The Primado is an AC-electrically powered total surgical system that allows for the use of multiple attachments to perform delicate bone dissection in neurological, maxillofacial, craniotomy, and spinal procedures, and in the ear nose, and throat area. A wide range of attachments includes a perforator drive, craniotome, straight/angle/malleable drills, and microsaws.

Device Description

The Primado Surgical System is an AC-electrically powered total surgical system that allows for the use of multiple attachments to perform delicate bone dissection in neurological procedures. The device consists of a control unit, foot controller, micromotor, motor cord, AC power cord, perforator drive, craniotome, straight/angle/malleable drills, and microsaws. The device does not come sterile and all parts that contact the patient as well as the AC power cord should be sterilized prior to the first use and after each use.

AI/ML Overview

Here's the analysis of the provided text regarding the Nakanishi Inc. Primado Surgical System:

This document is a 510(k) premarket notification summary, which focuses on demonstrating substantial equivalence to predicate devices rather than providing a detailed study proving the device meets specific acceptance criteria in the manner one might expect for a diagnostic or AI-driven device.

Therefore, many of the requested fields (e.g., sample size, expert ground truth, MRMC study, AI improvement effect size, standalone performance, training set size) are not applicable or cannot be extracted from this type of regulatory submission. The "study" here is primarily a comparison to predicates and compliance with standards.

1. Table of Acceptance Criteria and Reported Device Performance

Feature	Acceptance Criteria (Predicate)	Reported Device Performance (New Device)
Intended Use	Delicate bone dissection in the ear, nose, and throat areas (K#080722 - Primado Neurological Drill); Cutting of soft tissue and bone in various surgical procedures (K#002523 - Advantage Drive System)	Delicate bone dissection in neurological, maxillofacial, craniotomy, and spinal procedures, and in the ear, nose, and throat areas.
Description	Electrically powered surgical instrument system and handpieces operated by foot controller	Electrically powered drill and surgical motor system and attachments operated by foot controller
Compliance with Standards	IEC 601-1, IEC 601-1-2, UL2601-1 (for K#002523)	IEC 60601-1, IEC 60601-1-2
High Speed	Up to 100,000 rpm	Up to 100,000 rpm
Low Speed	Up to 30 rpm (for K#002523)	Up to 234 rpm
Oscillating Saw	Up to 20,000 cpm	Up to 20,000 cpm
Sagittal Saw	Up to 20,000 cpm	Up to 20,000 cpm
Reciprocating Saw	Up to 17,000 cpm (for K#002523)	Up to 19,300 cpm
Patient Contact Materials	Unknown (for K#002523)	Surgical stainless steel; diamond

Note: The "acceptance criteria" here are defined by the characteristics of the predicate devices. The "reported device performance" is the characteristics of the new device, aiming to be substantially equivalent to the predicates. The comparison largely depends on claiming "identical" or "similar" specifications and compliance with relevant safety standards.

2. Sample size used for the test set and the data provenance

Not Applicable. This document is a 510(k) summary for a surgical drill system, not a diagnostic or AI device. The "test set" in this context refers to the device's technical specifications and compliance with standards, not a dataset of patient images or clinical outcomes. The demonstration of substantial equivalence relies on comparing technical specifications and intended use with previously cleared devices.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Not Applicable. This document does not pertain to establishing ground truth for a test set in the context of diagnostic performance. Technical specifications and safety compliance for a surgical drill system are typically evaluated against engineering standards and design requirements, not expert-established ground truths.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set

Not Applicable. See point 3.

5. 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

Not Applicable. This device is a surgical drill system. It does not involve human readers, AI, or diagnostic interpretation.

6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done

Not Applicable. This is a hardware surgical instrument, not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

Not Applicable / Based on Predicate Equivalence and Standards. The "ground truth" for this device's acceptance is its demonstrated equivalence in technical specifications, intended use, and adherence to recognized safety standards (like IEC 60601-1) compared to legally marketed predicate devices. There is no biological "ground truth" in the sense of pathology or outcomes data for the device itself in this submission.

8. The sample size for the training set

Not Applicable. There is no "training set" as this is not an AI/machine learning device.

9. How the ground truth for the training set was established

Not Applicable. See point 8.

