(29 days)
Not Found
No
The 510(k) summary describes a physical implantable device for spinal fusion and does not mention any software, algorithms, or data processing capabilities that would suggest the use of AI or ML. The performance studies focus on mechanical testing and engineering analysis of the physical device.
Yes
The device is described as an "intervertebral body fusion device" intended for "spinal fusion procedures" for patients with degenerative disc disease, which indicates it is used to treat a medical condition.
No
Explanation: The device is an intervertebral body fusion device used in spinal fusion procedures to treat degenerative disc disease, not to diagnose it.
No
The device description clearly details physical implants made of PEEK, titanium, and tantalum, which are hardware components. The performance studies also focus on mechanical testing of these physical implants.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly describes a surgical implant for spinal fusion procedures. This is a therapeutic device, not a diagnostic one.
- Device Description: The description details the physical characteristics and materials of a surgical implant designed to be placed within the body.
- Lack of Diagnostic Elements: There is no mention of analyzing biological samples (blood, tissue, etc.), detecting biomarkers, or providing diagnostic information.
- Performance Studies: The performance studies focus on mechanical testing and engineering analysis of the implant's structural integrity and equivalence to a predicate device, which is typical for surgical implants.
IVD devices are used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device does not fit that description.
N/A
Intended Use / Indications for Use
When used as a lumbar intervertebral body fusion device, the Biomet Spine Fusion System is intended for spinal fusion procedures to be used with autogenous bone graft in skeletally mature patients with degenerative disc disease ("DDD") at one or two contiguous spinal levels from L2-S1. DDD is defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies. These patients should have had six months of non-operative treatment. These DDD patients may have had a previous non-fusion spinal surgery at the involved spinal level(s), and may have up to Grade 1 spondylolisthesis or retrolisthesis at the involved level(s). The Biomet Spine Fusion System is to be implanted via an anterior or posterior approach and is to be combined with supplemental fixation. Approved supplemental fixation systems include the Biomet Spinal Fixation System. The expandable interbody fusion devices are not indicated for vertebral body replacement.
Product codes (comma separated list FDA assigned to the subject device)
MAX
Device Description
The Biomet Spine Fusion System implants are intervertebral body fusion/vertebral body replacement devices consisting of a rectangular or semi-rectangular shape and various heights and footprints. The devices have a hollowed out central area to accommodate bone graft. The upper and lower surfaces of the devices have a series of transverse grooves formed to improve stability and fixation once the device is inserted. The implants are available in a variety of sizes and configurations to approximate anatomical variation in different vertebral levels and/or patient anatomy. The implants are made of PEEK (OPTIMA LT1®) per ASTM F2026, titanium alloy (Ti-6A1-4V ELI) per ASTM F136, commercially pure titanium per ASTM F1580, and may include tantalum markers per ASTM F560. The expandable Biomet Spine Fusion System implants incorporate PEEK (OPTIMA LT1® per ASTM F2026) spacer components and titanium alloy (Ti-6Al-4V ELI per ASTM F136) endplate components that orient into predetermined lordotic angles of 0, 8 and 12 degrees. The expandable implants are available in 7 to 14mm heights, an 11mm width, and 25, 30 and 35mm lengths. The subject Biomet Spine Fusion System implant is provided sterile only.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Spinal levels 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)
An engineering analysis was performed to assess the introduction of tantalum markers within the locking mechanism of the subject expandable Biomet Spine Fusion System product family. The worst case construct was identified and characterized. The results of this engineering analysis demonstrated that no new mechanical testing is required. The analysis demonstrated the substantial equivalence of the new subject devices to the predicate device. The modified Biomet Spine Fusion System met all specified criteria and did not raise new safety or performance questions.
Mechanical testing on the predicate device (K151483) was conducted in accordance with FDA's Guidance for Industry and FDA Staff - Spinal System 510(k)s dated May 3, 2004 and Class II Special Controls Guidance Document: Intervertebral Body Fusion Device dated June 12, 2007. Performance testing included tests per ASTM F2077 (static and dynamic axial compression, static and dynamic shear compression, and static torsion) and ASTM F2267 (subsidence) and was performed to demonstrate substantial equivalence to the predicate device(s).
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.
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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 seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, stacked on top of each other.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
January 21, 2016
Biomet Spine, LLC Mr. Kyle Hoefling Regulatory Affairs Project Manager 310 Interlocken Parkway, Suite 120 Broomfield, Colorado 80021
Re: K153695
Trade/Device Name: Biomet Spine Fusion System Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral body fusion device Regulatory Class: Class II Product Code: MAX Dated: December 22, 2015 Received: December 23, 2015
Dear Mr. Hoefling:
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 Parts 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set
1
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,
Lori A. Wiggins -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)
Device Name Biomet Spine Fusion System
Indications for Use (Describe)
When used as a lumbar intervertebral body fusion device, the Biomet Spine Fusion System is intended for spinal fusion procedures to be used with autogenous bone graft in skeletally mature patients with degenerative disc disease ("DDD") at one or two contiguous spinal levels from L2-S1. DDD is defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies. These patients should have had six months of non-operative treatment. These DDD patients may have had a previous non-fusion spinal surgery at the involved spinal level(s), and may have up to Grade 1 spondylolisthesis or retrolisthesis at the involved level(s). The Biomet Spine Fusion System is to be implanted via an anterior or posterior approach and is to be combined with supplemental fixation. Approved supplemental fixation systems include the Biomet Spinal Fixation System. The expandable interbody fusion devices are not indicated for vertebral body replacement
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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Image /page/3/Picture/0 description: The image shows the logo for Biomet Spine. The word "BIOMET" is in large, bold, sans-serif font. Below that, in a smaller font, is the word "SPINE". The logo is simple and modern.
