(61 days)
The TWIN POWER TURBINE handpiece is for use by authorized persons in the practice of dentistry.
TWIN POWER TURBINE is a dental handpiece. This device receives energy resources in handpiece such as air for high speed air turbine, cooling water for cutting and light source for illumination, through the tubes connected to a dental unit. The cooling water is fed part of cutting treatment through pouring holes.
The provided document is a 510(k) summary for a dental handpiece, focusing on establishing substantial equivalence to a predicate device rather than providing a detailed study of its performance against specific acceptance criteria. Therefore, much of the requested information regarding acceptance criteria, specific performance metrics, and detailed study design (sample size, ground truth, expert qualifications, etc.) is not present in the document.
Here's what can be extracted and what is missing:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Reported Device Performance (Comparison to Predicate) |
|---|---|
| Indication for use | Identical |
| Target population | Identical |
| Design | Similar |
| Materials | Similar |
| Performance | Similar |
| Sterility | Similar |
| Biocompatibility | Similar |
| Mechanical safety | Similar |
| Chemical safety | Similar |
| Anatomical sites | Similar |
| Human factors | Similar |
| Energy used and/or delivered | Similar |
| Compatibility | Similar |
| Standards met | Similar |
| Electrical safety | Similar |
| Thermal safety | Not applicable |
| Radiation safety | Not applicable |
Missing Information: The document does not provide specific quantitative or qualitative acceptance criteria for these categories (e.g., "Must meet ISO X for sterility" or "Performance must achieve Y RPM"). Instead, it broadly states "Similar" or "Identical" in comparison to the predicate device. Therefore, no specific 'device performance' metrics are reported, beyond the general claim of similarity/identity.
2. Sample size used for the test set and the data provenance
Missing Information: The document does not describe any specific test set size or data provenance (e.g., country of origin, retrospective/prospective) for a study of the device's performance. The submission relies on demonstrating substantial equivalence to a predicate device rather than presenting new clinical performance data.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Missing Information: No information is provided regarding experts or ground truth establishment for a test set, as no specific performance study is detailed.
4. Adjudication method for the test set
Missing Information: No adjudication method is mentioned, as no specific test set or performance study is described.
5. 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
Missing Information: This document describes a dental handpiece, which is a physical tool, not an AI-powered diagnostic or assistive technology. Therefore, an MRMC study with AI assistance is not applicable and was not performed or mentioned.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Missing Information: As a physical dental handpiece, this question is not applicable.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)
Missing Information: No ground truth information is provided, as no specific performance study is detailed. The "ground truth" for this 510(k) submission is the pre-existing regulatory approval and established performance of the predicate device.
8. The sample size for the training set
Missing Information: No training set is applicable or mentioned, as this is not an AI/machine learning device.
9. How the ground truth for the training set was established
Missing Information: As no training set is applicable, no ground truth establishment method is provided.
Summary of the Study that Proves the Device Meets Acceptance Criteria (as per the document):
The "study" presented in this 510(k) summary is a comparison to a legally marketed predicate device (Synea-HS High-Speed Handpiece from A-Dec, Incorporated, K992011).
- Methodology: The manufacturer performed a comparative analysis of the "TECHNOLOGICAL CHARACTERISTICS" of the TWIN POWER TURBINE against the predicate device. This comparison covered aspects like indication for use, target population, design, materials, performance, sterility, biocompatibility, safety features (mechanical, chemical, electrical), anatomical sites, human factors, energy usage, compatibility, and standards met.
- Proof of Meeting Acceptance Criteria: The conclusion drawn from this comparison is that the TWIN POWER TURBINE is "substantially equivalent" to the predicate device. The document states: "This device is safe and effective as the other predicate device cited above. This is better expressed in the tabulated comparison as below." The "acceptance criteria" here implicitly align with the performance and safety characteristics of the predicate device. By demonstrating that the new device is "Identical" or "Similar" across all listed technological characteristics, the submission asserts that it meets the implied "acceptance criteria" of being as safe and effective as its legally marketed equivalent.
In essence, for a 510(k) submission of this nature, the "study" is the demonstration of substantial equivalence, and the "acceptance criteria" are met if the FDA agrees that the new device does not raise new questions of safety or effectiveness compared to the predicate device.
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0434 ું જ
FEB 1 6 2005
510(k) SUMMARY
J. MORITA MFG. CORP.'s TWIN POWER TURBINE 4H/DI
1. Submitter Name and Address with Phone/Fax :
| Registration No. 2081055 | Registration No. 3002807636 |
|---|---|
| Initial Distributor: | Manufacturer: |
| J. Morita USA, Inc. | J. MORITA MFG. CORP. |
| 9 Mason | 680 Higashihama Minami-cho |
| Irvine, CA 92618 | Fushimi-ku, Kyoto |
| USA | Japan 612-8533 |
| Telephone: 949-581-9600 | +81-75-611-2141 |
| Facsimile: 949-581-9688 | +81-75-605-2354 |
2. 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
September 29, 2004 3. Date summary prepared:
4. Device Name:
| Trade or Proprietary Name: | TWIN POWER TURBINE PAR seriesPAR-4H series(PAR-4HE/ PAR-4HE-O/ PAR-4HS/ PAR-4HS-O)PAR-DI series(PAR-E-DI/ PARE-O-DI/ PAR-S-DI/ PAR-S-O-DIPAR-M-DI/ PAR-M-O-DI) |
|---|---|
| Common Name: | Air powered dental handpiece |
| Classification Name: | Dental handpiece and accessories(21CFR 872.4200 ) |
| Product Code : | EFB ( "Handpiece, Air-powered, Dental " ) |
-
- Substantial Equivalency is claimed against the following device: Synea-HS High-Speed Handpiece from A-Dec, Incorporated ( K992011) .
