(135 days)
The 430 Torque High-Speed Handpiece Series are used by trained dental professionals for a variety of procedures including but not limited to caries and amalgam removal, restorative work and crown preparation.
The 430 Torque High-Speed Handpiece Series consists of a fiber optic high speed handpiece, marketed as a SWL and a non-fiber optic handpiece, marketed as a SW handpiece. Each is a pneumatically driven hand- held device that is capable of reaching rotational speeds of 350,000 to 450,000 rpms at a recommended air pressure of 38-43 PSI. The series delivers on average up to 20 watts of power providing .269 oz.-in. of stall torque. The handpieces are constructed of stainless steel, including the internal air and water tubes which provide drive air to the turbine assembly and cooling water to the work site. The stainless steel and aluminum air driven turbine assembly provides spin to the bur, and incorporates lubefree ceramic bearings (K905155) and a push button autochuck. The rotor is larger than the rotor of the predicate, yielding a higher cutting torque. The fiber optics in the SWL version of the handpiece are lead-free, multi-core glass rod that transmit light from the fiber optic swivel coupler to the oral cavity. The 430 Torque High-Speed handpiece Series can be assembled to quick disconnect couplers that are ISO Type 3 and ISO Type 2 connections, available as fiber optic or non-fiber optic versions, using a halogen bulb or LED technology. All couplers are autoclavable with the exception of the LED coupler that incorporates the electronics internally.
This looks like a 510(k) summary for a dental handpiece, and not a study on a medical device that uses artificial intelligence or machine learning. Therefore, most of the requested information (acceptance criteria, sample sizes, ground truth establishment, expert qualifications, MRMC studies) is not applicable.
However, I can extract the relevant performance data and mention the standards used for testing.
1. Table of Acceptance Criteria and Reported Device Performance
For dental handpieces, the "acceptance criteria" are generally compliance with recognized consensus standards for safety and performance. The document doesn't explicitly state quantitative acceptance criteria in a pass/fail format, but rather demonstrates compliance with a standard and compares performance metrics to predicate devices.
| Characteristic | Acceptance Standard / Predicate Range | Reported Device Performance (430 Torque High-Speed Handpiece Series) |
|---|---|---|
| Performance Standard | ISO 7785-1 (for predicates) | ISO 14457:2012 Dentistry – Handpieces and motors (for proposed device) |
| Rotational Speed (no load) | 430,000 rpms (at 30-34 PSI) | 350,000 to 450,000 rpms (at 38-43 PSI) |
| Power | 14 watts (on average) | Up to 20 watts (on average) |
| Stall Torque | 0.181 oz.-in. | 0.269 oz.-in. |
| Sterilization Standard | AAMI TIR No. 12-1994, FDA June 1996 guidance document | ANSI/AAMI ST79:2010 & A4:2013, AAMI/ANSI/ISO 14937:2009, ANSI/AAMI ST81:2004 (R2010) |
| Biocompatibility | Known biocompatible materials (400/300 series stainless steel) | Identical material composition and manufacturing process to predicates (stainless steel, aluminum) |
| Risk Analysis Standard | ISO14971:2012 | ISO14971:2012 Medical devices - Application of risk management to medical devices (for proposed device and current for predicates) |
Notes on the Table:
- The proposed device (430 Torque High-Speed Handpiece Series) demonstrates improved performance (higher power, higher rotational speed, higher stall torque) compared to its predicates, while still being considered substantially equivalent.
- The "acceptance criteria" are implied by meeting or exceeding the performance of the predicate devices and complying with relevant international standards for safety and performance (e.g., sterilization, risk management, performance standards for dental handpieces).
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
This information is not provided in the document. The document refers to "Performance testing ... in accordance with ISO 14457:2012 Dentistry – Handpieces and motors" and "Sterilization validation...". These are bench tests, and the sample size or specific data provenance (country, retrospective/prospective) are not detailed within this 510(k) summary. Given the nature of a 510(k) submission for a mechanical device, the data would typically be generated during product development and testing, likely by the manufacturer, Dentalez, Inc. (USA).
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
This is not applicable as this is a mechanical dental device and not an AI/ML diagnostic or prognostic device requiring expert ground truth for image or data interpretation. The "ground truth" for this device's performance is established through objective physical measurements according to specified ISO standards.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This is not applicable for the same reasons as point 3.
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
This is not applicable as this is a mechanical dental device and not an AI/ML device.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
This is not applicable as this is a mechanical dental device and not an AI/ML device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The "ground truth" for this device's performance is objective physical measurements (e.g., rotational speed, power, stall torque) and compliance with recognized consensus standards (e.g., ISO 14457:2012 for performance, ANSI/AAMI ST79:2010 for sterilization, ISO 14971:2012 for risk analysis).
8. The sample size for the training set
This is not applicable as this is a mechanical dental device and does not involve a "training set" in the context of AI/ML.
9. How the ground truth for the training set was established
This is not applicable as this is a mechanical dental device and does not involve a "training set."
