(355 days)
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No
The 510(k) summary describes a mechanical implant (cervical plate system) and its MR compatibility testing. There is no mention of AI, ML, image processing, or any software-driven analytical capabilities.
Yes
The MaxAn Anterior Cervical Plate System is intended for temporary stabilization during cervical fusions to treat various conditions like degenerative disc disease, trauma, tumors, and deformity, which are all therapeutic interventions.
No
The device is a cervical plate system used for anterior interbody fixation to stabilize the spine during fusions. It is an implantable medical device used for treatment, not for diagnosing conditions.
No
The device description explicitly states that the system consists of titanium alloy plates and screws, which are hardware components. The submission also details performance studies related to the physical properties of these components (MR compatibility, torque, compression, torsion).
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Description: The MaxAn® Anterior Cervical Plate System is a surgical implant consisting of titanium plates and screws. It is used within the body for spinal fixation.
- Intended Use: The intended use is for anterior interbody fixation of the cervical spine, which is a surgical procedure, not a diagnostic test performed on a sample.
The description clearly indicates a surgical implant used for structural support and stabilization within the body, which falls under the category of a medical device, but not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The MaxAn® Anterior Cervical Plate System is intended for anterior interbody fixation of the cervical spine. Indications for use include the temporary stabilization of the anterior spine during the development of cervical fusions in patients with degenerative disc disease (as defined by neck pain of discogenic origin confirmed by patient history and radiographic studies), trauma including fractures, tumors, deformity (defined as kyphosis, lordosis), pseudarthroses, and/or failed previous fusions. The intended levels for treatment range from C2-T1.
Product codes (comma separated list FDA assigned to the subject device)
KWQ
Device Description
The MaxAn® Anterior Cervical Plate System Cervical Plate System consists of titanium alloy plates and screws intended for use in anterior cervical discectomy and fusion (ACDF) procedures. Cervical plates are intended for use at 1-5 levels, and are available in lengths from 8mm-130mm. Screws are available in both fixed and variable versions in sizes 4.0mm and 4.5mm in various lengths. All components are available in both sterile and non-sterile configurations.
The purpose of this submission is to add MR Conditional labeling for the components of the MaxAn system.
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
cervical spine, C2-T1
Indicated Patient Age Range
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Intended User / Care Setting
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Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
MR compatibility testing was conducted according to the following ASTM standards:
- ASTM F2052-06
- ASTM F2119-07 ●
- ASTM F2182-11a
Qualitative torque testing was presented.
Static compression bending, static torsion and dynamic compression tests were conducted according to ASTM F1717-04 Spinal Constructs in a Vertebrectomy Model.
Test results indicate that the MaxAn Cervical Plate System meets the ASTM recommendations for MR Conditional labeling in terms of device heating, magnetically induced displacement and MRI artifacts.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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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.
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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).
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§ 888.3060 Spinal intervertebral body fixation orthosis.
(a)
Identification. A spinal intervertebral body fixation orthosis is a device intended to be implanted made of titanium. It consists of various vertebral plates that are punched into each of a series of vertebral bodies. An eye-type screw is inserted in a hole in the center of each of the plates. A braided cable is threaded through each eye-type screw. The cable is tightened with a tension device and it is fastened or crimped at each eye-type screw. The device is used to apply force to a series of vertebrae to correct “sway back,” scoliosis (lateral curvature of the spine), or other conditions.(b)
Classification. Class II.
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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, stacked on top of each other, resembling a bird-like shape.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
November 5, 2014
Mr. Spencer Kimber Regulatory Affairs Specialist Biomet Spine, LLC 310 Interlocken Parkway, Suite 120 Broomfield, Colorado 80021
Re: K133518
Trade/Device Name: MaxAn® Anterior Cervical Plate System Regulation Number: 21 CFR 888.3060 Regulation Name: Spinal intervertral body fixation orthosis Regulatory Class: Class II Product Code: KWQ Dated: October 3, 2014 Received: October 6, 2014
Dear Mr. Kimber:
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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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 at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/Resourcesfor You/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
K133518 510(k) Number (if known):
Device Name: MaxAn® Anterior Cervical Plate System
Indications for Use:
The MaxAn® Anterior Cervical Plate System is intended for anterior interbody fixation of the cervical spine. Indications for use include the temporary stabilization of the anterior spine during the development of cervical fusions in patients with degenerative disc disease (as defined by neck pain of discogenic origin confirmed by patient history and radiographic studies), trauma including fractures, tumors, deformity (defined as kyphosis, lordosis), pseudarthroses, and/or failed previous fusions. The intended levels for treatment range from C2-T1.
