(179 days)
K161957 W&H Implantmed SI-1015
Not Found
No
The device description and performance studies focus on mechanical and electrical functions, sterilization, and biocompatibility, with no mention of AI or ML capabilities.
No.
The device is used to cut maxilla/mandible during oral surgery and dental implant operations, which is an invasive procedure rather than a therapeutic one.
No
This device is described as an instrument for oral surgery and dental implant operations, primarily used to drive surgical tools for cutting the maxilla/mandible. Its function is to perform surgical procedures, not to diagnose conditions.
No
The device description explicitly lists multiple hardware components including a Control Unit, Foot Control, Micromotor, and Handpiece.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the device is for "dental implant" and "oral surgery." It describes the mechanical action of cutting bone (maxilla/mandible) using surgical drills and burs. This is a surgical procedure performed directly on the patient's body.
- Device Description: The description details the components (Control Unit, Foot Control, Micromotor, Handpiece) and their function in driving surgical tools for cutting bone. There is no mention of analyzing samples from the human body (like blood, urine, tissue, etc.) or providing diagnostic information based on such analysis.
- Lack of IVD Characteristics: The text does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples.
- Detecting or measuring substances in samples.
- Providing diagnostic information about a patient's health status based on sample analysis.
- Using reagents or calibrators.
The device is a surgical tool used for mechanical manipulation during dental procedures, not for in vitro diagnostic testing.
N/A
Intended Use / Indications for Use
Surgic Pro+ / Surgic Pro
The Surgic Pro+ / Surgic Pro 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.
The SG20 and X-SG20L
This medical device is for oral surgery and dental implant operation. This device is driven by an electronic micromotor for oral surgery and dental implant. The device is intended to transmit the rotation of the power source at different gear ratios, thereby moving instruments such as surgical burs or surgical drills to cut the maxilla / mandible during oral surgery and dental implant.
Product codes (comma separated list FDA assigned to the subject device)
EBW, KMW, EGS
Device Description
The Surgic Pro+ / Surgic Pro consists of the Control Unit, the Foot Control, Micromotor, Handpiece, and accessories for use with specific Motors. Components and accessories are included with each series set in accordance to the client's specific needs and requirements. The Control Unit drives the Motors during procedures and is used to control the functions related to the Motor such as rotational direction. The Control Unit is available without data storage capability or USB REC Key and USB flash drive socket for the Surgic Pro and with data storage capability and USB REC Key and USB flash drive socket for the Surgic Pro+ . The Surgic Pro+ has the same features as Surgic Pro with the addition of the USB data storage system.
The Handpieces included within this submission are intended for use in oral surgery and dental implant operation. This device is driven by an electronic micromotor for oral surgery and dental implant. The device is intended to transmit the rotation of the power source at different gear ratios, thereby moving instruments such as surgical burs or surgical drills to cut the maxilla / mandible during oral surgery and dental implant. Available Handpieces include Optic Ti-Max X-SG20L and Non-Optic S- Max SG20. Optic and non-optic contra angle Handpieces are available to be used with the Motors to ensure torque accuracy. The Handpieces are designed for use with surgical burs that are φ2.35mm and conform to Type 1 of ISO 1797-1 (EN ISO 1797) standard.
Two models of the Micromotor with Motor cord are available, SGL70M Optic Motor and SG70M Non-Optic Motor. The SGL70M Optic Motor contains LED illumination of over 32,000 LUX.
The Foot Control allows operation of all functions within the preset parameters without touching the control panel to avoid accidental activation of the Micromotor outside the present limit. The Foot Controller provides the user with "hands-free" control of the coolant flow, program selection, forward/reverse rotational direction selection, and speed during operation.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
maxilla / mandible, mouth
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
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)
The Surgic Pro+ / Surgic Pro was developed and is produced under considerations of all applicable technical standards, internal specifications, and FDA guidance documents. The product's conformance with applicable international and internal standards was verified in the course of bench testing. Tests were performed on the handpiece including verification/validation testing to internal functional specifications which demonstrated that the device is substantially equivalent. Sterilization has been validated in conformance to the FDA recognized consensus standard AAMI/ANSI/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." Documentation was provided demonstrating that the Surgic Pro+ / Surgic Pro complies with the FDA requirements stated in Guidance for the Reprocessing Medical Devices in Health Care Settings: Validation Methods and Labeling - Guidance for Industry and Food and Drug Administration Staff. Biocompatibility evaluations were selected in accordance with AAMI/ANSI/ISO 10993-1: "Biological evaluation of medical devices - Part 1: Evaluation and testing" and FDA Guidance "Use on International Standard ISO 10993, "Biological evaluation of medical devices - Part 1: Evaluation and Testing". Documentation was provided demonstrating compliance of the Surgic Pro+/Surgic Pro to all FDA requirements stated in Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices, including results of verification/validation plus traceability of verification/validation tests to software requirements and software risk hazards. Electrical safety was conducted and performed in accordance with IEC 60601-1. In addition, testing for conformity to ISO standard 14457 has been conducted.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
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.
