(45 days)
No
The device description and performance studies focus on the mechanical properties and intended use of spinal implants, with no mention of AI/ML or related technologies.
Yes
The device is intended to provide immobilization of spinal segments as an adjunct to fusion for various acute and chronic instabilities and conditions, which are therapeutic indications.
No
The ASTRA-OCT Spine System is an implant system intended to provide immobilization of spinal segments as an adjunct to fusion for various spinal instabilities and deformities. It consists of physical components like screws, rods, and plates, and does not claim to diagnose conditions, but rather treat them.
No
The device description explicitly lists physical components such as screws, plates, hooks, and rods, which are hardware implants.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the ASTRA-OCT Spine System implants are for providing immobilization of spinal segments as an adjunct to fusion for various spinal instabilities and conditions. This is a surgical implant used in vivo (within the body) to treat a physical condition.
- Device Description: The device description lists components like screws, plates, hooks, and rods, which are all physical implants.
- IVD Definition: An In Vitro Diagnostic device is defined as a medical device intended to be used in vitro (outside the body) for the examination of specimens, including blood, tissue, and urine, from the human body to provide information for diagnostic, monitoring, or compatibility purposes.
The ASTRA-OCT Spine System does not fit the definition of an IVD. It is a surgical implant used to treat spinal conditions directly within the patient's body.
N/A
Intended Use / Indications for Use
The ASTRA-OCT Spine System implants are intended to provide immobilization of spinal segments as an adjunct to fusion for the following acute and chronic instabilities of the craniocervical junction, the cervical spine (C1-C7) and the thoracic spine (T1-T3):
- Traumatic spinal fractures and/or Traumatic dislocations;
- Instability or deformity;
- Failed previous fusions (e.g. pseudoarthrosis);
- Tumors involving the cervical/thoracic spine; and
- Degenerative disease, including intractable radiculopathy, neck and/or arm pain of discogenic origin as confirmed by radiographic studies, and degenerative disease of the facets with instability.
The ASTRA-OCT Spine System implants are also intended to restore the integrity of the spinal column even in the absence of fusion for a limited time period in patients with advanced stage tumors involving the cervical spine in whom life expectancy is of insufficient duration to permit achievement of fusion.
In order to achieve additional levels of fixation, the ASTRA-OCT Spine System rods may be connected to other occipital cervical thoracic or thoracolumbar stabilization rod systems ranging in diameter from 3.5mm, including the ASTRA or APEX Spine Systems, using corresponding connectors.
Product codes (comma separated list FDA assigned to the subject device)
NKG, KWP
Device Description
The ASTRA-OCT Spine System consists of a series of polyaxial screws, occipital screws, occipital plates, hooks, rods, lateral connectors, rod-to-rod connectors, set screws, and cross connectors.
Materials:
Titanium alloy per ASTM F136 CoCr allov per ASTM F1537
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
craniocervical junction, the cervical spine (C1-C7) and the thoracic spine (T1-T3)
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 (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 F2706, "Standard Test Methods for Occipital-Cervical and Occipital-Cervical-Thoracic Spinal Implant Constructs in a Vertebrectomy Model". Testing included Static Compression Bending Tests, Static Tension Bending Test, Static Torsion Tests, Dynamic Compression Bending Tests and Dynamic Torsion Tests.
- ASTM F1798 "Standard Guide for Evaluating the Static and Fatigue 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 ASTRA-OCT Spine System results being equivalent to the predicate systems.
Clinical Test Summary:
No clinical studies were performed.
Conclusion:
Published literature and performance testing demonstrate that the ASTRA-OCT Spine is substantially equivalent to the predicate devices in terms of indications for use, design, material, performance and function.
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.
K080828, K110353, K151885, K090714, K091365, K093434, K110522, K123656, K143471, K090549, K133698, K141897, K142838, K013222, K022190, K030103, K041203, K151885, K150552, K132122
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.
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
§ 888.3075 Posterior cervical screw system.
