(267 days)
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No
The document describes a dental surgical device with standard control and connectivity features. There is no mention of AI or ML capabilities in the intended use, device description, or performance studies.
No
The device is used to cut hard tissues and facilitate dental implant procedures, which are surgical interventions, not therapeutic treatments.
No
The device is primarily used for cutting hard tissues and controlling dental micromotors during dental oral surgery and dental implant procedures. While it can display ISQ values from an external measurement device (Osseo100+), its core function is not diagnostic.
No
The device description clearly outlines hardware components including a Control Unit, Foot Control, and Motor, in addition to software features.
Based on the provided information, the Surgic Pro2 is not an In Vitro Diagnostic (IVD) device.
Here's why:
- Intended Use: The intended use is clearly stated as "dental oral surgery and dental implant." It is designed to "cut hard tissues in the mouth" using a micromotor and handpieces. This is a surgical procedure performed directly on a patient.
- Device Description: The description details a system for controlling a dental motor and handpieces for surgical procedures. It mentions features like speed control, coolant flow, and connectivity to other devices for displaying information related to the procedure (like ISQ values, which are measured by a separate device).
- Lack of In Vitro Activity: An IVD device is used to examine specimens derived from the human body (like blood, urine, tissue) in vitro (outside the body) to provide information for diagnosis, monitoring, or screening. The Surgic Pro2 does not perform any such analysis of biological specimens. It is a tool used in vivo (within the body) during a surgical procedure.
- No Mention of Specimen Analysis: The document does not mention any component or function related to collecting, preparing, or analyzing biological specimens.
The connection to the "Osseo 100+" ISQ measurement device might seem confusing, but the Surgic Pro2 is only displaying the data from that separate device. The Osseo 100+ itself might be considered an IVD depending on its specific function and intended use, but the Surgic Pro2 is not performing the measurement or analysis.
Therefore, the Surgic Pro2 is a surgical device used in dental procedures, not an IVD.
N/A
Intended Use / Indications for Use
The Surgic Pro2 is intended for use in dental oral surgery and dental implant. The main unit is designed to be used with a specific dental micromotor that drives dental handpieces fitted with appropriate tools to cut hard tissues in the mouth.
Product codes (comma separated list FDA assigned to the subject device)
EBW
Device Description
The Surgic Pro2 consists of the Control Unit, the Foot Control, Motor and accessories. The Control Unit drives the Motors during procedures and is used to control the functions related to the Motor such as rotational direction. The Foot Control provides the user with "hands-free" control of the coolant flow, program selection, forward/reverse rotational direction, and speed during operation. Two models of the Motor with Motor cord are available, SGL80M Optic Motor. The SGL80M Optic Motor contains LED illumination of over 32,000 LUX. Each Motor is included with each series set in accordance to the client's specific needs and requirements.
The Surgic Pro2 is intended for use in dental implant. The main unit is designed to be used with a specific dental micromotor that drives dental handpieces fitted with appropriate tools to cut hard tissues in the mouth.
Features of this product are Bluetooth connectivity with a Foot Control, "Osseo 100+" ISQ measurement device *, and other company's products "iPad". The ISQ values measured by the "can be displayed on the Surgic Pro2 control unit. The "iPad" can display information on the control unit including ISQ values on the dedicated application for Surgic Pro2. The displayed information can be stored in the iPad.
- The ISQ value is measured by the Osseo100+ and the ISQ value displayed on the display of the SurgicPro2 connected via Bluetooth.
The product is provided unsterilized, and the motors are washed and sterilized at a medical institution, and used repeatedly. The product has no bio-contact components.
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
mouth
Indicated Patient Age Range
Not Found
Intended User / Care Setting
dental oral surgery
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
For Surgic Pro2, the following non-clinical tests were performed to support substantial equivalence of the subject device. Performance Test:
The Surgic Pro2 subject instrument was subjected to verification and validation testing for motor performance, reprocessing, software, electrical safety, EMC, and cybersecurity to support substantial equivalence. The results of the exith the requirements of the following standards and guidance. The performance test results support the substantial equivalence of the subject Surgic Pro2 to the precedent device.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
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Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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.