510(k) Summary
This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of 21 CFR § 807.92.
| Preparation Date: | December 22, 2015 |
|---|---|
| Applicant/Sponsor: | Biomet Spine LLC. |
| 310 Interlocken Parkway, Suite 120 | |
| Broomfield, CO 80021 | |
| Contact Person: | Kyle Hoefling |
| Regulatory Affairs Product Manager | |
| Phone: 303-465-8963 | |
| Fax: 303-501-8444 | |
| Trade Name: | Biomet Spine Fusion System |
| Common Name: | Intervertebral Body Fusion Device, Lumbar |
| Device Class: | Class II |
| Classification Name | Intervertebral fusion device with bone graft, lumbar |
| Product Code: | MAX |
| Device Panel - Regulation No .: | Orthopedic - 21 CFR 888.3080 |
| Primary Predicate: | Biomet Spine Fusion System K151483 |
Device Description:
The Biomet Spine Fusion System implants are intervertebral body fusion/vertebral body replacement devices consisting of a rectangular or semi-rectangular shape and various heights and footprints. The devices have a hollowed out central area to accommodate bone graft. The upper and lower surfaces of the devices have a series of transverse grooves formed to improve stability and fixation once the device is inserted. The implants are available in a variety of sizes and configurations to approximate anatomical variation in different vertebral levels and/or patient anatomy. The implants are made of PEEK (OPTIMA LT1®) per ASTM F2026, titanium alloy (Ti-6A1-4V ELI) per ASTM F136, commercially pure titanium per ASTM F1580, and may include tantalum markers per ASTM F560. The expandable Biomet Spine Fusion System implants incorporate PEEK (OPTIMA LT1® per ASTM F2026) spacer components and titanium alloy (Ti-6Al-4V ELI per ASTM F136) endplate components that orient into predetermined lordotic angles of 0, 8 and 12 degrees. The expandable implants are available in 7 to 14mm heights, an 11mm width, and 25, 30 and 35mm lengths. The subject Biomet Spine Fusion System implant is provided sterile only.
Indications for Use:
When used as a lumbar intervertebral body fusion device, the Biomet Spine Fusion System is intended for spinal fusion procedures to be used with autogenous bone graft in skeletally mature
4
patients with degenerative disc disease ("DD") at one or two contiguous spinal levels from L2-S1. DDD is defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies. These patients should have had six months of non-operative treatment. These DDD patients may have had a previous non-fusion spinal surgery at the involved spinal level(s), and may have up to Grade 1 spondylolisthesis or retrolisthesis at the involved level(s). The Biomet Spine Fusion System is to be implanted via an anterior or posterior approach and is to be combined with supplemental fixation. Approved supplemental fixation systems include the Biomet Spine Spinal Fixation System. The expandable interbody fusion devices are not indicated for vertebral body replacement.
Summary of Technologies:
The technological characteristics of the subject Biomet Spine Fusion System components remain the same as, or similar to, the predicate devices in regards to intended use, indications for use, design, manufacturing methods, fundamental technology, and operational principles. The purpose of this submission is to add a tantalum marker to the cam locking mechanism.
Performance Data:
An engineering analysis was performed to assess the introduction of tantalum markers within the locking mechanism of the subject expandable Biomet Spine Fusion System product family. The worst case construct was identified and characterized. The results of this engineering analysis demonstrated that no new mechanical testing is required. The analysis demonstrated the substantial equivalence of the new subject devices to the predicate device. The modified Biomet Spine Fusion System met all specified criteria and did not raise new safety or performance questions.
Mechanical testing on the predicate device (K151483) was conducted in accordance with FDA's Guidance for Industry and FDA Staff - Spinal System 510(k)s dated May 3, 2004 and Class II Special Controls Guidance Document: Intervertebral Body Fusion Device dated June 12, 2007. Performance testing included tests per ASTM F2077 (static and dynamic axial compression, static and dynamic shear compression, and static torsion) and ASTM F2267 (subsidence) and was performed to demonstrate substantial equivalence to the predicate device(s).
Substantial Equivalence:
The modified Biomet Spine Fusion System implants included in this submission have the same intended use, indications, technological characteristics, and principles of operation as the previously cleared Biomet Spine Fusion System (K151483). The minor differences in the new components do not raise any new issues of safety or effectiveness.
Conclusion:
The Biomet Spine Fusion System is substantially equivalent to the predicate systems as a spinal fusion device in regards to intended use, indications for use, fundamental technology including design, manufacturing methods, sterility, and operational principles. Furthermore, an engineering analysis and other supporting information sufficiently demonstrate the substantial equivalence of the subject components to the Biomet Spine Fusion System to the predicate system. Based on this information, the subject modifications do not raise any new issues regarding the safety or efficacy when compared to its predicates.