Under the supervision of a healthcare professional, OASIS® dry mouth relief discs have been formulated for the relief of chronic and temporary xerostomia (dry mouth), which may be a result of disease such as Sjogren's Syndrome, oral inflammation, medication, chemo or radiotherapy, stess or aging.

OTC labeling stipulates that OASIS® mouth moisturizing discs have been specially formulated for the relief of dry mouth symptoms such as difficulties in swallowing, speech, and changes in taste. These symptoms may be brought on by disease, stress, aging or medication.

Device Description

OASIS® is a disc that is allowed to dissolve slowly in the mouth. The product contains a lubricating polymer, with other ingredients to produce a pleasant flavored disc. The discs are presented in containers of various counts.

AI/ML Overview

The provided text describes a 510(k) premarket notification for a medical device (OASIS® Dry Mouth Relief Discs OR OASIS® Mouth Moisturizing Discs). It is a submission for a substantially equivalent device, not a new device requiring extensive clinical trials with acceptance criteria and performance studies in the way a novel AI/software medical device would.

Therefore, many of the requested categories (such as sample size for test/training set, number of experts for ground truth, adjudication method, MRMC studies, standalone performance, etc.) are not applicable to this type of regulatory submission. This document focuses on demonstrating similarity to already cleared devices.

Here's a breakdown of what is available from the provided text, aligning with the spirit of your request where possible, and indicating N/A where information for AI/software device studies is not relevant:

1. Table of Acceptance Criteria and Reported Device Performance

For this type of device, "acceptance criteria" and "reported device performance" are primarily demonstrated through substantial equivalence to predicate devices with a similar intended use and technological characteristics. The criteria are thus implied by the characteristics of the predicate devices and the safety/effectiveness assessment by the FDA.

Acceptance Criteria (Implied)	Reported Device Performance (Summary)
Safety: Device is safe for its intended use.	Functional and performance evaluation conducted; all results are satisfactory. No adverse events reported or expected, given similarity to predicates.
Effectiveness: Device effectively addresses dry mouth symptoms.	Intended for "relief of dry mouth symptoms" and "relief of chronic and temporary xerostomia." Claims are consistent with predicate devices.
Substantial Equivalence: Similar intended use and technological characteristics to legally marketed predicate devices.	OASIS® has the same intended use/indications and similar technological characteristics (e.g., ready to use, take as needed, symptomatic treatment of xerostomia, oral cavity use, non-sterile presentation) to three predicate devices (Salivart, SST, Salinum/Oraclair).

2. Sample size used for the test set and the data provenance

Sample size: Not applicable for this type of submission. This is not a study comparing the device to a control group or assessing its performance on a dataset of clinical cases in the way an AI/software device would. The evaluation is based on functional and performance assessment and comparison to predicate devices.
Data provenance: Not applicable.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Not applicable. There is no "ground truth" establishment in the context of clinical images or data for this device submission.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set

Not applicable.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

Not applicable. This device is not an AI/software device that assists human readers.

6. If a standalone (i.e., algorithm only without human-in-the loop performance) was done

Not applicable. This device is not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

Not applicable in the typical sense. The "ground truth" for this submission revolves around established safety and effectiveness of the predicate devices and the consistency of the new device's characteristics with those predicates and known medical principles regarding dry mouth relief.

8. The sample size for the training set

Not applicable. There is no training set for this type of device.

9. How the ground truth for the training set was established

Not applicable.

Study that proves the device meets the acceptance criteria:

The provided text states: "Functional and performance evaluation has been conducted to assess the safety and effectiveness of OASIS® discs. All results are satisfactory."

This statement, combined with the detailed comparison to predicate devices (Section 6, Table provided), constitutes the "study" or evidence demonstrating that the device meets the implied acceptance criteria for a 510(k) submission. The FDA, by issuing the 510(k) clearance, concurred that the device is substantially equivalent to legally marketed predicate devices and therefore is considered safe and effective for its intended use. The actual details of the "functional and performance evaluation" are not provided in this summary document, as is typical for 510(k) summaries which often highlight conclusions rather than raw data.

Summary

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K041563

AUG 2 7 2004

H. 510(k) Summary

1. Submission Applicant & Correspondent:

Name:	GlaxoSmithKline Consumer Healthcare, L.P.
Address:	1500 Littleton Road
	Parsippany, NJ 07054-3884
Phone No .:	(973) 889-2566
Contact Person:	Anthony Amitrano, U.S. Director Regulatory Affairs
	anthony.g.amitrano@gsk.com

2. Name of Device:	OASIS®
Trade/Proprietary/Model Name:	OASIS® Dry Mouth Relief Discs OROASIS® Mouth Moisturizing Discs

	3. Devices to Which New Device is Substantially Equivalent:
Gebauer Company:	Salivart cleared in 510(k) K981693
Sinclair Pharmaceuticals:	SST cleared in 510(k) K023046
Sinclair Pharmaceuticals:	Salinum or Oraclair cleared in 510(k) K024148

1. Device Description:
  OASIS® is a disc that is allowed to dissolve slowly in the mouth. The product contains a lubricating polymer, with other ingredients to produce a pleasant flavored disc. The discs are presented in containers of various counts.