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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
June 20, 2024
Nakanishi Inc. Mr. Satoru Ikeda Regulatory Affairs Department TIX TOWER UENO 9F 4-8-1. Higashiueno Taito-ku, Tokyo 110-0015 JAPAN
Re: K233117
Trade/Device Name: Surgic Pro2 (Surgic Pro2 OPT), Surgic Pro2 (Surgic Pro2 NON-OPT) Regulation Number: 21 CFR 872.4200 Regulation Name: Dental Handpiece And Accessories Regulatory Class: Class I, reserved Product Code: EBW Dated: May 21, 2024 Received: May 21, 2024
Dear Satoru Ikeda:
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 (the 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 available at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
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Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30. Design controls; 21 CFR 820.90. Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 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 Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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).
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Sincerely,
Michael E. Adjodha -S
Michael E. Adjodha, MChE, RAC, CQIA Assistant Director DHT1B: Division of Dental and ENT Devices OHT1: Office of Ophthalmic, Anesthesia, Respiratory, ENT and Dental Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
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Indications for Use
Submission Number (if known)
Device Name
Surgic Pro2 (Surgic Pro2 OPT); Surgic Pro2 (Surgic Pro2 NON-OPT)
Indications for Use (Describe)
The Surgic Pro2 is intended for use in dental oral surgery and dental implant. The main unit is designed to be used with a specific dental micromotor that drives dental handpieces fitted with appropriate tools to cut hard tissues in the mouth.
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)
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510(k) #: K233117
510(k) Summary
Prepared on: 2024-06-20
Contact Details
21 CFR 807.92(a)(1)
| Applicant Name | NAKANISHI INC. | ||||
|---|---|---|---|---|---|
| Applicant Address | 700 Shimohinata Kanuma Tochigi 322-8666 Japan | ||||
| Applicant Contact Telephone | +81-289-64-7277 | ||||
| Applicant Contact | Mr. Masaaki Kikuchi | ||||
| Applicant Contact Email | nskra@nsk-nakanishi.co.jp | ||||
| Correspondent Name | NAKANISHI INC. | ||||
| Correspondent Address | TIX TOWER UENO 9F 4-8-1, Higashiueno Taito-ku Tokyo 110-0015 | ||||
| Japan | |||||
| Correspondent Contact Telephone | +81-358-28-8590 | ||||
| Correspondent Contact | Mr. Satoru Ikeda | ||||
| Correspondent Contact Email | nskra-contact@nsk-nakanishi.co.jp | ||||
| Device Name | 21 CFR 807.92(a)(2) | ||||
| Device Trade Name | Surgic Pro2 (Surgic Pro2 OPT); | ||||
| Surgic Pro2 (Surgic Pro2 NON-OPT) | |||||
| Common Name | Dental handpiece and accessories | ||||
| Classification Name | Controller, Foot, Handpiece And Cord | ||||
| Regulation Number | 872.4200 | ||||
| Product Code | EBW | ||||
| Legally Marketed Predicate Devices | 21 CFR 807.92(a)(3) | ||||
| Predicate # | Predicate Trade Name (Primary Predicate is listed first) | Product Code | |||
| K173905 | Surgic Pro+ / Surgic Pro | EBW | |||
| K161957 | W&H Implantmed SI-1015 Incl. Accessories | EBW | |||
| K161213 | XSmart iQ | EBW | |||
| Device Description Summary | 21 CFR 807.92(a)(4) |
The Surgic Pro2 consists of the Control Unit, the Foot Control, Motor and accessories. The Control Unit drives the Motors during procedures and is used to control the functions related to the Motor such as rotational direction. The Foot Control provides the user with "hands-free" control of the coolant flow, program selection, forward/reverse rotational direction, and speed during operation. Two models of the Motor with Motor cord are available, SGL80M Optic Motor. The SGL80M Optic Motor. The SGL80M Optic Motor
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contains LED illumination of over 32,000 LUX. Each Motor is included with each series set in accordance to the client's specific needs and requirements.
The Surgic Pro2 is intended for use in dental implant. The main unit is designed to be used with a specific dental micromotor that drives dental handpieces fitted with appropriate tools to cut hard tissues in the mouth.
