(479 days)
The Maxima Electric System is intended to convert pneumatic output from a dental treatment center to electrical energy to drive an electric micro motor and to operate electrically- driven dental handpieces. This system is designed for use by a trained professional in the field of general dentistry.
Maxima Electric System is a system attached to dental system to operate Electricallydriven low speed handpieces. The common gear ratio is 1:1 and 1:5, the speed range is from 100 to 40,000 rpm. Software used on control box is to control speed, forward and reverse direction of the handpieces; turn on an off the cooling water and LED light. There are 3 memories for speed of common low speed handpieces can be save into the program. The air hose is connect the air and water from 4-hole standard handpiece hose from dental system to the control unit, the existing air pedal from dental system is to turn on and off and control speed by converting pneumatic from dental system to electrical energy to operate electric handpieces. The control box is power by a power supply AC/DC voltage 36 VDC. Maxima Electric System consists of the following components: 1-Control Unit 2-Motor Cable 3-Micromotor (Model ELM-B40S) 4-Accessories including the following a-Foot switch (optional) b-AC/DC Adapter c-AC cord A control unit, Motor Cable and a Micro-motor.
The provided document is a 510(k) Pre-Market Notification for the Maxima Electric System, a dental device. It does not describe a study involving an AI/ML algorithm or its performance criteria, but rather focuses on demonstrating substantial equivalence to a predicate device. Therefore, many of the requested fields cannot be filled based on the provided text.
Here's an analysis based on the available information:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly state "acceptance criteria" for the device's overall performance in a quantitative manner as one would for an AI/ML model. Instead, it demonstrates substantial equivalence to a predicate device by comparing technological characteristics and performance testing.
| Feature/Characteristic | Acceptance Criteria (Implicit from Predicate) | Reported Device Performance (Maxima Electric System) |
|---|---|---|
| Indications for Use | Convert pneumatic output to electrical energy to drive electric micro-motor for electrically-driven handpieces in general dentistry. | Same as predicate. |
| Patient Contact | None | None |
| Device Design | Power Supply, Control Box, Micro Motor, AC cord. | Power Supply, Control Box, Micro Motor, AC cord. |
| Speed control button | Yes | Yes |
| Speed Range | 100-40,000 rpm | 100-40,000 rpm |
| Digital Speed reading | Yes | Yes |
| Rotation Control | Clockwise & Counter Clockwise | Clockwise & Counter Clockwise |
| Light ON/OFF | Yes | Yes |
| Water Spray ON/OFF | Yes | Yes |
| Programmable setting | 2 | 3 |
| Power Supply | 100-240 VAC, 47-63 Hz, 36-38 V DC, 120 W | 100-240 VAC, 47-63 Hz, 36-38 V DC, 105 W |
| Micro Motor Speed | 40,000 rpm | 40,000 rpm |
| Micro Motor Dimensions | 21mm (Diameter) x 65mm (Length) | 20mm (Diameter) x 63mm (Length) |
| Micro Motor Weight | 69.6 gm | 69 gm |
| Micro Motor LED | White LED | White LED |
| Torque | 3.0 N-Cm | 3.0 N-Cm |
| Max Air Pressure | 5.0 Bar | 4.0 Bar Max. |
| Max Water Pressure | 2.0 Bar | 2.5 Bar Max. |
| Handpiece Connection | ISO-3964 | ISO-3964 |
| Dental System Connection | ISO-9168 | ISO-9168 |
| Performance Testing (Speed Vs Torque) | Similar trend between test and predicate over 250 cycles. | "no significant differences in performance of testing handpieces after 250 cycles... The Speed Vs Torque table shows the similar trend..." |
2. Sample size used for the test set and the data provenance
The document mentions "250 cycles of testing" for handpieces to compare Speed Vs Torque performance between the subject device and the predicate. It does not provide details on the number of handpieces tested, the specific testing parameters beyond "Speed Vs Torque," or the data provenance (e.g., country of origin, retrospective/prospective). This testing appears to be a bench test, not clinical data.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. The ground truth, in this context, is derived from engineering specifications, industry standards (ISO), and the performance metrics of the predicate device, not direct expert interpretation of clinical data.
4. Adjudication method for the test set
Not applicable. This is not a study that uses human adjudication for a test set. Bench testing results are compared to established benchmarks or predicate device performance.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
Not applicable. This device is a dental handpiece system, not an AI/ML diagnostic or assistive tool. No MRMC study was performed.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. The device is hardware with embedded software for control, not a standalone algorithm in the context of AI/ML. The "software used on control box is to control speed, forward and reverse direction of the handpieces; turn on an off the cooling water and LED light." This is basic control software, not an AI algorithm.
7. The type of ground truth used
The "ground truth" for this submission is based on:
- Engineering Specifications and Standard Compliance: Adherence to standards like ISO 14971, ISO 17665-1, ISO 17665-2, ISO 10993-1, ISO 10993-5, IEC 60601-1, IEC 60601-1-2, ISO 14457, IEC 60601-1-6, IEC 63266, and IEC 80601-2-60.
