SLIVASURE

K051409 · Scandinavian Formulas, Inc. · LED · Aug 8, 2005 · Hematology

Device Facts

• Record ID: K051409
• Device Name: SLIVASURE
• Applicant: Scandinavian Formulas, Inc.
• Product Code: LED · Hematology
• Decision Date: Aug 8, 2005
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 864.1850
• Device Class: Class 1
• Attributes: Therapeutic

Intended Use

SalivaSure™ promotes lubrication of oral mucosa that may be dry due to the side effects of medication, chemo or radiotherapy, or as a symptom of Sjogren's Syndrome, or because of oral inflammation. SalivaSure™ provides temporary relief from dry mouth or damaged salivary function. The Over The Counter labeling indicates that SalivaSure™ is suitable for relief from dry mouth.

Device Story

SalivaSure is an oral lubricant designed to provide temporary relief from dry mouth (xerostomia). It functions by coating and lubricating the oral mucosa to mitigate dryness caused by various medical conditions or treatments, including medication side effects, chemotherapy, radiotherapy, Sjogren's Syndrome, and oral inflammation. The device is intended for use by patients as an over-the-counter product. It serves as a supportive care measure to improve patient comfort by restoring moisture to the oral cavity.

Clinical Evidence

No clinical data provided; bench testing only.

Indications for Use

Indicated for patients experiencing dry mouth (xerostomia) due to medication side effects, chemotherapy, radiotherapy, Sjogren's Syndrome, or oral inflammation. Suitable for OTC use for temporary relief of dry mouth and lubrication of oral mucosa.

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.

Submission Summary (Full Text)

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Image /page/0/Picture/1 description: The image shows the seal of the Department of Health and Human Services (HHS). The seal features a stylized eagle with three lines representing its body and wings. The words "DEPARTMENT OF HEALTH AND HUMAN SERVICES. USA" are arranged in a circular pattern around the eagle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

AUG 8 - 2005

Scandinavian Formulas, Incorporated c/o Ms. Catherine P. Peklak 140 East Church St. Sellersville, Pennsylvania 18960

Re: K051409

Trade/Device Name: Slivasure Regulation Number: NONE Regulatory Class: Unclassified Product Code: LED Dated: May 26, 2005 Received: June 1, 2005

Dear Ms. Peklak:

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 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. Peklak

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 you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at [phone]. Also, please note the regulation 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 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/industry/support/index.html.

Sincerely yours,

Siputa Y. Michen Ons.

Chíu 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): KO51409

Device Name: SalivaSure

Indications For Use:

SalivaSure™ promotes lubrication of oral mucosa that may be dry due to the side SalivaSure™ promotes non radiotherapy, or as a symptom of Sjogrem of Sjogeren's effects of medication, chemo of real inflammation. SalivaSure™ provides temporary Synolome, or because of orar the or damaged salivary function.

The Over The Counter labeling indicates that SalivaSure™ is suitable for relief from dry mouth.

Prescription Use (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use (21 CFR 807 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Susan Rusiye

(Division Sign-Off) (Division Sign-On)
Division of Anesthesiology, General Hospital, Division of Anostriosial Devices

510(k) Number: ـ

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