(185 days)
AIR TORX is used as a motor to drive attachments by air supplied from the treatment unit's air supply system. Attachments are geared handpieces that are used to drill and polish teeth.
This instrument is designed for dental treatment such as grinding, drilling and polishing teeth.
The provided text is a 510(k) summary for a dental handpiece (AIR TORX) and does not contain information about studies proving the device meets specific acceptance criteria as it would for a software AI/ML device.
The document states that the device is classified as a non-exempt Class I device and its substantial equivalence is based on similar general intended uses, principles of operation, and technological characteristics to a predicate device (MICRO AIR MOTOR A-25LT, K944713). It explicitly states that "these differences do not raise new questions of safety or effectiveness," which means that extensive new performance studies (like those requiring acceptance criteria, test sets, or ground truth establishment) are generally not required for Class I devices deemed substantially equivalent through this pathway.
Therefore, I cannot provide the requested information. The document focuses on demonstrating substantial equivalence to a predicate device rather than detailing studies with acceptance criteria, sample sizes, expert ground truth, or adjudication methods typically associated with proving the performance of novel medical devices, especially AI/ML-based ones.
Specifically, the following requested information is absent from the provided text:
- A table of acceptance criteria and the reported device performance: Not present. The comparison table is for "Technological characteristics" and primarily states "Similar" for most categories.
- Sample size used for the test set and the data provenance: Not applicable/not present. No clinical or performance test set is described.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable/not present.
- Adjudication method for the test set: Not applicable/not present.
- 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 applicable/not present. This device is a mechanical dental handpiece, not an AI system.
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable/not present.
- The type of ground truth used: Not applicable/not present.
- The sample size for the training set: Not applicable/not present.
- How the ground truth for the training set was established: Not applicable/not present.
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510(k) SUMMARY
J. MORITA USA Inc.'s AIR TORX Type: TRA-200, TRA-200-CP3, TRA-200-CP4
1. NAME OF DEVICE
OCT 1 6 2009 AIR TORX Trade or Proprietary Name: Type: TRA-200, TRA-200-CP3, TRA-200-CP4 Handpiece, Air-powered, Dental Common Name:
2. SUBMITTER NAME AND ADDRESS WITH PHONE/FAX
| Registration No. 2081055Initial Distributor:J. Morita USA, Inc.9 MasonIrvine, CA 92618USATelephone: 949-581-9600Facsimile: 949-581-9688 | Registration No. 3002807636Manufacturer:J. MORITA MFG. CORP.680 Higashihama Minami-choFushimi-ku, KyotoJapan 612-8533+81-75-611-2141+81-75-605-2354 |
|---|---|
| --------------------------------------------------------------------------------------------------------------------------------------------------------------------- | --------------------------------------------------------------------------------------------------------------------------------------------------------------------------------- |
3. CONTACT PERSON
Keith A. Barritt Fish & Richardson P.C. 1425 K Street, N.W. Suite 1100 Washington, DC 20005 Phone: (202) 783-5070 Facsimile: (202) 783-2331
4. DATE SUMMARY PREPARED: April 8, 2009
5. DEVICE CLASSIFICATION/CLASSIFICATION PANEL
The Air Torx has been classified as non-exempt Class I devices. Device classification: 21CFR 872.4200 Dental handpiece and accessories
Device classification panel:
872 Dental Devices
84
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6. DEVICE DESCRIPTION/SUBSTANTIAL EQUIVALENCE
DEVICE DESCRIPTION
This instrument is designed for dental treatment such as grinding, drilling and polishing teeth.
SUBSTANTIAL EQUIVALENCE
Comparison summary table with predicate device is as follows. AIR TORX and its predicate device has similar general intended uses, similar principles of operation, and similar technological characteristics. Although there are minor differences in the characteristics of the AIR TORX and its predicate devices, these differences do not raise new questions of safety or effectiveness.
Comparison summary table
Name and 510(k) number of predicate device: MICRO AIR MOTOR A-25LT, K944713
| Technological characteristics | Comparison result |
|---|---|
| Indication for use | Similar |
| Target population | Similar |
| Design | Similar |
| Materials | Unknown |
| Performance | Similar |
| Sterility | Similar |
| Biocompatibility | Unknown |
| Mechanical safety | Similar |
| Chemical safety | Similar |
| Anatomical sites | Similar |
| Human factors | Similar |
| Energy used and/or delivered | Similar |
| Compatibility with environment and other devices | Similar |
| Where used | Similar |
| Standards met | Unknown |
| Electrical safety | N/A |
| Thermal safety | Unknown |
7. INDICATIONS FOR USE
AIR TORX is used as a motor to drive attachments by air supplied from the treatment unit's air supply system.
Attachments are geared handpieces that are used to drill and polish teeth.
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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized depiction of an eagle or bird with outstretched wings. The bird is positioned to the right of a circular border containing the text "DEPARTMENT OF HEALTH & HUMAN SERVICES U.S.A."
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room W-O66-0609 Silver Spring, MD 20993-0002
NOV 18 2009
J. Morita USA, Incorporated C/O Mr. Keith A. Barritt Fish & Richardson P.C. 1425 K Street, Northwest, Suite 1100 Washington, DC 20005
Rc: K091065 Trade/Device Name: AIR TORX Regulation Number: 21 CFR 872.4200 Regulation Name: Dental Handpiece and Accessories Regulatory Class: I Product Code: EFB Dated: September 30, 2009 Received: October 1, 2009
Dear Mr. Barritt:
This letter corrects our substantially equivalent letter of October 16, 2009.
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 (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 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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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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); 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.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please contact the CDRH/Office of Surveillance and Biometrics/Division of Postmarket Surveillance at 240-276-3464. For more information regarding the reporting of adverse events, please go to http://www.fda.gov/cdrh/mdr/.
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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Wh for
Susan Runner, D.D.S., M.A. Acting Division Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known):
091065
Device Name:
AIR TORX
. Indications For Use:
AIR TORX is used as a motor to drive attachments by air supplied from the treatment unit's air supply system.
Attachments are geared handpieces that are used to drill and polish teeth.
Prescription Use (Part 21 CFR 801 Subpart D) AND/OR ·
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Kein Muly fa MSR
(Division Sign-Off)
Division of Anesthesiology, General Hospital Infection Control, Dental Devices
Page 1 of
510(k) Number: K091065
§ 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.