(125 days)
No
The summary describes a physical medical device (cervical interbody fusion device and anterior cervical plate) and its mechanical testing. There is no mention of software, algorithms, image processing, or any terms related to AI or ML.
Yes
Explanation: The device is intended to treat degenerative disc disease, trauma, tumors, deformity, pseudoarthrosis, failed previous fusion, spondylolisthesis, and spinal stenosis in the cervical spine, which are all medical conditions.
No
The device is an interbody fusion device designed to provide structural stability in the cervical spine. It acts as a mechanical support during fusion and does not diagnose disease.
No
The device description clearly indicates it is a physical implant (cervical interbody fusion device, plate, screws, spikes) made from radiolucent polymer and titanium alloy. There is no mention of software as a component or the primary function of the device.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are devices used to examine specimens taken from the human body, such as blood, urine, or tissue, to provide information about a person's health.
- Device Description: The text clearly describes the Elevation Spine Saber-C System as a cervical interbody fusion device and an anterior cervical fixation device. These are surgically implanted devices used to provide structural support and promote bone fusion in the spine.
- Intended Use: The intended use is for treating degenerative disc disease, trauma, tumors, deformity, etc., by providing structural stability and fixation in the cervical spine. This involves surgical implantation, not the analysis of bodily specimens.
The device's function is mechanical and structural within the body, which is the opposite of how IVDs operate.
N/A
Intended Use / Indications for Use
The Elevation Spine Saber-C System is a cervical interbody for use in skeletally mature patients with degenerative disc disease (DDD) of the cervical spine (C2-T1) and is for use at a single spinal level. DDD is defined as discogenic pain with degeneration of the disc confirmed by history and radiographic studies. These patients should be skeletally mature and have had at least six (6) weeks of non-operative treatment. The SABER-C Spacer is to be filled with autograft bone and/or allogenic bone graft composed of cancellous and/or corticocancellous bone.
The SABER-C Spacer is intended to be used with supplemental fixation, such as anterior cervical plates or posterior cervical screw fixation. When the SABER-C Spacer is used with the SABER-C Anterior Cervical Plate and screws, the plate-spacer-screw assembly can be used as a stand-alone device with the SABER-C Anterior Cervical Plate acting as the supplemental fixation. When the SABER-C Spacer is used with the SABER-C Anterior Cervical Plate and spikes, the plate-spacer-spike assembly should be used with additional supplemental fixation such as posterior cervical screw fixation.
The SABER-C Anterior Cervical Plate, when used without the spacer component and with screws, is intended for anterior screw fixation to the cervical spine (C2-C7) for the following indications: degenerative disc disease (as defined by neck pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies), trauma (including fractures), tumors, deformity (defined as kyphosis, or scoliosis), pseudoarthrosis, failed previous fusion, spondylolisthesis, and spinal stenosis. The Anterior Cervical Plate is not to be used with spikes when used without the Spacer component.
Product codes (comma separated list FDA assigned to the subject device)
OVE, ODP, KWO
Device Description
The SABER-C System is a cervical interbody fusion device used to provide structural stability in skeletally mature individuals following discectomy. The SABER-C System is inserted through an anterior cervical approach and is available in various geometric and material options to fit the clinical needs of the patient. The SABER-C System Anterior Cervical Plate is an anterior cervical fixation device this is available in various geometric and fixation options and can be used with various types of interbody spacers.
The SABER-C System is made from radiolucent polymer, with titanium alloy or tantalum markers, as specified in ASTM F2026. ASTM F136. ASTM F1295, and ASTM F560. The SABER-C Anterior Cervical Plate and two fixation options, spike or screws, are manufactured from titanium alloy, as specified in ASTM F136 and ASTM F1295. The plate is not to be used with spikes when used without the Spacer component.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
cervical spine (C2-T1), cervical spine (C2-C7)
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)
The SABER-C System Anterior Cervical Integrated Fixation Spacer System was designed and tested as an interbody fusion device for the cervical spine. The objective of this testing was to demonstrate that the subject device is equivalent to predicate devices with respect to testing recommended in ASTM F2077-14 and F2267-11.
Three configurations of the Elevation Spine Saber-C System were tested in static and dynamic axial compression, compression-shear, and torsion per ASTM F2077-14, subsidence per ASTM 2267-11, and expulsion. Additionally, a cadaver implantation study was performed on the plate and spacer assembly when used with spiked fixation.
