NUVASIVE VUEPOINT OCT SYSTEM

K093319 · Nuvasive, Inc. · KWP · Jun 23, 2010 · Orthopedic

Device Facts

• Record ID: K093319
• Device Name: NUVASIVE VUEPOINT OCT SYSTEM
• Applicant: Nuvasive, Inc.
• Product Code: KWP · Orthopedic
• Decision Date: Jun 23, 2010
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 888.3050
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The VuePoint® OCT System is intended to promote fusion of the cervical spine and occipito-thoracic junction (Occiput-T3), and indicated for: 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/Dislocation, 4. Spinal Stenosis, 5. Atlantoaxial fracture with instability, 6. Occipitocervical dislocation, 7. Spinal tumor and/or 8. Revision of previous cervical spine surgery. The occipital bone screws are limited to occipital fixation only, The use of polyaxial screws is limited to placement in the upper thoracic spine (TI-T3) in treating thoracic conditions only. They are not intended to be placed in the cervical spine. The VuePoint OCT System can also be linked to the NuVasive SpheRx Spinal System via the rod to rod connectors or transition rods.

Device Story

Spinal fixation system consisting of screws, rods, offset connectors, set screws, and cross connectors; components rigidly locked in configurations to accommodate patient anatomy; used by surgeons in clinical settings to promote spinal fusion; provides mechanical stabilization of cervical spine and occipito-thoracic junction; can be linked to NuVasive SpheRx Spinal System via transition rods; benefits patient by stabilizing spine and facilitating fusion in degenerative, traumatic, or oncologic conditions.

Clinical Evidence

Bench testing only. Static and dynamic torsion and compression testing per ASTM draft standard WK455-Z9592Z; interconnection testing per ASTM F1798. Results demonstrate performance meeting or exceeding predicate devices.

Technological Characteristics

Spinal fixation orthosis; components include screws, rods, offset connectors, set screws, cross connectors. Materials and design equivalent to predicates. Testing performed per ASTM draft standard WK455-Z9592Z (static/dynamic torsion and compression) and ASTM F1798 (interconnection).

Indications for Use

Indicated for patients requiring cervical spine and occipito-thoracic (Occiput-T3) fusion due to degenerative disc disease, degenerative spondylolisthesis with neurologic impairment, fracture/dislocation, spinal stenosis, atlantoaxial fracture with instability, occipitocervical dislocation, spinal tumor, or revision of previous cervical surgery. Occipital screws limited to occipital fixation; polyaxial screws limited to T1-T3 thoracic placement.

Regulatory Classification

Identification

A spinal interlaminal fixation orthosis is a device intended to be implanted made of an alloy, such as stainless steel, that consists of various hooks and a posteriorly placed compression or distraction rod. The device is implanted, usually across three adjacent vertebrae, to straighten and immobilize the spine to allow bone grafts to unite and fuse the vertebrae together. The device is used primarily in the treatment of scoliosis (a lateral curvature of the spine), but it also may be used in the treatment of fracture or dislocation of the spine, grades 3 and 4 of spondylolisthesis (a dislocation of the spinal column), and lower back syndrome.

Predicate Devices

• NuVasive OCT System (K071435)
• NuVasive SpheRx® II Pedicle Screw System (K092287)
• DePuy Spine™ MOUNTAINEER™ OCT Spinal System (K080828)

Submission Summary (Full Text)

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JUN 2 3 2010

NUVASIVE
Creative Spine Technology

# 510(k) Summary

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

#### A. Submitted by:

Sheila Bruschi Senior Regulatory Affairs Associate NuVasive, Incorporated 7475 Lusk Blvd. San Diego, California 92121 Telephone: [phone] Fax: [phone]

Date Prepared: June 14, 2010

#### B. Device Name

| Trade or Proprietary Name: | <i>NuVasive® VuePoint® OCT System</i> |
|----------------------------|-------------------------------------------------------------------------------|
| Common or Usual Name: | Spinal Fixation Appliances |
| Classification Name: | Appliance, Fixation, Spinal Interlaminal and Spinal Pedicle Fixation Orthosis |
| Device Class: | Class II |
| Classification: | §888.3050 |
| Product Code: | KWP |

#### C. Predicate Devices

The subject VuePoint OCT System is substantially equivalent to the following predicate devices currently distributed commercially in the U.S .:

- . K071435 - NuVasive OCT System
- K092287 NuVasive SpheRx® II Pedicle Screw System ●
- K080828 DePuy Spine™ MOUNTAINEER™ OCT Spinal System .

