(567 days)
Mechanical drive unit with coolant supply for transmission instruments with ISO 3964 (DIN13940) compatible coupling system, for use in dental surgery, implantology and maxillofacial surgery (CMF) for treatment of dental hard tissue.
The Implanter is intended for use in dental surgery, implantology and maxillofacial surgery (CMF) for treatment of dental hard tissue. The submission consists of: - the control unit - a motor with cable with light (sterilizable: SPM58L) - a wired foot control (MF4) - and as an attachment the surgical contra-angle handpieces (with LED:WP-1L/without LED:WP-1). Eight different programs can be selected by the user. Switching between these programs is performed by foot control or via touch display. The programs include Positioning, Hole-drilling, Hole-Broadening, Tapping, Implanting, Lock the Abutment Screw, User Defined Mode and Cleaning. The control unit is intended to be used with the motor SPM58L. To run the Implanter according to its intended use, Guilin Woodpecker provides two different surgical handpieces.
The provided text is a 510(k) Summary for a medical device called "Implanter incl. Accessories." It details the device's indications for use, comparisons to a predicate device, and non-clinical testing performed to demonstrate substantial equivalence.
However, the document states, "No clinical data is needed to demonstrate substantial equivalence." This means there was no study conducted to prove the device meets acceptance criteria using performance metrics like sensitivity, specificity, or reader improvement with AI assistance.
Therefore, I cannot provide information on acceptance criteria and a study that proves the device meets them in the format requested, as that type of study was explicitly not conducted or deemed necessary for this 510(k) submission.
The document focuses on demonstrating substantial equivalence to an already legally marketed device (the predicate device) through non-clinical testing, rather than proving a specific performance level of a novel AI algorithm.
Below is a breakdown of the information that is available in the provided text, focusing on the nearest equivalents to your requested points:
1. A table of acceptance criteria and the reported device performance
Since this is a 510(k) submission focused on substantial equivalence through non-clinical testing, there are no specific performance acceptance criteria like sensitivity/specificity or reader improvement from an AI study. Instead, the acceptance criteria are implicit in the conformity to established medical device standards and FDA guidance documents and the demonstration that technological differences do not impact safety or effectiveness compared to the predicate device.
The "reported device performance" is demonstrated through the satisfactory completion of these non-clinical tests.
| Acceptance Criteria (Implicit) | Reported Device Performance |
|---|---|
| Conformity with IEC 60601-1 (Medical electrical equipment Part 1: General requirements for basic safety and essential performance) | Demonstrated conformity with IEC 60601-1. |
| Conformity with IEC 60601-1-2 (Medical electrical equipment Part 1-2: General requirements for basic safety and essential performance Collateral Standard: Electromaqnetic compatibility) | Demonstrated conformity with IEC 60601-1-2. |
| Handpiece function and lifecycle according to ISO 14457:2017 (Dentistry-Handpieces and Motors) | Verified handpiece function and lifecycle according to ISO 14457:2017. |
| Software validation in conformity with IEC 62304 (Medical device software - Software lifecycle processes) and FDA Guidance for a MODERATE level of concern. | Validated software for the device and its foot control in conformity with IEC 62304 and FDA Guidance (MODERATE level of concern). |
| Thermal safety in conformity with IEC 62471:2004 (Photobiological safety of lamps and lamp systems) | Verified thermal safety in conformity with IEC 62471:2004. |
| Biocompatibility of patient contacting components according to ISO 10993-1, ISO 10993-5, ISO 10993-10, and ISO 7405. | Evaluated biocompatibility of patient contacting components according to ISO 10993-1, ISO 10993-5, ISO 10993-10, and ISO 7405. For differences in motor and handpiece materials, testing per ISO 10993 addresses potential concerns. |
| Conformity with IEC 60601-1-1 (Medical electrical equipment - Part 1-1: General requirements for safety - Collateral standard: Safety requirements for medical electrical systems). | Verified conformity with IEC 60601-1-1. |
| Reprocessing (Cleaning, Sterilization) validation according to FDA Guidance titled "Reprocessing Medical Devices in Health Care Settings: Validation Methods and Labeling". | Validated reprocessing (Cleaning, Sterilization). Differences in cleaning methods were deemed not to affect substantial equivalence according to validation. Sterilization cycle parameters for dynamic-air-removal were identical to the predicate device. |
| Conformity with FDA Guidance on Dental Handpieces titled "Dental Handpieces – Premarket Notification [510(k)] Submissions". | Verified conformity with FDA Guidance on Dental Handpieces. |
