Playground For All Love Sesh 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

Playground For All Love Sesh is a non-sterile, unscented, water-based personal lubricant that provides lubrication during intimate sexual activity. The subject device is compatible with natural rubber latex and polyisoprene condoms and is not compatible with polyurethane condoms. Its formulation consists of Water. Glycerin, Propanediol, Bamboo Bioferment PF, Sodium Hyaluronate, CMC Cellulose, Citric Acid, Carubba Blend, Tocopheryl Acetate, Sodium Benzoate, Potassium Sorbate. Playground For All Love Sesh is for over-the-counter (OTC) use and is offered in 3.7 fl. oz PET bottles and 0.17 fl. oz PET/Foil packettes.

AI/ML Overview

The provided document describes the "Playground For All Love Sesh" personal lubricant (K222567) and its clearance by the FDA based on substantial equivalence to a predicate device.

Here's an analysis of the acceptance criteria and the study that proves the device meets them:

1. Table of Acceptance Criteria and Reported Device Performance

The device specifications outlined in Table 1 (page 4) indicate the acceptance criteria, and the "Summary of Non-Clinical Performance Testing" (pages 5 and 6) reports that the device meets these.

Property	Acceptance Criteria (Specification)	Reported Device Performance
Appearance	Gel	Gel (as per Table 1)
Color	Clear to hazy white cream	Clear to hazy white cream (as per Table 1)
Odor	Characteristic	Characteristic (as per Table 1)
Viscosity (per USP<912>)	1000 – 6000 cps	Device maintains specifications (as shown in Table 1) over its shelf-life, implying it meets this.
pH (per USP<791>)	4.0 - 5.5	Device maintains specifications (as shown in Table 1) over its shelf-life, implying it meets this.
Osmolality (per USP<785>)	2000 – 6000 mOsm/kg	Device maintains specifications (as shown in Table 1) over its shelf-life, implying it meets this.
Total Aerobic Microbial Count (TAMC, per USP <61>)	<100 cfu/g	Device maintains specifications (as shown in Table 1) over its shelf-life, implying it meets this.
Total Yeast and Mold Count (TYMC, per USP <61>)	<10 cfu/g	Device maintains specifications (as shown in Table 1) over its shelf-life, implying it meets this.
Pseudomonas aeruginosa	Absent	Device maintains specifications (as shown in Table 1) over its shelf-life, implying it meets this.
Staphylococcus aureus	Absent	Device maintains specifications (as shown in Table 1) over its shelf-life, implying it meets this.
Candida albicans	Absent	Device maintains specifications (as shown in Table 1) over its shelf-life, implying it meets this.
Escherichia coli	Absent	Device maintains specifications (as shown in Table 1) over its shelf-life, implying it meets this.
Salmonella/Shigella	Absent	Device maintains specifications (as shown in Table 1) over its shelf-life, implying it meets this.
Antimicrobial Effectiveness Testing (Bacteria)	Meets USP <51> criteria for category 2. No less than 2.0 log reduction from initial count at 14 days and no increase from the 14-day count at 28 days	Device maintains specifications (as shown in Table 1) over its shelf-life, implying it meets this.
Antimicrobial Effectiveness Testing (Yeast and Molds)	No increase from the initial calculated count at 14 and 28 days	Device maintains specifications (as shown in Table 1) over its shelf-life, implying it meets this.
Biocompatibility (Cytotoxicity)	Non-cytotoxic	Results demonstrate the device is non-irritating, non-sensitizing, and not acutely, systemically toxic. (Implies non-cytotoxic based on ISO 10993-5 testing)
Biocompatibility (Sensitization)	Non-sensitizing	Results demonstrate the device is non-irritating, non-sensitizing, and not acutely, systemically toxic.
Biocompatibility (Vaginal Irritation)	Non-irritating	Results demonstrate the device is non-irritating, non-sensitizing, and not acutely, systemically toxic.
Biocompatibility (Acute Systemic Toxicity)	Not acutely, systemically toxic	Results demonstrate the device is non-irritating, non-sensitizing, and not acutely, systemically toxic.
Shelf-Life	6 months (maintains specifications)	Results from real-time testing demonstrated that the device maintains its specifications (as shown in Table 1) over the duration of its shelf-life (6 months).
Condom Compatibility (Natural Rubber Latex)	Compatible	The results of this test showed Playground For All Love Sesh is compatible with natural rubber latex and polyisoprene condoms.
Condom Compatibility (Polyisoprene)	Compatible	The results of this test showed Playground For All Love Sesh is compatible with natural rubber latex and polyisoprene condoms.
Condom Compatibility (Polyurethane)	Not compatible	Results showed Playground For All Love Sesh is not compatible with polyurethane condoms. (This is stated as a product characteristic and consistent with the predicate, rather than a failure of an acceptance criterion for broader compatibility, as the device's indications of use already specify incompatibility).

