(34 days)
When used as a pedicle screw fixation system in the lumbar spine of skeletally mature patients, the IST Pedicle Screw System is intended for immobilization and stabilization of spinal segments as an adjunct to fusion in the treatment of the following acute and chronic instabilities or deformities of the lumbar spine: 1) degenerative disc disease (as defined by back pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies) 2) spinal stenosis, 3) spondylolisthesis, 4) fracture, 5) deformity, 6) spinal tumor and 7) failed previous fusion (pseudoarthrosis).
In addition, when used as a pedicle screw fixation system, the IST Pedicle Screw System is intended for skeletally mature patients: 1) having severe spondylolisthesis (Grades 3 and 4) of the L5-S1 vertebra, 2) who are receiving fusion by autogenous bone graft only; 3) who are having the device fixed or attached to the lumbar and sacral spine (L3 and below); and 4) who are having the device removed after the development of a solid fusion mass.
The IST Pedicle Screw System includes pedicle screws. polyaxial screw heads, locking caps and rods. The components are fabricated from titanium alloy (ASTM F-136). The system can be used in either percutaneous or open surgery procedures. The system components are provided clean and nonsterile for steam sterilization at the user's facility.
This document is a 510(k) summary for the Innovative Spinal Technologies Pedicle Screw System. It provides information for marketing the device. However, it does not contain any performance data from a study used to prove the device meets specific acceptance criteria.
Here's why and what's missing:
- "PERFORMANCE DATA: Performance data were submitted." This line indicates that performance data was submitted to the FDA, but the document itself does not present or describe that data, nor does it list specific acceptance criteria.
- 510(k) Pre-market Notification: A 510(k) is a pre-market submission demonstrating that the device is "substantially equivalent" to a legally marketed predicate device. While this process may involve some performance testing, the 510(k) summary provided here focuses on the device description, intended use, and substantial equivalence, rather than detailed study results against acceptance criteria as requested in the prompt.
Therefore, I cannot fulfill your request for:
- A table of acceptance criteria and reported device performance.
- Sample sizes and data provenance (for a study of performance).
- Number and qualifications of experts for ground truth.
- Adjudication method.
- MRMC comparative effectiveness study details.
- Standalone performance details.
- Type of ground truth used.
- Sample size for the training set.
- How ground truth for the training set was established.
This document serves as a regulatory clearance document, not a detailed scientific study report.
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DEC 2 7 2005
510(k) SUMMARY -
November 23, 2005
| SUBMITTER: | Innovative Spinal TechnologiesPO Box 110Mansfield, MA 02048 |
|---|---|
| CONTACT PERSON: | Stephen PalumboInnovative Spinal TechnologiesTelephone: 508/618-1295Fax: 508/618-1296 |
| TRADE NAME: | IST Pedicle Screw System |
| FDA CLASSIFICATION/CODE: | 888. 3070; MNI, MNH, NKB |
DEVICE DESCRIPTION: The IST Pedicle Screw System includes pedicle screws. polyaxial screw heads, locking caps and rods. The components are fabricated from titanium alloy (ASTM F-136). The system can be used in either percutaneous or open surgery procedures. The system components are provided clean and nonsterile for steam sterilization at the user's facility.
INTENDED USE: When used as a pedicle screw fixation system in the lumbar spine of skeletally mature patients, the IST Pedicle Screw System is intended for immobilization and stabilization of spinal segments as an adjunct to fusion in the treatment of the following acute and chronic instabilities or deformities of the lumbar spine: 1) degenerative disc disease (as defined by back pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies) 2) spinal stenosis, 3) spondylolisthesis, 4) fracture, 5) deformity, 6) spinal tumor and 7) failed previous fusion (pseudoarthrosis).
In addition, when used as a pedicle screw fixation system, the IST Pedicle Screw System is intended for skeletally mature patients: 1) having severe spondylolisthesis (Grades 3 and 4) of the L5-S1 vertebra, 2) who are receiving fusion by autogenous bone graft only; 3) who are having the device fixed or attached to the lumbar and sacral spine (L3 and below); and 4) who are having the device removed after the development of a solid fusion mass.
