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 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.

AI/ML Overview

Here's an analysis of the acceptance criteria and study information for the P300 Attachment and NSK Sterile Cutting Accessories, based on the provided FDA 510(k) summary:

This device is not an AI/ML device, but a surgical attachment. Therefore, most of the requested AI/ML specific criteria (sample size for test set, data provenance, number of experts, adjudication, MRMC study, standalone performance, training set size and ground truth establishment for training set) are not applicable.

Acceptance Criteria and Reported Device Performance

The device appears to be a traditional medical device (Powered Simple Cranial Drills, Burrs, Trephines, and Their Accessories), and the FDA 510(k) summary focuses on demonstrating substantial equivalence to a predicate device through non-clinical bench testing, rather than a clinical study with traditional acceptance criteria for diagnostic performance metrics (e.g., sensitivity, specificity, AUC).

The acceptance criteria are implied by the successful completion of specific non-clinical tests and demonstrations of compliance with relevant standards. The "performance" section describes the results of these tests, which effectively serve as the reported device performance meeting the implicit acceptance criteria of the standards and internal specifications.

Acceptance Criteria (Implied)	Reported (Met) Device Performance
Biocompatibility:
- Non-cytotoxic (ISO 10993-5)	- Cell culture treated with test sample exhibited slight reactivity (Grade 1), and after maximum cleaning/disinfection cycle, exhibited no reactivity (Grade 0). Concluded as Non-cytotoxic.
- Non-sensitizing (ISO 10993-10)	- Test article extracts showed no evidence of causing delayed dermal contact sensitization. Concluded as Non-sensitization.
- Non-irritating (Intracutaneous Reactivity Test, ISO 10993-10)	- All animals appeared normal throughout the study. All injection sites appeared normal immediately following injection. Concluded as Non-irritability.
- Non-toxic (Acute Systemic Toxicity Test, ISO 10993-11)	- No mortality or evidence of systemic toxicity from the extracts injected into mice. Concluded as Non-toxic.
- Non-pyrogenic (Material-Medicated Pyrogenicity Test, ISO 10993-11)	- Total rise of rabbit temperatures during the 3-hour observation period was within acceptable USP requirements. Met requirements for absence of pyrogens. Concluded as Non-pyrogenic.
- Non-hemolytic (ASTM F756 & ISO 10993-4)	- Hemolytic index for the test article extract indicated the hemolytic grade was within the non-hemolytic range. Concluded as Non-hemolytic.
Reprocessing:
- Compliance with reprocessing standards (ISO 17664, ISO 17665-1,	- Testing demonstrated compliance to applicable standards for reprocessing (ISO 17664:2017, ISO 17665-1:2006, ANSI/AAMI ST79:2017).
ANSI/AAMI ST79)
Sterilization:
- Compliance with sterilization standard (ISO 11137-2)	- Testing demonstrated compliance to the applicable standard for sterilization (ISO 11137-2:2013).
Functional Performance:
- Meet internal functional specifications	- Verification/validation testing to internal functional specifications demonstrated that the device is as safe and effective as the predicate device. The conclusion states "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."
- Maximum Rotation: 80,000 min-1	- Reported as 80,000 min-1 (Identical to predicate).

