(128 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 Implantmed SI-1015 is intended for use in dental surgery, implantology and maxillofacial surgery (CMF) for treatment of dental hard tissue.
The new Implantmed SI-1015 is a redesigned version of the old one.
The submission consists of :
- the control unit,
- a motor with cable with or without light (EM-19 LC/EM-19),
- a wireless or wired foot control (S-NW or S-N2),
- the Osstell Module (SI-SQ)
- and as an attachment the surgical handpieces
- (WS-56 L, WS-75 L, WS-91 L, WS-92 L and S-11 L).
The user can select five different programs. Switching between these programs is performed by foot control or via touch display.
Programs 1-3 are used for adjusting the speed and programs 4-5 are for adjusting the torque.
The control unit is intended to be used with the EM-19 or EM-19 L motor.
The Implantmed SI-1015 will be delivered with software on the control unit.
To run the Implantmed SI-1015 according to its intended use, W&H provides five different surgical handpieces.
This document concerns the 510(k) premarket notification for the "Implantmed SI-1015 incl. Accessories," a dental handpiece and accessories, and not an AI/ML powered device. As such, the concept of "acceptance criteria" and "study that proves the device meets the acceptance criteria" in the context of AI/ML performance metrics (such as accuracy, sensitivity, specificity, and the involvement of ground truth, expert opinions, sample sizes for training/testing, MRMC studies, or standalone algorithm performance) is not applicable here.
Instead, the document focuses on demonstrating substantial equivalence to a previously legally marketed predicate device (Implantmed SI-915/923, cleared under K052741) based on non-clinical performance testing and functional comparison.
Here's a breakdown of the provided information, reinterpreted to align with device performance and comparison for a traditional medical device:
1. Table of Acceptance Criteria and Reported Device Performance (Reinterpreted as comparison to predicate and safety standards)
| Feature/Test | Acceptance Criteria (Demonstrated Equivalence/Compliance) | Reported Device Performance (Implantmed SI-1015) |
|---|---|---|
| Intended Use | Identical to predicate device. | Mechanical drive unit with coolant supply for transmission instruments with ISO 3964 (DIN 13940) compatible coupling system, for use in dental surgery, implantology and maxillofacial surgery (CMF) for treatment of dental hard tissue. (Identical to predicate). |
| Technological Characteristics | Main technological characteristics same or similar to predicate. | Control Unit: Main dimensions: 100x262x291mm (Predicate: 90x252x254mm). Front panel: TFT display with capacitive touch (Predicate: Graphical display without backlighting). Programs: 5 (same as predicate). Irrigation: 100ml/min (same as predicate). Irrigation Tubing can be inserted ergonomically on the unit's side face (Predicate: inserted on front face). Foot Control: Features: 4 buttons for pump on/off, Forward/reverse, Change programs, Motor control (on/off and variable) (all same as predicate). Power supply: wireless via 3xAA batteries (Predicate: wired via cable). Motor with cable: Length: 71.65 mm, With LED contacts (Predicate: 75 mm, Without LED contacts). W&H SI-SQ (Osstell Module): Connection via USB-cable (Predicate (Osstell ISQ): Stand-alone device). Differences noted for Foot Control, Motor, and SI-SQ, but deemed not to raise additional questions regarding substantial equivalence. |
| Material Composition | Identical to predicate device. | Control unit housing: plastic material (Same as predicate). Tubing outer sheath: Customer specific (Same as predicate). Motor with cable: Stainless steel (Same as predicate). Surgical handpieces: Chromium coated steel and chromium coated brass (Same as predicate). SI-SQ: Stainless steel (Same as predicate). |
| Hygiene/Maintenance | Identical to predicate device. | Lubrication: After max. 30 minutes of use (EM-19 LC/EM-19: No lubrication needed) (Same as predicate). Cleaning: Rinse under demineralized water (< 38°C/100°F) with aid of brush (Same as predicate). Disinfection: Wiping disinfection using disinfectant cloths (Same as predicate). Sterilization: Dynamic-air-removal sterilizers: 270°F (132°C) for 4 minutes or Gravity displacement sterilizers: 270°F (132°C) for 15 minutes (Same as predicate). |