Prescription Use X (Part 21 CFR 801 Subpart D)
AND/OR
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)
(Division Sign-Off Division of Orthopedic Devices 510(k) Number: K133518
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Image /page/3/Picture/0 description: The image shows the logo for Biomet Spine. The word "BIOMET" is in a bold, sans-serif font, with each letter enclosed in a rectangular box. Below "BIOMET" is the word "SPINE" in a smaller, sans-serif font. The logo is black and white.
510(k) Summary
This 510(k) summary is being submitted in accordance with the requirements of 21 CFR § 807.92.
| Preparation Date: | October 3, 2014 |
|---|---|
| Applicant/Sponsor: | Biomet Spine |
| 399 Jefferson Road | |
| Parsippany, NJ 07054 | |
| Contact Person: | Spencer Kimber |
| Regulatory Affairs Specialist | |
| Phone: 303-501-8523 | |
| Fax: 303-501-8444 | |
| Trade name: | MaxAn® Anterior Cervical Plate System |
| Common Name: | Spinal Intervertebral Body Fixation Orthosis |
| Classification Name | |
| (Product Code): | Appliance, Fixation, Spinal Intervertebral Body (KWQ) |
| Device Panel - Regulation | |
| No.: | Orthopedic - 21 CFR 888.3060 |
| Primary Predicate: | K080646 |
Device Description:
The MaxAn® Anterior Cervical Plate System Cervical Plate System consists of titanium alloy plates and screws intended for use in anterior cervical discectomy and fusion (ACDF) procedures. Cervical plates are intended for use at 1-5 levels, and are available in lengths from 8mm-130mm. Screws are available in both fixed and variable versions in sizes 4.0mm and 4.5mm in various lengths. All components are available in both sterile and non-sterile configurations.
The purpose of this submission is to add MR Conditional labeling for the components of the MaxAn system.
Indications for Use:
The MaxAn® Anterior Cervical Plate System is intended for anterior interbody fixation of the cervical spine. Indications for use include the temporary stabilization of the anterior spine during the development of cervical fusions in patients with degenerative disc disease (as defined by neck pain of discogenic origin confirmed by patient history and radiographic studies), trauma including fractures, tumors, deformity (defined as kyphosis, lordosis, or scoliosis), pseudarthroses, and/or failed previous fusions. The intended levels for treatment range from C2-T1.
Summary of Technologies:
The technological characteristics of the MaxAn Anterior Cervical Plate System are unchanged from its original clearance in K080646 in regards to intended use, indications, design, materials, manufacturing methods, sterility, fundamental technology, and operational principles.
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Performance Data:
MR compatibility testing was conducted according to the following ASTM standards:
- ASTM F2052-06
- ASTM F2119-07 ●
- ASTM F2182-11a
Qualitative torque testing was presented.
Static compression bending, static torsion and dynamic compression tests were conducted according to ASTM F1717-04 Spinal Constructs in a Vertebrectomy Model.
Test results indicate that the MaxAn Cervical Plate System meets the ASTM recommendations for MR Conditional labeling in terms of device heating, magnetically induced displacement and MRI artifacts.
Substantial Equivalence:
The addition of MR Conditional Labeling does not alter the substantial equivalence of the MaxAn Cervical Plate System, which was previously cleared in K080646.
Conclusion:
The non-clinical testing provided in this submission supports the addition of MR Conditional labeling for the MaxAn Cervical Plate System. Based upon the testing provided, and the additional labeling, the subject device is as safe and effective as the predicate device.