(34 days)
There are no predicate devices listed in the input.
Not Found
No
The summary describes a mechanical pedicle screw system and does not mention any software, algorithms, or AI/ML capabilities.
Yes
The device is intended for the immobilization and stabilization of spinal segments as an "adjunct to fusion in the treatment of ... instabilities or deformities of the lumbar spine." This indicates its use in the treatment of medical conditions, thereby qualifying it as a therapeutic device.
No
The text describes a pedicle screw fixation system intended for immobilization and stabilization of spinal segments as an adjunct to fusion, not for diagnosing medical conditions.
No
The device description explicitly lists hardware components (pedicle screws, polyaxial screw heads, locking caps, and rods) made from titanium alloy.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly describes a surgical implant system used for stabilizing the spine during fusion procedures. This is a therapeutic device, not a diagnostic one.
- Device Description: The description details physical components like screws, rods, and caps made of titanium alloy, designed for surgical implantation. This aligns with a surgical device, not a diagnostic test.
- Lack of Diagnostic Elements: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting biomarkers, or providing information for diagnosis.
IVD devices are used to examine specimens derived from the human body to provide information for the diagnosis, prevention, monitoring, treatment, or alleviation of disease. This device does not fit that description.
N/A
Intended Use / Indications for 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.
Product codes
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
lumbar spine, L5-S1 vertebra, lumbar and sacral spine (L3 and below)
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
Performance data were submitted.
Key Metrics
Not Found
Predicate Device(s)
Not Found
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
DEC 2 7 2005
510(k) SUMMARY -
November 23, 2005
| SUBMITTER: | Innovative Spinal Technologies
PO Box 110
Mansfield, MA 02048 |
|------------------------------|---------------------------------------------------------------------------------------------------|
| CONTACT PERSON: | Stephen Palumbo
Innovative Spinal Technologies
Telephone: 508/618-1295
Fax: 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.
1
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
2
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