| The technological characteristic differences between the proposed device and the predicate device do not affect the substantial equivalence and do not raise new risks. (e.g., higher mechanical output power, lower motor torque, different number of programs, wired vs. wireless foot control for predicate) | Performance testing was conducted to address differences. For instance, the higher mechanical output power (120W vs 80W predicate) was deemed not to lead to negative effects due to constructive power reserves (small difference in motor torque). The differing number of programs were supported by performance testing. The wired foot control (versus wireless on predicate) was resolved by noting the reference device used a wired control. Changes in motor and handpiece materials were addressed by ISO 10993 testing. |
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
This information is not provided in the document. The testing described is non-clinical, likely bench testing performed by the manufacturer (Guilin Woodpecker Medical Instrument Co., Ltd. in China) or a contracted lab. Details on specific sample sizes for each non-clinical test (e.g., how many handpieces were tested for lifecycle, how many components for biocompatibility) are not included in this summary.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
This information is not applicable/not provided. The device is an "Implanter incl. Accessories" (a dental handpiece and motor system), not an AI diagnostic imaging device. Therefore, there is no "ground truth" established by clinical experts in the context of diagnostic interpretation. The "ground truth" for non-clinical testing refers to established engineering standards, physical measurements, and chemical analyses.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not applicable/not provided. Adjudication methods like "2+1" typically refer to the process of resolving discrepancies among multiple human readers in a clinical study involving subjective interpretation. Since this is non-clinical testing of a physical medical device, such an adjudication method is not relevant.
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
No, a multi-reader, multi-case (MRMC) comparative effectiveness study was not done. The document explicitly states: "No clinical data is needed to demonstrate substantial equivalence." This type of study is relevant for AI-powered diagnostic aids, which this device is not. It is a mechanical dental instrument.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
Not Applicable. This device is a mechanical dental instrument, not an AI algorithm. Its performance is inherent in its physical and functional specifications.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
As explained in point 3, the concept of "ground truth" in the clinical diagnostic sense (like expert consensus or pathology for imaging) is not applicable here. The "ground truth" for this device's non-clinical testing refers to:
- Established national and international engineering standards (e.g., IEC 60601-1, ISO 14457, IEC 62304, ISO 10993 series, IEC 62471).
- FDA guidance documents specific to medical electrical equipment, software, biocompatibility, reprocessing, and dental handpieces.
- Objective physical and chemical measurements (e.g., power output, torque, speed range, material composition analysis, sterilization efficacy, electromagnetic compatibility).
8. The sample size for the training set
This information is not applicable/not provided. This device is a mechanical medical instrument, not an AI model that requires a training set.
9. How the ground truth for the training set was established
This question is not applicable. Since there is no AI model or training set, there is no ground truth established for a training set.
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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
November 21, 2022
Guilin Woodpecker Medical Instrument Co., Ltd. % Fu Ailing Consultant Shenzhen Joyantech Consulting Co., Ltd. 1713A, 17th Floor, Block A, Zhongguan Times Square Liuxian Avenue, Xili Town Nashan District Shenzhen, Guangdong 518055 CHINA
Re: K211358
Trade/Device Name: Implanter incl. Accessories Regulation Number: 21 CFR 872.4200 Regulation Name: Dental Handpiece And Accessories Regulatory Class: Class I, reserved Product Code: EBW Dated: October 25, 2022 Received: October 25, 2022
Dear Fu Ailing:
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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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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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 of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely.
Michael E. Adjodha -S
Michael E. Adjodha, M.ChE. Assistant Director DHT1B: Division of Dental and ENT Devices OHT1: Office of Ophthalmic, Anesthesia, Respiratory, ENT and Dental Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K211358
Device Name Implanter incl. Accessories
Indications for Use (Describe)
Mechanical drive unit with coolant supply for transmission instruments with ISO 3964 (DIN13940) compatible coupling system, for use in dental surgery, implantology and maxillofacial surgery (CMF) for treatment of dental hard tissue.
| Type of Use (Select one or both, as applicable) |
|---|
| ------------------------------------------------- |
X Prescription Use (Part 21 CFR 801 Subpart D)
| Over-The-Counter Use (21 CFR 801 Subpart C)
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Version:A/0
Product: Implanter
510(k) Summary — K211358
This 510(k) Summary is submitted according to the requirements of 21 CFR §807.92.