| Electrical Safety | Compliance with IEC 60601-1:2005. | Passed Electrical Safety Tests according to IEC 60601-1:2005. |
| Electromagnetic Compatibility (EMC) | Compliance with IEC 60601-1-2:2007. | Passed Electromagnetic Compatibility Test according to IEC 60601-1-2:2007. For wireless foot control, EMC testing for communication loss risk was performed per IEC 60601-1-2:2007. |
| Handpiece Function & Lifecycle Testing | Compliance with ISO 14457:2012. | Performed product testing of handpiece function and lifecycle testing per ISO 14457:2012. Results demonstrate substantial equivalence. |
| Software Validation | Compliance with IEC 62304:2006. | Software validation according to IEC 62304:2006. For wireless foot control, software verification/validation was conducted according to IEC 62304:2006. |
| Thermal Safety | Compliance with IEC 62471:2006. | Thermal safety according to IEC 62471:2006. |
| Biocompatibility | Materials in contact with patient are identical to previously cleared devices or meet ISO 10993-5 and ISO 7405:2008. | Patient contacting materials are identical to those in previously cleared W&H surgical handpieces K011061 and K080939. Cytotoxicity Testing per EN ISO 10993-5:2009-06 was performed. Evaluation meets requirements of ISO 7405:2008. |
| Mechanical Output Power (Max.) | Deemed not to lead to a negative effect on substantial equivalence. | 80 W (Predicate: 70 W). Acknowledged difference, but stated "does not lead to any negative effect regarding substantial equivalence because of the constructive power reserves of the motor (no big difference between 5.5 Ncm – 6.2 Ncm for the motor)." |
| Torque at the Motor | Deemed not to lead to a negative effect on substantial equivalence. | 6.2 Ncm (Predicate: 5.5 Ncm). Acknowledged difference, but stated "does not lead to any negative effect regarding substantial equivalence because of the constructive power reserves of the motor (no big difference between 5.5 Ncm – 6.2 Ncm for the motor)." |
| Speed Range of Motor | Identical to predicate device. | 200 – 40,000 rpm (Same as predicate). |
| Supply Voltage | Identical to predicate device. | 100-130 VAC (Same as predicate). |
| Rated Current | Similar to predicate device. | 0.3 - 1.6 A (Predicate: 0.2 - 1.6 A). Deemed "None" difference in the table, implying acceptable similarity. |
| Frequency | Identical to predicate device. | 50-60 Hz (Same as predicate). |
2. Sample size used for the test set and the data provenance
- Not Applicable in AI/ML context. The testing described is primarily for engineering performance verification (e.g., electrical safety, EMC, handpiece function, software validation) and material biocompatibility, rather than diagnostic accuracy on a "test set" of patient data. The provenance of these engineering test results is internal to the manufacturer (W&H Dentalwerk Bürmoos GmbH).
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Not Applicable in AI/ML context. Ground truth, in the sense of expert annotation for a diagnostic algorithm, is not relevant for this type of device. The "ground truth" here is compliance with established international standards (e.g., IEC, ISO) and comparison to the predicate device's known performance for mechanical properties, safety, and function.
4. Adjudication method
- Not Applicable in AI/ML context. This concept relates to resolving discrepancies in expert labels for ground truth. Not relevant here.
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 is not an AI-assisted diagnostic device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not Applicable. This is not an AI algorithm. It is a mechanical drive unit for dental surgery.
7. The type of ground truth used
- Not Applicable in AI/ML context. For this device, the "ground truth" or reference for performance and safety is compliance with relevant international standards (IEC 60601-1, IEC 60601-1-2, ISO 14457, IEC 62304, IEC 62471, EN ISO 10993-5, ISO 7405) and direct comparison to the performance and specifications of the legally marketed predicate device (Implantmed SI-915/923).
8. The sample size for the training set
- Not Applicable in AI/ML context. This device does not involve machine learning or a training set.