Results: In summary, the results of the performance testing demonstrate that the Elevation Spine SABER-C is substantially equivalent with respect to its intended use, geometry, materials, and the method of fixation.
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.
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
§ 888.3080 Intervertebral body fusion device.
(a)
Identification. An intervertebral body fusion device is an implanted single or multiple component spinal device made from a variety of materials, including titanium and polymers. The device is inserted into the intervertebral body space of the cervical or lumbosacral spine, and is intended for intervertebral body fusion.(b)
Classification. (1) Class II (special controls) for intervertebral body fusion devices that contain bone grafting material. The special control is the FDA guidance document entitled “Class II Special Controls Guidance Document: Intervertebral Body Fusion Device.” See § 888.1(e) for the availability of this guidance document.(2) Class III (premarket approval) for intervertebral body fusion devices that include any therapeutic biologic (e.g., bone morphogenic protein). Intervertebral body fusion devices that contain any therapeutic biologic require premarket approval.
(c)
Date premarket approval application (PMA) or notice of product development protocol (PDP) is required. Devices described in paragraph (b)(2) of this section shall have an approved PMA or a declared completed PDP in effect before being placed in commercial distribution.
0
August 7, 2019
Image /page/0/Picture/1 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.
Elevation Spine % Mr. Steve Brown QA/RA Manager CoorsTek Medical 560 West Golf Course Road Providence. Utah 84332
Re: K190885
Trade/Device Name: Elevation Spine Saber-C System Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral Body Fusion Device Regulatory Class: Class II Product Code: OVE, ODP, KWO Dated: July 12, 2019 Received: July 15, 2019
Dear Mr. Brown:
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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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) for
1
devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). 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 (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely.
for Melissa Hall Assistant Director DHT6B: Division of Spinal Devices OHT6: Office of Orthopedic Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K190885
Device Name Elevation Spine Saber-C System
Indications for Use (Describe)
Indications for Use:
The Elevation Spine Saber-C System is a cervical interbody for use in skeletally mature patients with degenerative disc disease (DDD) of the cervical spine (C2-T1) and is for use at a single spinal level. DDD is defined as discogenic pain with degeneration of the disc confirmed by history and radiographic studies. These patients should be skeletally mature and have had at least six (6) weeks of non-operative treatment. The SABER-C Spacer is to be filled with autograft bone and/or allogenic bone graft composed of cancellous and/or corticocancellous bone.
The SABER-C Spacer is intended to be used with supplemental fixation, such as anterior cervical plates or posterior cervical screw fixation. When the SABER-C Spacer is used with the SABER-C Anterior Cervical Plate and screws, the plate-spacer-screw assembly can be used as a stand-alone device with the SABER-C Anterior Cervical Plate acting as the supplemental fixation. When the SABER-C Spacer is used with the SABER-C Anterior Cervical Plate and spikes, the plate-spacer-spike assembly should be used with additional supplemental fixation such as posterior cervical screw fixation.
The SABER-C Anterior Cervical Plate, when used without the spacer component and with screws, is intended for anterior screw fixation to the cervical spine (C2-C7) for the following indications: degenerative disc disease (as defined by neck pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies), trauma (including fractures), tumors, deformity (defined as kyphosis, or scoliosis), pseudoarthrosis, failed previous fusion, spondylolisthesis, and spinal stenosis. The Anterior Cervical Plate is not to be used with spikes when used without the Spacer component.
| 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
| Device Trade Name: | Elevation Spine Saber-C System |
|---|---|
| Date: | July 12, 2019 |
| Sponsor: | Elevation Spine |
| 2511 Garden Rd. Suite B260 | |
| Monterey, CA 93940 | |
| (650) 302-7504 | |
| Contact Person: | Steve Brown |
| Manufacturer: | Elevation Spine |
| Common Name: | Anterior Cervical Integrated Fixation Spacer System |
| Device Classification: | Class II |
| Classification Name: | Intervertebral body fusion device, Spinal intervertebral body fixation orthosis |
| Regulation: | 888.3080 |
| 888.3060 | |
| Device Regulation Panel: | Orthopedic |
| Device Product Code: | OVE, ODP, KWQ |
Purpose:
The purpose of this Traditional 510(k) submission is to gain clearance for the Elevation Spine Saber-C System.
