Play and Joy Water-Based Lubricant

K221137 · Innovemed Bio-Tech Co., Ltd. · NUC · Jul 11, 2023 · Obstetrics/Gynecology

Device Facts

• Record ID: K221137
• Device Name: Play and Joy Water-Based Lubricant
• Applicant: Innovemed Bio-Tech Co., Ltd.
• Product Code: NUC · Obstetrics/Gynecology
• Decision Date: Jul 11, 2023
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 884.5300
• Device Class: Class 2

Intended Use

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 Story

Water-based personal lubricant; provides lubrication and moisture during intimate sexual activity. Applied topically to penile and/or vaginal areas by the user. Compatible with natural rubber latex, polyisoprene, and polyurethane condoms. Packaged in 50 mL and 100 mL polyethylene tubes with polypropylene caps. Non-sterile, clear, semi-viscous liquid. Benefits include enhanced comfort during sexual activity. No clinical data; performance established via bench testing for biocompatibility, condom compatibility, and physical specifications.

Clinical Evidence

No clinical data. Bench testing only: biocompatibility (cytotoxicity, sensitization, vaginal irritation, acute systemic toxicity per ISO 10993), condom compatibility (ASTM D7661-10), and shelf-life stability (accelerated aging).

Technological Characteristics

Water-based lubricant; ingredients include 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, sodium benzoate. Physical specs: pH 4.92-5.38 (USP <791>), viscosity 1727-3463 cps (USP <912>), osmolality 944-984 mOsm/kg (USP <785>). Non-sterile. Polyethylene tube packaging.

Indications for Use

Indicated for penile and/or vaginal application to lubricate and moisturize, enhance ease and comfort of intimate sexual activity, and supplement natural lubrication. Compatible with natural rubber latex, polyurethane, and polyisoprene condoms. For over-the-counter use.

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

• Solevy Co. LLC Water-Based Lubricant (K203654)

Submission Summary (Full Text)

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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 ([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) K221137

### Device Name Play and Joy Water-Based Lubricant

### Indications for Use (Describe)

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.

| 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: [phone] E-Mail: Linda(@innovemed.biz

#### 2 Submission Correspondent:

Charles Shen Manton Business and Technology Services 37 Winding Ridge, Oakland, New Jersey 07436, USA Tel: [phone] Email: [e-mail]

#### 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

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.

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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 not<br>less than 2.0 log reduction at 14 days and no<br>increase from 14-day count at the 28-day<br>count. Yeast and molds should show no<br>increase from the initial calculated count at 14<br>and 28 days |
| Total yeast and mold count (TYMC, per USP<br><61>) | <10 cfu/g |
| Total aerobic microbial count (TAMC, per<br>USP <61>) | <100 cfu/g |
| Absence of Pathogenic Organisms (P.<br>aeruginosa, S. aureus, Salmonella/Shigella, E.<br>coli, and C. albicans) | Absent |

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

#### 7 Indications for Use:

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.

#### 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<br>(K221137) | Predicate device<br>(K203654) | Comparison |
|------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Device Name | Play and Joy Water-<br>Based Lubricant | Solevy Co. LLC Water-<br>Based Lubricant | N/A |
| Device Model | 50 mL and 100 mL<br>(1.7/3.4 fl. Oz) | 1, 2.5, 4.5, 8, and 16 fl. oz | N/A |
| Manufacturer | InnoveMed Bio-tech<br>Co., Ltd | Solevy Co. LLC | N/A |
| Indications for Use | Play and Joy Water-Based<br>Lubricant is a water-based<br>personal lubricant, for<br>penile and/or vaginal<br>application, intended to<br>lubricate and moisturize, to<br>enhance the ease and<br>comfort of intimate sexual<br>activity and supplement<br>the body's natural<br>lubrication. This product is<br>compatible with natural<br>rubber latex, polyurethane,<br>and polyisoprene<br>condoms. | Solevy Co. LLC Water-<br>Based Lubricant is a<br>water-based personal<br>lubricant, for penile<br>and/or vaginal<br>application, intended to<br>lubricate and moisturize,<br>to enhance the ease and<br>comfort of intimate sexual<br>activity and supplement<br>the body's natural<br>lubrication. This product<br>is compatible with natural<br>rubber latex,<br>polyurethane, and<br>polyisoprene condoms. | The indications for<br>use and intended<br>use of the subject<br>and predicate<br>devices are the<br>same. |
| Base type | Water-based | Water-based | Same |
| Rx/OTC | OTC | OTC | Same |
| Sterile | No | No | Same |
| Ingredients | Water (Aqua)<br>Xantham gum<br>Glycerine<br>Chondrus crispus extract<br>Sodium hyaluronate<br>Saccharide isomerate<br>Hydroxyethylcellulose<br>Citric acid<br>Sodium citrate<br>Lactic acid<br>1,2-pentanediol<br>Phenoxyethanol<br>Iodopropynyl<br>butylcarbamate<br>Hydroxyacetophenone<br>Gluconolactone<br>Sodium benzoate | Glycerin<br>Water<br>Cellulose gum<br>Methylparaben<br>Propylparaben | Different: There<br>are differences in<br>the subject and<br>predicate device<br>formulations. These<br>differences in<br>device formulations<br>do not raise<br>different questions<br>of safety and<br>effectiveness<br>(S&E). |
| Appearance | Clear, semi-viscous<br>liquid | Clear, semi-viscous<br>liquid | Same |
| Color | Colorless | Colorless | Same |
| Odor | Odorless | Odorless | Same |
| PH@25° C | 4.92-5.38 | 6.0-7.0 | Different: The pH<br>for the subject<br>device is lower than<br>the predicate<br>device. This<br>difference in pH |
| | | | |
| Viscosity | 1727-3463 cps | 1,200 - 1,800 cps | does not raise<br>different questions<br>of S&E.<br><b>Different:</b> The<br>viscosity range for<br>the subject device is<br>wider than the<br>predicate device.<br>This difference<br>does not raise<br>different questions<br>of S&E. |
| Specific Gravity | 1.04-1.08 | 1.12- 1.20 | Similar |
| Osmolality | 944-984 mOsm/kg | 750 - 950 mOsm/kg | <b>Different:</b> The<br>osmolality of the<br>subject device is<br>higher than the<br>predicate device.<br>This difference<br>does not raise<br>different questions<br>of S&E. |
| Antimicrobial<br>Effectiveness Tested<br>per USP<62> | Yes | Yes | Same |
| Total yeast and mold<br>(TYMC) | <10 cfu/g | <10 cfu/g | Same |
| Total aerobic<br>microbial<br>count (TAMC) | <100 cfu/g | <100 cfu/g | Same |
| Absence of Pathogenic<br>Organisms per USP<br><62> | Yes | Yes | Same |
| Condom<br>Compatibility | Compatible with natural<br>rubber latex,<br>polyurethane, and<br>polyisoprene<br>condoms | Compatible with natural<br>rubber latex,<br>polyurethane, and<br>polyisoprene<br>condoms | Same |
| Biocompatibility<br>Tested | Yes | Yes | Same |
| Shelf life | 6 months | 36 months | <b>Different:</b> The<br>shelf-life for the<br>subject device is<br>less than the<br>predicate device.<br>This difference<br>does not raise<br>different questions<br>of 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