(76 days)
Not Found
No
The 510(k) summary describes a physical intervertebral body fusion device and its mechanical testing, with no mention of software, algorithms, or any AI/ML related terms or concepts.
Yes
The device is described as an intervertebral body fusion device indicated for patients with degenerative disc disease to alleviate symptoms and facilitate fusion, fulfilling the purpose of a therapeutic device.
No
The device description clearly states "The MIDLINE™ is a radiolucent intervertebral body fusion device and unicortical cancellous bone screws intended to be used without supplemental fixation." This indicates it is a therapeutic implant for spinal fusion, not a diagnostic tool.
No
The device description explicitly states it is a "radiolucent intervertebral body fusion device and unicortical cancellous bone screws," which are physical hardware components.
No, 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, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Description: The provided text describes the MIDLINE™ as an "intervertebral body fusion device and unicortical cancellous bone screws." This is an implantable surgical device used to fuse vertebrae in the spine.
- Intended Use: The intended use clearly states it's for "use with autogenous bone graft in patients with degenerative disc disease (DDD) at one or two contiguous levels from L2 to S1." This is a surgical procedure, not a diagnostic test performed on a sample.
- Lack of IVD Characteristics: The description does not mention any testing of biological samples, reagents, or diagnostic procedures.
The MIDLINE™ is a surgical implant, not a diagnostic device.
N/A
Intended Use / Indications for Use
The MIDLINE™ is indicated for use with autogenous 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 MIDLINE™ is a stand-alone system intended to be used with the bone screws provided and requires no additional supplementary fixation systems.
The MIDLINE™ system must be used with bone grafting material (autograft only).
Product codes (comma separated list FDA assigned to the subject device)
OVD
Device Description
The MIDLINE™ is a radiolucent intervertebral body fusion device and unicortical cancellous bone screws intended to be used without supplemental fixation. The purpose of this 510(k) is to modify the STALIF™ TT and STALIF MIDLINE™ (K101301, K073109) to include modified geometries.
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)
Testing performed indicate that the MIDLINE™ is as mechanically sound as predicate devices. Testing included static/dynamic compression, static/dynamic compression-shear, static dynamic torsion, subsidence, and expulsion per ASTM F2077-11 and ASTM F2267-04(2011).
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
K133286 Page 1 of 2
510(k) Summary
JAN - 9 2014
Contact:
Mr. Justin Eggleton Musculoskeletal Clinical & Regulatory Advisers, LLC 1331 H Street NW, 12th Floor Washington, DC 20005 202.552.5800
21 CFR $888.3080, Intervertebral body fusion device
MIDLINE™ Device Trade Name:
Manufacturer:
MIDLINE
lanufacturer:
Centinel Spine. Inc
900 Airport Road, Suite 3B West Chester, PA 19380
December 11, 2013 Date Prepared:
Classification:
Class: Il
Product Code: OVD
Indications For Use:
The MIDLINE™ is indicated for use with autogenous 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 MIDLINETM is a stand-alone system intended to be used with the bone screws provided and requires no additional supplementary fixation systems.
The MIDLINE™ system must be used with bone grafting material (autograft only).
Device Description:
The MIDLINE™ is a radiolucent intervertebral body fusion device and unicortical cancellous bone screws intended to be used without supplemental fixation. The purpose of this 510(k) is to modify the STALIF™ TT and STALIF MIDLINE™ (K101301, K073109) to include modified geometries.
1
Predicate Device(s):
MIDLINE™ was shown to be substantially equivalent to the previously cleared STALIF™ devices (K101301, K073109) and Theken Spine Vu aPOD (K101310) and has the same indications for use, design, function, and materials used.
Performance Standards:
Testing performed indicate that the MIDLINE™ is as mechanically sound as predicate devices. Testing included static/dynamic compression, static/dynamic compression-shear, static dynamic torsion, subsidence, and expulsion per ASTM F2077-11 and ASTM F2267-04(2011).
Conclusion:
Centinel Spine provided sufficient information to demonstrate the MIDLINE™ is substantially equivalent to predicate STALIF™ devices (K101301, K073109) and Theken Spine Vu aPOD (K101310).
2
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the seal is a stylized graphic of an abstract human figure, represented by three curved lines, with arms outstretched.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
January 9, 2014
Centinel Spine, Incorporated % Mr. Justin Eggleton Director, Spine Regulatory Affairs Musculoskeletal Clinical Regulatory Advisers, LLC 1331 H Street Northwest, 12th Floor Washington, District of Columbia 20005
Re: K133286
Trade/Device Name: MIDLINETM Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral body fusion device Regulatory Class: Class II Product Code: OVD Dated: December 12, 2013 Received: December 13, 2013
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. Iisting 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
3
Page 2 - Mr. Justin Eggleton
device-related 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 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. Meikerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Indications for Use
510(k) Number (if known): K133286
Device Name: MIDLINETM
The MIDLINETM is indicated for use with autogenous 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 MIDLINE™ is a stand-alone system intended to be used with the bone screws provided and requires no additional supplementary fixation systems.
The MIDLINE™ system must be used with bone grafting material (autograft only).
Prescription Use V AND/OR (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Anton E. Dmitriev, PhD Division of Orthopedio Devices