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

AI/ML Overview

I am sorry, but based on the provided text, there is no information about acceptance criteria or a study that proves the device meets specific acceptance criteria in a quantitative manner.

The document is a 510(k) summary for a medical device (Biotène Dry Mouth Oral Rinse) and focuses on demonstrating substantial equivalence to predicate devices, rather than presenting a detailed study with acceptance criteria and performance metrics.

Here's a breakdown of what is and is not available in the provided text regarding your request:

Information Present in the Document:

Device Description: Biotène Dry Mouth Oral Rinse is an artificial saliva substitute containing moisturizers, humectants, a protein, and salivary enzymes to relieve and treat dry mouth symptoms.
Intended Use/Indications for Use: Relieves the symptoms of dry mouth; refreshes, moisturizes, cleans, soothes oral irritation, and lubricates oral dryness.
Predicate Devices: Laclede, Inc. Oral Balance Gel (K061331) and Oral Balance Liquid (K061331).
Nonclinical Tests: The document states that "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."
Clinical Tests: It states, "It has also been shown in clinical studies to be effective (Use Studies)." It then specifies, "No other clinical tests were performed other than a Use Study for this submission."

Information NOT Present in the Document (and therefore cannot be provided by me):

A table of acceptance criteria and reported device performance: This is completely absent. The document only states it was shown to be "effective" in "Use Studies" but provides no quantitative results, metrics, or comparison to specific acceptance thresholds.
Sample sized used for the test set and the data provenance: While a "Use Study" is mentioned, no details about its design, sample size, or data provenance are provided.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable or not mentioned, as no specific ground truth or expert consensus method for a test set is described.
Adjudication method for the test set: Not applicable or not mentioned.
Multi Reader Multi Case (MRMC) comparative effectiveness study: Not mentioned. This type of study is more common for imaging diagnostics, not typically for oral rinse effectiveness.
Standalone (i.e. algorithm only without human-in-the-loop performance) study: Not applicable, as this is a physical product, not an algorithm.
The type of ground truth used: Not explicitly stated. For a "Use Study," it would likely be patient-reported outcomes or clinical assessment of dry mouth symptoms, but no specifics are given.
The sample size for the training set: Not applicable, as this is not an AI/algorithm-based device requiring a training set in that context.
How the ground truth for the training set was established: Not applicable.

In summary, the provided text serves as a regulatory submission (510(k) summary) focused on demonstrating substantial equivalence, not a detailed scientific report on a specific study with acceptance criteria and quantitative performance metrics. While it mentions "Use Studies" proving effectiveness, it does not elaborate on the methodology, results, or specific criteria met.

Summary

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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.

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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 (800) 638-2041 or (301) 796-7100 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

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.

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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 DryMouth OralRinse	Oral Balance Gel	Oral BalanceLiquid
INTENDED USE	SymptomaticTreatment ofXerostomia	SymptomaticTreatment ofXerostomia	SymptomaticTreatment ofXerostomia
METHOD OF USE	Ready to useliquid	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.

Regulation Number and Section

N/A