5.1 Administrative Information
| Date Summary prepared | November 17, 2022 |
|---|---|
| Manufacturer information | Submitter's Name: Guilin Woodpecker Medical InstrumentCo., Ltd.Address: Information Industrial Park, Guilin National High-Tech Zone, Guilin, Guangxi, 541004, P.R. ChinaContact person: Yang YunfengTEL: +86-773-2350532FAX: +86-773-5822450Mail: ipr@glwoodpecker.com |
| Submission Correspondent | Company Name: Shenzhen Joyantech Consulting Co., Ltd.Address: Room 1713A, 17 Floor, Block A, Zhongguan TimesSquare, Liuxian Avenue, Xili Town, NanshanDistrict, Shenzhen, Guangdong, 518055, ChinaContact person: Ms. Fu AilingE-Mail: aileen@cefda.comImage: [Logo] |
| Establishment registrationnumber | 3005581016 |
5.2 Device Information
| Type of 510(k) submission: | Traditional |
|---|---|
| Common Name: | Controller, Foot, Handpiece and Cord |
| Trade Name: | Implanter incl. Accessories |
| Model: | Implanter |
| Classification name: | Dental Handpiece and Accessories |
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Product: Implanter
Version:A/0
| Review Panel: | Dental |
|---|---|
| Product Code: | EBW |
| Device Class: | I |
| Regulation Number: | 21 CFR 872.4200 |
5.3 Predicate Device
Predicate Device
| Sponsor: | W&H DENTALWERK BÜRMOOS GMBH |
|---|---|
| Device: | Implantmed SI-1015 incl. Accessories |
| 510(K) Number: | K161957 |
Reference Device
| Sponsor: | W&H Dentalwerk Buermoos GmbH |
|---|---|
| Device: | ImplantMED SI-915 (115V Version) ImplantMED SI-923(230V Version) Incl. Accessories |
| 510(K) Number: | K052741 |
5.4 Device Description
The Implanter is intended for use in dental surgery, implantology and maxillofacial surgery (CMF) for treatment of dental hard tissue.
The submission consists of:
- the control unit
- a motor with cable with light (sterilizable: SPM58L)
- a wired foot control (MF4)
- and as an attachment the surgical contra-angle handpieces (with LED:WP-1L/without LED:WP-1)
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| Guilin Woodpecker | 009_510(k) Summary |
|---|---|
| Product: Implanter | Version: A/0 |
Eight different programs can be selected by the user. Switching between these programs is performed by foot control or via touch display.
The programs include Positioning, Hole-drilling, Hole-Broadening, Tapping, Implanting, Lock the Abutment Screw, User Defined Mode and Cleaning.
The control unit is intended to be used with the motor SPM58L.
To run the Implanter according to its intended use, Guilin Woodpecker provides two different surgical handpieces.
| Type | Transmission ratio | Max. speed | Max. torque |
|---|---|---|---|
| WP-1L | 20:1 | 40,000 | 80 Ncm |
| WP-1 | 20:1 | 40,000 | 80 Ncm |
5.5 Indications for Use
lmplanter (incl.SPM58L):
Mechanical drive unit with coolant supply for transmission instruments with ISO 3964 (DIN13940) compatible coupling system, for use in dental surgery, implantology and maxillofacial surgery (CMF) for treatment of dental hard tissue.
