ACUMEN SURGICAL NAVIGATION SYSTEM

K031337 · Biomet, Inc. · HAW · Sep 15, 2003 · Neurology

Device Facts

• Record ID: K031337
• Device Name: ACUMEN SURGICAL NAVIGATION SYSTEM
• Applicant: Biomet, Inc.
• Product Code: HAW · Neurology
• Decision Date: Sep 15, 2003
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 882.4560
• Device Class: Class 2

Intended Use

The Acumen™ Surgical Navigation System is intended to assist the surgeon in providing orientation and reference information to anatomical structures during open or percutaneous orthopedic procedures. The Acumen™ System is indicated for use in surgical knee and trauma procedures, in which the use of stereotaxic surgery may be appropriate, and where reference to rigid anatomical bony structures can be identified relative to a CT or MRI based model, fluoroscopy or an imageless model of the anatomy. These procedures include, but are not limited to knee arthroplasty or trauma reconstructive procedures.

Device Story

Acumen™ Surgical Navigation System assists surgeons during orthopedic procedures by providing anatomical orientation and reference information. System utilizes passive markers (spheres) attached to surgical instruments; infrared camera tracks marker position and orientation. Instruments function independently, attached to patient, or connected to implant preparation/insertion tools. Each instrument features unique passive marker geometry for identification by camera and Z-KAT, Inc. software. System used in OR by surgeons for knee and trauma procedures. Output provides real-time spatial reference of instruments relative to patient anatomy (CT/MRI/fluoroscopy/imageless models), aiding surgical precision and decision-making during arthroplasty or reconstruction. Instruments are single-use.

Clinical Evidence

No clinical data. Substantial equivalence established via bench testing and software verification/validation.

Technological Characteristics

Stereotaxic instrument system; passive optical tracking using infrared camera and spherical markers. Instruments are single-use. Software-driven navigation. Connectivity via camera system to workstation. No specific material standards or algorithm architecture details provided.

Indications for Use

Indicated for patients undergoing orthopedic knee and trauma procedures, including knee arthroplasty and trauma reconstruction, where stereotaxic surgery is appropriate and rigid bony structures can be referenced to CT, MRI, fluoroscopy, or imageless anatomical models.

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

• Voyager™ Linux (K023975)
• Flurelab Plus (K013025)

Submission Summary (Full Text)

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## SEP 1 5 2003

03/337

Image /page/0/Figure/2 description: The image shows the word "BIOMET" in a bold, sans-serif font. The letters are outlined in black, with the interior of the letters being white. The word "INC" is written in a smaller font size and is located below and to the right of the word "BIOMET". The letters "INC" are also outlined in black, with the interior of the letters being white.

## Summary of Safety and Effectiveness

| Applicant/Sponsor: | Biomet Orthopedics, Inc.<br>P.O. Box 587<br>Warsaw, Indiana 46581-0587 |
|--------------------------------------------------------------------------------|----------------------------------------------------------------------------------------|
| Contact Person: | Kristine C. (Kacy) Arnold, RN. MBA<br>Telephone: [phone]<br>Fax: [phone] |
| Proprietary Name: | Acumen™ Surgical Navigation System |
| Common Name: | Instrument, Stereotaxic |
| Classification Name: | Stereotaxic Instrument (21 CFR 882.4560) |
| Device Classification: | Class II |
| Legally Marketed<br>Devices to Which<br>Substantial Equivalence<br>is claimed: | Voyager™ Linux (K023975)<br>Flurelab Plus (K013025) |

Device Description: The Acumen™ Surgical Navigation System includes general instrumentation that is utilized with application specific software developed and supplied by Z-KAT, Inc. (Hollywood, Florida).

Passive markers (spheres) are attached onto the Acumen™ instrumentation. An infrared light source generated by the camera reflects off of the passive markers to allow their position and orientation to be identified. The Acumen™ instruments are used as: 1) an independent instrument, 2) connected to instruments, which are attached to the patient, or 3) connected to the associated implant preparation and insertion instrumentation.

All Acumen™ instruments will have a minimum of three (3) passive markers to be tracked by the camera system. They will also be rigidly connected to the instrumentation. Each Acumen™ instrument, utilized in the surgical procedure, will have a defined geometry of the passive marker position for a unique identification by the camera and software system.

The instruments can be utilized with knee and trauma applications. The Acumen™ instruments are designed as one-time use components.

Intended Use: The Acumen™ Surgical Navigation System is intended to assist the surgeon in providing orientation and reference information to anatomical structures during open or percutaneous orthopedic procedures. The Acumen™ Navigation System is indicated for use in surgical knee and trauma procedures, in which the use of stereotaxic surgery may be appropriate, and where reference to rigid anatomical bony structures can be identified relative to a CT or MRI based model, fluoroscopy or an imageless model of the anatomy.

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These procedures include, but are not limited to knee arthroplasty or trauma reconstructive procedures.

Summary of Technologies: The Acumen™ Surgical Navigation System's technological characteristics are similar to or identical to the predicate devices.

Non-Clinical Testing: Software verification and validation was performed to establish substantial equivalence to the predicate devices.

Clinical Testing: Clinical testing was not used to establish substantial equivalence.

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle or bird symbol, with three curved lines representing the bird's head and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular pattern around the bird symbol.

Public Health Service

SEP 1 5 2003

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Ms. Kristine C. Arnold, RN, MBA Regulator Affairs Specialist Biomet, Inc. 56 E. Bell Drive P.O. Box 587 Warsaw, Indiana 46581-0587

Re: K031337

Trade/Device Name: Acumen™ Navigation System Regulation Number: 21 CFR 882.4560 Regulation Name: Stereotaxic instrument Regulatory Class: II Product Code: HAW Dated: July 10, 2003 Received: July 14, 2003

Dear Ms. Arnold:

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 such 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); 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 - Ms. Kristine C. Arnold, RN, MBA

This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate 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), please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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/dsma/dsmamain.html

Sincerely yours,

Muriam C. Provost

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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Image /page/4/Picture/15 description: The image shows the word "BIOMET" in a bold, sans-serif font. The letters are all capitalized and enclosed in a rectangular border. To the right of the word "BIOMET" is the abbreviation "INC.", which is also in a sans-serif font but is smaller than the word "BIOMET".

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510 (k) Number (if known) : _ | < 0 3 / 3 3 1

Device Name: Acumen™ Surgical Navigation Systems

Indications for Use:

The Acumen™ Surgical Navigation System is intended to assist the surgeon in providing orientation and reference information to anatomical structures during open or percutaneous orthopedic procedures. The Acumen™ System is indicated for use in surqical knee and trauma procedures, in which the use of stereotaxic surqery may be appropriate, and where reference to rigid anatomical bony structures can be identified relative to a CT or MRI based model, fluoroscopy or an imageless model of the anatomy. These procedures include, but are not limited to knee arthroplasty or trauma reconstructive procedures.

Miriam C. Provost

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

510(k) Number K63/337

(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)