(196 days)
The EndoPilot2 systems are dental devices which combine in a single control unit an endo motor to clean the root canal, a dental obturator to fill and pressurize, an electronic apex locator to locate the file tip in the rot canal and an ultrasonic-handpiece for root-canal cleaning and preparation.
The EndoPilot is intended solely for use by trained dental professional health care facilities on patients that need root-canal-treatment.
The EndoPilot2 systems, including the models "comfort", "plus", "ultra plus" and the model variant under brand "CanalPro Jeni" (marketed by Distributor Coltène/Whaledent Inc. and identical for technical aspects to model EndoPilot² comfort) are standalone AC-powered dental control units with a touch display to which multiple hand-held dental handpieces for root canal preparation (Apex measurement, EndoMotor, Ultrasonic handpiece) and/or root-canal filling (DownPack, BackFill handpiece) can be connected.
These multifunctional devices are intended for use by professionals in the dental clinic use environment. Based on the modular concept of these EndoPilot2 systems different handpieces can be combined with the control unit and different device variants (systems) of the EndoPilot²exist. The key hand-held components like handpieces or endodontic tools of the EndoPilot² are medical devices commercially available by themselves and have separate FDA registration or clearance for marketing in the US.
The provided document describes the EndoPilot2, a dental device, for which the manufacturer, Schlumbohm GmbH & Co. KG, sought 510(k) clearance from the FDA. The submission (K202906) claims substantial equivalence to predicate devices: EMS-200 and SUPRASSON P5 NEWTRON. The document details the non-clinical performance data used to support this claim.
Here's an analysis of the provided information concerning acceptance criteria and supporting studies:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not present a formal table of "acceptance criteria" against which specific quantitative numerical performance metrics of the EndoPilot2 are directly compared. Instead, it describes various non-clinical performance tests conducted and states that the device "PASSED required testing" or "all requirements were met."
Therefore, I will extract the performance specifications and the stated outcome for the most relevant functional components where quantitative values are mentioned, and then for other types of tests, I will summarize the general pass/fail outcome.
| Acceptance Criteria (Predicate Device Specification or Standard Requirement) | Reported Device Performance (EndoPilot2) |
|---|---|
| Apex Locator Function (Based on Predicate EMS-200) | |
| Accuracy of Apex Locating point < ±0.5 mm | Accuracy of Apex Locating point < ±0.5 mm (Stated to be the Same as predicate) |
| Endodontic Motor Function (Based on Predicate EMS-200) | |
| File Rotation Speed: 250-800 rpm | File Rotation Speed: 200-1000 rpm (considered "Similar," both are low speed ranges for dental motors) |
| Torque limit value: 0.6-5.0 Ncm | Torque limit value: 0.2-5.0 Ncm (considered "Similar") |
| Obturation Unit Function (Based on Predicate EMS-200) | |
| Working temperature up to 300°C adjustable (DownPack) | Working temperature up to 300°C adjustable (Identical to predicate) |
| Working temperature up to 200°C adjustable (BackFill) | Working temperature up to 200°C adjustable (Identical to predicate) |
| Ultrasonic Unit Function (Based on Predicate SUPRASSON P5 NEWTRON) | |
| Intermittent operation: 5 min/10 min | Intermittent operation: 1 min/3 min (considered "Similar") |
| Vibration frequency: 27 to 33 kHz | Vibration frequency: 27 to 33 kHz (Stated to be the Same as predicate) |
| General Performance & Safety Standards | |
| Biocompatibility (ISO 10993-1, 5, 10) | PASSED |
| Electrical Safety (IEC 60601-1, IEC 80601-2-60) | PASSED |
| Electromagnetic Compatibility (IEC 60601-1-2, IEC 61000-3/4 series) | PASSED |
| Reprocessing Validation (FDA Guidance, cleaning & sterilization) | PASSED |
| Coupling between handpieces and motors (ISO 3964, ISO 14457) | all specifications dimensions, tolerances and the extraction force requirements were met |
| Software V&V (IEC 62304, FDA Cybersecurity Guidance) | PASSED required testing (Moderate Level of Concern software, system compatibility, risk analysis, cybersecurity risks addressed) |
| Usability Engineering (IEC 62366-1) | PASSED |
| Risk Management (EN ISO 14971) | all requirements were met and risks reduced as far as possible. |
2. Sample Size Used for the Test Set and the Data Provenance
The document does not specify a "test set" in the context of patient data or clinical images. The performance data presented are from non-clinical (bench) tests on the device itself, comparing its specifications and performance to established standards or predicate devices. No information is provided regarding the sample size of devices tested or any provenance related to patient data (country of origin, retrospective/prospective). This is typical for a 510(k) for a device like this, which relies on engineering and standards compliance rather than clinical study data.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts
This question is not applicable to the provided information. No "test set" with ground truth established by experts (e.g., radiologists) is mentioned. The studies are non-clinical engineering and performance tests against defined technical specifications and standards.
