(118 days)
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No
The summary describes a mechanical spinal fixation system and does not mention any software, algorithms, or AI/ML capabilities.
Yes
The device is described with "Intended Use / Indications for Use" for conditions like spondylolisthesis, degenerative disc disease, deformities, tumor, fracture, and previous failed surgery, with the goal of fixation and stabilization. These are therapeutic interventions.
No
Explanation: The provided text describes the intended use and components of the ISOLA Spinal System, which are implants for spinal fixation. There is no mention of the device being used to diagnose conditions or process diagnostic information.
No
The device description explicitly details physical components like hooks, rods, connectors, wires, cables, and screws, indicating it is a hardware-based medical device.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use describes the device as implants and components for spinal fixation (pedicle screws, hooks, wires, etc.) used in surgical procedures to stabilize the spine. This is a therapeutic and structural function, not a diagnostic one.
- Device Description: The description details the physical components of the system (hooks, rods, connectors, screws, wires, cables) which are all hardware used for surgical implantation.
- No Mention of Biological Samples: IVD devices are used to examine specimens derived from the human body (blood, urine, tissue, etc.) to provide information for diagnosis, monitoring, or treatment. There is no mention of this device interacting with or analyzing biological samples.
- No Mention of Diagnostic Purpose: The stated purposes are for fixation, stabilization, and addressing conditions like spondylolisthesis, degenerative disc disease, deformities, tumor, fracture, and failed surgery. These are all related to treating or managing structural issues of the spine, not diagnosing a condition based on biological analysis.
Therefore, the ISOLA Spinal System, as described, is a surgical implant system, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
When labeled for pedicle screw fixation, the ISOLA implants are intended for use in grade 3 or 4 spondylolisthesis at the fifth lumbar - first sacral vertebral (L5-S1) joint utilizing autologous bone graft and intended to be removed after solid fusion is attained.
The ISOLA Spinal System, when not used with pedicle screws, is intended for hook, wire, and/or sacral/iliac screw fixation from T1 to the ilium/sacrum. The non-pedicle screw indications are spondvlolisthesis, degenerative disc disease (defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies), deformittes (scoliosis, lordosis and kyphosis), turnor, fracture and previous failed surgery.
As a whole, the ISOLA Spinal System is intended for TI-sacral fixation. Screw fixation is from L3-S1.
Product codes
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Device Description
The Pediatric ISOLA Components consist of side-tightening hooks with downsized dimensions to accommodate the anatomic limitations found where internal fixation is performed on pediatric or small stature individuals. The hooks are used with components already available in the ISOLA Spine System including 3/16 inch diameter rods, transverse connectors, sublaminar wires and cables, dual and tandem connectors, slotted connectors, sacral and iliac screws.
All implant components are manufactured of ASTM F-138 stainless steel.
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
Spinal interlaminal fixation orthosis; fifth lumbar - first sacral vertebral (L5-S1) joint; T1 to the ilium/sacrum; TI-sacral; L3-S1
Indicated Patient Age Range
Pediatric or small stature individuals
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 show the constructs of the ISOLA Pediatric Components to perform consistently with 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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§ 888.3050 Spinal interlaminal fixation orthosis.
(a)
Identification. A spinal interlaminal fixation orthosis is a device intended to be implanted made of an alloy, such as stainless steel, that consists of various hooks and a posteriorly placed compression or distraction rod. The device is implanted, usually across three adjacent vertebrae, to straighten and immobilize the spine to allow bone grafts to unite and fuse the vertebrae together. The device is used primarily in the treatment of scoliosis (a lateral curvature of the spine), but it also may be used in the treatment of fracture or dislocation of the spine, grades 3 and 4 of spondylolisthesis (a dislocation of the spinal column), and lower back syndrome.(b)
Classification. Class II.
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ISOLA SYSTEM ISOLA Pediatric Components 510(k) SUMMARY
NOV 27 1996
| COMPANY: | AcroMed Corporation
3303 Carnegie Avenue
Cleveland, OH 44115 |
|-----------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| TRADENAME: | ISOLA Pediatric Components
used with the ISOLA System |
| CLASSIFICATION: | Spinal interlaminal fixation orthosis
Class II |
| DESCRIPTION: | The Pediatric ISOLA Components consist of side-tightening hooks
with downsized dimensions to accommodate the anatomic
limitations found where internal fixation is performed on pediatric or
small stature individuals. The hooks are used with components
already available in the ISOLA Spine System including 3/16 inch
diameter rods, transverse connectors, sublaminar wires and cables,
dual and tandem connectors, slotted connectors, sacral and iliac
screws. |
| MATERIAL: | All implant components are manufactured of ASTM F-138 stainless
steel. |
| INDICATIONS: | When labeled for pedicle screw fixation, the ISOLA implants are
intended for use in grade 3 or 4 spondylolisthesis at the fifth lumbar -
first sacral vertebral (L5-S1) joint utilizing autologous bone graft and
intended to be removed after solid fusion 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 visceral injury. |
1
The ISOLA Spinal 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 the ilium/sacrum. spondvlolisthesis, degenerative disc disease (defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies), deformittes (scoliosis, lordosis and kyphosis), turnor, fracture and previous failed surgery.
As a whole, the ISOLA Spinal System is intended for TI-sacral fixation. Screw fixation is from L3-S1.
Contraindications for the use of the ISOLA System include active systemic infection or infection localized to the site of the proposed implantation. Severe osteoporosis may prevent adequate fixation of spinal anchors and thus preclude the use of this or any other posterior spinal instrumentation system.
Any entity or condition that totally precludes the possibility of fusion, i.e., cancer, kidney dialysis, or osteopenia are relative contraindications. Other relative contraindications include obesity, certain degenerative diseases, and foreign body sensitivity. In addition, the patient's occupation or activity level or mental capacity may be relative contraindications to this surgery. Specifically, patients because of their occupation or lifestyle, or because of conditions such as mental illness, alcoholism of drug abuse, may place undue stresses on the implant.
PERFORMANCE DATA:
Static and fatigue testing show the constructs of the ISOLA Pediatric Components to perform consistently with previously cleared components.
SUBSTANTIAL EQUIVALENCE:
The ISOLA Pediatric components are equivalent to other ISOLA Components in intended use and attachment.