:
- Substantial Equivalency is claimed against the following device: Synea-HS High-Speed Handpiece from A-Dec, Incorporated ( K992011) .
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6. Description of the device:
VII-1 DEVICE DESCRIPTION
TWIN POWER TURBINE is a dental handpiece
This device receives energy resources in handpiece such as air for high speed air turbine, cooling water for cutting and light source for illumination, through the tubes connected to a dental unit.
The cooling water is fed part of cutting treatment through pouring holes.
TWIN POWER TURBINE is classified into the model as is shown below Table-1 from the variations of light and motor.
| (-: not included ) | ||||||
|---|---|---|---|---|---|---|
| Name | Model | Main Body | Coupling | |||
| Body | Light | Headassembly | 4-holecoupling | TubeconnectionISO9168 | ||
| TWINPOWERTURVINE4H | PAR-4HE | PAR-4HE | - | Standard | CP-4,CP4-A or CP4-W | Type-B |
| PAR-4HE-O | PAR-4HE-O | Included | Standard | CP4-O,CP4-AO or CP4-WO | Type-C | |
| PAR-4HS | PAR-4HS | - | Torque-up | CP-4,CP4-A or CP4-W | Type-B | |
| PAR-4Hseries | PAR-4HS-O | PAR-4HS-O | Included | Torque-up | CP4-O,CP4-AO or CP4-WO | Type-C |
| TWINPOWERTURVINEP | PAR-E DI | PAR-EDI | - | Standard | - | - |
| PAR-E-O DI | PAR-E-ODI | Included | Standard | - | - | |
| PAR-Diseries | PAR-S DI | PAR-S DI | - | Torque-up | - | - |
| PAR-S-O DI | PAR-S-ODI | Included | Torque-up | - | - | |
| PAR-M DI | PAR-MDI | - | Miniature | - | - | |
| PAR-M-O DI | PAR-M-O DI | Included | Miniature | - | - |
Models of PAR series Table-1
2/3
And Children Children
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7. Intended Use
TWIN POWER TUBINE is for use by authorized persons in the practice of the dentistry.
Safety and effectiveness of the device 8.
This device is safe and effective as the other predicate device cited above. This is better expressed in the tabulated comparison as below.
Substantial Equivalent comparison summary table
| The predicate device and its 510k number: | |
|---|---|
| Synea-HS High-Speed Handpiece from A-Dec, Incorporated K992011 | |
| Attachment inside notification submission file | |
| The promotional materials of its predicate device, Attachment 3 | |
| TECHNOLOGICALCHARACTERISTICS | Comparison result |
| Indication for use | Identical |
| Target population | Identical |
| Design | Similar |
| Materials | Similar |
| Performance | Similar |
| Sterility | Similar |
| Biocompatibility | Similar |
| Mechanical safety | Similar |
| Chemical safety | Similar |
| Anatomical sites | Similar |
| Human factors | Similar |
| Energy used and/or delivered | Similar |
| Compatibility with environmentand other devices | Similar |
| Where used | Identical |
| Standards met | Similar |
| Electrical safety | Similar |
| Thermal safety | Not applicable |
| Radiation safety | Not applicable |
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Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a circle with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the top half of the circle. Inside the circle is an abstract symbol that resembles a stylized caduceus, which is a symbol often associated with healthcare. The symbol is composed of three curved lines that converge at the bottom.
Public Health Service
FEB 1 6 2005
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
J. Morita USA, Incorporated C/O Mr. Keith A. Barritt Fish & Richardson P.C. 1425 K Street, N.W. 11" Floor Washington, DC 20005
Re: K043498
Trade/Device Name: Twin Power Turbine High Speed Air Turbine Dental Handpiece Regulation Number: 872.4200 Regulation Name: Dental Handpiece and Accessories Regulatory Class: I Product Code: EFB Dated: December 16, 2004 Reccived: December 17, 2004
Dear. Mr. Barritt:
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 application (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 cither class II (Special Controls) or class III (PMA), it may be subject to such additional controls. Existing major regulations affecting vour 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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Page 2 - Mr. Barritt
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); 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.
This letter will allow you to begin marketing your device as described in your Section 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 regulation (21 CFR Part 801), please contact the Office of Compliance at (240) 276- . Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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 (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Greta Michie Davis
Chiu Lin, Ph.D. 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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498
Indications for Use
510(k) Number (if known): K#043498
TWIN POWER TURBINE high speed air turbine dental handpiece Device Name: Indications For Use:
The TWIN POWER TURBINE handpiece is for use by authorized persons in the practice of dentistry,
Prescription Use x (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)
Susan Purge
on Skin-Off) tion of Anesthesiology. General Hospital, con Control, Dental Devices
Number K043498
Page 1 of ____________________________________________________________________________________________________________________________________________________________________
§ 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.