(76 days)
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).
Here's an analysis of the provided text regarding the MIDLIN E™ device, addressing your specific questions:
1. Table of Acceptance Criteria and Reported Device Performance
The provided text focuses on the device's mechanical performance relative to predicate devices, rather than clinical efficacy. Therefore, the "acceptance criteria" are based on established mechanical testing standards for intervertebral body fusion devices.
| Acceptance Criteria (Mechanical Testing Standards) | Reported Device Performance |
|---|---|
| ASTM F2077-11: | MIDLINE™ was shown to be as mechanically sound as predicate devices. The following tests were performed: |
| - Static Compression | - Successfully tested |
| - Dynamic Compression | - Successfully tested |
| - Static Compression-Shear | - Successfully tested |
| - Dynamic Compression-Shear | - Successfully tested |
| - Static Torsion | - Successfully tested |
| - Dynamic Torsion | - Successfully tested |
| ASTM F2267-04(2011): | |
| - Subsidence | - Successfully tested |
| - Expulsion | - Successfully tested |
2. Sample Size Used for the Test Set and Data Provenance
The document does not specify the exact sample sizes (number of devices) used for each mechanical test. Mechanical tests typically use a small, representative sample of devices.
The data provenance is from laboratory mechanical testing conducted by the manufacturer, Centinel Spine, Inc. It is not patient or clinical data, so terms like "country of origin" or "retrospective/prospective" don't directly apply in the clinical sense. These are engineering/material science tests.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This question is not applicable in the context of this submission. The "ground truth" for mechanical performance tests is established by adherence to the specified ASTM standards and the measurements obtained from the testing equipment, not by human expert consensus or clinical assessment of a test set.
4. Adjudication Method for the Test Set
This question is not applicable. Adjudication methods like 2+1 or 3+1 are used for clinical studies involving human interpretation or subjective assessment. For mechanical testing, the results are objectively measured against predefined criteria in the standards.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size
No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This submission pertains to a 510(k) for a medical device (intervertebral body fusion device), which typically relies on mechanical and material equivalence to predicate devices, not clinical efficacy studies involving human readers and AI. The document does not mention any AI component or human-in-the-loop performance.
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done
No, a standalone (algorithm only) performance study was not done. This refers to mechanical testing of a physical device, not an algorithm.
7. The Type of Ground Truth Used
The ground truth used for this submission is the established mechanical performance characteristics required by the ASTM standards (F2077-11 and F2267-04(2011)) for intervertebral body fusion devices. The device's performance was compared to these standards and to the performance of predicate devices.
8. The Sample Size for the Training Set
This question is not applicable. "Training set" refers to data used to train an algorithm, typically in the context of AI or machine learning. This submission is for a physical medical device and its mechanical equivalence, not an algorithm.
9. How the Ground Truth for the Training Set Was Established
This question is not applicable, as there is no "training set" in the context of this device's submission.
Summary of the Study:
The study described is a series of bench-top mechanical performance tests comparing the MIDLINE™ device to its predicate devices and against recognized industry standards (ASTM F2077-11 and ASTM F2267-04(2011)). The goal was to demonstrate substantial equivalence in mechanical characteristics. The tests covered various loading conditions relevant to an intervertebral body fusion device, including compression, compression-shear, torsion, subsidence, and expulsion. The conclusion was that the MIDLINE™ device is "as mechanically sound as predicate devices," thereby supporting its substantial equivalence claim for 510(k) clearance.
{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
§ 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.