(81 days)
Not Found
No
The device description and intended use describe a tablet formulation for oral lubrication, with no mention of AI or ML technology.
Yes
Explanation: The device is intended to provide temporary relief for symptoms of xerostomia (dry mouth) and promotes lubrication of oral mucosa, which are therapeutic claims.
No
The device description and intended use indicate that SINCLAIR SST™ is for promoting lubrication and providing temporary relief for dry mouth symptoms by dissolving a tablet in the mouth. It does not mention diagnosing any condition.
No
The device description explicitly states that the device is a tablet formulation, which is a physical product, 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 promote lubrication of oral mucosa and provide temporary relief for dry mouth symptoms. This is a therapeutic or palliative function, not a diagnostic one.
- Device Description: The device is a tablet that dissolves in the mouth to provide electrolytes. This is a physical/chemical action within the oral cavity, not a test performed on a sample taken from the body to diagnose a condition.
- Lack of Diagnostic Elements: There is no mention of analyzing a sample (blood, saliva, tissue, etc.), detecting biomarkers, or providing information for the diagnosis of a disease or condition.
- Predicate Devices: The predicate devices listed (Salivart and Caphosol) are also products intended for the relief of dry mouth, not for diagnostic purposes.
In summary, the device's function is to alleviate symptoms of 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
"Under the supervision of a healthcare professional, SINCLAIR SST™ promotes lubrication of oral mucosa that may be dry (xerostomia) due to, as may occur in a variety of circumstances including, medication, chemo or radiotherapy, Sjogren's Syndrome or oral inflammation. SINCLAIR SST™ provides temporary relief for damaged salivary function.
Over the counter labeling stipulates that SINCLAIR SST™ is suitable for temporary relief of dry mouth symptoms."
Product codes
LED
Device Description
"SST™ is formulated as a tablet that is allowed to dissolve slowly in the mouth. The tablets are presented in containers of various counts. They contain a mixture of electrolytes in a pleasant flavored tablet."
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
Under the supervision of a healthcare professional
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)
"Functional and performance testing has been conducted to assess the safety and effectiveness of SSTTM and all results are satisfactory."
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 864.1850 Dye and chemical solution stains.
(a)
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.(b)
Classification. Class I (general controls). These devices are exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 864.9. These devices are also exempt from the current good manufacturing practice requirements of the quality system regulation in part 820 of this chapter, with the exception of § 820.180, with respect to general requirements concerning records, and § 820.198, with respect to complaint files.
0
Image /page/0/Picture/1 description: The image shows the logo for Sinclair Broadcast Group. The logo consists of the word "SINCLAIR" in a sans-serif font, with a stylized oval shape above and below the word. The oval is broken into two parts, with the top part curving downwards and the bottom part curving upwards, creating a visual effect of an orbit or ring around the word.
Attachment 7 510(k) Summary
September 10, 2002
DEC 0 2 2002
- Submission Applicant & Correspondent: Sinclair Pharmaceuticals Limited Name: Address:
Borough Road Godalming Surrey GU7 2AB United Kingdom
Phone No.: +44 1483 428 611 Contact Person: Denise Swift, Director of Regulatory Affairs
- Name of Device: SSTTM SALIVA SUPPORTING TABLETS
Trade/Proprietary/Model Name: Common or Usual Name: Classification Names:
SSTTM SALIVA SUPPORTING TABLETS Dental: Saliva, artificial Dental: Saliva, artificial
- Devices to Which New Device is Substantially Equivalent:
Gebauer Company: Salivart cleared in 510(k) K981693 and Inpharma AB: Caphosol cleared in 510(k) K991938
- Device Description:
SST™ is formulated as a tablet that is allowed to dissolve slowly in the mouth. The tablets are presented in containers of various counts. They contain a mixture of electrolytes in a pleasant flavored tablet.
- Intended Use of the Device:
Under the supervision of a healthcare professional, SINCLAIR SST™ promotes lubrication of oral mucosa that may be dry (xerostomia) due to, as may occur in a variety of circumstances including, medication, chemo or radiotherapy, Sjogren's Syndrome or oral inflammation. SINCLAIR SST™ provides temporary relief for damaged salivary function.
Over the counter labeling stipulates that SINCLAIR SST™ is suitable for temporary relief of dry mouth symptoms.
1
-
- Summary of Technological Characteristics of the Device Compared to the Predicate Devices:
SST™ has the same intended/indications for use as the predicate devices Gebauer Company Salivart and Inpharma AB Caphosol.
- Summary of Technological Characteristics of the Device Compared to the Predicate Devices:
| Product
| Name | SST | Salivart | Caphosol |
|---|---|---|---|
| Method of | |||
| Use | Ready to use | Ready to use | Mix solutions |
| A & B | |||
| # of | |||
| applications | |||
| per day | Take as | ||
| needed up to | |||
| 16 tablets per | |||
| day | Take as needed | Take as needed | |
| Claim | Symptomatic | ||
| treatment of | |||
| xerostomia. | Symptomatic | ||
| treatment of | |||
| xerostomia. | Symptomatic | ||
| treatment of | |||
| xerostomia. | |||
| Area of Use | Oral cavity | Oral cavity | Oral cavity |
| Disease State | Xerostomia | Xerostomia | Xerostomia |
| Type of | |||
| Product | Tablet | Solution | Solution |
| Presentation | Non Sterile | Non Sterile | Non Sterile |
- Tests and Conclusions:
Functional and performance testing has been conducted to assess the safety and effectiveness of SSTTM and all results are satisfactory.
2
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular arrangement of text that reads "DEPARTMENT OF HEALTH & HUMAN SERVICES USA". Inside the circle is an abstract symbol that resembles a stylized caduceus or a representation of human figures. The logo is black and white and appears to be slightly distressed or aged.
Food and Drug Administrat 9200 Corporate Boulevard Rockville MD 20850 .
Ms. Denise Swift Director, Regulatory Affairs Sinclair Pharmaceuticals, Limited Borough Road, Godalming. Surrey GU7 2AB UNITED KINGDOM
Re: K023046
Trade/Device Name: Sinclair SSTTM Regulation Number: None Regulation Name: Dental, Saliva Artificial Regulatory Class: Unclassified Product Code: LED Dated: September 10, 2002 Received: September 12, 2002
Dear Ms. Swift:
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 vour 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. Swif
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 vou desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at (301) 594-4613. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address
http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely yours
Timblay A. Ulatowski Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
4
Attachment 3
Indications for Use Statement
510(k) Number (if known)
Device Name
N2 5046
SINCLAIR SST™
Indications for Use
Under the supervision of a healthcare professional, SINCLAIR SST™ promotes lubrication of oral mucosa that may be dry (xerostomia) due to, as may occur in a variety of circumstances including, medication, chemo or radiotherapy, Sjogren's Syndrome or oral inflammation. SINCLAIR SST TM provides temporary relief for damaged salivary function.
Over the counter labeling stipulates that SINCLAIR SST™ is suitable for temporary relief of dry mouth symptoms.
PLEASE DO NOT WRITE BELOW THIS LINE- CONTINUE ON ANOTHER PAGE IF NEEDED
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use (per 21 CFR 801.109) OR
Over-The Counter Use
Swear Rourty
(Division Sign-Off) Division of Anesthesiology, General Hospital, Infection Control, Dental Devices
KO23046 510(k) Number ________________________________________________________________________________________________________________________________________________________________