5.6 Indication for Use and Technological Characteristics of the Subject Device Compared to the Predicate Device
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Table 1 Comparison of Indications for Use and Technological Characteristics Between the Subject Device and the Predicate Device
| General Specification Implanter incl. Accessories | ||||||
|---|---|---|---|---|---|---|
| ID | ComparisonItem | Proposed DeviceImplanter incl.Accessories | Predicate DeviceImplantmed SI-1015incl. AccessoriesK161957 | Reference DeviceImplantMED SI-915 (115VVersion) ImplantMED SI-923 (230V Version) Incl.AccessoriesK052741 | Difference Between theProposed Device and thePredicate Device | |
| 1 | Picture | Image: Proposed Device Implanter incl. Accessories | Image: Predicate Device Implantmed SI-1015 incl. Accessories K161957 | Image: Reference Device ImplantMED SI-915 (115V Version) ImplantMED SI-923 (230V Version) Incl. Accessories K052741 | - | |
| 2 | Name | Implanter | Implantmed SI-1015 | Implantmed SI-915/923 | - | |
| 3 | Manufacturer | Guilin WoodpeckerMedical Instrument Co.,Ltd. | W&H DentalwerkBürmoos GmbH | W&H Dentalwerk BürmoosGmbH | - | |
| Product: Implanter | Version:A/0 | |||||
| 4 | Where Used | Dental practice, dental clinic | Dental practice, dental clinic | Dental practice, dental clinic | None | |
| 5 | Indication for Use | Mechanical drive unit with coolant supply for transmission instruments with ISO 3964 (DIN13940) compatible coupling system, for use in dental surgery, implantology and maxillofacial surgery (CMF) for treatment of dental hard tissue. | Mechanical drive unit with coolant supply for transmission instruments with ISO 3964 (DIN13940) compatible coupling system, for use in dental surgery, implantology and maxillofacial surgery (CMF) for treatment of dental hard tissue. | Mechanical drive unit with coolant supply for transmission instruments with coupling system according to ISO 3964 (Din 13.940) The equipment is a drive unit for use in dental surgery, implantology and maxilla-facial surgery for treatment of dental hard tissue. | None | |
| 6 | Control Unit | Main dimensions:276x267x110 mmFront panel:Display with capacitive touchPrograms:8 programs for various | Main dimensions:100x262x291 mmFront panel:Display with capacitive touchPrograms:5 programs for various | Main dimensions:90x252x254mmFront panel:Graphical display without backlightingPrograms:5 programs for various | Yes.For Guilin Woodpecker Medical Instrument Co., Ltd., there are 8 programs:1. Positioning,2. Hole-drilling,3. Hole-Broadening,4. Tapping, |
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009_510(k) Summary
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| Product: Implanter | Version:A/ | |||||
|---|---|---|---|---|---|---|
| stages of implantology | stages of implantology | stages of implantology | 5. Implanting, | |||
| Irrigation: | Irrigation: | Irrigation: | 6. Lock the abutment screw, | |||
| 110ml/min. | 100ml/min. | 100ml/min. | 7. User defined Mode, | |||
| 8. Cleaning | ||||||
| For W&H Dentalwerk BürmoosGmbH, there are | ||||||
| Irrigation Tubing can beinserted ergonomically onthe unit's side face | Irrigation Tubing can beinserted ergonomically onthe unit's side face | Irrigation Tubing can beinserted on the unit's frontface | 5 programs: | |||
| Drill function, | ||||||
| Drill function, | ||||||
| Drill function, | ||||||
| Thread-cutter function, | ||||||
| Implant insertion. Similarfunctions include: | ||||||
| 2 vs a or b or c; | ||||||
| 4 vs d; | ||||||
| 5 vs e. | ||||||
| The additional programs | ||||||
| included for the proposeddevice include 1,3,6,7 and 8. | ||||||
| 1 – Includes set ranges ofspeed and torque for | ||||||
| positioning of implantplacement. | ||||||
| Product: Implanter | Version:A/C | |||||
| 3 – Includes set ranges ofspeed and torque for hole-broadening procedures.6 – Includes set ranges ofspeed and torque forplacement of the abutmentscrew.7 – User defined mode foruse with a straight handpiecewith ball drill bit.8 – Used to adjust the watercapacity.Differences betweenfunctions are supported byperformance testing. | ||||||
| 7 | Foot Control | Main dimension:249.7x181.7x160.8Features:4 buttons for pump on/offForward/reverseChange programs | Main dimension:154x202x210Features:4 buttons for pump on/offForward/reverseChange programs | Main dimension:215x190x40 (withoutcable)Features:4 buttons for pump on/offForward/reverseChange programs | Yes. The power supply ofthe proposed device isperformed via wired footcontrol not viawireless control. Thereference device alsoincludes a wired footcontrol. | |
