HEMI-ARC SURGICAL NAVIGATOR

K013257 · Nuvasive, Inc. · HAW · Oct 30, 2001 · Neurology

Device Facts

• Record ID: K013257
• Device Name: HEMI-ARC SURGICAL NAVIGATOR
• Applicant: Nuvasive, Inc.
• Product Code: HAW · Neurology
• Decision Date: Oct 30, 2001
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 882.4560
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The NuVasive™ Guided Spinal Arthroscopy System consists of a Surgical Navigator with adjustable cannula guides, and various percutaneous surgical cannulae and instrumentation. This System is intended to assist in gaining controlled percutaneous access to, and visualization of, the spinal nerves, foramina, vertebra, intervertebral disc, and surrounding tissues of the spine via uniportal or biportal posterior, lateral, or posterolateral approach, where anatomical restrictions safely permit. It is intended for use under real-time, or near real-time (i.e., successive static image) radiographic visualization via image-intensified Carm fluoroscopy. The System is designed for use with NuVasive™ spinal arthroscopes and percutaneous surgical instrumentation, but may be used with other arthroscopes and instrumentation having compatible diameter and length, and which are indicated for use in the spine.

Device Story

Hemi-Arc Surgical Navigator acts as instrument holder/guide for spinal arthroscopy; provides controlled percutaneous access to spinal anatomy. Device utilizes real-time or near real-time C-arm fluoroscopy for alignment; adjustable cannula guides allow precise positioning of surgical instrumentation. Used in clinical settings by surgeons; assists in navigating spinal nerves, foramina, vertebrae, and discs. Output is physical guidance for instruments; helps avoid damage to surrounding tissues like nerves or dura. Benefits patient through controlled, minimally invasive access.

Clinical Evidence

No clinical data; bench testing only.

Technological Characteristics

Mechanical instrument holder/guide frame; adjustable in multiple planes of motion; compatible with standard spinal arthroscopes and percutaneous instrumentation. No software or electronic components described.

Indications for Use

Indicated for patients requiring percutaneous access to and visualization of spinal nerves, foramina, vertebrae, intervertebral discs, and surrounding spinal tissues via uniportal or biportal posterior, lateral, or posterolateral approaches.

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

• Surgical Guide Frame (NuVasive, Inc.)

Submission Summary (Full Text)

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

OCT 3 0 2001

# NuVasive™, Inc.

KO13257 Special 510(k) Premarket Notification Hemi-Arc™ Surgical Navigator

# VII. 510(k) Summary

In accordance with Title 21 of the Code of Federal Regulations, Part 807, and in particular \$807.92, the following summary of information is provided:

#### Submitted by: A.

Laetitia Bernard Manager of Regulatory Affairs NuVasive™, Incorporated 10065 Old Grove Road San Diego, California 92131 Telephone: [phone] Telefacsimile: [phone]

#### B. Device Name

Trade Name: Hemi-Arc™ Surgical Navigator

Common or Usual Name: Arthroscope, Stereotaxic Frame

Classification Name: Arthroscope, Stereotaxic Instrument

#### C. Predicate Devices

The subject Hemi-Arc™ Surgical Navigator is substantially equivalent to the Surgical Guide Frame currently manufactured and distributed commercially in the U.S. by NuVasive™, Inc.

#### D. Device Description

The Hemi-Arc™ Surgical Navigator essentially serves as an instrument holder and guide which is intended to be aligned with the operative site using real time, or near real-time (i.e. success static images) image-intensified C-arm fluoroscopy. The Hemi-ArcTM guide frame is adjustable in several planes of motion, and their fluoroscopic alignment with spinal anatomical features provides the path of entry of subsequent arthroscopic instrumentation to be precisely controlled, thereby avoiding damage to surrounding tissues such as nerves or dura.

