LUBRIGLIDE

K973557 · Qualis, Inc. · KMJ · Oct 10, 1997 · General Hospital

Device Facts

• Record ID: K973557
• Device Name: LUBRIGLIDE
• Applicant: Qualis, Inc.
• Product Code: KMJ · General Hospital
• Decision Date: Oct 10, 1997
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.6375
• Device Class: Class 1

Intended Use

Lubriglide is a non-sterile personal lubricant for over-the-counter use. Its primary use is to apply the product to the genital area to reduce the discomfort associated with sexual activity. Lubriglide can also be used to lubricate rectal thermometers, tampons, douches, and enemas.

Device Story

Lubriglide is a water-based, water-soluble personal lubricant designed to mimic natural body fluids. It is non-irritating, non-staining, non-toxic, and easily removed with water. The device is intended for over-the-counter use by consumers to reduce discomfort during sexual activity or to facilitate the insertion of medical devices like rectal thermometers, tampons, douches, and enemas. It is applied topically by the user.

Clinical Evidence

No clinical data. Evidence consists of non-clinical bench testing, including accelerated stability testing (assigned two-year expiration) and antimicrobial preservative challenge testing.

Technological Characteristics

Water-based, water-soluble personal lubricant. Non-sterile. Formulated to be non-irritating, non-staining, and non-toxic.

Indications for Use

Indicated for over-the-counter use as a personal lubricant applied to the genital area to reduce discomfort during sexual activity; also indicated for lubrication of rectal thermometers, tampons, douches, and enemas.

Regulatory Classification

Identification

A patient lubricant is a device intended for medical purposes that is used to lubricate a body orifice to facilitate entry of a diagnostic or therapeutic device.

Predicate Devices

• Astroglide (K935299)

Submission Summary (Full Text)

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OCT . 0 1997

## 510 (k) Summary of Information Respecting Safety and Effectiveness 9.

- A. Legally Marketed Device.
Qualis claims substantial equivalence to Astroglide (K935299), currently in commercial distribution by Bio Film, Inc.

- B. Device Description.
Lubriglide is a water-based, water-soluble personal lubricant designed to imitate the body's own lubricating fluids. It is nonirritating, non-staining, and won't dry out or leave behind any solid residues. Lubriglide is non-toxic and is easily removed with water.

- C. Intended Use.
Lubriglide is a non-sterile personal lubricant for over-the-counter use. It can also be used to lubricate rectal thermometers, tampons, douches, and enemas.

- D. Comparison with Predicate Device.
A summary comparison of the features of Lubriglide and the Predicate Device (Astroglide) is provided in Table 1.

- E. Performance Data.
Non-clinical studies.

- 1. Stability.
Lubriglide successfully passed the requirements of the Qualis, Inc., accelerated stability protocol and has been assigned a two-year expiration period.

- 2. Preservative Effectiveness.
Lubriglide successfully passed the requirements of the Qualis, Inc., antimicrobial preservative challenge.

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- Comparison with Predicate Device. 3.
i

Lubriglide was compared to Astroglide on the basis of perceptual qualities, physical and chemical properties, ingredients list review, label claims, and packaging. The result of this review was a "Satisfactory" comparison.

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DEPARTMENT OF HEALTH & HUMAN SERVICES • USA

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20856

Mary Finn, Ph.D. Director of Regulatory Affairs Qualis, Incorporated 4600 Park Avenue 50321 Des Moines, Iowa

OCT 10 1997

K973557 Re : Lubriglide Trade Name: Requlatory Class: I Product Code: KMJ Auqust 25, 1997 Dated: September 19, 1997 Received:

Dear Dr. Finn:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). You may, therefore, market the device, subject to the general controls provisions The general controls provisions of the Act of the Act. include requirements for annual reqistration, listing of devices, qood 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 Requlations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (QS) for Medical Devices: General requlation (21 CFR Part 820) and that, through periodic (QS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP requlation may result in regulatory In addition, FDA may publish further announcements action. concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531

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Page 2 - Dr. Finn

through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or requlations.

This letter will allow you to begin marketing your device as described in your 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 requlation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to
premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number [phone] or [phone] or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".

Sincerely yours,

Susan Turner

imothy A. Ulatowski Director Division of Dental, Infection Control and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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5 10(k) Number (if known): K973557

Device Name:

Lubriglide

Indications For Usc:

Lubriglide is a non-sterile personal lubricant for over-the-counter use. Its primary use is to apply the product to the genital area to reduce the discomfort associated with sexual activity. Lubriglide can also be used to lubricate rectal thermometers, tampons, douches, and enemas.

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

Concilitence of CDRH, Office of Device Evaluation (ODE)

Patricia Ciccole

(Division Sign-Off) Division of Dental, Infaction Control, and General Hospital I 510(k) Number

Prescription Use (Per 21 CFR 801.109) OR

Over-The-Counter Use /

(Optional Formal 1-2-96)

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