(113 days)
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No
The summary describes a mechanical spinal fixation system and does not mention any AI or ML components or functionalities.
Yes.
The device is intended for patients with severe spondylolisthesis (Grades 3 and 4) having fusions at the L5-S1 joint, indicating a direct involvement in treating a medical condition.
No
Explanation: The device is described as a multi-component spinal system (pedicle screws, rods, and spacers) intended for surgical fusion of the L5-S1 joint in patients with severe spondylolisthesis. It is a physical implant used for treatment and support, not for diagnosis or detection of a condition.
No
The device description clearly outlines physical components made of titanium alloy (screws, rods, spacers) and performance studies focus on mechanical properties, indicating a hardware-based medical device.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body (like blood, urine, or tissue) to provide information about a person's health.
- Device Description: The provided description clearly states that the DDS Spinal System is a multi-component system consisting of pedicle screws, rods, and spacers made of titanium alloy. These are physical implants used to stabilize the spine.
- Intended Use: The intended use is for surgical implantation to fix/attach to the lumbar and sacral spine for patients with severe spondylolisthesis. This is a surgical procedure, not a diagnostic test performed on a sample.
The device is a surgical implant used to treat a physical condition, not a diagnostic tool used to analyze biological samples.
N/A
Intended Use / Indications for Use
It is intended for patients with severe spondylolisthesis (Grades 3 and 4) having fusions at the L5-S1 joint using autogenous bone graft, to be fixed/attached to the lumbar and sacral spine. The components are intended to be removed after development of a solid fusion mass. The screws are limited to L3-S1 or iliac screw fixation.
Product codes
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Device Description
The DDS Spinal System is a multi-component system consisting of pedicle screws, rods and spacers. The screws are available in five lengths and one diameter; the rods in twelve lengths and the spacers in three thicknesses. The screws are fabricated from titanium alloy (Ti-6Al-4V) that conforms to ASTM F136 The screws have a 6,5 mm thread diameters and are available in five lengths, 35, 40, 45, 50 and 55 mm. The rods are also manufactured from Ti-6Al-4V and are 5 mm in diameter. The rods are available in 12 lengths ranging from 40 mm to 600 mm. Round, smooth spacers of three different heights (2, 4, and 6 mm) slide over the threaded portion of the screw to facilitate implantation of neighboring screws at the same level. The spacers are also made of Ti-6Al-4V.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
L5-S1 joint, lumbar and sacral spine, L3-S1 or iliac
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
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)
Test Results: The results of the testing are sunmarized in the following table and graph.
| Test | # of Specimens | Max. Load | Deformation | Stiffness |
|---|---|---|---|---|
| Axial Compression | 5 | 1403.2+/-90.6 N | 2.69+/-.61 mm | 929.2+/-117.6 N/mm |
| Bending | 5 | 24.38+/-.63 Nm | 20.86+/-1.67 mm | 3.07+/-.53 Nm/mm |
| Torsion | 5 | 42.30+/-2.44 Nm | 38 degrees | 2.58+/-.09 Nm/deg |
| Screw Pullout* | 16 | 818.5+/-341.8 N | NA | NA |
| Screw Pullout** | 5 | 785.0+/-289.7 N | NA | NA |
*Unembedded specimens
**Wrapped, embedded specimens
Image /page/1/Figure/4 description: The image is a plot titled "Bending Fatigue". The x-axis is labeled "Cycles to Failure" and ranges from 10,000 to 10,000,000. The y-axis is labeled "Load, N" and ranges from 0 to 600. There are 6 data points plotted on the graph, showing a general trend of decreasing load with increasing cycles to failure.
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.
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
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
K96-0107
Summary of Safety and Effectiveness
MAY - 3 1996
April 3, 1996 Encore Orthopedics™, Inc. 8900 Shoal Creek Building 300 Austin, TX 78757 512-795-8696 Ashley M. Bock
Trade Name. DDS Spinal System
Common Name: Spondylolisthesis Spinal Fixation Device
Classification Name: Unclassified, preamendments device
Description: The DDS Spinal System is a multi-component system consisting of pedicle screws, rods and spacers. The screws are available in five lengths and one diameter; the rods in twelve lengths and the spacers in three thicknesses. The screws are fabricated from titanium alloy (Ti-6Al-4V) that conforms to ASTM F136 The screws have a 6,5 mm thread diameters and are available in five lengths, 35, 40, 45, 50 and 55 mm. The rods are also manufactured from Ti-6Al-4V and are 5 mm in diameter. The rods are available in 12 lengths ranging from 40 mm to 600 mm. Round, smooth spacers of three different heights (2, 4, and 6 mm) slide over the threaded portion of the screw to facilitate implantation of neighboring screws at the same level. The spacers are also made of Ti-6Al-4V.
Intended Use: It is intended for patients with severe spondylolisthesis (Grades 3 and 4) having fusions at the L5-S1 joint using autogenous bone graft, to be fixed/attached to the lumbar and sacral spine. The components are intended to be removed after development of a solid fusion mass. The screws are limited to L3-S1 or iliac screw fixation.
Comparable Features to Predicate Device(s): Features comparable to predicate devices include Moss Spinal System cleared for commercial distribution in K894184.
Test Results: The results of the testing are sunmarized in the following table and graph.
1
Page 2 Encore Orthopedics, Inc. 510(k) Submission DDS Spinal System
| Test | # of Specimens | Max. Load | Deformation | Stiffness |
|---|---|---|---|---|
| Axial Compression | 5 | $1403.2\pm90.6$ N | $2.69\pm.61$ mm | $929.2\pm117.6$ |
| N/mm | ||||
| Bending | 5 | $24.38\pm.63$ Nm | $20.86\pm1.67$ | |
| mm | $3.07\pm.53$ | |||
| Nm/mm | ||||
| Torsion | 5 | $42.30\pm2.44$ | ||
| Nm | 38 degrees | $2.58\pm.09$ | ||
| Nm/deg | ||||
| Screw Pullout* | 16 | $818.5\pm341.8$ N | NA | NA |
| Screw Pullout** | 5 | $785.0\pm289.7$ N | NA | NA |
*Unembedded specimens
**Wrapped, embedded specimens
Image /page/1/Figure/4 description: The image is a plot titled "Bending Fatigue". The x-axis is labeled "Cycles to Failure" and ranges from 10,000 to 10,000,000. The y-axis is labeled "Load, N" and ranges from 0 to 600. There are 6 data points plotted on the graph, showing a general trend of decreasing load with increasing cycles to failure.