9. How the ground truth for the training set was established
- Not Applicable in AI/ML context. This device does not involve machine learning or a training set.
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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
November 23, 2016
W&H Dentalwerk Bürmoos GmbH Anja Lindner Mag., Regulatory Affairs Ignaz-Glaser-Straße 53 Buermoos, Salzburg 5111 Austria
Re: K161957
Trade/Device Name: Implantmed SI-1015 incl. Accessories Regulation Number: 21 CFR 872.4200 Regulation Name: Dental Handpiece and Accessories Regulatory Class: Class I Product Code: EBW
Dated: October 24, 2016 Received: October 27, 2016
Dear Anja Lindner:
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.
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 devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in
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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 contact the Division of Industry and Consumer Education 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. 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
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 Industry and Consumer Education 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.
Michael J. Ryan -S
for Tina Kiang, Ph.D. Acting Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control, and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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510(k) Indications for Use Statement
Indications for Use
510(k) number:
Device Name:
Implantmed SI-1015 incl. Accessories
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.
Prescription Use × (Part 21 CFR 801 Subpart D)
AND/OR
Over The Counter Use (Part 21 CFR 807 Subpart C)
Concurrence of CDRH, Office of Device Evaluation (ODE)
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510(k) SUMMARY
| Submitter | W & H DENTALWERK BÜRMOOS GMBHIgnaz-Glaser-Strasse 53A - 5111 BürmoosAustriaTel.: 0043 -6274 / 6236 -397Fax: 0043 -6274 / 6236 -55 |
|---|---|
| RegistrationNumber | 9681479 |
| ContactPerson | Mag. Anja LINDNER |
| Date Summarywas Prepared | 21st of November, 2016 |
| Device Name | Implantmed SI-1015 incl. Accessories |
| ClassificationName | Dental Handpiece and Accessories |
| Common/UsualName | Controller, Foot, Handpiece and Cord |
| RegulationNumber | 21 CFR 872.4200 |
| Regulatoryclass | I |
| Product Code | EBW |
| PredicateDevices | Primary Predicate:"Implantmed SI-915/923", W&H Dentalwerk Bürmoos GmbH; clearedunder K052741 |
| Reference devices for the accessories:"Osstell ISQ Implant Stability Meter", Osstell®; cleared via K082523 | |
| „Surgical contra-angle handpieces”, W&H Dentalwerk, Bürmoos; clearedunder K011061 and K080939 | |
| The predicate has not been subject to a design-related recall. |
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| DeviceDescription | The Implantmed SI-1015 is intended for use in dental surgery, implantology andmaxillofacial surgery (CMF) for treatment of dental hard tissue.The new Implantmed SI-1015 is a redesigned version of the old one.The submission consists of :- the control unit,- a motor with cable with or without light (EM-19 LC/EM-19),- a wireless or wired foot control (S-NW or S-N2),- the Osstell Module (SI-SQ)- and as an attachment the surgical handpieces- (WS-56 L, WS-75 L, WS-91 L, WS-92 L and S-11 L).The user can select five different programs. Switching betweenthese programs is performed by foot control or via touch display.Programs 1-3 are used for adjusting the speed and programs4-5 are for adjusting the torque.The control unit is intended to be used with the EM-19 or EM-19 L motor.The Implantmed SI-1015 will be delivered with software on the control unit.To run the Implantmed SI-1015 according to its intended use, W&H providesfive different surgical handpieces. | ||
|---|---|---|---|
| Type | Transmission ratio | Max. speed | Max. torque |
