(123 days)
Not Found
No
The device description and performance studies focus on the chemical composition and clinical effectiveness of an oral rinse, with no mention of AI or ML technologies.
Yes
Explanation: The device is intended to relieve and treat the symptoms of dry mouth, acting as an artificial saliva substitute with lubricating, moisturizing, soothing, and refreshing properties, thereby addressing a medical condition.
No
The device is described as an artificial saliva substitute intended to relieve the symptoms of dry mouth, not to diagnose a condition.
No
The device description clearly states it is a liquid product supplied in bottles and pouches, indicating it is a physical substance, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to relieve the symptoms of dry mouth, refresh, moisturize, clean, soothe oral irritation, and lubricate oral dryness. This is a therapeutic or symptomatic relief purpose, not a diagnostic one.
- Device Description: The description details an artificial saliva substitute with moisturizing and lubricating properties. It does not mention any components or mechanisms for analyzing biological samples (like blood, urine, saliva, etc.) to diagnose a condition.
- Lack of Diagnostic Language: The entire description focuses on treating symptoms and providing relief, not on identifying or measuring a disease or condition.
- Performance Studies: The performance studies mentioned are toxicology, stability, and use studies, which are typical for therapeutic or symptomatic relief devices, not IVDs which would focus on diagnostic accuracy metrics.
IVD devices are specifically designed to examine specimens derived from the human body to provide information for the diagnosis, prevention, monitoring, treatment, or alleviation of disease. This device does not fit that definition.
N/A
Intended Use / Indications for Use
Relieves the symptoms of dry mouth; refreshes, moisturizes, cleans, soothes oral irritation, and lubricates oral dryness.
Product codes (comma separated list FDA assigned to the subject device)
76 LFD
Device Description
Biotène Dry Mouth Oral Rinse is a specially formulated artificial saliva substitute which contain 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 liquid products are supplied in PET bottles of various sizes, including an 8 oz., 16 oz., and 33.8 oz., and also 15 ml. multilayer laminated foil pouches.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Oral Cavity
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Biotène Dry Mouth Oral Rinse has been shown in non-clinical studies to be safe (Toxicology Assessments), and stable (Stability Studies) for its intended use. It has also been shown in clinical studies to be effective (Use Studies). Biocompatibility is addressed in the Statements of Toxicological Evaluation. No other clinical tests were performed other than a Use Study for this submission.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
N/A
0
61477
SECTION 5: 510(K) SUMMARY
SEP 2 8 2010
SUBMITTER INFORMATION 1.
Name:
Address:
Address.
Contact Person:
Telephone/Fax:
1500 Littleton·Road Parsippany, NJ 07054-3884
GlaxoSmithKline Consumer Healthcare
Wendy A. McManus
973-889-4415 973-889-2501 (fax)
Date Summary Prepared:
May 25, 2010
2. DEVICE NAME
Biotène Dry Mouth Oral Rinse Device Name: Trade or Proprietary Name: Biotène Dry Mouth Oral Rinse Common or Usual Name: Saliva, Artificial Classification Name (if known): Saliva, Artificial
IDENTIFICATION OF EQUIVALENCE 3.
Laclede, Inc. Laclede, Inc.
Oral Balance Gel cleared in K061331 Oral Balance Liquid cleared in K061331
DEVICE DESCRIPTION 4.
Biotène Dry Mouth Oral Rinse is a specially formulated artificial saliva substitute which contain 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 liquid products are supplied in PET
1
Image /page/1/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized caduceus symbol, which is a staff with two snakes coiled around it, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" arranged in a circular pattern around the symbol. The logo is black and white.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
Ms. Wendy McManus Regulatory Associate GlaxoSmithKline Consumer Healthcare (GSKCH) 1500 Littleton Road Parsippany, New Jersey 07054
SEP 2 8 2010
Re: K101477
Trade/Device Name: Biotene Dry Mouth Oral Rinse Regulation Number: Regulatory Class: Unclassified Product Code: 76 LFD Dated: September 17, 2010 Received: September 20, 2010
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.
2
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 (OS) 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.
Cintron i, ont
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
3
Biotène Dry Mouth Oral Rinse GlaxoSmithKline Consumer Healthcare, L.P.
SECTION 4: INDICATIONS FOR USE STATEMENT
SEP 2 8 2010
510(k) Number (if known): N/A
Device Name: Biotène Dry Mouth Oral Rinse
Indications for Use:
Relieves the symptoms of dry mouth; refreshes, moisturizes, cleans, 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
OR
Over-The-Counter Use
(Per 21 CFR 801.109)
Susan Russon
(Division Sign-Off) (Division of Anesthesiology, General Hospital Infection Control, Dental Devices
510(k) Number.
47
4
510K Notification
SEP 2 8 2010
bottles of various sizes, including an 8 oz., 16 oz., and 33.8 oz., and also 15 ml. multilayer laminated foil pouches.
STATEMENT OF INTENDED USE 5.
Relieves and treats the symptoms of dry mouth; refreshes mouth odors, cleans, soothes oral irritations, moisturizes, lubricates, and diminishes dry discomfort. The Indication for Use: Relieves the symptoms of dry mouth; refreshes, moisturizes, cleans, soothes oral irritations, and lubricates oral dryness.
SUMMARY OF THE TECHNOLOGICAL CHARACTERISTICS 6.
Characteristics of the device compared to the predicate devices.
| PRODUCT | Biotène Dry
Mouth Oral
Rinse | Oral Balance Gel | Oral Balance
Liquid |
|---------------------|-------------------------------------------|-------------------------------------------|-------------------------------------------|
| INTENDED USE | Symptomatic
Treatment of
Xerostomia | Symptomatic
Treatment of
Xerostomia | Symptomatic
Treatment of
Xerostomia |
| METHOD OF USE | Ready to use
liquid | Ready to use gel | Ready to use liquid |
| APPLICATION 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 |
| PRESENTATION | Non-sterile | Non-sterile | Non-sterile |
Substantial Equivalence Comparison Chart
7. Discussion and conclusions from the nonclinical and clinical tests
Biotène Dry Mouth Oral Rinse has been shown in non-clinical studies to be safe (Toxicology Assessments), and stable (Stability Studies) for its intended use. It has also been shown in clinical studies to be effective (Use Studies). Biocompatibility is addressed in the Statements of Toxicological Evaluation. No other clinical tests were performed other than a Use Study for this submission.