MAYFIELD/ACCISS OPERATING ARM SYSTEM AND MAYFIELD/OPTICAL ACCISS SYSTEM

K013428 · Ohio Medical Instrument Co., Inc. · HAW · Apr 4, 2002 · Neurology

Device Facts

• Record ID: K013428
• Device Name: MAYFIELD/ACCISS OPERATING ARM SYSTEM AND MAYFIELD/OPTICAL ACCISS SYSTEM
• Applicant: Ohio Medical Instrument Co., Inc.
• Product Code: HAW · Neurology
• Decision Date: Apr 4, 2002
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 882.4560
• Device Class: Class 2

Intended Use

The MAYFIELD®/ACCISS™ Operating Arm System and the MAYFIELD®/Optical ACCISS™ System are indicated for open and percutaneous procedures for any medical condition where reference to a rigid anatomical structure, such as the skull, a long bone, or vertebra, or previously placed fiducial markers, can be identified relative to a CT or MRI and the use of stereotactic surgery may be considered appropriate. Representative uses would be for cranial, spinal and ENT procedures.

Device Story

Computer-based image-guided stereotactic planning system; utilizes pre-operative or intra-operative CT or MRI data; correlates image data to patient anatomy via mechanical or optical locating methods; assists surgeons in planning and executing surgical procedures; used in clinical settings for cranial, spinal, and ENT procedures; provides spatial reference to rigid anatomical structures or fiducial markers; facilitates surgical navigation and decision-making; hardware and software remain unchanged from previous versions.

Clinical Evidence

No clinical data provided; device is substantially equivalent to previously cleared systems with no changes to hardware or software.

Technological Characteristics

Stereotaxic instrument; utilizes CT or MRI image data; mechanical or optical locating methods for patient registration; computer-based planning system; no changes to existing hardware or software specifications.

Indications for Use

Indicated for patients undergoing open or percutaneous cranial, spinal, or ENT procedures where stereotactic surgery is appropriate and rigid anatomical structures (skull, long bone, vertebra) or fiducial markers can be identified via CT or MRI.

Regulatory Classification

Identification

A stereotaxic instrument is a device consisting of a rigid frame with a calibrated guide mechanism for precisely positioning probes or other devices within a patient's brain, spinal cord, or other part of the nervous system.

Predicate Devices

• StealthStation® System (K981686)
• Medivision IGS System (K003699)
• StealthStation® Generation 3 System (K001153)
• VectorVision2 (K005389)

Submission Summary (Full Text)

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K013428

APR 0 4 2002

## 510(k) Summary MAYFIELD®/ACCISS™ Operating Arm System and MAYFIELD®/Optical ACCISS™ System Revised Indication

## Contact:

Kenneth B. Miller Manager, Regulatory Ohio Medical Instrument Company, Inc. 4900 Charlemar Drive Cincinnati, OH 45227

Telephone: [phone]

Prepared by:

K. M. Associates 10 Oak Point Wrentham, MA 02093

Contact: Don Lincoln

Telephone: [phone]

Trade Names:

# MAYFIELD®/ACCISS™ Operating Arm System and MAYFIELD®/Optical ACCISS™ System

Computer-based Image-guided Stereotactic Planning Common Name: System

Instrument, Stereotaxic (84HAW) Classification Name:

#### Substantial Equivalence

K981686 StealthStation® System, is claimed to: K003699 Medivision IGS System K001153 StealthStation® Generation 3 System K005389 VectorVision2

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Device Description: The devices are not changed either in hardware or software. They remain as shown in K955397, K982244, K991267, and K992843.

This notification only relates to a revision of the Indications for Use to a closer alignment riflis notinoution only rolatoo to a rothfor the devices shown above to which Substantial Equivalence is claimed.

All of these devices use CT or MRI data gathered prior to, or during, a surgery that is then correlated to the patient by way of various locating methods (mechanical, optical or ther concluded to the potware. This then allows the user to plan, and/or complete, the intended procedure.