2. Sample Size for the Test Set and Data Provenance

The document does not explicitly state the sample sizes used for each specific test (e.g., how many batches were tested for viscosity, or how many samples for biocompatibility).

Biocompatibility: Performed according to the 2020 FDA guidance document Use of International Standard ISO 10993-1. These are standard in-vitro and in-vivo tests that follow established protocols, but specific sample numbers (e.g., number of cells for cytotoxicity, number of animals for sensitization/irritation/toxicity) are not provided.
Shelf-Life: "Real-time testing" was used, but the number of samples or batches tested longitudinally over the 6-month shelf-life is not specified.
Condom Compatibility: Evaluated in accordance with ASTM D7661-10(R) 2017. This standard specifies methodological details, but the specific number of condoms or lubricant applications tested is not detailed in this summary.

Data Provenance: The studies are described as "Non-Clinical Performance Testing" conducted by the manufacturer or their designated labs as part of the submission to the U.S. FDA. The country of origin of the data is not explicitly stated but is implicitly tied to the U.S. regulatory process. The data is prospective in the sense that these tests were conducted specifically for this 510(k) submission.

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

This information is not provided in the document. For non-clinical tests like those conducted for a personal lubricant, the "ground truth" is typically established by objective, standardized laboratory measurements and interpretations by trained laboratory personnel or toxicologists, rather than a panel of clinical experts.

4. Adjudication Method for the Test Set

This information is not applicable and therefore not provided. Adjudication methods like 2+1 or 3+1 are typically used in clinical studies involving interpretation of medical images or patient outcomes, often with multiple readers or clinicians, to reach a consensus for ground truth. The tests performed here are laboratory-based, objective measurements.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

A MRMC comparative effectiveness study was not done. This type of study is relevant for medical devices, particularly AI-driven diagnostic tools, where multiple human readers (e.g., radiologists) interpret cases with and without AI assistance. This device is a personal lubricant, which does not involve human readers for interpretation.

6. Standalone Performance Study (i.e., algorithm only without human-in-the-loop performance)

A standalone performance study was not done in the context of an "algorithm only" as this is not an AI/software device. The entire performance evaluation summarized (biocompatibility, shelf-life, condom compatibility, physical/chemical/microbiological specifications) represents the "standalone" performance of the product itself, without human-in-the-loop interaction in an interpretive sense.

7. Type of Ground Truth Used

The ground truth for the performance claims (e.g., viscosity, pH, microbial counts, biocompatibility outcomes, condom compatibility) is based on objective laboratory measurements and internationally recognized standard test methods (e.g., USP, ISO, ASTM). These standards define specific procedures and criteria for determining whether a product meets a particular specification.

8. Sample Size for the Training Set

This information is not applicable and therefore not provided. The "Playground For All Love Sesh" is a physical product (a personal lubricant), not an AI algorithm. Therefore, there is no "training set" in the context of machine learning.

9. How the Ground Truth for the Training Set Was Established

This information is not applicable as there is no training set for this type of device.

Summary

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

Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

January 30, 2023

Playground For All Sandy Vukovic Official Correspondent 4645 California Street San Francisco, CA 94118

Re: K222567

Trade/Device Name: Playground For All Love Sesh Regulation Number: 21 CFR§ 884.5300 Regulation Name: Condom Regulatory Class: II Product Code: NUC Dated: December 29, 2022 Received: December 29, 2022

Dear Sandy Vukovic:

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.

