(127 days)
No
The document describes a mechanical spinal fixation system and does not mention any software, algorithms, or data processing capabilities that would indicate the use of AI or ML.
Yes.
The device is intended to treat various spinal conditions, including spondylolisthesis, fractures, scoliosis, and degenerative disc disease, which are therapeutic indications.
No
The device is a spinal system intended for immobilization and stabilization of spinal segments, as an adjunct to fusion. It is a surgical implant, not a tool for diagnosing medical conditions.
No
The device description clearly describes physical hardware components (bone screws, locking caps, cross connectors) intended for surgical implantation.
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 used for spinal fixation and stabilization. This is a therapeutic device, not a diagnostic one.
- Device Description: The description details physical components like bone screws, locking caps, and connectors, which are typical of surgical implants.
- Lack of Diagnostic Elements: There is no mention of analyzing biological samples (blood, tissue, etc.) or providing diagnostic information about a patient's condition. The device's purpose is to provide structural support and aid in fusion.
- Performance Studies: The performance studies mentioned are related to the mechanical strength and equivalence of the device as a surgical implant (Static Compression Bend, Static Torsion, Dynamic Compression). These are not typical performance metrics for an IVD.
In summary, the INNOVASIS 'Excella® Spinal System is a surgical implant designed for spinal fixation and stabilization, which falls under the category of medical devices, but not In Vitro Diagnostics.
N/A
Intended Use / Indications for Use
The INNOVASIS 'Excella® Spinal System, when used for pedicle screw fixation is intended only for patients:
- Having severe spondylolisthesis (Grade 3 & 4) at the L5-S1 joint;
- Who are receiving fusion using autogenous bone graft only;
- Who are having the device fixed or attached to the lumbar and sacral spine (L3 and below): and
- Who are having the device removed after the development of a solid fusion mass.
The INNOVASIS 'Excella®' 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 impairment;
- Fracture:
- Dislocation:
- Scoliosis:
- Kyphosis:
- Spinal tumor; and
- Previous failed fusion (pseudoarthrosis).
The INNOVASIS 'Excella® Spinal System, when used for anterolateral nonpedicle fixation, is intended for the following indications:
- Degenerative disc disease (as defined as back pain of discogenic origin with degenerative disc confirmed by patient history and radiographic studies):
- Spinal stenosis;
- Spondylolisthesis;
- Spinal deformities (i.e., scoliosis, kyphosis, and/or lordosis);
- Pseudoarthrosis;
- Tumor;
- Trauma (i.e. fracture or dislocation); and
- Previous failed fusion.
The INNOVASIS 'Excella®' Spinal System, when used for posterior non-pedicle screw fixation to the non-cervical spine, is intended for the following indications:
- Degenerative disc disease (defined as back pain of disogenic origin with degenerative disc confirmed by patient history and radiographic studies);
- Spinal stenosis;
- Spondylolisthesis;
- Spinal deformities (i.e. scoliosis, kyphosis and/or lordosis);
- Pseudoarthrosis;
- Tumor:
- Trauma (i.e. fracture or dislocation);
- Previous failed fusion.
Product codes
KWP, KWQ, MNI, MNH, NKB
Device Description
The Excella®-M Spinal System consists of 6AL-4V Titanium alloy implants meant to be used in a system. The monoaxial bone screws are offered in a variety of different lengths ranging from 30mm to 60mm as well as the following diameters. 5.5mm, 6.5mm and 7.5mm. The bone thread portion of the screws features a self-tapping, double lead thread, to reduce the number of revolutions for insertion. Locking screws include a buttress thread design for axial strength and to prevent screw loosening. The system uses 6mm Titanium rods, which are placed in the head of the screws and the system is locked in place with Titanium locking screws to grip the 6mm rods. The Cross Links consist of three components and are constructed to stabilize the relation between two rods.
The Excella® Spinal System broadens to include the Excella® -P bone screws, which feature a multi-axial joint for free motion of the screw head to allow the physician greater flexibility when placing the screws, and a series of 4.5mm diameter polyaxial bone screws of 30mm, 35mm, 40mm and 45mm lengths. The locking caps for Excella®-P are a two piece design which includes a threaded locking screw attached to an alignment cap. The alignment cap is attached to the bottom of the locking screw and rotates about the radial axis. The modified cross connectors come in various pre-assembled, adjustable lengths and allow for variation in vertical placement on two rods.