K161957 W&H Implantmed SI-1015
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.
Not Found
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.
0
Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left, there is a symbol of the Department of Health & Human Services. To the right of the symbol, there is the FDA logo in blue, followed by the words "U.S. FOOD & DRUG" in a larger font and "ADMINISTRATION" in a smaller font below it, also in blue.
Nakanishi Inc. % Ms. Katie Reneson Regulatory Specialist Ken Block Consulting 800 East Campbell Road, Suite 202 Richardson, Texas 75081
June 19, 2018
Re: K173905
Trade/Device Name: Surgic Pro, Surgic Pro+ Regulation Number: 21 CFR 872.4200 Regulation Name: Dental Handpiece And Accessories Regulatory Class: Class I Product Code: EBW Dated: May 29, 2018 Received: May 31, 2018
Dear Katie Reneson:
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 of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820);
1
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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm.
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/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely.
Mary S. Runner -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
2
Indications for Use
510(k) Number (if known) K173905
Device Name Surgic Pro+ / Surgic Pro
Indications for Use (Describe)
Surgic Pro+ / Surgic Pro
The Surgic Pro+ / Surgic Pro 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 the mouth.
SG20/ X-SG20L
This medical device is for oral surgery and dental implant operation.
This device is driven by an electronic micromotor for oral surgery and dental implant. The device is intended to transmit the rotation of the power source at different gear ratios, thereby moving instruments such as surgical drills to cut the maxilla / mandible during oral surgery and dental implant.
Type of Use (Select one or both, as applicable)
2 Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.
FOR FDA USE ONLY
Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
3
510(k) SUMMARY
| Submitter: | NAKANISHI INC.
700 Shimohinata
Kanuma-Shi, Tochigi-Ken Japan 322-8666 |
|----------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Mr. Kimihiko Satoh
General Manager, Regulatory Affairs, R&D Division
TEL: +81-3-5828-7716
FAX: +81-3-5828-0064
k-satoh@nsk-nakanishi.co.jp |
| Date Prepared: | May 29, 2018 |
| Trade Name: | Surgic Pro+ / Surgic Pro |
| Common Name: | Controller, Foot, Handpiece And Cord
Handpiece, Rotary Bone Cutting
Handpiece, Contra- And Right-Angle Attachment, Dental |
| Classification Name: | Dental handpiece and accessories. |
| Regulation: | 21 CFR 872.4120 Class II |
| Product Code: | EBW, KMW, EGS |
| Predicate Device: | K161957 W&H Implantmed SI-1015 |
| Device Description: | The Surgic Pro+ / Surgic Pro consists of the Control Unit, the Foot Control,
Micromotor, Handpiece, and accessories for use with specific Motors. Components
and accessories are included with each series set in accordance to the client's specific
needs and requirements. The Control Unit drives the Motors during procedures and is
used to control the functions related to the Motor such as rotational direction. The
Control Unit is available without data storage capability or USB REC Key and USB
flash drive socket for the Surgic Pro and with data storage capability and USB REC
Key and USB flash drive socket for the Surgic Pro+ . The Surgic Pro+ has the same
features as Surgic Pro with the addition of the USB data storage system.
The Handpieces included within this submission are intended for use in oral surgery
and dental implant operation. This device is driven by an electronic micromotor for
oral surgery and dental implant. The device is intended to transmit the rotation of the
power source at different gear ratios, thereby moving instruments such as surgical
burs or surgical drills to cut the maxilla / mandible during oral surgery and dental
implant. Available Handpieces include Optic Ti-Max X-SG20L and Non-Optic S-
Max SG20. Optic and non-optic contra angle Handpieces are available to be used with
the Motors to ensure torque accuracy. The Handpieces are designed for use with
surgical burs that are φ2.35mm and conform to Type 1 of ISO 1797-1 (EN ISO 1797)
standard.
Two models of the Micromotor with Motor cord are available, SGL70M Optic Motor
and SG70M Non-Optic Motor. The SGL70M Optic Motor contains LED illumination
of over 32,000 LUX. |
The Foot Control allows operation of all functions within the preset parameters without touching the control panel to avoid accidental activation of the Micromotor
Image /page/3/Picture/4 description: The image shows a hand holding a blue pen-like object. The hand is wearing a white glove. The pen-like object has a unique design with sharp edges and a curved shape. The text "Powerful Partners" is visible at the bottom of the image.
4
Image /page/4/Picture/0 description: The image shows the NSK logo in white against a blue background. The letters "NSK" are written in a bold, sans-serif font. A white line is above the letters.
outside the present limit. The Foot Controller provides the user with "hands-free" control of the coolant flow, program selection, forward/reverse rotational direction selection, and speed during operation.
Indications for Use:
Surgic Pro+ / Surgic Pro
The Surgic Pro+ / Surgic Pro 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.
The SG20 and X-SG20L
This medical device is for oral surgery and dental implant operation. This device is driven by an electronic micromotor for oral surgery and dental implant. The device is intended to transmit the rotation of the power source at different gear ratios, thereby moving instruments such as surgical burs or surgical drills to cut the maxilla / mandible during oral surgery and dental implant.
