(90 days)
No
The device description and performance studies focus on the mechanical properties and components of a spinal fixation system, with no mention of AI or ML.
Yes
The device is intended to provide immobilization of spinal segments as an adjunct to fusion in the treatment of various instabilities or deformities, and for pedicle screw fixation for the treatment of severe spondylolisthesis, all of which are considered therapeutic interventions for medical conditions.
No
Explanation: The ASTRA System is described as a "posterior spinal fixation system" intended for "immobilization of spinal segments as an adjunct to fusion" and for "pedicle screw fixation." Its indicated uses are related to the treatment of various spinal conditions, not for diagnosing them.
No
The device description explicitly states it is a "multiple component, posterior spinal fixation system which consists of rods, cannulated and non-cannulated monoaxial, uniplanar and polyaxial screws, hooks, iliac connectors, rod connectors, and cross connectors" made of "Titanium alloy" and "CoCr alloy," indicating it is a hardware-based implant system.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens taken from the human body (like blood, urine, or tissue) to provide information about a person's health. This testing is done outside of the body.
- ASTRA System Function: The ASTRA System is a surgical implant designed to be placed inside the body to stabilize the spine. It is a mechanical device used for structural support and fusion, not for analyzing biological samples.
- Intended Use: The intended use clearly describes the device's purpose as providing immobilization and fixation of spinal segments as an adjunct to fusion for various spinal conditions. This is a therapeutic and structural function, not a diagnostic one.
- Device Description: The description details the components of a spinal fixation system (rods, screws, hooks, etc.) made of materials like titanium and CoCr alloy. These are typical components of surgical implants, not IVDs.
- Performance Studies: The performance studies described are mechanical tests evaluating the strength and fatigue properties of the implant components, which are relevant for surgical devices, not IVDs.
The ASTRA System is a surgical implant used for spinal fixation and fusion.
N/A
Intended Use / Indications for Use
The ASTRA System is intended to provide immobilization 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; spinal tumor; and failed previous fusion (pseudo-arthrosis).
The ASTRA Spine System is also indicated for pedicle screw fixation for the treatment of severe spondylolisthesis (Grades 3 and 4) of the L5-S1 vertebra in skeletally mature patients receiving fusion by autogenous bone graft, with the device fixed or attached to the lumbar and sacral spine (levels of pedicle screw fixation are L3 to S1), and for whom the device is intended to be removed after solid fusion is attained.
The ASTRA System is also a sacral/iliac screw fixation system of the non-cervical spine indicated for degenerative disc disease (defined as discogenic back pain with degeneration of the disc confirmed by history and radies), spondylolisthesis, trauma (fracture and/or dislocation), spinal stenosis, deformities (scoliosis, lordosis and/or kyphosis), tumor, and previous failed fusion (pseudo-arthrosis).
When used in a percutaneous, posterior approach with AVANT Spine MIS instrumentation, the ASTRA Spine System is intended for non-cervical pedicle fixation for the following indications: degenerative discogenic back pain with degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, trauma (i.e., fracture or dislocation), spinal stenosis, curvatures (i.e., scoliosis, kyphosis), tumor, pseudo-arthrosis, and failed previous fusion in skeletally mature patients . Levels of fixation are for the thoracic, lumbar and sacral spine.
Product codes
NKB, MNI, MNH, KWP, KWQ
Device Description
The ASTRA Spine System is a top loading, multiple component, posterior spinal fixation system which consists of rods, cannulated and non-cannulated monoaxial, uniplanar and polyaxial screws, hooks, iliac connectors, rod connectors, and cross connectors. Most of the components are available in a variety of sizes to more closely match the patient's anatomy.
Materials:
Titanium alloy CoCr alloy
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Thoracic, lumbar, and sacral spine, L5-S1 vertebra, L3 to S1, non-cervical spine
Indicated Patient Age Range
Skeletally mature patients
Intended User / Care Setting
Prescription Use
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)
Non-clinical Test Summary:
The following tests were conducted:
- ASTM F1717, "Standard Test Methods for Spinal Implant Constructs in a Vertebrectomy . Model". Testing included Static Compression Bending Tests, Static Torsion Tests and Dynamic Compression Bending Tests.
