(209 days)
Not Found
No
The device description and performance studies focus on the chemical composition and physical properties of the spray, with no mention of AI or ML.
Yes
The device is intended to relieve and treat symptoms of dry mouth, soothe oral irritations, and diminish dry discomfort, which falls under the definition of therapeutic use.
No
The device is described as relieving and treating symptoms, not diagnosing conditions. It's a symptomatic relief product.
No
The device description clearly states it is a "specially formulated artificial saliva substitute" supplied in a "non-pressurized pump action spray bottle," indicating it is a physical product (liquid and bottle) and not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use/Indications for Use: The intended use is to relieve and treat the symptoms of dry mouth. This is a therapeutic or symptomatic relief purpose, not a diagnostic one.
- Device Description: The device is described as an artificial saliva substitute with moisturizing, lubricating, and soothing properties. It's applied directly to the oral cavity for symptom relief.
- Lack of Diagnostic Function: There is no mention of the device being used to test a sample (like blood, urine, or saliva) to diagnose a condition, monitor a disease, or screen for a health issue.
- Anatomical Site: The oral cavity is the site of application for symptom relief, not a source of a sample for in vitro testing.
- No Mention of Diagnostic Metrics: There are no mentions of diagnostic performance metrics like sensitivity, specificity, AUC, etc.
- Predicate Devices: The predicate devices listed are also products for relieving dry mouth symptoms, not diagnostic devices.
In summary, the device's function is to provide symptomatic relief for dry mouth, which falls under the category of a therapeutic or palliative device, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
Relieves and treats the symptoms of dry mouth; refreshes mouth odors, soothes oral irritations, moisturizes, lubricates, and diminishes dry discomfort. Indication for Use: Relieves the symptoms of dry mouth; refreshes, moisturizes, soothes oral irritation, and lubricates oral dryness.
Product codes
LFD
Device Description
Biotène Moisturizing Mouth Spray for Dry Mouth Symptom Relief is a specially formulated artificial saliva substitute which contains 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 spray is supplied in a 1.5 oz. non-pressurized pump action spray bottle fitted with cap.
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
Biotene Moisturizing Mouth Spray for Dry Mouth Symptom Relief has been shown in nonclinical studies to be safe (Toxicology Assessment) and stable (Stability Study) for its intended use. It has also been shown to be effective (Use Study).
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
N/A
0
うす乙
JUL 200 2011
5. 510(k) Summary
SUBMITTER INFORMATION 1.
| Name: | GlaxoSmithKline Consumer Healthcare | ||
|---|---|---|---|
| Address: | 1500 Littleton Road | ||
| Parsippany, NJ 07054-3884 | |||
| Contact Person: | Wendy A. McManus | ||
| Telephone/Fax: | 973-889-4415 | ||
| 973-889-2501 (fax) | |||
| Date Summary Prepared: | December 21, 2010 | ||
| 2. | |||
| DEVICE NAME | |||
| Device Name: | Biotène Moisturizing Mouth Spray for Dry | ||
| Mouth Symptom Relief | |||
| Trade or Proprietary Name: | Biotène Moisturizing Mouth Spray for Dry | ||
| Mouth Symptom Relief | |||
| Common or Usual Name: | Saliva, Artificial | ||
| Classification Name (if known): | Saliva, Artificial |
IDENTIFICATION OF EQUIVALENCE 3.
| Laclede, Inc. | Oral Balance Gel cleared in (K061331) |
|---|---|
| Laclede, Inc. | Oral Balance Liquid cleared in (K061331) |
4. DEVICE DESCRIPTION
Biotène Moisturizing Mouth Spray for Dry Mouth Symptom Relief is a specially formulated artificial saliva substitute which contains moisturizers, humectants, a protein, and patented salivary enzymes that collectively have lubricating, moisturizing, soothing, and refreshing properties to relieve & treat the symptoms of
1
Image /page/1/Picture/1 description: The image shows a handwritten string of characters. The characters are 'K103745'. The characters are written in black ink on a white background. There is a line drawn underneath the characters.
Dry Mouth. The spray is supplied in a 1.5 oz. non-pressurized pump action spray bottle fitted with cap.
ડ. STATEMENT OF INTENDED USE
Relieves and treats the symptoms of dry mouth; refreshes mouth odors, soothes oral irritations, moisturizes, lubricates, and diminishes dry discomfort. Indication for Use: Relieves the symptoms of dry mouth; refreshes, moisturizes, soothes oral irritation, and lubricates oral dryness.
SUMMARY OF THE TECHNOLOGICAL CHARACTERISTICS 6.
| Substantial Equivalence Comparison Chart | |||
|---|---|---|---|
| PRODUCT: | Biotène | ||
| Moisturizing | |||
| Mouth Spray for | |||
| Dry Mouth | |||
| Symptom Relief | |||
| (Proposed Device) | Biotene Oral | ||
| Balance Gel | |||
| (Predicate 1) | Biotene Oral | ||
| Balance Liquid | |||
| (Predicate 2) | |||
| INTENDED USE | Symptomatic | ||
| Treatment of | |||
| Xerostomia | Symptomatic | ||
| Treatment of | |||
| Xerostomia | Symptomatic | ||
| Treatment of | |||
| Xerostomia | |||
| METHOD OF USE | Ready to use | ||
| spray | Ready to use | ||
| gel | Ready to use | ||
| liquid | |||
| APPLICATIONS 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 |
Characteristics of the device compared to the predicate devices.
7. Discussion and conclusions from the nonclinical and clinical tests
Non-sterile
PRESENTATION
Biotene Moisturizing Mouth Spray for Dry Mouth Symptom Relief has been shown in nonclinical studies to be safe (Toxicology Assessment) and stable (Stability Study) for its intended use. It has also been shown to be effective (Use Study).
Non-sterile
Non-sterile
2
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows a logo for the Department of Health & Human Services. The logo consists of a symbol with three curved lines, which is positioned to the right of the text. The text "DEPARTMENT OF HEALTH & HUMAN" is arranged vertically along the left side of the logo.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
Ms. Wendy A. McManus Regulatory Associate, US Regulatory Affairs Glaxosmithkline Consumer Healthcare (GSKCH) 1500 Littleton Road Parsippany, New Jersey 07054
JUL 20 2011
K103745 · Re:
Trade/Device Name: Biotene Moisturizing Mouth Spray for Dry Mouth Symptom Relief
Regulation Number: None Regulation Name: Cavity Varnish Regulatory Class: Unclassified Product Code: LFD Dated: May 24, 2011 Received: June 1, 2011
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.
3
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 (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/C entersOffices/CDRH/CDRHOffices/uc m 115809.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/Sa fety/ReportalProblem/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 vours.
Anthony D. Arme
Anthony D. Arme, P.S., M.S.
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
4
,
4. Indications for Use Statement
510(k) Number (if known): N/A
Device Name: Biotène Moisturizing Mouth Spray for Dry Mouth Symptom Relief
Indications for Use:
Relieves the symptoms of dry mouth; refreshes, moisturizes, 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_ X
(Per 21 CFR 801.109)
Scott Sumner
(Division Sign-Off) Division of Anesthesiology, General Hospital Infection Control, Dental Devices
510(k) Number: KD3745
Biotene Moisturizing Mouth Spray for Dry Mouth Symptom Relief
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