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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features the department's name encircling a symbol. The symbol consists of three stylized human profiles facing right, with a stylized caduceus-like design wrapping around them. The text reads "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA".
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
May 4,2016
Dentalez, Inc. Mr. Dan Laskowitz Engineering/Quality Manager 1816 Colonial Village Lane Lancaster, Pennsylvania 17601
Re: K153411
Trade/Device Name: 430 Torque High-speed Handpiece Series Regulation Number: 21 CFR 872.4200 Regulation Name: Dental Handpiece and Accessories Regulatory Class: Class I Product Code: EFB Dated: March 7, 2016 Received: March 8, 2016
Dear Mr. Lashkowitz:
This letter corrects our substantially equivalent letter of April 8, 2016.
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 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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
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.
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
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Page 2
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 Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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 go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Image /page/1/Picture/8 description: The image shows a signature that reads "Susan Runno DDS, MA". The signature is written in a cursive style with thick, black ink. The letters are connected, and the overall appearance is that of a handwritten name and credentials.
Erin I. Keith, M.S. Director Division of Anesthesiology, General Hospital, Respiratory, 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) K153411
Device Name
430 Torque High Speed Handpiece Series - 430 SWL Torque High Speed Handpiece, 430 SW Torque High Speed Handpiece
Indications for Use (Describe)
The 430 Torque High-Speed Handpiece Series are used by trained dental professionals for a variety of procedures including but not limited to caries and amalgam removal, restorative work and crown preparation.
Type of Use (Select one or both, as applicable)
| Prescription Use (Part 21 CFR 801 Subpart D) |
|---|
| Over-The-Counter Use (21 CFR 801 Subpart C) |
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430 Torque High-Speed Handpiece Series
l. SUBMITTER
DentalEZ Inc., StarDental Division 1816 Colonial Village Lane Lancaster, PA 17601 Phone: (717) 291-1161 Fax: (717) 391-2757 Contact Person: Dan Laskowitz, Engineering/Quality Manager Kay Engle, Regulatory Affairs Supervisor/QA Date prepared: March 7, 2016
II. DEVICE
Name of Device: 430 Torque High Speed Handpiece Series comprised of: 430 SWL Torque High Speed Handpiece 430 SW Torque High Speed Handpiece Common or Usual Name: High Speed Handpiece Classification Name: Handpiece, Air-powered, Dental (21 C.F.R. § 872.4200) Regulatory Class: I Product Code: EFB
III. PREDICATE DEVICE:
Primary predicate: 430 SW Non-Fiber Optic Handpiece (K902402) Reference predicate: 430 Series High Speed Handpiece (K982593 and K960719)
IV. DEVICE DESCRIPTION:
The 430 Torque High-Speed Handpiece Series consists of a fiber optic high speed handpiece, marketed as a SWL and a non-fiber optic handpiece, marketed as a SW handpiece. Each is a pneumatically driven hand- held device that is capable of reaching rotational speeds of 350,000 to 450,000 rpms at a recommended air pressure of 38-43 PSI. The series delivers on average up to 20 watts of power providing .269 oz.-in. of stall torque.
The handpieces are constructed of stainless steel, including the internal air and water tubes which provide drive air to the turbine assembly and cooling water to the work site. The stainless steel and aluminum air driven turbine assembly provides spin to the bur, and incorporates lubefree ceramic bearings (K905155) and a push button autochuck. The rotor is larger than the rotor of the predicate, yielding a higher cutting torque.
The fiber optics in the SWL version of the handpiece are lead-free, multi-core glass rod that transmit light from the fiber optic swivel coupler to the oral cavity.
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The 430 Torque High-Speed handpiece Series can be assembled to quick disconnect couplers that are ISO Type 3 and ISO Type 2 connections, available as fiber optic or non-fiber optic versions, using a halogen bulb or LED technology. All couplers are autoclavable with the exception of the LED coupler that incorporates the electronics internally.
The following describes the improvements that have been made to the 430 Series High-Speed Handpiece and 430 SW Non-Fiber Optic Handpieces since the last 510(k) clearances, which have also been incorporated into the 430 Torque High-Speed Handpiece Series:
-
- The fiber-optics used in the SWL version of the handpieces changed from bundled fiber optics to twin-fused solid rod fiber optics.
-
- The finish of the outer housings on the handpieces has been modified to have a dull appearance (satin) through a process called bead blasting. This is an aesthetic change only and does not affect the performance of the handpiece. The finish of the outer housing on the handpieces continues to be available in the glossy finish as cleared on the predicate devices.
V. INDICATIONS FOR USE:
The 430 Torque High Speed Handpiece Series are used by trained dental professionals for a variety of procedures including but not limited to caries and amalgam removal, restorative work and crown preparations.