- Predicate Device Performance: Direct comparison of technological characteristics and performance data (Speed Vs Torque) to a legally marketed predicate device (ELECTROtorque TLC4893 with INTRAmatic KL 702).
8. The sample size for the training set
Not applicable. This device does not involve an AI/ML algorithm that requires a training set.
9. How the ground truth for the training set was established
Not applicable. This device does not involve an AI/ML algorithm or a training set.
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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo features the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.
July 25, 2019
Handpiece Headquarters - HPR Inc. Sonny Phung Product Engineer 620 S. Placentia Avenue Placentia, California 92870
Re: K180845
Trade/Device Name: Maxima Electric System Regulation Number: 21 CFR 872.4200 Regulation Name: Dental Handpiece and Accessories Regulatory Class: Class I Product Code: EBW Dated: April 25, 2019 Received: April 26, 2019
Dear Sonny Phung:
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.
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
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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,
Srinivas Nandkumar, Ph.D. Acting 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):
Device Name: Maxima Electric System
Indications for Use:
The Maxima Electric System is intended to convert pneumatic output from a dental treatment center to electrical energy to drive an electric micro motor and to operate electrically- driven dental handpieces. This system is designed for use by a trained professional in the field of general dentistry.
Prescription Use AND/OR (Per 21 CFR 801 Subpart D) Subpart C)
Over-The-Counter Use
(Per 21 CFR 801
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
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Image /page/3/Picture/0 description: The image contains a logo for "Handpiece Headquarters", which is a company of Henry Schein. The words "Handpiece Headquarters" are stacked on top of each other, with the word "Handpiece" on top and "Headquarters" on the bottom. The words are in red and are in a bold font. Above the words is a jagged line that resembles a heartbeat monitor. Below the words is the text "A Henry Schein Company".
510(K) SUMMARY: K180845
Reference: 510(k) Traditional Premarket Notification for Maxima Electric System
a- Submitted by: HANDPIECE HEADQUARTERS 620 S. Placentia Ave. Placentia, CA 92870 Tel. 714-579-0175 Fax. 714-579-0186
- b- Contact person: Sonny Phung Tel. 714-579-0175 ext.4871 Fax. 714-579-0186 Email: son.phung@henryschein.com
c- Date summary prepared: July 23, 2019
d- Device Name:
Trade or Proprietary Name: Maxima Electric System
Common Name: Dental Handpiece and accessories
Classification Name: Dental Handpiece and accessories
Classification number: 21CFR 872.4200
Product code: EBW
Class: I
e- Substantial Equivalency is claimed against the following device:
ELECTROtorque TLC4893 with INTRAmatic KL 702 by Kaltenbach & Voight GmnbH 510(k) # K103027
f- Indications for Use
The Maxima Electric System is intended to convert pneumatic output from a dental treatment center to electrical energy to drive an electric micro motor and to operate electrically- driven dental handpieces. This system is designed for use by a trained
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professional in the field of general dentistry.
g- Description of the device:
Maxima Electric System is a system attached to dental system to operate Electricallydriven low speed handpieces. The common gear ratio is 1:1 and 1:5, the speed range is from 100 to 40,000 rpm.
Software used on control box is to control speed, forward and reverse direction of the handpieces; turn on an off the cooling water and LED light. There are 3 memories for speed of common low speed handpieces can be save into the program.
The air hose is connect the air and water from 4-hole standard handpiece hose from dental system to the control unit, the existing air pedal from dental system is to turn on and off and control speed by converting pneumatic from dental system to electrical energy to operate electric handpieces.
The control box is power by a power supply AC/DC voltage 36 VDC.
Maxima Electric System consists of the following components:
1-Control Unit 2-Motor Cable 3-Micromotor (Model ELM-B40S) 4-Accessories including the following a-Foot switch (optional) b-AC/DC Adapter c-AC cord
A control unit, Motor Cable and a Micro-motor.
