(94 days)
Not Found
No
The document describes a mechanical spinal fixation system and its components. There is no mention of software, algorithms, or any technology that would suggest the use of AI or ML. The performance studies are based on mechanical testing standards.
Yes.
The device's intended use is to provide immobilization and stabilization of spinal segments as an adjunct to fusion for treating various acute and chronic instabilities or deformities, which directly addresses a medical condition or disease.
No
The NuVasive Precept Spinal System is a pedicle screw fixation system intended to provide immobilization and stabilization of spinal segments, as an adjunct to fusion. It is a medical implant used for treatment, not for diagnosing conditions.
No
The device description explicitly states that the system consists of various screws, lock screws, rods, and associated general instruments, which are physical hardware components.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are devices used to examine specimens taken from the human body (like blood, urine, or tissue) to provide information for diagnosis, monitoring, or screening.
- Device Description: The NuVasive Precept Spinal System is described as a "pedicle screw system that consists of various screws, lock screws, rods, and associated general instruments." These are physical implants and surgical tools used within the body.
- Intended Use: The intended use clearly states the system is for "immobilization and stabilization of spinal segments" and is used as an "adjunct to fusion." This is a surgical intervention, not a diagnostic test performed on a specimen.
The device is a surgical implant system used to treat spinal conditions, not a diagnostic tool that analyzes biological samples.
N/A
Intended Use / Indications for Use
When used as a pedicle screw fixation system, the NuVasive Precept Spinal System is intended to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion in the following acute and chronic instabilities or deformities of the posterior thoracic, lumbar, and sacral spine:
- 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
- Scoliosis
- Kyphosis
- Spinal tumor and/or
- Failed previous fusion (pseudoarthrosis)
The Nu Vasive Precent Spinal System is also indicated for the treatment of severe spondylolisthesis (Grades 3 and 4) of the LS-S1 vertebral joint in skeletally mature patients receiving fusion by autogenous bone graft, having the device fixed or attached to the lumbar and sacral spine (L3 to sacrum), with removal of the implants of a solid fusion.
When used as an anterolateral non-pedicle screw system in the thoracic and lumbar spine, the NuVasive Precept Spinal System is also intended for the following indications:
- Degenerative disc disease (as defined by back pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies)
- Spinal stenosis
- Spondylolisthesis
- Spinal deformities
- Fracture
- Pseudoarthrosis
- Tumor resection and/or
- Failed previous fusion
When used for posterior non-cervical screw fixation in pediatric patients, NuVasive Precept Spinal System is indicated as an adjunct to fusion to treat adolescent idiopathic scoliosis. Additionally, the NuVasive Precept Spinal System is intended to treat pediatric patients diagnosed with the following conditions: spondylolysis, and fracture caused by tumor and/or trauma. Pediatric pedicle screw fixation is limited to a posterior approach and is intended to be used with autograft and/or allograft.
Product codes
NKB, KWP, KWQ
Device Description
The NuVasive Precept Spinal System is a pedicle screw system that consists of various screws, lock screws, rods, and associated general instruments. The Precept Spinal System offers a variety of components to suit the individual pathology and anatomical conditions of the patient. The purpose of this 510(k) submission is to introduce a sterile option for the implants and expanded the indications for use to include the treatment of adolescent idiopathic scoliosis.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
posterior thoracic, lumbar, and sacral spine; L5-S1 vertebral joint; L3 to sacrum
Indicated Patient Age Range
skeletally mature patients; pediatric patients; adolescent idiopathic scoliosis
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 NuVasive Precept Spinal System is substantially equivalent to the predicate device. The following attributes were evaluated and testing was performed where needed:
- Static Compression Bending per ASTM F1717
- Static Torsion per ASTM F1717
- Dynamic Compression Bending per ASTM F1717
- Static Tulip Pull-off per ASTM F1798
The results demonstrate that the subject NuVasive Precept Spinal System is substantially equivalent to the predicate.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
K102514, K122352, K121619, K090981, K161014
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 888.3070 Thoracolumbosacral pedicle screw system.
(a)
Identification. (1) Rigid pedicle screw systems are comprised of multiple components, made from a variety of materials that allow the surgeon to build an implant system to fit the patient's anatomical and physiological requirements. Such a spinal implant assembly consists of a combination of screws, longitudinal members (e.g., plates, rods including dual diameter rods, plate/rod combinations), transverse or cross connectors, and interconnection mechanisms (e.g., rod-to-rod connectors, offset connectors).(2) Semi-rigid systems are defined as systems that contain one or more of the following features (including but not limited to): Non-uniform longitudinal elements, or features that allow more motion or flexibility compared to rigid systems.