## D. Device Description

The NuVasive VuePoint OCT System consists of a variety of shapes and sizes of screws, rods, offset connectors, set screws, and cross connectors which can be rigidly locked in a variety of configurations to accommodate patient anatomy.

## E. Intended Use

The VuePoint® OCT System is intended to promote fusion of the cervical spine and occipito-thoracic junction (Occiput-T3), and indicated for:

- I. 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/Dislocation,

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- 4. Spinal Stenosis,
- 5. Atlantoaxial fracture with instability,
- 6. Occipitocervical dislocation,
- 7. Spinal tumor and/or
- 8. Revision of previous cervical spine surgery.

The occipital bone screws are limited to occipital fixation only,

The use of polyaxial screws is limited to placement in the upper thoracic spine (TI-T3) in treating thoracic conditions only. They are not intended to be placed in the cervical spine.

The VuePoint OCT System can also be linked to the NuVasive SpheRx Spinal System via the rod to rod connectors or transition rods.

#### F. Technological Characteristics

As was established in this submission, the subject VuePoint OCT System is substantially equivalent to other predicate devices cleared by the FDA for commercial distribution in the United States. The subject device was shown to be substantially equivalent and have the same technological characteristics to its predicate devices through comparison in areas including design, intended use, material composition, function, and range of sizes.

#### Performance Data G.

Nonclinical testing was performed to demonstrate that the subject VuePoint OCT System is substantially equivalent to other predicate devices. The following testing was performed:

- . Static and dynamic torsion per ASTM draft standard WK455-Z9592Z
- Static and dynamic compression per ASTM draft standard WK455-Z9592Z .
- . Interconnection testing per ASTM F1798

The results of these studies showed that the subject VuePoint OCT System meets or exceeds the performance of the predicate device, and the device was therefore found to be substantially equivalent.

#### H. Conclusions

Based on the indications for use, technological characteristics, performance testing, and comparison to predicate devices, the subject VuePoint OCT System has been shown to be substantially equivalent to legally marketed predicate devices, and safe and effective for its intended use.

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## DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three lines forming its body and wings. The eagle is encircled by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" in a circular arrangement.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002

JUN 23 2010

NuVasive, Inc. % Ms. Sheila Bruschi Senior Regulatory Affairs Associate 7475 Lusk Boulevard San Diego, California 92121

Re: K093319

Trade/Device Name: VuePoint® OCT System Regulation Number: 21 CFR 888.3050 Regulation Name: Spinal interlaminal fixation orthosis Regulatory Class: Class II Product Code: KWP Dated: May 19, 2010 Received: May 20, 2010

Dear Ms. Bruschi:

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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you; however, that device labeling must be truthful and not misleading.

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

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Page 2 - Ms. Sheila Bruschi

CFR Part 807); labeling (21 CFR Part 801); medical device reporting (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.

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/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 [phone] or [phone] or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely yours.

Barbara Budim

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

Enclosure

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# Indications for Use

510(k) Number (if known): K093319

Device Name: VuePoint® OCT System

Indications For Use:

The VuePoint® OCT System is intended to promote fusion of the cervical spine and occipito-thoracic junction (Occiput-T3), and is indicated for: (1) Degenerative disc disease (as defined by back pain of discogenic origin with degeneration of the disc by patient history and radiographic studies), (2) Degenerative confirmed spondylolisthesis with objective evidence of neurologic impairment, (3) Fracture/Dislocation, (4) Spinal Stenosis, (5) Atlantoaxial fracture with instability, (6) Occipitocervical dislocation, (7) Spinal tumor and/or (8) Revision of previous cervical spine surgery.

The occipital bone screws are limited to occipital fixation only.

The use of polyaxial screws is limited to placement in the upper thoracic spine (T1-T3) in treating thoracic conditions only. They are not intended to be placed in the cervical spine.

The VuePoint OCT System can also be linked to the NuVasive SpheRx Spinal System via the rod to rod connectors or transition rods.

Prescription Use (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)

signature

(Division Sign-Off) Division of Surgical, Orthopedic, and Restorative Devices

KO93319 510(k) Number_

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