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

Device Description

Biotène Moisturizing Mouth Spray for Dry Mouth Symptom Relief is a specially formulated artificial saliva substitute which contains 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 spray is supplied in a 1.5 oz. non-pressurized pump action spray bottle fitted with cap.

AI/ML Overview

Here's an analysis of the provided text regarding the acceptance criteria and supporting studies for the Biotène Moisturizing Mouth Spray for Dry Mouth Symptom Relief:

First, it's critical to note that the provided documents are a 510(k) Summary and an FDA clearance letter. A 510(k) submission generally focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than proving performance against specific quantitative acceptance criteria through rigorous clinical trials like a PMA would. Therefore, the information typically requested in your prompt (e.g., sample sizes for test/training sets, number of experts for ground truth, MRMC studies, standalone performance metrics) is usually not extensively detailed or even present in a 510(k) summary for a device like this.

The "studies" mentioned are non-clinical assessments to demonstrate safety and stability, and a "use study" for effectiveness. These are typically not analogous to the algorithm performance studies one would see for AI/ML medical devices.

1. Table of Acceptance Criteria and Reported Device Performance

Based on the provided text, the acceptance criteria are not quantitative metrics typical for an AI device (e.g., sensitivity, specificity, AUC). Instead, the acceptance criteria for this device appear to be qualitative demonstrations of safety, stability, and effectiveness in relieving dry mouth symptoms, benchmarked against legally marketed predicate devices.

Acceptance Criteria Category	Specific Acceptance Criteria (Inferred)	Reported Device Performance
Safety	Device is safe for its intended use.	"Biotène Moisturizing Mouth Spray for Dry Mouth Symptom Relief has been shown in nonclinical studies to be safe (Toxicology Assessment) for its intended use." (Section 7)
Stability	Device maintains its properties over time for its intended use.	"Biotène Moisturizing Mouth Spray for Dry Mouth Symptom Relief has been shown in nonclinical studies to be [...] stable (Stability Study) for its intended use." (Section 7)
Effectiveness	Device relieves and treats the symptoms of dry mouth.	"Biotène Moisturizing Mouth Spray for Dry Mouth Symptom Relief has been shown in [...] to be effective (Use Study)." (Section 7)The FDA's clearance letter states "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..." implying it meets the effectiveness profile of the predicates.
Substantial Equivalence	Device is as safe and effective as a legally marketed predicate device.	The entire 510(k) submission and FDA clearance are based on demonstrating substantial equivalence to "Oral Balance Gel cleared in (K061331)" and "Oral Balance Liquid cleared in (K061331)". The "Substantial Equivalence Comparison Chart" (Section 6) details similar intended use, method of use, applications per day, disease state, area of use, and product type.

2. Sample Size Used for the Test Set and Data Provenance

The document does not specify a "test set" in the context of an AI/ML algorithm evaluation. The studies mentioned ("Toxicology Assessment," "Stability Study," "Use Study") are non-clinical or general product performance evaluations. Therefore, sample sizes for these are not provided in this summary, and data provenance (country, retrospective/prospective) is also not detailed.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications

This information is not applicable to the provided document. The studies conducted (toxicology, stability, use study) for this type of device do not typically involve experts establishing "ground truth" in the way an AI algorithm for diagnostic imaging would.

4. Adjudication Method (e.g., 2+1, 3+1, none) for the Test Set

Not applicable, as no "test set" for an AI algorithm's performance is described.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No MRMC study is mentioned or implied. This device is an artificial saliva substitute, not an AI-assisted diagnostic tool that would typically undergo such studies.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study

Not applicable. This is not an AI algorithm; it's a topical medical device.

7. Type of Ground Truth Used

The concept of "ground truth" as applied to AI/ML algorithms is not relevant here. The "effectiveness" of the device was likely assessed through a "Use Study" where subjects used the product and reported symptomatic relief, or through objective measures relevant to dry mouth. Its safety was assessed via toxicology.

8. Sample Size for the Training Set

Not applicable, as there is no AI algorithm and therefore no "training set."

9. How the Ground Truth for the Training Set Was Established

Not applicable, as there is no AI algorithm and no "training set."