4. Adjudication Method for the Test Set
This question is not applicable. There is no mention of an adjudication method as there were no expert assessments of a test set. The compliance was determined by technical testing and validation against standards.
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
This question is not applicable. The EndoPilot2 is a physical dental device for root canal procedures, not an AI-powered diagnostic or assistive tool for human readers interpreting medical images. Therefore, an MRMC study and effects of AI assistance are outside the scope of this submission.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done
This question is not applicable. The device is not an algorithm, but a physical system of integrated dental tools. The performance refers to the device's functional capabilities (e.g., motor speed, torque, temperature control, apex locator accuracy) and compliance with safety and design standards.
7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)
For the non-clinical performance tests, the "ground truth" or reference points were:
- Predicate Device Specifications: The technical specifications (e.g., apex locator accuracy, motor speed ranges, obturation temperatures, ultrasonic frequency) of the legally marketed predicate devices (EMS-200 and SUPRASSON P5 NEWTRON).
- International and National Standards: Recognized standards for medical device safety, biocompatibility, electromagnetic compatibility, reprocessing, software, usability, and risk management (e.g., ISO 10993, IEC 60601-1, IEC 62304, EN ISO 14971, ISO 3964, ISO 14457).
8. The Sample Size for the Training Set
This question is not applicable. The EndoPilot2 is a hardware device, 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, as there is no training set for this type of device.
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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 USA 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.
April 13, 2021
Schlumbohm GmbH & Co. KG % Oliver Eikenberg, PhD Senior Consultant QA/RA Emergo Global Consulting, LLC 2500 Bee Cave Road, Building 1, Suite 300 Austin, Texas 78746
Re: K202906
Trade/Device Name: EndoPilot2 Regulation Number: 21 CFR 872.4850 Regulation Name: Ultrasonic Scaler Regulatory Class: Class II Product Code: ELC, EKX, EKR, LQY Dated: March 2. 2021 Received: March 9, 2021
Dear Oliver Eikenberg:
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 mav. 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.
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
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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 (OS) 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 mediation-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,
Bobak Shirmohammadi -S
For Michael Adjodha Assistant Director DHT1B: Division of Dental 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) K202906
Device Name EndoPilot2
Indications for Use (Describe)
The EndoPilote systems are dental devices which combine in a single control unit an endo motor to clean the root canal, a dental obturator to fill and pressurize, an electronic apex locator to locate the file tip in the rot canal and an ultrasonic-handpiece for root-canal cleaning and preparation.
