(59 days)
Not Found
No
The device description and intended use clearly define a mechanical spinal fixation system comprised of screws, rods, and connectors. There is no mention of any software, algorithms, or data processing that would indicate the use of AI or ML. The performance studies are mechanical tests, not related to algorithmic performance.
Yes
The device is intended to immobilize and stabilize spinal segments to treat various acute and chronic deformities, including degenerative spondylolisthesis, fractures, dislocations, scoliosis, kyphosis, spinal tumors, and failed fusions. These uses are directly aimed at treating or alleviating a disease or injury, classifying it as a therapeutic device.
No
The Innovasis 'Excella-M' Spinal System is an implantable device used as an adjunct to spinal fusion, providing immobilization and stabilization of spinal segments. It is a treatment device, not a diagnostic one.
No
The device description explicitly states it is comprised of physical components made of Titanium Alloy, such as screws and rods, and is intended for surgical implantation.
Based on the provided text, the Innovasis 'Excella-M' Spinal System is not an In Vitro Diagnostic (IVD) device.
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 provide information for diagnosis, monitoring, or screening.
- Device Description: The description clearly states that the Innovasis 'Excella-M' Spinal System is a system of implants (screws, rods, cross-connector) made of titanium alloy, intended to be surgically attached to the spine.
- Intended Use: The intended use describes the system's purpose as providing immobilization and stabilization of spinal segments as an adjunct to fusion for various spinal conditions. This is a surgical intervention, not a diagnostic test performed on samples outside the body.
Therefore, the Innovasis 'Excella-M' Spinal System is a surgical implant device, not an IVD.
N/A
Intended Use / Indications for Use
The Innovasis 'Excella-M' Spinal System is intended for use in the non-cervical area of the spine.
The INNOVASIS 'Excella-M' Spinal System, when used for pedicle screw fixation is intended only for patients:
- a) Having severe spondyloysthesis (Grade 3 & 4) at the L5-S1 joint;
- b) Who are receiving fusion using autogenous bone graft only;
- c) Who are having the device fixed or attached to the lumbar and sacral spine (1.3 and below): and
- d) Who are having the device removed after the development of a solid fusion mass.
The INNOVASIS 'Excella-M' Spinal System, when used as a pedicle screw system in skeletally mature patients, is intended to provide immobilization and stabilization of spinal segments, as an adjunct to fusion, in treatment of the following acute and chronic deformities of the thoracic, lumbar, and sacral spine:
- Degenerative spondylolisthesis with objective evidence of neurologic a) Fracture; c) Dislocation; d) Scloiosis; e) Kyphosis; f) impairment b) Spinal tumor, and g) Previous failed fusion (pseudarthrosis).
The INNOVASIS 'Excella-M' Spinal System, when used for anterolateral non-pedicle fixation, is intended for the following indications: - Degenerative disc disease (as defined as back pain of discogenic origin with a) degenerative disc confirmed by patient history and radiographic studie);
- b) Spinal stenosis; c) Spondylolisthesis; d) Spinal deformities (i.e., scloliosis, kyphosis, and/or lordosis).
- e) Pseudarthrosis; f) Tumor; g) Trauma (i.e. fracture or dislocation); and
- h) Previous failed fusion.
The INNOVASIS 'Excella-M' Spinal System, when used for posterior non-pedicle screw fixation to the non-cervical spine, is intended for the following indications:
- a) Degenerative disc disease (defined as back pain of disogenic origin with degenerative disc confirmed by patient history and radiographic studies);
- b) Spinal stenosis; c) Spondylolisthesis; d) Spinal deformities (i.e. scolosis, kyphosis and/or lordosis);
- e) Pseudoarthrosis; f) Tumor; g) Trauma (i.e. fracture or dislocation); and
- h) Previous failed fusion.
Product codes (comma separated list FDA assigned to the subject device)
KWQ, KWP, MNH, MNI
Device Description
The INNOVASIS 'Excella-M' Spinal System is a 6-4 Titanium Alloy device comprised of a variety of non-sterile, single use components of 2 size diameters (6.5 & 7.5mm) and various lengths of monoaxial Pedicle Screws with an assortment of various lengths 6.0mm Rods.
The INNOVASIS 'Cross Link' is a modification to the 'Excella-M' Spinal System that allows the surgeon to build a spinal implant construct to increase rotational stability.
The system is attached to the vertebral body by means of screws to the non-cervical spine.
The INNOVASIS 'Excella-M' Spinal System consists of an assortment of screws, rods, cross-connector and related instrumentation as implant offerings specific to this system.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Non-cervical area of the spine, L5-S1 joint, lumbar and sacral spine (L3 and below), thoracic, lumbar, and sacral spine.