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 and below), thoracic, lumbar, and sacral spine, non-cervical 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)
Performance testing per ASTM F1717 for Static Compression Bend, Static Torsion and Dynamic Compression has demonstrated that the Excella-P® Spinal System is substantially equivalent to the predicate devices.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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
Special 510(k) Submission
Innovasis Inc. Innovasis Excella® Spinal System.
510(k) Summarv
August 7, 2007
| Company: | Innovasis Inc.
614 East 3900 South
Salt Lake City, UT 84107 | NOV 1 6 2007 |
|--------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------|
| Contact: | Warren M. Dansie
Phone: (801) 261-2236
Fax: (801) 261-0573 | |
| Trade Name: | Excella® Spinal system | |
| Common Name: | Rod and Screw Spinal Instrumentation | |
| Classification: | Product Codes: KWP, KWQ, MNI, MNH, NKB
Regulation Numbers: 21 CRF 888.3050, 888.3060,
888.3070
Classification Names:
Spinal Intervertebral Body Fixation Orthosis.
Spinal Interlaminal Fixation Orthosis
Spondylolisthesis Spinal Fixation Device System
Pedicle Screw Spinal System
Panel code: 87 | |
| Substantially
Equivalent Devices: | - K042143 - Excella-M® - Innovasis
-
K974749 – Synergy VLS™ Open – Interpore Cross
-
K022623 - Moss Miami™ - Depuy | |
-
K050461 Xia™ Stryker
-
K022191 Tenor™- Medtronic
Predicate Device Description:
The Excella®-M Spinal System consists of 6AL-4V Titanium alloy implants meant to be used in a system. The monoaxial bone screws are offered in a variety of different lengths ranging from 30mm to 60mm as well as the following diameters. 5.5mm, 6.5mm and 7.5mm. The bone thread portion of the screws features a self-tapping, double lead thread, to reduce the number of revolutions for insertion. Locking screws include a buttress thread design for axial strength and to prevent screw loosening. The system uses 6mm Titanium rods, which are placed in the head of the screws and the system is locked in place with Titanium locking screws to grip the 6mm rods. The Cross Links consist of three components and are constructed to stabilize the relation between two rods.
1
Innovasis Inc. Innovasis Excella® Spinal System.
Modified Device Description:
The Excella® Spinal System broadens to include the Excella® -P bone screws, which feature a multi-axial joint for free motion of the screw head to allow the physician greater flexibility when placing the screws, and a series of 4.5mm diameter polyaxial bone screws of 30mm, 35mm, 40mm and 45mm lengths. The locking caps for Excella®-P are a two piece design which includes a threaded locking screw attached to an alignment cap. The alignment cap is attached to the bottom of the locking screw and rotates about the radial axis. The modified cross connectors come in various pre-assembled, adjustable lengths and allow for variation in vertical placement on two rods.
Technological Comparison:
The implants are machined from the same Medical Grade Titanium (6AL-4V) per ASTM 136-02. Performance testing per ASTM F1717 for Static Compression Bend, Static Torsion and Dynamic Compression has demonstrated that the Excella-P® Spinal System is substantially equivalent to the predicate devices. The intended use of the Excella®-P device is the same as the predicate Excella®-M device, thus the Excella® System includes both the Excella®-M device and the Excella®-P device.
Indications for use are as follows:
The INNOVASIS 'Excella® Spinal System, when used for pedicle screw fixation is intended only for patients:
- Having severe spondylolisthesis (Grade 3 & 4) at the L5-S1 joint; a)
- Who are receiving fusion using autogenous bone graft only; b)
- C) Who are having the device fixed or attached to the lumbar and sacral spine (L3 and below): and
- Who are having the device removed after the development of a solid d) fusion mass.
The INNOVASIS 'Excella®' 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:
- a) Degenerative spondylolisthesis with objective evidence of neurologic impairment;
- Fracture: b)
- Dislocation: C)
- Scoliosis: d)
- Kyphosis: e)
- Spinal tumor; and f)
- Previous failed fusion (pseudoarthrosis). g)
2
Special 510(k) Submission
Innovasis Inc. Innovasis Excella® Spinal System.
