(88 days)
Not Found
No
The device description focuses on mechanical components (screws, rods) and surgical techniques, with no mention of AI or ML. The "Mentions AI, DNN, or ML" section explicitly states "Not Found".
Yes
The device is described as an "immobilization and stabilization of spinal segments" system intended to treat various acute and chronic instabilities of the spine, which directly addresses a medical condition.
No
The device is described as a spinal screw system used for immobilization and stabilization of spinal segments, which is a treatment rather than a diagnostic function.
No
The device description explicitly states it consists of physical components like pedicle screws and rigid connecting rods made of titanium alloy, which are hardware.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Description: The description clearly states that the Extended VertiFlex® Spinal Screw System is a "posterior, non-cervical instrumentation system consisting of both pedicle screws and rigid connecting rods." These are implanted directly into the patient's spine.
- Intended Use: The intended use describes the device's function in providing "immobilization and stabilization of spinal segments" as an "adjunct to fusion." This is a surgical intervention, not a diagnostic test performed on a sample outside the body.
Therefore, the device is a surgical implant, not an in vitro diagnostic.
N/A
Intended Use / Indications for Use
When used as a posterior, noncervical pedicle screw system, the Extended VertiFlex® Spinal Screw 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 of the thoracic, lumbar, and sacral spine:
- Degenerative disc disease (DDD) as defined by back pain of discogenic origin . with degeneration of the disc confirmed by patient history and radiographic studies;
- Severe spondylolisthesis (Grades 3 and 4) of the L5-S1 vertebra; .
- Degenerative spondylolisthesis; ●
- Trauma (i.e., fracture or dislocation); .
- . Spinal stenosis;
- Deformities or curvatures (i.e., scoliosis, kyphosis, and/or lordosis); .
- Tumor , .
- Pseudoarthrosis; and/or .
- Failed previous fusion. .
Product codes (comma separated list FDA assigned to the subject device)
MNH, MNI, NKB
Device Description
The Extended VertiFlex® Spinal Screw System is a posterior, non-cervical instrumentation system consisting of both pedicle screws and rigid connecting rods. Screws are of polyaxial or monoaxial (fixed) top-loading design, are composed of titanium alloy conforming to ASTM F136, and are available in a range of diameters and lengths to accommodate physiological requirements. The rods are composed of titanium conforming to ASTM F67, and are available in both straight and curved (pre-lordosed) styles, and in a range of lengths to accommodate both single-level and multiple levels procedures. The System may be implanted by either conventional surgical methods, or via minimally-invasive/percutaneous techniques, although the line extension which is a subject of this submission is designed specifically to facilitate MIS/percutaneous use. Manual instrumentation for implantation of the System is available for both conventional and minimally-invasive procedures. The modifications that are the subject of this submission consist of the addition of rod and screw components designed to more easily create multi-level constructs percutaneously, and screws having smaller diameters. Screws, rods, and instruments are offered non-sterile.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Spinal segments in the thoracic, lumbar, and sacral spine
Indicated Patient Age Range
Skeletally mature patients
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)
No clinical testing was conducted to support this submission. Verification and validation tests were completed, and all acceptance criteria were met.
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.
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
§ 888.3070 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
073245 age 1 of 2
FEB 15 2005
5.0 510(k) SUMMARY
In accordance with Title 21 Code of Federal Regulations (21 CFR), Part 807, and in particular, §807.92, the following 510(k) summary is provided for the Extended VertiFlex® Spinal Screw System:
5.1 Submitted By:
VertiFlex®, Incorporated 1351 Calle Avanzado San Clemente, California 92673
Contact: Steve Reitzler, Vice President of Regulatory & Quality Assurance
Date Prepared: November 14, 2007
5.2 Device Name
| Trade or Proprietary Name: | Extended VertiFlex® Spinal Screw System |
|---|---|
| Common or Usual Name: | Pedicle Screw System |
| Classification Name: | Pedicle Screw Spinal System |
| Classification Regulation: | 21 CFR, §888.3070 |
| Product Codes: | MNH, MNI, NKB |
5.3 Predicate Devices
The subject device is substantially equivalent, in whole or in part, to the following commercially available predicate devices:
VertiFlex® Spinal Screw System (VertiFlex®, Inc., K062670)
5.4 Device Description
The Extended VertiFlex® Spinal Screw System is a posterior, non-cervical instrumentation system consisting of both pedicle screws and rigid connecting rods. Screws are of polyaxial or monoaxial (fixed) top-loading design, are composed of titanium alloy conforming to ASTM F136, and are available in a range of diameters and lengths to accommodate physiological requirements. The rods are composed of titanium conforming to ASTM F67, and are available in both straight and curved (pre-lordosed) styles, and in a range of lengths to accommodate both single-level and multiple levels procedures. The System may be implanted by either conventional surgical methods, or via minimallyinvasive/percutaneous techniques, although the line extension which is a subject of this submission is designed specifically to facilitate MIS/percutaneous use. Manual instrumentation for implantation of the System is available for both conventional and minimally-invasive procedures. The modifications that are the subject of this submission consist of the addition of rod and screw components designed to more easily create multi-level constructs percutaneously, and screws having smaller diameters. Screws, rods, and instruments are offered non-sterile.
