(63 days)
K1091623, K050082
No
The summary describes a mechanical implant system and does not mention any AI/ML components or related performance metrics.
No.
A therapeutic device is one that treats a disease or condition. This device is an implant for spinal stabilization and reinforcement, which is a structural support and not a direct therapy.
No
The device is described as a system of plates and screws used to hold graft material in place and reinforce the spine during laminoplasty procedures. Its intended use is therapeutic (preventing expulsion or impingement of graft material), not diagnostic.
No
The device description explicitly states it consists of plates and screws made from titanium alloy, which are hardware components. The performance studies also describe mechanical testing of these hardware components.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the device is used in surgical procedures on the spine to hold graft material in place. This is a surgical implant, not a diagnostic test performed on samples taken from the body.
- Device Description: The device is described as plates and screws made of titanium alloy, designed for surgical implantation.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting specific substances, or providing diagnostic information based on in vitro testing.
IVD devices are used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. The NuVasive® Camber Laminoplasty System is a surgical implant used to physically support spinal structures.
N/A
Intended Use / Indications for Use
The NuVasive® Camber Laminoplasty System is intended for use in the lower cervical and upper thoracic spine (C3 to T3) in laminoplasty procedures. The Camber Laminoplasty System is used to hold the allograft or autograft material in place in order to prevent the allograft or autograft material from expulsion, or impinging the spinal cord.
Product codes
NQW
Device Description
The NuVasive® Camber Laminoplasty System consists of plates and screws of various sizes made from titanium alloy (ASTM F136) to provide reinforcement while expanding the spinal canal and preserving the posterior elements. Instruments required to implant the device are also available.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
lower cervical and upper thoracic spine (C3 to 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
Non-clinical testing was performed to demonstrate that the subject Camber Laminoplasty System is substantially equivalent to other predicate devices. Engineering rationale and the following testing was performed:
- . Axial Pullout (per ASTM F2193)
- Static 3-Point Bend
- Dynamic 3-Point Bend
The results demonstrate that the subject Camber Laminoplasty System meets the same criteria as the predicate devices, and the subject device was therefore found to be substantially equivalent to the predicate. No clinical studies were conducted.
Key Metrics
Not Found
Predicate Device(s)
NuVasive® Laminoplasty Fixation System & LeVerage LFS System (K1091623), Medronic Centerpiece Plate Fixation System (K050082)
Reference Device(s)
NuVasive® VuePoint® II OCT System (K180198), NuVasive Affix II Spinous Process Plate System (K132411)
Predetermined Change Control Plan (PCCP) - All Relevant Information
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
Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
July 3, 2019
NuVasive, Incorporated Thao Huynh Specialist. Regulatory Affairs 7475 Lusk Boulevard San Diego, California 92121
Re: K191169
Trade/Device Name: NuVasive® Camber Laminoplasty System Regulation Number: 21 CFR 888.3050 Regulation Name: Spinal interlaminal fixation orthosis Regulatory Class: Class II Product Code: NQW Dated: April 30, 2019 Received: May 1, 2019
Dear Thao Huynh:
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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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 CFR Part 807); labeling (21 CFR Part
1
801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Ronald P. Jean, Ph.D. Assistant Director DHT6B: Division of Spinal Devices OHT6: Office of Orthopedic Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2020 See PRA Statement below.
510(k) Number (if known)
Device Name NuVasive® Camber Laminoplasty System
Indications for Use (Describe)
The NuVasive® Camber Laminoplasty System is intended for use in the lower cervical and upper thoracic spine (C3 to T3) in laminoplasty procedures. The Caminoplasty System is used to hold the allograft or autograft material in place in order to prevent the allograft or autograft material from expulsion, or impinging the spinal cord.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| × Prescription Use (Part 21 CFR 801 Subpart D) | Over-The-Counter Use (21 CFR 801 Subpart C) |
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Image /page/3/Picture/0 description: The image shows the logo for NuVasive. The logo consists of a stylized leaf shape in purple and gray on the left, followed by the word "NUVASIVE" in gray. The logo is simple and modern, and the colors are muted.
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:
Submitted By A.
Thao Huynh Specialist, Regulatory Affairs NuVasive, Incorporated 7475 Lusk Blvd. San Diego, California 92121 Telephone: (858) 320-5256
Date Prepared: July 2, 2019
B. Device Name
| Trade Name: | NuVasive® Camber Laminoplasty System |
|---|---|
| Common Name: | Spinal Interlaminal Fixation Orthosis |
| Classification Name: | Orthosis, Spine, Plate, Laminoplasty, Metal |
| Regulation Number: | 21 CFR § 888.3050 |
| Product Code: | NQW |
C. Predicate Devices
The subject NuVasive® Camber Laminoplasty System is substantially equivalent to the primary predicate device, NuVasive® Laminoplasty Fixation System & LeVerage LFS System (K1091623), and additional predicate Medronic Centerpiece Plate Fixation System (K050082). NuVasive® VuePoint® II OCT System (K180198) and NuVasive Affix II Spinous Process Plate System (K132411) are also used as reference predicates.
D. Device Description
The NuVasive® Camber Laminoplasty System consists of plates and screws of various sizes made from titanium alloy (ASTM F136) to provide reinforcement while expanding the spinal canal and preserving the posterior elements. Instruments required to implant the device are also available.
E. Indications for Use
The NuVasive® Camber Laminoplasty System is intended for use in the lower cervical and upper thoracic spine (C3 to T3) in laminoplasty procedures. The Camber Laminoplasty System is used to hold the allograft or autograft material in place in order to prevent the allograft or autograft material from expulsion, or impinging the spinal cord.
F. Technological Characteristics
As was established in this submission, the subject Camber Laminoplasty System is substantially equivalent to other predicate devices cleared by the FDA for commercial distribution in the United States.
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Image /page/4/Picture/0 description: The image shows the Nuvasive logo. The logo consists of a stylized leaf shape in purple and gray on the left, followed by the word "NUVASIVE" in gray. The leaf shape is partially purple and partially gray, with the purple portion being on top. The word "NUVASIVE" is in a sans-serif font and is all uppercase.
The subject device was shown to be substantially equivalent and have equivalent technological characteristics to its predicate devices through comparison in areas including design, labeling/intended use, material composition, and function.
G. Performance Data
Non-clinical testing was performed to demonstrate that the subject Camber Laminoplasty System is substantially equivalent to other predicate devices. Engineering rationale and the following testing was performed:
- . Axial Pullout (per ASTM F2193)
- Static 3-Point Bend
- Dynamic 3-Point Bend
The results demonstrate that the subject Camber Laminoplasty System meets the same criteria as the predicate devices, and the subject device was therefore found to be substantially equivalent to the predicate. No clinical studies were conducted.
H. Conclusions
The subject NuVasive® Camber Laminoplasty System has been shown to be substantially equivalent to legally marketed predicate devices for its intended use.