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Intended Use of the Device:

Rx:

Over-the-counter:

1. Summary of the Technological Characteristics of the Device Compared to the Predicate Devices:
  OASIS® has the same intended use/indications as the predicate devices Gebauer Company Salivart, Sinclair Pharmaceuticals SST, and Sinclair Pharmaceuticals Salinum or Oraclair and is described in the following table.

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Product Name	OASIS	Salivart	SST	Salinum orOraclair
Method of Use	Ready to use	Ready to use	Ready to use	Ready to use
# ofApplicationsper Day	Take asneeded	Take asneeded	Take asneeded up to16 tablets perday	Take asneeded
Claim	Symptomatictreatment ofxerostomia	Symptomatictreatment ofxerostomia	Symptomatictreatment ofxerostomia	Symptomatictreatment ofxerostomia
Area of Use	Oral cavity	Oral cavity	Oral cavity	Oral cavity
Disease State	Xerostomia	Xerostomia	Xerostomia	Xerostomia
Type ofProduct	Disc	Solution	Tablet	Solution
Presentation	Non sterile	Non sterile	Non sterile	Non sterile

7. Tests and Conclusions:

Functional and performance evaluation has been conducted to assess the safety and effectiveness of OASIS® discs. All results are satisfactory.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized eagle with three bars representing the human services aspect. The eagle is positioned to the right of the circular text that reads "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA".

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

AUG 2 7 2004

Mr. Anthony G. Amitrano Director, U.S. Regulatory Affairs GlaxoSmithKline Consumer Healthcare, L.P. 1500 Littleton Road Parsippany, New Jersey 07054-3884

Re: K041563

K041505
Trade/Device Name: OASIS® Dry Mouth Relief Discs OR Mouth Moisturizing Discs Regulation Number: Unclassified Regulation Name: None Regulatory Class: None Product Code: LFD Dated: June 9, 2004 Received: June 11, 2004

Dear Mr. Amitrano:

We have reviewed your Section 510(k) premarket notification of intent to market the device We have reviewed your becases on and the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in indications for use stated in the ensiesary, to the enactment date of the Medical Device Interstate connineree prior to ria, 25, 20, 20, 20, 2017 11:42 pm accordance with the provisions of Amendinents, or to devroos that have a ct (Act) that do not require approval of a premarket the rederal Pood, Drug, and Coment , therefore, market the device, subject to the general approval application (1 Mr.). - The general controls provisions of the Act include Controls provisions of the rion 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 If your device is classified (boo as a 107.07) in a controls. Existing major regulations affecting (FMA), it may of subjoct to back adding the casing the 21, Parts 800 to 898. In your device can be found in the Seas nouncements concerning your device in the Federal Register.

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Page 2 -- Ms. Amitrano

Please be advised that FDA's issuance of a substantial equivalence determination does not Please be advised that ITDA s Issualled of a backance complies with other requirements mean that FDA has made a deceminations administered by other Federal agencies.
of the Act or any Federal statutes and regulations administered by other Federal status in of the Act of any rederal statues and reguirements . including, but not limited to: registration .
You must comply with all the Act's requirements . . . . . . . . . . . . . . You must comply with an the Tec s requirements) in CFR Part 801); good manufacturing practice and listing (21 CFR Part 807), laboling (21 CFR Part 820), and if
requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820), and if requirements as set forth in the quality Systems (Sections 531-542 of the Act); 21 CFR 1000-1050.

This letter will allow you to begin marketing your device as described in your Section 5 10(k) I his letter will anow you to begin malibating , butantial equivalence of your device to a a
nd the premarket notification. The PDA initing of substants of the results 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), If you desire specific advice for your de room at (301) 594-4613. Also, please note the regulation
N please contact the Office of Comphanos as (50%) - 10% - 10% Part 807.97). You
entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the may obtain other general miorination on your itsp. I spistance at its toll-free Division of Binan 2001 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely yours,

Chiu Lin, Ph.D. 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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Indications for Use

510(k) Number (if known): K041563

OASIS® Dry Mouth Relief Discs OR Mouth Moisturizing Discs Device Name:

Indications For Use:

Under the supervision of a healthcare professional, OASIS® dry mouth relief discs have been formulated for the relief of chronic and temporary xerostomia (drv mouth), which may be a result of diseases such as Sjogren's Syndrome, oral inflammation, medication, chemo or radiotherapy, stress or aging.

OASIS® mouth moisturizing discs have been formulated for relief of dry mouth symptoms such as difficulties in swallowing, speech and changes in taste. These symptoms may be brought on by disease, stress, aging or medication.

Prescription Use
(Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use (21 CFR 801 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Susan Runge

Page 1 of

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

510(k) Number: K041561

Regulation Number and Section

N/A