The EndoPilot is intended solely for use by trained dental professional health care facilities on patients that need root-canal-treatment.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| Prescription Use (Part 21 CFR 801 Subpart D) | Over The Counter Use (21 CFR 801 Subpart C) |
X Prescription Use (Part 21 CFR 801 Subpart D)
] Over-The-Counter Use (21 CFR 801 Subpart C)
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510(k) Summary
K202906
EndoPilot2
1. Submission Sponsor
Schlumbohm GmbH & Co. KG Klein Floyen 8-10 D-24616 Brokstedt, Schleswig-Holstein , GERMANY Phone: +49-(0)4324-8929-0 Contact: Gerald Schlumbohm , Managing Director E-mail: gs@schlumbohm.de
2. Submission Correspondent
Emergo Global Consulting, LLC 2500 Bee Cave Road Building 1, Suite 300 Austin, TX 78746 Office Phone: (512) 327-9997 Email: LST.AUS.ProjectManagement@ul.com Contact: Oliver Eikenberg, PhD Title: Senior Consultant, Quality & Regulatory Affairs
3. Date Prepared
April 12, 2021
4. Device Identification
Trade/Proprietary Name: EndoPilot2
| Common/Usual Name: | Dental hand instrument |
|---|---|
| Classification Name: | Ultrasonic Scaler |
| Regulation Number: | 21 CFR 872.4850 |
| Product Code: | ELC Ultrasonic scalerEKX direct drive, AC-powered handpieceEKR endodontic plugger, root canalLQY root apex locator (unclassified), |
| Class: | Class II |
| Classification Panel: | Dental |
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5. Legally Marketed Predicate Device(s)
For the Endodontic unit systems (applicable to all EndoPilot²model variants): Primary Predicate
Device name: EMS-200 510(k) number: K153285 Manufacturer: Meta Systems Co., Ltd., Korea
For the Ultrasonic Unit (applicable only to EndoPilot²model variant "ultra" and " ultra plus"): Reference Device
Device name: SUPRASSON P5 NEWTRON 510(k) number: K050895 Manufacturer: SATELEC-ACTEON Group
6. Indication for Use Statement
The EndoPilot² systems are dental devices which combine in a single control unit an endo motor to clean the root canal, a dental obturator to fill and pressurize, an electronic apex locator to locate the file tip in the root canal and an ultrasonic-handpiece for root-canal cleaning and preparation.
The EndoPilot² is intended solely for use by trained dental professionals in professional health care facilities on patients that need root-canal-treatment.
7. Device Description
The EndoPilot2 systems, including the models "comfort", "plus", "ultra plus" and the model variant under brand "CanalPro Jeni" (marketed by Distributor Coltène/Whaledent Inc. and identical for technical aspects to model EndoPilot² comfort) are standalone AC-powered dental control units with a touch display to which multiple hand-held dental handpieces for root canal preparation (Apex measurement, EndoMotor, Ultrasonic handpiece) and/or root-canal filling (DownPack, BackFill handpiece) can be connected.
These multifunctional devices are intended for use by professionals in the dental clinic use environment. Based on the modular concept of these EndoPilot2 systems different handpieces can be combined with the control unit and different device variants (systems) of the EndoPilot²exist. The key hand-held components like handpieces or endodontic tools of the EndoPilot² are medical devices commercially available by themselves and have separate FDA registration or clearance for marketing in the US.
8. Substantial Equivalence Discussion
The following tables compare the EndoPilot2 to the predicate devices EMS-200 and SUPRASSON P5 NEWTRON with respect to indications for use, principles of operation, technological characteristics, components, and performance, and forms the basis for the determination of substantial equivalence. The subject device does not raise any new questions of safety or effectiveness as compared to the predicate devices.
