(47 days)
The VSP System is indicated for degenerative spondylolisthesis, in skeletally mature patients, with objective evidence of neurologic impairment, fracture, dislocation, scoliosis, kyphosis, spinal tumor, and failed previous fusion (pseudarthrosis). Levels of fixation are for the thoracic, lumbar and sacral spine.
The VSP System is also indicated for pedicle screw fixation for severe spondylolisthesis (Grades 3 and 4) at L5-S1, in skeletally mature patients, when autogenous bone graft is used, when affixed to the posterior lumbosacral spine, and intended to be removed after solid fusion is attained. Levels of fixation are from L3-S1.
The primary purpose of this premarket notification is to add indications to the marketing clearance for the pedicle screws which may be used as a spinal anchor in the VSP System. All implant components are manufactured of either ASTM F-138 or F-1314 stainless steel or ASTM F-136 titanium alloy.
The provided text describes a 510(k) submission for the ISOLA SPINAL SYSTEM Pedicle Screw Indications (VSP System), which is an orthopedic device. This type of regulatory submission focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than proving clinical efficacy or safety through new clinical studies with defined acceptance criteria and performance metrics.
Therefore, the input does not contain information about:
- Acceptance criteria and reported device performance
- Sample size and data provenance for a test set
- Number and qualifications of experts for ground truth
- Adjudication method
- Multi-Reader Multi-Case (MRMC) comparative effectiveness study
- Standalone (algorithm only) performance
- Type of ground truth used
- Sample size for the training set
- How ground truth for the training set was established
The document is a 510(k) summary and an FDA clearance letter, which means that the device's acceptable performance is demonstrated by its substantial equivalence to an existing, legally marketed device. The core of this submission is to add new indications for use for the pedicle screws within the VSP System, not to present new performance data from a clinical study.
Therefore, I cannot populate the requested table and answer the questions based on the provided text, as the information is not present.
The document states: "The VSP System manufactured from either stainless steel or titanium alloy is substantially equivalent, for purposes of this 510(k) adding indications, to itself. This 510(k) seeks to add labeled indications pursuant to a reclassification order. The device design remains the same." This explicitly indicates that no new performance data or studies defining acceptance criteria are being presented; rather, the focus is on regulatory reclassification and expanded indications for an existing, already cleared device.
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JAN 20 1999
ISOLA SPINAL SYSTEM Pedicle Screw Indications 510(k) SUMMARY
| COMPANY: | DePuy AcroMed, Inc.3303 Carnegie AvenueCleveland, OH 44115 |
|---|---|
| TRADENAME: | VSP System |
| CLASSIFICATION: | Labeled for pedicle screw use: Class II |
| DESCRIPTION: | The primary purpose of this premarket notification is to addindications to the marketing clearance for the pedicle screws whichmay be used as a spinal anchor in the VSP System. |
| MATERIAL: | All implant components are manufactured of either ASTM F-138 orF-1314 stainless steel or ASTM F-136 titanium alloy. |
| INDICATIONS: | The VSP System is indicated for degenerative spondylolisthesis, inskeletally mature patients, with objective evidence of neurologicimpairment, fracture, dislocation, scoliosis, kyphosis, spinal tumor,and failed previous fusion (pseudarthrosis). Levels of fixation arefor the thoracic, lumbar and sacral spine. |
| The VSP System is also indicated for pedicle screw fixation forsevere spondylolisthesis (Grades 3 and 4) at L5-S1, in skeletallymature patients, when autogenous bone graft is used, when affixed tothe posterior lumbosacral spine, and intended to be removed aftersolid fusion is attained. Levels of fixation are from L3-S1. | |
| SUBSTANTIALEQUIVALENCE: | The VSP System manufactured from either stainless steel ortitanium alloy is substantially equivalent, for purposes of this510(k) adding indications, to itself. This 510(k) seeks to addlabeled indications pursuant to a reclassification order. The devicedesign remains the same. |
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Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES-USA" around the perimeter. Inside the circle is an abstract symbol that resembles an eagle or bird in flight, composed of three curved lines.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JAN 20 1999
Ms. Pam Corsillo Regulatory Submissions Associate DePuy AcroMed, Inc. 3303 Carnegie Avenue Cleveland, Ohio 44115
K984348 Re : TiMX Low Back System Trade Name: K984350 VSP System Trade Name: Regulatory Class: II Product Codes: MNI, MNH, and KWP Dated: December 3, 1998 Received: December 4, 1998
Dear Ms. Corsillo:
We have reviewed your Section 510(k) notifications of intent we nave reviewed jees referenced above and we have determined these devices are substantially equivalent (for the indications for use stated in the enclosures) to 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). You may, therefore, market the devices, 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 devices are classified (see above) into either class (Special Controls) or class III (Premarket Approval), they II may be subject to such additional controls. Existing major regulations affecting your devices can be found in the Code of Federal Requlations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (QS) for Medical General requlation (21 CFR Part 820) and that, Devices: through periodic (QS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory In addition, FDA may publish further announcements action. Please note: concerning your devices in the Federal Register. this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
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Page 2 - Ms. Pam Corsillo
This letter will allow you to begin marketing your devices as described in your 510 (k) premarket notification. The FDA finding of substantial equivalence of your devices to legally marketed predicate devices results in a classification for your devices and thus, permits your devices to proceed to the market.
If you desire specific advice for your devices on our labeling requlation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4659. Additionally, for questions on the promotion and advertising of your devices, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".
Sincerely yours,
Celia M. Witten, Ph.D., M.D.
Director Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosures
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510(k) Number (if known): K984350
VSP System (Stainless Steel and Titanium) Device Name:
Indications for Use:
The VSP System is indicated for degenerative spondylolisthesis, in skeletally mature patients, with objective evidence of neurologic impairment, fracture, dislocation, scoliosis, kyphosis, spinal tumor, and failed previous fusion (pseudarthrosis). Levels of fixation are for the thoracic, lumbar and sacral spine.
The VSP System is also indicated for pedicle screw fixation for severe spondylolisthesis The VSI System is also manake betally mature patients, when autogenous bone graft is (Grades 3 and 4) at 25 01, and intention lumbosacral spine, and intended to be removed affer solid fusion is attained. Levels of fixation are from L3-S1.
| (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF | |
|---|---|
| NEEDED) |
| Concurrence of CDRH, Office of Device Evaluation (ODE) | ||
|---|---|---|
| (Division Sign-Off) | ||
| Division of General Restorative Devices | ||
| 510(k) Number | K984380 | |
| Prescription Use (per 21 CRF 801.109) | X | |
| OR | Over-The-Counter Use | |
| (Optional Format 1-2-96) |
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§ 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.