(196 days)
Not Found
No
The device description and performance studies focus on the mechanical and electrical aspects of an ultrasonic surgical device with selectable modes and irrigation, with no mention of AI or ML technologies.
Yes
The device is intended for use in dental applications such as bone cutting, calculus removal, periodontal pocket lavage, scaling, root planning, and retrograde preparation of root canals, all of which are therapeutic procedures.
No
The device is described as a surgical tool for procedures like bone cutting, calculus removal, and root canal preparation, not for diagnosing conditions.
No
The device description clearly states it is a hand-held ultrasonic surgical device connected to a control console, involving hardware components like a handpiece, control console, and peristaltic pump.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens taken from the human body (like blood, urine, tissue) to provide information about a person's health. This testing is done outside of the body.
- Device Function: The Piezo Bone Surgery device is used directly on the patient during dental procedures. It performs actions like bone cutting, calculus removal, and root canal preparation within the oral cavity.
- Intended Use: The stated intended uses are all clinical procedures performed on a living patient.
- Device Description: The description details a surgical device used for physical manipulation within the mouth, not for analyzing biological samples.
Therefore, the Piezo Bone Surgery device is a surgical device used in dental procedures, not an In Vitro Diagnostic device.
N/A
Intended Use / 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 -
Product codes (comma separated list FDA assigned to the subject device)
DZI, ELC
Device Description
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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.
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Image /page/0/Picture/0 description: The image shows a logo for a company called "Woodpecker". The logo features a stylized drawing of a woodpecker's head and neck on the left side. To the right of the woodpecker image, the word "WOODPECKER" is written in a bold, sans-serif font. The logo appears to be simple and clean, with a focus on the company name and a recognizable image of a woodpecker.
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
-
- 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
- Company:
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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Image /page/1/Picture/1 description: The image shows a logo for "WOODPECKER". To the left of the word "WOODPECKER" is a cartoon drawing of a woodpecker. The woodpecker is facing left and has a small circle with an R in it below it.
4. Classifications Names & Citations :
21CFR 872.4120, DZI, Drill, Bone, Powered, Class2
Description :
5.1 General
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.
- 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
2
Image /page/2/Picture/1 description: The image shows a logo with a stylized drawing of a woodpecker on the left and the word "WOODPECKER" on the right. The woodpecker is drawn with simple lines, and the word "WOODPECKER" is in a sans-serif font. The logo is black and white.
- Scaling and root planning
- Retrograde preparation of root canals
-
- 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 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 | The Piezosurgery 3 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 |
| Operation | Using piezoelectric ultrasonic technology to
generate mechanical micro vibrations for bone
cutting and ultrasonic scaling, with minimal trauma
to soft tissue. | Using piezoelectric ultrasonic technology to
generate mechanical micro vibrations for bone
cutting and ultrasonic scaling, with minimal trauma
to 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 connected
Cord interrupted
Insert broken or not correctly tightened | No hand piece connected
Cord interrupted
Insert broken or not correctly tightened |
| Power Modes | ROOT mode
BONE mode | ROOT mode
BONE mode
IMPL mode |
| IEC60601-1 Class | Type B
Class I | Type B
Class 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°C
Relative humidity from 30% to 70%
from -10°C to +50°C | from +10°C to +40°C
Relative 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 surgery
Implantology
Periodontal surgery
Surgical orthodontics | Oral surgery
Implantology
Periodontal surgery
Surgical orthodontics |
| Biocompatibility | Complying with ISO10993-1 | Complying with ISO10993-1 |
| Weight and Size | 3.8KG
L×W×H:333×255×167mm | 3.2 kg
L×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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Image /page/4/Picture/0 description: The image shows the word "WOODPECKER" in a vertical orientation. Below the word is a logo of a woodpecker. The woodpecker is facing left and has a long beak.
桂 林 市 啄 木 鸟 医 疗 器 械 有 限 公 司
GUILIN WOODPECKER Medical Instrument Co.,LTD.
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Image /page/5/Picture/0 description: The image shows a logo for a company called "WOODPECKER". To the left of the company name is a stylized drawing of a woodpecker. The woodpecker is facing left and has a long beak. Below the woodpecker is the registered trademark symbol.
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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Image /page/6/Picture/1 description: The image is a black and white logo for the Department of Health & Human Services - USA. The logo features a stylized image of an eagle with its wings spread, and three wavy lines below it. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle.
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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Image /page/8/Picture/0 description: The image shows a logo for "WOODPECKER". To the left of the word "WOODPECKER" is a cartoon drawing of a woodpecker. The woodpecker is facing left and has a small circle with an R in it below it.
GUILIN WOODPECKER Medical Instrument Co
Indications for Use
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
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510(k) Number
1 ર