The HHC-replacement turbine is used in the Midwest Tradition High Speed Dental Handpiece, which is intended for removing carious material, cavity preparations, finishing tooth preparations, reducing hard tooth structures, restorations and polishing teeth.

Device Description

The HHC-Push button air turbine is a complete air turbine which will be offered as replacement turbine for Midwest Tradition original turbine.

High pressured air directly impacts the blade pockets of the impeller through an air intake tube located inside the handpiece body, which causes the air turbine to rotate at a high speed. The dental cutting bur connects to the turbine's shank (spindle), which rotates at the same speed as the impeller. Cooling water flows through an inlet water tube at high pressure and blows out at an angle near the dental cutting bur to reduce temperature at cutting area.

AI/ML Overview

Acceptance Criteria and Device Performance Study for HHC-Push Button Replacement Turbine

This document outlines the acceptance criteria and the study that demonstrates the HHC-Push button replacement turbine’s performance, based on the provided 510(k) summary (K100389).

1. Acceptance Criteria and Reported Device Performance

The acceptance criteria for the HHC-Push button replacement turbine are established through direct comparison to a predicate device, the NSK- Replacement Turbine for Midwest Tradition Handpiece Products of NSK NAKANISHI INC. (K971774). The study aimed to demonstrate substantial equivalence by meeting or exceeding the predicate's performance specifications.

Characteristic / Acceptance Criteria	Subject Device: HHC-Midwest Tradition Replacement Turbine Performance	Predicate: NSK-Midwest Tradition Replacement Turbine Performance
Operation Mode:
Intake air pressure	35 psi - speed 420,000 rpm. Min.	35 psi - speed 420,000 rpm Min.
Chuck:
Outside diameter	0.125"	0.125"
Chuck length	0.425"	0.435"
Actuator height	0.034"	0.038"
Bur extraction force	5 lbs Min. push and pull forces/ 100 inspection using ONMI gauge/ per specification indicated on drawing	5 lbs Min. push and pull forces- tested on predicate device
Air pressure	35 psi. recommended	35 psi.
Water pressure	2 bar	2 bar
Speed Rpm	420,000 rpm. Min.	420,000 rpm. Min.
Conformance standard for shanks	Meet I.S.O standard Shank diameter from 0.0625" to 0.0630"	Meet I.S.O standard shank

Summary of Device Performance: "The HHC-Push button air turbine performance tests were carried out to evaluate it against the predicate device. In all instances the HHC-Push button air turbine functioned as intended, results observed were as expected, and was determined to have comparable performance and safety as compared to the predicate."

2. Sample Size and Data Provenance

Sample Size for Test Set: The document states that "100 inspection using ONMI gauge" was performed for bur extraction force, implying a sample size of 100 units for this specific test. For other parameters, specific sample sizes are not explicitly mentioned, but the comparison implies testing was conducted on a sufficient number of units to establish equivalence.
Data Provenance: The study was conducted by Handpiece Headquarters as part of their 510(k) submission. The data is retrospective, generated specifically for showing substantial equivalence to a legally marketed device. The country of origin of the data is not explicitly stated, but it can be inferred to be the United States, given the FDA submission.

3. Number of Experts and Qualifications for Ground Truth

Experts: Not applicable. This study does not involve human expert interpretation of data to establish ground truth. It is a performance study comparing engineering specifications and functional output.

4. Adjudication Method for the Test Set

Adjudication Method: Not applicable. This study does not involve human adjudication. The performance metrics are objective and measurable engineering parameters.

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

MRMC Study: No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not performed. This type of study is typically used for diagnostic devices involving human interpretation of medical images or data. The HHC-Push button replacement turbine is a dental handpiece component, and its effectiveness is determined by its mechanical and operational performance, not by diagnostic accuracy or human interpretation.

6. Standalone (Algorithm Only) Performance Study

Standalone Performance Study: Not applicable. This device is a mechanical component, not an algorithm. Its performance is inherent to its design and manufacturing, evaluated through direct physical and functional testing.

7. Type of Ground Truth Used

Type of Ground Truth: The ground truth for this study is based on engineering specifications and established performance standards for dental handpiece turbines, as exemplified by the predicate device. The performance of the subject device was compared directly to these objective, measurable parameters.

8. Sample Size for the Training Set

Sample Size for Training Set: Not applicable. This device is not an AI/ML algorithm that requires a training set.

9. How Ground Truth for the Training Set was Established

Ground Truth for Training Set: Not applicable, as there is no training set for this device.

Summary

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K100389

Handpiece
Headquarters

AUG 2 2010

A HENRY SCHEIN® COMPANY

510(K) SUMMARY:

HHC- push button replacement turbine for Midwest Tradition.

210K

a- Submitted by:

HANDPIECE HEADQUARTERS 620 S. Placentia Ave. Placentia, CA 92870 Tel. 714-579-0175 Fax. 714-579-0186

b- Contact person: ·

Tina Steffanie-Oak Tel. 717-335-7230, ext. 4150 Fax. 717-335-7240 tina.steffanie-oak@henryschein.com Email:

c- Date summary prepared:

Revised 06-10-10

d- Device Name:

HHC- push button replacement turbine for Midwest Tradition Trade or Proprietary Name:

Common Name: Classification Name: Air-Power Dental Handpiece Dental Handpiece and accessories (21CFR 872.4200) Class: I

Product Code:

EFB "Handpiece, Air-powered, Dental"

e- Substantial Equivalency is claimed against the following device:

NSK- Replacement Turbine for Midwest Tradition Handpiece Products of NSK NAKANISHI INC. (K971774)

f- Description of the device:

The HHC-Push button air turbine is a complete air turbine which will be offered as replacement turbine for Midwest Tradition original turbine.

