The ProDrive Replacement Turbine is a high-speed air-powered turbine designed to be installed in existing, legally marketed dental handpieces. The ProDrive Replacement Turbine is appropriate for use with ProDrive carbide and diamond cutting instruments. A push-button spindle mechanism is used to grip the shanks of the cutting instruments. The unique geometry of the bur shank and turbine spindle securely locks the bur in the turbine eliminating the slipping that can occur over time with traditional burs and turbines. In addition to improved performance and durability, the secure locking mechanism enhances the safety of the ProDrive Replacement Turbine by reducing the risk of accidental disengagement of burs from the handpiece during operation. When fully seated, the length that the ProDrive bur extends from the handpiece is the same as that of the standard bur/turbine assembly. In addition, the ProDrive system incorporates the ability to index the bur to a second, extended, position effectively improving on the visibility angle and the utility of the handpiece without adversely affecting its performance. Because of the unique geometry of the ProDrive Replacement Turbine it is appropriate for use only in combination with ProDrive carbide and diamond cutting instruments. Standard round-shank burs will not fit into the ProDrive chuck, preventing their unintended use. ProDrive burs, however, will fit in traditional friction-grip chucks and will meet appropriate performance requirements when used in this way. With the exception of the unique drive-lock spindle, the ProDrive Replacement Turbine consists of commercially available replacement parts currently used to refurbish dental handpieces in the United States. The spindle is composed entirely of stainless steel. The predicate device spindle is also manufactured from stainless steel. Therefore, the products are considered to be identical in materials used in their manufacture. ProDrive burs are composed of tungsten vanadium stainless steel, coated with carbide or diamond cutting surfaces. The ProDrive burs are machined for ProDrive Systems Inc. by the bur manufacturer to the unique shank geometry required by the ProDrive drive-lock mechanism. In all other respects the burs are identical to commercially available burs currently distributed in the United States. The use of stainless steel in the manufacture of ProDrive spindles and burs ensures biocompatibility and resistance to corrosion.

AI/ML Overview

This document describes the ProDrive Replacement Turbine, a dental device, and its conformity to established standards.

Here's an analysis of the provided text in relation to your request about acceptance criteria and a study:

1. Table of Acceptance Criteria and Reported Device Performance

The document explicitly states that the ProDrive Replacement Turbine "meets or exceeds all of the applicable performances standards outlined in ISO 7785-1:1997(E)." It then lists specific characteristics that this standard addresses.

Acceptance Criteria (from ISO 7785-1:1997(E))	Reported Device Performance
Extraction force	Meets or exceeds standard
Resistance to corrosion	Meets or exceeds standard
Torque	Meets or exceeds standard
Noise level	Meets or exceeds standard
Eccentricity	Meets or exceeds standard
Speed	Meets or exceeds standard
Air pressure	Meets or exceeds standard
Sterility validation	Meets or exceeds standard
Stall torque	Meets or exceeds standard
Reprocessing	Meets or exceeds standard

Furthermore, the document states: "Extensive testing indicates that after 250 sterilization cycles the ProDrive Replacement Turbine continues to meet all performance requirements."

2. Sample Size Used for the Test Set and Data Provenance

The document does not explicitly state the numerical sample size used for the performance testing. It simply refers to "Extensive testing." The data provenance (country of origin, retrospective/prospective) is also not detailed.

3. Number of Experts Used to Establish Ground Truth and Qualifications

The document does not mention the use of experts to establish a "ground truth" in the way it's typically understood for AI/diagnostic studies. The testing appears to be based on adherence to a recognized international standard (ISO 7785-1:1997(E)) and device-specific performance evaluations. Therefore, no information on the number or qualifications of experts is provided.

4. Adjudication Method

Since the testing is against a standard and doesn't involve subjective interpretation by multiple experts establishing a "ground truth" from complex data (like medical images), an explicit adjudication method (e.g., 2+1, 3+1) is not applicable or mentioned.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No. This document does not describe an MRMC comparative effectiveness study involving human readers or AI assistance. The study focuses on the device's technical performance against a standard and in comparison to a predicate device, not on diagnostic accuracy improvements with AI.