(b)
Classification. (1) Class II (special controls), when intended to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of the following acute and chronic instabilities or deformities of the thoracic, lumbar, and sacral spine: severe spondylolisthesis (grades 3 and 4) of the L5-S1 vertebra; degenerative spondylolisthesis with objective evidence of neurologic impairment; fracture; dislocation; scoliosis; kyphosis; spinal tumor; and failed previous fusion (pseudarthrosis). These pedicle screw spinal systems must comply with the following special controls:(i) Compliance with material standards;
(ii) Compliance with mechanical testing standards;
(iii) Compliance with biocompatibility standards; and
(iv) Labeling that contains these two statements in addition to other appropriate labeling information:
“Warning: The safety and effectiveness of pedicle screw spinal systems have been established only for spinal conditions with significant mechanical instability or deformity requiring fusion with instrumentation. These conditions are significant mechanical instability or deformity of the thoracic, lumbar, and sacral spine secondary to severe spondylolisthesis (grades 3 and 4) of the L5-S1 vertebra, degenerative spondylolisthesis with objective evidence of neurologic impairment, fracture, dislocation, scoliosis, kyphosis, spinal tumor, and failed previous fusion (pseudarthrosis). The safety and effectiveness of these devices for any other conditions are unknown.”
“Precaution: The implantation of pedicle screw spinal systems should be performed only by experienced spinal surgeons with specific training in the use of this pedicle screw spinal system because this is a technically demanding procedure presenting a risk of serious injury to the patient.”
(2) Class II (special controls), when a rigid pedicle screw system is intended to provide immobilization and stabilization of spinal segments in the thoracic, lumbar, and sacral spine as an adjunct to fusion in the treatment of degenerative disc disease and spondylolisthesis other than either severe spondylolisthesis (grades 3 and 4) at L5-S1 or degenerative spondylolisthesis with objective evidence of neurologic impairment. These pedicle screw systems must comply with the following special controls:
(i) The design characteristics of the device, including engineering schematics, must ensure that the geometry and material composition are consistent with the intended use.
(ii) Non-clinical performance testing must demonstrate the mechanical function and durability of the implant.
(iii) Device components must be demonstrated to be biocompatible.
(iv) Validation testing must demonstrate the cleanliness and sterility of, or the ability to clean and sterilize, the device components and device-specific instruments.
(v) Labeling must include the following:
(A) A clear description of the technological features of the device including identification of device materials and the principles of device operation;
(B) Intended use and indications for use, including levels of fixation;
(C) Identification of magnetic resonance (MR) compatibility status;
(D) Cleaning and sterilization instructions for devices and instruments that are provided non-sterile to the end user; and
(E) Detailed instructions of each surgical step, including device removal.
(3) Class II (special controls), when a semi-rigid system is intended to provide immobilization and stabilization of spinal segments in the thoracic, lumbar, and sacral spine as an adjunct to fusion for any indication. In addition to complying with the special controls in paragraphs (b)(2)(i) through (v) of this section, these pedicle screw systems must comply with the following special controls:
(i) Demonstration that clinical performance characteristics of the device support the intended use of the product, including assessment of fusion compared to a clinically acceptable fusion rate.
(ii) Semi-rigid systems marketed prior to the effective date of this reclassification must submit an amendment to their previously cleared premarket notification (510(k)) demonstrating compliance with the special controls in paragraphs (b)(2)(i) through (v) and paragraph (b)(3)(i) of this section.
0
Image /page/0/Picture/2 description: The image is a black and white 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 perimeter. Inside the circle is a stylized image of three human profiles facing to the right, with the profiles overlapping each other.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
September 28, 2017
NuVasive, Incorporated Ms. Marysa E. Loustalot Senior Regulatory Affairs Specialist 7475 Lusk Boulevard San Diego, California 92121
Re: K171894
Trade/Device Name: NuVasive® Precept™ Spinal System Regulation Number: 21 CFR 888.3070 Regulation Name: Thoracolumbosacral pedicle screw system Regulatory Class: Class II Product Code: NKB, KWP, KWQ Dated: August 28, 2017 Received: August 29, 2017
Dear Ms. Loustalot:
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 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device
1
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 contact the Division of Industry and Consumer Education (DICE) at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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
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 Industry and Consumer Education (DICE) at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely,
Ronald P. Jean -S for
Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known)
K171894
Device Name NuVasive® Precept™ Spinal System
Indications for Use (Describe)
When used as a pedicle screw fixation system, the NuVasive Precept Spinal System is intended to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion in the following acute and chronic instabilities or deformities of the posterior thoracic, lumbar, and sacral spine:
-
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
-
- Scoliosis
-
- Kyphosis
-
- Spinal tumor and/or
-
- Failed previous fusion (pseudoarthrosis)
The Nu Vasive Precent Spinal System is also indicated for the treatment of severe spondylolisthesis (Grades 3 and 4) of the LS-S1 vertebral joint in skeletally mature patients receiving fusion by autogenous bone graft, having the device fixed or attached to the lumbar and sacral spine (L3 to sacrum), with removal of the implants of a solid fusion.
