NAVIPRO KNEE SOFTWARE MODULE

K033668 · Kinamed, Inc. · HAW · Mar 11, 2004 · Neurology

Device Facts

• Record ID: K033668
• Device Name: NAVIPRO KNEE SOFTWARE MODULE
• Applicant: Kinamed, Inc.
• Product Code: HAW · Neurology
• Decision Date: Mar 11, 2004
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 882.4560
• Device Class: Class 2

Intended Use

The NaviPro™ Knee Software Module is an extension of the NaviPro™ Navigation System whose purpose is to measure the spatial orientation of the resection guides and limb alignment during total knee replacement surgery, and for assessing soft tissue balance and changes in the limb mechanical axis as a result of the knee replacement. General spatial measurements may be made and recorded as deemed necessary by the surgeon user.

Device Story

NaviPro™ Knee Software Module extends NaviPro™ Navigation System; utilizes optical localizing camera and infra-red trackers attached to patient anatomy and surgical instruments. System calculates spatial position/orientation of bones and instruments intra-operatively without pre-operative CT or fluoroscopy. Surgeon uses calibrated measurement probe to palpate landmarks; system computes joint centers and mechanical axis. Output provides real-time assessment of implant position, orientation, and soft-tissue balance during knee replacement. Used in OR by surgeons to guide resection and verify alignment; aids clinical decision-making regarding implant placement and soft-tissue balancing to potentially improve surgical outcomes.

Clinical Evidence

No clinical data provided. Substantial equivalence is based on technological characteristics and bench testing of the navigation system's ability to track and calculate spatial orientation.

Technological Characteristics

Optical navigation system using infra-red trackers; calibrated measurement probe; real-time spatial tracking of resection guides and anatomical landmarks. Does not require pre-operative imaging (CT/fluoroscopy). Software-based calculation of joint centers and mechanical axis. Standalone navigation module.

Indications for Use

Indicated for patients undergoing total knee replacement surgery. Used by surgeons to measure spatial orientation of resection guides, limb alignment, soft tissue balance, and mechanical axis changes.

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

• OrtholYilot® (K003347)
• NaviPro™ (K020764)

Submission Summary (Full Text)

{0}------------------------------------------------

# MAR 1 1 2004

## 510(k) Summary

| Submitter: | Kinamed, Inc. |
|-----------------|-------------------------------|
| Address: | 820 Flynn Road |
| | Camarillo, CA 93012 |
| Phone number: | [phone] |
| Fax number: | [phone] |
| Contact person: | Vineet K. Sarin Ph.D. |
| Date prepared: | November 21, 2003 |
| Trade name: | NaviPro™ Knee Software Module |

Substantial equivalence claimed to: 1. OrtholYilot® (K003347) filed by Kinaned Inc. 2. NaviPro™ (K020764) filed by Kinamed, Inc.

#### Description:

The NaviPro™ Knee Software Module is an extension of the previously cleared The Navil Navigation System. It uses an optical localizing camera and infra-red Navil 10 - Navigation 173.60m. 'It ucces an valial position of bones and medical instruments during knee replacements obtained from the system allow for intra-operative assessments of implant position, orientation, and soft-tissue balance.

#### Intended use:

The NaviPro" Knee Software Module is an extension of the NaviPro" Navigation The Navil 10 - Rife® Ourpose is to measure the spatial orientation of the resection guides and System whose parpose is to tinee replacement surgery, and for assessing soft tissue mino angininent daming toan mechanical axis as a result of the knee replacement. General spatial measurements may be made and recorded as deemed necessary by the surgeon user.

# Summary of technological characteristics:

Sunlinary of recument generts the position of the tibial and femur resection guides during knee replacement surgery, and measures changes in the mechanical axis of the limb as a result of prosthetic implantation. Pre-operative CT or fluoroscopic imaging the min as a reader of problement patient and computer is established by infra-red 15 untiecessary. The this betrocely attached to the patient and surgical instruments. An felfective trackers that are books is linked to the computer calculates the position and orientation of the trackers.

A calibrated measurement probe is also outfitted with infra-red trackers and can be A canorated measurement prove is allent. NaviPro™ Knee requires only the information provided by the trackers and palpated landmarks to determine the spatial mionnations of the resection guides. joint centers, and mechanical axis.

{1}------------------------------------------------

Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized depiction of an eagle with three wavy lines representing its body and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle symbol.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAR 1 1 2004

Mr. Vineet K. Sarin, Ph.D. Director of Research and Development Kinamed. Inc. 820 Flynn Road Camarillo, California 93012

Re: K033668

Trade/Device Name: NaviPro™ Knee Software Module Regulation Number: 21 CFR 882.4560 Regulation Name: Stereotaxic instrument Regulatory Class: II Product Code: HAW Dated: January 23, 2004 Received: January 23, 2004

Dear Dr. Sarin:

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 sct 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.

{2}------------------------------------------------

Page 2 - Mr. Vineet K. Sarin, Ph.D.

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,

Miriam 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

{3}------------------------------------------------

## (2) Indications for Use

510(k) Number (if known): K033668

Device Name:

NaviPro™ Knee Software Module

Indications For Use:

The NaviPro™ Knee Software Module is an extension of the NaviPro™ Navigation System whose purpose is to measure the spatial orientation of the resection guides and limb alignment during total knee replacement surgery, and for assessing soft tissue balance and changes in the limb mechanical axis as a result of the knee replacement. General spatial measurements may be made and recorded as deemed necessary by the surgeon user.

Prescription Use X (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use (21 CFR 807 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Miriam C. Provost

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

Page 1 of

**510(k) Number** K033668