6. Standalone (Algorithm Only) Performance Study

No. The ProDrive Replacement Turbine is a mechanical dental handpiece component, not an algorithm or AI system. Therefore, a standalone algorithm-only performance study is not applicable.

7. Type of Ground Truth Used

The "ground truth" in this context is defined by the performance requirements outlined in ISO 7785-1:1997(E) and the comparative performance against a legally marketed predicate device. This is a standards-based and objective measurement-based "ground truth," rather than expert consensus, pathology, or outcomes data.

8. Sample Size for the Training Set

The concept of a "training set" is not applicable here as this is a physical medical device, not a machine learning algorithm.

9. How the Ground Truth for the Training Set Was Established

Not applicable, as there is no training set mentioned or implied for an AI/ML algorithm.

Summary

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Image /page/0/Picture/0 description: The image shows the logo for "PRODRIVE SYSTEMS". The logo is in black and white, with the word "PRODRIVE" in large, bold letters. Below the word "PRODRIVE" is the word "SYSTEMS" in smaller letters. The letter "O" in "PRODRIVE" is replaced with a circle.

K06 2219

510(k) SUMMARY

ProDrive Replacement Turbine ProDrive Systems Inc.

AUG - 4 2006

Owned by:

ProDrive Systems Inc. 812 Commerce Drive Ogdensburg, NY 13669 USA

Contact Person:

Clive Hooton, Vice President Quality ProDrive Systems Inc. 812 Commerce Drive Ogdensburg, NY 13669 USA

Date of Summary:

June 28, 2006

Device Name:

ProDrive Replacement Turbine Proprietary Name: Common Name: turbine assembly for dental handpiece Classification Name: Handpiece, Air-powered, Dental Product Code: EFB ("Dental handpiece and accessories", 21CFR 872.4200)

Predicate Device:

Proprietary Name: 430 Series High Speed handpeice 510(k) Number: K960719 Product Code: EFA*

Note that this handpiece is incorrectly identified in the CDRH database as EFA (handpiece, belt and/or gear driven, dental). It is, in fact, an air-powered handpiece (EFB), as is the device presented in this submission.

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Image /page/1/Picture/0 description: The image shows the logo for "PRODRIVE SYSTEMS". The word "PRODRIVE" is in large, bold, sans-serif font, with a circle in place of the letter "O". Below "PRODRIVE" is the word "SYSTEMS" in a smaller, sans-serif font.

Description of Device:

The ProDrive Replacement Turbine is a high-speed air-powered turbine designed to be installed in existing, legally marketed dental handpieces.

The ProDrive Replacement Turbine is appropriate for use with ProDrive carbide and diamond cutting instruments. A push-button spindle mechanism is used to grip the shanks of the cutting instruments. The unique geometry of the bur shank and turbine spindle securely locks the bur in the turbine eliminating the slipping that can occur over time with traditional burs and turbines. In addition to improved performance and durability, the secure locking mechanism enhances the safety of the ProDrive Replacement Turbine by reducing the risk of accidental disengagement of burs from the handpiece during operation.

When fully seated, the length that the ProDrive bur extends from the handpiece is the same as that of the standard bur/turbine assembly. In addition, the ProDrive system incorporates the ability to index the bur to a second, extended, position effectively improving on the visibility angle and the utility of the handpiece without adversely affecting its performance.

Because of the unique geometry of the ProDrive Replacement Turbine it is appropriate for use only in combination with ProDrive carbide and diamond cutting instruments. Standard round-shank burs will not fit into the ProDrive chuck, preventing their unintended use. ProDrive burs, however, will fit in traditional friction-grip chucks and will meet appropriate performance requirements when used in this way.

With the exception of the unique drive-lock spindle, the ProDrive Replacement Turbine consists of commercially available replacement parts currently used to refurbish dental handpieces in the United States. The spindle is composed entirely of stainless steel. The predicate device spindle is also manufactured from stainless steel. Therefore, the products are considered to be identical in materials used in their manufacture.