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Table 5A – Comparison of Characteristics between Subject Device and Predicate Device EMS-200
| Attribute | SUBJECT DEVICE | PREDICATE DEVICE /510(k) HOLDER (K153285) | DeviceComparison |
|---|---|---|---|
| Manufacturer | Schlumbohm GmbH & Co. KG | Meta Systems Co., Ltd. | |
| Trade Name | EndoPilot2 | EMS-200 | |
| Regulation Number | 872.4200 Dental Handpiece and Accessories | Same | |
| Regulation Name | EKX, direct drive, ac-powered handpiece | ||
| Product Codes | 872.4565 Dental hand instrumentEKR, endodontic plugger, root canalLQY, root apex locator (unclassified)872.4850 Ultrasonic scalerELC Ultrasonic scaler | NA | See secondpredicate inTable 5B |
| Indications for Use | The EndoPilot2 systems are dental deviceswhich combine in a single control unit anendo motor to clean the root canal, adental obturator to fill and pressurize, anelectronic apex locator to assist theoperator to locate the file tip in the rootcanal and an ultrasonic-handpiece for root-canal cleaning and preparation.The EndoPilot2 is intended solely for useby trained dental professionals inprofessional health care facilities onpatients that need root-canal-treatment. | The EMS-200 is a dental devicewhich combines in a single LCDunit an endo motor which ablatesthe tooth to expand the rootcanal, a dental obturator to filland pressurize various shapedpackaging elements and anelectronic apex locator whichassists the operator the locationof the front tip in the root canal,for use by trained dentalprofessionals. | SimilarThe difference inindications foruse result out ofthe differentdesign andmodules usedfor both devices.The intendeduse is the same. |
| Professional Use | Dental professionals | Same | |
| Location of Use | Dental practice | Same | |
| Mode of Action | Endo-Motor: ablates the tooth to clean the root canal (rotating endo-files)Obturation Unit: to fill and pressurize various shaped packing elements(Warming up by a resistance-wire)Apex locator: to ensure the location of the front tip in root canal throughchanges of electric resistance value into one unit (Electrical impedance)Display: displayed through a single touch screen | Same | |
| AC/DCPowersupply | AC: 100-240 V, 50/60 HzDC: 12 V, 1.5 A | AC: 100-240 V, 50/60 HzDC: 12 V, 5.0 A | SimilarSmall DCdifference resultsout of the lowerpowerconsumption forEndoPilot2systempower adapters |
| Battery Operated | Yes, Li-Ion battery, 7.2 V,power output 48 Wh | no | DifferentBattery tested forIEC 62133 andanUN 38.3 Test |
| Attribute | SUBJECT DEVICE | PREDICATE DEVICE /510(k) HOLDER (K153285) | K202906DeviceComparison |
| Manufacturer | Schlumbohm GmbH & Co. KG | Meta Systems Co., Ltd. | |
| Trade Name | EndoPilot2 | EMS-200 | |
| Componentsforsystems | 1) Control unit with display panel (touchscreen), 5 connecting sockets, a microSDslot, power supply and wireless foot switch2) Apex cable set (Lip-clip, Cap for Lip-clip,Cable for file clamp, File clamp, Retainerfor apex cable, measuring cable)3) Contra-angle for apex measurement4) Endodontic Motor with apex measuringcontact5) DownPack (D-Pack) handpiece with LEDindicator6) BackFill handpiece (K042828)7) Ultrasonic handpiece, UltrasonicModule (K050895) | 1) Control unit with display panel(touch screen), 4 connectingsockets, power supply2) Electronic apex locator andaccessories (lip holder, cableassembly and 2 kinds of fileholder).3) Contra-angle for apexmeasurement4) Endodontic-motor Handpiecewith apex measuring contact5) Obturation Unit (K031664)6) BackFill handpiece included inObturation Unit (see 5)7) NA | SimilarThesmalldifferencesindesign do notraisenewquestionsofsubstantialequivalence |
| Processing(reuse of componentssterilized by user) | To be reprocessed in the dental practice before re-use. | SimilarManuals includereprocessinginstructionbased on ISO17664/17665-1 | |
| Electrical Safety | IEC 60601-1 | IEC 60601-1 | Same |
| Protection type andlevel against electricshock | Class II equipment, Type BF applied part | Class I equipment, Type B appliedpart | SimilarEquivalenttechnology isused, |
