(69 days)
Not Found
Not Found
No
The summary describes a mechanical implant system for spinal fusion and does not mention any software, algorithms, or AI/ML capabilities.
Yes
The device is intended for anterior screw fixation of the cervical spine to provide stabilization as an adjunct to cervical fusion, addressing conditions like degenerative disc disease, trauma, and spinal stenosis. These are therapeutic interventions.
No
The device is described as an implant system (plates and screws) used for stabilization during cervical fusion, not for diagnosing conditions. Its intended use is to provide fixation and stabilization, not to detect, diagnose, or monitor health conditions.
No
The device description explicitly states it consists of "a variety of plates and screws," which are physical hardware components.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to examine specimens taken from the human body (like blood, urine, tissue) to provide information about a person's health. This information is used for diagnosis, monitoring, or screening.
- Device Description and Intended Use: The NuVasive HELIX Mini Anterior Cervical Plating System is a surgical implant designed for fixation and stabilization of the cervical spine. It is a physical device implanted into the body during surgery.
- Lack of IVD Characteristics: The provided information does not mention any analysis of biological specimens, laboratory testing, or diagnostic information derived from such testing.
Therefore, based on the provided description, the NuVasive HELIX Mini Anterior Cervical Plating System is a surgical implant, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The NuVasive HELIX Mini 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 Mini 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 Mini 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, 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, lighter 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:
Submitted by: A.
Laetitia Cousin Director of Regulatory and Clinical Affairs, and Quality Assurance NuVasive, Incorporated 4545 Towne Centre Court San Diego, California 92121 Telephone: (858) 909-1868 Fax: (858) 909-2068
JAN 29 2002
Device Name B.
| Trade or Proprietary Name: | NuVasive HELIX Mini 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 Mini ACP System is substantially equivalent to the HELIX ACT System currently distributed commercially in the U.S. by NuVasive.
D. Device Description
The NuVasive HELIX Mini 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 Mini 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 Mini 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 Creative Spine Technology". The logo features the company name in bold, sans-serif font, with the tagline "Creative Spine Technology" in a smaller, lighter font underneath. To the left of the company name is a curved line that appears to be a stylized representation of a spine.
F. Comparison to Predicate Devices
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.
H. Summary of Clinical Tests
(Not Applicable).
2
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/12 description: The image shows the logo for the Department of Health & Human Services - USA. The logo consists of a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES-USA" arranged around the circumference. Inside the circle is a stylized emblem featuring three abstract, bird-like shapes stacked vertically, creating a sense of upward movement.
Public Health Service
JAN 2 9 2008
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
NuVasive, Incorporated % Ms. Laetitia Cousin Director of Regulatory and Clinical Affairs and Ouality Assurance 4545 Towne Centre Court San Diego, CA 92121
Re: K073275
Trade/Device Name: Helix Mini Anterior Cervical Plate System Regulation Number: 21 CFR 888.3060 Regulation Name: Spinal intervertebral body fixation orthosis Regulatory Class: Class II Product Code: KWQ Dated: January 7, 2007 Received: January 8, 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, 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 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 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.
3
Page 2 - Ms. Laetitia Cousin
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 Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Mark H. Millman
Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
K073275
Page 1 of 1
Indications for Use
510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________
Device Name: HELIX Mini Anterior Cervical Plating System
Indications For Use:
The NuVasive HELIX Mini 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 Mini 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 X (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 Budup for you
(Division Sign-Off)
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(Division Sign-Off)
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Division of General, Restorative, and Neurological Devices
510(k) Number KD2325