(53 days)
For the removal of plaque For cleaning teeth For healthier gums For fresh breath
PlusTron Ion Toothbrush System
The provided document is a 510(k) clearance letter from the FDA for a device named "PlusTron Ion Toothbrush System." This type of document primarily confirms that a new medical device is substantially equivalent to a legally marketed predicate device, allowing it to be marketed. It does not typically contain detailed information about specific acceptance criteria or study results in the manner requested.
Therefore, it is not possible to provide the requested information based solely on the provided text. The document is a regulatory approval, not a technical report detailing performance studies.
Here's a breakdown of why each requested point cannot be answered:
- A table of acceptance criteria and the reported device performance: This information is not present in the 510(k) clearance letter. Such details would typically be in the 510(k) submission itself, which is not provided.
- Sample size used for the test set and the data provenance: Not available. The letter mentions "substantial equivalence" but doesn't detail performance studies or the data used for comparison.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not available. This level of detail about expert review or ground truth establishment is not part of an FDA clearance letter.
- Adjudication method for the test set: Not available.
- If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance: Not available. This device is a toothbrush system, not an AI diagnostic tool, so an MRMC study is highly unlikely and certainly not mentioned.
- If a standalone (i.e. algorithm only without human-in-the loop performance) was done: Not available, and not applicable as this is not an algorithm-based device.
- The type of ground truth used (expert concensus, pathology, outcomes data, etc): Not available.
- The sample size for the training set: Not available, and not applicable for this type of device.
- How the ground truth for the training set was established: Not available, and not applicable for this type of device.
In summary, the provided FDA 510(k) clearance letter is a regulatory document and does not contain the detailed study information or performance data requested.
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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
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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
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REVISED 6/11/97
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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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§ 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.