(266 days)
Not Found
No
The document describes a mechanical spinal fixation system and its intended use, with no mention of software, algorithms, or any technology related to AI or ML. The performance studies are mechanical tests, not algorithmic performance evaluations.
No
The device is a system for spinal fusion and stabilization, intended to provide mechanical support and promote arthrodesis (fusion of joints), rather than actively delivering a therapeutic agent or energy.
No
The device is described as an implant system for spinal fusion (Nextgen Altius OCT System), which is a treatment rather than a diagnostic tool. Its intended uses are for stabilization as an adjunct to fusion for various spinal conditions, not for diagnosing them.
No
The device description and performance studies clearly indicate this is a system of physical implants (screws, rods, connectors) used for spinal stabilization, not a software-only device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly describes a surgical implant system for stabilizing the cervical spine and occipito-cervico-thoracic junction. This is a physical device used in vivo (within the body) during surgery.
- Device Description: The description mentions a "line extension to Nextgen Altius OCT System to add an alternate style of multiaxial screws to the system." This further confirms it's a physical implant.
- Anatomical Site: The specified anatomical site is the "cervical spine and occipito-cervico-thoracic junction (occiput -T3)," which is a part of the human body.
- Performance Studies: The performance studies described are mechanical tests (static interconnection testing, compression bending fatigue, dissociation testing) conducted on the device itself, not on biological samples.
- Predicate Devices: The predicate devices listed are also spinal implant systems.
IVD devices are used in vitro (outside the body) to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening. This device does not fit that description.
N/A
Intended Use / Indications for Use
When intended for stabilization as an adjunct to fusion of the cervical spine and occipito-cervico-thoracic junction (occiput -T3), the Nextgen Altius OCT System is intended for use with allograft or autograft and indicated for: DDD (neck pain of discogenic origin with degeneration of the disc as confirmed by patient history and radiographic studies); spondylolisthesis; deformities or curvatures (i.e., scoliosis); pseudoarthrosis; spinal stenosis; trauma, (i.e., fracture or dislocation); atlanto/axial fracture with instability; occipito-cervical dislocation; revision of previous cervical spine surgery; and tumors.
The occipital bone screws are limited to occipital fixation only.
The use of pedicle screws is limited to placement in T1-T3 in treating thoracic conditions only. They are not intended to be placed in or treat conditions involving the cervical spine.
The Nextgen Altius OCT System can also be linked to the Biomet Polaris Systems via transitional rods or using Altius Rod Connectors or Polaris Dominoes. Please refer to the individual system's package insert for a list of indications for use for each system.
Product codes (comma separated list FDA assigned to the subject device)
KWP, MNI, MNH
Device Description
This submission is a line extension to Nextgen Altius OCT System to add an alternate style of multiaxial screws to the system.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
cervical spine, occipito-cervico-thoracic junction (occiput -T3), T1-T3
Indicated Patient Age Range
Not Found
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)
Mechanical testing was conducted in accordance with FDA's Guidance for Industry and FDA Staff - Spinal System 510(k)s dated May 3, 2004. Per the guidance document, the following testing was conducted: static interconnection testing and compression bending fatigue. Testing was conducted in accordance with ASTM F1717, Standard Test Methods for Spinal Implant Constructs in a Vertebrectomy Model and ASTM F1798, Standard Guide for Evaluating the Static and Fatigue Properties of Interconnection Mechanisms and Subassemblies Used in Spinal Arthrodesis Implants. Dissociation testing was also conducted. The mechanical testing verifies that the subject components are substantially equivalent to other spinal systems currently on the market and has met all mechanical test requirements based on the worst-case construct testing.
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.
K122378, K113593, K043229, K110522, K113434, K071905
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
§ 888.3050 Spinal interlaminal fixation orthosis.
(a)
Identification. A spinal interlaminal fixation orthosis is a device intended to be implanted made of an alloy, such as stainless steel, that consists of various hooks and a posteriorly placed compression or distraction rod. The device is implanted, usually across three adjacent vertebrae, to straighten and immobilize the spine to allow bone grafts to unite and fuse the vertebrae together. The device is used primarily in the treatment of scoliosis (a lateral curvature of the spine), but it also may be used in the treatment of fracture or dislocation of the spine, grades 3 and 4 of spondylolisthesis (a dislocation of the spinal column), and lower back syndrome.(b)
Classification. Class II.
0
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 stylized depiction of three human profiles facing to the right, arranged in a way that they appear to be interconnected or overlapping. The profiles are rendered in a dark color, creating a silhouette effect. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the profile graphic.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
December 15, 2014
Biomet Spine (aka EBI, LLC) Mr. Ted Kuhn Regulatory Affairs Product Manager 399 Jefferson Road Parsippany, New Jersey 07054
Re: K140734
Trade/Device Name: Nextgen Altius OCT System Regulation Number: 21 CFR 888.3050 Regulation Name: Spinal interlaminal fixation orthosis Regulatory Class: Class II Product Code: KWP, MNI, MNH Dated: November 13, 2014 Received: November 14, 2014
Dear Mr. Kuhn:
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
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" (21 CFR 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) K140734
Device Name Nextgen Altius OCT System
Indications for Use (Describe)
When intended for stabilization as an adjunct to fusion of the cervical spine and occipito-cervico-thoracic junction (occiput -T3), the Nextgen Altius OCT System is intended for use with allograft or autograft and indicated for: DDD (neck pain of discogenic origin with degeneration of the disc as confirmed by patient history and radiographic studies); spondylolisthesis; deformities or curvatures (i.e., scoliosis); pseudoarthrosis; spinal stenosis; trauma, (i.e., fracture or dislocation); atlanto/axial fracture with instability; occipitocervical dislocation; revision of previous cervical spine surgery; and tumors.