1
5.5 Intended Use
The subject device is indicated for use as follows:
When used as a posterior, noncervical pedicle screw system, the Extended VertiFlex® Spinal Screw 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 of the thoracic, lumbar, and sacral spine:
- Degenerative disc disease (DDD) as defined by back pain of discogenic origin . with degeneration of the disc confirmed by patient history and radiographic studies;
- Severe spondylolisthesis (Grades 3 and 4) of the L5-S1 vertebra; .
- Degenerative spondylolisthesis; ●
- Trauma (i.e., fracture or dislocation); .
- . Spinal stenosis;
- Deformities or curvatures (i.e., scoliosis, kyphosis, and/or lordosis); .
- Tumor , .
- Pseudoarthrosis; and/or .
- Failed previous fusion. .
Comparison to Predicate Device 5.6
In accordance with the agency guideline entitled The New 510(k) Paradigm -Alternate Approaches to Demonstrating Substantial Equivalence in Premarket Notifications (March 1998), VertiFlex® has established, through rigorous design control processes conforming to 21 CFR §820.30, and a comprehensive risk analysis. that the subject Extended VertiFlex® Spinal Screw System is substantially equivalent to the commercially-available predicate VertiFlex® Spinal Screw System. Further, the subject modifications (a) do not alter the intended use, (b) do not alter the fundamental technological principles of the device, and (c) continue to meet all design input requirements.
5.7 Summary of Non-Clinical Tests
Such verification and validation tests as were identified as appropriate to address the results of a risk analysis for the subject Extended VertiFlex® Spinal Screw System were completed, and all acceptance criteria were met.
Summary of Clinical Tests 5.8
No clinical testing was conducted to support this submission.
5.9 Conclusions
The results of all design, risk analysis, and verification and validation activities support the substantial equivalence of the subject Extended VertiFlex® Spinal Screw System to the predicate VertiFlex® Spinal Screw System, and establish that the subject device continues to meet all design input requirements.
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Image /page/2/Picture/2 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 eagle emblem with three parallel lines forming the body and wings.
FEB 1 5 2008
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Vertiflex, Inc. % Mr. Steve Reitzler 1351 Calle Avanzada San Clamente, CA 92673
Re: K073245
Trade/Device Name: Extended Vertiflex Spinal Screw System Regulation Number: 21 CFR 888.3070 Regulation Name: Pedicle screw spinal system Regulatory Class: III Product Code: NKB, MNI, MNH Dated: January 14, 2008 Received: January 16, 2008
Dear Mr. Reitzler:
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 - Mr. Steve Reitzler
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 its toll-free number (800) 638-2041 or (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Mark M. Millican
Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Page 1 of 1
Indications for Use
510(k) Number (if known): 长073245
Device Name: Extended VertiFlex® Spinal Screw System
Indications for Use:
When used as a posterior, noncervical pedicle screw system, the Extended VertiFlex® Spinal Screw 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 of the thoracic, lumbar, and sacral spine:
- Degenerative disc disease (DDD) as defined by back pain of discogenic origin . with degeneration of the disc confirmed by patient history and radiographic studies;
- Severe spondylolisthesis (Grades 3 and 4) of the L5-S1 vertebra;
- Degenerative spondylolisthesis; ●
- Trauma (i.e., fracture or dislocation); .
- Spinal stenosis; .
- Deformities or curvatures (i.e., scoliosis, kyphosis, and/or lordosis); ●
- Tumor;
- Pseudoarthrosis; and/or
- Failed previous fusion.
Prescription Use (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device
510(k) Number K073245