K Number
K990324
Device Name
NUVASIVE GUIDED SPINAL ARTHROSCOPY SYSTEM
Manufacturer
Date Cleared
1999-10-05

(245 days)

Product Code
Regulation Number
888.1100
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The NuVasive Guided Spinal Arthroscopy System consists of a rigid instrument Guide Frame with adjustable cannula guides, and various arthroscopic cannulae and instrumentation. The System is intended to assist in gaining controlled percutaneous access to, and visualization of, the spinal nerve root, foramina, intervertebral disc, and surrounding tissues of the spine via uniportal or biportal posterior 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 C-arm fluoroscopy. The System is designed for use with the NuVasive Spinal Arthroscope, but may be used with other arthroscopes having a minimum working length of 400 mm, an outer sheath diameter of 5.0 mm, and which are indicated for use in the spine.
Device Description
The subject System consists of a rigid instrument guide frame adjustable in multiple dimensions and planes, a series of expanding tip cannulae which can be introduced with precision to the operative site through the guide frame, and related manual arthroscopic instruments. Under radiographic guidance, the System assists the physician in gaining controlled, percutaneous access to the spine and adjacent tissues and structures, via uniportal or biportal approach.
More Information

Not Found

N/A

No
The description focuses on mechanical guidance and manual instrumentation under radiographic visualization, with no mention of AI/ML for image analysis, decision support, or automated control.

No
The device aids in gaining access to and visualizing spinal tissues; it does not directly treat a medical condition.

No

The device is described as assisting in gaining controlled percutaneous access to and visualization of spinal structures. Its purpose is to facilitate surgical access and procedures, not to identify or diagnose a disease or condition. The text focuses on its use as a surgical tool for access and visualization during intervention.

No

The device description explicitly states that the system consists of a rigid instrument guide frame, cannulae, and manual arthroscopic instruments, which are all hardware components.

Based on the provided information, this device is not an IVD (In Vitro Diagnostic).

Here's why:

  • IVD Definition: In Vitro Diagnostics are devices intended for use in the collection, preparation, and examination of specimens taken from the human body (such as blood, urine, or tissue) to provide information for diagnostic purposes.
  • Device Function: The NuVasive Guided Spinal Arthroscopy System is a surgical instrument system designed to assist in gaining access to and visualizing structures within the spine during a surgical procedure. It is used in vivo (within the living body) with real-time imaging, not for analyzing in vitro specimens.
  • Intended Use: The intended use clearly describes a surgical assistance system for access and visualization, not for analyzing biological samples.

Therefore, this device falls under the category of surgical instruments or systems, not In Vitro Diagnostics.

N/A

Intended Use / Indications for Use

The NuVasive Guided Spinal Arthroscopy System consists of a rigid instrument Guide Frame with adjustable cannula guides, and various arthroscopic cannulae and instrumentation. The System is intended to assist in gaining controlled percutaneous access to, and visualization of, the spinal nerve root, foramina, intervertebral disc, and surrounding tissues of the spine via uniportal or biportal posterior 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 C-arm fluoroscopy. The System is designed for use with the NuVasive Spinal Arthroscope, but may be used with other arthroscopes having a minimum working length of 400 mm, an outer sheath diameter of 5.0 mm, and which are indicated for use in the spine.

Product codes

HRX

Device Description

The subject System consists of a rigid instrument guide frame adjustable in multiple dimensions and planes, a series of expanding tip cannulae which can be introduced with precision to the operative site through the guide frame, and related manual arthroscopic instruments. Under radiographic guidance, the System assists the physician in gaining controlled, percutaneous access to the spine and adjacent tissues and structures, via uniportal or biportal approach.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

real-time, or near real-time (i.e., successive static image) radiographic visualization via image-intensified C-arm fluoroscopy

Anatomical Site

spinal nerve root, foramina, intervertebral disc, and surrounding tissues of the spine

Indicated Patient Age Range

Not Found

Intended User / Care Setting

physician / Not Found

Description of the training set, sample size, data source, and annotation protocol

Not Found

Description of the test set, sample size, data source, and annotation protocol

Not Found

Summary of Performance Studies

Not applicable

Key Metrics

Not Found

Predicate Device(s)

Not Found

Reference Device(s)

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information

Not Found

§ 888.1100 Arthroscope.

(a)
Identification. An arthroscope is an electrically powered endoscope intended to make visible the interior of a joint. The arthroscope and accessories also is intended to perform surgery within a joint.(b)
Classification. (1) Class II (performance standards).(2) Class I for the following manual arthroscopic instruments: cannulas, currettes, drill guides, forceps, gouges, graspers, knives, obturators, osteotomes, probes, punches, rasps, retractors, rongeurs, suture passers, suture knotpushers, suture punches, switching rods, and trocars. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 888.9.

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大99032

VII. 510(k) Summarv

In accordance with the Safe Medical Devices Act (SMDA) of 1990, and Title 21 of the Code of Federal Regulations (21 CFR), Part 807, and in particular §807.92, the following summary of safety and effectiveness information is provided:

Submitted by A.

