(88 days)
Not Found
No
The 510(k) summary describes a physical intervertebral body fusion cage and associated screws. There is no mention of software, algorithms, or any technology that would suggest the use of AI or ML. The performance studies are biomechanical and literature reviews, not related to AI/ML performance metrics.
Yes.
The device is indicated for use in patients with degenerative disc disease (DDD) at one or two contiguous levels from L2 to S1 to alleviate discogenic back pain and aid in spinal fusion.
No.
Explanation: This device is an intervertebral body fusion cage intended for treatment of degenerative disc disease, not for diagnosis.
No
The device description clearly states it is a physical intervertebral body fusion cage made from PEEK-OPTIMA® LT1 with titanium alloy screws and tantalum marker wires. It is a hardware implant.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body (like blood, urine, or tissue) to detect diseases, conditions, or infections.
- Device Description: The description clearly states that the STALIF devices are "radiolucent intervertebral body fusion cages with unicortical cancellous bone screws." These are implants designed to be surgically placed within the spine.
- Intended Use: The intended use is for "fusion in patients with degenerative disc disease (DDD) at one or two contiguous levels from L2 to S1." This is a surgical procedure involving the implantation of a device, not a diagnostic test performed on a sample outside the body.
The device is a surgical implant used for spinal fusion, not a diagnostic tool.
N/A
Intended Use / Indications for Use
The STALIF TT™, STALIF MIDLINE®, MIDLINE II™, and MIDLINE II-Ti™ is indicated for use with bone graft (autograft bone and/or allogenic bone graft composed of cancellous bone graft) in patients with degenerative disc disease (DDD) at one or two contiguous levels from L2 to S1. These DDD patients may also have up to Grade I Spondylolisthesis or retrolisthesis at the involved levels. DDD is defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies. These patients should be skeletally mature and have had six months of non-operative treatment. Patients with previous non-fusion spinal surgery at the treated level may be treated. These implants may be implanted via a laparoscopic or an open anterior approach.
The STALIF TT™, STALIF MIDLINE II™, and MIDLINE II-Ti™ is a stand-alone system intended to be used with the bone screws provided and requires no additional supplementary fixation systems.
The STALIF TT™, STALIF MIDLINE II™, and MIDLINE II-Ti™ system must be used with autograft and/or allogenic bone graft composed of cancellous and/or corticocancellous bone graft.
Product codes (comma separated list FDA assigned to the subject device)
OVD
Device Description
STALIF TTTTT, MIDLINE™/ MIDLINE II-Ti™ are radiolucent intervertebral body fusion cages with unicortical cancellous bone screws. It is intended to be used as an IBF cage without supplementary fixation. The cross section profile of the STALIF devices are similar to that of the vertebral body endplate with central cavity that can be packed with autograft or allograft. The STALIF devices are manufactured from PEEK-OPTIMA® LT1 with titanium alloy screws and X-ray marker wires manufactured from unalloyed Tantalum (ASTM F-560). The MIDLINE II-Ti™ is identical to this design with a titanium plasma spray coating on the device endplates.
The purpose of the subject 510(k) was to expand the indications to include use with allograft (i.e., allogenic bone graft composed of cancellous and/or corticocancellous bone graft).
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
L2 to S1
Indicated Patient Age Range
skeletally mature
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)
A comprehensive, clinical literature review and PearlDiver reimbursement were conducted to assess the safety and efficacy of allograft used in conjunction with this device in the lumbar spine. This review concluded that there were no additional risks due to the modified indications for this device. Biomechanical studies were performed to demonstrate equivalence to interbody cages with supplemental fixation. No new mechanical tests were performed since there were no design changes to the device.
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
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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
June 8, 2015
Centinel Spine, Incorporated % Mr. Justin Eggleton Director, Spine Regulatory Affairs Musculoskeletal Clinical Regulatory Advisors, LLC. 1331 H Street, Northwest 12th Floor Washington, District of Columbia 20005
Re: K150643
Trade/Device Name: Centinel Spine STALIF TT™, STALIF MIDLINE 9, MIDLINE II™ and MIDLINE II-TiTM Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral body fusion device Regulatory Class: Class II Product Code: OVD Dated: March 11, 2015 Received: March 12, 2015
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
1
Page 2 – Mr. Justin Eggleton
(21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) 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" (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 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 yours,
Mark N. Melkerson -S
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
510(k) Number (if known) K150643
Device Name
Centinel Spine STALIF TT™, STALIF MIDLINE®, MIDLINE II™, and MIDLINE II-Ti™
Indications for Use (Describe)
The STALIF TT™, STALIF MIDLINE®, MIDLINE II™, and MIDLINE II-Ti™ is indicated for use with bone graft (autograft bone and/or allogenic bone graft composed of cancellous bone graft) in patients with degenerative disc disease (DDD) at one or two contiguous levels from L2 to S1. These DDD patients may also have up to Grade I Spondylolisthesis or retrolisthesis at the involved levels. DDD is defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies. These patients should be skeletally mature and have had six months of non-operative treatment. Patients with previous non-fusion spinal surgery at the treated level may be treated. These implants may be implanted via a laparoscopic or an open anterior approach.
