SST SALIVA SUPPORTING TABLETS

K023046 · Sinclair Pharmaceuticals, Ltd. · LED · Dec 2, 2002 · Hematology

Device Facts

• Record ID: K023046
• Device Name: SST SALIVA SUPPORTING TABLETS
• Applicant: Sinclair Pharmaceuticals, Ltd.
• Product Code: LED · Hematology
• Decision Date: Dec 2, 2002
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 864.1850
• Device Class: Class 1
• Attributes: Therapeutic

Intended Use

Under the supervision of a healthcare professional, SINCLAIR SST™ promotes lubrication of oral mucosa that may be dry (xerostomia) due to, as may occur in a variety of circumstances including, medication, chemo or radiotherapy, Sjogren's Syndrome or oral inflammation. SINCLAIR SST™ provides temporary relief for damaged salivary function. Over the counter labeling stipulates that SINCLAIR SST™ is suitable for temporary relief of dry mouth symptoms.

Device Story

SST Saliva Supporting Tablets are flavored, electrolyte-containing tablets designed to dissolve slowly in the mouth. Used for symptomatic treatment of xerostomia (dry mouth) caused by medication, radiation, chemotherapy, or conditions like Sjogren's Syndrome. The device provides lubrication to the oral mucosa and temporary relief for damaged salivary function. It is intended for both professional-supervised use and over-the-counter use for symptom relief. The patient places the tablet in the mouth to dissolve, providing a non-sterile, ready-to-use alternative to liquid artificial saliva solutions.

Clinical Evidence

Bench testing only.

Technological Characteristics

Tablet formulation containing a mixture of electrolytes. Non-sterile. Ready-to-use. Designed for slow dissolution in the oral cavity.

Indications for Use

Indicated for patients experiencing dry mouth (xerostomia) due to medication, chemotherapy, radiotherapy, Sjogren's Syndrome, or oral inflammation. Suitable for temporary relief of dry mouth symptoms.

Regulatory Classification

Identification

Dye and chemical solution stains for medical purposes are mixtures of synthetic or natural dyes or nondye chemicals in solutions used in staining cells and tissues for diagnostic histopathology, cytopathology, or hematology.

Predicate Devices

• Salivart (K981693)
• Caphosol (K991938)

Submission Summary (Full Text)

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K023044

Image /page/0/Picture/1 description: The image shows the logo for Sinclair Broadcast Group. The logo consists of the word "SINCLAIR" in a sans-serif font, with a stylized oval shape above and below the word. The oval is broken into two parts, with the top part curving downwards and the bottom part curving upwards, creating a visual effect of an orbit or ring around the word.

Attachment 7 510(k) Summary

September 10, 2002

DEC 0 2 2002

1. Submission Applicant & Correspondent: Sinclair Pharmaceuticals Limited Name: Address:

Borough Road Godalming Surrey GU7 2AB United Kingdom

Phone No.: [phone] Contact Person: Denise Swift, Director of Regulatory Affairs

2. Name of Device: SSTTM SALIVA SUPPORTING TABLETS

Trade/Proprietary/Model Name: Common or Usual Name: Classification Names:

SSTTM SALIVA SUPPORTING TABLETS Dental: Saliva, artificial Dental: Saliva, artificial

3. Devices to Which New Device is Substantially Equivalent:

Gebauer Company: Salivart cleared in 510(k) K981693 and Inpharma AB: Caphosol cleared in 510(k) K991938

4. Device Description:

SST™ is formulated as a tablet that is allowed to dissolve slowly in the mouth. The tablets are presented in containers of various counts. They contain a mixture of electrolytes in a pleasant flavored tablet.

5. Intended Use of the Device:

Under the supervision of a healthcare professional, SINCLAIR SST™ promotes lubrication of oral mucosa that may be dry (xerostomia) due to, as may occur in a variety of circumstances including, medication, chemo or radiotherapy, Sjogren's Syndrome or oral inflammation. SINCLAIR SST™ provides temporary relief for damaged salivary function.

Over the counter labeling stipulates that SINCLAIR SST™ is suitable for temporary relief of dry mouth symptoms.

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- 6. Summary of Technological Characteristics of the Device Compared to the Predicate Devices:
SST™ has the same intended/indications for use as the predicate devices Gebauer Company Salivart and Inpharma AB Caphosol.

| Product<br>Name | SST | Salivart | Caphosol |
|---------------------------------|--------------------------------------------------|--------------------------------------------|--------------------------------------------|
| Method of<br>Use | Ready to use | Ready to use | Mix solutions<br>A & B |
| # of<br>applications<br>per day | Take as<br>needed up to<br>16 tablets per<br>day | Take as needed | Take as needed |
| Claim | Symptomatic<br>treatment of<br>xerostomia. | Symptomatic<br>treatment of<br>xerostomia. | Symptomatic<br>treatment of<br>xerostomia. |
| Area of Use | Oral cavity | Oral cavity | Oral cavity |
| Disease State | Xerostomia | Xerostomia | Xerostomia |
| Type of<br>Product | Tablet | Solution | Solution |
| Presentation | Non Sterile | Non Sterile | Non Sterile |

7. Tests and Conclusions:

Functional and performance testing has been conducted to assess the safety and effectiveness of SSTTM and all results are satisfactory.

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## DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular arrangement of text that reads "DEPARTMENT OF HEALTH & HUMAN SERVICES USA". Inside the circle is an abstract symbol that resembles a stylized caduceus or a representation of human figures. The logo is black and white and appears to be slightly distressed or aged.

Food and Drug Administrat 9200 Corporate Boulevard Rockville MD 20850 .

Ms. Denise Swift Director, Regulatory Affairs Sinclair Pharmaceuticals, Limited Borough Road, Godalming. Surrey GU7 2AB UNITED KINGDOM

Re: K023046

Trade/Device Name: Sinclair SSTTM Regulation Number: None Regulation Name: Dental, Saliva Artificial Regulatory Class: Unclassified Product Code: LED Dated: September 10, 2002 Received: September 12, 2002

Dear Ms. Swift:

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.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such additional controls. Existing major regulations affecting vour 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. Swif

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); 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.

This letter will allow you to begin marketing your device as described in your Section 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 vou desire specific advice for your device on our labeling regulation (21 CFR Part 801), 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" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained 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/cdrh/dsma/dsmamain.html

Sincerely yours

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

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### Attachment 3

### Indications for Use Statement

510(k) Number (if known)

Device Name

N2 5046

SINCLAIR SST™

Indications for Use

Under the supervision of a healthcare professional, SINCLAIR SST™ promotes lubrication of oral mucosa that may be dry (xerostomia) due to, as may occur in a variety of circumstances including, medication, chemo or radiotherapy, Sjogren's Syndrome or oral inflammation. SINCLAIR SST TM provides temporary relief for damaged salivary function.

Over the counter labeling stipulates that SINCLAIR SST™ is suitable for temporary relief of dry mouth symptoms.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use (per 21 CFR 801.109) OR

Over-The Counter Use

Swear Rourty

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

KO23046 510(k) Number ________________________________________________________________________________________________________________________________________________________________