K Number

Device Name

Manufacturer

NUVASIVE, INC.

Date Cleared

2004-04-12

(152 days)

Product Code

Regulation Number

Type

Panel

Reference & Predicate Devices

N/A

Predicate For

N/A

Intended Use

When used as a pedicle screw fixation system, the NuVasive Spinal System is intended to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of the following acute and chronic instabilities or deformities of the posterior thoracic, lumbar, and sacral spinc: (1) degenerative disc disease (as defined by back pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies), (2) degenerative spondylolisthesis with objective evidence of neurologic impairment, (3) fracture, (4) dislocation, (5) scoliosis, (6) kyphosis, (7) spinal tumor, and/or (8) failed previous fusion (pseudoarthrosis).

The NuVasive Spinal System is also indicated for the treatment of severe spondylolisthesis (Grades 3 and 4) of the L5-S1 vertebral joint in skeletally mature patients receiving fusion by autogenous bone graft, having the device fixed or attached to the lumbar and sacral spine (1.3 to sacrum), with removal of the implants after attainment of a solid fusion.

When used as an anterolateral non-nedicle screw system in the thoracic and lumbar spine. the NuVasive Spinal System is also intended for the following indications: (1) degenerative disc disease (as defined by back pain of discogenic origin with degencration of the disc confirmed by patient history and radiographic studies), (2) spinal stenosis, (3) spondylolisthesis, (4) spinal deformities, (5) fracture, (6) pseudoarthosis, (7) tumor resection, and/or (8) failed previous fusion.

Device Description

The NuVasive Spinal System consists of a variety of polyaxial screws, fixed angle screws, rods, locking nuts, and transverse connectors. Implant components can be rigidly locked into a variety of different configurations to suit the individual pathology and anatomical conditions of the patient.

AI/ML Overview

This document describes a 510(k) premarket notification for the NuVasive Spinal System, a medical device. The information provided in the input is insufficient to complete the requested table and details regarding acceptance criteria and a study proving the device meets those criteria.

Here's why and what information is missing:

Acceptance Criteria and Device Performance: The document is a 510(k) summary, which focuses on demonstrating substantial equivalence to a predicate device. It states, "Mechanical testing was presented," but does not provide any specific acceptance criteria (e.g., strength, fatigue life, displacement limits) nor the quantitative results of these tests (the reported device performance). Without this data, a table like the one requested cannot be constructed.
Study Details (Sample Sizes, Data Provenance, Ground Truth, Experts, Adjudication, MRMC, Standalone): The document explicitly states, "Summary of Clinical Tests (Not Applicable)." This means no clinical studies were performed to demonstrate the safety and effectiveness of the device. The 510(k) pathway for this device relies on demonstrating substantial equivalence through mechanical testing and comparison to predicate devices, not clinical performance data from human subjects.

Therefore, the requested information for acceptance criteria and the study that proves the device meets them cannot be extracted from the provided text.

However, I can explain the general context based on the provided document:

General Device Type and Approval Process:

The NuVasive Spinal System is a spinal implant for fixation and stabilization of spinal segments.
It's a Class III device (Pedicle Screw Spinal System).
It was cleared via a 510(k) premarket notification (K033546), signifying that the FDA determined it is "substantially equivalent" to predicate (already legally marketed) devices. This means it has the same intended use, technological characteristics, and raises no new safety or effectiveness concerns as the predicate device(s).

What a 510(k) submission typically entails for this type of device (though specific details are not in the provided text):

For a spinal implant, "acceptance criteria" and "device performance" in a 510(k) submission primarily refer to bench (mechanical) testing designed to ensure the device meets established standards for strength, fatigue, and other relevant mechanical properties to function safely within the human body. These tests are usually conducted in vitro.

Mechanical Testing: This would typically involve tests like:
- Static Compression/Bending/Torsion: To assess the immediate strength and rigidity of the components.
- Dynamic (Fatigue) Testing: To simulate repetitive loading over time, ensuring the device can withstand physiological stresses without failure (e.g., millions of cycles at specific load levels).
- Pull-out strength: For screws into artificial bone.
- Insertion/Removal torque: For screws.
- Corrosion resistance.
- Material characterization.

Missing Information (Summary):