| Product: Implanter | Version:A/0 | |||||
| Motor control (on/off and variable) | Motor control (on/off and variable) | Motor control (on/off and variable) | ||||
| Power supply:WiredVia cable | Power supply:WirelessVia 3xAA batteries | Power supply:wiredvia cable | ||||
| 8 | Motor withCable | Length:110 mmWith LED contactswithout LED contacts | Length:71.65 mmWith LED contacts | Length:75 mmWithout LED contacts | Yes. The motor is with LEDcontacts or without LEDcontacts. The predicatedevice includes LEDcontacts and the referencedevice includes no LEDcontacts. | |
| 9 | Module | / | W&H SI-SQ:Connection via USB-cable | Osstell ISQ:Stand-alone device | Yes. The proposed devicedoes not include a module.However, performancetesting has been includeddemonstrating its use. |
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009_510(k) Summary
| Version:A/Product: Implanter | ||||||
|---|---|---|---|---|---|---|
| Technical Data/Functions Implanter incl. Accessories | ||||||
| ID | ComparisonItem | Proposed DeviceImplanter incl.Accessories | Predicate DeviceImplantmed SI-1015incl. Accessories | Reference DeviceImplantMED SI-915 (115VVersion) ImplantMED SI-923 (230V Version) Incl.Accessories | Difference Between theProposed Device and thePredicate Device | |
| 10 | Max.Mechanicaloutput power | 120 W | 80 W | 70 W | Yes. Due to different designscheme, the proposeddevice has the higherpower, but this does notlead to any negative effectregarding substantialequivalence because of theconstructive powerreserves of the motor (nobig difference between5.5 Ncm - 6.2 Ncm for themotor). | |
| 11 | Torque at themotor | 5.5 Ncm | 6.2 Ncm | 5.5 Ncm | Yes. The proposed deviceoffers a lower maximumlevel of torque output at themotor: 5.5 Ncm. However,this is in alignment with thereference device. | |
| Version:A/0Product: Implanter | ||||||
| 12 | Speed rangeof motor | 300 - 40,000 rpm | 200 - 40,000 rpm | 200 - 40,000 rpm | None | |
| 13 | Supplyvoltage | 100-120 VAC | 100-130 VAC | 100-130 VAC | None | |
| 14 | Ratedcurrent | 1.5-2 A | 0.3-1.6 A | 0.2-1.6 A | Yes. This does not affectsubstantial equivalenceaccording to performancetesting. | |
| 15 | Frequency | 50-60 Hz | 50-60 Hz | 50-60 Hz | None | |
| Material | ||||||
| ID | ComparisonItem | Proposed DeviceImplanter incl.Accessories | Predicate DeviceImplantmed SI-1015incl. Accessories | Reference DeviceImplantMED SI-915 (115VVersion) ImplantMED SI-923 (230V Version) Incl.Accessories | Difference Between theProposed Device and thePredicate Device | |
| 16 | Control unithousing | Plastic material | Plastic material | Plastic material | None | |
| 17 | Tubing outershealth | Customer specific | Customer specific | Customer specific | None | |
| Product: Implanter Version:A/C | ||||||
| 18 | Motor withcable | Stainless Steel,Aluminum Alloy (Motor)and Silicone, Siliconedioxide,Polydimethylsiloxane(Cable) | Stainless steel | Stainless steel | Yes. This does not raise anyadditional questions regardingsubstantial equivalenceaccording to testingconducted per ISO 10993. | |
| 19 | Surgicalhandpieces | Chromium plated steeland chromium coatedbrass | Chromium coated steeland chromium coatedbrass | Chromium coated steeland chromium coatedbrass | Yes. This does not raise anyadditional questionsregarding substantialequivalence according totesting conducted per ISO10993. | |
| 20 | Module | / | Stainless steel | Stainless steel | Yes. The proposed devicedoes not include a module.Therefore, materialcomposition is not applicable. | |
| Hygiene/MaintenanceSurgical Handpieces WP-1L/WP-1, Motors SPM58L, and others | ||||||
| Product: Implanter Version:A/0 | ||||||
| ID | ComparisonItem | Proposed DeviceImplanter incl.Accessories | Predicate DeviceImplantmed SI-1015incl. Accessories | Reference DeviceImplantMED SI-915 (115VVersion) ImplantMED SI-923 (230V Version) Incl.Accessories | Difference Between theProposed Device and thePredicate Device | |
| 21 | Lubrication | After max. 30 minutes ofuseSPM58L:No lubrication is needed | After max. 30 minutes ofuseEM-19 LC/EM-19:No lubrication is needed | After max. 30 minutes ofuseMotor with cable:No lubrication is needed | None | |
| 22 | Cleaning | Rinse under distilledwater or deionized water(<45 °C/113°F) with asoft cloth | Rinse underdemineralized water (< 38 °C/100°F) with aid ofbrush | Rinse under demineralizedwater (< 38°C/100°F) withaid of brush | Yes. This does not affectsubstantial equivalenceaccording to reprocessingvalidation. | |