Indications for Use:
Indications for Use:
The Elevation Spine Saber-C System is a cervical interbody fusion device intended for use in skeletally mature patients with degenerative disc disease (DDD) of the cervical spine (C2-T1) and is for use at a single spinal level. DDD is defined as discogenic pain with degeneration of the disc confirmed by history and radiographic studies. These patients should be skeletally mature and have had at least six (6) weeks of non-operative treatment. The SABER-C Spacer is to be filled with autograft bone and/or allogenic bone graft composed of cancellous and/or corticocancellous bone.
The SABER-C Spacer is intended to be used with supplemental fixation, such as anterior cervical plates or posterior cervical screw fixation. When the SABER-C Spacer is used with the SABER-C Anterior Cervical Plate and screws, the plate-spacer-screw assembly can be used as a stand-alone device with the SABER-C Anterior Cervical Plate acting as the supplemental fixation. When the SABER-C Spacer is used with the SABER-C Anterior Cervical Plate and
4
spikes, the plate-spacer-spike assembly should be used with additional supplemental fixation such as posterior cervical screw fixation.
The SABER-C Anterior Cervical Plate, when used without the spacer component and with screws, is intended for anterior screw fixation to the cervical spine (C2-C7) for the following indications: degenerative disc disease (as defined by neck pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies), trauma (including fractures), tumors, deformity (defined as kyphosis, lordosis, or scoliosis), pseudoarthrosis, failed previous fusion, spondylolisthesis, and spinal stenosis. The Anterior Cervical Plate is not to be used with spikes when used without the Spacer component.
Device Description:
The SABER-C System is a cervical interbody fusion device used to provide structural stability in skeletally mature individuals following discectomy. The SABER-C System is inserted through an anterior cervical approach and is available in various geometric and material options to fit the clinical needs of the patient. The SABER-C System Anterior Cervical Plate is an anterior cervical fixation device this is available in various geometric and fixation options and can be used with various types of interbody spacers.
The SABER-C System is made from radiolucent polymer, with titanium alloy or tantalum markers, as specified in ASTM F2026. ASTM F136. ASTM F1295, and ASTM F560. The SABER-C Anterior Cervical Plate and two fixation options, spike or screws, are manufactured from titanium alloy, as specified in ASTM F136 and ASTM F1295. The plate is not to be used with spikes when used without the Spacer component.
| Implant Materials | |
|---|---|
| Material: | Standard: |
| Implant Grade PEEK | ASTM F2026-17 Standard Specification for Polyetheretherketone |
| (PEEK) Polymers for Surgical Implant Applications. | |
| Titanium | ASTM F136-13 Standard Specification for Wrought Titanium-6 |
| Aluminum-4 ELI (Extra Low Interstitial) Alloy for Surgical | |
| Implant Application (UNS R56401) | |
| ASTM F1472-14 Standard Specification for Wrought Titanium-6 | |
| Aluminum-4 Vanadium Alloy for Surgical Implant Application | |
| (UNS R56400) | |
| Titanium alloy coating | ASTM F1580-18 Standard Specification for Titanium and |
| Titanium-6 Aluminum-4 Alloy Powders for Coating of Surgical | |
| Implants |
5
Legally Marketed Predicate Devices:
Globus Coalition AGX (Primary Predicate) K142218 K173115
Technological Characteristics:
There are no technological characteristics that raise new issues of safety or effectiveness. The Elevation Spine SABER-C is substantially equivalent with respect to its intended use, geometry, materials, and the method of fixation.
Performance Testing:
The SABER-C System Anterior Cervical Integrated Fixation Spacer System was designed and tested as an interbody fusion device for the cervical spine. The objective of this testing was to demonstrate that the subject device is equivalent to predicate devices with respect to testing recommended in ASTM F2077-14 and F2267-11.
Three configurations of the Elevation Spine Saber-C System were tested in static and dynamic axial compression, compression-shear, and torsion per ASTM F2077-14, subsidence per ASTM 2267-11, and expulsion. Additionally, a cadaver implantation study was performed on the plate and spacer assembly when used with spiked fixation.
Conclusion
In summary, the results of the performance testing demonstrate that the Elevation Spine SABER-C is substantially equivalent with respect to its intended use, geometry, materials, and the method of fixation.