FOR PLAY, SLIP, PREPAIR - PERSONAL LUBRICANTS

K051688 · Trimensa Pharmaceuticals · NUC · Jul 12, 2006 · Obstetrics/Gynecology

Device Facts

• Record ID: K051688
• Device Name: FOR PLAY, SLIP, PREPAIR - PERSONAL LUBRICANTS
• Applicant: Trimensa Pharmaceuticals
• Product Code: NUC · Obstetrics/Gynecology
• Decision Date: Jul 12, 2006
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 884.5300
• Device Class: Class 2

Indications for Use

ForPlay, SLIP and PrePair personal Lubricants are medical devices intended for medical purposes to lubricate a body orifice to facilitate entry of diagnostic or therapeutic devices. ForPlay SLIP and PrePair Personal Lubricants are recommended as personal lubricants and are principally intended to supplement the body's natural lubrication, to moisturize and enhance the comfort and ease of intimacy with or without a condom.

Device Story

ForPlay, SLIP, and PrePair are water-based, high-viscosity personal lubricants; colorless, odorless, non-sticky, non-greasy, and water-soluble. Used by consumers to supplement natural lubrication or facilitate medical device insertion. Applied topically to body orifices or condoms. Benefits include enhanced comfort and ease of intimacy; easy removal via water rinsing. No clinical data or complex algorithms involved.

Clinical Evidence

No clinical data.

Technological Characteristics

Water-based gel/liquid formulation. Ingredients: purified water, glycerine, cellulose thickeners, methylparaben, propylparaben. Non-sterile. Packaged in plastic containers. Standalone product; no electronics, software, or energy source.

Indications for Use

Indicated for individuals requiring lubrication of body orifices to facilitate diagnostic or therapeutic device entry, or as a personal lubricant to supplement natural lubrication and enhance comfort during intimacy, with or without 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

• Lifestyles Liquid Personal Lubricant (K033076)
• K-Y Liquid Personal Lubricant (K955648)

Submission Summary (Full Text)

{0}------------------------------------------------

# Koslbea

## 510(K) Summary

JUL 1 2 2006

| Applicant: | TRIMENSA PHARMACEUTICALS<br>1050 Lawrence Drive<br>Newbury Park CA 91320 USA |
|------------|------------------------------------------------------------------------------|
| Phone: | [phone] |
| Fax: | [phone] |
| Contact: | Robin James Ogilvie (ex. 102) |
| Email: | [e-mail] |
| Date: | June 20, 2005 |

MULTIPLE Trade Name(s): Device:

| ForPlay | Personal Lubricant(s) |
|---------|-----------------------|
| SLIP | Personal Lubricant(s) |

PrePair Personal Lubricant(s)

{1}------------------------------------------------

| Common name | Personal Lubricant(s) |
|-------------------------|-------------------------------------------------------------------------------------------|
| Classification name(s): | Patient Lubricant<br>Product Code: 85 MMS / 21CFR section 880.6375<br>Regulatory Class: I |
| and | |
| | Condom<br>Product Code: 85 HIS / 21 CFR section 884.5300 |

Reguatory Class: II

McNeil-PPC, Inc.

K955648

Information supporting the claims of substantial equivalence, as defined under the Federal Food, Drug and Cosmetic act, with respect to safety and effectiveness is summarized below: For the convenience of the reviewer, this summary is formatted in accordance with the Agency's final ruling on,"510(K) Summaries and 510(K) Statements" (21CFR 807).

New Device Names: ForPlay Personal Lubricant(s) SLIP Personal Lubricant(s) PrePair Personal Lubricant(s) Lifestyles Liquid Personal Lubricant, Predicated Devices: Ansell Healthcare, Inc. K033076 K-Y Liquid Personal Lubricant

{2}------------------------------------------------

#### Technological Characteristics:

ForPlay, SLIP and PrePair Personal Lubricant(s) formulations contain ingredients which are Substantially Equivalent to the predicate devices submitted Below,

#### Summary of Technological Characteristics:

The table below compares the technological characteristics of ForPlay, SLIP and PrePair Personal Lubricant(s) to the predicate device brands of: Lifestyles Liquid Personal Lubricant, Lifestyles Liquid Personal Lubricant with Aloe & Vitamin E, Lifestyles Liquid Personal Lubricant Strawberry and K-Y Liquid Personal Lubricant.

