BIOTENE DRY MOUTH MOUTHWASH, BIOTENE PBF DRY MOUTH MOUTHWASH

K101477 · Glaxosmithkline Consumer Healthcare (Gskch) · LFD · Sep 28, 2010 · DE

Device Facts

• Record ID: K101477
• Device Name: BIOTENE DRY MOUTH MOUTHWASH, BIOTENE PBF DRY MOUTH MOUTHWASH
• Applicant: Glaxosmithkline Consumer Healthcare (Gskch)
• Product Code: LFD · DE
• Decision Date: Sep 28, 2010
• Decision: SESE
• Submission Type: Traditional
• Device Class: Class U
• Attributes: Therapeutic

Intended Use

Relieves and treats the symptoms of dry mouth; refreshes mouth odors, cleans, soothes oral irritations, moisturizes, lubricates, and diminishes dry discomfort. The Indication for Use: Relieves the symptoms of dry mouth; refreshes, moisturizes, cleans, soothes oral irritations, and lubricates oral dryness.

Device Story

Biotène Dry Mouth Oral Rinse is an artificial saliva substitute formulated with moisturizers, humectants, a protein, and salivary enzymes. It is used to relieve and treat symptoms of dry mouth by lubricating, moisturizing, soothing, and refreshing the oral cavity. The product is supplied as a liquid in various bottle sizes and laminated foil pouches. It is intended for over-the-counter use by patients to manage xerostomia symptoms as needed.

Clinical Evidence

Evidence includes non-clinical toxicology assessments, stability studies, and a clinical 'Use Study' to demonstrate effectiveness. Biocompatibility is supported by toxicological evaluations.

Technological Characteristics

Artificial saliva substitute containing moisturizers, humectants, a protein, and salivary enzymes. Supplied as a non-sterile liquid in PET bottles or laminated foil pouches. Ready-to-use formulation.

Indications for Use

Indicated for individuals experiencing symptoms of dry mouth (xerostomia) to provide relief, moisturization, lubrication, and soothing of oral irritation.

Predicate Devices

• Oral Balance Gel (K061331)
• Oral Balance Liquid (K061331)

Submission Summary (Full Text)

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# 61477

## SECTION 5: 510(K) SUMMARY

## SEP 2 8 2010

#### SUBMITTER INFORMATION 1.

Name:

Address:

Address.

Contact Person:

Telephone/Fax:

1500 Littleton·Road Parsippany, NJ 07054-3884

GlaxoSmithKline Consumer Healthcare

Wendy A. McManus

973-889-4415 973-889-2501 (fax)

Date Summary Prepared:

May 25, 2010

#### 2. DEVICE NAME

Biotène Dry Mouth Oral Rinse Device Name: Trade or Proprietary Name: Biotène Dry Mouth Oral Rinse Common or Usual Name: Saliva, Artificial Classification Name (if known): Saliva, Artificial

#### IDENTIFICATION OF EQUIVALENCE 3.

Laclede, Inc. Laclede, Inc.

Oral Balance Gel cleared in K061331 Oral Balance Liquid cleared in K061331

#### DEVICE DESCRIPTION 4.

Biotène Dry Mouth Oral Rinse is a specially formulated artificial saliva substitute which contain moisturizers, humectants, a protein, and patented salivary enzymes, that collectively have lubricating, moisturizing, soothing, and refreshing properties to relieve & treat the symptoms of Dry Mouth. The liquid products are supplied in PET

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Image /page/1/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized caduceus symbol, which is a staff with two snakes coiled around it, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" arranged in a circular pattern around the symbol. The logo is black and white.

### DEPARTMENT OF HEALTH & HUMAN SERVICES

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

Ms. Wendy McManus Regulatory Associate GlaxoSmithKline Consumer Healthcare (GSKCH) 1500 Littleton Road Parsippany, New Jersey 07054

SEP 2 8 2010

Re: K101477

Trade/Device Name: Biotene Dry Mouth Oral Rinse Regulation Number: Regulatory Class: Unclassified Product Code: 76 LFD Dated: September 17, 2010 Received: September 20, 2010

Dear Ms. McManus:

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.

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### Page 2- Ms. McManus

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-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) 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 go to

http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR 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 Small Manufacturers. International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely yours.

Cintron i, ont

Anthony D. Watson, B.S., M.S., M.B.A. Director

Division of Anesthesiology, general Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Biotène Dry Mouth Oral Rinse GlaxoSmithKline Consumer Healthcare, L.P.

## SECTION 4: INDICATIONS FOR USE STATEMENT

SEP 2 8 2010

510(k) Number (if known): N/A

Device Name: Biotène Dry Mouth Oral Rinse

Indications for Use:

Relieves the symptoms of dry mouth; refreshes, moisturizes, cleans, soothes oral irritation, and lubricates oral dryness.

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

Concurrence of CDRH, Officers of Device Evaluation (ODE)

Prescription Use

OR

Over-The-Counter Use

(Per 21 CFR 801.109)

Susan Russon

(Division Sign-Off) (Division of Anesthesiology, General Hospital Infection Control, Dental Devices

510(k) Number.

47

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510K Notification

## SEP 2 8 2010

bottles of various sizes, including an 8 oz., 16 oz., and 33.8 oz., and also 15 ml. multilayer laminated foil pouches.

#### STATEMENT OF INTENDED USE 5.

Relieves and treats the symptoms of dry mouth; refreshes mouth odors, cleans, soothes oral irritations, moisturizes, lubricates, and diminishes dry discomfort. The Indication for Use: Relieves the symptoms of dry mouth; refreshes, moisturizes, cleans, soothes oral irritations, and lubricates oral dryness.

#### SUMMARY OF THE TECHNOLOGICAL CHARACTERISTICS 6.

Characteristics of the device compared to the predicate devices.

| PRODUCT | Biotène Dry<br>Mouth Oral<br>Rinse | Oral Balance Gel | Oral Balance<br>Liquid |
|---------------------|-------------------------------------------|-------------------------------------------|-------------------------------------------|
| INTENDED USE | Symptomatic<br>Treatment of<br>Xerostomia | Symptomatic<br>Treatment of<br>Xerostomia | Symptomatic<br>Treatment of<br>Xerostomia |
| METHOD OF USE | Ready to use<br>liquid | Ready to use gel | Ready to use liquid |
| APPLICATION PER DAY | As needed | As needed | As needed |
| DISEASE STATE | Xerostomia | Xerostomia | Xerostomia |
| AREA OF USE | Oral Cavity | Oral Cavity | Oral Cavity |
| TYPE OF PRODUCT | Liquid | Gel | Liquid |
| PRESENTATION | Non-sterile | Non-sterile | Non-sterile |

## Substantial Equivalence Comparison Chart

## 7. Discussion and conclusions from the nonclinical and clinical tests

Biotène Dry Mouth Oral Rinse has been shown in non-clinical studies to be safe (Toxicology Assessments), and stable (Stability Studies) for its intended use. It has also been shown in clinical studies to be effective (Use Studies). Biocompatibility is addressed in the Statements of Toxicological Evaluation. No other clinical tests were performed other than a Use Study for this submission.