Playground For All Love Sesh

K222567 · Playground For All · NUC · Jan 30, 2023 · Obstetrics/Gynecology

Device Facts

• Record ID: K222567
• Device Name: Playground For All Love Sesh
• Applicant: Playground For All
• Product Code: NUC · Obstetrics/Gynecology
• Decision Date: Jan 30, 2023
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 884.5300
• Device Class: Class 2

Intended 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.

Device Story

Water-based, non-sterile, unscented personal lubricant; provides lubrication during intimate sexual activity. Applied topically by user. Compatible with natural rubber latex and polyisoprene condoms; incompatible with polyurethane condoms. Packaged in PET bottles or PET/Foil packettes. Benefits include enhanced ease and comfort during sexual activity by supplementing natural lubrication.

Clinical Evidence

Bench testing only. Biocompatibility testing per ISO 10993-1 (cytotoxicity, sensitization, vaginal irritation, acute systemic toxicity) confirmed non-irritating, non-sensitizing, and non-toxic profile. Condom compatibility tested per ASTM D7661-10(R) 2017. Shelf-life validated via real-time testing.

Technological Characteristics

Water-based gel; ingredients include water, glycerin, propanediol, bamboo bioferment, sodium hyaluronate, CMC cellulose, citric acid, carubba blend, tocopheryl acetate, sodium benzoate, potassium sorbate. pH 4.0-5.5; viscosity 1000-6000 cps; osmolality 2000-6000 mOsm/kg. Tested per USP <912>, <791>, <785>, <61>, <62>, and <51>.

Indications for Use

Indicated for penile and/or vaginal application to moisturize and lubricate during intimate sexual activity; supplements natural lubrication. Compatible with natural rubber latex and polyisoprene condoms; contraindicated for use with polyurethane condoms.

Regulatory Classification

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.

Special Controls

*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.

Predicate Devices

• Medley (K212000)

Submission Summary (Full Text)

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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.

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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 ([e-mail]) or phone [phone] 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) K222567

Device Name Playground For All Love Sesh

#### Indications for Use (Describe)

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.

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

| Prescription Use (Part 21 CFR 201 Subpart D) | <input type="checkbox"/> |
|----------------------------------------------|-------------------------------------|
| Over-The-Counter Use (21 CFR 201 Subpart C) | <input checked="" type="checkbox"/> |

|_ | 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 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: [phone] Email: sandy(@helloplayground.com

- 2. 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

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.

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 |

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| 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, per<br>USP <61>) | <100 cfu/g |
| Total Yeast and Mold Count (TYMC, per<br>USP <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 (per<br>USP <51>) | Specification |
| Bacteria | Meets USP <51> criteria for category 2.<br>No less than 2.0 log reduction from initial<br>count at 14 days and no increase from the 14-<br>day count at 28 days |
| Yeast and Molds | No increase from the initial calculated count at<br>14 and 28 days |

#### 6. 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.

#### 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 Sesh<br>K222567<br>Subject Device | Medley<br>K212000<br>Predicate 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 |

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| Base type | Water | Water |
|------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Primary ingredients | Water, Glycerin, Propanediol, Bamboo<br>Bioferment PF, Sodium Hyaluronate,<br>CMC Cellulose, Citric Acid, Carubba<br>Blend, Tocopheryl Acetate, Sodium<br>Benzoate, Potassium Sorbate | Water, Hydroxyethylcellulose,<br>Xanthan Gum, Hyaluronic Acid,<br>Zemea Propanediol, Glycerin Water,<br>Dimethicone, Hydrogenated Lecithin,<br>Sodium Benzoate, Potassium Sorbae,<br>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 Microbial<br>count (TAMC) per USP <61> | <100 cfu/g | <10 cfu/g |
| Total Yeast and Mold Count<br>(TYMC) per USP < 61> | <10 cfu/g | <10 cfu/g |
| Absence of Pathogenic<br>Organisms per USP <62> | Yes | Yes |
| Antimicrobial Effectiveness<br>Tested per USP <51> | Yes | Yes |
| Condom Compatibility | Compatible with natural rubber latex and<br>polyisoprene condoms | Compatible with natural rubber latex<br>and 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,

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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.