PACEMAKER High-Speed Handpiece, models PM-MQ and PM-M are intended for removing carious material, reducing hard tooth structure, cavity prepardtion, finishing tooth preparations and restorations and polishing teeth.

Device Description

The PACEMAKER High-Speed Handpiece is a high speed dental handpiece with a lightly textured finish for enhanced grip. It is a hand-held, channeled instrument that is powered by compressed air that is delivered through a hose to an air channel in the handpiece. This impels the turbine in the head of the handpiece to revolve. Other internal channels deliver air and water to the head for cleaning and cooling. Any common dental bur is held in place in the handpiece head by a pushbutton.

There are three major parts which are made metal: a standard turbine, the threaded connector at the back end which attaches to the standard air/water hose in the dental unit, and the internal tubes that carry the chip air and water. These three parts are substantially equivalent to those in the predicate device.

Similar to the predicate device, the PACEMAKER High-Speed Handpiece must be cleaned and lubricated with a quality commercial dental handpiece cleaner/lubricant. It is supplied non-sterile, but must be sterilized before use, as with the predicate device. It will be packaged as a single unit or in multiples.

AI/ML Overview

Here's an analysis of the provided text regarding acceptance criteria and the study conducted for the PACEMAKER High-Speed Handpiece:

The provided 510(k) summary does not include detailed acceptance criteria or a study proving the device meets them in the quantifiable terms typically associated with AI/medical device performance evaluation. This submission is for a dental handpiece, a mechanical device, and the regulatory approach for such devices differs significantly from that for AI-driven software or diagnostic tools.

Instead of clinical performance metrics like sensitivity, specificity, or reader improvement, the submission focuses on demonstrating substantial equivalence to predicate devices through non-clinical testing against recognized standards.

Here's a breakdown based on your requested information, acknowledging the limitations given the nature of the device:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criterion	Reported Device Performance
Conformance to ISO 7785-1:1997	Performed testing against this standard. (Implies conformance was achieved for substantial equivalence claim)
Conformance to ISO 9168:1991	Performed testing against this standard. (Implies conformance was achieved for substantial equivalence claim)
Materials are biocompatible	Materials used are "well-known biocompatible."
Safe and effective for intended use	Concluded to be "both safe and effective for its intended use" based on non-clinical tests and comparison to predicates.

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

Sample Size: Not specified. For mechanical device testing against ISO standards, the "sample size" would typically refer to the number of units tested. This information is not provided in this summary.
Data Provenance: Not applicable in the context of clinical data. The testing was non-clinical, likely performed in a controlled laboratory environment to assess mechanical properties and safety.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Those Experts

This is not applicable as there is no "ground truth" in the clinical sense for this type of mechanical device submission described. The evaluation relies on standardized non-clinical tests.

4. Adjudication Method for the Test Set

Not applicable as there is no human interpretation or subjective assessment of a diagnostic output that would require adjudication. The testing involved objective measurements against established ISO standards.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, and the effect size of how much human readers improve with AI vs without AI assistance

No, an MRMC study was not done. This device is a mechanical dental handpiece, not an AI-driven diagnostic or assistive tool. Therefore, the concept of "human readers" or "AI assistance" does not apply.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done

No, a standalone performance evaluation (in the context of an algorithm) was not done. This is a mechanical device, not an algorithm. Its "standalone" performance refers to its ability to meet engineering specifications and safety standards as tested in the lab.

7. The Type of Ground Truth Used

The "ground truth" for this device is conformance to established international engineering and safety standards (ISO 7785-1:1997 and ISO 9168:1991), alongside comparison to the known performance and safety profiles of legally marketed predicate devices. There is no pathology, expert consensus (in the diagnostic sense), or outcomes data used for "ground truth" here.

8. The Sample Size for the Training Set

Not applicable. There is no "training set" as this is a mechanical device, not a machine learning model.

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

Not applicable. As noted above, there is no training set for this type of device.

Summary of the Study:

The "study" conducted for the PACEMAKER High-Speed Handpiece was a non-clinical performance evaluation against two internationally recognized ISO standards:

ISO 7785-1:1997: Specifies requirements for dental handpieces.
ISO 9168:1991: Specifies methods for the determination of noise emitted by dental handpieces.

The purpose of these tests was to demonstrate that the device's design and performance are comparable to the predicate devices and meet established safety and performance benchmarks for dental handpieces. The submission concludes that, based on these non-clinical tests and the comparison to predicate devices, the PACEMAKER High-Speed Handpiece is "both safe and effective for its intended use" and "substantially equivalent" to its predicates. No clinical trials were performed.