- ASTM F1798 "Standard Guide for Evaluating the Static and Fatique Properties of Interconnection Mechanisms and Subassemblies used in Spinal Arthrodesis Implants". Testing included Axial Gripping, Torsional Gripping, Static Flexion-Extension and Dynamic Flexion-Extension.
The results of this testing were compared to predicate systems, with the results being equal to or higher than the predicate systems.
Clinical Test Summary
No clinical studies were performed
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
K062513, K092825, K102488, K110906, K132603, K060748, K071373, K113666, K954696, K980288, K950697, K000536, K940631, K081252
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
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol that resembles a stylized caduceus, with three human profiles facing to the right.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
May 19, 2015
SpineCraft, LLC Ms. Ami Akallal-Asaad Vice President, Regulatory Affairs & Quality Assurance 777 Oakmont Lane Westmont, Illinois 60559
Re: K150417
Trade/Device Name: ASTRA Spine System Regulation Number: 21 CFR 888.3070 Regulation Name: Pedicle screw spinal system Regulatory Class: Class III Product Code: NKB, MNI, MNH, KWP, KWQ Dated: February 12, 2015 Received: February 18, 2015
Dear Ms. Akallal-Asaad:
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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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); medical device reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set
1
Page 2 - Ms. Ami Akallal-Asaad
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.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely vours.
Lori A. Wiggins -S
for
Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known)
K150417
Device Name
ASTRA SPINE SYSTEM
Indications for Use (Describe)
The ASTRA System is intended to provide immobilization 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; spinal tumor; and failed previous fusion (pseudo-arthrosis).
The ASTRA Spine System is also indicated for pedicle screw fixation for the treatment of severe spondylolisthesis (Grades 3 and 4) of the L5-S1 vertebra in skeletally mature patients receiving fusion by autogenous bone graft, with the device fixed or attached to the lumbar and sacral spine (levels of pedicle screw fixation are L3 to S1), and for whom the device is intended to be removed after solid fusion is attained.
The ASTRA System is also a sacral/iliac screw fixation system of the non-cervical spine indicated for degenerative disc disease (defined as discogenic back pain with degeneration of the disc confirmed by history and radies), spondylolisthesis, trauma (fracture and/or dislocation), spinal stenosis, deformities (scoliosis, lordosis and/or kyphosis), tumor, and previous failed fusion (pseudo-arthrosis).
When used in a percutaneous, posterior approach with AVANT Spine MIS instrumentation, the ASTRA Spine System is intended for non-cervical pedicle fixation for the following indications: degenerative discogenic back pain with degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, trauma (i.e., fracture or dislocation), spinal stenosis, curvatures (i.e., scoliosis, kyphosis), tumor, pseudo-arthrosis, and failed previous fusion in skeletally mature patients . Levels of fixation are for the thoracic, lumbar and sacral spine.
| Type of Use (Select one or both, as applicable) |
|---|
| ☑Prescription Use (Part 21 CFR 801 Subpart D) |
| ☐Over-The-Counter Use (21 CFR 801 Subpart C) |
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3
510(k) Summary for the ASTRA Spine System
In accordance with 21 CFR 807.92 of the Federal Code of Regulations the following 510(k) summary is submitted for the ASTRA Spine System.
Date Prepared: February 12, 2015
| 1. Submitter: | Contact Person: |
|---|---|
| SpineCraft, LLC | Ami Akallal-Asaad |
| 777 Oakmont Lane | VP, Regulatory Affairs & QA |
| Westmont, IL 60559 USA | SpineCraft, LLC |
| Tel: 1 630-920-7300. | a.asaad@spinecraft.com |
| Fax: 1 630-920-7310 |
| 2. Trade name: | ASTRA Spine System |
|---|---|
| Common Name: | Pedicle screw system |
| Classification Name: | Pedicle screw spinal system per MNI 888.3070 |
| Pedicle screw spinal system per MNH 888.3070 | |
| Pedicle screw spinal system per NKB 888.3070 | |
| Spinal interlaminal fixation orthosis per KWP 888.3050 | |
| Spinal intervertebral body fixation orthosis per KWQ 888.3060 | |
| Class III |
3. Primary predicate or legally marketed device which is substantially equivalent:
- Expedium,Viper Spine System (K131802) DePuy Spine
Additional predicate devices: 4.
