Play&Joy InvisiLube Lubricant Capsule

K220646 · Innovemed Bio-Tech Co., Ltd. · NUC · Jul 10, 2023 · Obstetrics/Gynecology

Device Facts

• Record ID: K220646
• Device Name: Play&Joy InvisiLube Lubricant Capsule
• Applicant: Innovemed Bio-Tech Co., Ltd.
• Product Code: NUC · Obstetrics/Gynecology
• Decision Date: Jul 10, 2023
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 884.5300
• Device Class: Class 2

Indications for Use

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. This product is compatible with natural rubber latex, polyisoprene, and polyurethane condoms

Device Story

Play & Joy InvisiLube Lubricant Capsule is a non-sterile, personal lubricant designed for vaginal application to enhance comfort during sexual activity. The device consists of an anhydrous silicone-based lubricant (Cyclopentasiloxane, Dimethiconol, Dimethicone) encapsulated within a gelatin shell (gelatin, glycerin, phatic acid, water). It is intended for over-the-counter use by consumers. The capsule is applied vaginally, where it provides lubrication. It is compatible with natural rubber latex, polyisoprene, and polyurethane condoms. The device benefits the patient by supplementing natural lubrication and reducing friction during intimate activity.

Clinical Evidence

No clinical data. Bench testing only. Biocompatibility testing performed per ISO 10993-1 (cytotoxicity, sensitization, vaginal irritation, acute systemic toxicity) confirmed the device is non-sensitizing, non-irritating, and not systemically toxic. Condom compatibility confirmed per ASTM D7661-10. Shelf-life validated via accelerated aging per ASTM 1980-16.

Technological Characteristics

Silicone-based lubricant (Dimethicone, Dimethiconol, Cyclopentasiloxane) in a gelatin capsule (gelatin, glycerin, phatic acid, water). Viscosity 75-201 cps. Non-sterile. Shelf life 6 months. Tested per ASTM D7661-10 (condom compatibility) and ASTM 1980-16 (accelerated aging).

Indications for Use

Indicated for over-the-counter use by adults for vaginal application to moisturize, lubricate, and enhance comfort during intimate sexual activity; supplements natural lubrication. Compatible with natural rubber latex, polyisoprene, and 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

• K-Y Brand Liquibeads (K122061)

Submission Summary (Full Text)

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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 ([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) 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.<br>Datang District.,<br>Taipei City 10357, Taiwan (R.O.C.) |
| Phone: | ([phone]) |
| Email: | [e-mail] |

#### 2. Correspondent Information

| Company: | Shenzhen World Eye Consulting Co., Ltd. |
|----------|------------------------------------------------------------------------------------------------------------|
| Contact: | Charles Shen |
| Address: | 05, area B, 1st floor, building R, No. 13<br>Yuansheng lane, Changzhen community<br>Shenzhen, China 518132 |
| Phone: | [phone] |
| Email: | [e-mail] |

#### 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

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.

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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, per<br>USP <61> | <100cfu/g |
| Total Yeast and Mold Count (TYMC, per<br>USP <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

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. This product is compatible with natural rubber latex, polyisoprene, and polyurethane condoms

#### 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 InvisiLube<br>Lubricant Capsule<br>K220646<br>Subject Device | K-Y Brand Liquibeads<br>K122061<br>Predicate Device |
|----------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Device Classification Name | Lubricant, Personal | Lubricant, Personal |
| Indications for Use | Play & Joy InvisiLube Lubricant<br>Capsule is a personal lubricant for over-<br>the counter use, for vaginal application,<br>intended to moisturize and lubricate, to<br>enhance the ease and comfort of intimate<br>sexual activity and supplement the<br>body's natural lubrication. This product<br>is compatible with natural rubber latex,<br>polyisoprene, and polyurethane condoms | K-y(r) brand liquibeads(r) vaginal<br>moisturizer is a personal lubricant for<br>over-the-counter use, for vaginal<br>application, intended to moisturize<br>and lubricate, to enhance the ease and<br>comfort of intimate sexual activity and<br>supplement the body's natural<br>lubrication. This product is compatible<br>with natural rubber latex,<br>polyisoprene, and polyurethane |

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| | | condoms. The product is delivered by |
|-----------------------------------------|--------------------------------------------------------------------------------------------|----------------------------------------------------------------|
| | | an applicator. |
| Base type | Silicone | Silicone |
| Primary ingredients | Dimethicone, Dimethiconol,<br>Cyclopentasiloxane, Glycerin, Gelatin,<br>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 Microbial<br>count (TAMC) | <100 cfu/g | <100 cfu/g |
| Total Yeast and Mold Count<br>(TYMC) | <10 cfu/g | <10 cfu/g |
| Absence of Pathogenic<br>Organisms | Yes | Yes |
| Condom Compatibility | Compatible with natural rubber latex,<br>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.