(243 days)
No
The device description and performance studies focus on the mechanical properties and structural components of a spinal fixation system, with no mention of AI/ML or image processing.
Yes
The device is intended to promote fusion of the cervical spine and occipito-thoracic junction to treat various spinal conditions, which indicates a therapeutic purpose.
No
Explanation: The VuePoint® OCT System is described as a surgical implant system consisting of screws, rods, and connectors intended to promote fusion of the cervical spine and occipito-thoracic junction. Its indications for use are related to treating various spinal conditions, not to diagnose them.
No
The device description explicitly lists physical components such as screws, rods, and connectors, indicating it is a hardware-based medical device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly describes a surgical implant system designed to promote fusion of the cervical spine and occipito-thoracic junction. This is a therapeutic intervention, not a diagnostic test performed on biological samples.
- Device Description: The device consists of physical components like screws, rods, and connectors, which are used in surgery. This is consistent with a surgical implant, not an IVD.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting specific analytes, or providing diagnostic information based on in vitro testing.
Therefore, the VuePoint® OCT System is a surgical device, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The VuePoint® OCT System is intended to promote fusion of the cervical spine and occipito-thoracic junction (Occiput-T3), and indicated for:
-
- Degenerative disc disease (as defined by back pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies),
-
- Degenerative spondylolisthesis with objective evidence of neurologic impairment,
-
- Fracture/Dislocation,
-
- Spinal Stenosis,
-
- Atlantoaxial fracture with instability,
-
- Occipitocervical dislocation,
-
- Spinal tumor and/or
-
- 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.
Product codes
KWP
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
cervical spine and occipito-thoracic junction (Occiput-T3), occipital bone, upper thoracic spine (T1-T3)
Indicated Patient Age Range
Not Found
Intended User / Care Setting
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 888.3050 Spinal interlaminal fixation orthosis.
(a)
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.(b)
Classification. Class II.
0
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: (858) 320-4515 Fax: (858) 320-4615
Date Prepared: June 14, 2010
B. Device Name
| Trade or Proprietary Name: | NuVasive® VuePoint® OCT System |
|---|---|
| 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),
-
- Degenerative spondylolisthesis with objective evidence of neurologic impairment,
-
- Fracture/Dislocation,
1
-
- Spinal Stenosis,
-
- Atlantoaxial fracture with instability,
-
- Occipitocervical dislocation,
-
- Spinal tumor and/or
-
- 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.
2
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
3
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 (800) 638-2041 or (301) 796-7100 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
4
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_
Page 1 of 1