(a)
Identification. Posterior cervical screw systems are comprised of multiple, interconnecting components, made from a variety of materials that allow an implant system to be built from the occiput to the upper thoracic spine to fit the patient's anatomical and physiological requirements, as determined by preoperative cross-sectional imaging. Such a spinal assembly consists of a combination of bone anchors via screws (i.e., occipital screws, cervical lateral mass screws, cervical pedicle screws, C2 pars screws, C2 translaminar screws, C2 transarticular screws), longitudinal members (e.g., plates, rods, including dual diameter rods, plate/rod combinations), transverse or cross connectors, interconnection mechanisms (e.g., rod-to-rod connectors, offset connectors), and closure mechanisms (e.g., set screws, nuts). Posterior cervical screw systems are rigidly fixed devices that do not contain dynamic features, including but not limited to: non-uniform longitudinal elements or features that allow more motion or flexibility compared to rigid systems.Posterior cervical screw systems are intended to provide immobilization and stabilization of spinal segments in patients as an adjunct to fusion for acute and chronic instabilities of the cervical spine and/or craniocervical junction and/or cervicothoracic junction such as: (1) Traumatic spinal fractures and/or traumatic dislocations; (2) deformities; (3) instabilities; (4) failed previous fusions (
e.g., pseudarthrosis); (5) tumors; (6) inflammatory disorders; (7) spinal degeneration, including neck and/or arm pain of discogenic origin as confirmed by imaging studies (radiographs, CT, MRI); (8) degeneration of the facets with instability; and (9) reconstruction following decompression to treat radiculopathy and/or myelopathy. These systems are also intended to restore the integrity of the spinal column even in the absence of fusion for a limited time period in patients with advanced stage tumors involving the cervical spine in whom life expectancy is of insufficient duration to permit achievement of fusion.(b)
Classification. Class II (special controls). The special controls for posterior cervical screw systems are:(1) The design characteristics of the device, including engineering schematics, must ensure that the geometry and material composition are consistent with the intended use.
(2) Nonclinical performance testing must demonstrate the mechanical function and durability of the implant.
(3) Device components must be demonstrated to be biocompatible.
(4) Validation testing must demonstrate the cleanliness and sterility of, or the ability to clean and sterilize, the device components and device-specific instruments.
(5) Labeling must include the following:
(i) A clear description of the technological features of the device including identification of device materials and the principles of device operation;
(ii) Intended use and indications for use including levels of fixation;
(iii) Device specific warnings, precautions, and contraindications that include the following statements:
(A) “Precaution: Preoperative planning prior to implantation of posterior cervical screw systems should include review of cross-sectional imaging studies (
e.g., CT and/or MRI) to evaluate the patient's cervical anatomy including the transverse foramen, neurologic structures, and the course of the vertebral arteries. If any findings would compromise the placement of these screws, other surgical methods should be considered. In addition, use of intraoperative imaging should be considered to guide and/or verify device placement, as necessary.”(B) “Precaution: Use of posterior cervical pedicle screw fixation at the C3 through C6 spinal levels requires careful consideration and planning beyond that required for lateral mass screws placed at these spinal levels, given the proximity of the vertebral arteries and neurologic structures in relation to the cervical pedicles at these levels.”
(iv) Identification of magnetic resonance (MR) compatibility status;
(v) Cleaning and sterilization instructions for devices and instruments that are provided non-sterile to the end user, and;
(vi) Detailed instructions of each surgical step, including device removal.
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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
SpineCraft LLC Ms. Ami Akallal-Asaad Vice President of Regulatory Affairs & Quality Assurance 777 Oakmont Lane Westmont, Illinois 60559
Re: K181350 Trade/Device Name: ASTRA-OCT Spine System Regulatory Class: Unclassified Product Code: NKG, KWP Dated: May 18, 2018 Received: May 22, 2018
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 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.
1
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 comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Colin O'neill -S for MNM
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) K181350
Device Name
ASTRA-OCT Spine System
Indications for Use (Describe)
The ASTRA-OCT Spine System implants are intended to provide immobilization of spinal segments as an adjunct to fusion for the following acute and chronic instabilities of the craniocervical junction, the cervical spine (C1-C7) and the thoracic spine (T1-T3):
- · Traumatic spinal fractures and/or Traumatic dislocations;
- Instability or deformity;
- · Failed previous fusions (e.g. pseudoarthrosis);
- · Tumors involving the cervical/thoracic spine: and
· Degenerative disease, including intractable radiculopathy, neck and/or arm pain of discogenic origin as confirmed by radiographic studies, and degenerative disease of the facets with instability.
The ASTRA-OCT Spine System implants are also intended to restore the integrity of the spinal column even in the absence of fusion for a limited time period in patients with advanced stage tumors involving the cervical spine in whom life expectancy is of insufficient duration to permit achievement of fusion.
In order to achieve additional levels of fixation, the ASTRA-OCT Spine System rods may be connected to other occipital cervical thoracic or thoracolumbar stabilization rod systems ranging in diameter from 3.5mm, including the ASTRA or APEX Spine Systems, using corresponding connectors.
| 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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510(K) Summary for the ASTRA-OCT Spine System
In accordance with 21 CFR 807.92 of the Federal Code of Requlations the following 510(k) Summary is submitted for the ASTRA-OCT Spine System.