When used as an anterolateral non-pedicle screw system in the thoracic and lumbar spine, the NuVasive Precept Spinal System is also intended for the following indications:
- Degenerative disc disease (as defined by back pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies)
-
- Spinal stenosis
-
- Spondylolisthesis
-
- Spinal deformities
-
- Fracture
-
- Pseudoarthrosis
-
- Tumor resection and/or
-
- Failed previous fusion
When used for posterior non-cervical screw fixation in pediatric patients, NuVasive Precept Spinal System is indicated as an adjunct to fusion to treat adolescent idiopathic scoliosis. Additionally, the NuVasive Precept Spinal System is intended to treat pediatric patients diagnosed with the following conditions: spondylolysis, and fracture caused by tumor and/or trauma. Pediatric pedicle screw fixation is limited to a posterior approach and is intended to be used with autograft and/or allograft.
Type of Use (Select one or both, as applicable)
X Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
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Image /page/3/Picture/0 description: The image shows the logo for Nuvasive. The logo consists of a stylized purple and gray leaf-like shape on the left, followed by the word "NUVASIVE" in gray, sans-serif font. The logo is simple and modern, with a clean design.
NuVasive® Precept Spinal System
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:
Marysa E. Loustalot Senior Regulatory Affairs Specialist NuVasive, Incorporated 7475 Lusk Blvd. San Diego, California 92121 Telephone: (858) 909-1800
Date Prepared: September 27, 2017
B. Device Name
| Trade or Proprietary Name: | NuVasive ® Precept ™ Spinal System |
|---|---|
| Common or Usual Name: | Pedicle Screw System |
| Classification Name: | Thoracolumbosacral Pedicle Screw System |
| Device Class: | Class II |
| 21 CFR § 888.3070 | |
| Classification: | NKB, KWP, KWQ |
| Product Code: |
C. Predicate Devices
The subject device is substantially equivalent to the primary predicate device NuVasive SpheRx II MAS Deformity Spinal System (K102514) and additional predicate devices, NuVasive Precept Spinal System (K122352), NuVasive Polyaxial Spinal Screws (K121619), and the NuVasive SpheRx PPS System (K090981), NuVasive Reline System (K161014).
D. Device Description
The NuVasive Precept Spinal System is a pedicle screw system that consists of various screws, lock screws, rods, and associated general instruments. The Precept Spinal System offers a variety of components to suit the individual pathology and anatomical conditions of the patient. The purpose of this 510(k) submission is to introduce a sterile option for the implants and expanded the indications for use to include the treatment of adolescent idiopathic scoliosis.
4
Traditional 510(k) Premarket NuVasive® Precept Spinal System
E. Intended Use
When used as a pedicle screw fixation system, the NuVasive Precept Spinal System is intended to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of the following acute and chronic instabilities or deformities of the posterior thoracic, lumbar, and sacral spine:
-
- 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
-
- Scoliosis
-
- Kyphosis
-
- Spinal tumor and/or
-
- Failed previous fusion (pseudoarthrosis)
The NuVasive Precept Spinal System is also indicated for the treatment of severe spondylolisthesis (Grades 3 and 4) of the L5-S1 vertebral joint in skeletally mature patients receiving fusion by autogenous bone graft, having the device fixed or attached to the lumbar and sacral spine (L3 to sacrum), with removal of the implants after attainment of a solid fusion.
When used as an anterolateral non-pedicle screw system in the thoracic and lumbar spine, the NuVasive Precept Spinal System is also intended for the following indications:
- Degenerative disc disease (as defined by back pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies)
-
- Spinal stenosis
-
- Spondylolisthesis
-
- Spinal deformities
-
- Fracture
-
- Pseudoarthrosis
-
- Tumor resection and/or
-
- Failed previous fusion
When used for posterior non-cervical screw fixation in pediatric patients, NuVasive Precept Spinal System is indicated as an adjunct to treat adolescent idiopathic scoliosis. Additionally, the NuVasive Precept Spinal System is intended to treat pediatric patients diagnosed with the following conditions: spondylolisthesis, spondylolysis, and fracture caused by tumor and/or trauma. Pediatric pedicle screw fixation is limited to a posterior approach and is intended to be used with autograft and/or allograft.
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Image /page/5/Picture/1 description: The image shows the logo for Nuvasive. The logo consists of a stylized purple and gray leaf-like shape on the left, followed by the word "NUVASIVE" in gray, sans-serif font. The logo is simple and modern, with a clean design.
F. Technological Characteristics
As was established in this submission, the subject NuVasive Precept Spinal 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 equivalent technological characteristics to its predicate device through comparison in areas including design, labeling/intended use, material composition, and function.
G. Performance Data
Nonclinical testing was performed to demonstrate that the subject NuVasive Precept Spinal System is substantially equivalent to the predicate device. The following attributes were evaluated and testing was performed where needed:
- Static Compression Bending per ASTM F1717
- . Static Torsion per ASTM F1717
- Dynamic Compression Bending per ASTM F1717
- Static Tulip Pull-off per ASTM F1798
The results demonstrate that the subject NuVasive Precept Spinal System is substantially equivalent to the predicate.
H. Conclusions
The subject NuVasive Spinal System has been shown to be substantially equivalent to legally marketed predicate devices for its intended use.