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which rotates at the same speed as the impeller. Cooling water flows through an inlet water tube at high pressure and blows out at an angle near the dental cutting bur to reduce temperature at cutting area.

g- Statement of Intended Use:

This HHC-Push button air turbine is intended to use with Midwest Tradition Handpiece in replacement of Midwest Tradition's original turbine.

The Midwest Tradition Handpiece with the replacement turbine is used by authorized persons in the practice of dentistry.

The replacement turbine is used in the Midwest Tradition High Speed Dental Handpiece, which is intended for removing carious material, cavity preparations, finishing tooth preparations, reducing hard tooth structures, restorations and polishing teeth.

h- Safety and effectiveness of the device:

The HHC-Push button air turbine is as safe and effective as the predicate device as cited above.

1 - Device and Predicate Comparison Table:

Descriptive Information	Subject Device: HHC-MidwestTradition Replacement Turbine	Predicate: NSK-Midwest TraditionReplacement Turbine
Indication of use	This HHC-Push button air turbine isintended to use in Midwest TraditionHandpiece in replacement of MidwestTradition's original turbine.The Dental Handpiece with thereplacement turbine is used byauthorized persons in the practice ofdentistry.This replacement turbine used inMidwest Tradition Handpiece isintended for removing carious material,cavity preparations, finishing toothpreparations, reducing hard toothstructures, restorations and polishingteeth:	The devices claimed herein are the air turbinesonly, not the handpiece itself.The devices are intended for use in theMidwest's Quiet-air or Tradition handpieces, inplace of Midwest's original turbines.The device, therefore, is, with Midwesthandpiece, intended for use in general dentalapplications, such as cutting a tooth for crownpreparation, cavity preparation, finishing thecrown, inlay or the filling, etc.
Device Design:
Operation mode	Intake air pressure 35 psi- speed420,000 rpm. Min.	Intake air pressure 35 psi- speed 420,000 rpmMin.
Air/water ports	N/A	N/A
Fiber Optics	N/A	N/A
Type of chuck	Push button chuck (auto chuck)	Push button chuck(auto chuck)

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Coupling dimensions	n/a	n/a
Accessories	n/a	n/a
Composition of material
Spindle	440C stainless steel (see more details in attachment 4 material table)	Stainless steel
Impeller	Aluminum (see more details in attachment 4 material table)	Aluminum
Bearings	440C stainless steel. (see more details in attachment 4 material table)	Stainless steel
O-ring	Buna (see more details in attachment 4 material table)	Buna
Technical specification
Chuck	Push button chuck spindleOutside diameter: 0.125"Chuck length: 0.425"Actuator height: 0.034"	Push Button:Outside diameter: 0.125"Chuck length: 0.435"Actuator height: 0.038"
Light intensity	n/a	n/a
Bur extraction force	5 lbs Min. push and pull forces/ 100 inspection using ONMI gauge/ per specification indicated on drawing	5 lbs Min. push and pull forces- tested on predicate device
Air pressure	35 psi. recommended	35 psi.
Water pressure	2 bar	2 bar
Speed Rpm	420,000 rpm. Min.	420,000 rpm. Min.
Hose connection	n/a	n/a
Conformance standard for shanks	Meet I.S.O standard Shank diameter from 0.0625" to 0.0630"	Meet I.S.O standard shank
Lubricant	n/a	Dental lubricated oil
		Lubricant recommended but specific type and it is not indicated in labeling.

J - Performance Data:

The HHC-Push button air turbine performance tests were carried out to evaluate it In all instances the HHC-Push button air turbine against the predicate device. functioned as intended, results observed were as expected, and was determined to have comparable performance and safety as compared to the predicate.

No clinical data was required.

K -Conclusion:

Based on the information in the notification Handpiece Headquarters believes that this HHC-Push button air turbine is substantially equivalent to the claimed predicate device. (NSK- Replacement Turbine for Midwest Tradition Handpiece Products of NSK-NAKANISHI INC. (K971774))

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Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three lines representing its wings and legs. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the eagle.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002

Ms. Tina Steffanie-Oak Senior Regulatory Specialist Handpiece Headquarters 620 S. Placentia Avenue Placentia, California 92870

AUG 1, 2 2010

Re: K100389

Trade/Device Name: HHC- push button replacement turbine for Midwest Tradition Regulation Number: 21 CFR 872.4200 Regulation Name: Dental Handpiece and Accessories Regulatory Class: II Product Code: EFB Dated: August 6, 2010 Received: August 6, 2010

Dear Ms. Steffanie-Oak:

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 preemarket approval application (PMA). You may, therefore, market the device, subject to the emeral 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 - Ms. Steffanie-Oak

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 go to

http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. 10, 10, 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 vours.

Wh for

Anthony D. Watson, B.S., M.S., M.B.A. 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

AUG 1 2 2010

510(k) Number (if known): Kloo389

Device Name: HHC- push button replacement turbine for Midwest Tradition

Indications for Use:

This HHC-Push button air turbine is intended for use with the Midwest Tradition Handpiece in replacement of Midwest Tradition's original turbine.

The Dental Handpiece with the HHC- replacement turbine is used by authorized persons in the practice of dentistry.

Prescription Use .X AND/OR (Per 21 CFR 801 Subpart D) Subpart C)

Over-The-Counter Use

(Per 21 CFR 801

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Loe Miley for MSP Page 1 of 1
(Division Sign-Off)

Division of Anesthesiology, General Hospital Infection Control, Dental Devices

510(k) Number:

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.