| WS-56 L | 1:1 | 50,000 | not applicable |
| WS-75 L | 20:1 | 50,000 | 70 Ncm |
| WS-91 L | 1:2.7 | 50,000 | not applicable |
| WS-92 L | 1:2.7 | 50,000 | not applicable |
| S-11 L | 1:1 | 50,000 | not applicable |
| Indications forUse: | Implantmed SI-1015 (incl. EM-19/EM-19 L):Mechanical drive unit with coolant supply for transmission instruments with ISO3964(DIN 13940) compatible coupling system, for use in dental surgery, implantologyand maxillofacial surgery (CMF) for treatment of dental hard tissue. |
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| General specification SI-1015 incl. Accessories | |||||
|---|---|---|---|---|---|
| Item | New device | predicate device | Difference | ||
| Picture | Image: Implantmed SI-1015 | Image: Implantmed SI-915/923 | - | ||
| Name | Implantmed SI-1015 | Implantmed SI-915/923 | - | ||
| Manufacturer | W&H DentalwerkBürmoos GmbH | W&H DentalwerkBürmoos GmbH | - | ||
| Where used | Dental practice, dentalclinic | Dental practice, dentalclinic | none | ||
| TechnologicalCharacteristics | Indicationsfor use | Mechanical drive unitwith coolant supply fortransmissioninstruments with ISO3964 (DIN 13940)compatible couplingsystem, for use indental surgery,implantology andmaxillofacial surgery(CMF) for treatment ofdental hard tissue. | Mechanical drive unitwith coolant supply fortransmissioninstruments withcoupling systemaccording to ISO 3964(Din 13.940) Theequipment is a driveunit for use in dentalsurgery, implantologyand maxilla-facialsurgery for treatment ofdental hard tissue. | none | |
| Control Unit | Main dimensions:100x262x291mmFront panel:TFT display withcapacitive touchPrograms:5 programs for variousstages of implantologyIrrigation:100ml/min. | Main dimensions:90x252x254mmFront panel:Graphical displaywithout backlightingPrograms:5 programs for variousstages of implantologyIrrigation:100ml/min. | none | ||
| Irrigation Tubing canbe insertedergonomically on theunit's side face | inserted on the unit'sfront face | ||||
| Main dimension:154x202x210 | Main dimension:215x190x40 (withoutcable) | ||||
| Foot Control | Features:4 buttons for pumpon/offForward/reverseChange programs | Features:4 buttons for pumpon/offForward/reverseChange programs | Yes,the power supply ofthe new Implantmed isperformed via wirelessfoot control not viacable. | ||
| Motor control (on/offand variable) | Motor control (on/offand variable) | ||||
| Power supply:wirelessvia 3xAA batteries | Power supply:wiredvia cable | ||||
| Motorwithcable | Length:71,65 mmWith LED contacts | Length:75 mmWithout LED contacts | Yes,the new motor withLED contacts (EM-19LC) disposes of betterlightning at a lowertemperature as theenergy transfer isprovided via directvoltage supply and notvia generator anymore. However, thisdoes not raise anyadditional questionsregarding substantialequivalence. | ||
| SI-SQ | W&H SI-SQ:Connection via USB-cable | Osstell ISQ:Stand-alone device | Yes, the Osstell ISQ isalready cleared formarket (K082523). TheW&H SI-SQ has thesame intended use,consists of the samematerials and issterilized the sameway as the OsstellISQ. The onlydifferences are thelabeling (W&H) andthe connection - as theSI-SQ is no stand-alone device.However, this does notraise any additionalquestions regardingsubstantial | ||
| equivalence. | |||||
| Technical data/FunctionsImplantmed SI-1015 | |||||
| New Device | Predicate Device | Difference | |||
| Max.mechanicaloutputpower | 80 W | 70 W | Yes5 | ||
| Torque atthe motor | 6.2 Ncm | 5.5 Ncm | Yes5 | ||
| Speed rangeof motor | 200 – 40,000 rpm | 200 – 40,000 rpm | None | ||
| Supplyvoltage | 100-130 VAC | 100-130 VAC | None | ||
| Ratedcurrent | 0.3 - 1.6 A | 0.2 - 1.6 A | None | ||
| Frequency | 50-60 Hz | 50-60 Hz | None |
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lt allows in its program 4 to adjust torque values up to 80 Ncm (which are needed for implant systems) - instead of previous maximum of 50 Ncm.