| Feature | ForPlay | SLIP | PrePair | Lifestyles | K-Y Liquid |
|-------------------------------------|-----------------------------|-----------------------------|-----------------------------|---------------------------|---------------------|
| 510(K) # | N/A | N/A | N/A | K033076 | K955648 |
| Manufacturer | TRIMENSA<br>Pharmaceuticals | TRIMENSA<br>Pharmaceuticals | TRIMENSA<br>Pharmaccuticals | Ansell<br>Healthcare, Inc | McNeil-<br>PPC, Inc |
| Contains<br>Purified Water | Yes | Yes | Yes | Yes | Yes |
| Contains<br>Glycerine | Yes | Yes | Yes | Yes | Yes |
| Contains<br>Cellulose<br>Thickeners | Yes | Yes | Yes | Yes | Yes |
| Contains<br>Methylparaben | Yes | Yes | Yes | Yes | Yes |
| Contains<br>Propylparaben | Yes | Yes | Yes | Yes | Yes |
| Labeled<br>Water soluble | Yes | Yes | Yes | Yes | Yes |
| Labeled<br>Non-Staining | Yes | Yes | Yes | Yes | Yes |
| Labeled<br>Condom<br>Compatible | Yes | Yes | Yes | Yes | Yes |
| Container<br>Material | Plastic | Plastic | Plastic | Plastic | Plastic |
| Sterile | No | No | No | No | No |

{3}------------------------------------------------

#### Device Description:

"ForPlay, SLIP and PrePair Personal Lubricants" are colorless, odorless, non-sticky, non-greasy, nonirritating water based lubricants. They are water-soluble, high viscosity gels and liquids. Because they are water-soluble, ForPlay, SLIP and PrePair Personal Lubricants are easily rinsed off with water leaving NO residue.

{4}------------------------------------------------

Image /page/4/Picture/0 description: The image shows the logo for the Department of Health & Human Services - USA. The logo consists of a stylized eagle or bird-like symbol with three curved lines forming its body and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the bird symbol.

Food and Drug Administration 9200 Corporate Blvd. Rockville MD 20850

JUL 1 2 2006

Mr. Robin J. Ogilvie President Trimensa Pharamaceuticals 1050 Lawrence Drive NEWBURY PARK CA 91320

Re: K051688

Trade/Device Name: ForPlay, SLIP and PrePair Personal Lubricants Regulation Number: 21 CFR 884.5300 Regulation Name: Condom Regulatory Class: II Product Code: NUC Dated: June 6, 2006 Received: June 7, 2006

#### Dear Mr. Ogilvie:

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.

If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval), it may be subject to such 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.

Image /page/4/Picture/10 description: The image shows a circular logo with the text "1906-2006" at the top and "FDA Centennial" in the center. There are three stars below the word "Centennial". The logo is surrounded by text that reads "Dedicated to Leaders in Consumer Protection in the Science of Food".

{5}------------------------------------------------

Page 2 -

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); 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.

This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at one of the following numbers, based on the regulation number at the top of this letter:

| 21 CFR 876.xxx | (Gastroenterology/Renal/Urology) | 240-276-0115 |
|----------------|----------------------------------|--------------|
| 21 CFR 884.xxx | (Obstetrics/Gynecology) | 240-276-0115 |
| 21 CFR 894.xxx | (Radiology) | 240-276-0120 |
| Other | | 240-276-0100 |

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number [phone] or [phone]

or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Nancy C. Hogdon

Nancy C. Brogdon Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

{6}------------------------------------------------

### Indications for Use

510(k) Number (if known): K051688

Device Name: ForPlay: SLIP and PrePair

Indications For Use:

ForPlay, SLIP and PrePair personal Lubricants are medical devices intended for medical purposes to lubricate a body orifice to facilitate entry of diagnostic or therapeutic devices. ForPlay SLIP and PrePair Personal Lubricants are recommended as personal lubricants and are principally intended to supplement the body's natural lubrication, to moisturize and enhance the comfort and ease of intimacy with or without a condom.

NO Prescription Use (Part 21 CFR 801 Subpart D)

AND/OR

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

Use YES
(C)

(PLEASE DO NOT WRITE BELOW THIS LINE CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

CONTINUE

Division Sign Off

CONTINUE ON ANOTHER PAGE IF

(Division Sign-Off) Division of Reproductive, Abdominal and Radiological Devices 510(k) Number

Page 1 of 1