(70 days)
No
The document describes a mechanical spinal implant (pedicle screw) and its components, with no mention of software, algorithms, or any technology related to AI or ML.
No
This device is a pedicle screw designed for spinal fixation and fusion, a surgical implant, not a therapeutic device in the sense of delivering active treatment or therapy.
No
The device is a surgical implant (pedicle screw) used with a spinal system to provide fixation. Its intended use describes its role in treating conditions like spondylolisthesis, degenerative disc disease, and deformities, but it does not perform any diagnostic function.
No
The device description clearly details a physical pedicle screw made of stainless steel, along with associated wires and cables. There is no mention of any software component.
Based on the provided text, 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, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Description and Intended Use: The description clearly states that the AcroMed Cable/Wire Pedicle Screw is a surgical implant designed to be used in spinal fusion procedures. It is a physical component of a spinal system used to stabilize the spine.
- No Mention of Biological Samples or Testing: The text does not mention any interaction with biological samples, laboratory testing, or diagnostic purposes.
Therefore, the AcroMed Cable/Wire Pedicle Screw falls under the category of a surgical implant or medical device used for structural support and stabilization, not an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
The AcroMed Cable/Wire Pedicle Screw is designed to be utilized with the ISOLA Spine System (K951657). When used with pedicle screws, the ISOLA implants are intended for use in grade 3 or 4 spondylolisthesis at L5-S1 utilizing autologous bone graft and intended to be removed after solid fusion is attained. Levels of attachment for the indication range from L3 to the sacrum.
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 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
Not Found
Device Description
The AcroMed Cable/Wire Pedicle Screw is a pedicle screw with a modified grooved head and hole through the base of the head. The ISOLA rod is placed on top of the screw so that the rod fits in the groove. The groove is sized to accommodate both the 4.75 mm and 6.35 mm diameter rods.
The AcroMed Cable/Wire Pedicle Screw is intended for use with 18 gauge wire (304.8 mm in length) (K895439), which adjoins the screw to the rod. Alternatively, stainless steel Songer cable (K935481) may be used in place of 18 gauge wire. The wire or cable is threaded through the hole at the base of the screw head and the wire is twisted or the cable is crimped over the top of the rod.
The screw is available in cancellous lengths of 25.0 mm, 30.0 mm, and 35.0 mm.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
T1 to the ilium/sacrum, L3-S1, L5-S1
Indicated Patient Age Range
Not Found
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
Static and fatigue testing show the AcroMed Cable/Wire Pedicle Screw to perform consistent with previously cleared components.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
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
ISOLA SYSTEM AcroMed Cable/Wire Pedicle Screw 510(k) SUMMARY
ースマ、アルバイクなの
| COMPANY: | DEC 16 1996
AcroMed Corporation
3303 Carnegie Avenue
Cleveland, OH 44115 |
|-----------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| TRADENAME: | AcroMed Cable/Wire Pedicle Screw |
| CLASSIFICATION: | Spondylolisthesis Spinal Fixation Device
Unclassified, preamendment device system |
| DESCRIPTION: | The AcroMed Cable/Wire Pedicle Screw is a pedicle screw with a
modified grooved head and hole through the base of the head. The
ISOLA rod is placed on top of the screw so that the rod fits in the
groove. The groove is sized to accommodate both the 4.75 mm and
6.35 mm diameter rods.
The AcroMed Cable/Wire Pedicle Screw is intended for use with 18
gauge wire (304.8 mm in length) (K895439), which adjoins the screw
to the rod. Alternatively, stainless steel Songer cable (K935481) may
be used in place of 18 gauge wire. The wire or cable is threaded
through the hole at the base of the screw head and the wire is twisted
or the cable is crimped over the top of the rod.
The screw is available in cancellous lengths of 25.0 mm, 30.0 mm, and
35.0 mm. |
| MATERIAL: | The AcroMed Cable/Wire Pedicle Screw is manufactured from implant
grade stainless steel conforming to ASTM F1314 specifications. The
wire is made from stainless steel conforming to ASTM F1350
specifications. Stainless steel Songer cables are manufactured from
stainless steel conforming to ASTM F138 specifications. |
1
| INDICATIONS: | The AcroMed Cable/Wire Pedicle Screw is designed to be utilized
with the ISOLA Spine System (K951657). When used with pedicle
screws, the ISOLA implants are intended for use in grade 3 or 4
spondylolisthesis at L5-S1 utilizing autologous bone graft and
intended to be removed after solid fusion is attained. Levels of
attachment for the indication range from L3 to the sacrum. |
|-----------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | 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
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 show the AcroMed Cable/Wire Pedicle
Screw to perform consistent with previously cleared components. |
| SUBSTANTIAL
EQUIVALENCE: | The AcroMed Cable/Wire Pedicle Screw is equivalent to other
AcroMed pedicle screws as cleared under K951657 and to the
Harrington Lag Screw, manufactured by Zimmer beginning in the
1960's |
A Company Control Control Controlled Controlled Controlled Comparis Comments of Children
ンです。 . . . . . ささした . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .