(79 days)
The Camber Spine Technologies Diagon Oblique Cage is indicated for intervertebral body fusion procedures in skeletally mature patients with degenerative disc disease (DDD) of the lumbar spine at one or two contiguous levels from L2-S1. DDD is defined as discogenic pain with degeneration of the disc confirmed by history and radiographic studies. These DDD patients may also have up to Grade I spondylolisthesis or retrolisthesis at the involved level(s). Camber Spine Technologies Diagon Oblique Cage is to be used with autologous bone graft and implanted via an open transforaminal or posterior approach.
Camber Spine Technologies Diagon Oblique Cage implants are to be used with supplemental fixation. Patients should have at least six (6) months of non-operative treatment prior to treatment with an intervertebral cage.
Camber Spine Technologies, Diagon Oblique Cage is a device for interbody fusion of the anterior column of the spine. These cages are hollow so that bone can grow through the device, fusing the adjacent bony surfaces.
Camber Spine Technologies, Diagon Oblique Cage is a hollow device with texture on two opposing convex sides, and is offered in various lengths, widths, heights and shapes. Camber Spine designed the Camber Spine Technologies, Diagon Oblique Cage to be placed through a transforaminal or posterior approach and to address vertebrae in the lumbosacral region of the spine.
The Camber Spine Technologies, Diagon Oblique Cage is made from Implant grade (PEEK) per ASTM2026 (Solvay Zeniva ZA-500) which is a radiolucent material with embedded tantalum x-ray markers as specified in ASTM F560.
Here's an analysis of the provided text regarding the acceptance criteria and study for the Camber Spine Technologies Diagon Oblique Cage:
It's important to note that the provided document is a 510(k) summary for a medical device (an intervertebral fusion cage), not an AI/software device. Therefore, many of the requested categories related to AI performance, ground truth, and expert evaluation are not applicable. I will address the applicable sections and indicate where information is not present due to the nature of the device.
Acceptance Criteria and Device Performance Study for Camber Spine Technologies Diagon Oblique Cage
This document describes the non-clinical testing performed to demonstrate that the Camber Spine Technologies Diagon Oblique Cage is substantially equivalent to its predicate devices. The studies focus on mechanical properties relevant to an intervertebral fusion device.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Test Performed) | Reported Device Performance (Met Criteria?) |
|---|---|
| Static Compression Test per ASTM F2077 | Met the acceptance criteria |
| Static Compression Shear Test per ASTM F2077 | Met the acceptance criteria |
| Subsidence Test per ASTM F2267 | Met the acceptance criteria |
| Static Expulsion Test | Met the acceptance criteria |
2. Sample Size Used for the Test Set and Data Provenance
The document does not specify the exact sample sizes (N) for each of the non-clinical tests conducted (Static Compression, Static Compression Shear, Subsidence, Static Expulsion).
Data provenance is not applicable in the context of these non-clinical, in-vitro mechanical tests. These tests are conducted in a laboratory setting on manufactured devices.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This information is not applicable. The "ground truth" for mechanical performance tests of a physical device is determined by the results of the standardized tests themselves, measured against predefined engineering specifications and ASTM standards, not by human expert interpretation in the way AI ground truth is established.
4. Adjudication Method for the Test Set
This is not applicable to non-clinical mechanical testing. Test results are compared directly against established ASTM standards and internal specifications.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size
No, an MRMC comparative effectiveness study was not done. This type of study is relevant for evaluating the performance of diagnostic imaging or AI algorithms where human interpretation is involved. The device in question is a physical implant.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
This is not applicable. The device is a physical intervertebral cage, not an algorithm or AI system.
7. The Type of Ground Truth Used
The "ground truth" for the non-clinical tests is established by engineering specifications and standardized test methods (ASTM standards F2077, F2267). The device's performance is objectively measured against the criteria outlined in these standards and internal design requirements.
8. The Sample Size for the Training Set
This is not applicable. There is no concept of a "training set" for the type of non-clinical mechanical testing described for this physical medical device. Manufacturing processes are validated, but this is distinct from training an AI model.
9. How the Ground Truth for the Training Set Was Established
This is not applicable, as there is no training set for this type of device and testing.
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Special 510(k) Summary
mar 2 0 2014
as required by section 807.92(c).
