The Guilin Woodpecker Medical Instrument Co., Ltd. Piezo Bone Surgery device is a dental device used in oral surgery situations. In this submission, it is intended to be used for bone cutting in oral surgery, removing supra and sub-gingival calculus deposits, stains from teeth, periodontal pocket lavage with simultaneous ultrasonic tip movement, scaling, root planning, and retrograde preparation of root canals.

The device is a hand held ultrasonic surgical device, which is connected via a cord to the control console. The device operates at frequency range of 24 to 29.5 kHz. There are three modes of operation, which are selectable from the control console. The practitioner can select the Bone, Root or Clean modes of operation. Each mode has a different power mode, with the Bone mode giving the most power. Irrigation to the tip is provided and adjustable via the control console. Water flow for the irrigation is provided via a peristaltic pump.

A selection of tips is available for the dental professional to select and use for the specific dental procedure. The available tips are shown in the User's manual and also in the advertisement brochure.

This device is not delivered sterile, but must be sterilized after each use. Instructions for cleaning and sterilization are provided within the User's Manual.

AI/ML Overview

The provided document is a 510(k) summary for the Guilin Woodpecker Medical Instrument Co., Ltd. Piezo Bone Surgery device, model Ultrasurgery. It primarily focuses on demonstrating substantial equivalence to a predicate device (MECTRON, Piezosurgery, K091227) rather than establishing novel acceptance criteria or performing extensive clinical studies to prove performance against those criteria.

Therefore, the document does not contain the level of detail typically found in a study demonstrating device performance against specific acceptance criteria. Instead, it relies on demonstrating that the new device is substantially similar in design, intended use, and technical characteristics to a previously cleared device, which implicitly means it should perform similarly.

Here's an analysis based on the information available in the document:

1. Table of acceptance criteria and reported device performance:

The document doesn't explicitly state quantitative acceptance criteria for performance in the same way a clinical trial would. Instead, it describes "safety and performance data" and concludes that "All test results were satisfactory," implying that the device met internal or regulatory standards primarily focused on safety and technical specifications, drawing equivalence to a predicate device.

Acceptance Criteria (Implied / Stated)	Reported Device Performance
Safety and Effectiveness (General principle for 510(k) clearance)	Satisfactory, based on comparison to predicate device and compliance with relevant standards. The device is deemed substantially equivalent to the predicate (MECTRON, Piezosurgery, K091227) for the stated indications for use.
Compliance with Electrical, Mechanical, Environmental Safety Standards (e.g., EN/IEC 60601-1, IEC60601-1-2)	All test results were satisfactory. This implies that the device met the requirements of these standards for electrical safety, mechanical robustness, and electromagnetic compatibility.
Biocompatibility (e.g., ISO10993-1, ISO10993-5, ISO10993-10, ISO 7405:2008)	All test results were satisfactory. The device is described as "Complying with ISO10993-1" for its tip material (stainless steel) and other components in contact with the patient. Specific cytotoxicity testing (ISO10993-5, ISO10993-10) was also performed and found satisfactory.
Risk Management (e.g., ISO 13485, ISO 14971)	All test results were satisfactory. This indicates that a risk management process was followed, and identified risks were mitigated to acceptable levels.
Performance Testing (effectiveness and accuracy)	All test results were satisfactory. This is a general statement, without specific quantitative metrics or studies detailed in the summary. The performance is compared to the predicate device, which also uses "piezoelectric ultrasonic technology to generate mechanical micro vibrations for bone cutting and ultrasonic scaling, with minimal trauma to soft tissue." Consistency in intended use and operational principles supports the claim of similar performance.
Intended Use Equivalence (Bone cutting, calculus removal, periodontal lavage, scaling/root planning, retrograde root canal prep)	The intended uses of the subject device are identical to those of the predicate device, supporting substantial equivalence.
Technical Characteristics Equivalence (Operation, Medium, Tip material, Frequency, Voltage, APC, Power modes, Sterilization, etc.)	Comparative tables indicate substantial similarity across numerous technical specifications (e.g., operation principle, tip material, frequency range, voltage supply, APC circuit, power modes, sterilization methods). Key differences like working frequency range (24KHz~29.5 KHz vs 24 KHz to 36 KHz) and intermittent operation cycles (60" ON 10" OFF vs 60" ON 30" OFF) are present but are implicitly considered not to raise new questions of safety or effectiveness.

2. Sample size used for the test set and the data provenance:

The document does not describe specific clinical test sets with sample sizes or data provenance (e.g., country of origin, retrospective/prospective). The performance claims are primarily supported by engineering and laboratory testing against recognized standards (e.g., IEC, ISO) and a comparison to a predicate device. There is no mention of a patient or clinical data set for performance evaluation in this 510(k) summary.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

Not applicable. As no clinical test set is described, there's no mention of experts establishing ground truth or their qualifications.

4. Adjudication method for the test set:

Not applicable. No clinical test set is described.

