(47 days)
Not Found
Not Found
No
The provided text focuses on the intended use, device description (materials and levels of fixation), and indications for use of a pedicle screw system. There is no mention of AI, ML, image processing, or any data-driven algorithms typically associated with AI/ML in medical devices. The "Mentions AI, DNN, or ML" and "Mentions image processing" fields are explicitly marked as "Not Found".
Yes
The device is indicated for treating various spinal conditions such as degenerative spondylolisthesis, fracture, dislocation, and scoliosis, which are considered therapeutic purposes.
No
The VSP System is described as a surgical implant system (pedicle screws) used for spinal fixation and is not intended for diagnostic purposes. Its use is based on existing diagnoses (e.g., degenerative spondylolisthesis, fracture, scoliosis), and it does not generate diagnostic information itself.
No
The device description explicitly states that the primary purpose is to add indications for pedicle screws, which are physical implants made of stainless steel or titanium alloy. This indicates the device includes hardware components.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use/Indications for Use: The intended use describes the device as a system for spinal fixation in patients with various spinal conditions. This is a therapeutic and surgical application, not a diagnostic one.
- Device Description: The device is described as a system of pedicle screws and other implant components made of stainless steel or titanium alloy. These are physical implants used in surgery, not reagents, instruments, or software used to examine specimens from the human body.
- Lack of IVD characteristics: There is no mention of the device being used to examine specimens (blood, tissue, etc.) or to provide information about a patient's health status based on such examination.
In summary, the VSP System is a surgical implant used for spinal stabilization, which falls under the category of medical devices, but not specifically In Vitro Diagnostics.
N/A
Intended Use / 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 (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.
Product codes (comma separated list FDA assigned to the subject device)
MNI, MNH, KWP
Device Description
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
thoracic, lumbar and sacral spine; L5-S1; L3-S1 (posterior lumbosacral 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)
Not Found
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
§ 888.3070 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
JAN 20 1999
ISOLA SPINAL SYSTEM Pedicle Screw Indications 510(k) SUMMARY
| COMPANY: | DePuy AcroMed, Inc.
3303 Carnegie Avenue
Cleveland, OH 44115 |
|-----------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| TRADENAME: | VSP System |
| CLASSIFICATION: | Labeled for pedicle screw use: Class II |
| DESCRIPTION: | 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. |
| MATERIAL: | All implant components are manufactured of either ASTM F-138 or
F-1314 stainless steel or ASTM F-136 titanium alloy. |
| INDICATIONS: | 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. |
| SUBSTANTIAL
EQUIVALENCE: | 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. |
.
1
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.
2
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 | |
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| NEEDED) |
| Concurrence of CDRH, Office of Device Evaluation (ODE) | ||
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| (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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