Date Prepared: July 6, 2018
-
- Submitter: SpineCraft, LLC 777 Oakmont Lane Westmont, IL 60559 USA Tel: 1 630-920-7300. Fax: 1 630-920-7310
Contact Person: Ami Akallal-Asaad VP, Requlatory Affairs & QA SpineCraft. LLC a.asaad@spinecraft.com
- Submitter: SpineCraft, LLC 777 Oakmont Lane Westmont, IL 60559 USA Tel: 1 630-920-7300. Fax: 1 630-920-7310
-
- Trade name: ASTRA-OCT Spine System Classification Name: Orthosis, cervical pedicle screw spinal fixation NKG Unclassified, Pre-Amendment
Spinal interlaminal fixation orthosis per KWP 888.3050 Class II
- Trade name: ASTRA-OCT Spine System Classification Name: Orthosis, cervical pedicle screw spinal fixation NKG Unclassified, Pre-Amendment
-
- Primary predicate or legally marketed device which is substantially equivalent:
-
- Additional predicate devices:
- VERTEX Reconstruction System (K090714 / K091365 / K093434 / K110522 / K123656 / ● K143471) Medtronic
- SYNAPSE System (K090549 / K133698 / K141897 / K142838) Synthes Spine ●
- Summit OCT (K013222 / K022190/ K030103 / K041203 / K151885) Depuy Spine ●
- ELLIPSE and PROTEX CT Occipito-Cervico-Thoracic Spinal Systems (K150552) Globus ● Medical
- Kestrel Posterior Cervical Spine System (K132122) SPINE360
-
- Reference predicate devices
-
- Description of the device:
The ASTRA-OCT Spine System consists of a series of polyaxial screws, occipital screws, occipital plates, hooks, rods, lateral connectors, rod-to-rod connectors, set screws, and cross connectors.
Materials:
Titanium alloy per ASTM F136 CoCr allov per ASTM F1537
7. Substantial equivalence claimed to predicate devices
ASTRA System is substantially equivalent to the MOUNTAINEER OCT Spinal System (K042508 / K080828 / K103100 / K110353 / K132332 / K151885) and VERTEX Reconstruction
4
System (K090714 / K091365 / K093434 / K110522 / K123656 / K143628) in terms of intended use, design, materials used, mechanical safety and/or performances.
8. Indications for Use:
The ASTRA-OCT Spine System implants are intended to provide immobilization of spinal segments as an adjunct to fusion for the following acute and chronic instabilities of the craniocervical junction, the cervical spine (C1-C7) and the thoracic spine (T1-T3):
- Traumatic spinal fractures and/or Traumatic dislocations; ●
- . Instability or deformity;
- Failed previous fusions (e.g. pseudoarthrosis); ●
- Tumors involving the cervical/thoracic spine; and Degenerative disease, including intractable ● radiculopathy and/or myelopathy, neck and/or arm pain of discogenic origin as confirmed by radiographic studies, and degenerative disease of the facets with instability.
The ASTRA-OCT Spine System implants are also intended to restore the integrity of the spinal column even in the absence of fusion for a limited time period in patients with advanced stage tumors involving the cervical spine in whom life expectancy is of insufficient duration to permit achievement of fusion.
In order to achieve additional levels of fixation, the ASTRA-OCT Spine System rods may be connected to other occipital cervical thoracolumbar stabilization rod systems ranqinq in diameter from 3.5mm to 6.35mm, including the ASTRA or APEX Spine Systems, using corresponding connectors.
9. Summary of the technological characteristics compared to predicate
Intended Use
The ASTRA-OCT Spine System and all the predicates have similar intended uses.
Materials
The ASTRA-OCT Spine System is fabricated from the same material as the predicate devices.
Design Features/Functions
The ASTRA-OCT Spine System and the cited predicate devices share similar basic design features and functions.
Dimensions
The ASTRA-OCT Spine System is dimensionally similar to the cited predicate devices.
Sterilization
The ASTRA-OCT Spine System is provided non-sterile and the cited predicate devices are nonsterile for single use only.
Performance Specification
Mechanical testing confirmed the ASTRA-OCT Spine System demonstrated equivalent performance to the cited predicate device under the same test conditions.
10. 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.
- o ASTM F2706, "Standard Test Methods for Occipital-Cervical and Occipital-Cervical-Thoracic Spinal Implant Constructs in a Vertebrectomy Model". Testing included Static Compression
5
Bending Tests, Static Tension Bending Test, Static Torsion Tests, Dynamic Compression Bending Tests and Dynamic Torsion Tests.
- . ASTM F1798 "Standard Guide for Evaluating the Static and Fatigue 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 ASTRA-OCT Spine System results being equivalent to the predicate systems.
11. Clinical Test Summary
No clinical studies were performed
12. Conclusion Nonclinical and Clinical
Published literature and performance testing demonstrate that the ASTRA-OCT Spine is substantially equivalent to the predicate devices in terms of indications for use, design, material, performance and function.