Summary

{0}------------------------------------------------

510(k) Summary

SEP 0 9 2010

Summary Prepared Date: 06/01/2010

Submission Sponsor:

KIOIES

Delma Medical Instrument (Guangzhou) Co., Ltd. 17 Xiang Shan Road High and New Technology Industrial Development Zone Guangzhou, Guangdong China 510663

Submission Correspondent:

Mr. Leon Lu Director of Regulatory Affairs

MEDevice Services, LLC 3500 South Dupont Highway Dover, Delaware 19901 USA Phone: 1-877-202-1588 Fax: 1-888-202-8884 Email: info@medeviceservices.com www.medeviceservices.com

Trade/Device Name: PACEMAKER High-Speed Handpiece, models PM-MQ and PM-M

Common or Usual Name: handpiece, air-powered, dental Device Class: 1 Classification Name: handpiece, air-powered, dental Regulation Number: 21 CFR 872.4200 Product Code: EFB Review Panel: Dental

Predicate Device:

K052822, THUNGER TIGER CORP. . TIGER 100, TIGER 101, TIGER 200, TIGER 201, TIGER 202
K062812, THUNGER TIGER CORP. . TIGER 300T, TIGER 300K, TIGER 300W, TIGER 300B, TIGER 300N

{1}------------------------------------------------

K062740. JINDELL MEDICAL INSTRUMENTS CO., LTD. . JINDELL HIGH SPPED AIR TURBINE HANDPIECE, MODELS SW, SP, SU, ETU, MU
K093084, ROLENCE ENT INC. . ROLENCE DENTAL HIGH SPEED HANDPIECE, RHP
K063110. SHANGHAI DENTAL INSTRUMENT FACTORY . CST61 HIGH SPEED TURBINE HANDPIECE
K021250, MK-DENT PUSH BUTTON HIGHSPEED HANDPIECE, 4 � HOLES. MODELS HS 2012 (STANDARD HEAD) & HS 2014 (SMALL HEAD)

Device Description:

Intended Use:

PACEMAKER High-Speed Handpiece carries the following label:

{2}------------------------------------------------

CAUTION: Federal (US) law restricts the use of this device to licensed professionals.

Comparison to Predicate Devices:

The PACEMAKER High-Speed Handpiece is essentially the same as or similar to the predicate device in terms of the intended use, design and construction, performance characteristics. The materials used are well-known biocompatible, so no new issues of biocompatibility are raised with regard to this device.

Discussion of Non-Clinical Tests Performed:

The performance of PACEMAKER High-Speed Handpiece following ISO 7785-1:1997 and ISO 9168:1991 were conducted.

Therefore, we conclude that the PACEMAKER High-Speed Handpiece is both safe and effective for its intended use.

Discussion of Clinical Tests Performed:

None

Conclusion:

The proposed device is as safe and effective as the predicate devices. The proposed device has the same intended uses and indications, similar technological characteristics, and principles of operation as its predicate device. The minor differences between the proposed device and its predicate devices raise no new issues of safety or effectiveness. Thus, the PACEMAKER High-Speed Handpiece, models PM-MQ and PM-M are substantially equivalent to its predicate devices.

{3}------------------------------------------------

Image /page/3/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS) of the United States of America. The seal features a stylized eagle with its wings spread, symbolizing protection and service. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" are arranged in a circular pattern around the eagle, indicating the name of the department.

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

Delma Medical Instrument (Guangzhou) Company, Limited C/O Mr. Leon Lu MEDevice Services, LLC 3500 South Dupont Highway Dover, Delaware 19901

SEP 0 9 2010

Re: K101551

Trade/Device Name: PACEMAKER High- Speed Handpiece, models PM-MQ and PM-M Regulation Number: 21 CFR 872.4200 Regulation Name: Dental Handpiece and Accessories Regulatory Class: I (Non-Exempt) Product Code: EFB Dated: August 26, 2010 Received: September 2, 2010

Dear Mr. Lu:

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.

{4}------------------------------------------------

Page 2- Mr. Lu

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 reportung (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. 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/Resourcesfor You/Industry/default.htm.

Sincerely vours.

James J. Roberts
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

{5}------------------------------------------------

Indications for Use

510(k) Number (if known):

Device Name: PACEMAKER High-Speed Handpiece, models PM-MQ and PM-M

Indications for Use:

PACEMAKER High-Speed Handpiece carries the following label: CAUTION: Federal (US) law restricts the use of this device to licensed professionals.

Over-The-Counter Use AND/OR Prescription Use × (Part 21 CFR 801 Subpart D) (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 Ruane

(Division Sign-Off) (Division Sign-Off)
Division of Anesthesiology, General Hospital
Division of Anesthesion Creat Devices Division of Anesthoology
Infection Control, Dental Devices

510(k) Number: K101531

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.