(89 days)
Not Found
Not Found
No
The summary describes a mechanical implant system for spinal fixation and does not mention any software, algorithms, or AI/ML capabilities.
Yes
The device is intended to provide stabilization as an adjunct to cervical fusion for conditions such as degenerative disc disease, spondylolisthesis, and trauma, which indicates a therapeutic purpose.
No
The device is described as an anterior screw fixation system and surgical implant for spinal stabilization and fusion, not for diagnosing conditions.
No
The device description explicitly states that the system consists of "a variety of plates and screws," which are physical hardware components. There is no mention of software being the primary or sole component of the device.
Based on the provided information, the NuVasive HELIX ACP System is not an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use clearly states it's for "anterior screw fixation of the cervical spine" and provides "stabilization as an adjunct to cervical fusion." This describes a surgical implant used in vivo (within the body) to provide structural support.
- Device Description: The description confirms it consists of "plates and screws," which are physical implants.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens (like blood, tissue, or urine) in vitro (outside the body) to provide information about a patient's health status, diagnose, monitor, or screen for diseases.
IVD devices are typically used in laboratories or point-of-care settings to analyze biological samples. The NuVasive HELIX ACP System is a surgical implant used directly on the patient's spine.
N/A
Intended Use / Indications for Use
The NuVasive HELIX ACP System is intended for anterior screw fixation of the cervical spine. These implants have been designed to provide stabilization as an adjunct to cervical fusion. Indications for the use of this implant system include degenerative disc disease defined as neck pain of discogenic origin with the degeneration of the disc confirmed by history and radiographic studies, spondylolisthesis, trauma, spinal stenosis, deformity, tumor, pseudarthrosis or failed previous fusion.
WARNING: The NuVasive HELIX ACP System is not intended for screw attachment or fixation to the posterior elements (pedicles) of the cervical, thoracic or lumbar spine.
Product codes (comma separated list FDA assigned to the subject device)
KWQ
Device Description
The NuVasive HELIX ACP System consists of a variety of plates and screws designed to provide stabilization as an adjunct to cervical fusion.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
cervical spine
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)
Mechanical testing was presented.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Not Found
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
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
§ 888.3060 Spinal intervertebral body fixation orthosis.
(a)
Identification. A spinal intervertebral body fixation orthosis is a device intended to be implanted made of titanium. It consists of various vertebral plates that are punched into each of a series of vertebral bodies. An eye-type screw is inserted in a hole in the center of each of the plates. A braided cable is threaded through each eye-type screw. The cable is tightened with a tension device and it is fastened or crimped at each eye-type screw. The device is used to apply force to a series of vertebrae to correct “sway back,” scoliosis (lateral curvature of the spine), or other conditions.(b)
Classification. Class II.
0
Image /page/0/Picture/0 description: The image shows the logo for "NUVASIVE Creative Spine Technology". The logo features a stylized "N" with a curved line above it and a series of small circles within the letter. Below the main text, the words "Creative Spine Technology" are written in a smaller font.
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:
A. Submitted by:
Laetitia Cousin Director of Regulatory Affairs and Quality Assurance NuVasive, Incorporated 4545 Towne Centre Court San Diego. California 92121 Telephone: (858) 909-1868 Fax: (858) 909-2068
AUG - 8 2007
B. Device Name
| Trade or Proprietary Name: | NuVasive HELIX ACP System |
|---|---|
| Common or Usual Name: | Cervical Plate and Screw System |
| Classification Name: | Spinal Intervertebral Body Fixation Orthosis |
| Device Class: | Class II |
| Classification: | §888.3060 |
| Product Code: | KWQ |
C. Predicate Devices
The subject HELIX ACP System is substantially equivalent to the Gradient Plus System currently distributed commercially in the U.S. by NuVasive.
D. Device Description
The NuVasive HELIX ACP System consists of a variety of plates and screws designed to provide stabilization as an adjunct to cervical fusion.
E. Intended Use
The NuVasive HELIX ACP System is intended for anterior screw fixation of the cervical spine. These implants have been designed to provide stabilization as an adjunct to cervical fusion. Indications for the use of this implant system include degenerative disc disease defined as neck pain of discogenic origin with the degeneration of the disc confirmed by history and radiographic studies, spondylolisthesis, trauma, spinal stenosis, deformity, tumor, pseudarthrosis or failed previous fusion.
WARNING: The NuVasive HELIX ACP System is not intended for screw attachment or fixation to the posterior elements (pedicles) of the cervical, thoracic or lumbar spine.
1
Image /page/1/Picture/0 description: The image shows the logo for NUVASIVE, a medical device company. The logo features a stylized "N" with a curved line above it, followed by the word "NUVASIVE" in bold, sans-serif font. Below the company name is the tagline "Creative Spine Technology" in a smaller, italicized font.
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.
G. Summary of Non-Clinical Tests
Mechanical testing was presented.
Summary of Clinical Tests H.
(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 consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized symbol that resembles an abstract caduceus or a bird-like figure with three curved lines.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
AUG - 8 2007
NuVasive, Incorporated % Ms. Laetitia Cousin Director of Regulatory Affairs, Clinical Affairs and Quality Assurance 4545 Towne Centre Court San Diego, California 92121
Re: K071329
Trade/Device Name: NuVasive HELIX ACP System Regulation Number: 21 CFR 888.3060 Regulation Name: Spinal intervertebral body fixation orthosis Regulatory Class: Class II Product Code: KWQ Dated: July 20, 2007 Received: July 23, 2007
Dear Ms. Cousin:
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. Ilsting 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
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Page 2 - Ms. Laetitia Cousin
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. 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), please contact the Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at (240) 276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at (240) 276-3464. You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at toll-free number (800) 638-2041 or (240) 276-3150 or the Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours.
Barbara Buehrig
Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
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K071329
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Indications for Use
KOZI329 510(k) Number (if known):
Device Name: HELIX Anterior Cervical Plating System
Indications For Use:
The NuVasive HELIX Anterior Cervical Plating System is intended for anterior screw fixation of the cervical spine. These implants have been designed to provide stabilization as an adjunct to cervical fusion. Indications for the use of this implant system include degenerative disc disease defined as neck pain of discogenic origin with the degeneration of the disc confirmed by history and radiographic studies, spondylolisthesis, trauma, spinal stenosis, deformity, tumor, pseudarthrosis or failed previous fusion.
WARNING: The NuVasive HELIX Anterior Cervical Plating System is not intended for screw attachment or fixation to the posterior elements (pedicles) of the cervical, thoracic or lumbar spine.
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)
Barbara Buellup for Mpd
Division Sign Off
Division of General, Restorative, and Neurological Devices
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510(k) Number K071329