(122 days)
The Spinal Elements Cervical Intervertebral Body Fusion System is a stand-alone interbody fusion device intended for spinal fusion procedures at one level (C3-C7) in skeletally mature patients with degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies) of the cervical spine. Implants are to be implanted via an open, anterior approach and packed with autogenous bone. These patients may have had a previous non-fusion spinal surgery at the involved spinal level(s).
Patients must have undergone a regimen of at least six (6) weeks of non-operative treatment prior to being treated with these devices.
The implant is designed to accommodate two screws. Two screws should be used to ensure adequate fixation of the implant.
Spinal Elements' Cervical Intervertebral Body Fusion System is composed of an implant body and fixation screws. The implant body is a generally box-shaped device with holes through its body for the placement of graft material. Additionally, it has teeth located on its superior and inferior external surfaces to help keep the device from migrating once placed in its desired location. There are also screw holes located in the implant body. Each screw hole is lined in its internal surface with a titanium ring insert.
Screws pass through screw holes of the implant body and affix to bone to help prevent implant migration. When fully seated, the screw head rests on the titanium insert of the screw hole.
Device implant bodies are made from either titanium alloy (Ti-6A1-4V) conforming to ASTM F 136 or ISO 5832-3 or polyetheretherketone conforming to ASTM F 2026.
Screws are made from Ti-6AI-4V per ASTM F 136 or ISO 5832-3 with certain subcomponents manufactured from nitinol conforming to ASTM F2063.
Here's an analysis of the provided text regarding the acceptance criteria and study for the Cervical Intervertebral Body Fusion System:
The document provided is a 510(k) summary for a medical device seeking clearance, not a peer-reviewed study report. Therefore, it focuses on demonstrating substantial equivalence to previously cleared devices rather than a standalone clinical study with detailed acceptance criteria and performance metrics in the way a clinical trial for a new drug or novel high-risk device might.
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria described are primarily related to mechanical performance and substantial equivalence to predicate devices. The document does not explicitly state numerical "acceptance criteria" in the format of, for example, "Sensitivity >= X% and Specificity >= Y%." Instead, it states that the device must perform as intended based on comparison to cleared devices.
| Acceptance Criteria Category | Specific Criteria/Tests | Reported Device Performance | Comments |
|---|---|---|---|
| Mechanical Performance | Static Compression (ASTM F 2077-03) | "All test results indicate the device will perform as intended based on a comparison to devices cleared for similar or identical indications for use." | This implies the device met or exceeded the performance of the predicate devices in these tests. No specific numerical thresholds or results are provided. |
| Static Torsion (ASTM F 2077-03) | (Same as above) | ||
| Dynamic Compression (ASTM F 2077-03) | (Same as above) | ||
| Dynamic Torsion (ASTM F 2077-03) | (Same as above) | ||
| Subsidence Testing (ASTM F 2267-04) | (Same as above) | ||
| Substantial Equivalence | Equivalence in Indications for Use | "virtually the same" to predicate devices K071833 and K083389 | |
| Equivalence in Intended Use | "virtually the same" to predicate devices K071833 and K083389 | ||
| Equivalence in Surgical Technique | "virtually the same" to predicate devices K071833 and K083389 | ||
| Equivalence in Materials | "virtually the same" to predicate devices K071833 and K083389 (Ti-6A1-4V or PEEK) | ||
| Equivalence in Technological Characteristics | "virtually the same" to predicate devices K071833 and K083389 |
2. Sample Size Used for the Test Set and Data Provenance
The document describes non-clinical mechanical testing. For such testing, the "test set" would refer to the number of physical devices or components subjected to the mechanical tests. The document does not specify the sample size (N) for these mechanical tests. It also does not involve human data, so discussions of country of origin or retrospective/prospective data are not applicable here.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This section is not applicable. For mechanical testing of implantable devices, "ground truth" is established by engineering standards (e.g., ASTM F2077, ASTM F2267) and laboratory measurements rather than expert consensus on medical images or clinical outcomes.
4. Adjudication Method for the Test Set
This section is not applicable as it pertains to human-based assessment or clinical trials, not mechanical testing.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
There was no MRMC study conducted or described. This type of study is relevant for diagnostic AI devices, not for a spinal implant primarily evaluated through mechanical performance and substantial equivalence.
6. If a Standalone (i.e. algorithm only without human-in-the loop performance) was done
There was no standalone algorithm performance study as this is a physical medical device, not an AI-driven diagnostic or therapeutic algorithm.
7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)
The ground truth for the performance claim is based on established engineering standards (ASTM) for mechanical testing and the performance profiles of predicate devices that have already received regulatory clearance. The "ground truth" is that the device meets the mechanical robustness requirements as defined by these standards and performs comparably to or better than similar predicate devices.
8. The Sample Size for the Training Set
This section is not applicable. There is no "training set" in the context of mechanical testing for substantial equivalence of a physical medical device. The "training" for the device's design and manufacturing is based on established engineering principles, material science, and the designs of previously successful devices.
9. How the Ground Truth for the Training Set was Established
This section is not applicable for the same reasons as #8. The "ground truth" (i.e., how optimal design and performance were determined) for the device's development would be based on biomechanical principles, material properties, and the historical performance and safety of similar devices already on the market.