The occipital bone screws are limited to occipital fixation only.
The use of pedicle screws is limited to placement in T1-T3 in treating thoracic conditions only.
They are not intended to be placed in or treat conditions involving the cervical spine.
The Nextgen Altius OCT System can also be linked to the Biomet Polaris Systems via transitional rods or using Altius Rod Connectors or Polaris Dominoes. Please refer to the individual system's package insert for a list of indications for use for each system.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| Prescription Use (Part 21 CFR 801 Subpart D) | Over-The-Counter Use (21 CFR 801 Subpart C) |
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
3
Image /page/3/Picture/0 description: The image shows the logo for Biomet Spine. The logo is in black and white and features the word "BIOMET" in a stylized font. Below the word "BIOMET" is the word "SPINE" in a smaller, sans-serif font. The logo is simple and modern.
10(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 15, 2014 |
|---|---|
| Applicant/Sponsor: | Biomet Spine |
| 399 Jefferson Road | |
| Parsippany, NJ 07054 | |
| Contact Person: | Ted Kuhn |
| Phone: 303-501-8549 | |
| Fax: 303-501-8444 | |
| Trade name: | Nextgen Altius OCT System |
| Common Name: | Occipito-cervico-thoracic spinal fixation system |
| Product Code & Classification | |
| Name: | KWP - Spinal interlaminal fixation orthosis |
| MNI & MNH – Noncervical, pedicle screw spinal system | |
| Device Panel - Regulation No.: | Orthopedic - 21 CFR 888 3050 and 888 3070 |
Device Description:
This submission is a line extension to Nextgen Altius OCT System to add an alternate style of multiaxial screws to the system.
Indications for Use:
When intended for stabilization as an adjunct to fusion of the cervical spine and occipitocervico-thoracic junction (occiput -T3), the Nextgen Altius OCT System is intended for use with allograft or autograft and indicated for: DDD (neck pain of discogenic origin with degeneration of the disc as confirmed by patient history and radiographic studies); spondylolisthesis; deformities or curvatures (i.e., scoliosis, kyphosis and/or lordosis); pseudoarthrosis; spinal stenosis; trauma, (i.e., fracture or dislocation); atlanto/axial fracture with instability; occipitocervical dislocation; revision of previous cervical spine surgery; and tumors.
The occipital bone screws are limited to occipital fixation only.
The use of pedicle screws is limited to placement in T1-T3 in treating thoracic conditions only. They are not intended to be placed in or treat conditions involving the cervical spine.
The Nextgen Altius OCT System can also be linked to the Biomet Polaris Systems via transitional rods or using Altius Rod Connectors or Polaris Dominoes. Please refer to the individual system's package insert for a list of indications for use for each system.
4
Summary of Technologies:
The technological characteristics of the new components are the same as, or similar to, the predicate devices in regards to design, indications for use and operational principle.
Performance Data:
Mechanical testing was conducted in accordance with FDA's Guidance for Industry and FDA Staff - Spinal System 510(k)s dated May 3, 2004. Per the guidance document, the following testing was conducted: static interconnection testing and compression bending fatigue. Testing was conducted in accordance with ASTM F1717, Standard Test Methods for Spinal Implant Constructs in a Vertebrectomy Model and ASTM F1798, Standard Guide for Evaluating the Static and Fatigue Properties of Interconnection Mechanisms and Subassemblies Used in Spinal Arthrodesis Implants. Dissociation testing was also conducted. The mechanical testing verifies that the subject components are substantially equivalent to other spinal systems currently on the market and has met all mechanical test requirements based on the worst-case construct testing.
Substantial Equivalence:
The subject components being added to the Nextgen Altius OCT System are substantially equivalent to the current components in the primary predicate Nextgen Altius OCT System (K122378) and the following additional predicates: Nextgen Altius OCT System (K113593 and K043229), Medtronic Vertex Reconstruction System (K110522), and Lanx Posterior Cervicothoracic Spinal Fixation System (K113434 and K071905). The Nextgen Altius OCT System is substantially equivalent to these predicate systems with respect to intended use and indications, technological characteristics, and principles of operation and do not present any new issues of safety or effectiveness.
Conclusion:
The Nextgen Altius OCT System is substantially equivalent to the predicate systems when used as an occipito-cervico-thoracic spinal fixation device. The intended use and fundamental technology of the system remain unchanged. Furthermore, mechanical testing and other supporting information sufficiently demonstrate the substantial equivalence of the subject components to the other components in the Nextgen Altius OCT System. Based on this information, the subject components do not raise any new issues regarding the safety or efficacy.