Features of this product are Bluetooth connectivity with a Foot Control, "Osseo 100+" ISQ measurement device *, and other company's products "iPad". The ISQ values measured by the "can be displayed on the Surgic Pro2 control unit. The "iPad" can display information on the control unit including ISQ values on the dedicated application for Surgic Pro2. The displayed information can be stored in the iPad.
- The ISQ value is measured by the Osseo100+ and the ISQ value displayed on the display of the SurgicPro2 connected via Bluetooth.
The product is provided unsterilized, and the motors are washed and sterilized at a medical institution, and used repeatedly. The product has no bio-contact components.
Intended Use/Indications for Use
21 CFR 807.92(a)(5)
The Surgic Pro2 is intended for use in dental implant. The main unit is designed to be used with a specific dental micromotor that drives dental handpieces fitted with appropriate tools to cut hard tissues in the mouth.
Indications for Use Comparison
Both the Indications for Use for the subject device and the Indications for Use for the predicate device are intended for dental applications, including dental oral surgery and dental implant. The only difference between the Indications for Use is the Device Name
Technological Comparison
The Surgic Pro2 is an AC-electrically powered dental surgical system that transmits power to compatible handpieces and controls their functions. The software allows for the control of the device features such as brightness, coolant flow, rotation direction, program selection, calibration, speed, torque, and sound volume. Surgic Pro2 also provides Foot Control and connection to external devices via a Bluetoothe connection. The subject device shares these technical characteristics with the predicate and reference devices. The proposed device also has some differences in technological characteristics from those of the predicate and reference devices. These differences are only minor, such as basic shape, structure, Bluetooth version, and removal of some accessories, and reflect user preferences, market strategies, and version updates, and do not affect the substantial equivalence of the subject device.
Non-Clinical and/or Clinical Tests Summary & Conclusions 21 CFR 807.92(b)
For Surgic Pro2, the following non-clinical tests were performed to support substantial equivalence of the subject device. Performance Test:
The Surgic Pro2 subject instrument was subjected to verification and validation testing for motor performance, reprocessing, software, electrical safety, EMC, and cybersecurity to support substantial equivalence. The results of the exith the requirements of the following standards and guidance.
· ISO 14457:2017 "Dentistry - Handpieces and motors"
· ISO 17665-1.2006 "Sterilization of health care products - Moist heat - Part 1: Requirements for the development validation and routine control of a sterilization process for medical devices"
• ISO 17664-1:2021 "Processing of health care products - Information to be provided by the medical device manufacturer for the processing of medical devices - Part 1: Critical and semi-critical medical devices"
· ISO 17664-2:2021 "Processing of health care products - Information to be provided by the medical device manufacturer for the processing of medical devices - Part 2: Non-critical medical devices."
· IEC 62304:2006+AMD1:2015 "Medical device software - Software life cycle processes"
• IEC 60601-1:2005+AMD1:2012+AMD2:2020 "Medical electrical equirements for basic safety and essential performance"
· IEC 60601-1-2:2014 "Medical electrical equipments for basic safety and essential performance -
Collateral Standard: Electromagnetic disturbances - Requirements and tests"
· IEEE/ANSI C63.27:2021 "American National Standard forEvaluation of Wireless Coexistence"
· AAMI TIR57:2016 "Principles for medical device security - Risk management"
· IEC 81001-5-1:2021 "Health software and heath IT systems sfety, effectiveness and security - Part 5-1:Security - Activities in the procuct life cycle"
· FDA guidance document "Dental Handpieces - Premarket Notification [510(k)] Submissions"
- · FDA guidance document "Reprocessing Medical Devices in Health Care Settings: Validation Methods and Labeling"
- · FDA guidance document "Content of Premarket Submissions for Device Software Functions"
21 CFR 807.92(a)(6)
21 CFR 807.92(a)(5)
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· FDA guidance document "Cybersecurity in Medical Devices: Quality System Content of Premarket Submissions" Biocompatibility:
No biocompatibility test was required to support the substantial equivalence of the Surgic Pro2."
The performance test results support the substantial equivalence of the subject Surgic Pro2 to the precedent device.