correspondent Information

Company:	Shenzhen World Eye Consulting Co., Ltd.
Contact:	Charles Shen
Address:	05, area B, 1st floor, building R, No. 13Yuansheng lane, Changzhen communityShenzhen, China 518132
Phone:	(608) 217-9358
Email:	cyshen@aol.com

3. Date prepared: July 10, 2023

4. Device Information

Device Name:	Play & Joy InvisiLube Lubricant Capsule
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 Brand Liquibeads
510(k) Number:	K122061
Manufacturer:	Johnson & Johnson Healthcare Products

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

6. Device Description

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Device specifications are listed in Table 1 below.

Property	Specification
Appearance	Colorless
Color	Clear
Odor	Odorless
Viscosity	75 - 201 cps
Total Aerobic Microbial Count (TAMC, perUSP <61>	<100cfu/g
Total Yeast and Mold Count (TYMC, perUSP <61>	<10cfu/g
Water Activity	<0.3 Aw
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 Play & Joy InvisiLube Lubricant Capsule

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

	Play & Joy InvisiLubeLubricant CapsuleK220646Subject Device	K-Y Brand LiquibeadsK122061Predicate Device
Device Classification Name	Lubricant, Personal	Lubricant, Personal
Indications for Use	Play & Joy InvisiLube LubricantCapsule is a personal lubricant for over-the counter use, for vaginal application,intended to moisturize and lubricate, toenhance the ease and comfort of intimatesexual activity and supplement thebody's natural lubrication. This productis compatible with natural rubber latex,polyisoprene, and polyurethane condoms	K-y(r) brand liquibeads(r) vaginalmoisturizer is a personal lubricant forover-the-counter use, for vaginalapplication, intended to moisturizeand lubricate, to enhance the ease andcomfort of intimate sexual activity andsupplement the body's naturallubrication. This product is compatiblewith natural rubber latex,polyisoprene, and polyurethane

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		condoms. The product is delivered by
		an applicator.
Base type	Silicone	Silicone
Primary ingredients	Dimethicone, Dimethiconol,Cyclopentasiloxane, Glycerin, Gelatin,Phatic Acid, Water	Dimethicone, gelatin, glycerin, water
Rx/OTC	OTC	OTC
Sterile	No	No
Appearance/color	Colorless	Colorless
Odor	Odorless	Odorless
Viscosity	75-201 cps	Not Specified
Total Aerobic Microbialcount (TAMC)	<100 cfu/g	<100 cfu/g
Total Yeast and Mold Count(TYMC)	<10 cfu/g	<10 cfu/g
Absence of PathogenicOrganisms	Yes	Yes
Condom Compatibility	Compatible with natural rubber latex,polyisoprene, and polyurethane condoms	Compatible with natural rubber latex, and polyisoprene condoms
Biocompatibility Tested	Yes	Yes
Shelf life	6 months	36 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 formulation, 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 2020FDA 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 (ISO10993-5:2009)
Sensitization (ISO 10993-10:2010)
Vaginal Irritation (ISO10993-10:2010) ●
Acute Systemic Toxicity (ISO 10993-11:2017) ●

The results of testing demonstrate that the subject device is non-sensitizing, non-irritation, and not systemically toxic.

Shelf-Life

The subject device has a shelf-life of 6 months. Results from accelerated aging per ASTM 1980-16

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demonstrated that the device maintains its specifications (as shown in Table 1) over the duration of its shelf-life.

Condom Compatibility

The compatibility of Play & Joy InvisiLube Lubricant Capsule 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 Play & Joy InvisiLube Lubricant Capsule to be compatible with natural rubber latex, polyisoprene, and polyurethane condoms.

10. Conclusion

The results of the performance testing described above demonstrate that Play & Joy InvisiLube Lubricant Capsule 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.