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1-Front panel
| No. | Description | Function |
|---|---|---|
| 1 | Rotation directionselection button | Used to select the rotational direction (CW/CCW)of the motor and change the mode. |
| 2 | Motor operationdirection indicator | Displays the current operation direction of themotor (it is turned when the opposite direction isselected). |
| 3 | Motor LED ON/OFFbutton | Used to turn on and off the motor LED andrelease the mode. |
| 4 | Motor LED statedindicator | Displays the set state of the motor LED (LED Onmeans the LED is turned on). |
| 5 | Spray button | Used to switch on or off the spray function. |
| 6 | Spray state indicator | Displays the operational state of the sprayfunction; water is sprayed when it is On. |
| 7 | Speed controller | Used to set the rotational speed andthemaximum speed of the motor. |
| 8 | Selected gear indicator | Displays the selected gear ratio of the handpiece. |
| 9 | Program selectionbutton | Used to save the currently set value in thememory / select a saved program. |
| 10 | Gear selection button | Used to select the gear ratio of the handpiececonnected to the motor. |
| 11 | Speed indicator | Displays the rotational speed of the handpiece. |
2-Rear
| No. | Description | Function |
|---|---|---|
| 1 | Tubing Connector | Supplies air and water. ※ ISO 9168(type 3) |
| 2 | Foot SwitchConnector | Connects the control unit with the foot switch. |
| 3 | Motor Connector | Serves as a connection to run the micromotor (itcannot be separated from the control unit). |
| 4 | Power Switch | Power switch of the control unit. |
| 5 | Adapter Connector | Connector through which power gets supplied fromthe adapter. |
| 6 | Motor Cable | Connects the control unit and motor. |
| 7 | Motor Cap | Connects the motor and motor cable. |
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3-Micro Motor (ELM-B40S)
| No. | Description | Function |
|---|---|---|
| 1 | Handpiececonnector | Connects the micromotor and handpiece.※ ISO 3964(type 3) |
| 2 | Body | Body component through which electricalenergy gets converted into rotational motions. |
| 3 | LED | LED installed in the motor. |
4) AC/DC Adapter, AC Cord
| No. | Description | Function |
|---|---|---|
| 1 | AC/DC Adapter | Switches commonly used power input to rechargeablevoltage |
| 2 | Connection Jack | Connection jack with the control box |
| 3 | AC Cord | Power cord connection cable to supply operating voltage |
h- Comparison of technological characteristics:
1- Comparison table:
| Subject Device: MaximaElectric System | Predicate: ELECTROtorqueTLC4893 with INTRAmatic KL 702 | |
|---|---|---|
| Indication of use | The Maxima Electric System isintended to convert pneumaticoutput from a dental treatmentcenter to electrical energy todrive an electric micro motorfor operation of electrically-driven dental handpieces. Thissystem is designed for use bya trained professional in thefield of general dentistry. | The ELECTROtorqueTLC4893 is intended toconvert pneumatic output froma dental treatment center toelectrically energy to drive theINTRAmatic KL 702 motor foroperation of electrically-drivenhandpieces. This devices aredesigned for use by a trainedprofessional in the field ofgeneral dentistry. |
| Patient contactinformation | None | None |
| Device Design:Including Components | Power Supply, Control Box,Micro Motor, AC cord. | Power Supply, Control Box,Micro Motor, AC cord. |
| Control Unit |
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| Speed control button | Yes | Yes |
|---|---|---|
| Speed Range | 100-40,000 rpm | 100-40,000 rpm |
| Digital Speed reading | yes | Yes |
| Rotation Control | Clockwise & Counter Clockwise | Clockwise & Counter Clockwise |
| Light ON/OFF | yes | Yes |
| Water Spray ON/OFF | yes | Yes |
| Programmable setting | 3 | 2 |
| Power Supply | 100-240 VAC47-63 Hz36-38 V DC105 W | 100-240 VAC47-63 Hz36-38 V DC120 W |
| Micro Motor | 40,000 rpm20mm (Diameter) x 63mm (Length)69 gmWhite LEDYes3.0 N-Cm4.0 Bar Max.2.5 Bar Max.According to ISO-3964According to ISO-9168 (connect to 4-hole standard handpiece hose of dental system) | 40,000 rpm21mm (Diameter) x 65mm (Length)69.6 gmWhite LEDYes3.0 N-Cm5.0 Bar2.0 BarAccording to ISO-3964According to ISO-9168 |
2-Comparison of performance testing:
Based on performance testing results, there are no significant differences in performance of testing handpieces after 250 cycles of testing by using Maxima Electric System and KaVo Electro Torque. The Speed Vs Torque table shows the similar trend of speed and torque from the beginning of the test to the end of 250 cycles of testing.
The performance of the Maxima Electric System on the testing handpiece is similar to the performance of the KaVo Electric torque on the testing the handpiece regarding to Speed Vs Torque.
i- Bench Performance Testing Conducted:
· Risk Analysis per ISO 14971
·Sterilization and cleaning/disinfection validation per ISO 17665-1, ISO 17665-2, and FDA Guidance Document for Reprocessing of Medical Device
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- · Moderate level of software documentation and verification per the FDA Guidance Document for Software Contained in Medical Devices
- · Biocompatibility Assessment per FDA Guidance Document of Use of ISO 10993-1 and Cytotoxicity testing per ISO 10993-5
- · EMC and Electrical safety testing per IEC 60601-1 and IEC 60601-1-2
- · Evaluation of conformance to ISO 14457, IEC 60601-1-6, IEC 63266, and IEC 80601-2-60.
j- Conclusion:
Base on comparison table, the design and operation of this product has similar intend of use, similar principle of operation and similar technological characteristics such as components for the system, similar control box with software to control speed, similar micromotor, similar connection to dental system and similar performance testing data. Handpiece headquarters believes that this Maxima Electric System is substantially equivalent to the claimed predicated 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.