P300 Attachment

K202120 · Nakanishi, Inc. · HBE · Oct 22, 2021 · Neurology

Device Facts

• Record ID: K202120
• Device Name: P300 Attachment
• Applicant: Nakanishi, Inc.
• Product Code: HBE · Neurology
• Decision Date: Oct 22, 2021
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 882.4310
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The P300 Attachment is intended to be used with electric and pneumatic surgical instruments and cutting accessories for cutting, drilling, removal, and shaping of bone in the procedures of: Neuro, Spine, Orthopedic, and General Surgery. NSK Sterile Cutting Accessory(ies) is for single use only. This device is intended for use, in conjunction with P300 Attachment, in cutting, drilling, removal, and shaping of bone in the procedures of: Neuro, Spine, Orthopedic, ENT, Maxillofacial, and General Surgery.

Device Story

P300 Attachment is a powered surgical instrument accessory designed for use with the Primado2 Total Surgical System; system provides mechanical power to attachment. Device consists of Standard and Slim attachment families with various lengths and configurations (straight, angled, curved). Input is mechanical energy from surgical motor; output is rotation of cutting accessories (burs, drills) for bone manipulation. Used in OR by surgeons; device features non-slip grip and adjustable bur length. Benefits include precise bone shaping/removal in neuro, spine, orthopedic, ENT, and maxillofacial procedures. Device is non-sterile (reprocessable) or single-use (accessories).

Clinical Evidence

No clinical data included. Bench testing only. Biocompatibility testing (ISO 10993-5, -10, -11, -4) confirmed non-cytotoxic, non-sensitizing, non-irritating, non-toxic, non-pyrogenic, and non-hemolytic status. Reprocessing and sterilization validation performed per ISO 17664, ISO 17665-1, ANSI/AAMI ST79, and ISO 11137-2.

Technological Characteristics

Materials: stainless steel (SUS303, SUS304, SUS316F2), PEEK, Copper-Beryllium alloy, fluorocarbon rubber. Energy: mechanical (driven by motor). Form factor: straight/angled/curved attachments, 11-240mm lengths. Connectivity: none. Sterilization: Pre-vacuum (132°C, 4 min). Standards: ISO 10993, ISO 17664, ISO 11137, ASTM F756.

Indications for Use

Indicated for patients undergoing neuro, spine, orthopedic, ENT, maxillofacial, and general surgical procedures requiring bone cutting, drilling, removal, or shaping.

Regulatory Classification

Identification

Powered simple cranial drills, burrs, trephines, and their accessories are bone cutting and drilling instruments used on a patient's skull. The instruments are used with a power source but do not have a clutch mechanism to disengage the tip after penetrating the skull.

Predicate Devices

• Nakanishi Primado2 Total Surgical System (K132264)

Reference Devices

• Stryker MIS Attachments and Cutting Accessories (K143540)
• Stryker Elite and Heavy Duty (HD) Attachments (K143320)

Submission Summary (Full Text)

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March 29, 2022

Image /page/0/Picture/1 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left, there 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 FDA logo is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

Nakanishi Inc. % Gregory Woodard Biomedical Engineer Ken Block Consulting LLC 800 East Campbell Road, Suite 202 Richardson, Texas 75081

Re: K202120

Trade/Device Name: P300 Attachment; NSK Sterile Cutting Accessories Regulation Number: 21 CFR 882.4310 Regulation Name: Powered Simple Cranial Drills, Burrs, Trephines, and Their Accessories Regulatory Class: Class II Product Code: HBE, ERL, EOJ, HWE, GFF

Dear Gregory Woodard:

The Food and Drug Administration (FDA) is sending this letter to notify you of an administrative change related to your previous substantial equivalence (SE) determination letter dated October 22, 2021. Specifically, FDA is updating this SE letter to include the trade name and Indications for Use statement for the NSK Sterile Cutting Accessories as an administrative correction.

Please note that the 510(k) submission was not re-reviewed. For questions regarding this letter, please contact Adam Pierce, Ph.D., OHT5: Office of Neurological and Physical Medicine Devices, 240-402-6128, Adam. [e-mail].

