Uberlube

K151647 · Uberlube, LLC · NUC · Sep 23, 2015 · Obstetrics/Gynecology

Device Facts

• Record ID: K151647
• Device Name: Uberlube
• Applicant: Uberlube, LLC
• Product Code: NUC · Obstetrics/Gynecology
• Decision Date: Sep 23, 2015
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 884.5300
• Device Class: Class 2

Indications for Use

Überlube 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

Überlube is a clear, colorless, semi-viscous silicone-based personal lubricant. It is applied topically to the penis or vagina by the user to moisturize, lubricate, and enhance comfort during intimate sexual activity. The device supplements natural body lubrication. It is packaged in glass bottles with pump tops, foil samples, stoppered glass vials, or plastic bottles. It is intended for over-the-counter use. The lubricant is non-sterile and functions via physical lubrication properties. It provides a benefit by reducing friction during sexual activity.

Clinical Evidence

No clinical data. Evidence consists of bench testing: biocompatibility (cytotoxicity, vaginal irritation, sensitization, systemic toxicity) per ISO 10993-1; condom compatibility per ASTM D7661-10; microbial limits per USP <61> and <62>; and real-time aging tests confirming a 3-year shelf life.

Technological Characteristics

Silicone-based personal lubricant. Non-sterile. Packaged in glass, plastic, or foil. Biocompatibility per ISO 10993-1. Condom compatibility per ASTM D7661-10. Microbial quality per USP <61> and USP <62>.

Indications for Use

Indicated for individuals requiring penile and/or vaginal lubrication to enhance comfort during intimate sexual activity and supplement 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

• JO Premium Personal Lubricant (K132954)

Submission Summary (Full Text)

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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the top half of the circle. Inside the circle is a stylized image of three human profiles facing to the right, stacked slightly on top of each other.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

September 23, 2015

Uberlube, LLC % John Ziobro Principal Consultant SpectraMedEx, LLC 117 West South Street Oconomowoc. WI 53066

Re: K151647

Trade/Device Name: Überlube® Regulation Number: 21 CFR 884.5300 Regulation Name: Condom Regulatory Class: II Product Code: NUC Dated: June 16, 2015 Received: June 25, 2015

Dear John Ziobro,

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. 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 (reporting of medical device

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

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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.

You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

# Benjamin R. Fisher -S

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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# Indications for Use

510(k) Number (if known) K151647

Device Name Uberlube

### Indications for Use (Describe)

Überlube 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 ( <i>Select one or both, as applicable</i> ): |
|-----------------------------------------------------------|
|-----------------------------------------------------------|

| <span></span> Research Use (Part 21 CFR 201 Subpart D) | Over-The-Counter Use (21 CFR 201 Subpart G) |
|--------------------------------------------------------|---------------------------------------------|
|--------------------------------------------------------|---------------------------------------------|

__ Prescription Use (Part 21 CFR 801 Subpart D)

|X | Over-The-Counter Use (21 CFR 801 Subpart C)

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Image /page/3/Picture/0 description: The image shows the logo for "überlube". The logo consists of a black Erlenmeyer flask on the left, followed by the word "überlube" in a simple, sans-serif font. The two dots above the "u" in "überlube" are also visible.

# Überlube LLC® Personal Lubricant Traditional 510(k) Summary

# K151647

- Überlube LLC 1. Applicant Name: 2611 Hartzell St. Evanston, IL 60201 Phone: [phone] Establishment Registration Number: pending
- Submission Correspondent: On behalf of Überlube LLC, the following consultant is assigned the responsibility 2. of submission correspondence:

John F. Ziobro Principal Consultant SpectraMedEx, LLC 117 W. South Street Oconomowoc, WI 53066 262-719-8922

- 3. Trade Name: Überlube
- 4. Common Name: Personal Lubricant
- Überlube is a clear, colorless, semi-viscous silicone-based personal lubricant that is Description: న్. compatible with condoms made of natural rubber latex and polyisoprene. The device is not compatible for use with polyurethane condoms. The device is a non-sterile lubricant designed to moisturize and lubricate, to enhance the ease and comfort of intimate sexual activity and supplement the body's natural lubrication. The product is normally packaged in glass bottles with pump tops or in foil samples. It may also be packaged in stoppered glass vials or plastic bottles. The specifications for Überlube include appearance, odor, viscosity, total aerobic microbial count, total yeast and mold count, and absence of pathogenic organisms.

#### 6. Classification Regulation, Class & Product Code & Panel:

Regulation: 21 CFR 884.5300, Condom Classification: Class II Product Code: NUC Panel: Obstetrics/Gynecology

- 7. Reason for Traditional 510(k):
New Device

| 8. | Predicate Device(s): | 510(k) Number: | K132954 |
|----|----------------------|----------------|-------------------------------|
| | Manufacture: | | United Consortium |
| | Trade Name: | | JO Premium Personal Lubricant |
| | Product Code: | | NUC |
| | Classification: | | Class II |

- 9. Summary Date: May 15, 2015
# 10. Indication for Use

Überlube 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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Image /page/4/Picture/0 description: The image shows the logo for "überlube". The logo consists of a black flask on the left and the word "überlube" on the right. The word is in a sans-serif font and is all lowercase.

# Überlube LLC® Personal Lubricant Traditional 510(k) Summary

## 11. Comparison to Predicates

Überlube has the same intended use and technological characteristics as the predicate device.

### 12. Performance Data

Testing per ASTM D7661-10 indicated that Überlube is compatible with natural rubber latex and polyisoprene condoms. It is not compatible with polyurethane condoms.

Biocompatibility testing per ISO 10993-1, including cytotoxicity, vaginal irritation, sensitization and systemic toxicity, demonstrate that Überlube is biocompatible.

Microbial limits testing conducted per USP <61> and USP <62> indicated microbial quality.

Real-time aging tests indicate a 3-year shelf life for the lubricant.

### 13. Conclusion

Überlube is substantially equivalent to the predicate device.