The STALIF TT™, STALIF MIDLINE II™, and MIDLINE II-Ti™ is a stand-alone system intended to be used with the bone screws provided and requires no additional supplementary fixation systems.
The STALIF TT™, STALIF MIDLINE II™, and MIDLINE II-Ti™ system must be used with autograft and/or allogenic bone graft composed of cancellous and/or corticocancellous bone graft.
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: | Centinel Spine STALIF TTTM, STALIF MIDLINE®, MIDLINE
IITM, and MIDLINE II-TiTM |
|----------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Manufacturer: | Centinel Spine, Inc.
900 Airport Road, Suite 3B
West Chester, PA 19380 |
| Contact: | Mr. John Parry
Group Manager, Lumbar Technologies
Phone: (484) 887.8813 |
| Prepared by: | Mr. Justin Eggleton
Musculoskeletal Clinical Regulatory Advisers, LLC
1331 H Street NW, 12th Floor
Washington, DC 20005
Phone: (202) 552-5800
jeggleton@mcra.com |
| Date Prepared: | June 4, 2015 |
| Classifications: | 21 CFR §888.3080, Intervertebral Body Fusion Device. |
| Class: | II |
| Product Codes: | OVD |
| Primary Predicate Device: | K141942, (Centinel Spine MIDLINE IITM, and MIDLINE II-TiTM) |
| Additional Predicate
Devices: | K101301, K073109 (Centinel Spine STALIF TTTM, STALIF
MIDLINE®) |
Indications For Use:
The STALIF TT™, STALIF MIDLINE®, MIDLINE II™, and MIDLINE II-Ti™ is indicated for use with bone graft (autograft bone and/or allogenic bone graft composed of cancellous and/or corticocancellous bone graft) in patients with degenerative disc disease (DDD) at one or two contiguous levels from L2 to S1. These DDD patients may also have up to Grade I Spondylolisthesis or retrolisthesis at the involved levels. DDD is defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies. These patients should be skeletally mature and have had six months of non-operative treatment. Patients with previous non-fusion spinal surgery at the treated level may be treated. These implants may be implanted via a laparoscopic or an open anterior approach.
4
The STALIF TT™, STALIF MIDLINE®, MIDLINE II™, and MIDLINE II-Ti™ is a standalone system intended to be used with the bone screws provided and requires no additional supplementary fixation systems.
The STALIF TT™. STALIF MIDLINE@. MIDLINE III™. and MIDLINE II-Ti™ system must be used with autograft and/or allogenic bone graft composed of cancellous and/or corticocancellous bone graft.
Device Description:
STALIF TTTTT, MIDLINE™/ MIDLINE II-Ti™ are radiolucent intervertebral body fusion cages with unicortical cancellous bone screws. It is intended to be used as an IBF cage without supplementary fixation. The cross section profile of the STALIF devices are similar to that of the vertebral body endplate with central cavity that can be packed with autograft or allograft. The STALIF devices are manufactured from PEEK-OPTIMA® LT1 with titanium alloy screws and X-ray marker wires manufactured from unalloyed Tantalum (ASTM F-560). The MIDLINE II-Ti™ is identical to this design with a titanium plasma spray coating on the device endplates.
The purpose of the subject 510(k) was to expand the indications to include use with allograft (i.e., allogenic bone graft composed of cancellous and/or corticocancellous bone graft).
Predicate Device (Summary of Technological Characteristics):
The subject STALF TTT", STALIF MIDLINE®, MIDLINE III™ Interbody Fusion Device System is substantially equivalent to the predicate MIDLINE™MIDLINE II-Ti™ Interbody Fusion Device System (K141942), STALIF MIDLINE® (K101301) and STALIF TTM (K073109) with respect to indications, design, function, and materials.
Substantial Equivalence:
The subject and predicate STALIF TT™, STALIF MIDLINE®, MIDLINE III™, and MIDLINE II-Ti™ Device Systems are similar in design, material, and indicated use. A comprehensive, clinical literature review and PearlDiver reimbursement were conducted to assess the safety and efficacy of allograft used in conjunction with this device in the lumbar spine. This review concluded that there were no additional risks due to the modified indications for this device. Biomechanical studies were performed to demonstrate equivalence to interbody cages with supplemental fixation. No new mechanical tests were performed since there were no design changes to the device.
Conclusion:
The Centinel Spine STALIF TT™, STALIF MIDLINE®, MIDLINE III™, and MIDLINE II-Ti™ have been modified to expand the indications to permit use with allograft (i.e., allogenic bone graft composed of cancellous and/or corticocancellous bone graft). The 510(k) demonstrates substantial equivalence to predicate devices.