Sincerely,

## Xiaolin Zheng -S

Xiaolin Zheng, Ph.D. Director DHT5A: Division of Neurosurgical, Neurointerventional and Neurodiagnostic Devices OHT5: Office of Neurological and Physical Medicine Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

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Image /page/1/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.

October 22, 2021

Nakanishi Inc. % Gregory Woodard Ken Block Consulting LLC 800 East Campbell Road, Suite 202 Richardson. Texas 75081

Re: K202120

Trade/Device Name: P300 Attachment Regulation Number: 21 CFR 882.4310 Regulation Name: Powered Simple Cranial Drills, Burrs, Trephines, And Their Accessories Regulatory Class: Class II Product Code: HBE, ERL, HWE Dated: September 21, 2021 Received: September 22, 2021

Dear Gregory Woodard:

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 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

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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(@tda.hhs.gov) or phone [phone] or 301-796-7100).

Sincerely,

# Adam D. Pierce -S

Adam D. Pierce, Ph.D. Assistant Director Neurosurgical Devices Team Division of Neurosurgical, Neurointerventional and Neurodiagnostic Devices Office of Health Technologies 5, Neurological & Physical Medicine Devices Office of Product Evaluation & Ouality Center for Devices and Radiological Health U.S. Food and Drug Administration

Enclosure

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## Indications for Use

510(k) Number (if known) K202120

Device Name

P300 Attachment; NSK Sterile Cutting Accessories

Indications for Use (Describe)

The P300 Attachment is intended to be used with electric and pneumatic surgical instruments and cutting accessories for cutting, drilling, removal, and shaping of bone in the procedures of: Neuro, Spine, Orthopedic, and General Surgery.

NSK Sterile Cutting Accessory(ies) is for single use only. This device is intended for use, in conjunction with P300 Attachment, in cutting, drilling, removal, and shaping of bone in the procedures of: Neuro, Spine, Orthopedic, ENT, Maxillofacial, and General Surgery.

| Type of Use (Select one or both, as applicable) | |
|----------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------|
| <div> <span> ☑ Prescription Use (Part 21 CFR 801 Subpart D) </span> </div> | <div> <span> ☐ Over-The-Counter Use (21 CFR 801 Subpart C) </span> </div> |

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# K202120 510(k) SUMMARY

| Submitter: | NAKANISHI INC.<br>700 Shimohinata<br>Kanuma, Tochigi 322-8666 Japan | | |
|--------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------|------------------------------------------------------------------------------|
| Contact Person: | Mr. Masaaki Kikuchi<br>General Manager, Quality/Regulatory Affairs Dept.<br>TEL: [phone]<br>FAX: [phone]<br>[e-mail] | | |
| Date Prepared: | March 25, 2022 | | |
| Submission Type: | Traditional 510(k) Submission | | |
| Trade Name: | P300 Attachment; NSK Sterile Cutting Accessories | | |
| Classification Name: | Powered Simple Cranial Drills, Burrs, Trephines, and Their Accessories | | |
| Primary<br>Classification: | HBE | 882.4310 | Drills, Burs, Trephines & Accessories (Simple, Powered) |
| Subsequent<br>Classifications: | ERL | 874.4250 | Drill, Surgical, ENT (Electric or Pneumatic), Including Handpiece |
| | EQJ | 874.4140 | Bur, Ear, Nose and Throat |
| | HWE | 878.4820 | Instrument, Surgical, Orthopedic, AC-Powered, Motor and Accessory/Attachment |
| | GFF | 878.4820 | Bur, Surgical, General & Plastic Surgery |
| Predicate Device: | Nakanishi Primado2 Total Surgical System<br>510(k) Number: K132264<br>Product Codes: HBC, ERL<br>Product Codes for Accessories: DZI, DZJ, ERL, GEY, HBC, HBE, HWE, GFF, EQJ | | |
| Reference Devices: | Stryker MIS Attachments and Cutting Accessories<br>510(k) Number: K143540<br>Product Codes: HBE<br>Subsequent Product Code: ERL<br><br>Stryker Elite and Heavy Duty (HD) Attachments<br>510(k) Number: K143320<br>Product Code: HBE<br>Secondary Product Codes: ERL, HBB, DZI | | |