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

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

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

Indications for Use

510(k) Number (if known) K222567

Device Name Playground For All Love Sesh

Indications for Use (Describe)

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

Prescription Use (Part 21 CFR 201 Subpart D)
Over-The-Counter Use (21 CFR 201 Subpart C)

|_ | Prescription Use (Part 21 CFR 801 Subpart D)

X 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 K22567 Playground For All Love Sesh

1. Submitter Information

Applicant: Playground For All Contact: Sandy Vukovic Official Correspondent Address: 4645 California Street, San Francisco, CA 94118 USA Phone: (650) 246-9653 Email: sandy(@helloplayground.com

1. Date prepared: January 25, 2023

3. Subject Device Information

Device Trade Name: Playground For All Love Sesh Common Name: Personal Lubricant Regulation Number: 21 CFR 884.5300 Regulation Name: Condom Product Code: NUC (lubricant, personal) Device Class: Class II

4. Predicate Device Information

Device Name: Medley 510(k) Number: K212000 Manufacturer: Good Clean Love, Inc

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

5. Device Description

Its formulation consists of Water. Glycerin, Propanediol, Bamboo Bioferment PF, Sodium Hyaluronate, CMC Cellulose, Citric Acid, Carubba Blend, Tocopheryl Acetate, Sodium Benzoate, Potassium Sorbate

Playground For All Love Sesh is for over-the-counter (OTC) use and is offered in 3.7 fl. oz PET bottles and 0.17 fl. oz PET/Foil packettes.

Device specifications for the Playground For All Love Sesh are listed in Table 1 below.

Table 1: Device Specifications for Playground For All Love Sesh

Property	Specification
Appearance	Gel
Color	Clear to hazy white cream

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

Odor	Characteristic
Viscosity (per USP<912>)	1000 – 6000 cps
pH (per USP<791>)	4.0 - 5.5
Osmolality (per USP<785>)	2000 – 6000 mOsm/kg
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/Shigella	Absent
Antimicrobial Effectiveness Testing (perUSP <51>)	Specification
Bacteria	Meets USP <51> criteria for category 2.No less than 2.0 log reduction from initialcount at 14 days and no increase from the 14-day count at 28 days
Yeast and Molds	No increase from the initial calculated count at14 and 28 days

6. Indications for Use

7. 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: Intended Use and Technological Characteristics Comparison of the Subject and Predicate Device

	Playground For All Love SeshK222567Subject Device	MedleyK212000Predicate Device
Indications for Use	Playground For All Love Sesh 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.	Medley 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

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

Base type	Water	Water
Primary ingredients	Water, Glycerin, Propanediol, BambooBioferment PF, Sodium Hyaluronate,CMC Cellulose, Citric Acid, CarubbaBlend, Tocopheryl Acetate, SodiumBenzoate, Potassium Sorbate	Water, Hydroxyethylcellulose,Xanthan Gum, Hyaluronic Acid,Zemea Propanediol, Glycerin Water,Dimethicone, Hydrogenated Lecithin,Sodium Benzoate, Potassium Sorbae,DL Lactic Acid
Rx/OTC	OTC	OTC
Sterile	No	No
Appearance	Gel, Clear to hazy white cream	Gel, Colorless to Yellow and Cloudy
Odor	Characteristic	Characteristic
Viscosity per USP <912>	1000 - 6000 cps	12500 - 25000 cps
pH per USP <791>	4.0 - 5.5	3.5 - 4.0
Osmolality per USP <785>	2000 - 6000 mOsm/Kg	250 - 400 mOsm/kg
Total Aerobic Microbialcount (TAMC) per USP <61>	<100 cfu/g	<10 cfu/g
Total Yeast and Mold Count(TYMC) per USP < 61>	<10 cfu/g	<10 cfu/g
Absence of PathogenicOrganisms per USP <62>	Yes	Yes
Antimicrobial EffectivenessTested per USP <51>	Yes	Yes
Condom Compatibility	Compatible with natural rubber latex andpolyisoprene condoms	Compatible with natural rubber latexand polyisoprene condoms
Biocompatibility Tested	Yes	Yes

The subject and predicate device have similar indications for use and the same intended use – to provide lubrication for intimate sexual activity. The subject and predicate device have different technological characteristics, including different formulations, and specifications for appearance, TAMC, viscosity, pH, and osmolality. 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 testing was 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 demonstrate that the subject device is non-irritating, non-sensitizing,

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

and not acutely, systemically toxic.

Shelf-Life

The subject device has a shelf-life of 6 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.

Condom Compatibility

The compatibility of Playground For All Love Sesh 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 Playground For All Love Sesh is compatible with natural rubber latex and polyisoprene condoms. Results showed Playground For All Love Sesh is not compatible with polyurethane condoms.

10. Conclusion

The results of the performance testing described above demonstrate that Playground For All Love Sesh 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.