SuperSlyde Personal Lubricant

K172306 · Icm Pharma Pte, Ltd. · NUC · Apr 19, 2018 · Obstetrics/Gynecology

Device Facts

• Record ID: K172306
• Device Name: SuperSlyde Personal Lubricant
• Applicant: Icm Pharma Pte, Ltd.
• Product Code: NUC · Obstetrics/Gynecology
• Decision Date: Apr 19, 2018
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 884.5300
• Device Class: Class 2

Indications for Use

SuperSlyde lubricant 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 condoms. This product is not compatible with polyurethane and polyisoprene condoms.

Device Story

SuperSlyde is an anhydrous, non-sterile, clear, silicone-based personal lubricant; composed of dimethicone and dimethiconol. Intended for over-the-counter use by consumers to enhance comfort during intimate sexual activity. Applied topically to penile and/or vaginal areas. Acts as a physical lubricant to reduce friction. Packaged in polyethylene terephthalate (PET) bottles with polypropylene (PP) caps. Does not contain water; therefore, osmolality, pH, and antimicrobial effectiveness testing are not applicable. Provides patient benefit by supplementing natural lubrication and facilitating sexual activity.

Clinical Evidence

Bench testing only. Biocompatibility testing performed per ISO 10993-5:2009 (cytotoxicity), ISO 10993-10:2010 (sensitization and vaginal irritation), and ISO 10993-11:2006 (acute systemic toxicity). Condom compatibility evaluated per ASTM D7661-10; confirmed compatible with natural rubber latex condoms, but incompatible with polyisoprene and polyurethane condoms. Shelf life testing confirms specifications are met over the proposed duration.

Technological Characteristics

Anhydrous silicone-based formulation (dimethicone and dimethiconol). Non-sterile. Packaged in PET bottles with PP caps. Tested for biocompatibility per ISO 10993 standards and condom compatibility per ASTM D7661-10.

Indications for Use

Indicated for penile and/or vaginal application to moisturize and lubricate, enhancing ease and comfort of intimate sexual activity and supplementing natural lubrication. Compatible with natural rubber latex condoms; contraindicated for use with polyurethane and polyisoprene 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

• Wet Platinum Premium Lubricant (K130012)

Submission Summary (Full Text)

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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 and 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.

April 19, 2018

ICM Pharma Pte Ltd Moturi Srinivasa Rao Regulatory Affairs Manager 26 Kallang Place #05-17 Singapore, 339157 Sg

Re: K172306

Trade/Device Name: SuperSlyde Personal Lubricant Regulation Number: 21 CFR§ 884.5300 Regulation Name: Condom Regulatory Class: II Product Code: NUC Dated: March 15, 2018 Received: March 19, 2018

Dear Moturi Srinivasa Rao:

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. 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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(Sections 531-542 of the Act); 21 CFR 1000-1050.

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); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions

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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely,

Joyce M. Whang -S

for

Benjamin R. Fisher, Ph.D. Director Division of Reproductive, Gastro-Renal, and Urological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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## 510(k) Summary

## K172306

| | K172306 | ICM PHARMA PTE LTD |
|-----------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------|
| | | 26 Kallang Place #05-17 Singapore 339157 |
| Submitted by: | ICM Pharma Pte Ltd | Tel: [phone] Fax: [phone] |
| | 26 Kallang Place #05-17 | E-mail: [e-mail] |
| | Singapore 339157 | Website: www.icmpharma.com.sg |
| Contact Person: | Moturi Srinivasa Rao<br>ICM Pharma Pte Ltd<br>26 Kallang Place #05-17<br>Singapore 339157<br>Tel: [phone]<br>Fax: [phone]<br>email: [e-mail] | Co. Regn No: 198601755R |
| Date Prepared: | 08/03/2018 | |
| Proposed Trade<br>Name: | SuperSlyde Personal Lubricant | |
| Common Name: | Personal Lubricant | |
| Classification Name: | Condom<br>21 CFR884.5300<br>Class II<br>NUC (lubricant, personal) | |
| Predicate Device | Wet Platinum Premium Lubricant<br>510(k) No: K130012<br>The predicate device has not been subject to a design related recall. | |
| Device Description: | SuperSlyde is an anhydrous, non-sterile, clear, silicone-soluble liquid for use as a personal<br>lubricant. It is made of dimethicone and dimethiconol. | |
| | The specifications for SuperSlyde include appearance, color, odor, viscosity, total aerobic<br>microbial count per USP <61>, total yeast and mold count per USP <61> and absence of<br>pathogenic organisms per USP <62>. Osmolality, pH and antimicrobial effectiveness test<br>parameters are not applicable because the subject lubricant is non-aqueous based<br>formulation. | |
| | The product is packaged in a polyethylene terephthalate (PET) bottle with a screw-on,<br>press-top polypropylene (PP) in volumes of 100ml, 250ml and 400ml. | |
| Indications for Use: | SuperSlyde lubricant is a personal lubricant, for penile and/or vaginal application, intended to<br>moisturize and lubricate, to enhance the ease and comfort of intimate sexual activity and<br>supplement the body's natural lubrication. This product is compatible with natural rubber<br>latex condoms. This product is not compatible with polyurethane and polyisoprene condoms. | |
| Technological<br>Characteristics: | SuperSlyde has similar ingredients to the predicate device. However, SuperSlyde and the<br>predicate device have different technological characteristics, including their formulation and<br>specifications. The differences in technological characteristics do not raise different<br>questions of safety or effectiveness. | |
| Summary of Performance Testing: | | |
| Biocompatibility: | SuperSlyde Personal Lubricant has undergone biocompatibility testing including cytotoxicity,<br>sensitization, vaginal irritation and acute systemic toxicity testing per ISO 10993-5:2009, ISO<br>10993-10:2010, ISO 10993-10:2010 and ISO 10993-11:2006, respectively. The testing found<br>that SuperSlyde Personal Lubricant is biocompatible. | |
| Condom<br>Compatibility | The compatibility of the subject device with natural rubber latex, polyisoprene, and<br>polyurethane condoms was evaluated in accordance with ASTM D7661-10 Standard Test<br>Method for Determining Compatibility of Personal Lubricants with Natural Rubber Latex<br>Condoms. The results of this test demonstrated that the subject device is compatible with<br>natural rubber latex condoms. This product is not compatible with polyisoprene and<br>polyurethane condoms. | |
| Shelf Life Testing: | The results of shelf life testing demonstrate that the subject device meets its specifications<br>over the duration of its proposed shelf life. | |
| Conclusion: | The performance data demonstrate that the SuperSlyde Lubricant is substantially equivalent<br>to its proposed predicate device. | |