(125 days)
When used as a cervical intervertebral fusion device, the Coveris Cage is indicated for use at one level in the cervical spine, from C3-C7, 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 and with supplemental fixation systems (such as anterior cervical plating systems, or posterior systems) cleared for use in the cervical spine.
The Camber Spine Coveris 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. 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 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.
Here's an analysis of the acceptance criteria and study information for the Camber Spine Coveris Cage (K133529) based on the provided text:
Acceptance Criteria and Device Performance (Non-Clinical Study)
The provided document describes physical and mechanical tests demonstrating the device's substantial equivalence to predicate devices. It states that "The results of these studies showed that the Coveris Cage met the acceptance criteria." However, the exact numerical acceptance criteria for each test are not specified in the provided text. The table below lists the tests performed and the general statement about meeting acceptance criteria.
| Test Performed | Acceptance Criteria (Not Specified) | Reported Device Performance |
|---|---|---|
| Static and Dynamic Compression Test | Not specified | Met the acceptance criteria |
| Static and Dynamic Compression Shear | Not specified | Met the acceptance criteria |
| Static and Dynamic Torsional | Not specified | Met the acceptance criteria |
| Subsidence Test per ASTM F2267 | Not specified | Met the acceptance criteria |
| Wear Debris ASTM F2077 and ASTM F1877 | Not specified | Met the acceptance criteria |
| Static Expulsion Test | Not specified | Met the acceptance criteria |
Study Details:
-
Sample size used for the test set and the data provenance:
- The document describes non-clinical (mechanical) testing, not a study involving human or animal subjects that would typically have a "test set" and "data provenance" in the traditional sense of a clinical or AI study.
- The tests were performed on the Camber Spine Coveris Cage device itself to evaluate its mechanical properties and compare them to predicate devices. The sample size for these mechanical tests (e.g., number of cages subjected to each test) is not specified.
- Data provenance (country of origin, retrospective/prospective) is not applicable as this was a device's physical characteristic testing, not patient data.
-
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- This is not applicable as the study involved mechanical testing of a medical device, not a diagnostic or AI-driven assessment requiring expert-established ground truth. The "ground truth" for these tests would be the physical and mechanical properties measured and compared against established ASTM standards and predicate device performance.
-
Adjudication method for the test set:
- This is not applicable given the nature of the mechanical testing performed.
-
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:
- No, an MRMC comparative effectiveness study was not performed, nor is it relevant for this type of device (intervertebral body fusion cage). This device is a physical implant, not an AI diagnostic tool.
-
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- No, this is not applicable as the device is not an algorithm or AI system.
-
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- The "ground truth" here is the established performance standards for intervertebral body fusion devices, as defined by ASTM international standards (e.g., ASTM F2077, ASTM F2267, ASTM F1877) and the performance characteristics of legally marketed predicate devices. The device's performance was measured against these mechanical and material benchmarks.
-
The sample size for the training set:
- This is not applicable. There was no "training set" as this was not an AI or machine learning study.
-
How the ground truth for the training set was established:
- This is not applicable as there was no training set. The "ground truth" for assessing device performance was based on recognized engineering standards and comparison to predicate devices, as elaborated in point 6.
{0}------------------------------------------------
MAR 2 0 2014
Page 1 of 3
Traditional 510(k) Summary
as required by section 807.92(c).