Summary of Device and Approval Context:

This document describes the 510(k) clearance for "Biotène Moisturizing Mouth Spray for Dry Mouth Symptom Relief." The approval is based on demonstrating substantial equivalence to existing predicate devices (Biotene Oral Balance Gel and Liquid). The "studies" mentioned are:

Toxicology Assessment: To demonstrate safety.
Stability Study: To demonstrate product shelf-life and consistency over time.
Use Study: To demonstrate effectiveness in relieving dry mouth symptoms.

These are common types of non-clinical and basic clinical/user studies for medical devices like artificial saliva substitutes, and do not involve the kind of rigorous performance metrics or AI-specific evaluation criteria found in AI/ML device clearances.

Summary

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K103745

JUL 200 2011

5. 510(k) Summary

SUBMITTER INFORMATION 1.

Name:	GlaxoSmithKline Consumer Healthcare
Address:	1500 Littleton RoadParsippany, NJ 07054-3884
Contact Person:	Wendy A. McManus
Telephone/Fax:	973-889-4415973-889-2501 (fax)
Date Summary Prepared:	December 21, 2010
2.DEVICE NAME
Device Name:	Biotène Moisturizing Mouth Spray for DryMouth Symptom Relief
Trade or Proprietary Name:	Biotène Moisturizing Mouth Spray for DryMouth Symptom Relief
Common or Usual Name:	Saliva, Artificial
Classification Name (if known):	Saliva, Artificial

IDENTIFICATION OF EQUIVALENCE 3.

Laclede, Inc.	Oral Balance Gel cleared in (K061331)
Laclede, Inc.	Oral Balance Liquid cleared in (K061331)

4. DEVICE DESCRIPTION

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Dry Mouth. The spray is supplied in a 1.5 oz. non-pressurized pump action spray bottle fitted with cap.

ડ. STATEMENT OF INTENDED USE

SUMMARY OF THE TECHNOLOGICAL CHARACTERISTICS 6.

Substantial Equivalence Comparison Chart
PRODUCT:	BiotèneMoisturizingMouth Spray forDry MouthSymptom Relief(Proposed Device)	Biotene OralBalance Gel(Predicate 1)	Biotene OralBalance Liquid(Predicate 2)
INTENDED USE	SymptomaticTreatment ofXerostomia	SymptomaticTreatment ofXerostomia	SymptomaticTreatment ofXerostomia
METHOD OF USE	Ready to usespray	Ready to usegel	Ready to useliquid
APPLICATIONS 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

Characteristics of the device compared to the predicate devices.

7. Discussion and conclusions from the nonclinical and clinical tests

Non-sterile

PRESENTATION

Biotene Moisturizing Mouth Spray for Dry Mouth Symptom Relief has been shown in nonclinical studies to be safe (Toxicology Assessment) and stable (Stability Study) for its intended use. It has also been shown to be effective (Use Study).

Non-sterile

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows a logo for the Department of Health & Human Services. The logo consists of a symbol with three curved lines, which is positioned to the right of the text. The text "DEPARTMENT OF HEALTH & HUMAN" is arranged vertically along the left side of the logo.

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

Ms. Wendy A. McManus Regulatory Associate, US Regulatory Affairs Glaxosmithkline Consumer Healthcare (GSKCH) 1500 Littleton Road Parsippany, New Jersey 07054

JUL 20 2011

K103745 · Re:

Trade/Device Name: Biotene Moisturizing Mouth Spray for Dry Mouth Symptom Relief

Regulation Number: None Regulation Name: Cavity Varnish Regulatory Class: Unclassified Product Code: LFD Dated: May 24, 2011 Received: June 1, 2011

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 (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.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/C entersOffices/CDRH/CDRHOffices/uc m 115809.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/Sa fety/ReportalProblem/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 vours.

Anthony D. Arme
Anthony D. Arme, P.S., M.S.

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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K103745

4. Indications for Use Statement

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

Device Name: Biotène Moisturizing Mouth Spray for Dry Mouth Symptom Relief

Indications for Use:

Relieves the symptoms of dry mouth; refreshes, moisturizes, 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_ X

(Per 21 CFR 801.109)

Scott Sumner

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

510(k) Number: KD3745

Biotene Moisturizing Mouth Spray for Dry Mouth Symptom Relief

Volume 1 Page 5 of 33

Regulation Number and Section

N/A