(261 days)
The Camber Spine Technologies TLS 5.0 Interbody 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 TLS 5.0 Interbody Cage is to be used with autologous bone graft and implanted via an open transforaminal or posterior approach.
Camber Spine Technologies TLS 5.0 Interbody 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, TLS 5.0 Interbody 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, TLS 5.0 Interbody 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, TLS 5.0 Interbody Cage to be placed through a transforaminal or posterior approach and to address vertebrae in the lumbosacral region of the spine.
The provided text describes the Camber Spine Technologies TLS 5.0 Interbody Cage, a medical device, and its regulatory submission. It does not describe an AI or algorithm-based device. Therefore, many of the requested details, such as sample size for test sets, data provenance, number of experts for ground truth, adjudication methods, MRMC studies, standalone performance, and training set information, are not applicable or cannot be extracted.
However, the document does contain information regarding acceptance criteria and the studies performed to demonstrate equivalence.
Here's an analysis based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Test) | Reported Device Performance (Result) |
|---|---|
| Static and Dynamic Compression Test (per ASTM F2077) | Met the acceptance criteria. |
| Static and Dynamic Compression Shear Test (per ASTM F2077) | Met the acceptance criteria. |
| Subsidence Test (per ASTM F2267) | Met the acceptance criteria. |
| Wear Debris Test (per ASTM F2077 and ASTM F1877) | Met the acceptance criteria. |
| Static Expulsion Test | Met the acceptance criteria. |
| Sterility Assurance Level (SAL) of 10-6 (for implants, instruments, and cases) per ISO 17665 (using half-cycle method) | Validation testing confirmed SAL of 10-6. |
2. Sample Size for Test Set and Data Provenance
- Not Applicable. This document describes the non-clinical testing of a physical medical device (interbody cage) for mechanical and material properties, not an AI or algorithm. The "test set" for this context would refer to the physical units of the device subjected to the aforementioned tests. The document does not specify the number of units tested for each non-clinical test.
- Data Provenance: Not applicable in the context of AI/algorithm data provenance (country of origin, retrospective/prospective clinical data). The data provenience refers to the results of engineering and material science tests.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
- Not Applicable. This is a physical device, and the ground truth for its performance is established through standardized ASTM tests and ISO sterilization validation, which have objective physical outcomes (e.g., force at failure, wear rates, sterilization efficacy). This does not involve expert interpretation or consensus as would be required for labeling medical images for AI.
4. Adjudication Method for the Test Set
- Not Applicable. As per point 3, the "test set" for this device's evaluation involved objective, standardized engineering tests, not subjective interpretations requiring adjudication.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
- No. The document explicitly states: "No clinical tests were performed." Therefore, no MRMC study was conducted. Details about human reader improvement with AI assistance are not relevant here.
6. Standalone (Algorithm Only) Performance Study
- No. This is a physical interbody cage, not an algorithm or AI device. Therefore, a standalone algorithm performance study is not applicable.
7. Type of Ground Truth Used
- For the non-clinical tests (mechanical properties, wear, expulsion) and sterilization validation: Objective physical measurements and engineering standards (ASTM and ISO).
- For the overall substantial equivalence: The "ground truth" used for regulatory submission is the performance and indications for use of legally marketed predicate devices. The device's performance against the acceptance criteria (derived from standards and predicate device performance) serves as the basis for demonstrating substantial equivalence.
8. Sample Size for the Training Set
- Not Applicable. This is a physical device, not an AI/ML algorithm. There is no "training set" in this context. The "design process" for such a device would involve engineering design, material selection, and manufacturing process development, not machine learning training.
9. How the Ground Truth for the Training Set Was Established
- Not Applicable. As per point 8, there is no training set mentioned or implied for this device.
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Image /page/0/Picture/1 description: The image shows the logo for Camber Spine Technologies. The logo consists of a stylized letter "C" in a square on the left, followed by the words "Camber Spine Technologies" on the right. The words "Camber" and "Spine" are stacked on top of each other, with "Technologies" below.
l
JAN 1 1 2013
510(k) Summary
as required by section 807.92(c).