| 23 | Disinfection | Wiping disinfection usingdisinfectant cloths | Wiping disinfection usingdisinfectant cloths | Wiping disinfection usingdisinfectant cloths | None | |
| 24 | Sterilization | Dynamic-air-removalsterilizers:270 °F (132 °C) for 4minutes | Dynamic-air-removalsterilizers:270 °F (132 °C) for 4minutes orGravity displacementsterilizers:270 °F (132 °C) for 15minutes | Dynamic-air-removalsterilizers:270°F (132°C) for 4minutes orGravity displacementsterilizers:270°F (132°C) for 15minutes | None. Same Sterilization CycleParameters for Dynamic-air-removal. |
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Guilin Woodpecker
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From above table, the proposed device and the predicate device have identical indications for use. Although there are subtle technological characteristic differences between the proposed device and the predicate device, the technological characteristic differences discussed do not affect the substantial equivalence.
5.7 Brief discussion of the non-clinical tests
To verify the performance requirements of the proposed device, the following tests were performed in accordance with listed standards and FDA guidance documents. Testing results demonstrate substantial equivalence.
- To verify the conformity of the proposed device with the requirements of IEC 60601-1:(Medical electrical equipment Part 1: General requirements for basic safety and essential performance).
- To verify the conformity of the proposed device with the requirements of IEC 60601-1-2:(Medical electrical equipment Part 1-2: General requirements for basic safety and essential performance Collateral Standard: Electromaqnetic compatibility).
- To verify the handpiece function and lifecycle according to ISO 14457:2017: (Dentistry-Handpieces and Motors).
- To validate the proposed device's software and its foot control's software respectively in conformity with IEC 62304 (Medical device software - Software lifecycle processes) and FDA Guidance titled "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices" for a MODERATE level of concern.
- To verify the thermal safety in conformity with the standard IEC 62471:2004: (Photobiological safety of lamps and lamp systems).
- To evaluate the biocompatibility of patient contacting components of the proposed device according to the requirements ISO 10993-1 (Biological evaluation of medical devices -Part 1: Evaluation and testing within a risk management process), ISO 10993-5 (Biological evaluation of medical devices Part 5: Test for cytotoxicity), ISO 10993-10 ( Biological evaluation of medical devices - Part 10: Tests for skin sensitization ) and ISO 7405 (Dentistry - Evaluation of biocompatibility of medical devices used in dentistry).
- To verify the conformity of the proposed device with the requirements of IEC 60601-1-2:(Medical electrical equipment Part 1-2: General requirements for basic safety and essential performance Collateral Standard: Electromagnetic compatibility) and IEC 60601-1-1 (Medical electrical equipment - Part 1-1: General requirements for safety - Collateral standard: Safety requirements for medical electrical systems).
- To validate the reprocessing (Cleaning, Sterilization) according to FDA Guidance titled "Reprocessing Medical Devices in Health Care Settings: Validation Methods and Labeling -Guidance for Industry and Food and Drug Administration Staff,"
- To verify the conformity of the proposed device with the requirements of FDA Guidance on Dental Handpieces titled "Dental Handpieces – Premarket Notification [510(k)] Submissions.
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5.8 Brief discussion of clinical tests
No clinical data is needed to demonstrate substantial equivalence.
5.9 Other information (such as required by FDA guidance/Test)
N/A.
5.10 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 indications for use of the proposed device is identical to that of the predicate device. .
- The technological characteristic differences between the proposed device and the predicate . device do not affect the substantial equivalence, so no new risk is raised.
- Demonstrated by the safety and performance tests, the characteristics of the proposed device . are substantially equivalent to those of the predicate device.
§ 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.