| ElectromagneticCompatibilityElectric Safety Tests | IEC 60601-1-2IEC 61000-3 seriesIEC 61000-4 series (2,3,4,5,6,8,11)IEC 80601-2-60 | IEC 60601-1-2IEC 61000-4 series (2,3,4,5,6,8,11) | Similar |
| Technological comparison of System Component Functions | |||
| Control Unit and display, Apex cable set and foot switch | |||
| DisplayDeviceFunction | LCD Touchscreen for display of workingcomponents | LCD Touchscreen for display ofworking components, stand | Similar |
| FunctionalSpecification | All main function can be selected directly at the start screenThe device switches off after a longer period of non-operation | Same | |
| AccessoryFoot switch Function | Single wireless footswitch or optionalTwin wireless foot switch | NA, Function is started by pressinga switch by finger | DifferentThe foot switchprovides |
| Wirelessconnection/Bluetooth | 2.402-2.480 GHz, TX Power: +7 dBm | NA | differentmethod to startthe device |
| Attribute | SUBJECT DEVICE | PREDICATE DEVICE /510(k) HOLDER (K153285) | K202906DeviceComparison |
| Manufacturer | Schlumbohm GmbH & Co. KG | Meta Systems Co., Ltd. | |
| Trade Name | EndoPilot2 | EMS-200 | |
| Apex locator (Apex cable set) | |||
| Function | Apex location of the front tip (of the endo-file) in the root canal throughchanges of electric resistance value | Same | |
| Apex locator | Electronic apex locator (Schlumbohm) | Electronic apex locator | Same |
| Apex cable setcomponents(material) | Lip clip (Stainless-Steel)cap for lip-clip plug socket (POM-C)58 mm 2mm | Lip holder (Stainless steel)64 mm 2 mm | SimilarSame materialused for maincomponentssmall differencein design doesnot impactthe device |
| File clamp (USP Plastic Class VI),cable for file clamp (TPR Plastic Class VI)Length 65 mm , Diameter 12 mmMeasuring cable (PVC), 1.5 m twin cableRetainer for apex cable (Stainless steel)(rest at the device) | File holder B (Silicone rubber &PBT),With cableLength 68 mm , Diameter 9.5 mmProbe cord (PVC), 1.8 m twin cableNo retainer | ||
| FunctionalSpecification | Accuracy ofApex Locating point < ±0.5 mm | Accuracy ofApex Locating point < ±0.5 mm | Same |
| Contra angle | |||
| Function | holds the "drill bit" and/or endodontic files used in endodontic procedurese.g. root canal preparation | Same | |
| FunctionalSpecification | ø20 x 94 mm, Weight 52.0gTorque range: Max. 5 Ncm +/- 10%(Gear ratio: 1:1) | ø16.7 x 63 mm, Weight 34.8gTorque range: 0.6 ~ 6.4 NcmContra Angle: ACL (B) - 42EP (Gear16:1 ) | Similar |
| Mode of Operation: | Forward and reverse | Same | |
| Material | Hard chrome plated brass | Hard chrome plated aluminumStainless steel | Similar |
| Accessories(Endo Files) | Database with preset values forparameters for selected Endodontic Filesfrom File-manufacturers | Database for parameters forselected Endodontic Files | Similar |
| Attribute | SUBJECT DEVICE | PREDICATE DEVICE /510(k) HOLDER (K153285) | K202906Device Comparison |
| Manufacturer | Schlumbohm GmbH & Co. KG | Meta Systems Co., Ltd. | |
| Trade Name | EndoPilot2 | EMS-200 | |
| Endodontic motor | |||
| Function | Micro motor (dental handpiece) provides power for contra angle to be usedtogether in standard endodontic procedures (root canal preparation) | Same | |
| FunctionalSpecification | ø21 x L 107 mmWeight 132 g (including wire)File Rotation Speed : 200-1000 rpmTorque limit value : 0.2-5.0 NcmGear ratio 1: 1 (contra angle)Auto-reverse modeAuto-stop modeSpeed ControlTorque control | ø20 x L 108 mmWeight 106 g (including wire)File Rotation Speed : 250-800 rpmTorque limit value : 0.6-5.0 NcmGear ratio 16: 1 (contra angle)Auto-reverse modeAuto-stop modeSpeed ControlTorque control | SimilarBoth rotation speed are low speed ranges for dental motors |
| Material | Stainless steel | Plastic, aluminum, stainless steel | Similar |
| Obturation Unit Back (DownPack, BackFill handpiece, Gutta Percha) | |||
| Function | fill and pressurize various shaped packing elements (Gutta percha) | Same | |
| Reference to FDA-cleared component | K042828,Obtura Heated Gutta Percha System,by YOUNG OS LLC | K031664 Endodontic ObturationUnit by Sybron Endo | Similar |