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### K202120

510(k) SUMMARY Device Description: The P300 Attachment is a powered bone cutting and drilling instruments designed to be used with the Primado2 Total Surgical System (K132264), which provides mechanical power to the attachment. The P300 Attachment is comprised of two families: Standard Attachment 300 and Slim Attachment 300. The Standard Attachment 300 and Slim Attachment 300 consist of angled and straight types of attachments with varying lengths. The Standard Attachment 300 is an attachment to the Primado2 Total Surgical System that can be in either a straight or angled configuration and comes in 5 different tube lengths, ranging from 12 mm to 79 mm. Accessories compatible with the Standard Attachment 300 include 52 NSK Sterile Cutting Accessories, a STD Attachment Beak, and 4 Irrigation Nozzles. The Slim Attachment 300 consists of 2 parts, a Slim Attachment Hub that comes in 2 configurations (straight or angled) and a Slim Tube that comes in 8 configurations and varies in tube lengths from 110 mm to 240 mm, and can be straight, curved, or angled. Accessories compatible with the Slim Attachment 300 include 49 NSK Sterile Cutting Accessories, a Slim Tube Beak and a Slim Tube Hood, and 2 Irrigation Nozzles. The Standard Attachment 300 and Slim Attachment 300 share the same Cleaning Tools for automated cleaning, manual cleaning, and purging. For both the Standard Attachment 300 and the Slim Attachment 300, the length of the bur can be adjusted in six levels. Both the Standard and Slim attachments include a non-slip surface etching on the grip. The attachments consist of stainless steel, polytetrafluoroethylene, Copper-Beryllium Alloy, fluorocarbon rubber, and PEEK. Indication for Use: The P300 Attachment is intended to be used with electric and pneumatic surgical instruments and cutting accessories for cutting, drilling, removal, and shaping of bone in the procedures of: Neuro, Spine, Orthopedic, ENT, Maxillofacial, and General Surgery. NSK Sterile Cutting Accessory(jes) is for single use only. This device is intended for use, in conjunction with P300 Attachment, in cutting, drilling, removal, and shaping of bone in the procedures of: Neuro, Spine, Orthopedic, ENT, Maxillofacial, and General Surgery. Summary of As with the attachments in the predicate device referenced above, the P300 Technological Attachment includes standard and slim attachments for use with the Primado2 Characteristics: Total Surgical System. Comparisons with the predicate device show the characteristics of the proposed device to the P300 Attachment to be substantially equivalent to the predicate device. Any differences in the technological characteristics are minor and reflect market strategy and/or perceived user preferences and do not impact the safety, effectiveness, or substantial equivalence of the device. The following table summarizes the comparison of the proposed device with the predicate device for indications for use and technological characteristics.

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Image /page/6/Picture/0 description: The image shows the logo for NSK, a Japanese manufacturer of bearings. The logo consists of the letters "NSK" in a bold, sans-serif font. The letters are white and are set against a blue background. A white swoosh-like shape is above the letters, adding a dynamic element to the design.

