(30 days)
The biotene Oral Balance Gel, biotene Dry Mouth Oral Rinse and biotene Moisturizing Mouth Spray intended use is to relieve the symptoms of dry mouth, refresh, moisturize, clean, soothe oral irritation and lubricate oral dryness.
Not Found
This document is a 510(k) clearance letter from the FDA for Biotene Oral Balance Gel, Biotene Dry Mouth Oral Rinse, and Biotene Moisturizing Mouth Spray. It states that these devices are substantially equivalent to legally marketed predicate devices.
The information requested in the prompt regarding acceptance criteria and a study proving the device meets these criteria is typically found in the 510(k) submission itself, or in supporting documentation attached to the submission. This FDA clearance letter and its attached "Indications for Use Statement" do not contain the detailed information necessary to answer the questions about acceptance criteria, device performance, study design, sample sizes, expert qualifications, adjudication methods, or ground truth establishment.
The document confirms the device names and their intended use to relieve symptoms of dry mouth. However, it does not provide any specific quantitative performance metrics, study results, or details on how substantial equivalence was demonstrated beyond the general statement of equivalence to predicate devices.
Therefore, I cannot provide the requested table or answer the specific questions based solely on the provided text.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
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Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
January 4, 2013
Mr. Paul Krumm Regulatory Affairs Manager GlaxoSmithKline Consumer Healthcare (GSKCH) 1500 Littleton Road PARSIPPANY NJ 07054
Re: K123731
Trade/Device Name: Biotene Oral Balance Gel, Biotene Dry Mouth Oral Rinse, Biotene Moisturizing Mouth Spray
Regulation Number: Unclassified Regulation Name: Saliva, Artificial Regulatory Class: Unclassified Product Code: LFD Dated: December 4, 2012 Received: December 10, 2012
Dear Mr. Krumm:
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 - Mr. Krumm
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 of medical devicerelated 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/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,
Anthony De m
Anthony D. Watson, B.S., M.S., M.B.A. Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use Statement
510(k) Number (If known):
Devices Names: biotene Oral Balance Gel, biotene Dry Mouth Oral Rinse, biotene Moisturizing Mouth Spray
Indications for Use: The biotene Oral Balance Gel, biotene Dry Mouth Oral Rinse and biotene Moisturizing Mouth Spray intended use is to relieve the symptoms of dry mouth, refresh, moisturize, clean, soothe oral irritation and lubricate oral dryness.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use (Per 21 CFR 801.109)
AND/OR
Over-The-Counter Use
2013.01.04 Susan Runner DDS, MA 12:41:11 -05'00'
(Division Sign-Off) (Division Sign-Off)
Division of Anesthesiology, General Hospital
Division of Anesthesiology, General Devices Division of Ancounters
510(k) Number: K12373
Biotene Artificial Saliva Products Modifications
Volume 1 Page 34 of 52
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