(139 days)
Not Found
No
The provided text describes a standard cervical intervertebral fusion device made of PEEK with tantalum markers. There is no mention of AI, ML, image processing, or any data-driven analytical capabilities. The performance studies mentioned are mechanical testing and literature review, not AI/ML model validation.
Yes
The device is an intervertebral body fusion device used to treat degenerative disc disease and is implanted to maintain disc space distraction and facilitate fusion, which constitutes a therapeutic intervention.
No
The device is an intervertebral body fusion device used to maintain disc space distraction in skeletally mature adults requiring intervertebral body fusion. Its purpose is structural support and fusion promotion, not to diagnose a condition.
No
The device description clearly states it is a physical implant (cage) made of PEEK material with tantalum markers, intended for surgical implantation in the cervical spine. This is a hardware device, not software.
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 used for spinal fusion. It is a physical device implanted into the body to provide structural support and facilitate bone growth.
- Device Description: The description details the materials and design of a surgical cage, not a test or reagent used to examine samples outside the body.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting biomarkers, or providing diagnostic information based on laboratory testing.
IVD devices are used to examine specimens from the human body to provide information for diagnosis, monitoring, or screening. This device is a therapeutic implant used in a surgical procedure.
N/A
Intended Use / Indications for Use
When used as a cervical intervertebral fusion devices are indicated for use at one or two contiguous levels in the cervical spine, from C2-T1, in skeletally mature patients who have had six weeks of non-operative treatment for the treatment of degenerative disc disease (DDD) with up to Grade 1 spondylolisthesis. DDD is defined as neck pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. The device is intended for use with autogenous bone graft or allogenic bone graft composed of cancellous and/or corticocancellous bone graft and with supplemental fixation (such as anterior cervical plating systems) systems) systems cleared for use in the cervical spine.
Product codes (comma separated list FDA assigned to the subject device)
ODP
Device Description
The Camber Spine Coveris Cervical Cage series of intervertebral body fusion devices are used to maintain disc space distraction in skeletally mature adults requiring intervertebral body fusion. They are designed to be used in conjunction with supplemental spinal fixation instrumentation. The series is comprised of cages of various fixed heights and shapes for placement in the cervical spine. There are different cages designed for specific regions of the spine and approaches to the spine. Each cage has a hollow center to allow placement of graft material inside of the cage. Ridges on the superior and inferior surfaces of the device help to grip the endplates and prevent expulsion.
The Coveris Cervical Cage of intervertebral body fusion devices are made from the PEEK radiolucent material with embedded tantalum x-ray markers as specified in ASTM F2026 and ASTM F560, respectively.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Radiographic studies
Anatomical Site
cervical spine, from C2-T1
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)
Comprehensive, clinical literature review data have been provided to investigate the risks and benefits associated with using allogenic bone graft with the Coveris Cervical Cage System and use at two contiguous levels. Static compression and static torsion testing were performed per ASTM F2077.
The clinical literature suggests that there is a positive benefit associated with allograft and use at two contiguous levels with minimal risk.
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.
Not Found
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
DEPARTMENT OF HEALTH & HUMAN SERVICES
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
Camber Spine Technologies % Margeaux Rogers Senior Associate, Regulatory Affairs MCRA, LLC 1050 K Street NW, Suite 1000 Washington, District of Columbia 20001 July 13, 2017
Re: K170550
Trade/Device Name: Coveris Cervical Cage System Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral body fusion device Regulatory Class: Class II Product Code: ODP Dated: June 22, 2017 Received: June 23, 2017
Dear Ms. Rogers:
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
Image /page/0/Picture/11 description: The image shows the logo for the Department of Health & Human Services - USA. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized graphic of three human profiles facing to the right, stacked on top of each other.
1
Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical devicerelated 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.
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/ResourcesforYou/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.