| FunctionalSpecification | Manual DownPack handpieceø14 x L 130.5 mm, weight 72 gWorking temperature up to 300°C adjustable | Electronic DownPack handpieceø27 x L 212 mm, weight 200 gWorking temperature up to 300 °C adjustable | SimilarThe difference in use (manual, electronic) is verified in the respective 510(k),Design is similar, working temperature is identical. |
| Pack tip/heating tip (E & Q Master; elements free), FDA-registered by MetaBiomed | Pack tip (5 sizes) | ||
| Manual BackFill handpiece(K042828)ø Heating Unit 12.5 mm x 150.5 mm x21.5 mm, Weight: 63gWorking temperature up to 200 °C, adjustableBackFill NeedlesDiameter: 20 gauge, 23 gauge, 25 gaugeworking length 25.5 mm | Electronic BackFill handpiece(K031664)Ø 20 x L 153 mm,weight 104 gWorking temperature up to 200°C, adjustableBackFill NeedleDiameter:23 gauge and 25 gaugeworking length 25 mm | ||
| SUBJECT DEVICE | PREDICATE DEVICE /510(k) HOLDER (K050895) | DeviceComparison | |
| Manufacturer | Schlumbohm GmbH & Co. KG | SATELEC-ACTEON GROUP | |
| Trade Name | EndoPilot2 | SUPRASSON P5 NEWTRON | |
| Product Codes | ELC Ultrasonic scaler | Same | |
| RegulationNumberand Regulation Name | 872.4850 Ultrasonic Scaler | Same | |
| Indications for Use | The EndoPilot2 systems are a dentaldevices which combine in a singlecontrol unit an endo motor to cleanthe root canal, a dental obturatorto fill and pressurize, an electronicapex locator to assist the operatorto locate the file tip in the rootcanal and an ultrasonic-handpiecefor root-canal cleaning andpreparation.The EndoPilot2 is intended solelyfor use by trained dentalprofessionals in professional healthcare facilities on patients that needroot-canal-treatment. | The SUPRASSON P5 NEWTRON is amulti-purpose piezoelectric ultrasonicgenerator: it is an upgraded generationof the SUPRASSON P5 BoosterPiezoelectric Ultrasonic ScalingGenerators from SATELEC whichreceived 510(k) clearance for dentalapplications (K961158) on May 23,1996, including the technology of theSP NEWTRON module which received510(k) clearance fordentalapplications(K033764) on March 1, 2004.The SUPRASSON P5 NEWTRONmaintains all the functions and the keycomponents of the SUPRASSON P5Booster and SP NEWTRON Module; it isa stand-alone device manufactured bySATELEC, all with the samecomponents and materials used in themanufacture of the originalSUPRASSON P5 Booster and SPNEWTRON module.The intended use, technicalperformance, and clinical indicationsare equivalent to those of theirpredicate devices, the SUPRASSON P5Booster (K961158) and SP NEWTRONModule (K033764).The SUPRASSON P5 NEWTRONconsists of three main components:the ultrasonic handpiece instrument,the control panel case, and thefootswitch. | SimilarThe difference inintended useresult out of thedifferent designand modulesused for bothdevices.The SUPRASSONP5 NEWTRON is astandalonedevice while theultrasonicmodule in theEndoPilot2 isconnectedthrough thecontrol unit. |
| SUBJECT DEVICE | PREDICATE DEVICE /510(k) HOLDER (K050895) | K202906DeviceComparison | |
| Manufacturer | Schlumbohm GmbH & Co. KG | SATELEC-ACTEON GROUP | |
| Trade Name | EndoPilot² | SUPRASSON P5 NEWTRON | |
| Components | Control-Unit:EndoPilot² unit with integratedultrasonic module with connectingsocket.(the ultrasonic module is identical toSUPRASSON SP NEWTRON-module)Ultrasonic handpiece:Handpiece (SUPRASSON SP NEWTRON)Universal wrench for ultrasonic tipsUltrasonic handpiece cableTwin wireless foot switch (Singlefootswitch or optional Twin-type) | Control-UnitSUPRASSON P5 NEWTRONUltrasonic handpiece:Handpiece (SUPRASSON SP NEWTRON)Universal wrench for ultrasonic tipsUltrasonic handpiece cableFootswitch with cordSingle footswitch | SimilarThe sameultrasonic moduleis used. Thedifference in useof the ultrasonicmodule result outof the connectionto the EndoPilot²system |
| Intermittent operation | 1 min/3 min (endodontic treatment) | 5 min/10 min (endodontictreatment) | Similar |
| Vibration frequency | 27 to 33 kHz | 27 to 33 kHz | Same |
