(90 days)
The #8C Renegade Dental Handpiece is intended for use in general dentistry by licensed professionals for removing carious material, reducing hard tooth surfaces, cavity preparations, restorations, restorations and polishing teeth.
The #8C Renegade is a high speed air turbine handpiece with a push-button autochuck. The handpiece is powered by compressed air (26-35 psi) which activates an air turbine causing rotation of the chuck holding a burr (not supplied with the handpiece) at 380,000-530,000 rpm. The handpiece handle and head are constructed of chrome plated brass. The handpiece features a four (4) hole connector for air and water input and return. The head and burr are cooled by a water/air mist. The handpiece is supplied non-sterile and must be cleaned, lubricated and sterilized prior to each patient use.
Here's a breakdown of the acceptance criteria and the study information for the #8C Renegade Dental Handpiece based on the provided document:
This document is a 510(k) premarket notification for a dental handpiece, arguing for "substantial equivalence" to a predicate device rather than introducing a novel AI device. Therefore, the questions related to AI performance, ground truth, and human reader improvement are not directly applicable in this context. The focus is on demonstrating that the new device is as safe and effective as a legally marketed predicate device through non-clinical testing.
1. Table of Acceptance Criteria and the Reported Device Performance
The acceptance criteria are implicitly derived from the characteristics and performance of the predicate device, as the goal is to demonstrate "substantial equivalence." The reported device performance is compared to the predicate device's characteristics.
Implicit Acceptance Criteria & Reported Device Performance
| Characteristic/Criterion | Predicate Device (Thunder Tiger Dental Air-Powered Handpiece) | Proposed Device (#8C Renegade Dental Handpiece) | Acceptance Status (Implicit) |
|---|---|---|---|
| Indications for Use | Removing carious material, reducing hard tooth structure, cavity preparation, finishing tooth preparations, restorations, and polishing teeth. | Removing carious material, reducing hard tooth surfaces, cavity preparation, finishing tooth preparations, restorations, and polishing teeth. | Met: Identical intended uses. |
| Device Design: Operational Mode | 4-holes | 4-holes | Met: Matches predicate. |
| Device Design: Fiber Optics | No | No | Met: Matches predicate. |
| Device Design: Dimensions | Head: Φ12mm X 12mm to Φ12mm X 12.4mmLength: not provided | Head: Φ12.5mm X 13.3mmLength: 123.1mm | Met: Slight differences in head dimensions, but considered minor and do not raise new safety/effectiveness issues (as per conclusion). |
| Device Design: Type of chuck | Push-button autochuck | Push-button autochuck | Met: Identical. |
| Device Design: Type of connector | ISO-B, Midwest coupler | ISO-B, Midwest coupler | Met: Identical. |
| Device Design: Materials | Surface: Chrome plated | Waterline: 440C stainless steelSurface: chrome plated brass | Met: Similar, and biocompatibility testing noted. |
| Specifications: Burr Extraction Force | 35 N | 26 N | Met: Within acceptable range for function, difference considered minor. |
| Specifications: Burr Size | 1.59-1.60 diameter, 19-25mm and 16-21mm length | 1.6 diameter, 19mm length | Met: Compatible with common burr sizes. |
| Specifications: Water flow rate | >50mL/min | 120mL/min | Met: Exceeds predicate's minimum. |
| Specifications: Air pressure | 1.0-3.0bar | 2.0bar | Met: Within predicate's operational range. |
| Specifications: Speed (rpm) | ≥ 300,000 | 380,000-530,000 | Met: Exceeds predicate's minimum. |
| Specifications: Lubricant | Lubricant is required | Lubricant is required | Met: Identical. |
| Sterility | Provided non-sterile, must be sterilized prior to each patient use | Provided non-sterile, must be cleaned and sterilized prior to each patient use | Met: Both require sterilization before use. Differences are minor (proposed device adds "cleaned"). |
| Biocompatibility | (Implicitly safe and effective) | Finished, sterilized device meets ISO 10993-1 biocompatibility requirements. | Met: Demonstrated compliance with recognized standard. |
Summary of Acceptance: The device is accepted as "substantially equivalent" because its characteristics, indications for use, and performance, as demonstrated through bench testing, are comparable to or exceed the predicate device, and any differences do not raise new safety or effectiveness issues.
2. Sample size used for the test set and the data provenance
- Sample Size: Not explicitly stated. The document refers to "Bench testing," which typically involves testing a limited number of manufactured units to verify specifications and performance. Details like the exact number of handpieces tested for each parameter (e.g., burr extraction force, water flow rate, speed) are not provided in this summary.