Summary

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K083112
pg 1 of 3

510(k) SUMMARY

Nakanishi Inc. Primado Surgical System

Name of Device and Name/Address of Sponsor

Trade or Proprietary Name:	Primado Surgical System
Common Name:	electric surgical motorsystem; ENT surgical drill system
Classification Name:	motor, drill, electric; ear, nose, and throat electric or pneumatic surgical drill (21 CFR 882.4360 and 874.4250)
Product Code:	HBC, ERL

Nakanishi Inc. 700 Shimohinata Kanuma-shi Tockigi-ken 322-8666 Japan

Contact:	Ms. Tomoko Hirabayashi
Telephone:	011-81-289-64-3380
Facsimile:	011-81-289-62-6665
Date Prepared:	April 23, 2009

Intended Use

The Primado Surgical System is an AC-electrically powered total surgical system that allows for the use of multiple attachments to perform delicate bone dissection in neurological, maxillofacial, craniotomy, and spinal procedures, and in the ear, nose, and throat area. A wide range of attachments includes a perforator drive, craniotome, straight/angle/malleable drills, and microsaws.

Technological Characteristics and Substantial Equivalence

The Primado Surgical System is substantially equivalent in terms of safety and effectiveness to NSK's own previously authorized Primado device (K#080722) and the Advantage Drive System (K#002523). A chart comparing the Primado to the predicate devices is attached.

APR 2 9 2009

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Substantial Equivalency Chart

ITEMS	NEW DEVICE	PREDICATEDEVICE	PREDICATEDEVICE
1. ClassificationNo.	HBC, ERL	ERL	HBC, GEY
2. C.F.R. SectionNo.	882.4360 and874.4250	874.4250	882.4360 and878.4820
3. ClassificationPanel	Neurology and Ear,Nose & Throat	Ear, Nose & Throat	Neurology andGeneral and PlasticSurgery
4. ClassificationName	Motor, Drill,Electric	Drill, Surgical, ENT(Electric OrPneumatic) IncludingHandpiece	Motor, Drill, Electricand Motor, SurgicalInstrument, Ac-Powered
5. Class	II	II	II
6. 510(k) Number	N/A	K#080722	K#002523
7. Manufacturer	NAKANISHI INC.	NAKANISHI INC.	LINVATEC CORP
8. ProprietaryName	Primado SurgicalSystem	PrimadoNeurological Drill	Advantage DriveSystem
9. Description	Electricallypowered drill andsurgical motorsystem andattachmentsoperated by footcontroller	Identical	Electrically poweredsurgical instrumentsystem andhandpieces operatedby foot controller
10. Intended use	Delicate bonedissection inneurological,maxillofacial,craniotomy, andspinal procedures,and in the ear nose,and throat areas	Delicate bonedissection in the ear,nose, and throat areas	Cutting of soft tissueand bone inarthroscopic, foot,hand, medialsternotomy,neurosurgical,orthopedic,otolaryngological,oral/maxillofacial,plastic/reconstructive, andspinal surgicalprocedures
11. Compliancewith standards	IEC 60601-1IEC 60601-1-2	Identical	IEC 601-1IEC 601-1-2UL2601-1
12. High speed	Up to 100,000 rpm	Identical	Identical
13. Low speed	Up to 234 rpm	Identical	Up to 30 rpm
14. Oscillatingsaw	Up to 20,000 cpm	Identical	Identical
15. Sagittal saw	Up to 20,000 cpm	Identical	Identical
16. Reciprocatingsaw	Up to 19,300 cpm	Identical	Up to 17,000 cpm
17. Patient contactmaterials	Surgical stainlesssteel; diamond	Identical	Unknown

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40560854.doc

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DEPARTMENT OF HEALTH & HUMAN SERVICES

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Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Nakanishi, Inc. c/o Keith A. Barritt Fish & Richardson P.C. 1425 K Street, N.W. Suite 1100 Washington, DC 20005

APR 2 9 2009

Re: K083112

Trade/Device Name: Primado Surgical System Regulation Number: 21 CFR 882.4360 Regulation Name: Electric cranial drill motor Regulatory Class: Class II Product Code: HBC Dated: March 10, 2009 Received: March 11, 2009

Dear Mr. Barritt:

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.

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 (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); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please contact the CDRH/Office of Surveillance and Biometrics/Division of Postmarket Surveillance at 240-276-3464. For more information regarding the reporting of adverse events, please go to http://www.fda.gov/cdrh/mdr/.

You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

M.B. Eglehus, MD

Malvina B. Eydelman, M.D. Director Division of Ophthalmic and Ear, Nose and Throat Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use 1. 1. 1. 1.

: : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : :

510(k) Number (if known): 083112

.. .. ... .. . . . .

Device Name: Primado

Indications For Use:

Prescription Use x (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use (21 CFR 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

(Division Sign-Off) Division of Ophthalmic and Ear, Nose and Throat Devices
510(k) Number	K083112

4-1
Prescription Use (Per 21 CFR 801.109)

Regulation Number and Section

§ 882.4360 Electric cranial drill motor.

(a)
Identification. An electric cranial drill motor is an electrically operated power source used with removable rotating surgical cutting tools or drill bits on a patient's skull.(b)
Classification. Class II (performance standards).