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:

Not applicable. This device is a Piezo Bone Surgery device, not an AI-assisted diagnostic or imaging device used by human readers. Therefore, an MRMC study or AI-assistance effectiveness is not relevant to this submission.

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

Not applicable. This is a physical medical device, not a standalone algorithm.

7. The type of ground truth used:

The "ground truth" for the claims of safety and effectiveness appears to be established through:

Compliance with international standards: (e.g., EN/IEC 60601-1, ISO10993 series, ISO 14971) through laboratory testing.
Substantial Equivalence to a legally marketed predicate device: The regulatory clearance of the predicate device (MECTRON, Piezosurgery, K091227) serves as the benchmark for safety and effectiveness. The comparison table (pages 3-4) highlights that the subject device shares the same intended use, operational principle, tip material, and similar technical specifications as the predicate.

8. The sample size for the training set:

Not applicable. This is a conventional medical device, not an AI/ML-based device that relies on a "training set" in the context of machine learning.

9. How the ground truth for the training set was established:

Not applicable. (See #8)

Summary

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幸林市陈木鸟医疗器械有限 A WILLINE WOODDECKED Medical Instrument

NOV 1 8 2011

ﺴﺘﻨﺪ

510(k) Summary

This summary of 510(k) safety and effectiveness information is being submitted in accordance with requirements of 21 CFR Part 807.92.

Date: February 4, 2011

1. Company:
  Name - Guilin Woodpecker Medical Instrument Co., Ltd. Address - Information Industrial Park, Guilin National High-Tech Zone District, Guilin, Guangxi, 541004, P.R. China Telephone - +86-773-5855340 Fax – +86-733-5855351 Contact - Mr. Wu Xunxian Email – woodpeckera@mailgl.cn

Correspondent:

Name- IRC Address- 77325 Joyce Way, Echo, Oregon 97826 Telephone- 931-625-4938 Fax- 541-376-5063 Contact- Charlie Mack Email- charliemack@irc-us.com

Device :

Trade/proprietary name: Piezo Bone Surgery, Model Ultrasurgery Common Name : Drill, bone, powered Classification Name : Bone cutting instrument and accessories

3. Predicate Devices :

MECTRON, Piezo Bone Surgery, Piezosurgery, K091227

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4. Classifications Names & Citations :

21CFR 872.4120, DZI, Drill, Bone, Powered, Class2

Description :

5.1 General

This device is not delivered sterile, but must be sterilized after each use. Instructions for cleaning and sterilization are provided within the User's Manual.

Indication for use :

The Piezo Bone Surgery is intended for use in the following dental applications:

Bone cutting for use in oral surgery
Removing supra and sub-gingival calculus deposits and stains from teeth
Periodontal pocket lavage with simultaneous ultrasonic tip movement

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Scaling and root planning
Retrograde preparation of root canals
1. Comparison with predicate device :

Guilin Woodpecker Medical Instrument Co., Ltd. believes that the Piezo Bone Surgery device, model Ultrasurgery is substantially equivalent to the Mectron, Piezosurgery® (K091227).

Please see the next two pages for a comprehensive comparison with the predicate device.

