(21 days)
This device, a small, battery-powered, light-weight, low-speed electric motor handpiece, runs at 200 rpm to 2000 rpm, and is intended for use in light general dental, prophylaxis, or endodontic works, where low speed is required.
a small, battery-powered, light-weight, low-speed electric motor handpiece, runs at 200 rpm to 2000 rpm. A variety of detachable heads, each of which is pushed into or pulled out of the motor handpiece, are available to perform required job, such as a prophy head for screw-in or snap-on prophy cups and brushes, a latch head for latch reamer or latch file, a 1/4-turn head, up-down head, 10:1 reduction speed head, etc.
The provided text is an FDA 510(k) clearance letter for a dental device, the "PROPHY-MATE Motor Handpiece." This type of document is a regulatory approval, not a scientific study report. As such, it does not contain any of the requested information regarding acceptance criteria, device performance studies, sample sizes, expert qualifications, ground truth establishment, or specific study methodologies.
The letter explicitly states that the device is deemed "substantially equivalent" to devices marketed prior to May 28, 1976. This means the FDA's decision is based on a comparison to existing, legally marketed predicate devices, rather than requiring new clinical trials or performance studies with acceptance criteria as one would find for a novel device.
Therefore, I cannot provide the requested information from the given text.
Here's a breakdown of why this information is missing:
- Acceptance Criteria and Reported Device Performance: Not included. The letter is about regulatory clearance based on substantial equivalence, not a detailed performance report.
- Sample Size and Data Provenance: Not applicable to this type of regulatory submission. The substantial equivalence pathway typically relies on existing knowledge and comparison to predicate devices, not new sample-based studies.
- Number of Experts and Qualifications: Not mentioned. Expert review in this context would be part of the FDA's internal process for assessing the 510(k) submission against the predicate device, not for establishing ground truth in a clinical study.
- Adjudication Method: Not applicable. There's no clinical trial data with adjudication described.
- Multi Reader Multi Case (MRMC) Comparative Effectiveness Study: Not mentioned and highly unlikely for a device seeking 510(k) clearance through substantial equivalence for a basic dental handpiece.
- Standalone (algorithm only) Performance: Not applicable, as this is a mechanical dental handpiece, not an AI or algorithm-driven device.
- Type of Ground Truth Used: Not applicable. There's no clinical study described that would require a ground truth.
- Sample Size for Training Set: Not applicable, as there's no machine learning model or algorithm being trained.
- How Ground Truth for Training Set was Established: Not applicable.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular arrangement of text that reads "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA". Inside the circle is a symbol that resembles three stylized human figures or abstract shapes, arranged in a way that suggests movement or connection.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAR 2 4 1999
Mr. Hiroji Sekiguchi Marketing Manager, N. American Official Correspondent Nakanishi, Incorporated 340 Kamihinata, Kanuma-Shi, Tochigi-Ken 322-8666, JAPAN
Re : K990682 Prophy-Mate Motor Handpiece, Models Prophy-Trade Name: Mate (600 rpm & 2000 rpm) Regulatory Class: I Product Code: EKX Dated: March 2, 1999 March 2, 1999 Received:
Dear Mr. Sekiquchi
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 general 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. ਸ substantially equivalent determination assumes compliance with the Good Manufacturing Practice for Medical Devices: General (GMP) regulation (21 CFR Part 820) and that, through periodic GMP inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements 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 through 542 of
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Page 2 — Mr. Sekiguchi
the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
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) 594-4692. Additionally, for questions on the promotion 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,
Patricia Cucentiffz
Timothy A. Ulatowski Director Division of Dental, Infection Control, and General Hospital Devices Office of Device Evaluation Center for Devices and Radioloqical Health
Enclosure
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510(k) Number (if known):
Devicc Namc: PROPHY-MATE Motor Handpiece (6000rpm Max.)
Indications For Use:
This device, a small, battery-powered, light-weight, low-speed electric motor handpiece, runs at 200 rpm to 2000 rpm, and is intended for use in light general dental, prophylaxis, or endodontic works, where low speed is required.
Remarks:
A variety of detachable heads, each of which is pushed into or pulled out of the motor handpiece, are available to perform required job, such as a prophy head for screw-in or snap-on prophy cups and brushes, a latch head for latch reamer or latch file, a 1/4-turn head, up-down head, 10:1 reduction speed head, etc.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Coucurrence of CDRH, Office of Device Evaluation (ODE)
Susan Russo
(Division Sign-Off)
Division of Dental, Infection Control,
and General Hospital Devices
510(k) Number K990682
Prescription Use
(Per 21 CFR 801.109) ✓
OR
4 - 1
Over-The-Counter Use
(Optional Formal 1-2-9
§ 872.4200 Dental handpiece and accessories.
(a)
Identification. A dental handpiece and accessories is an AC-powered, water-powered, air-powered, or belt-driven, hand-held device that may include a foot controller for regulation of speed and direction of rotation or a contra-angle attachment for difficult to reach areas intended to prepare dental cavities for restorations, such as fillings, and for cleaning teeth.(b)
Classification. Class I.