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
Mechanical testing in accordance with the "Guidance for Industry and FDA Staff Spinal System 510(k)s", issued May 3, 2004 was presented.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
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.
Blackstone Spinal Fixation System (K994217), DePuy Acromed Moss Miami system (K992168), Synthes Universal Spinal System (K990745), Interpore Cross Synergy IQ Spinal System (K012871)
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.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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.
0
OCT 7 - 2004
510(k) Summary of Safety and Effectiveness
SAFE MEDICAL DEVICES ACT OF 1990 510(k) Summary
| Name of Firm: | Innovasis, Inc.
997 East 3900 South, Suite 103
Salt Lake City, Utah 84124 |
|--------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 510(k) Contact: | Brent A. Felix
Same address as above |
| Trade Name: | 'Excella-M' Spinal System |
| Common Name: | Rod and Screw Spinal Instrumentation |
| Classification: | Spinal Intervetebral Body Fixation Orthosis (21 CRF 888.3060)
Spinal Interlaminal Fixation Orthosis (21 CFR 888.3050)
Spondylolisthesis Spinal Fixation System (21 CRF 888.3070)
Pedicle Screw Spinal System (21 CRF 888.3070) |
| Device Product Code: | KWQ, KWP, MNH, MNI. The Panel code is 87. |
| Substantially
Equivalent Devices: | Blackstone Spinal Fixation System (K994217)
DePuy Acromed Moss Miami system (K992168)
Synthes Universal Spinal System (K990745)
Interpore Cross Synergy IQ Spinal System (K012871) |
Device Description:
The INNOVASIS 'Excella-M' Spinal System is a 6-4 Titanium Alloy device comprised of a variety of non-sterile, single use components of 2 size diameters (6.5 & 7.5mm) and various lengths of monoaxial Pedicle Screws with an assortment of various lengths 6.0mm Rods.
The INNOVASIS 'Cross Link' is a modification to the 'Excella-M' Spinal System that allows the surgeon to build a spinal implant construct to increase rotational stability.
The system is attached to the vertebral body by means of screws to the non-cervical spine.
The INNOVASIS 'Excella-M' Spinal System consists of an assortment of screws, rods, cross-connector and related instrumentation as implant offerings specific to this system.
1
Intended Use:
The Innovasis 'Excella-M' Spinal System is intended for use in the non-cervical area of the spine.
Indications for use are as follows:
The INNOVASIS 'Excella-M' Spinal System, when used for pedicle screw fixation is intended only for patients:
- a) Having severe spondyloysthesis (Grade 3 & 4) at the L5-S1 joint;
- b) Who are receiving fusion using autogenous bone graft only;
- c) Who are having the device fixed or attached to the lumbar and sacral spine (1.3 and below): and
- d) Who are having the device removed after the development of a solid fusion mass.
The INNOVASIS 'Excella-M' Spinal System, when used as a pedicle screw system in skeletally mature patients, is intended to provide immobilization and stabilization of spinal segments, as an adjunct to fusion, in treatment of the following acute and chronic deformities of the thoracic, lumbar, and sacral spine:
-
Degenerative spondylolisthesis with objective evidence of neurologic a) Fracture; c) Dislocation; d) Scloiosis; e) Kyphosis; f) impairment b) Spinal tumor, and g) Previous failed fusion (pseudarthrosis).
The INNOVASIS 'Excella-M' Spinal System, when used for anterolateral non-pedicle fixation, is intended for the following indications: -
Degenerative disc disease (as defined as back pain of discogenic origin with a) degenerative disc confirmed by patient history and radiographic studie);
-
b) Spinal stenosis; c) Spondylolisthesis; d) Spinal deformities (i.e., scloliosis, kyphosis, and/or lordosis).
-
e) Pseudarthrosis; f) Tumor; g) Trauma (i.e. fracture or dislocation); and
-
h) Previous failed fusion.
The INNOVASIS 'Excella-M' Spinal System, when used for posterior non-pedicle screw fixation to the non-cervical spine, is intended for the following indications:
- a) Degenerative disc disease (defined as back pain of disogenic origin with degenerative disc confirmed by patient history and radiographic studies);
- b) Spinal stenosis; c) Spondylolisthesis; d) Spinal deformities (i.e. scolosis, kyphosis and/or lordosis);
- e) Pseudoarthrosis; f) Tumor; g) Trauma (i.e. fracture or dislocation); and
- h) Previous failed fusion.
2