(69 days)
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Not Found
No
The provided text does not mention AI, ML, image processing, or any other technology typically associated with AI/ML in medical devices. The intended use describes a topical lubricant.
No
The device provides temporary relief of symptoms (dry mouth) and promotes lubrication, which aligns with symptom relief rather than treatment of a disease or condition for therapeutic effect.
No
Explanation: The "Intended Use / Indications for Use" section states that SalivaSure™ "promotes lubrication of oral mucosa" and "provides temporary relief from dry mouth." It describes a product for symptomatic relief and lubrication, not for identifying or diagnosing a disease or condition.
No
The provided 510(k) summary describes a product called SalivaSure™ which is intended to promote lubrication of oral mucosa and provide temporary relief from dry mouth. The description focuses on the intended use and indications for use, which are related to a substance or product applied to the oral mucosa. There is no mention of software, hardware, or any digital component in the provided text. Therefore, based on this information, it appears to be a physical product (likely a liquid, gel, or spray) and not a software-only medical device.
Based on the provided information, SalivaSure™ is not an In Vitro Diagnostic (IVD).
Here's why:
- Intended Use: The intended use describes SalivaSure™ as a product that promotes lubrication of oral mucosa and provides temporary relief from dry mouth. This is a therapeutic or palliative function, not a diagnostic one.
- Mechanism of Action: The description focuses on providing lubrication and relief, which are physical effects on the oral mucosa. IVDs typically work by analyzing biological samples (like blood, urine, or saliva) to detect or measure substances related to a disease or condition.
- Lack of Diagnostic Claims: There are no claims that SalivaSure™ is used to diagnose, monitor, or screen for any disease or condition.
In summary, SalivaSure™ is intended to alleviate symptoms of dry mouth, not to diagnose the underlying cause. This aligns with the definition of a medical device that provides symptomatic relief, rather than an IVD.
N/A
Intended Use / Indications for Use
SalivaSure™ promotes lubrication of oral mucosa that may be dry due to the side effects of medication, chemo radiotherapy, or as a symptom of Sjogeren's Syndrome, or because of oral inflammation or damaged salivary function. The Over The Counter labeling indicates that SalivaSure™ is suitable for relief from dry mouth.
Product codes
LED
Device Description
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Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
oral mucosa
Indicated Patient Age Range
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Intended User / Care Setting
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Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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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
§ 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.
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Image /page/0/Picture/1 description: The image shows the seal of the Department of Health and Human Services (HHS). The seal features a stylized eagle with three lines representing its body and wings. The words "DEPARTMENT OF HEALTH AND HUMAN SERVICES. USA" are arranged in a circular pattern around the eagle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
AUG 8 - 2005
Scandinavian Formulas, Incorporated c/o Ms. Catherine P. Peklak 140 East Church St. Sellersville, Pennsylvania 18960
Re: K051409
Trade/Device Name: Slivasure Regulation Number: NONE Regulatory Class: Unclassified Product Code: LED Dated: May 26, 2005 Received: June 1, 2005
Dear Ms. Peklak:
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.
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Page 2 - Ms. Peklak
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 (240) 276-0115. 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/industry/support/index.html.
Sincerely yours,
Siputa Y. Michen Ons.
Chíu Lin, Ph.D. Director Division of Anesthesiology, General Hospital 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): KO51409
Device Name: SalivaSure
Indications For Use:
SalivaSure™ promotes lubrication of oral mucosa that may be dry due to the side SalivaSure™ promotes non radiotherapy, or as a symptom of Sjogrem of Sjogeren's effects of medication, chemo of real inflammation. SalivaSure™ provides temporary Synolome, or because of orar the or damaged salivary function.
The Over The Counter labeling indicates that SalivaSure™ is suitable for relief from dry mouth.
Prescription Use (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Susan Rusiye
(Division Sign-Off) (Division Sign-On)
Division of Anesthesiology, General Hospital, Division of Anostriosial Devices
510(k) Number: ـ
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