Maxima Electric System

{0}------------------------------------------------ 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 {1}------------------------------------------------ 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 {2}------------------------------------------------ #### 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) {3}------------------------------------------------ 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 {4}------------------------------------------------ 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. {5}------------------------------------------------ # 1-Front panel | No. | Description | Function | |-----|----------------------------------------|---------------------------------------------------------------------------------------------------------------------| | 1 | Rotation direction<br>selection button | Used to select the rotational direction (CW/CCW)<br>of the motor and change the mode. | | 2 | Motor operation<br>direction indicator | Displays the current operation direction of the<br>motor (it is turned when the opposite direction is<br>selected). | | 3 | Motor LED ON/OFF<br>button | Used to turn on and off the motor LED and<br>release the mode. | | 4 | Motor LED stated<br>indicator | Displays the set state of the motor LED (LED On<br>means 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 spray<br>function; water is sprayed when it is On. | | 7 | Speed controller | Used to set the rotational speed and<br>the<br>maximum speed of the motor. | | 8 | Selected gear indicator | Displays the selected gear ratio of the handpiece. | | 9 | Program selection<br>button | Used to save the currently set value in the<br>memory / select a saved program. | | 10 | Gear selection button | Used to select the gear ratio of the handpiece<br>connected 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 Switch<br>Connector | Connects the control unit with the foot switch. | | 3 | Motor Connector | Serves as a connection to run the micromotor (it<br>cannot be separated from the control unit). | | 4 | Power Switch | Power switch of the control unit. | | 5 | Adapter Connector | Connector through which power gets supplied from<br>the adapter. | | 6 | Motor Cable | Connects the control unit and motor. | | 7 | Motor Cap | Connects the motor and motor cable. | {6}------------------------------------------------ ## 3-Micro Motor (ELM-B40S) | No. | Description | Function | |-----|------------------------|-------------------------------------------------------------------------------------------| | 1 | Handpiece<br>connector | Connects the micromotor and handpiece.<br>※ ISO 3964(type 3) | | 2 | Body | Body component through which electrical<br>energy 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 rechargeable<br>voltage | | 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: Maxima<br>Electric System | Predicate: ELECTROtorque<br>TLC4893 with INTRAmatic KL 702 | |----------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Indication of use | The Maxima Electric System is<br>intended to convert pneumatic<br>output from a dental treatment<br>center to electrical energy to<br>drive an electric micro motor<br>for operation of electrically-<br>driven dental handpieces. This<br>system is designed for use by<br>a trained professional in the<br>field of general dentistry. | The ELECTROtorque<br>TLC4893 is intended to<br>convert pneumatic output from<br>a dental treatment center to<br>electrically energy to drive the<br>INTRAmatic KL 702 motor for<br>operation of electrically-driven<br>handpieces. This devices are<br>designed for use by a trained<br>professional in the field of<br>general dentistry. | | Patient contact<br>information | None | None | | Device Design:<br>Including Components | Power Supply, Control Box,<br>Micro Motor, AC cord. | Power Supply, Control Box,<br>Micro Motor, AC cord. | | Control Unit | | | {7}------------------------------------------------ | 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 VAC<br>47-63 Hz<br>36-38 V DC<br>105 W | 100-240 VAC<br>47-63 Hz<br>36-38 V DC<br>120 W | | Micro Motor | 40,000 rpm<br>20mm (Diameter) x 63mm (Length)<br>69 gm<br>White LED<br>Yes<br>3.0 N-Cm<br>4.0 Bar Max.<br>2.5 Bar Max.<br>According to ISO-3964<br>According to ISO-9168 (connect to 4-hole standard handpiece hose of dental system) | 40,000 rpm<br>21mm (Diameter) x 65mm (Length)<br>69.6 gm<br>White LED<br>Yes<br>3.0 N-Cm<br>5.0 Bar<br>2.0 Bar<br>According to ISO-3964<br>According 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 {8}------------------------------------------------ - · 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.