(273 days)
Not Found
No
The device description and intended use clearly indicate it is a saliva substitute with lubricating properties, and there is no mention of AI or ML in the provided text.
Yes.
The device is used to relieve symptoms of xerostomia (dry mouth) which is a medical condition, aligning with the definition of a therapeutic device.
No
The device is described as an "oral saliva substitute" formulated for the "relief of chronic and temporary xerostomia (dry mouth)" and "dry mouth symptoms." Its function is to provide relief and lubrication, not to diagnose a condition.
No
The device description clearly states it is an oral saliva substitute containing gel-forming substances and is packaged in bottles or pipettes, 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 for the relief of dry mouth symptoms (xerostomia). This is a therapeutic or palliative purpose, addressing a physical symptom.
- Mechanism of Action: The device works by providing lubrication and moisture to the oral cavity using gel-forming substances. This is a physical action, not a diagnostic test performed on a sample from the body.
- No mention of diagnostic testing: There is no indication that this device is used to analyze a sample (like blood, urine, saliva, etc.) to diagnose a disease or condition.
- Anatomical Site: The device is applied to the oral cavity, which is the site of the symptom, not a sample collection site for diagnostic purposes.
IVD devices are specifically designed to perform tests on samples taken from the human body to provide information for the diagnosis, monitoring, or treatment of diseases or conditions. This device does not fit that description.
N/A
Intended Use / Indications for Use
Under the supervision of a healthcare professional, SALINUM® has been formulated for the relief of chronic and temporary xerostomia (dry mouth), which may be a result of disease, medication, oncology therapy, stress or aging.
ORACLAIR has been formulated for the relief of dry mouth symptoms such as difficulties in swallowing, speech and changes in taste. These symptoms may be brought on by disease, stress, aging or medication.
Product codes (comma separated list FDA assigned to the subject device)
LFD
Device Description
SALINUM® / ORACLAIR is an oral saliva substitute which contains gel-forming substances (polysaccharides) from linseed that have lubricating and moistening properties. The product is preserved, buffered and packed in white PET (polyethylene terephthalate) bottles of various sizes with polypropylene disc top caps or single dose (2ml) polythene pipettes in strips of 10 packed in a cardboard carton.
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
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 SALINUM® and all results are satisfactory.
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
Attachment 7 510(k) Summary
December 12, 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:
SALINUM® OR ORACLAIR
Trade/Proprietary/Model Name: Common or Usual Name: Classification Names:
SALINUM® OR ORACLAIR Dental: Saliva, artificial Dental: Saliva, artificial
-
- Device Description:
SALINUM® / ORACLAIR is an oral saliva substitute which contains gel-forming substances (polysaccharides) from linseed that have lubricating and moistening properties. The product is preserved, buffered and packed in white PET (polyethylene terephthalate) bottles of various sizes with polypropylene disc top caps or single dose (2ml) polythene pipettes in strips of 10 packed in a cardboard carton.
- Device Description:
-
- Intended Use of the Device:
Under the supervision of a healthcare professional, SALINUM® has been formulated for the relief of chronic and temporary xerostomia (dry mouth), which may be a result of disease, medication, oncology therapy, stress or aging.
- Intended Use of the Device:
Over the counter Labeling stipulates that ORACLAIR has been formulated for the relief of dry
Image /page/0/Picture/19 description: The image shows the text "SEP 1 5 2003" in the upper left corner. Below this is the Sinclair logo. The word "CONFIDENTIAL" is written in a large font at the bottom right of the image.
1
CONFIDENTIAL
mouth symptoms such as difficulties in swallowing, speech and changes in taste. These symptoms may be brought on by disease, stress, aging or medication.
-
- Summary of Technological Characteristics of the Device Compared to the Predicate Devices:
SALINUM® / ORACLAIR 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 | Salinum® /
Oraclair | Salivart | Caphosol |
|---------------------------------|--------------------------------------------|--------------------------------------------|--------------------------------------------|
| Method of
Use | Ready to use | Ready to use | Mix solutions
A & B |
| # of
applications
per day | Take as
needed | 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 | Solution | 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 SALINUM® and all results are satisfactory.
2
Image /page/2/Picture/1 description: The image shows the seal of the U.S. Department of Health & Human Services. The seal is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol that resembles an eagle or bird in flight, composed of three curved lines.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
SEP 1 5 2003
Ms. Denise Swift Director of Regulatory Affairs Sinclair Pharmaceuticals Limited Borough Road Godalming Surrey GU7 2AB UNITED KINGDOM
Re: K024148
Trade/Device Name: Salinum® or Oraclair Regulation Number: None Regulation Name: Regulatory Class: Unclassified Product Code: LFD Dated: March 4, 2003 Received: March 6, 2003
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 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. Swift
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 you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at (301) 594-4613. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely yours.
Susan Runnar
Susan Runner, DDS, MA Interim Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
CONFIDENTIAL
Attachment 3 Indications for Use Statement KOZ4148 510(k) Number (if known) SALINUM® / ORACLAIR Device Name Rx labeling: Indications for Use the supervision of a healthcare professional, Under SALINUM® has been formulated for the relief of chronic and temporary xerostomia (dry mouth), which may be a result of disease, medication, oncology therapy, stress or aging. Over the counter labelling ORACLAIR has been formulated for the relief of dry mouth symptoms such as difficulties in swallowing, speech and changes in taste. These symptoms may be brought on by
(Division Sign-Off) Division of Anesthesiology, General Hospital, Infection Control, Dental Devices
510(k) Number: K024148
PLEASE DO NOT WRITE BELOW THIS LINE- CONTINUE ON ANOTHER PAGE IF NEEDED
disease, stress, aging or medication.
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use OR (per 21 CFR 801.109) \
Over-The Counter Use