VIELLE LUBRICANT

K051288 · Cst Medical Limited · HIS · Feb 3, 2006 · Obstetrics/Gynecology

Device Facts

• Record ID: K051288
• Device Name: VIELLE LUBRICANT
• Applicant: Cst Medical Limited
• Product Code: HIS · Obstetrics/Gynecology
• Decision Date: Feb 3, 2006
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 884.5300
• Device Class: Class 2

Intended Use

Vielle™ personal lubricant is intended for personal lubrication, lubrication of a body orifice to facilitate use of diagnostic or therapeutic, to enhance condom use and for vaginal use.

Device Story

Vielle™ Lubricant is a clear, water-soluble, silicone-based gel intended for personal lubrication, facilitating diagnostic/therapeutic procedures, and enhancing condom use. It is applied topically to body orifices or condoms. The device is intended for over-the-counter use by individuals. It functions as a physical lubricant to reduce friction. The formulation is inert, contains no fragrances or petroleum-based chemicals, and does not support microbial contamination. It is designed to be compatible with latex condoms.

Clinical Evidence

No clinical data. Bench testing only, including biocompatibility testing for irritation and sensitization, and condom compatibility testing.

Technological Characteristics

Water-soluble, silicone-based gel. Inert formulation; no preservatives, fragrances, or petroleum-based chemicals. Latex compatible. Non-sterile. OTC use.

Indications for Use

Indicated for personal lubrication, lubrication of body orifices to facilitate diagnostic or therapeutic procedures, and enhancement of condom use. For vaginal use. OTC 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

• Instead, Inc. Instead Intimate Lubricant (K033776)
• Qualis, Inc. Personal Lubricating Gel (K04129)

Submission Summary (Full Text)

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

K051288

## FEB 3 2006

## 510K Summary

This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of 21 CFR 807.92

- 1 . Submitters Identification: CST Medical Ltd Antrobus House 18 College Street Petersfield Hants GU31 4AD UK
Contact Person: John Adcock Regulatory Specialist

Date of Summary: May 5, 2005

- Device Name: Vielle™ Lubricant 2.
- Classification Name: Lubricant (21 CFR 884.5300) ని.
- 4. Predicate Device: Instead, Inc. Instead Intimate Lubricant K033776 Personal Lubricating Gel Qualis, Inc. K04129

## 5. Intended Use: Vielle™ personal lubricant is intended for personal lubrication, lubrication of a body orifice to facilitate use of diagnostic or therapeutic, to enhance condom use and for vaginal use.

- 6. Device Description/Comparison: Vielle™ is a clear, water-soluble, silicone based gel. No fragrances or petroleum-based chemicals are used in the formulation.
A comparison of technological characteristics of the CST lubricant with predicate devices substantiates the substantial equivalence of the Vielle™ Lubricant to the predicate devices.

| | CST Medical<br>Vielle™ Lubricant | Instead, Inc<br>Instead Intimate<br>Lubricant | Qualis, Inc.<br>Personal<br>Lubricating Gel |
|--------------|----------------------------------|-----------------------------------------------|---------------------------------------------|
| Common Name | Lubricant | Lubricant | Lubricant |
| Product Code | 80 MMS | 80 MMS | 80 MMS |
| Intended Use | Personal | Personal | Personal |

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

K051288
Page 2 of 2

| | Lubricating Gel | Lubricating Gel | Lubricating Gel |
|----------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------|
| Indications for use | VielleTM personal<br>lubricant is<br>intended for<br>personal<br>lubrication,<br>lubrication of a<br>body orifice to<br>facilitate use of<br>diagnostic or<br>therapeutic, to<br>enhance condom<br>use and for vaginal<br>use.. | Personal<br>Lubricating Gel is<br>designed to<br>enhance the ease<br>and comfort of<br>intimate activity<br>and is compatible<br>with latex<br>condoms. | Personal<br>Lubricating Gel is<br>designed to<br>enhance the ease<br>and comfort of<br>intimate activity<br>and is compatible<br>with latex<br>condoms. |
| Over the Counter Use | YES | YES | YES |
| Water-soluble | YES | YES | YES |
| Contains<br>Preservatives | NO-Product is inert<br>& cannot support<br>Microbial<br>contamination. | YES | YES |
| Latex compatible<br>Tested | YES | YES | YES |
| Biocompatibility<br>Tested | YES | YES | YES |
| Antimicrobial Tested | YES | YES | YES |
| Sterile | NO | NO | NO |

Non-clinical testing of the Vielle™ Lubricant included compatibility
testing with condoms and biocompatibility testing for irritation and
sensitization.

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

Image /page/2/Picture/1 description: The image shows a logo with a circular border containing text, and an abstract bird-like figure in the center. The text around the border is not clearly legible, but it appears to be part of an official seal or emblem. The bird figure is stylized with thick, curved lines, giving it a sense of motion or flight.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

FEB 3 2006

CST Medical Ltd. c/o Mr. E. J. Smith E.J. Smith Associates 1676 Village Green, Suite A CROFTON MD 21114

Re: K051288 Trade/Device Name: Vielle™ Lubricant Regulation Number: 21 CFR §884.5300 Regulation Name: Condom Product Code: HIS Regulation Number: 21 CFR §880.6375 Regulation Name: Patient lubricant Product Code: KMJ Regulatory Class: II

> Dated: January 5, 2006 Received: January 9, 2006

Dear Mr. Smith:

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.

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.

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

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.xxxx | (Gastroenterology/Renal/Urology) | 240-276-0115 |
|-----------------|----------------------------------|--------------|
| 21 CFR 884.xxxx | (Obstetrics/Gynecology) | 240-276-0115 |
| 21 CFR 892.xxxx | (Radiology) | 240-276-0120 |
| Other | | 240-276-0100 |

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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

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

Indications for Use

510(k) Number (if known):

Device Name: Vielle™ Lubricant

Classification Panel: 880.6375

Indications for Use:

Vielle™ personal lubricant is intended for personal lubrication, lubrication of a body orifice to facilitate use of diagnostic or therapeutic, to enhance condom use and for vaginal use.

Prescription Use (Part 21 CFR 801 Subpart D) And/Or

Over the Counter Use (21 CFR 807 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Nancy Brogdon

Page 1 of

(Division Sign-Off)
Division of Reproductive, Abdominal,
and Radiological Devices
510(k) Number. K051288