| Activation | By footswitch, ON/OFF button | Same | |
| Cleaning, disinfection,sterilization | ISO 17664ISO 17665-1 | ISO 17665-1ISO 17665-2 | SimilarState of the artreprocessingstandards are met |
| AC/DC Power supply | AC: 100-240 V, 50/60 HzDC: 12 V, 1.5 A | AC: 110 V or 220/230 V, 50/60 Hz | Similaronly minordifference indesign; testingshows no newquestions raised. |
| WirelessConnectionFootswitch | 4.1 Bluetooth | NA | DifferentState of the artBluetoothstandardsdemonstratingcompliance. |
| Electrical Safety | IEC 60601-1 | IEC 60601-1 | Same |
| ElectromagneticCompatibility (EC) | IEC 60601-1-2IEC 61000-3 seriesIEC 61000-4 series (2,3,4,5,6,8,11) | IEC 60601-1-2(no further information available) | SimilarAdditionaltestingdemonstratecompliance to EC |
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Table 5B – Comparison of Main Characteristics between Subject Device and Predicate Device SUPRASSON P5 NEWTRON (this Ultrasonic Unit is only included in EndoPilot² variants "ultra" and "ultra plus")
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9. Non-Clinical Performance Data
To demonstrate the performance of EndoPilot²and to show substantial equivalence to the predicate device, Schlumbohm GmbH & Co. KG completed a number of non-clinical performance tests. Results confirm that the design inputs, function and performance specifications for the device are met. The EndoPilot® systems passed the testing in accordance with internal requirements, national standards, and international standards shown below, supporting its performance, and its substantial equivalence to the predicate device.
- . Biocompatibility evaluation per ISO 10993-1 assessed the risk for biocompatibility testing for cytotoxicity, sensitization and irritation to ISO 10993-5, 10; PASSED
- . Electrical safety testing per IEC 60601-1 and IEC 80601-2-60, PASSED required testing
- Electromagnetic Compatibility testing per IEC 60601-1-2 and IEC 61000-3-2, IEC 61000-3-3, IEC 61000-. 4-2, IEC 61000-4-3, IEC 61000-4-4, IEC 61000-4-5, IEC 61000-4-6, IEC 61000-4-11, PASSED required testing
- . Reprocessing validation (cleaning and sterilization) per the FDA Guidance Document "Reprocessing Medical Devices in Health Care Settings: Validation Methods and Labeling."
- . Coupling between handpieces and motors connected to dental units follows ISO 3964 and ISO 14457; all specifications dimensions, tolerances and the extraction force requirements were met
- . Software verification and validation testing has been completed on a functional level for a Moderate Level of Concern software including system compatibility testing, risk analysis per IEC 62304 and FDA Guidance "Content of Premarket Submissions for Management of Cybersecurity in Medical Devices, Guidance for Industry and Food and Drug Administration Staff" to address possible hazards, mitigations, and design considerations pertaining to intentional and unintentional cybersecurity risks associated with the device, , PASSED required testing
- Usability engineering testing per IEC 62366-1, PASSED
- Risk Management per EN ISO 14971, all requirements were met and risks reduced as far as possible.
10. Statement of Substantial Equivalence
The EndoPilot² systems have the same indications for use as the predicate devices EMS-200 and SUPRASSON P5 NEWTRON. Any minor differences in the technological characteristics of the subject device when compared to the predicate devices have been successfully evaluated through appropriate performance testing which demonstrates that the subject device, when compared to the predicate device, does not raise any new questions of substantial equivalence. The EndoPilot'systems have been determined to be substantially equivalent to predicate devices EMS-200 and SUPRASSON P5 NEWTRON.
§ 872.4850 Ultrasonic scaler.
(a)
Identification. An ultrasonic scaler is a device intended for use during dental cleaning and periodontal (gum) therapy to remove calculus deposits from teeth by application of an ultrasonic vibrating scaler tip to the teeth.(b)
Classification. Class II.