Information Category	Status in Provided Text
1. Table of Acceptance Criteria and Reported Device Performance	Not provided. The document states "Mechanical testing was presented" but gives no specific criteria (e.g., minimum load to failure, number of fatigue cycles without fracture) or the quantitative results of these tests.
2. Sample Size (Test Set) and Data Provenance	Not applicable for clinical studies. For mechanical testing, the "sample size" would refer to the number of devices or components tested. This detail is not provided. Data provenance would be the lab where tests were conducted.
3. Number of Experts and Qualifications (Ground Truth for Test Set)	Not applicable for clinical studies. For mechanical testing, "ground truth" is typically established by engineering standards (e.g., ASTM, ISO) and laboratory measurements. No human "experts" in the clinical sense are establishing ground truth for mechanical performance.
4. Adjudication Method (Test Set)	Not applicable.
5. MRMC Comparative Effectiveness Study and Effect Size (Human + AI vs. Human only)	Not applicable. This device is a physical implant, not an AI-assisted diagnostic or treatment planning tool. No human-in-the-loop AI component is mentioned.
6. Standalone Algorithm Performance (without human-in-the-loop)	Not applicable. The device is a physical implant, not an algorithm.
7. Type of Ground Truth Used	Not applicable for clinical studies. For mechanical testing, the "ground truth" would be the objective measurements obtained from laboratory equipment conforming to established engineering standards.
8. Sample Size for Training Set	Not applicable. As "Summary of Clinical Tests (Not Applicable)" explicitly states, no clinical studies were performed. This device is not an AI/ML algorithm that would require a "training set" of data in the common sense. For mechanical testing, there isn't really a "training set"; instead, tests are conducted according to standardized protocols.
9. How Ground Truth for Training Set Was Established	Not applicable. For mechanical testing, the "ground truth" (i.e., whether the device passed or failed a specific test) is established by directly measuring its performance against pre-defined engineering acceptance criteria, typically outlined in relevant ASTM or ISO standards, and comparing it to the performance of the predicate device (or exceeding it) to support substantial equivalence. This is not a "training set" in the AI/ML context.

Summary

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510(k) Premarket Notification Spinal System

VII. 510(k) Summary

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

A. Submitted by

Laetitia Bernard Manager of Regulatory Affairs and Quality Assurance NuVasive, Incorporated 10065 Old Grove Road San Diego, CA 92131 Telephone: (858) 527-1918 Date Prepared: November 11, 2003.

B. Device Name

Trade or Proprietary Name:	NuVasive Spinal System
Common or Usual Name:	Spinal Implants
Classification Name:	Pedicle Screw Spinal System, Spinal Interlaminal FixationOrthosis, Spinal Intervertebral Body Fixation orthosis.

C. Predicate Devices

The subject device is substantially equivalent to similar previously cleared devices.

D. Device Description

E. Intended Use

When used as a pedicle screw fixation system, the NuVasive Spinal System is intended to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of the following acute and chronic instabilities or deformities of the posterior thoracic, lumbar, and sacral spine: (1) degenerative disc disease (as defined by back pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies), (2) degenerative spondylolisthesis with objective evidence of neurologic impairment, (3) fracture, (4) dislocation, (5) scoliosis, (6) kyphosis, (7) spinal tumor, and/or (8) failed previous fusion (pseudoarthrosis).

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The NuVasive Spinal System is also indicated for the treatment of severe spondylolisthesis (Grades 3 and 4) of the L5-S1 vertebral joint in skeletally mature patients receiving fusion by autogenous bone graft, having the device fixed or attached to the lumbar and sacral spine (1,3 to sacrum), with removal of the implants after attainment of a solid fusion.

When used as an anterolateral non-pedicle screw system in the thoracic and lumbar spine, the NuVasive Spinal System is also intended for the following indications: (1) degenerative disc disease (as defined by back pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies), (2) spinal stenosis, (3) spondylolisthesis, (4) spinal deformities, (5) fracture, (6) pseudoarthosis, (7) tumor resection, and/or (8) failed previous fusion.

F. Comparison to Predicate Devices

As was established in this submission, the subject device is substantially equivalent to other devices cleared by the agency for commercial distribution in the United States.

Engineering drawings, labeling, and mcchanical testing have demonstrated that the subject device is substantially equivalent, if not identical, to its predicate devices in terms of design, materials of composition, indications for use, and such other characteristics as may be associated with the manufacture of any medical device.

G. Summary of Non-Clinical Tests

Mechanical testing was presented.

H. Summary of Clinical Tests

(Not Applicable).

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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 caduceus, which is a symbol often associated with medicine and healthcare. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES. USA" is arranged in a circular pattern around the caduceus.

NuVasive, Inc. % Ms. Laetitia Cousin 7475 Lusk Boulevard San Diego, California 92121

JUL 3 0 2009

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Re: K033546

Trade/Device Name: NuVasive Spinal System Regulation Number: 21 CFR 888.3070 Regulation Name: Pedicle Screw Spinal System Regulatory Class: III Product Code: NKB, MNH, MNI, KWQ Dated: January 22, 2004 Received: January 23, 2004

Dear Ms. Cousin:

This letter corrects our substantially equivalent letter of April 12, 2004.

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 (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 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); medical device reporting of medical device-related adverse events) (21 CFR 803); 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. Laetitia Cousin

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

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 (800) 638-2041 or (240) 276-3150 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely vours.

Sincerely yours,

Barbara Buett

Mark Melkerson Director Division of Surgical. Orthopedic. and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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V. Draft Labeling

A. Indications for Use

510(k) Number (if known):	------------------------------------------------------------------------------------------------------------------------------------------------------------------------------	1 KOSANComments of the more and complex and consisted in	5 4-6	ﻟ	and of the state of
---------------------------	--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------	--------------------------------------------------------------	-------	---	---------------------	--

Device Name: NuVasive Spinal System

Indications for Use:

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use (Pcr 21 CFR 801.109)

OR Over-The-Counter Use

Regulation Number and Section

N/A