- Data Provenance: The testing was "Bench testing" performed by the manufacturer (Handpiece Club, LLC) to support their 510(k) submission. There is no information regarding the country of origin of the data beyond it being generated for this regulatory submission. It is by nature "prospective" in the sense that the testing was conducted on manufactured samples of the new device for the purpose of this submission.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- This question is not applicable to this submission. The "ground truth" here is establishing that the device's technical specifications and performance are comparable to the previously cleared predicate device. This is determined through engineering/bench testing against predefined technical standards and comparison, not through expert clinical interpretation of results. No information about experts for establishing ground truth is provided or relevant here.
4. Adjudication method for the test set
- This question is not applicable to this submission. Adjudication methods like 2+1 or 3+1 are typically used for clinical studies involving human interpretation or agreement on a diagnosis or outcome. Since this is a bench testing summary for a dental handpiece, such adjudication is not performed. The data is objective measurement and comparison.
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
- No, an MRMC comparative effectiveness study was not done. This is a 510(k) submission for a conventional medical device (dental handpiece), not an AI-powered diagnostic or assistive tool. Clinical testing was explicitly not conducted, as stated in Section 8: "No clinical testing was conducted to support this submission." Therefore, questions about human readers, AI assistance, and effect size are not applicable.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- No, a standalone (algorithm only) performance study was not done. This device is a mechanical dental handpiece, not an algorithm or AI system. This question is not applicable.
7. The type of ground truth used
- The "ground truth" in this context is the technical specifications and performance characteristics of the predicate device (Thunder Tiger Dental Air-Powered Handpiece) and relevant industry standards (e.g., ISO 10993-1 for biocompatibility). The new device's performance is measured and compared against these established benchmarks to demonstrate substantial equivalence. It does not involve expert consensus, pathology, or outcomes data in the way an AI diagnostic tool would.
8. The sample size for the training set
- Not applicable. This device is not an AI/machine learning model, so there is no "training set."
9. How the ground truth for the training set was established
- Not applicable. As there is no training set, there is no ground truth for a training set to be established.
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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
October 28, 2014
Handpiece Club, Limited Liability Company C/O Dr. Tina Wu Regulatory Project Manager Aptiv Solutions 62 Forest Street, Suite 300 Marlborough, MA 01752
Re: K142063
Trade/Device Name: #8c Renegade Dental Handpiece Regulation Number: 21 CFR 872.4200 Regulation Name: Dental Handpiece and Accessories Regulatory Class: I Product Code: EFB Dated: July 29, 2014 Received: July 30, 2014
Dear Dr. Wu:
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. 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.
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Page 2 - Dr. Wu
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 Division of Small Manufacturers, International and Consumer Assistance at its tollfree number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/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 Small Manufacturers, International and Consumer Assistance 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,
Susan Runno DDS, MA
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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K142063
4. INDICATIONS FOR USE
| DEPARTMENT OF HEALTH AND HUMAN SERVICES | Form Approved: OMB No. 0910-0120 | |
|---|---|---|
| Food and Drug AdministrationIndications for Use | Expiration Date: January 31, 2017 | |
| See PRA Statement below. | ||
| 510(k) Number (if known)K142063 | ||
| Device Name#8C Renegade Dental Handpiece | ||
| Indications for Use (Describe)The #8C Renegade Dental Handpiece is intended for use in general dentistry by licensed professionals for removingcarious material, reducing hard tooth surfaces, cavity preparations, restorations, restorations and polishingteeth. | ||
| Type of Use (Select one or both, as applicable)2 Prescription Use (Part 21 CFR 801 Subpart D) | Over-The-Counter Use (21 CFR 801 Subpart C) | |
| PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED. | ||
| FOR FDA USE ONLY | ||
| Concurrence of Center for Devices and Radiological Health (CDRH) (Signature) | ||
| This section applies only to requirements of the Paperwork Reduction Act of 1995. | ||
| DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW. | ||
| The burden time for this collection of information is estimated to average 79 hours per response, including thetime to review instructions, search existing data sources, gather and maintain the data needed and completeand review the collection of information. Send comments regarding this burden estimate or any other aspectof this information collection, including suggestions for reducing this burden, to: | ||
| Department of Health and Human ServicesFood and Drug AdministrationOffice of Chief Information OfficerPaperwork Reduction Act (PRA) StaffPRAStaff(@fda.hhs.gov | ||
| information unless it displays a currently valid OMB number." | "An agency may not conduct or sponsor, and a person is not required to respond to, a collection of |
FORM FDA 3881 (1/14)
Page 1 of 1
EF PSC Publishing Services (301) 443-6748
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510(k) Summary for the Handpiece Club, LLC #8C Renegade Dental Handpiece
(per 21CFR 807.92 and http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/default.htm)
1. SUBMITTER/510(K) HOLDER
Handpiece Club, LLC 6960 Westcliff Drive Las Vegas, NV 89145
| Contact Person: | Chen-Yu Chen, CEO |
|---|---|
| Telephone: | 702-541-9874 |
Date Prepared: July 29, 2013
2. DEVICE NAME
| Proprietary Name: | #8C Renegade Dental Handpiece |
|---|---|
| Common/Usual Name: | Handpiece, dental, high speed, air turbine |
| Classification Name: | 21 CFR 872.4200 Dental handpieces and accessories |
| Class: | I |
| Classification Panel: | Dental |
| Product Code: | EFB |
3. PREDICATE DEVICES
- · Thunder Tiger Dental Air-Powered Handpiece (K052822)
4. DEVICE DESCRIPTION
The #8C Renegade is a high speed air turbine handpiece with a push-button autochuck. The handpiece is powered by compressed air (26-35 psi) which activates an air turbine causing rotation of the chuck holding a burr (not supplied with the handpiece) at 380,000-530,000 rpm. The handpiece handle and head are constructed of chrome plated brass. The handpiece features a four (4) hole connector for air and water input and return. The head and burr are cooled by a water/air mist.