R. Stephen Reitzler, RAC Voce President, Regulatory Affairs & Quality Assurance NuVasive, Incorporated 10065 Old Grove Road, Suite A San Diego, California 92131

B. Device Name

Trade or Proprietary Name:Guided Spinal Arthroscopy System
Common or Usual Name:Arthroscope accessories
Classification Name:Arthroscope [and accessories]

C. Predicate Devices

The subject device is substantially equivalent to the following predicate devices, among others:

INCLUSIVE™ Endoscope and Micro-Endo™ Instruments (Sofamor Danek) PercScope™ (Cl:arus Medical) Percutaneous Discectomy System (Richard Wolf Medical) Gouda Stereotactic Frame (neurological Devices) Stereoguide Breast Biopsy System (Lorad Corp.) ABBI™ System and Auto Suture® Dilating Cannula (U.S. Surgical Corp.) Mammotome Multi-Probe (Biopsys Medical) ENDOPATH™M Trocar Sleeve with Dilating Obturator (Ethicon)

D. Device Description

The subject System consists of a rigid instrument guide frame adjustable in multiple dimensions and planes, a series of expanding tip cannulae which can be introduced with precision to the operative site through the guide frame, and related manual arthroscopic instruments. Under radiographic guidance, the System assists the physician in gaining controlled, percutaneous access to the spine and adjacent tissues and structures, via uniportal or biportal approach.

1

E. Intended Use

The NuVasive Guided Spinal Arthroscopy System consists of a rigid instrument Guide Frame with adjustable cannula guides, and various arthroscopic cannulae and instrumentation. The System is intended to assist in gaining controlled percutaneous access to, and visualization of, the spinal nerve root, foramina, intervertebral disc, and surrounding tissues of the spine via uniportal or biportal posterior 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 C-arm fluoroscopy. The System is designed for use with the NuVasive Spinal Arthroscope, but may be used with other arthroscopes having a minimum working length of 400 mm, an outer sheath diameter of 5.0 mm, and which are indicated for use in the spine.

F. Comparison to Predicate Devices

The subject device has substantially equivalent indications for use as one or more of the predicate devices, being intended to provide controlled and precise alignment, orientation, and introduction of arthroscopic instruments to the spine, using a rigid guide frame and radiographic guidance;

The subject device is composed of the same or equivalent materials as one or more of the predicate devices, all of which are established as safe for their application in the subject device:

The subject device encompasses design features which are substantially equivalent to those offered by one or more of the predicate devices, including adjustment of the frame in multiple angles and planes under radiographic guidance to optimize surgical approach angles, an expanding cannula tip, and a selection of instrument and cannula diameters:

The System provides functions equivalent to those provided by one or more of the predicate devices, serving to establish a port of entry to the spine and adjacent tissues for the introduction and use of arthroscopic instrumentation in diagnostic and interventional percutaneous spinal procedures;

Further, the subject device is packaged and labeled in a manner substantially equivalent to one or more of the predicate devices.

G. Summary of Non-Clinical Tests

(Not applicable)

2

Summary of Clinical Tests H.

(Not applicable_

I. Conclusions of Non-Clinical and Clinical Tests

(Not applicable)

3

Image /page/3/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" arranged around the perimeter. Inside the circle is a stylized graphic of three human profiles facing to the right, with flowing lines representing hair or clothing.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

OCT 15 1999

Mr. Steve Reitzler, RAC Vice President, Regulatory Affairs and Quality Assurance Nuvasive, Inc. 10065 Old Grove Road, Suite A San Diego, California 92131

Re: K990324

Trade Name: NuVasive Guided Spinal Arthroscopy System Regulatory Class: II Product Code: HRX Dated: July 2, 1999 Received: July 7, 1999

Dear Mr. Reitzler:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). 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 (Premarket Approval), 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 895. A substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic (QS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

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Page 2 - Mr. Steve Reitzler

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្រី និង ក្រោយក្រោយ ស្រុក ប្រចាំ

This letter will allow you to begin marketing your device as described in your 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 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4595. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html"

Sincerely yours,

Styta Rlurlis
Celia M. Witten, Ph.D., M.D.

Celia M. Witten, Ph.D., M.D. Director Division of General and Restorative Devices Office of Device Evaluation

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V. Draft Labeling

A. Indications for Use

510(k) Number (if known): __ K990324

Device Name: NuVasive, Inc., Guided Spinal Arthroscopy System

Indications for Use:

The NuVasive Guided Spinal Arthroscopy System consists of a rigid instrument Guide Frame with adjustable cannula guides, and various arthroscopic cannulae and instrumentation. The System is intended to assist in gaining controlled percutaneous access to, and visualization of, the spinal nerve root, foramina, intervertebral disc, and surrounding tissues of the spine via uniportal or biportal posterior 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 C-arm fluoroscopy. The System is designed for use with the NuVasive Spinal Arthroscope, but may be used with other arthroscopes having a minimum working length of 400 mm, an outer sheath diameter of 5.0 mm, and which are indicated for use in the spine.

Concurrence of CDRH, Office of Device Evaluation (ODE)

Over-the-Counter Use Prescription Use OR (Per 21 CFR 801.109 Divisior Division c 510(k) Numb