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Element of comparison	Subject Device	Claimed SE Device
Manufacturer	WOODPECKER	MECTRON
Device name	Piezo Bone Surgery	Piezo Bone Surgery
Device model	Ultrasurgery	Piezosurgery ®
FDA510(K) No.	N/A	K091227
Intended use(s)	The Piezo Bone Surgery is intended for use in thefollowing dental applications:- Bone cutting for use in oral surgery- Removing supra and subgingival calculusdeposits and stains from teeth- Periodontal pocket lavage with simultaneousultrasonic tip movement- Scaling and root planning- Retrograde preparation of root canals	The Piezosurgery 3 is intended for use in thefollowing dental applications:- Bone cutting for use in oral surgery- Removing supra and subgingival calculusdeposits and stains from teeth- Periodontal pocket lavage with simultaneousultrasonic tip movement- Scaling and root planning- Retrograde preparation of root canals
Operation	Using piezoelectric ultrasonic technology togenerate mechanical micro vibrations for bonecutting and ultrasonic scaling, with minimal traumato soft tissue.	Using piezoelectric ultrasonic technology togenerate mechanical micro vibrations for bonecutting and ultrasonic scaling, with minimal traumato soft tissue.
Medium used	Purified water or normal saline	Purified water or normal saline
Tip material	Stainless steel	Stainless steel
Ultrasonic vibration style	Piezoelectric Wafer	Piezoelectric Wafer
Device for intermittent operation	Intermittent Operation 60" ON 10" OFF	Intermittent Operation 60" ON 30" OFF
Working frequency	24KHz~29.5 KHz	From 24 KHz to 36 KHz
Voltage supply	100-120VAC 50/60Hz	100-240 VAC 50/60 Hz
APC circuit protection systems	No hand piece connectedCord interruptedInsert broken or not correctly tightened	No hand piece connectedCord interruptedInsert broken or not correctly tightened
Power Modes	ROOT modeBONE mode	ROOT modeBONE modeIMPL mode
IEC60601-1 Class	Type BClass I	Type BClass I
Device classification using Directive 93/42EEC		Class II a
Peristaltic pump volume delivery		From 0 to 90 ml / min approx
Fuses	2×T1.0AL 250V	230 VAC 2 X 2 A T
Environmental operating conditions	from +10°C to +40°CRelative humidity from 30% to 70%from -10°C to +50°C	from +10°C to +40°CRelative humidity from 30% to 75%from -10°C to +70°C
Transport and storage environmental conditions	Relative humidity from 10% to 90%.Air pressure P: 500hPa/1060hPa	Relative humidity from 10% to 90%.Air pressure P: 500hPa/1060hPa
Where used	Oral surgeryImplantologyPeriodontal surgerySurgical orthodontics	Oral surgeryImplantologyPeriodontal surgerySurgical orthodontics
Biocompatibility	Complying with ISO10993-1	Complying with ISO10993-1
Weight and Size	3.8KGL×W×H:333×255×167mm	3.2 kgL×W×H:340 X 210 X 150 mm
Clean and disinfection method	Clean and disinfect the surfaces of the casting, the cords and their connectors using a cloth moistened with a mild detergent or disinfectant solution with a neutral pH (pH 7).	Clean and disinfect the surfaces of the casing, the rod, the hand piece-holder, the cords and their connectors using a low fiber release cloth moistened with a detergent solution (pH 6-9) and/or a mild disinfectant with a neutral pH (pH7).
Sterilization method	Maximum temperature of 135°C for a maximum of 20 minutes.	Maximum temperature of 135°C for a maximum of 20 minutes.
Components can be sterilized	Hand piece, Tips, Tip holder, Torque wrench, Pump tube, Cord/peristaltic pump tube connection, Hand piece holder	Hand piece, Inserts, Wrench for tightening the inserts, Tube for the peristaltic pump, Connection for the cord / tube of the peristaltic pump, Rod for supporting the bag, Support for the hand piece

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桂林市啄木鸟医疗器械有限公司
GUILIN WOODPECKER Medical Instrument Co.,LTD.

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7. Safety and Performance Data :

Electrical, mechanical, environmental safety and performance testing according to EN/ IEC 60601-1[1990] Medical electrical equipment Part 1: General Requirement for safety, IEC60601-1-2, EMC Compatibility, ISO10993-5 Cvtotoxicity. ISO10993-10 Cvtotoxicity. ISO 10993-1 Biological evaluation of Medical Devices Part-1; ISO 7405:2008 Dentistry --Evaluation of biocompatibility of Medical devices used for dentistry: ISO 13485- Risk Management; ISO 14971, Risk Management of Medical Devices. Performance testing was used to validate the effectiveness and accuracy of the device. All test results were satisfactory.

9. Conclusions:

In accordance with the Federal Food, Drug and Cosmetic Act, 21 CFR Part 807 and based on the information provided in this premarket notification Guilin Woodpecker Medical Instrument Co., Ltd. concludes that the Piezo Bone Surgery device, model Ultrasurgery is substantially equivalent to predicate devices as described herein.

END

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

Guilin Woodpacker Medical Instrument Company, Limited C/O Mr. Charlie Mack Principal Engineer International Regulatory Consultants 77325 Joyce Way Echo, Oregon 97826

NOV 1 8 2011

Re: K111290

Trade/Device Name: Piezo Bone Surgery Regulation Number: 21 CFR 872.4120 Regulation Name: Bone Cutting Instrument and Accessories Regulatory Class: II Product Code: DZI, ELC Dated: November 6, 2011 Received: November 9, 2011

Dear Mr. Mack:

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- Mr. Mack

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 (OS) 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 yours,

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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GUILIN WOODPECKER Medical Instrument Co

Indications for Use

510(k) Number (if known):

K11 290

Device Name: Piezo Bone Surgery

Indications For Use:

The Piezo Bone Surgery is intended for use in the following dental applications:

-Bone cutting for use in oral surgery
Removing supra and subgingival calculus deposits and stains from teeth -
Periodontal pocket lavage with simultaneous ultrasonic tip movement -
Scaling and root planning -
Retrograde preparation of root canals -

AND/OR 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 ANOTHER PAGE OF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

(Division Sign Division of Anesthesiology, General Hospital Intection Control, Dental Devices

Page 1 of 1

510(k) Number

1 ર

Regulation Number and Section

§ 872.4120 Bone cutting instrument and accessories.

(a)
Identification. A bone cutting instrument and accessories is a metal device intended for use in reconstructive oral surgery to drill or cut into the upper or lower jaw and may be used to prepare bone to insert a wire, pin, or screw. The device includes the manual bone drill and wire driver, powered bone drill, rotary bone cutting handpiece, and AC-powered bone saw.(b)
Classification. Class II.