(361 days)
Not Found
Not Found
No
The summary describes a formulation for dry mouth relief, not a software or hardware device that would typically incorporate AI/ML. There are no mentions of AI, ML, image processing, or data analysis.
Yes
The device is intended for the relief of dry mouth symptoms and can replace damaged or non-functioning salivary glands, addressing a medical condition.
No
The "Intended Use / Indications for Use" section states that the device is "formulated for the relief of dry mouth symptoms" and "relieves the problems of dry mouth," indicating it is a treatment or palliative device, not one used for diagnosis.
No
The provided text describes a product intended for the relief of dry mouth symptoms, which appears to be a formulation (likely a liquid, gel, or spray) and not a software application. There is no mention of software, hardware, or any digital component.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use describes the relief of symptoms associated with dry mouth and potentially replacing salivary gland function. This is a therapeutic or symptomatic relief purpose, not a diagnostic one.
- Lack of Diagnostic Claims: There are no mentions of diagnosing a condition, analyzing biological samples for diagnostic purposes, or providing information about a patient's health status based on in vitro testing.
- Device Description (Not Found): While the description is missing, the intended use is the primary indicator for IVD classification.
- No Mention of In Vitro Testing: The description of the intended use does not involve any testing of samples outside of the body.
IVDs are devices used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnostic, monitoring, or screening purposes. XEROSTOM®'s function as described is to alleviate symptoms within the mouth, not to analyze samples for diagnostic information.
N/A
Intended Use / Indications for Use
XEROSTOM® has been formulated to the relief of dry mouth symptoms such as difficulties in swallowing, speech, changes in taste, mouth discomfort, and other symptoms associated with dry mouth. These symptoms may be brought on by disease, stress, aging or medication. XEROSTOM® may be used to replace normal salivary glands are damaged or not functioning. XEROSTOM® relieves the problems of dry mouth.
Product codes
LFD
Device Description
Not Found
Mentions image processing
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Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
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)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Not Found
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
N/A
0
Image /page/0/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS) of the United States. The seal features a stylized depiction of human profiles facing right, arranged in a way that suggests unity and support. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" are arranged in a circular pattern around the central image.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
September 14, 2015
Bio Cosmetics, S. L. c/o Mr. Manoj Zacharias Liberty Management Group LTD 2871 Coastal Drive Aurora, IL 60503
Re: K142657
Trade/Device Name: Xerostom® Saliva Substitute Gel Regulation Number: N/A Regulation Name: Artificial Saliva Regulatory Class: Unclassified Product Code: LFD Dated: July 23, 2015 Received: August 5, 2015
Dear Mr. Zacharias:
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.
1
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 contact the Division of Industry and Consumer Education 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. 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 Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely vours.
Tina
Kiang-S
for Erin I. Keith, M.S. Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known): K142657
Device Name:
XEROSTOM® SALIVA SUBSTITUTE GEL.
Indications for Use:
XEROSTOM® has been formulated to the relief of dry mouth symptoms such as difficulties in swallowing, speech, changes in taste, mouth discomfort, and other symptoms associated with dry mouth. These symptoms may be brought on by disease, stress, aging or medication.
XEROSTOM® may be used to replace normal salivary glands are damaged or not functioning.
XEROSTOM® relieves the problems of dry mouth.
Prescription Use _____________________________________________________________________________________________________________________________________________________________
AND/OR
Over-The-Counter Use
(Part 21 CFR 801 Subpart D)
(21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostics and Radiological Health (OIR)
(Division Sign-Off)
Division of Radiological Health
Office of In Vitro Diagnostics and Radiological Health
510(k) _______________________________________________________________________________________________________________________________________________________________________
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