# K202120 510(k) SUMMARY

| | Proposed Device | Predicate Device | | |
|---------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------|-----------|
| Trade Name | P300 Attachment; NSK Sterile<br>Cutting Accessories | Primado2 | | |
| 510(k) Submitter<br>[Number] | NAKANISHI INC.<br>[K202120] | NAKANISHI INC.<br>[K132264] | | |
| Indications for<br>Use | The P300 Attachment is intended to<br>be used with electric and pneumatic<br>surgical instruments and cutting<br>accessories for cutting, drilling,<br>removal, and shaping of bone in the<br>procedures of: Neuro, Spine,<br>Orthopedic, ENT, Maxillofacial,<br>and General Surgery. | The Primado2 is an AC-electrically<br>powered total surgical system that is<br>intended for cutting, drilling,<br>sawing, and otherwise manipulating<br>soft tissue, hard tissue, bone, bone<br>cement, prosthesis, implant, and<br>other bone related tissue in a variety<br>of surgical procedures, including<br>but not limited to Cranial<br>(Craniofacial/ Maxillofacial), ENT,<br>Endoscopic /Arthroscopic, Neuro,<br>Orthopedic, Spinal, and General<br>surgical procedures. | SIMILAR | |
| Sterile Cutting<br>Accessories<br>Indications for<br>Use | NSK Sterile Cutting Accessory(ies)<br>is for single use only. This device is<br>intended for use, in conjunction<br>with P300 Attachment, in cutting,<br>drilling, removal, and shaping of<br>bone in the procedures of: Neuro,<br>Spine, Orthopedic, ENT,<br>Maxillofacial, and General Surgery. | NSK sterilized disposable products<br>(burs, saw blades and rasps) are<br>intended for use in bone surgery. | SIMILAR | |
| Product Codes | HBE, ERL, HWE, GFF, EQJ | HBC, ERL<br>Accessories:<br>DZI, DZJ, ERL, GEY, HBC, HBE,<br>HWE, GFF, EQJ | SIMILAR | |
| Attachments to be<br>Used with | Primado2 | Primado2 | IDENTICAL | |
| Types of<br>Attachments | Standard Attachment Series<br>Slim Attachment Series | Slim Attachment Series<br>Super Slim Attachment Series<br>Standard Angled Attachment Series<br>Standard Straight Attachment Series<br>Perforator/Craniotome Attachment<br>Series<br>High Speed Attachment Series<br>Contra Angle Attachment Series | SIMILAR | |
| Energy source to<br>attachments | Mechanical energy from attached<br>motor | Mechanical energy from attached<br>motor | IDENTICAL | |
| Maximum rotation | 80,000 min-1 | 80,000 min-1 | IDENTICAL | |
| Attachment Direct<br>or Indirect Patient<br>Contacting<br>Materials | SUS303, SUS304, SUS316F2,<br>SUS316F2 (TiCN), PEEK | SUS303, SUS304, SUS316F2,<br>SUS316F2 (TiCN), C3604B (NiCr),<br>SUS416F, SUS420J2, C5441B,<br>C5191B, SUS416, SUS420F,<br>ACD34, SUSNSK1 (TiCN), FKM | MODIFIED | |
| Types of Cutting<br>Accessories for<br>Attachments | Burs<br>Drills | Burs<br>Drills<br>Saws<br>Rasps | SIMILAR | |
| Outer Diameters<br>of Cutting<br>Accessories (Burs,<br>Drills) | Ф0.6-7.5 mm | Ф0.6-9.1 mm | SIMILAR | |
| Cleaning<br>Accessories | Yes | No | MODIFIED | |
| Adjustable Bur<br>Length | Yes | No | MODIFIED | |
| Lubrication | PANA Spray Plus (K163483) | PANA Spray Plus (K163483) | IDENTICAL | |
| | Automatic Cleaning<br>Or<br>Manual Cleaning | Automatic Cleaning<br>Or<br>Manual Cleaning | | |
| Cleaning | | | IDENTICAL | |
| Sterilization | Pre-Vacuum<br>(Dynamic Air Removal)<br>132 °C, 4 min.<br>Drying Time: 20 min. | Pre-Vacuum<br>(Dynamic Air Removal)<br>134 °C, 3 min.<br>Gravity Displacement<br>132 °C, 15 min | MODIFIED | |
| | Use Environment | Temperature: 0 - 40 °C<br>Humidity: 30 - 75 % | Temperature: 0 - 40 °C<br>(no condensation)<br>Humidity: 30 - 75 %<br>Atmospheric Pressure:<br>700 - 1,060 hPa | MODIFIED |
| | Store and<br>Transportation<br>Environment | Temperature: -10 - 50 °C<br>Humidity: 10 - 85 %<br>Atmospheric Pressure:<br>500 - 1,060 hPa | Temperature: -10 - 50 °C<br>Humidity: 10 - 85 %<br>Atmospheric Pressure:<br>500 - 1,060 hPa | IDENTICAL |
| Biocompatibility<br>Testing | Cytotoxicity<br>Sensitization<br>Intracutaneous Reactivity<br>Acute Systemic Toxicity<br>Material-Mediated Pyrogenicity<br>Indirect (Extract) Hemolysis | Cytotoxicity<br>Sensitization<br>Intracutaneous Reactivity<br>Acute Systemic Toxicity<br>Material-Mediated Pyrogenicity | MODIFIED | |

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# K202120 510(k) SUMMARY

The Operation Manuals provide detailed instructions and information for safe and effective use of the device and users are expected to adhere to the instructions and other information. The User's Manual explains how to use the Surgical System and other equipment. Connected medical equipment must comply with IEC 60601-1. Before using the product, be sure to read the manual thoroughly in order to utilize it more effectively.