ProDrive burs are composed of tungsten vanadium stainless steel, coated with carbide or diamond cutting surfaces. The ProDrive burs are machined for ProDrive Systems Inc. by the bur manufacturer to the unique shank geometry required by the ProDrive drive-lock mechanism. In all other respects the burs are identical to commercially available burs currently distributed in the

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Image /page/2/Picture/0 description: The image shows the logo for "PRODRIVE SYSTEMS". The word "PRODRIVE" is written in all capital letters, with a circle in place of the letter "O". The word "SYSTEMS" is written in smaller capital letters below the word "PRODRIVE".

United States. The use of stainless steel in the manufacture of ProDrive spindles and burs ensures biocompatibility and resistance to corrosion.

The ProDrive Replacement Turbine meets or exceeds all of the applicable performances standards outlined in ISO 7785-1:1997(E). Extensive testing indicates that after 250 sterilization cycles the ProDrive Replacement Turbine continues to meet all performance requirements.

Intended Use of Device:

The ProDrive Replacement Turbine is intended for use by authorized persons in the practice of dentistry. The intended use of the ProDrive Replacement Turbine is identical to that of the Predicate Device.

Comparison of Technological Characteristics to Predicate Device:

The following table compares the features of the ProDrive Replacement Turbine to the Predicate Device:

TECHNOLOGICAL CHARACTERISTIC	COMPARISON TO PREDICATE
Intended use	Identical
Indications for use	Identical
Target population	Identical
Anatomical sites	Identical
Where used	Identical
Energy used and/or delivered	Similar
Human factors	Similar
Design	Similar
Performance	Similar
Standards met	Similar
Materials	Identical
Biocompatibility	Identical
Compatibility with environment and other devices	Similar
Sterility	Similar
Electrical safety	Identical
Mechanical safety	Similar
Chemical Safety	Identical
Thermal safety	Similar
Radiation safety	Identical

Table 1: Substantial Equivalence Table

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Image /page/3/Picture/0 description: The image shows the logo for "PRODRIVE SYSTEMS". The word "PRODRIVE" is in large, bold, sans-serif font, with a circle replacing the letter "O". Below "PRODRIVE" is the word "SYSTEMS" in a smaller, lighter font.

Conclusions Drawn from Technical Comparison:

The ProDrive Replacement Turbine is essentially the same as the predicate device in terms of its intended use, operating principles and materials.

The ProDrive Replacement Turbine combined with ProDrive burs conform to the ISO 7785-1:1997(E) standard and the FDA Guidance Document on Dental Handpieces, which include testing and performance limits on the following characteristics:

●

Extraction force .
. Resistance to corrosion
Torque .

♥

Noise level .
Eccentricity Speed
Air pressure Sterility validation .
Stall torque
Reprocessing .

The performance testing of the ProDrive Replacement Turbine indicates that it functions as well as or better than the predicate device in all aspects examined. Therefore, we conclude that the ProDrive Replacement Turbine is both safe and effective for its intended use.

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Image /page/4/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized eagle with three lines forming its body and wings. The words "DEPARTMENT OF HEALTH AND HUMAN SERVICES . USA" are arranged in a circular pattern around the eagle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

ProDrive Systems, Incorporated C/O Mr. Mark Job Responsible Third Party Official Regulatory Technology Services, LLC 1394 25th Street, NW Buffalo, Minnesota 55313

AUG - 4 2006

Re: K062219

Trade/Device Name: ProDrive Systems Replacement Turbine Regulation Number: 21 CFR 872.4200 Regulation Name: Dental Handpiece and Accessories Regulatory Class: I Product Code: EFB Dated: July 31, 2006 Received: August 2, 2006

Dear Mr. Job:

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 Amendie comments, 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 approvisions 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 If your device is classes to such additional controls. Existing major regulations affecting (1 wr 1), it a 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. Job

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) 276-0115. 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours.

Swer Quare

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

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Indications for Use

510(k) Number (if known): Not yet assigned

The ProDrive Replacement Turbine Device Name:

To be used intraorally by trained dental professionals for Indications For Use: drilling and preparation of dental cavities for restoration, such as fillings.

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)

Super Quary

on Sign-Cif) ്ന of Anesthesiology, General Hospital, Jon Control, Dental Devices

. (1) Number:

Page 1 of ____________________________________________________________________________________________________________________________________________________________________

Regulation Number and Section

§ 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.