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

# Intended Use E.

The NuVasive™ Guided Spinal Arthroscopy System consists of a Surgical Navigator with adjustable cannula guides, and various percutaneous surgical cannulae and instrumentation. This System is intended to assist in gaining controlled percutaneous access to, and visualization of, the spinal nerves, foramina, vertebra, intervertebral disc, and surrounding tissues of the spine via uniportal or biportal posterior, lateral, or posterolateral approach, where anatomical restrictions safely permit. It is intended for use under real-time, or near real-time (i.e., successive static image) radiographic visualization via image-intensified Carm fluoroscopy. The System is designed for use with NuVasive™ spinal arthroscopes and percutaneous surgical instrumentation, but may be used with other arthroscopes and instrumentation having compatible diameter and length, and which are indicated for use in the spine.

## Comparison to Predicate Devices F.

The subject device has indications for use identical to those of its predicate, and employs the same principles of operation for alignment with the spinal operative site using real time, or near real-time (i.e. success static images) image-intensified C-arm fluoroscopy to provide access to subsequent arthroscopic instrumentation. Due to this equivalency, the device raises no new safety or effectiveness issues.

#### G. Summary of Design Control Activities

Design control activities employed to control the development of the modification to the Surgical Guide Frame included:

- a comprehensive Risk Analysis to identify potential risks and failures associated with ● operation of the device, any mitigations incorporated to reduce or eliminate those risks and failures, and an assessment of residual risk;
- a comprehensive program of verification and validation activities demonstrating that . acceptance criteria were met, and that design output satisfied design input.

## H. Summary of Clinical Tests

(Not applicable.)

## I. Conclusions

The subject device is substantially equivalent to the currently marketed predicate device, and its development has been adequately and appropriately conducted and validated under a comprehensive design control program complying with Title 21 CFR, §820.30.

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

Image /page/2/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS) of the United States. The seal features a stylized eagle with its wings spread, symbolizing protection and service. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle.

OCT 3 0 2001

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Ms. Laetitia Bernard Manager of Regulatory Affairs Nuvasive, Inc. 10065 Old Grove Road San Diego, California 92131

Re: K013257 Trade/Device Name: Hemi-Arc™ Surgical Navigator Regulation Number: 882.4560, 888.1100 Regulation Name: Stereotaxic instrument Arthroscope and accessories Regulatory Class: II Product Code: HAW, HRX Dated: September 28, 2001 Received: October 1, 2001

Dear Ms. Bernard:

We have reviewed your Section 510(k) premarket notification of intent to market the device w one reviews 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 for ass sured in the encreases of 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 I ou may, ateres 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.

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

# Page 2 - Ms. Laetitia Bernard

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 and additionally 21 CFR Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained 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,

Susa Welk, us

fv

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

{4}------------------------------------------------

## Indications for Use Statement D.

510(k) Number (if known):

Device Name: Hemi-ArcTM Surgical Navigator

Indications for Use:

The NuVasive™ Guided Spinal Arthroscopy System consists of a Surgical Navigator with adjustable cannula guides, and various percutaneous surgical cannulae and instrumentation. This System is intended to assist in gaining controlled percutaneous access to, and visualization of, the spinal nerves, foramina, vertebra, intervertebral disc, and surrounding tissues of the spine via uniportal or biportal posterior, lateral, or posterolateral approach, where anatomical restrictions safely permit. It is intended for posterelateral time, or near real-time (i.e., successive static image) radiographic visualization via image-intensified C-arm fluoroscopy. The System is designed for use with Nu Vasive™ spinal arthroscopes and percutaneous surgical instrumentation, but may be used with other arthroscopes and instrumentation having compatible diameter and length, and which are indicated for use in the spine.

Concurrence of CDRH, Office of Device Evaluation (ODE)

| Prescription Use | <div> <span></span> </div> |
|----------------------|----------------------------|
| (Per 21 CFR 801.109) | OR |

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

| 510(k) Number | K013254 |
|---------------|---------|
|---------------|---------|

Page - 10 -