PERFORMANCE DATA: Performance data were submitted.
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Image /page/1/Picture/1 description: The image shows the seal of the Department of Health and Human Services (HHS). The seal features the department's name encircling a symbol. The symbol consists of a stylized caduceus, which is a staff with two snakes entwined around it, often associated with medicine and healthcare. The seal is in black and white.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
DEC 2 7 2005
Mr. Stephen Palumbo Director, Quality & Regulatory Affairs Innovative Spinal Technologies PO Box 110 Mansfield, MA 02048
Re: K053276
Trade/Device Name: Pedicle Screw System Regulation Number: 21 CFR 888.3070 Regulation Name: Pedicle screw spinal system Regulatory Class: Class III Product Code: NKB, MNH, MNI Dated: November 23, 2005 Received: November 30, 2005
Dear Mr. Palumbo:
We have reviewed your Section 510(k) premarket notification of intent to market the device we nave reviewed your bector of the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for use stated in the encrosure) to regars the Medical Device Amendments, or to commerce prior to May 20, 1978, the exactions of the Federal Food, Drug, devices mat have occh recuired in assee approval of a premarket approval application (PMA). and Cosmette Act (71ct) that to nevice, subject to the general controls provisions of the Act. The 1 ou may, uiciclore, manol the Act include requirements for annual registration, listing of general controls provisions of the tice, 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 If your device is classified (500 a0070) als. Existing major regulations affecting your device can thay be subject to sach additions, Title 21, Parts 800 to 898. In addition, FDA may oc found in the Obas acements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean I Tease of advised that I DT Pressures of the complies with other requirements of the Act that 1171 has Intact a and regulations administered by other Federal agencies. You must or any I cacal statuted and regaranents, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set
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Page 2 - Mr. Palumbo
forth in the quality systems (QS) regulation (21 CFR Part 820); and If applicable, the electronic forth in the quality systems (Sections 531-542 of the Act); 21 CFR 1000-1050.
This letter will allow you to begin marketing your device as described in your Section 510(k) I his letter will anow you to begin marketing of substantial equivalence of your device to a legally premarket notification: The PDA mianing of casion 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 If you desire specific advice for your ac not 2011-01-20. Also, please note the regulation entitled, and contact the Office of Complanes at (210) = is = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = Misoranuing by reference to premantonions in the Act from the Division of Small other general Informational and Consumer Assistance at its toll-free number (800) 638-2041 or Manufacturers, Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Z. Mark N. Mcllroy
Mark N. Melkerson Acting Director Division of General, Restorative, and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indication for Use Statement
S 3276 510(k) Number:
Device Name: IST Pedicle Screw System
Indications:
Open or percutaneous approach:
When used as a pedicle screw fixation system in the lumbar spine of skeletally mature patients, the IST Pedicle Screw System is intended for immobilization and stabilization of spinal segments as an adjunct to fusion in the treatment of the following acute and chronic instabilities or deformities of the lumbar spine: 1) degenerative disc disease (as defined by back pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies) 2) spinal stenosis, 3) spondylolisthesis, 4) fracture, 5) deformity, 6) spinal tumor and 7) failed previous fusion (pseudoarthrosis).
In addition, when used as a pedicle screw fixation system, the IST Pedicle Screw System is intended for skeletally mature patients: 1) having severe spondylolisthesis (Grades 3 and 4) of the L5-S1 vertebra, 2) who are receiving fusion by autonemous bone graft only; 3) who are having the device fixed or attached to the lumban and sacral spine (L3 and below); and 4) who are having the device removed netar the development of a solid fusion mass.
Prescription Use _____________________________________________________________________________________________________________________________________________________________ or (21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
2
Division of General, Restorative, and Neurological Devices
510(k) Number_KOS 3276
November 22, 2005
§ 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.