Study Information

Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
- Sample Size: Not applicable. The "test set" in this context refers to samples used for non-clinical bench testing (e.g., cell cultures, animal models for biocompatibility, physical device units for functional testing). Specific numbers for these types of samples are not provided in the summary. For example, for the "Acute Systemic Toxicity Test," it mentions "mice" but not the count. The biocompatibility testing selected "worst-case representative models" (Slim Attachment 300, specific bur/nozzle models) for evaluation.
- Data Provenance: The manufacturing site for NAKANISHI INC. is listed as Kanuma, Tochigi 322-8666 Japan. The tests would likely have been conducted by or for the manufacturer. The FDA 510(k) summary does not specify the country of origin for the testing facilities, but it typically aligns with the manufacturer's region or accredited labs. All testing is prospective in nature, as it's conducted specifically for demonstrating the safety and effectiveness of the device being submitted.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience):
- Not applicable. This is a non-clinical submission for a surgical instrument. "Ground truth" in the context of expert consensus, as might be used for AI diagnostic devices, is not a concept applied here. The "truth" is established by adherence to recognized international and national standards (e.g., ISO, ASTM, ANSI/AAMI) for material safety, reprocessing, and sterilization, verified through laboratory testing.
Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not applicable. Adjudication methods are typically relevant for clinical studies or studies involving human interpretation of data where consensus is needed to establish ground truth for a diagnostic outcome. This submission relies on objective physical, chemical, and biological testing results.
If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
- No. This is a non-clinical submission for a mechanical surgical instrument. MRMC studies are used for evaluating the performance of AI/CADe diagnostic devices in conjunction with human readers.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- No. This device does not have an algorithm or AI component.
The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- For this device, the "ground truth" is defined by established scientific and engineering principles, as articulated in national and international standards (e.g., ISO 10993 for biocompatibility, ISO 17664/17665/ANSI/AAMI ST79 for reprocessing, ISO 11137-2 for sterilization). Compliance with these standards, demonstrated through specific laboratory tests (e.g., cytotoxicity assays, sensitization tests, pyrogenicity tests, material characterization), serves as the evidence that the device is safe and performs as intended.
The sample size for the training set:
- Not applicable. This device does not use an AI/ML algorithm that requires a training set.
How the ground truth for the training set was established:
- Not applicable, as there is no training set for an AI/ML algorithm.

Summary

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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. Pierce@fda.hhs.gov.

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 (1-800-638-2041 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)

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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K202120 510(k) SUMMARY