TLS 5.0 Interbody Cage
K121254
Camber Spine Technologies
401 Yankee Court
Newtown Square, PA 19073
Daniel A Pontecorvo
President
Phone: (484) 420-4671
Fax: 484 420-4928 ·
Email: delvalsyn@comcast.net
Submitted 1/7/13
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·
. .
| Submitter: | Camber Spine Technology401 Yankee CourtNewtown Square, PA 19073 |
|---|---|
| Contact Person | Daniel A PontecorvoPresidentPhone: (484) 420-4671Email: delvalsyn@comcast.net |
| Trade Name | Camber Spine Technologies TLS 5.0 Interbody Cage |
|---|---|
| Common Name | TLS 5.0 Interbody Cage |
| Device Class | Class II |
| Classification Nameand Number | Intervertebral Fusion Device With Bone Graft, Lumbar21 CFR 888.3080 |
| Classification Panel: | Orthopedic |
| Product Code | MAX |
| Reason for 510k | New Device |
| Predicate Devices | Corelink Foundation Cage (K 073440), Stryker AVS PL (K093704) &K2M Aleutian (K113138) |
| Device Description | Camber Spine Technologies, TLS 5.0 Interbody Cage is a device forinterbody fusion of the anterior column of the spine. These cages arehollow so that bone can grow through the device, fusing the adjacentbony surfaces.Camber Spine Technologies, TLS 5.0 Interbody Cage is a hollow devicewith texture on two opposing convex sides, and is offered in variouslengths, widths, heights and shapes. Camber Spine designed theCamber Spine Technologies, TLS 5.0 Interbody Cage to be placedthrough a transforaminal or posterior approach and to addressvertebrae in the lumbosacral region of the spine. |
2
,
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100 - 100 - 100
:
| The Camber Spine Technologies TLS 5.0 Interbody Cage is indicated for | |
|---|---|
| Intended Use | 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 TLS 5.0 | |
| Interbody Cage is to be used with autologous bone graft and implanted via | |
| an open transforaminal or posterior approach. | |
| Camber Spine Technologies TLS 5.0 Interbody 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. |
| Materials: | The implant is manufactured from ASTM2026 Solvay Zeniva |
|---|---|
| ZA-500 implant grade Polyetheretherketone (PEEK) |
| Statement of | Camber Spine Technologies TLS 5.0 Interbody Cage and its predicate devices have the same indications for use, similar design, and test results. |
|---|---|
| Technological | Both devices are manufactured using materials with a long history of use |
| Comparison | in orthopaedic implants. |
:
·
.
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| Nonclinical TestSummary | The following tests were performed to demonstrate that the Camber SpineTechnologies TLS 5.0 Interbody Cage is substantially equivalent to other predicatedevices.Static and Dynamic Compression Test per ASTM F2077 Static and Dynamic Compression Shear 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 Camber Spine Technologies TLS 5.0Interbody Cage met the acceptance criteria. |
|---|---|
| Clinical TestSummary | No clinical tests were performed. |
·
| Sterilization Information | |
|---|---|
| Implants | The Implant will be shipped non-sterile and will be autoclaveable, validation testing ofthe process was conducted (using the half-cycle method) to a Sterility Assurance Level(SAL) of 10-6 per ISO 17665. |
| Instruments andCase | The instrument and case will be shipped non-sterile and will be autoclaveable,validation testing of the process was conducted (using the half-cycle method) to aSterility Assurance Level (SAL) of 10-6 per ISO 17665. |
| Conclusion | The TLS 5.0 Interbody Cage is substantially equivalent to its predicate devices. This |
|---|---|
| conclusion is based upon the fact the Lumbar Cage and its predicate devices have the | |
| same indications for use, have a similar design, and similar test results. |
4
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Image /page/4/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with its wings spread, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle. The logo is black and white.
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 11, 2013
Camber Spine Technologies % Mr. Daniel A. Pontecorvo President 401 Yankee Court Newtown Square, Pennsylvania 19073
Re: K121254
Trade/Device Name: Camber Spine Technologies TLS 5.0 Interbody Cage Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral body fusion device Regulatory Class: Class II Product Code: MAX Dated: November 26, 2012 Received: November 28, 2012
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
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Page 2 - Mr. Daniel A. 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 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/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.
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
Device Name:
510(k) Number:
Camber Spine Technologies TLS 5.0 Interbody Cage
Indications:
The Camber Spine Technologies TLS 5.0 Interbody 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 TLS 5.0 Interbody Cage is to be used with autologous bone graft and implanted via an open transforaminal or posterior approach.
Camber Spine Technologies TLS 5.0 Interbody 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.
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)
AND NO
(Division Sign-Off) Division of Orthopedic Devices 510(k) Number: K121254
§ 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.