The handpiece is supplied non-sterile and must be cleaned, lubricated and sterilized prior to each patient use.
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5. INDICATION FOR USE/INTENDED USE
The #8C Renegade Dental Handpiece is intended for use in general dentistry by licensed professionals for removing carious material, reducing hard tooth surfaces, cavity preparation, finishing tooth preparations, restorations and polishing teeth.
6. SUMMARY OF TECHNOLOGICAL CHARACTERISTICS COMPARED TO THE PREDICATE DEVICE
The #8C Renegade Dental Handpiece is substantially equivalent to the Thunder Tiger Dental Air-Powered Handpiece (K052822) in terms of the indications for use, design (e.g., dimensions, type of chuck, type of connector), principles of operation, and technological characteristics. Both the proposed and predicate device are provided nonsterile and can be reused. The product must be cleaned and sterilized prior to each patient use.
7. SUMMARY OF NON-CLINICAL PERFORMANCE TESTING AS BASIS FOR SUBSTANTIAL EQUIVALENCE
Bench testing demonstrates that the #8C Renegade Dental Handpiece is substantially equivalent to the predicate device and is as safe and effective as the predicate device for the intended use described above. Additionally, the finished, sterilized device meets ISO 10993-1 biocompatibility requirements.
8. SUMMARY OF CLINICAL TESTING AS BASIS FOR SUBSTANTIAL EQUIVALENCE
No clinical testing was conducted to support this submission.
9. CONCLUSIONS DRAWN FROM NON-CLINICAL AND CLINICAL TESTS
Based on the descriptive information and performance testing, Handpiece Club, LLC has determined that the proposed #8C Renegade Dental handpiece is substantially equivalent to the predicate the Thunder Tiger Dental Air-Powered Handpiece (K052822) based on the similarities in intended use operational characteristic and functional characteristics. Differences between the two devices are minor and do not raise new safety or effectiveness issues. A side-by-side comparison of the predicate device and the proposed device is provided in the table at the end of this section.
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| Device Name | #8C Renegade Dental Handpiece(Handpiece Club, LLC) | Dental Air Powered Handpiece(Thunder Tiger Corp.) |
|---|---|---|
| Regulatory Status | Proposed device | K052822 |
| Indications for Use | The #8C Renegade Dental Handpiece isintended for use in general dentistry bylicensed professionals for removingcarious material, reducing hard toothsurfaces, cavity preparation, finishingtooth preparations, restorations andpolishing teeth. | Thunder Tiger Dental Air-PoweredHandpiece, models Tiger 100, Tiger 101,Tiger 200, Tiger 201, Tiger 202 areintended for removing carious material,reducing hard tooth structure, cavitypreparation, finishing tooth preparationsand restorations and polishing teeth. |
| Device Design | ||
| Operational Mode | 4-holes | 4-holes (feature on models #101-T4/M4and #101-3T4/3M4) |
| Fiber Optics | No | No |
| Dimensions | Head: Φ12.5mm X 13.3mmLength: 123.1mm | Head: Φ12mm X 12mm to Φ 12mm X12.4mmLength: not provided by the manufacturer |
| Type of chuck | Push-button autochuck | Push-button autochuck |
| Type of connector | ISO-B, Midwest coupler | ISO-B, Midwest coupler |
| Materials | Waterline: 440C stainless steelSurface: chrome plated brass | Surface: Chrome plated |
| Specifications | ||
| Burr Extraction Force | 26 N | 35 N |
| Burr Size | 1.6 diameter19mm length | 1.59-1.60 diameter19-25mm and 16-21mm length |
| Water flow rate | 120mL/min | >50mL/min |
| Air pressure | 2.0bar | 1.0-3.0bar |
| Speed (rpm) | 380,000-530,000 | ≥ 300,000 |
| Lubricant | Lubricant is required | Lubricant is required |
| Sterility | Provided non-sterile, must be cleanedand sterilized prior to each patient use | Provided non-sterile, must be sterilizedprior to each patient use |
Table 5-1. Side-by-Side Comparison of the #8C Renegade Dental Handpiece with Predicate Device
§ 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.