Performance: Non-clinical bench performance testing was performed on the P300 Attachment and NSK Sterile Cutting Accessories including verification/validation testing to internal functional specifications which demonstrated that the device is as safe and effective as the predicate device.

> The nature and duration of tissue contact for the device was determined to be limited (< 24 hour) contact with tissue, bone, and cerebrospinal fluid. Evaluations and validations for the P300 Attachment were conducted on the Slim Attachment 300, consisting of parts of each product family that were considered to be worst-case (Slim Attachment Hub P300-1AHS, Slim Tube P300-1T170, Slim Tube Hood P300-1T-H, Irrigation Nozzle P200-IN-1A175, and Bur PDS-1RD170-50), and demonstrate compliance to the applicable standards for biocompatibility (ISO 10993-1:2018, ISO 10993-5:2009, ISO 10993-10:2010, ISO 10993-11:2017). Also, indirect (extract) hemolysis testing performed in accordance with ASMT F756:2017 and ISO 10993-4:2017 using the worst-case representative models demonstrated that the P300 Attachment is non-hemolytic. Biocompatibility testing conducted is summarized in the table below.

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Image /page/8/Picture/0 description: The image shows the logo for NSK, a company that specializes in bearings and motion control technology. The logo consists of the letters "NSK" in a bold, sans-serif font. The letters are white and are set against a blue background. A white line extends over the top of the letters, creating a sense of movement and dynamism.

## K202120 510(k) SUMMARY

| Test | Result | Conclusion |
|--------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------|
| Cytotoxicity Test /<br>Colony Formation<br>Method<br>[ISO 10993-5] | Cell culture treated with test sample<br>exhibited slight reactivity (Grade 1) | Non-cytotoxic |
| Cytotoxicity Test / Colony<br>Formation Method<br>[ISO 10993-5]<br>(after maximum cleaning/<br>disinfection cycle) | Cell culture treated with test sample<br>exhibited no reactivity (Grade 0) | Non-cytotoxic |
| Sensitization Test / GPMT<br>Method<br>[ISO 10993-10] | The test article extracts showed no evidence<br>of causing delayed dermal contact<br>sensitization. | Non-sensitization |
| Intracutaneous Reactivity<br>Test [ISO 10993-10] | All animals appeared normal throughout the<br>study. All injection sites appeared normal<br>immediately following injection. | Non-irritability |
| Acute Systemic Toxicity<br>Test [ISO 10993-11] | There was no mortality or evidence of<br>systemic toxicity from the extracts injected<br>into mice. | Non-toxic |
| Material-Medicated<br>Pyrogenicity Test [ISO<br>10993-11] | The total rise of rabbit temperatures during<br>the 3-hour observation period was within<br>acceptable USP requirements. The test article<br>met the requirements for the absence of<br>pyrogens. | Non-pyrogenic |
| Indirect (Extract) Hemolysis<br>Test<br>[ASTM F756 & ISO<br>10993-4] | The hemolytic index for the test article extract<br>indicated the hemolytic grade was within the<br>non-hemolytic range. | Non-hemolytic |

Testing for the P300 Attachment was also conducted and demonstrated compliance to the applicable standards for reprocessing (ISO 17664:2017, ISO 17665-1:2006, ANSI/AAMI ST79:2017). Testing for the NSK Sterile Cutting Accessories was also conducted and demonstrated compliance to the applicable standard for sterilization (ISO 11137-2:2013).

The P300 Attachment and the NSK Sterile Cutting Accessories contain no software or electrical components, so no software or electrical safety and electromagnetic compatibility testing is included in this submission. No clinical data is included in this submission.

- Conclusion: The non-clinical bench performance testing data support the safety of the P300 Attachment and the NSK Sterile Cutting Accessories and the verification and validation demonstrate that the P300 Attachment and NSK Sterile Cutting Accessories are as safe and effective as the predicate and reference devices and performs as intended in the specified use conditions. Based on the similarities in intended use, principles of operation, functional design, and non-clinical bench performance testing data, the P300 Attachment and NSK Sterile Cutting Accessories are substantially equivalent to the predicate device listed above.