(215 days)
The Surgical Straight/Angle Handpiece Series is intended for use by licensed professionals for oral surgical and dental use. Typical uses include sectioning and removal of wisdom teeth, oral surgery (such as root tip resection. bone removal, bone shaping) and implant treatment (such as drilling the maxilla and mandible).
The Surgical Straight/Angle Handpiece features an allowable maximum motor speed at 40,000min-1. The handpieces are provided non-optic. The handpieces are designed with an angle appearance and a straight appearance. Models are available to be connected directly onto motors compliant to ISO 3964. All the devices are manufactured using stainless steel with some aluminum, and use a Bur Lock Ring Chuck Design. Available models include: Straight (1:1)- SGS-E, SGS-ES; Straight (1:2) - SGS-E2G, SGS-E2S; Angled (1:1) - SGA-E, SGA-ES; Angled (1:2) - SGA-E2G, SGA-E2S.
The provided text is a 510(k) summary for the "Nakanishi Inc. Surgical Straight/Angle Handpiece." This document describes a medical device seeking substantial equivalence to existing devices, not an AI/ML powered device. As such, it does not contain information related to acceptance criteria or studies involving AI/ML algorithms, human readers, ground truth, or training sets.
Therefore, I cannot extract the requested information regarding acceptance criteria and studies that prove an AI/ML device meets them from the given text.
The document discusses:
- Device Name: Surgical Straight/Angle Handpiece
- Intended Use: Oral surgical and dental use (e.g., sectioning and removal of wisdom teeth, oral surgery, implant treatment).
- Technological Characteristics: Maximum motor speed, non-optic, Bur Lock Ring Chuck Design, materials (stainless steel, aluminum), external water supply.
- Performance Testing: Bench testing against technical standards and internal specifications, sterilization validation (AAMI/ANSI/ISO 17665-1:2006, FDA Guidance for Reprocessing Medical Devices), biocompatibility evaluation (AAMI/ANSI/ISO 10993-1, FDA Guidance), and electrical safety (ISO 14457).
- Conclusion: The device is considered substantially equivalent to predicate devices based on similarities in intended use, principles of operation, functional design, and established medical use.
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November 21, 2017
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services seal on the left and the FDA acronym with the full name of the agency on the right. The FDA part of the logo is in blue, with the acronym in a blue square and the full name written out to the right of it. The full name reads "U.S. Food & Drug Administration".
Nakanishi Inc. c/o Belia Juarez Regulatory Project Manager Ken Block Consulting 1201 Richardson Dr. Richardson, Texas 75080
Re: K171155
Trade/Device Name: Surgical Straight/Angle Handpiece Regulation Number: 21 CFR 872.4120 Regulation Name: Bone Cutting Instrument and Accessories Regulatory Class: Class II Product Code: KMW, EGS Dated: October 20, 2017 Received: October 23, 2017
Dear Belia Juarez:
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);
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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 the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
For comprehensive regulatory information about mediation-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
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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below.
510(k) Number (if known) K171155
Device Name Surgical Straight/Angle Handpiece
Indications for Use (Describe)
The Surgical Straight/Angle Handpiece Series is intended for use by licensed professionals for oral surgical and dental use. Typical uses include sectioning and removal of wisdom teeth, oral surgery (such as root tip resection. bone removal, bone shaping) and implant treatment (such as drilling the maxilla and mandible).
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)
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FOR FDA USE ONLY
Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)
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NSI
←5. 510(k) SUMMARY
| Submitter: | NAKANISHI INC.700 ShimohinataKanuma-Shi, Tochigi-Ken Japan 322-8666 | ||
|---|---|---|---|
| Contact Person: | NAKANISHI INC.Mr. Kimihiko SatohGeneral Manager, Regulatory Affairs DeptTEL: +81-0289-64-3380FAX: +81-0289-62-6665k-satoh@nsk-nakanishi.co.jp | ||
| Date Prepared: | November 20, 2017 | ||
| Trade Name: | Surgical Straight/Angle Handpiece | ||
| Common Name: | Handpiece, Rotary Bone CuttingHandpiece, Contra-and Right-Angle Attachment, Dental | ||
| Classification Name: | Bone Cutting Instrument and Accessories | ||
| Regulation: | 21 CFR 872.4120Class II | ||
| Product Code: | KMW and EGS | ||
| Predicate Devices: | Primary: K111532 Anthogyr SAS | MontBlanc Surgical Contra-Angle Handpiece and Straight HandpieceSecondary: K970953 NAKANISHI INC.E-Type Speed Reducer Contra Angle | |
| DeviceDescription: | The Surgical Straight/Angle Handpiece features an allowable maximum motor speedat 40,000min-1. The handpieces are provided non-optic. The handpieces are designedwith an angle appearance and a straight appearance. Models are available to beconnected directly onto motors compliant to ISO 3964. All the devices aremanufactured using stainless steel with some aluminum, and use a Bur Lock RingChuck Design. Available models include: Straight (1:1)- SGS-E, SGS-ES; Straight(1:2) - SGS-E2G, SGS-E2S; Angled (1:1) - SGA-E, SGA-ES; Angled (1:2) - SGA-E2G, SGA-E2S. | ||
| Indicationsfor Use: | The Surgical Straight/Angle Handpiece Series is intended for use by licensedprofessionals for oral surgical and dental use. Typical uses include sectioning andremoval of wisdom teeth, cutting teeth, oral surgery (such as root tip resection, boneremoval, bone shaping) and implant treatment (such as drilling the maxilla andmandible). | ||
| Summary ofTechnologicalCharacteristics: | As with the predicate devices referenced above, the Surgical Straight/Anglehandpieces are intended for oral surgical and dental use. The handpieces are poweredby either an air-motor or electronic micro motors compliant to ISO 14457 withcouplings compliant to [ISO 3964 (EN ISO 3964)]. Friction Grip Burs that conform tostandard ISO 1797-1 (EN ISO 1797) are to be used with the Surgical Straight/AngleHandpieces. The allowable maximum motor speed rotation for the handpieces shouldbe set at 40,000min-1. The handpieces are provided non-optic. Overall dimensions,weight, angle, and gear ratio vary due to the differences in the device's compatibility. |
Image /page/3/Picture/6 description: In the image, a hand wearing a white glove is holding a blue plastic tool. The tool appears to be designed for a specific purpose, possibly related to crafting or assembly. The hand is positioned in a way that suggests the tool is being used or demonstrated. The text "Powerful Partners" is visible at the bottom of the image.
