(86 days)
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No
The summary describes a mechanical spinal fixation system and does not mention any software, algorithms, or data processing that would indicate the use of AI or ML.
Yes
The "Intended Use / Indications for Use" section states that the device is intended for use in various spinal conditions, including spondylolisthesis, degenerative disc disease, deformities, tumor, fracture, and previous failed surgery, with the purpose of spinal fusion and fixation. This falls under the definition of a therapeutic device designed to treat or alleviate a medical condition.
No
The ISOLA Spinal System is an implantable device used for spinal fusion and fixation, not for diagnosing medical conditions.
No
The device description clearly describes physical components (connectors, screws, nuts) and the intended use involves surgical implantation of these physical components for spinal fixation. There is no mention of software as the primary or sole component of the device.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly describes a surgical implant system for spinal fusion. It is used in vivo (within the body) to stabilize the spine.
- Device Description: The device description details mechanical components like connectors, screws, and nuts, which are typical of surgical implants.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens (like blood, urine, or tissue) in vitro (outside the body) to provide information about a patient's health.
IVD devices are used to diagnose diseases or other conditions, including a determination of the state of health, in order to cure, mitigate, treat, or prevent disease or its sequelae. This device's purpose is structural support and stabilization for spinal fusion.
N/A
Intended Use / Indications for Use
The ISOLA Spinal System, when used with pedicle screws, is intended for use in grade 3 or 4 spondylolisthesis at the fifth humbar - first sacral vertebral (L5-S1) joint utilizing autologous bone graft, having the device fixed or attached to the lumbar and sacral spine and intended to be removed after solid firsion is attained. Benefit of spinal fusions utilizing any pedicle screw fixation has not been adequately established in patients with stable spines. Potential risks identified with the use of this device system, which may require additional surgery, include: device component fracture, loss of fixation, non-union, fracture of the vertebra, neurological injury, and vascular or visoeral injury. The ISOLA Soinal System, when not used with pedicle screws, is intended for hook, wire, and/or sacral/iliac screw fixation from T1 to The non-pedicle screw indications are ilium/sacrum. the spondylolisthesis, degenerative disc disease (defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies), deformities (scoliosis, lordosis and kyphosis), tumor, fracture and previous failed surgery. As a whole, the ISOLA Spinal System is intended for T1-sacral fixation. Screw fixation is from L3-S1.
Product codes
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Device Description
The two piece Twister connector design utilizes the attributes of the one piece slotted connectors. It consists of a slotted transverse member with splines which mate with the splines of the V Groove body. Together these two pieces create the slotted connector assembly. The spline connection or joint is the medium by which the screw/connector interface can be manipulated and secured. This two piece design allows for intraoperative sagittal alignment in 7° increments. The slotted portion of each design provides further surgical latitude for placement of the screw. The machine threaded portion of the screw is locked to the connector with a nut. All implant components are manufactured of ASTM F 136 titanium alloy.
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
fifth humbar - first sacral vertebral (L5-S1) joint, lumbar and sacral spine, T1 to The ilium/sacrum, T1-sacral, L3-S1
Indicated Patient Age Range
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Intended User / Care Setting
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Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Static and fatigue testing shows the constructs of the ISOLA. Twister consistently with Connector to perform previously cleared components.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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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.
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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.
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Predetermined Change Control Plan (PCCP) - All Relevant Information
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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.
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K965046 ۱۰۶۵
MAR 1 4 1997
ISOLA SYSTEM ISOLA Twister Connector (Titanium) 510(k) SUMMARY
COMPANY: AcroMed Corporation 3303 Carnegie Avenue Cleveland, OH 44115 TRADENAME: ISOLA Twister Connector used with the ISOLA System Labeled for pedicle screw use: CLASSIFICATION: Spondylolisthesis spinal fixation device system; Unclassified, preamendments device system Labeled for previously cleared uses: Spinal interlaminal fixation orthosis; Class II DESCRIPTION: The two piece Twister connector design utilizes the attributes of the one piece slotted connectors. It consists of a slotted transverse member with splines which mate with the splines of the V Groove body. Together these two pieces create the slotted connector assembly. The spline connection or joint is the medium by which the screw/connector interface can be manipulated and secured. This two piece design allows for intraoperative sagittal alignment in 7° increments. The slotted portion of each design provides further surgical latitude for placement of the screw. The machine threaded portion of the screw is locked to the connector with a nut. MATERIAL: All implant components are manufactured of ASTM F 136 titanium alloy.
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INDICATIONS:
The ISOLA Spinal System, when used with pedicle screws, is intended for use in grade 3 or 4 spondylolisthesis at the fifth humbar - first sacral vertebral (L5-S1) joint utilizing autologous bone graft, having the device fixed or attached to the lumbar and sacral spine and intended to be removed after solid firsion is attained.
Benefit of spinal fusions utilizing any pedicle screw fixation has not been adequately established in patients with stable spines.
Potential risks identified with the use of this device system, which may require additional surgery, include: device component fracture, loss of fixation, non-union, fracture of the vertebra, neurological injury, and vascular or visoeral injury.
The ISOLA Soinal System, when not used with pedicle screws, is intended for hook, wire, and/or sacral/iliac screw fixation from T1 to The non-pedicle screw indications are ilium/sacrum. the spondylolisthesis, degenerative disc disease (defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies), deformities (scoliosis, lordosis and kyphosis), tumor, fracture and previous failed surgery.
As a whole, the ISOLA Spinal System is intended for T1-sacral fixation. Screw fixation is from L3-S1.
PERFORMANCE DATA:
Static and fatigue testing shows the constructs of the ISOLA. Twister consistently with Connector to perform previously cleared components.
SUBSTANTIAL EQUIVALENCE:
The ISOLA Twister Connector manufactured from thanium alloy is equivalent to the ISOLA Twister Connector manufactured from implant grade stainless steel and other AcroMed Slotted Connectors in intended use and attachment.
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