Camber Spine Technologies Diagon Oblique Cage K 134038
| Revised | March 20, 2014 |
|---|---|
| Submitter: | Camber Spine Technologies |
| 90 S. Newtown Street Rd., Suite #10 | |
| Newtown Square, PA 19073 | |
| Contact Person | Dan Pontecorvo |
| President | |
| Phone: 484-420-4219 | |
| Fax: (484) 318-8031 | |
| Email: delvalsyn@comcast.net | |
| Trade Name | Diagon Oblique Cage |
| Common Name | Oblique Cage |
| Device Class | Class II |
| Classification Name | Intervertebral Fusion Device With Bone Graft, Lumbar |
| and Number | 21 CFR 888.3080 |
| Classification Panel: | Orthopedic |
| Product Code | MAX |
| Predicate Devices | Camber Spine Technologies TLS 5.0 Interbody Cage (K121254) |
| Device Description | Camber Spine Technologies, Diagon Oblique Cage is a device |
| for interbody fusion of the anterior column of the spine. These | |
| cages are hollow so that bone can grow through the device, | |
| fusing the adjacent bony surfaces. | |
| Camber Spine Technologies, Diagon Oblique Cage is a hollow | |
| device with texture on two opposing convex sides, and is | |
| offered in various lengths, widths, heights and shapes. Camber | |
| Spine designed the Camber Spine Technologies, Diagon | |
| Oblique Cage to be placed through a transforaminal or | |
| posterior approach and to address vertebrae in the | |
| lumbosacral region of the spine. | |
| The Camber Spine Technologies, Diagon Oblique Cage is made | |
| from Implant grade (PEEK) per ASTM2026 (Solvay Zeniva ZA- | |
| 500) which is a radiolucent material with embedded tantalum | |
| x-ray markers as specified in ASTM F560. | |
| Indications for Use | The Camber Spine Technologies Diagon Oblique Cage is |
| indicated for intervertebral body fusion procedures in | |
| skeletally mature patients with degenerative disc disease | |
| (DDD) of the lumbar spine at one or two contiguous levels from | |
| L2-S1. DDD is defined as discogenic pain with degeneration of | |
| the disc confirmed by history and radiographic studies. These | |
| DDD patients may also have up to Grade I spondylolisthesis or | |
| retrolisthesis at the involved level(s). Camber Spine | |
| Technologies Diagon Oblique Cage is to be used with | |
| autologous bone graft and implanted via an open | |
| transforaminal or posterior approach. | |
| Camber Spine Technologies Diagon Oblique Cage implants are | |
| to be used with supplemental fixation. Patients should have at | |
| least six (6) months of non-operative treatment prior to | |
| treatment with an intervertebral cage. |
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| Statement ofTechnologicalComparison andFundamental ScientificTechnology | Camber Spine Diagon Oblique Cage and its predicate devicehave the same indications for use, similar design, samematerials, technology principles of operation and testresults. |
|---|---|
| ----------------------------------------------------------------------------------------- | -------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------- |
.
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.
.
| Nonclinical TestSummary | The following tests were performed to demonstrate that theCamber Spine Technologies Diagon Oblique Cage issubstantially equivalent to other predicate devices.Static Compression Test per ASTM F2077 Static Compression Shear ASTM F2077 Subsidence Test per ASTM F2267 Static Expulsion Test The results of these studies showed that the Camber SpineTechnologies Diagon Oblique Cage met the acceptance criteria. |
|---|---|
| Clinical Test Summary | n/a |
| Conclusion | Camber Spine Technologies Diagon Oblique Cage and its |
|---|---|
| predicate device have the same indications for use, similar | |
| design, and test results. Both devices are manufactured using | |
| materials with a long history of use in orthopaedic implants. |
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/3/Picture/1 description: The image contains the text 'Public Health Service' in a bold, sans-serif font. The text is arranged horizontally, with each word clearly legible. The overall appearance is clean and straightforward, suggesting a formal or official context.
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: K134038
Trade/Device Name: Camber Spine Technologies Diagon Oblique Cage Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral body fusion device Regulatory Class: Class II Product Code: MAX Dated: February 19, 2014 Received: February 21, 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.fda.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/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 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. Wigqins
- for Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
510(k) Number (if known) K134038
Device Name
Camber Spine Technologies Diagon Oblique Cage
Indications for Use (Describe)
The Camber Spine Technologies Diagon Oblique Cage is indicated for intervertebral body fusion procedures in skeletally mature patients with degenerative disc disease (DDD) of the lumbar spine at one or two contiguous levels from L2-S1. DDD is defined as discogenic pain with degeneration of the disc confirmed by history and radiographic studies. These DDD patients may also have up to Grade I spondylolisthesis at the involved level(s). Camber Spine Technologies Diagon Oblique Cage is to be used with autologous bone graft and implanted via an open transforminal or posterior approach.
Camber Spine Technologies Diagon Oblique Cage implants are to be used with supplemental fixation. Patients should have at least six (6) months of non-operative treatment prior to treatment with an intervertebral cage.
Type of Use (Select one or both, as applicable)
2 Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
·
PLEASE DO NOT WRITE BELOW THIS LINE -- CONTINUE ON A SEPARATE PAGE IF NEEDED.
FOR FDA USE ONLY
Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)
Anton E. Dmitriev, PhD
Division of Orthopedic Devices
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§ 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.