(67 days)
Not Found
No
The device description and lack of mention of AI/ML terms or performance studies indicate a simple mechanical device.
No
The device is described as a non-powered tool for removing plaque and food debris from the tongue, similar to a tongue cleaner, and its predicate device (K961574) is a manual tongue cleaner. These are generally considered oral hygiene devices, not therapeutic devices which typically imply treatment or prevention of a specific disease or condition beyond general hygiene.
No.
The device's sole stated intention is to remove plaque and food debris, which is a therapeutic or hygiene function, not a diagnostic one. There is no mention of it detecting, identifying, or assessing a medical condition.
No
The device description explicitly states it is a "formed piece of stainless steel," indicating it is a physical hardware device, 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 "remove plaque and food debris from the surface of the tongue." This is a mechanical action performed directly on the body, not a test performed on a sample taken from the body to diagnose a condition.
- Device Description: The device is a "formed piece of stainless steel." This describes a physical tool, not a reagent, instrument, or system used for in vitro testing.
- Lack of IVD Characteristics: The description lacks any mention of:
- Analyzing samples (blood, urine, tissue, etc.)
- Detecting or measuring substances in samples
- Providing information for diagnosis, monitoring, or screening of diseases or conditions based on in vitro analysis.
The device described is a tongue cleaner, which is a Class I medical device used for oral hygiene.
N/A
Intended Use / Indications for Use
The device is intended to remove plaque and food debris from the surface of the tongue.
Product codes (comma separated list FDA assigned to the subject device)
Not Found
Device Description
The device is a formed piece of stainless steel.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
tongue
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 Applicable.
Description of the test set, sample size, data source, and annotation protocol
Not Applicable.
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Summary of Performance Data: Not Applicable.
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.
U.S. Dentek' Sakool (K961574)
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
§ 872.6855 Manual toothbrush.
(a)
Identification. A manual toothbrush is a device composed of a shaft with either natural or synthetic bristles at one end intended to remove adherent plaque and food debris from the teeth to reduce tooth decay.(b)
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 872.9. If the device is not labeled or otherwise represented as sterile, it is 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/0 description: The image shows a black and white illustration of a geometric structure. The structure appears to be made of a grid-like pattern, with curved shapes that resemble arches or domes. The image has a high contrast, with the black lines of the grid standing out against the white background. The overall impression is one of a complex, abstract design.
Telefax International 23704-5 El Toro Road, Suite # 527 Lake Forest, CA 92630.
MAR 1 4 1997
970042
This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR Part 807.92.
SUMMARY OF SAFETY AND EFFECTIVENESS FOR OOLI-U (TONGUE SCRAPER)
Monday, December 30, 1996
-
- Telefax International, 23704-5 El Toro Road, Ste. 527, Lake Forest, CA 92630. Contact Person: Upen Shah, Tel.: (714)-581-1447, Fax: (714)-581-1448. 2. Proprietary Name: Ooli-U Common/Usual Name: Tongue Scraper/Tongue Cleaner Classification Name: Tongue Scraper 3. Predicate Device: U.S. Dentek' Sakool (K961574). 4. Description of Device: The device is a formed piece of stainless steel. న : Intended Use: The device is intended to remove plaque and food debris from the surface of the tongue. 6. Technological Characteristics: The only known difference from the predicate device, is the material from which is made of. Ours is stainless steel material that is commonly used in dental equipment and theirs is a plastic. From using these devices, the results are the same. 7. Summary of Performance Data: Not Applicable. 8. Conclusions Drawn From Nonclinical and Clinical Tests: Not Applicable ..