Camber Spine Technologies Coveris Cage K 133529
| Revised | March 20, 2014 |
|---|---|
| Submitter: | Camber Spine Technologies90 S. Newtown Street Rd., Suite #10Newtown Square, PA 19073 |
| Contact Person | Dan PontecorvoPresidentPhone: 484-420-4219Fax: (484) 318-8031Email: delvalsyn@comcast.net |
| Trade Name | Camber Spine Coveris Cage |
| Common Name | Intervertebral Body Fusion Device |
| Device Class | Class II |
| Classification Nameand Number | Intervertebral fusion device with bone graft, cervical21 CFR 888.3080 |
| Classification Panel: | Orthopedic |
| Product Code | ODP |
| Reason for 510k | New Device |
| Predicate Devices | Corelink Foundation Cage (K 073440), Nexxt Honour Spacer(K120345) & Spinal Elements Crystal (K073351) |
| Device Description | The Camber Spine Coveris Cage series of intervertebral body fusiondevices are used to maintain disc space distraction in skeletallymature adults requiring intervertebral body fusion. They aredesigned to be used in conjunction with supplemental spinal fixationinstrumentation. |
| The series is comprised of cages of various fixed heights and shapesfor placement in the cervical spine. Each cage has a hollow center toallow placement of graft material inside of the cage. Ridges on thesuperior and inferior surfaces of the device help to grip the endplatesand prevent expulsion.The Coveris Cage of intervertebral body fusion devices are madefrom the PEEK radiolucent material with embedded tantalum x-raymarkers as specified in ASTM F2026 and ASTM F560, respectively. | |
| Implants | The Implant will be shipped non-sterile and will be autoclaveable,validation testing of the process was conducted (using the half-cyclemethod) to a Sterility Assurance Level (SAL) of 10-6 per ISO 17665. |
l
{1}------------------------------------------------
| Intended Use | When used as a cervical intervertebral fusion device, the CoverisCage is indicated for use at one level in the cervical spine, from C3-C7, 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 neckpain of discogenic origin with degeneration of the disc confirmed byhistory and radiographic studies. The device is intended for use withautogenous bone graft and with supplemental fixation systems (suchas anterior cervical plating systems, or posterior systems) cleared foruse in the cervical spine. |
|---|---|
| -------------- | --------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------- |
| Materials: | The implant is manufactured from ASTM2026 Solvay ZenivaZA-500 implant grade Polyetheretherketone (PEEK) |
|---|---|
| ------------ | ------------------------------------------------------------------------------------------------------------- |
{2}------------------------------------------------
K133529
T
T
| Statement ofTechnologicalComparison | Camber Spine Coveris Cage and its predicate devices have the sameindications for use, similar design, and test results. Both devices aremanufactured using materials with a long history of use in orthopaedicimplants. |
|---|---|
| --------------------------------------------- | ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------- |
| Nonclinical TestSummary | The following tests were performed to demonstrate that the Camber Spine CoverisCage is substantially equivalent to other predicate devices.Static and Dynamic Compression Test per ASTM F2077 Static and Dynamic Compression Shear ASTM F2077 Static and Dynamic Torsional ASTM F2077 Subsidence Test per ASTM F2267 Wear Debris ASTM F2077 and ASTM F1877 Static Expulsion Test The results of these studies showed that the Coveris Cage met the acceptance criteria. |
|---|---|
| Clinical TestSummary | No clinical tests were performed. |
| Conclusion | |
|---|---|
| The Camber Spine Coveris Cage is substantially equivalent to its predicate devices. This conclusion is based upon the fact the Coveris Cage and its predicate devices have the same indications for use, have a similar design and technical characteristics, similar test results, and any differences do not raise question of safety and effectiveness. |
{3}------------------------------------------------
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized depiction of an eagle or bird-like figure with outstretched wings. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the bird-like figure. The logo is black and white.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
March 20, 2014
Camber Spine Technologies Mr. Daniel Pontecorvo President & CEO 90 South Newtown Street Road, Suite 10 Newtown Square, Pennsylvania 19073
Re: K133529
Trade/Device Name: Coveris Cage Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral Body Fusion Device Regulatory Class: Class II Product Code: ODP Dated: February 10, 2014 Received: February 18, 2014
Dear Mr. Pontecorvo:
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
{4}------------------------------------------------
Page 2 - Mr. Daniel Pontecorvo
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 Small Manufacturers, International and Consumer Assistance at its tollfree number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.lda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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 yours.
Lori A. Wiqqins
for
Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
{5}------------------------------------------------
Indications for Use
510(k) Number: K133529
Device Name: Coveris Cage
Indications for Use:
When used as a cervical intervertebral fusion device, the Coveris devices are indicated for use at one level in the cervical spine, from C3-C7, 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 and with supplemental fixation (such as anterior cervical plating systems, or posterior systems) systems cleared for use in the cervical spine.
AND/OR Over-the-counter _____________________________________________________________________________________________________________________________________________________________ Prescription Use X (Part 21 CFR 801 Subpart D) (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE) Anton E. Dmitriev, PhD
Division of Orthopedic Devices
§ 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.