(70 days)
No
The summary describes a mechanical interbody fusion device and its performance testing, with no mention of AI or ML capabilities.
Yes
The device is an intervertebral body fusion device used to treat degenerative disc disease and facilitate fusion, which directly addresses a medical condition.
No
The device description indicates that the Ti-Diagon Oblique TLIF is an interbody fusion device designed to facilitate spinal fusion, not to diagnose medical conditions. Its function is to be implanted, not to analyze or interpret data for diagnostic purposes.
No
The device description clearly states it is an "interbody fusion device" with a "hollow chamber" and "inferior and superior surfaces" with a "rough texture," indicating it is a physical implant, not software.
Based on the provided information, the Camber Spine Technologies Ti-Diagon® Oblique TLIF is not an IVD (In Vitro Diagnostic) device.
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens taken from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening.
- Device Function: The Ti-Diagon® Oblique TLIF is an implantable medical device designed to facilitate spinal fusion by providing structural support and a space for bone graft. It is surgically implanted into the patient's body.
- Intended Use: The intended use is for intervertebral body fusion procedures in patients with degenerative disc disease. This is a surgical treatment, not a diagnostic test performed on a specimen.
- No Specimen Analysis: The device description and intended use do not involve the analysis of any biological specimens from the patient.
Therefore, the Camber Spine Technologies Ti-Diagon® Oblique TLIF falls under the category of an implantable surgical device, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The Camber Spine Technologies Ti-Diagon® Oblique TLIF 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 radios. These DDD patients may also have up to Grade I spondylolisthesis at the involved level(s). Camber Spine Technologies Ti-Diagon® Oblique TLIF is to be used with autologous bone graft and implanted via an open transforaminal or posterior approach. Camber Spine Technologies Ti-Diagon Oblique TLIF 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.
Product codes
MAX
Device Description
The Camber Spine Technologies Ti-Diagon Oblique TLIF is an interbody fusion device with a hollow chamber to permit packing of autologous bone graft in order to facilitate fusion. The inferior and superior surfaces of the Ti-Diagon Oblique TLIF have a rough texture, as the result of a photochemical etching process, to help prevent movement of the device.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
radios
Anatomical Site
lumbar spine at one or two contiguous levels from L2-S1
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)
Testing performed indicates that the Ti-Diagon Oblique TLIF is as mechanically sound as predicate devices. Testing included static compression shear, dynamic compression, dynamic compression sheat, expulsion, and subsidence per ASTM F2077-14 and F2267-04. The results demonstrate that the acceptance criteria defined by predicate device performance were met.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Predetermined Change Control Plan (PCCP) - All Relevant Information
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
September 15, 2017
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
Camber Spine Technologies % Mr. Justin Eggleton Senior Director, Spine Regulatory Affairs
Re: K172064
MCRA, LLC
1050 K Street NW, Suite 1000
Washington, District of Columbia 20001
Trade/Device Name: Ti-Diagon Oblique TLIF Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral Body Fusion Device Regulatory Class: Class II Product Code: MAX Dated: July 5, 2017 Received: July 7, 2017
Dear Mr. Eggleton:
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
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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 (DICE) 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 (DICE) 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.
Katherine D. Kavlock -S
for
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) K172064
Device Name Ti-Diagon Oblique TLIF
Indications for Use (Describe)
The Camber Spine Technologies Ti-Diagon® Oblique TLIF 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 radios. These DDD patients may also have up to Grade I spondylolisthesis at the involved level(s). Camber Spine Technologies Ti-Diagon® Oblique TLIF is to be used with autologous bone graft and implanted via an open transforaminal or posterior approach.
Camber Spine Technologies Ti-Diagon® Oblique TLIF implants are to be used with supplemental fixation. Patients should have at least six (6) months of non-operative 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)
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FOR FDA USE ONLY
Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)
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510(k) Summary
| Device Trade Name: | Ti-Diagon Oblique TLIF | |
|---|---|---|
| Manufacturer: | Camber Spine Technologies | |
| 418 E. Lancaster Ave. | ||
| Wayne, PA 19087 | ||
| Contact: | Mr. Daniel A. Pontecorvo | |
| CEO | ||
| Phone: 484.427.7060 | ||
| Prepared by: | Justin Eggleton | |
| Musculoskeletal Clinical Regulatory Advisers, LLC | ||
| 1050 K Street NW, Suite 1000 | ||
| Washington, DC 20001 | ||
| Phone: 202.552.5800 | ||
| jeggleton@mcra.com | ||
| Date Prepared: | September 7, 2017 | |
| Classifications: | 21 CFR §888.3080, Intervertebral body fusion device | |
| Class: | II | |
| Product Codes: | MAX | |
| Primary Predicate: | Camber Spine Technologies TLS 5.0 Interbody Cage | |
| (K121254) | ||
| Additional Predicate(s): | Camber Spine Technologies Diagon Oblique Cage (K134038), and | |
| Aurora Spine Interbody Fusion System (K133967) | ||
| Reference Device: | Rhausler Plage™ Anterior Cervical Fusion System (K111272) |
Indications For Use:
The Camber Spine Technologies Ti-Diagon Oblique TLIF 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 Ti-Diagon Oblique TLIF is to be used with autologous bone graft and implanted via an open transforaminal or posterior approach. Camber Spine Technologies Ti
4
Diagon Oblique TLIF 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.
Device Description:
The Camber Spine Technologies Ti-Diagon Oblique TLIF is an interbody fusion device with a hollow chamber to permit packing of autologous bone graft in order to facilitate fusion. The inferior and superior surfaces of the Ti-Diagon Oblique TLIF have a rough texture, as the result of a photochemical etching process, to help prevent movement of the device.
Predicate Device:
The subject Ti-Diagon Oblique TLIF device is substantially equivalent to predicates Camber Spine Technologies TLS 5.0 Interbody Cage (K121254), Camber Spine Technologies Diagon Oblique Cage (K134038), and Aurora Spine Interbody Fusion System (K133967) with respect to indications, design, materials, function, manufacturing, and/or performance. Additional comparisons were made to the reference device Rhausler Plage™ Anterior Cervical Fusion System (K111272).
Performance Testing Summary:
Testing performed indicates that the Ti-Diagon Oblique TLIF is as mechanically sound as predicate devices. Testing included static compression shear, dynamic compression, dynamic compression sheat, expulsion, and subsidence per ASTM F2077-14 and F2267-04. The results demonstrate that the acceptance criteria defined by predicate device performance were met.
Substantial Equivalence:
The subject Ti-Diagon Oblique TLIF device was demonstrated to be substantially equivalent to predicates Camber Spine Technologies TLS 5.0 Interbody Cage (K121254), Camber Spine Technologies Diagon Oblique Cage (K134038), and Aurora Spine Interbody Fusion System (K133967) with respect to indications, design, materials, function, manufacturing, and/or performance. Additional comparisons were made to the reference device Rhausler Plage™ Anterior Cervical Fusion System (K111272).
Conclusion:
Camber Spine Technologies provided sufficient information to demonstrate the Ti-Diagon Oblique TLIF is substantially equivalent to predicates Camber Spine Technologies TLS 5.0 Interbody Cage (K121254). Camber Spine Technologies Diagon Oblique Cage (K134038). and Aurora Spine Interbody Fusion System (K133967) with respect to indications, design, materials, function, manufacturing, and/or performance. Additional comparisons were made to the reference device Rhausler Plage™ Anterior Cervical Fusion System (K111272).