Mark N. Melkerson -S
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)
Device Name Coveris Cervical Cage System
Indications for Use (Describe)
When used as a cervical intervertebral fusion devices are indicated for use at one or two contiguous levels in the cervical spine, from C2-T1, in skeletally mature patients who have had six weeks of non-operative treatment for the treatment of degenerative disc disease (DDD) with up to Grade 1 spondylolisthesis. DDD is defined as neck pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. The device is intended for use with autogenous bone graft or allogenic bone graft composed of cancellous and/or corticocancellous bone graft and with supplemental fixation (such as anterior cervical plating systems) systems) systems cleared for use in the cervical spine.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| ☑ Prescription Use (Part 21 CER 801 Subpart D) | □ Over-The-Counter Use (21 CER 801 Subpart C) |
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510(k) Summary
| Device Trade Name: | Coveris Cervical Cage System |
|---|---|
| Manufacturer: | Camber Spine Technologies |
| 418 E. Lancaster Ave. | |
| Wayne, PA 19087 | |
| Contact: | Mr. Joseph Nyahay |
| Product Development Engineer | |
| Camber Spine Technologies | |
| 418 E. Lancaster Ave. | |
| Wayne, PA 19087 | |
| Prepared by: | Ms. Margeaux Rogers |
| Musculoskeletal Clinical Regulatory Advisers, LLC | |
| 1050 K Street NW, Suite 1000 | |
| Washington, DC 20001 | |
| Phone: (202) 552-5800 | |
| mrogers@mcra.com | |
| Date Prepared: | February 23, 2017 |
| Classification: | 21 CFR §888.3080, Intervertebral body fusion device |
| Class: | II |
| Product Codes: | ODP |
Indications For Use:
When used as a cervical intervertebral fusion device, the Coveris devices are indicated for use at one or two contiguous levels in the cervical spine, from C2-T1, in skeletally mature patients who have had six weeks of non-operative treatment for the treatment of degenerative disc disease (DDD) with up to Grade 1 spondylolisthesis. DDD is defined as neck pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. The device is intended for use with autogenous bone graft or allogenic bone graft composed of cancellous and/or corticocancellous bone graft and with supplemental fixation (such as anterior cervical plating systems, or posterior systems) systems cleared for use in the cervical spine.
4
Device Description:
The Camber Spine Coveris Cervical Cage series of intervertebral body fusion devices are used to maintain disc space distraction in skeletally mature adults requiring intervertebral body fusion. They are designed to be used in conjunction with supplemental spinal fixation instrumentation. The series is comprised of cages of various fixed heights and shapes for placement in the cervical spine. There are different cages designed for specific regions of the spine and approaches to the spine. Each cage has a hollow center to allow placement of graft material inside of the cage. Ridges on the superior and inferior surfaces of the device help to grip the endplates and prevent expulsion.
The Coveris Cervical Cage of intervertebral body fusion devices are made from the PEEK radiolucent material with embedded tantalum x-ray markers as specified in ASTM F2026 and ASTM F560, respectively.
Predicate Device:
The primary predicate is the Coveris Cervical Cage System (K133529). The Medtronic Anatomic PEEK PTC Cervical Fusion System (K160528) is an additional predicate. The subject Coveris Cervical Cage System is substantially equivalent to the previously cleared Coveris Cervical Cage System (K133529) with respect to design, function and materials and predicate Medtronic Anatomic PEEK PTC Cervical Fusion System (K160528) with respect to indications, design, function, and materials.
Substantial Equivalence:
The Coveris Cervical Cage System and predicate Medtronic Anatomic PEEK PTC Cervical Fusion System (K160528) are similar in design, material, and indicated use, and are both cleared devices. They do differ in that the Medtronic Anatomic PEEK PTC Cervical Fusion System is indicated for use with allogenic bone graft at one or two contiguous levels. A comprehensive, clinical literature review has been conducted to investigate the risks and benefits associated with using allogenic bone graft with the Coveris Cervical Cage System and mutli-level use. The clinical literature suggests that there is a positive benefit associated with allograft and use at two contiguous levels with minimal risk.
Nonclinical Performance Testing:
Comprehensive, clinical literature review data have been provided to investigate the risks and benefits associated with using allogenic bone graft with the Coveris Cervical Cage System and use at two contiguous levels. Static compression and static torsion testing were performed per ASTM F2077.
Conclusion:
The Coveris Cervical Cage System has been modified to expand the indications to permit use with allograft and use at two contiguous levels, C2-T1. The 510(k) demonstrates substantial equivalence to predicate devices.