- APEX Spine System (K062513 / K092825 / K102488 / K110906 / K132603) SpineCraft ●
- . Xia Spinal System (K060748 / K071373 / K113666) Stryker
- Rogozinski (K954696) Smith Nephew ●
- . Silhouette (K980288) Zimmer Spine
- MOSS MIAMI SS (K950697 / K000536) DePuy Spine
- . Synergy VLS - open - (K940631) Cross Medical
- Ti Expedium 4.5 Spine System (K081252) DePuy Spine ●
5. Description of the device:
The ASTRA Spine System is a top loading, multiple component, posterior spinal fixation system which consists of rods, cannulated and non-cannulated monoaxial, uniplanar and polyaxial screws, hooks, iliac connectors, rod connectors, and cross connectors. Most of the components are available in a variety of sizes to more closely match the patient's anatomy.
Materials:
Titanium alloy CoCr alloy
6. Substantial equivalence claimed to predicate devices
ASTRA Spine System is substantially equivalent to the APEX Spine System (K062513 / K092825 / K102488 / K132603), Expedium Viper Spine System (K090648 / K102701 / K131802), Xia Spine System (K060748 / K071373 / K113666), Rogozinski (K954696), MOSS MIAMI SS
4
(K950697 / K000536), Synergy VLS – open – (K940631), and Ti Expedium 4.5 Spine System (K081252) in terms of intended use, design, materials used, mechanical safety and/or performances.
7. Intended Use:
The ASTRA Spine System is intended to provide immobilization 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; spinal tumor; and failed previous fusion (pseudoarthrosis).
The ASTRA Spine System is also indicated for pedicle screw fixation for the treatment of severe spondylolisthesis (Grades 3 and 4) of the L5-S1 vertebra in skeletally mature patients receiving fusion by autogenous bone graft, with the device fixed or attached to the lumbar and sacral spine (levels of pedicle screw fixation are L3 to S1), and for whom the device is intended to be removed after solid fusion is attained.
The ASTRA Soine System is also a sacral/iliac screw fixation system of the non-cervical spine indicated for degenerative disc disease (defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, trauma (fracture and/or dislocation), spinal stenosis, deformities (scoliosis, lordosis and/or kyphosis), tumor, and previous failed fusion (pseudo-arthrosis).
When used in a percutaneous posterior approach with AVANT MIS instrumentation, the ASTRA Spine System is intended for non-cervical pedicle fixation for the following indications: degenerative disc disease (defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, trauma (i.e., fracture or dislocation), spinal stenosis, curvatures (i.e., scoliosis, and/or lordosis), tumor, pseudoarthrosis, and failed previous fusion in skeletally mature patients . Levels of fixation are for the thoracic, lumbar and sacral spine.
8. Non-clinical Test Summary:
The following tests were conducted:
- ASTM F1717, "Standard Test Methods for Spinal Implant Constructs in a Vertebrectomy . Model". Testing included Static Compression Bending Tests, Static Torsion Tests and Dynamic Compression Bending Tests.
- . ASTM F1798 "Standard Guide for Evaluating the Static and Fatique Properties of Interconnection Mechanisms and Subassemblies used in Spinal Arthrodesis Implants". Testing included Axial Gripping, Torsional Gripping, Static Flexion-Extension and Dynamic Flexion-Extension.
The results of this testing were compared to predicate systems, with the results being equal to or higher than the predicate systems.
9. Clinical Test Summary
No clinical studies were performed
10. Conclusions Nonclinical and Clinical
The ASTRA Spine System is substantially equivalent to the predicate devices in terms of indications for use, design, material, performance and function.