Indication for Use: The MAYFIELD®/ACCISS™ Operating Arm System and the MAYFIELD®/Optical ACCISS™ System are indicated for open or percutaneous procedures for any medical condition where reference to a rigid anatomical structure, proooderoo for uny mourbarcenor vertebra, or previously placed fiducial markers, can be identified relative to a CT or MRI and the use of stereotaxic surgery may be considered appropriate. Representative uses would be for cranial, spinal and ENT procedures.

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# DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of an eagle with its wings spread.

#### Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Ohio Medical Instrument Company, Inc. Mr. Kenneth B. Miller Manager, Regulatory 4900 Charlemar Drive Cincinatti, Ohio 45227

APR 0 4 2002

Re: K013428

Re: K015428
Trade Name: Mayfield®/Acciss™ Operating Arm System and Mayfield®/Optical Acciss™ System Regulation Number: 882.4560 Regulation Name: Stereotaxic instrument Regulatory Class: II Product Code: HAW Dated: January 28, 2002 Received: January 31, 2002

Dear Mr. Miller:

We have reviewed your Section 510(k) premarket notification of intent to market the we have forlowed your books betermined the device is substantially equivalent (for the indications for use stated in the enclosure) to devices marketed in interstate (101 the maneations for abs base of the enactment date of the Medical Device commence prior to May 20, 1970, the been reclassified in accordance with the provisions Amendinents, or to doviets and Cosmetic Act (Act) that do not require approval of a of the Pederal I ood, Drug, and Obmit). You may, therefore, market the device, subject to promarket approval approvations of the Act. The general controls provisions of the Act the general connois provisions or aistration, 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 such additional controls. Existing major regulations (I will in they con be found in the Code of Federal Regulations, Title 21, Parts affecting your do for the may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does I louse be that FDA has made a determination that your device complies with other not moun that I DTP has or any Federal statutes and regulations administered by other requirements on the Provet comply with all the Act's requirements, including, but not 1 oderal agencies: "100 and listing (21 CFR Part 807); labeling (21 CFR Part 801); 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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## Page 2 - Mr. Kenneth Miller

This letter will allow you to begin marketing your device as described in your Section a This letter will anow you to begin manoming of substantial equivalence of your JTV(K) premiation noticate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 II you desire specific ad 150 for in vitro diagnostic devices), please contact the allt additionally 21 OFF Fur 8091106659. Additionally, for questions on the promotion Other of Compliance at (301), please contact the Office of Compliance at (301) 594and advertising of your the regulation entitled, (Misbranding by reference to premarket 4057. Allso, prease note and rogan. Other general information on your responsibilities nothecation((210) (21 CF R Pat-60197). She Division of Small Manufacturers, International under the Act may be obtained from the member (800) 6382041 or (301) 4436597 or at its anternet address HYPERLINK http://www.fda.gov/cdrh/dsma/dsmamain.html http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely yours,

Muriam C. Provost

for Celia M. Witten, Ph.D., M.D. Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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510(k) Number (if known):

K013428

MAYFIELD®/ACCISS™ Operating Arm System and Device Name: MAYFIELD®/Optical ACCISS™ System

## Indications For Use:

The MAYFIELD®/ACCISS™ Operating Arm System and the MAYFIELD®/Optical ACCISS™ System are indicated for open and percutaneous procedures for any medical condition where reference to a rigid anatomical structure, such as the sku!!, a long bone, or vertebra, or previously placed fiducial markers, can be identified relative to a CT or MRI and the use of stereotactic surgery may be considered appropriate. Representative uses would be for cranial, spinal and ENT procedures.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use (Per 21 CFR 801.109)

OR

Over-The-Counter Use

(Optional Format - 1 - 2 - 96)

Muriam C. Provost

(Division Sign-Off) Division of General, Restorative and Neurological Devices

510(k) Number K013428