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The handpieces overall length varies between 108.7mm-135mm depending on the model. The handpieces feature a Bur Lock Ring Chuck Design. The Surgical Straight/Angle Handpieces are provided non-sterile, so it must be sterilized prior to first use and sterilized after each subsequent use using steam sterilization (moist heat sterilization). All models feature an external water supply irrigation nozzle that is provided with the handpiece. The handpieces are composed of Stainless Steel and Aluminum and the water lines are composed of Stainless Steel (Grade SUS304T.)
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 does not impact the substantial equivalence of the device.
| Proposed: NAKANISHI INC.K171155 | Predicate: ANTHOGYR SAS[K111532] | |
|---|---|---|
| Trade Name | Surgical Straight/Angle Handpiece | MontBlanc Surgical Contra-AngleHandpiece and Straight Handpiece |
| Models | SGA-E, SGA-ES, SGA-E2G, SGA-E2SSGS-E, SGS-ES, SGS-E2G, SGS-E2S | 12200X, 12200XL, 12200XLED, 12400X,12400XLED |
| Indication for Use | The Surgical Straight/Angle HandpieceSeries is intended for use by licensedprofessionals for oral surgical and dentaluse. Typical uses include sectioning andremoval of wisdom teeth, cutting teeth,oral surgery (such as root tip resection,bone removal, bone shaping...) andimplant treatment (such as drilling themaxilla and mandible). | Indications are very widespread in thefield of implantology and surgery. Thementioned handpieces have beendeveloped especially for the followingapplications:-MontBlac Surgical Contra-anglehandpiece: for e.g. hemisection, wisdomtooth extraction.-MontBlac Surgical Straight handpiece:for e.g. application in the area of thefront teeth, root tip, resection, boneremoval, osteotomy on the upper andlower jaw, preprosthetic surgicalosteoplasty, sequestrum removal,fenestration on the alveolar appendix,opical ventilation, bone osteoplasty,bone smoothing |
| Handpiece Type | Straight, 20° Angle | Straight, Contra Angle |
| Operational Mode(s)Motor Connection | ISO 3964 motor connection | ISO 3964 motor connection |
| Weight | 59.5g to 103.5g | 125g straight98g contra-angle |
| Coupling Type | ISO 3964 Coupling | ISO 3964 Coupling |
| Burs | ISO 1797-1Type 2 | EN ISO 1797-1Contra: Type 3 Straight: Type 1 or 2 |
| Max Rotation Speed(motor) | $40,000min^{-1}$ | $40,000min^{-1}$ |
| Max rotation speed(handpiece) | $40,000min^{-1} to 80,000min^{-1}$ | $40,000min^{-1}to 120,000min^{-1}$ |
| Gear Ratio | 1:1 Direct Drive, 1:2 Increasing | 1:1 Direct Drive, 1:3 Increasing |
Summary of Performance Testing:
The Surgical Straight/Angle Handpiece 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 -
Image /page/4/Picture/6 description: In this image, a hand wearing a white glove is holding a blue medical device. The device appears to be some type of surgical instrument, possibly a clamp or forceps. The hand is positioned as if it is in the process of using the device. The text "Powerful Partners" is visible at the bottom of the image.
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Image /page/5/Picture/0 description: The image shows the logo for NSK, a Japanese manufacturer of bearings. The logo is white and is set against a blue background. The letters "NSK" are in a bold, sans-serif font, with the "N" and "S" connected by a curved line.
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 Surgical Straight/Angle Handpiece 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". In addition, testing for electrical safety was performed in accordance with ISO 14457.
Conclusion: NAKANISHI INC. considers the Surgical Straight/Angle Handpiece to be substantially equivalent to the predicate devices listed above. This conclusion is based on the similarities in primary intended use, principles of operation, functional design, and established medical use.
Section 5: Page 3 of 3
Image /page/5/Picture/3 description: The image shows a hand wearing a white glove holding a blue surgical instrument. The instrument appears to be a type of surgical dissector or similar tool, with a pointed tip and a handle designed for precise manipulation. The text "Powerful Partners" is visible at the bottom of the image, suggesting the instrument is part of a medical product line or partnership.
§ 872.4120 Bone cutting instrument and accessories.
(a)
Identification. A bone cutting instrument and accessories is a metal device intended for use in reconstructive oral surgery to drill or cut into the upper or lower jaw and may be used to prepare bone to insert a wire, pin, or screw. The device includes the manual bone drill and wire driver, powered bone drill, rotary bone cutting handpiece, and AC-powered bone saw.(b)
Classification. Class II.