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Spinal Elements, Inc. Premarket Notification - Cervical Intervertebral Body Fusion System
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ﻨﺎ ﺍﻟﻤﺴﺎﺣﺔ ﺍﻟﻤﺘﻮﻗﻊ ﺍﻟﻤﺘﻮﻗﻊ ﺍﻟﻤﺘﻮﻗﻊ ﺍﻟﻤﺘﻮﻗﻊ ﺍﻟﻤﺘﻮﻗﻊ ﺍﻟﻤﺘﻮﻗﻊ ﺍﻟﻤﺘﻮﻗﻊ ﺍﻟﻤﺘﻮﻗﻊ ﺍﻟﻤﺘﻮﻗﻊ ﺍﻟﻤﺘﻮﻗﻊ ﺍﻟﻤﺘﻮﻗﻊ ﺍﻟﻤﺘﻮﻗﻊ ﺍﻟﻤﺘﻮﻗﻊ ﺍﻟﻤﺘﻮﻗﻊ ﺍﻟﻤﺘﻮﻗﻊ ﺍﻟﻤﺘﻮﻗﻊ ﺍﻟﻤﺘﻮﻗﻊ ﺍﻟﻤﺘﻮﻗﻊ ﺍﻟﻤﺘﻮﻗﻊ ﺍﻟﻤﺘﻮﻗﻊ ﺍﻟ
510(k) Summary Cervical Intervertebral Body Fusion System
510(k) Number K122771
JAN 1 0 2013
Manufacturer Identification Submitted by:
Spinal Elements, Inc. 2744 Loker Ave. W., Suite 100 Carlsbad, CA 92010 ) 760-607-0121
Contact Information:
Benjamin A. Kimball Regulatory Affairs Manager Spinal Elements, Inc. 2744 Loker Ave. W., Suite 100 Carlsbad, CA 92010 760-607-1816 Bkimball(@spinalelements.com
January 9, 2013 Date Prepared:
Proprietary Name Cervical Intervertebral Body Fusion System Intervertebral Body Fusion Device Common Name Device Classification 21 CFR 888.3080 (Intervertebral Body Fusion Device) Proposed Regulatory Class Class II Device Product Code OVE
Purpose of this Special 510(k)
This 510(k) seeks clearance for a new system.
Device Description
Spinal Elements' Cervical Intervertebral Body Fusion System is composed of an implant body and fixation screws. The implant body is a generally box-shaped device with holes through its body for the placement of graft material. Additionally, it has teeth located on its superior and inferior external surfaces to help keep the device from migrating once placed in its desired location. There are also screw holes located in the implant body. Each screw hole is lined in its internal surface with a titanium ring insert.
Screws pass through screw holes of the implant body and affix to bone to help prevent implant migration. When fully seated, the screw head rests on the titanium insert of the screw hole.
Device implant bodies are made from either titanium alloy (Ti-6A1-4V) conforming to ASTM F 136 or ISO 5832-3 or polyetheretherketone conforming to ASTM F 2026.
This 510(k) seeks clearance for a new system.
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Screws are made from Ti-6AI-4V per ASTM F 136 or ISO 5832-3 with certain subcomponents manufactured from nitinol conforming to ASTM F2063.
Intended Use of the Device
The Spinal Elements Cervical Intervertebral Body Fusion System is a stand-alone interbody fusion device intended for spinal fusion procedures at one level (C3-C7) in skeletally mature patients with degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies) of the cervical spine. Implants are to be implanted via an open, anterior approach and packed with autogenous bone. These patients may have had a previous nonfusion spinal surgery at the involved spinal level(s).
Patients must have undergone a regimen of at least six (6) weeks of non-operative treatment prior to being treated with these devices.
The implant is designed to accommodate two screws. Two screws should be used to ensure adequate fixation of the implant.
Performance Data
Non-clinical, mechanical testing was performed to determine the performance profile of the device. Testing included:
- Static Compression testing as per ASTM F 2077-03 A
-
Static Torsion testing as per ASTM F 2077-03
-
Dynamic Compression testing as per ASTM F 2077-03
-
Dynamic Torsion testing as per ASTM F 2077-03
-
Subsidence Testing as per ASTM F 2267-04
All test results indicate the device will perform as intended based on a comparison to devices cleared for similar or identical indications for use.
Substantial Equivalence
The device seeking clearance is substantially equivalent to the Spinal Elements Mosaic system cleared under K071833, and the Globus Coalition system cleared under K083389. The indications for use, intended use, surgical technique, materials, and technological characteristics are virtually the same.
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Image /page/2/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized depiction of an eagle or bird-like figure with three curved lines representing its body and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES-USA" is arranged in a circular pattern around the bird symbol.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
Letter dated: January 10, 2013
Spinal Elements, Incorporated % Mr. Benjamin A. Kimball Regulatory Affairs Manager 2744 Loker Avenue West, Suite 100 Carlsbad. California 92010
Re: K122771
Trade/Device Name: Cervical Intervertebral Body Fusion System Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral body fusion device Regulatory Class: Class II Product Code: OVE Dated: December 3, 2012 Received: December 10, 2012
Dear Mr. Kimball:
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 (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.
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Page 2 - Mr. Benjamin A. Kimball
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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/ReportalProblem/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 Small Manufacturers, International and Consumer Assistance 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.
Mark N. Melkerson
Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) K:122771
Device Name: Cervical Intervertebral Body Fusion System
Indications for Use:
The Spinal Elements Cervical Intervertebral Body Fusion System is a stand-alone interbody fusion device intended for spinal fusion procedures at one level (C3-C7) in skeletally mature patients with degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies) of the cervical spine. Implants are to be implanted via an open, anterior approach and packed with autogenous bone. These patients may have had a previous non-fusion spinal surgery at the involved spinal level(s).
Patients must have undergone a regimen of at least six (6) weeks of non-operative treatment prior to being treated with these devices.
The implant is designed to accommodate two screws. Two screws should be used to ensure adequate fixation of the implant.
Prescription Use × (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Page 1 of _ 1_
Ronald P. Jean -S
(Division Sign-Off) Division of Orthopedic Devices 510(k) Number: K122771
§ 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.