Summary of Technological Characteristics:
The Surgic Pro+ / Surgic Pro is an AC-electrically powered dental surgical system that powers and controls the functions of the compatible handpiece attachments. The software allows for the control of the device features such as brightness, coolant flow, rotational direction, gear ratio, device programming, calibration, speed, torque, data recording, and sound volume. The proposed device shares technological characteristics with the predicate devices. The proposed device also has some differences in technological characteristics from those of the predicate devices. Any differences in the technological characteristics are minor and reflect market strategy and/or perceived user preferences and do not impact the substantial equivalence of the device.
| | Proposed Device: NAKANISHI Inc.
[K173905] | Predicate Device: W&H
[K161957] |
|-----------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Trade Name | Surgic Pro+
Surgic Pro | Implantmed SI-1015 |
| Indication for
Use | Surgic Pro+ / Surgic Pro
The Surgic Pro+ / Surgic Pro 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. | 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. |
| Indication for
Use | SG20/ X-SG20L
This medical device is for oral surgery and dental
implant operation. This device is driven by an
electronic micromotor for oral surgery and dental
implant. The device is intended to transmit the
rotation of the power source at different gear
ratios, thereby moving instruments such as
surgical burs or surgical drills to cut the maxilla /
mandible during oral surgery and dental implant. | |
| Package
Contents | Control Unit
Micromotor (Optic or Non-Optic)
Foot Controller
Handpiece (Optic or Non-Optic)
Irrigation tube (5 pcs)
Operation Manual | Control Unit
Micromotor
Foot Controller (wired or wireless)
Irrigation Tube
Operation Manual |
| Memory | 8 Pre-set implant systems
8 user defined
of 8 steps each | 5 programs for various stages of
implantology. Programs 1-3 are for adjusting
speed and programs
Programs 4-5 are adjusting the torque |
Page 2 of 3
Image /page/4/Picture/10 description: In this image, a hand wearing a white glove is holding a blue surgical instrument. The instrument appears to be a type of forceps or clamp, with a unique design featuring angled arms and a pointed tip. The hand is positioned as if using the instrument for a precise task. The text "Powerful Partners" is at the bottom of the image.
Headquarters : 700 Shimohihata Kanuma-shi Tochigi 322-8666, Japan NAKANISHI INC. Tokyo Office : MY Building 1-13-3 Ueno Taito-ku Tokyo 110-0005, Japan www.nsk-inc.com
5
| Data Storage
Output | USB
.csv and .bmp formats | USB
.csv and .pdf formats |
|-----------------------------------------|--------------------------------|--------------------------------|
| Micromotor
Torque | 5 - 80Ncm | 5 - 80Ncm |
| Micromotor
Rotation
Speed Range | 200-40,000 min-1 | 200-40,000 rpm |
| Handpiece
Coupling | ISO 3964 | ISO 3964 |
| Handpiece
Chuck
Mechanism | Push-button | Push-button |
| Bur | Ø 2.35mm/ Type 1
(ISO 1797) | Ø 2.35mm/ Type 1
(ISO 1797) |
| Foot Control
Degree of
Protection | IPX8 | IPX8 |
Performance Testing:
The Surgic Pro+ / Surgic Pro was developed and is produced under considerations of all applicable technical standards, internal specifications, and FDA guidance documents. The product's conformance with applicable international and internal standards was verified in the course of bench testing. Tests were performed on the handpiece including verification/validation testing to internal functional specifications which demonstrated that the device is substantially equivalent. Sterilization has been validated in conformance to the FDA recognized consensus standard AAMI/ANSI/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." Documentation was provided demonstrating that the Surgic Pro+ / Surgic Pro complies with the FDA requirements stated in Guidance for the Reprocessing Medical Devices in Health Care Settings: Validation Methods and Labeling - Guidance for Industry and Food and Drug Administration Staff. Biocompatibility evaluations were selected in accordance with AAMI/ANSI/ISO 10993-1: "Biological evaluation of medical devices - Part 1: Evaluation and testing" and FDA Guidance "Use on International Standard ISO 10993, "Biological evaluation of medical devices - Part 1: Evaluation and Testing". Documentation was provided demonstrating compliance of the Surgic Pro+/Surgic Pro to all FDA requirements stated in Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices, including results of verification/validation plus traceability of verification/validation tests to software requirements and software risk hazards. Electrical safety was conducted and performed in accordance with IEC 60601-1. In addition, testing for conformity to ISO standard 14457 has been conducted.
- NAKANISHI INC. considers the Surgic Pro+ / Surgic Pro to be substantially Conclusion: equivalent to the predicate device listed above. This conclusion is based on the similarities in intended use, principals of operation, functional design, and established medical use.
Page 3 of 3
Image /page/5/Picture/5 description: In the image, a hand wearing a white glove is holding a blue plastic tool. The tool has a pointed end and a wider, flat end. The hand is holding the tool at an angle, and the background is blurred. The text "Powerful Partners" is visible at the bottom of the image.