This does not lead to any negative effect regarding substantial equivalence because of the constructive power reserves of the motor (no big difference between 5.5 Ncm – 6.2 Ncm for the motor).
| Materials | ||||
|---|---|---|---|---|
| Item | New device | Predicate device | Difference | |
| Control unithousing | plastic material | plastic material | None | |
| Tubing outersheath | Customer specific | Customer specific | None | |
| Motor with cable | Stainless steel | Stainless steel | None | |
| Surgicalhandpieces | Chromium coated steel andchromium coated brass | Chromium coated steel andchromium coated brass | None | |
| SI-SQ | Stainless steel | Stainless steel | None | |
| Hygiene / MaintenanceSurgical Handpieces (WS-56 L, WS-75 L, S-11 L, WS-91 L, WS-92 L), EM-19, EM-19 LCand SI-SQ | ||||
| Item | New device | Predicate device | Difference | |
| Lubrication | after max. 30 minutes of useEM-19 LC/ EM-19:No lubrication is needed | after max. 30 minutes of useMotor with cable:No lubrication is needed | None | |
| Cleaning | rinse under demineralizedwater (< 38°C/100°F) withaid of brush | rinse under demineralizedwater(< 38°C/100°F) with aid ofbrush | None | |
| Disinfection | wiping disinfection usingdisinfectant cloths | wiping disinfection usingdisinfectant cloths | None | |
| Sterilization | Dynamic-air-removalsterilizers: 270°F (132°C)for 4 minutes or | Dynamic-air-removalsterilizers: 270°F (132°C) for4 minutes or | None | |
| Gravity displacementsterilizers:270°F (132°C) for 15minutes | Gravity displacementsterilizers:270°F (132°C) for 15 minutes | |||
| W&H's Implantmed SI-1015 represents a redesigned and improvedversion of the predicate device.The technical principle is the same as within the predicate device.The main technological characteristics are the same or, at least, quite similar tothose of the comparable product.The Indications for Use statement for the Implantmed SI-1015 isidentical to the predicate device. | ||||
| Comparison ofthe device tothe predicatedevice | The target field of application, the intended use, functions andtechnological features, performance parameter and material are the same or,at least, quite similar to those of the predicate device.The new device is substantially equivalent to the predicate device. |
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Implantmed SI-1015 incl. Accessories
Section 5 Page 6 of 7
510(k) Summary
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| PerformanceTesting | Electrical Safety Tests according to IEC 60601-1:2005, Medical electricalequipment– Part 1: General requirements for basic safety and essential performance. |
|---|---|
| Electromagnetic Compatibility Test according to IEC 60601-1-2:2007:General requirement for basic safety and essential performance –Collateral standard: Electromagnetic compatibility – Requirements and tests | |
| Product testing of handpiece function and lifecycle testing were performedper ISO 14457:2012: Dentistry – Handpieces and Motors.The results demonstrate substantial equivalence in this regard. | |
| Software validation according to IEC 62304:2006: Medical device software –Part 1:Guidance on the application of ISO 14972 to medical device software | |
| Thermal safety according to the standard IEC 62471:2006:Photobiological safety of lamps and lamp systems | |
| Evaluation of biocompatibility is based upon the fact that patientcontacting materials in the subject handpiece are identical to those in thepreviously W&H surgical handpieces K011061 and K080939, which, ashandpieces,present the same level and duration of contact.In addition, Cytotoxicity Testing per EN ISO 10993-5:2009-06 was performed.This evaluation meets the requirements of ISO 7405:2008 for preclinicalevaluation of biocompatibility of dental devices. | |
| For the new wireless foot control (S-NW) software verification/validation of thefunctions of the foot control was conducted according to IEC 62304:2006.Additionally, EMC testing was performed to evaluate the risk of communicationloss according to IEC 60601-1-2:2007 and Electrical Safety Tests have beendone according to IEC 60601-1-1:2005. | |
| ClinicalTesting | |
| Conclusion | W&H considers the “Implantmed SI-1015 incl. Accessories” to besubstantially equivalent to the predicate devices listed above. This conclusion isbased on the similarities in intended use, principles of operation, functionaldesign, and establishment medical use. Differences between the devices shownin the side-by-side comparison table above are minor and do not have anynegative effect on equivalence. |
§ 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.