(53 days)
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Not Found
No
The summary does not mention AI, ML, or any related concepts like image processing, training sets, or performance metrics typically associated with AI/ML devices. The description is for a standard toothbrush system.
No.
- The device is intended for the removal of plaque, cleaning teeth, healthier gums, and fresh breath, which are general hygiene and cosmetic purposes rather than treating or preventing a specific disease or condition.
No
The "Intended Use / Indications for Use" section describes the device as being for the removal of plaque, cleaning teeth, healthier gums, and fresh breath, which are all preventative and hygienic functions, not diagnostic ones.
No
The device description explicitly states "PlusTron Ion Toothbrush System," which strongly implies a hardware component (the toothbrush) is part of the system, not just 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 removal of plaque, cleaning teeth, healthier gums, and fresh breath. These are all related to oral hygiene and physical cleaning, not the diagnosis of diseases or conditions using in vitro methods (testing samples like blood, urine, or tissue outside the body).
- Device Description: It's described as a "PlusTron Ion Toothbrush System," which is consistent with a device used for oral hygiene.
- Lack of IVD Indicators: There is no mention of analyzing biological samples, detecting biomarkers, or any other activities typically associated with IVDs.
Therefore, this device falls under the category of a general medical device for oral hygiene, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
For the removal of plaque For cleaning teeth For healthier gums For fresh breath
Product codes (comma separated list FDA assigned to the subject device)
MMD
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
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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.)
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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.
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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
§ 872.6865 Powered toothbrush.
(a)
Identification. A powered toothbrush is an AC-powered or battery-powered device that consists of a handle containing a motor that provides mechanical movement to a brush intended to be applied to the teeth. The device is 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.
0
Image /page/0/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo consists of a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, with flowing lines that suggest movement or progress.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Mr. Michael D. Sobo ·President SAS Group, Incorporated 220 White Plains Road Tarrytown, New York 10591
JUN 24 1997
Re: K971639 Trade Name: Plustron Ion Toothbrush System Requlatory Class: Unclassified Product Code: MMD Dated: April 25, 1997 Received: May 2, 1997
Dear Mr. Sobo:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). You may, therefore, market the device, subject to the qeneral controls provisions The general controls provisions of the Act 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 (Premarket Approval), it may be subject to such additional controls. Existing major requlations affecting your device can be found in the Code of Federal Requlations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the current Cood Manufacturing Practice requirement, as set forth in the Quality System Regulation (QS) for Medical Devices: General requlation (21 CFR Part 820) and that, through periodic (QS) inspections, the Food and Druq Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory In addition, FDA may publish further announcements action. concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531
1
Page 2 - Mr. Sobo
through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or requlations.
This letter will allow you to begin marketing your device as described in your 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 requlation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4618. Additionally, for questions on eem reason 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" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".
Sincerely yours,
Patricea Cucenti / foc
Timothy A. Ulatowski Director Division of Dental, Infection Control and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
REVISED 6/11/97
I । of Pagc
к97-1639 510(k) Number (if known): _
Device Name:_ PlusTron Ion Toothbrush System
Indications For Use:
For the removal of plaque For cleaning teeth For healthier gums For fresh breath
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
| Concurrence of CDRH, Office of Device Evaluation (ODE) | ||
|---|---|---|
| (Division Sign-Off) | ||
| Division of Dental, Infection Control, and General Hospital Devices | ||
| 510(k) Number | K971639 | |
| Prescription Use | ||
| (Per 21 CFR 801.109) | OR | Over-The-Counter Use |
(Optional Format 1-2-96)
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