PRIMADO

K083112 · Nakanishi, Inc. · HBC · Apr 29, 2009 · Neurology

Device Facts

• Record ID: K083112
• Device Name: PRIMADO
• Applicant: Nakanishi, Inc.
• Product Code: HBC · Neurology
• Decision Date: Apr 29, 2009
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 882.4360
• Device Class: Class 2
• Attributes: Therapeutic

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.

Device Story

Primado Surgical System is an AC-electrically powered surgical motor system; used for delicate bone dissection in neurological, maxillofacial, craniotomy, spinal, and ENT procedures. System components include control unit, foot controller, micromotor, motor cord, and various attachments (perforator drive, craniotome, drills, microsaws). Operated by surgeons in clinical settings; foot controller regulates motor speed. Device provides mechanical power to attachments for cutting bone and soft tissue. Benefits include versatility through interchangeable attachments for diverse surgical applications. Device is non-sterile; requires sterilization prior to use.

Clinical Evidence

Bench testing only. No clinical data provided.

Technological Characteristics

AC-electrically powered surgical motor system. Components: control unit, foot controller, micromotor, attachments. Materials: surgical stainless steel, diamond. High speed up to 100,000 rpm; low speed up to 234 rpm; oscillating/sagittal saw up to 20,000 cpm; reciprocating saw up to 19,300 cpm. Standards: IEC 60601-1, IEC 60601-1-2. Non-sterile; requires sterilization.

Indications for Use

Indicated for patients requiring delicate bone dissection during neurological, maxillofacial, craniotomy, spinal, and ear, nose, and throat surgical procedures.

Regulatory Classification

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.

Predicate Devices

• Primado Neurological Drill (K080722)
• Advantage Drive System (K002523)

Submission Summary (Full Text)

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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 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. The Primado has already been cleared for marketing for "delicate bone dissection in the ear, nose, and throat areas" under K#080722.

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 | PREDICATE<br>DEVICE | PREDICATE<br>DEVICE |
|----------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 1. Classification<br>No. | HBC, ERL | ERL | HBC, GEY |
| 2. C.F.R. Section<br>No. | 882.4360 and<br>874.4250 | 874.4250 | 882.4360 and<br>878.4820 |
| 3. Classification<br>Panel | Neurology and Ear,<br>Nose & Throat | Ear, Nose & Throat | Neurology and<br>General and Plastic<br>Surgery |
| 4. Classification<br>Name | Motor, Drill,<br>Electric | Drill, Surgical, ENT<br>(Electric Or<br>Pneumatic) Including<br>Handpiece | Motor, Drill, Electric<br>and Motor, Surgical<br>Instrument, Ac-<br>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. Proprietary<br>Name | Primado Surgical<br>System | Primado<br>Neurological Drill | Advantage Drive<br>System |
| 9. Description | Electrically<br>powered drill and<br>surgical motor<br>system and<br>attachments<br>operated by foot<br>controller | Identical | Electrically powered<br>surgical instrument<br>system and<br>handpieces operated<br>by foot controller |
| 10. Intended use | Delicate bone<br>dissection in<br>neurological,<br>maxillofacial,<br>craniotomy, and<br>spinal procedures,<br>and in the ear nose,<br>and throat areas | Delicate bone<br>dissection in the ear,<br>nose, and throat areas | Cutting of soft tissue<br>and bone in<br>arthroscopic, foot,<br>hand, medial<br>sternotomy,<br>neurosurgical,<br>orthopedic,<br>otolaryngological,<br>oral/maxillofacial,<br>plastic/<br>reconstructive, and<br>spinal surgical<br>procedures |
| 11. Compliance<br>with standards | IEC 60601-1<br>IEC 60601-1-2 | Identical | IEC 601-1<br>IEC 601-1-2<br>UL2601-1 |
| 12. High speed | Up to 100,000 rpm | Identical | Identical |
| 13. Low speed | Up to 234 rpm | Identical | Up to 30 rpm |
| 14. Oscillating<br>saw | Up to 20,000 cpm | Identical | Identical |
| 15. Sagittal saw | Up to 20,000 cpm | Identical | Identical |
| 16. Reciprocating<br>saw | Up to 19,300 cpm | Identical | Up to 17,000 cpm |
| 17. Patient contact<br>materials | Surgical stainless<br>steel; 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 [phone]. 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 [phone] or [phone] 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.

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510(k) Number (if known): 083112

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

Device Name: Primado

Indications For Use:

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.

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 |

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Prescription Use (Per 21 CFR 801.109)