The INNOVASIS 'Excella® Spinal System, when used for anterolateral nonpedicle fixation, is intended for the following indications:
- a) Deqenerative disc disease (as defined as back pain of discogenic origin with degenerative disc confirmed by patient history and radiographic studies):
- Spinal stenosis; b)
- Spondylolisthesis; C)
- Spinal deformities (i.e., scoliosis, kyphosis, and/or lordosis); ರು)
- e) Pseudoarthrosis;
- Tumor; f)
- Trauma (i.e. fracture or dislocation); and g)
- Previous failed fusion. h)
The INNOVASIS 'Excella® Spinal System, when used for posterior non-pedicle screw fixation to the non-cervical spine, is intended for the following indications:
- Degenerative disc disease (defined as back pain of disogenic origin with a) degenerative disc confirmed by patient history and radiographic studies);
- Spinal stenosis; c) Spondylolisthesis; b)
- Spinal deformities (i.e. scoliosis, kyphosis and/or lordosis); d)
- e) Pseudoarthrosis;
- Tumor: ()
- Trauma (i.e. fracture or dislocation); g)
- h) Previous failed fusion.
3
Image /page/3/Picture/1 description: The image contains the text "Public Health Service". The text is in a simple, sans-serif font and is horizontally aligned. The text is likely part of a document or sign, indicating an affiliation with a public health organization.
Image /page/3/Picture/2 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized eagle with three lines representing its wings and body. The eagle is positioned within a circle, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged around the upper portion of the circle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
NOV 1 6 2007
Innovasis, Inc % Mr. Warren Dansie 614 East 3900 South Salt Lake City, Utah 84107
Re: K071921
Trade/Device Name: Innovasis Excella® Spinal System Regulation Number: 21 CFR 888.3070 Regulation Name: Pedicle Screw Spinal System Regulatory Class: Class III Product Codes: NKB. KWP. MNI, MNH Dated: October 21, 2007 Received: November 1, 2007
Dear Mr Dansie:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA 's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
4
Page 2 – Mr. Warren Dansie
This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at (240) 276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at (240) 276-3464. You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at toll-free number (800) 638-2041 or (240) 276-3150 or the Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely vours.
Barbara Buchner
Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
5
Indications for Use
510(k) Number (if known): K071921
Device Name: Excella-P
Indications For Use:
The INNOVASIS 'Excella™' Spinal System, when used for pedicle screw_fixation_is intended only for patients:
a) Having severe spondylolisthesis (Grade 3 & 4) at the L5-S1 joint;
b) Who are receiving fusion using autogenous bone graft only;
b) Who are having the device fixed or attached to the lumbar and sacral spine (L3 and below);
and
d) Who are having the device removed after the development of a solid fusion mass.
(continued on Page 2)
X Prescription Use (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Barbara Buchum
Division of General, Restorative, and Neurological Devices
Page 1 of 2
510(k) Number K071921
6
(continued from Page 1)
The INNOVASIS 'Excella™' Spinal System, when used as a pedicle screw system in The INNOWAGIO Excellts, is intended to provide immobilization and stabilization of SKeletally Thature 'pational in treatment of the following acute and chronic deformities of the thoracic, lumbar, and sacral spine:
Degenerative spondylolisthesis with objective evidence of neurologic a) impairment;
- Fracture; b)
- Dislocation: C)
- Scoliosis: d)
- Kvphosis: e)
- Spinal tumor; and ()
- Previous failed fusion (pseudarthrosis). ದಿ)
The INNOVASIS 'Excella™' 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 studies);
- Spinal stenosis; b)
- Spondylolisthesis; C)
- Spinal deformities (i.e., scoliosis, kyphosis, and/or lordosis); d)
- Pseudoarthrosis; e)
- Tumor: f)
- Trauma (i.e. fracture or dislocation); and a)
- Previous failed fusion. h)
The INNOVASIS 'Excella™' Spinal System, when used for posterior non-pedicle screw fixation to the non-cervical spine, is intended for the following indications:
- Degenerative disc disease (defined as back pain of disogenic origin with a) degenerative disc confirmed by patient history and radiographic studies);
- Spinal stenosis; c) Spondylolisthesis; b)
- Spinal deformities (i.e. scoliosis, kyphosis and/or lordosis); d)
- Pseudoarthrosis; e)
- Tumor: ।
- Trauma (i.e. fracture or dislocation); ದ)
- Previous failed fusion. h)
Barbara Bonem
Page 2 of 2
Division of General, Restorative, and Neurological Devices
510(k) Number K071921