Submitter:	NAKANISHI INC.700 ShimohinataKanuma, Tochigi 322-8666 Japan
Contact Person:	Mr. Masaaki KikuchiGeneral Manager, Quality/Regulatory Affairs Dept.TEL: +81-289-64-7277FAX: +81-289-62-9738m-kikuchi@nsk-nakanishi.co.jp
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
PrimaryClassification:	HBE	882.4310	Drills, Burs, Trephines & Accessories (Simple, Powered)
SubsequentClassifications:	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 System510(k) Number: K132264Product Codes: HBC, ERLProduct Codes for Accessories: DZI, DZJ, ERL, GEY, HBC, HBE, HWE, GFF, EQJ
Reference Devices:	Stryker MIS Attachments and Cutting Accessories510(k) Number: K143540Product Codes: HBESubsequent Product Code: ERLStryker Elite and Heavy Duty (HD) Attachments510(k) Number: K143320Product Code: HBESecondary 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 SterileCutting Accessories	Primado2
510(k) Submitter[Number]	NAKANISHI INC.[K202120]	NAKANISHI INC.[K132264]
Indications forUse	The P300 Attachment is intended tobe used with electric and pneumaticsurgical instruments and cuttingaccessories for cutting, drilling,removal, and shaping of bone in theprocedures of: Neuro, Spine,Orthopedic, ENT, Maxillofacial,and General Surgery.	The Primado2 is an AC-electricallypowered total surgical system that isintended for cutting, drilling,sawing, and otherwise manipulatingsoft tissue, hard tissue, bone, bonecement, prosthesis, implant, andother bone related tissue in a varietyof surgical procedures, includingbut not limited to Cranial(Craniofacial/ Maxillofacial), ENT,Endoscopic /Arthroscopic, Neuro,Orthopedic, Spinal, and Generalsurgical procedures.	SIMILAR
Sterile CuttingAccessoriesIndications forUse	NSK Sterile Cutting Accessory(ies)is for single use only. This device isintended for use, in conjunctionwith P300 Attachment, in cutting,drilling, removal, and shaping ofbone in the procedures of: Neuro,Spine, Orthopedic, ENT,Maxillofacial, and General Surgery.	NSK sterilized disposable products(burs, saw blades and rasps) areintended for use in bone surgery.	SIMILAR
Product Codes	HBE, ERL, HWE, GFF, EQJ	HBC, ERLAccessories:DZI, DZJ, ERL, GEY, HBC, HBE,HWE, GFF, EQJ	SIMILAR
Attachments to beUsed with	Primado2	Primado2	IDENTICAL
Types ofAttachments	Standard Attachment SeriesSlim Attachment Series	Slim Attachment SeriesSuper Slim Attachment SeriesStandard Angled Attachment SeriesStandard Straight Attachment SeriesPerforator/Craniotome AttachmentSeriesHigh Speed Attachment SeriesContra Angle Attachment Series	SIMILAR
Energy source toattachments	Mechanical energy from attachedmotor	Mechanical energy from attachedmotor	IDENTICAL
Maximum rotation	80,000 min-1	80,000 min-1	IDENTICAL
Attachment Director Indirect PatientContactingMaterials	SUS303, SUS304, SUS316F2,SUS316F2 (TiCN), PEEK	SUS303, SUS304, SUS316F2,SUS316F2 (TiCN), C3604B (NiCr),SUS416F, SUS420J2, C5441B,C5191B, SUS416, SUS420F,ACD34, SUSNSK1 (TiCN), FKM	MODIFIED
Types of CuttingAccessories forAttachments	BursDrills	BursDrillsSawsRasps	SIMILAR
Outer Diametersof CuttingAccessories (Burs,Drills)	Ф0.6-7.5 mm	Ф0.6-9.1 mm	SIMILAR
CleaningAccessories	Yes	No	MODIFIED
Adjustable BurLength	Yes	No	MODIFIED
Lubrication	PANA Spray Plus (K163483)	PANA Spray Plus (K163483)	IDENTICAL
	Automatic CleaningOrManual Cleaning	Automatic CleaningOrManual Cleaning
Cleaning			IDENTICAL
Sterilization	Pre-Vacuum(Dynamic Air Removal)132 °C, 4 min.Drying Time: 20 min.	Pre-Vacuum(Dynamic Air Removal)134 °C, 3 min.Gravity Displacement132 °C, 15 min	MODIFIED
	Use Environment	Temperature: 0 - 40 °CHumidity: 30 - 75 %	Temperature: 0 - 40 °C(no condensation)Humidity: 30 - 75 %Atmospheric Pressure:700 - 1,060 hPa	MODIFIED
	Store andTransportationEnvironment	Temperature: -10 - 50 °CHumidity: 10 - 85 %Atmospheric Pressure:500 - 1,060 hPa	Temperature: -10 - 50 °CHumidity: 10 - 85 %Atmospheric Pressure:500 - 1,060 hPa	IDENTICAL
BiocompatibilityTesting	CytotoxicitySensitizationIntracutaneous ReactivityAcute Systemic ToxicityMaterial-Mediated PyrogenicityIndirect (Extract) Hemolysis	CytotoxicitySensitizationIntracutaneous ReactivityAcute Systemic ToxicityMaterial-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 /Colony FormationMethod[ISO 10993-5]	Cell culture treated with test sampleexhibited slight reactivity (Grade 1)	Non-cytotoxic
Cytotoxicity Test / ColonyFormation Method[ISO 10993-5](after maximum cleaning/disinfection cycle)	Cell culture treated with test sampleexhibited no reactivity (Grade 0)	Non-cytotoxic
Sensitization Test / GPMTMethod[ISO 10993-10]	The test article extracts showed no evidenceof causing delayed dermal contactsensitization.	Non-sensitization
Intracutaneous ReactivityTest [ISO 10993-10]	All animals appeared normal throughout thestudy. All injection sites appeared normalimmediately following injection.	Non-irritability
Acute Systemic ToxicityTest [ISO 10993-11]	There was no mortality or evidence ofsystemic toxicity from the extracts injectedinto mice.	Non-toxic
Material-MedicatedPyrogenicity Test [ISO10993-11]	The total rise of rabbit temperatures duringthe 3-hour observation period was withinacceptable USP requirements. The test articlemet the requirements for the absence ofpyrogens.	Non-pyrogenic
Indirect (Extract) HemolysisTest[ASTM F756 & ISO10993-4]	The hemolytic index for the test article extractindicated the hemolytic grade was within thenon-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.

Regulation Number and Section

§ 882.4310 Powered simple cranial drills, burrs, trephines, and their accessories.

(a)
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.(b)
Classification. Class II (performance standards).