VI. COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE PREDICATE DEVICE:
The 430 Torque High-Speed Handpieces and the primary predicate device are both air-driven handpieces used to perform a variety of dental procedures. The proposed devices and the primary predicate device have the same technological characteristics:
- Single water spray without cooling air
- Push button autochuck turbine assembly
- Bur extraction force ●
- Use of the same materials ●
- No lubrication required ●
- Autoclavable
- Connect to coupler allow for ease of rotation on tubing ●
The following technological differences exist between the 430 Torque High-Speed Handpiece and the primary predicate:
- . Free run speed (handpiece speed in RPM with no load applied)
- Power .
- Stall torque ●
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The proposed 430 SWL Torque High-Speed Handpiece and the reference predicate device have the same technological similarities and differences as noted above for the primary predicate. In addition, the reference predicate incorporates fiber optics for illumination of the work area. The fiber optics used in the reference predicate device are incorporated in the proposed 430 SWL Torque High-Speed Handpiece.
The following table summarizes the comparison of the 430 Torque High-Speed Handpieces Series to the primary predicate device and reference predicate for indications for use and technological characteristics.
| Indications for use and technological characteristics. | |||
|---|---|---|---|
| Device | Submission deviceK153411 430 Torque HighSpeed Handpiece Series | Primary predicateK902402 SW Non-FiberOptic Handpiece | Reference predicatesK982593 and K960719 430Series High SpeedHandpiece |
| Indications forUse | The 430 Torque High SpeedHandpiece Series are usedby trained dentalprofessionals for a varietyof procedures including butnot limited to caries andamalgam removal,restorative work andcrown preparations. | High-speed dentalhandpieces used by traineddental professionals fordrilling in the oral cavity forprocedures including butnot limited to cariesremoval, restorative workand crown preparations. | High-speed dentalhandpieces used intraorallyby trained dentalprofessionals for drillingand preparation of dentalcaries for restoration suchas fillings. |
| Materialcomposition | Stainless steel, aluminum;optional bead blastedouter surface | Stainless steel, aluminum | Stainless steel, aluminum |
| Components | High speed pneumaticdriven handpiece withoption of twin fused solidrod fiber optic withceramic lube free bearings | High speed pneumaticdriven handpiece withceramic bearings | High speed pneumaticdriven handpiece withceramic bearings withoption of bundled fiberoptics; autochuck and lubefree bearings |
| Biocompatibility | Identical materialcomposition andmanufacturing process tothe predicates | The design incorporateseither 400 series stainlesssteel or 300 series stainlesssteel for deviceconstruction. Thesematerials are known fortheir corrosion resistanceand are biocompatible withtissue encountered duringuse. | The design incorporateseither 400 series stainlesssteel or 300 series stainlesssteel for deviceconstruction. Thesematerials are known fortheir corrosion resistanceand are biocompatible withtissue encountered duringuse. These materials areidentical to the predicate430 series high speed |
| handpiece currentlymanufactured by StarDental. | |||
| Sterilization | Sterilization validation inaccordance withANSI/AAMI ST79:2010 &A4:2013, AAMI/ANSI/ISO14937:2009 andANSI/AAMI ST81:2004(R2010) | Sterilization validationreport references AAMI TIRNo. 12-1994 | Sterilization validationcarried out in accordancewith the FDA June 1996guidance document todental handpiecemanufacturers. |
| Performance | Capable of reachingrotational speeds of350,000 to 450,000 rpmsat a recommended airpressure of 38-43 PSI;delivers on average up to20 watts of powerproviding .269 oz.-in. ofstall torque.Performance testing incompliance with ISO14457:2012 Dentistry -Handpieces and motors | Capable of reachingrotational speeds of430,000 rpms at arecommended air pressureof 30 PSI; delivers onaverage 14 watts of powerproviding .181 oz.-in. ofstall torque.Performance testing incompliance with ISO 7785-1 Dental Handpieces – Part1: High-speed air turbinehandpieces | Capable of reachingrotational speeds of430,000 rpms at arecommended air pressureof 34 PSI; delivers onaverage 14 watts of powerproviding .181 oz.-in. ofstall torque.Performance testing incompliance with ISO 7785-1 Dental Handpieces – Part1: High-speed air turbinehandpieces |
| Risk analysis | ISO14971:2012 Medicaldevices - Application ofrisk management tomedical devices | Risk analysis at time ofsubmission unknown.Current risk analysis perISO14971:2012 –Application of riskmanagement to medicaldevices. | Risk analysis at time ofsubmission unknown.Current risk analysis perISO14971:2012 –Application of riskmanagement to medicaldevices. |
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VII. PERFORMANCE DATA
Performance testing was completed in accordance with ISO 14457:2012 Dentistry – Handpieces and motors.
Sterilization validation for the sterilization of the handpieces was performed in accordance to ANSI/AAMI ST79:2010 & A4:2013, AAMI/ANSI/ISO 14937:2009 and ANSI/AAMI ST81:2004 (R2010).
A risk analysis for the 430 Torque High-Speed Handpiece Series was developed using ISO14971:2012.
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VIII. CONCLUSION
Based upon the comparison of technological characteristics, demonstrated through bench testing and intended use, the 430 Torque High-Speed Handpiece Series is substantially equivalent to the predicate devices.
§ 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.