(271 days)
Not Found
No
The summary describes a mechanical implant and associated instruments for spinal fusion, with no mention of software, algorithms, or data processing that would indicate AI/ML.
Yes
Explanation: The device is an expandable interbody fusion device indicated for patients with degenerative disc disease to provide support and correction during lumbar intervertebral body fusion, which directly addresses a medical condition and aims to restore function.
No
The device is an expandable interbody fusion device designed for use in spinal fusion surgery, not for diagnosing medical conditions.
No
The device description explicitly details physical components made of PEEK, tantalum, titanium, stainless steel, silicone, and aluminum, including expandable cages, instruments, cases, trays, and lids. This indicates a hardware-based medical device, not a software-only one.
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 for spinal fusion. It is used in the body to provide structural support and facilitate bone growth.
- Device Description: The device description details physical implants (cages) and surgical instruments. These are used directly in a surgical procedure on a patient.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens (like blood, urine, or tissue) in vitro (outside the body) to provide information about a patient's health status.
IVD devices are used to perform tests on samples taken from the body to diagnose, monitor, or screen for diseases or conditions. This device is a therapeutic implant used during surgery.
N/A
Intended Use / Indications for Use
The ELEVATE™ Spinal System Expandable Interbody Fusion Device is indicated for interbody fusion 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 1 Spondylolisthesis 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. These implanted via an open or a minimally invasive posterior approach. These implants are to be used with autogenous bone graft. These devices are intended to be used with supplemental fixation instrumentation, which has been cleared by the FDA for use in the lumbar spine.
Product codes
MAX
Device Description
The ELEVATE™ Spinal System consists of polyetheretherketone (PEEK) with tantalum markers and titanium expandable cages of various length and heights, which can be surgically implanted between two lumbar or lumbarsacral vertebral bodies to give support and correction during lumbar intervertebral body fusion. The hollow geometry of the implants allows them to be packed with autogenous bone graft. This system also includes stainless steel and silicone instruments used to facilitate the implantation of the subject cages. Finally, the subject system includes case, trays, and lids used to package, ship and can be used to sterilize the non-sterile instruments in the subject system. The case, trays, and lids are manufactured from aluminum with either silicone or nylon coated brackets.
The ELEVATE™ Spinal System will be available in similar sizes as the predicate systems.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
L2 to S1 (lumbar or lumbosacral vertebral bodies)
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: Biocompatibility, Mechanical Testing, MR-safety evaluation.
Sample Size: Not specified.
Key Results:
- Biocompatibility evaluation conducted in accordance with FDA's Draft Guidance for Industry and FDA Staff "Use of International Standard ISO-10993, Biological Evaluation of Medical Devices Part 1: Evaluation and Testing" issued April, 23, 2013. Implants are permanent, >30 day body contact. Instruments are external communicating, limited, up to 24 hours body contact. No biocompatibility testing was conducted on subject devices as materials have a long history of safe and effective use in predicate devices.
- Mechanical testing completed on the subject ELEVATE™ Spinal System in accordance with ASTM F2077-11 "Test Methods for Intervertebral Body Fusion Devices" and ASTM F2267-4 (2011) "Standard Test Method for Measuring Load Induced Subsidence of Intervertebral Body Fusion Device Under Static Axial Compression". Tests included Static Compression, Compression Fatigue, Static Compression-Shear, Compression-Shear Fatigue, and Subsidence, all meeting predetermined acceptance criteria.
- Additional radiographic verification testing completed demonstrating substantial equivalence to predicates.
- MR-safety evaluated in accordance with FDA Guidance "Establishing Safety and Compatibility of Passive Implants in the Magnetic Resonance (MR) Environment" and standards ASTM F2052, ASTM F2213, ASTM F2119, and ASTM F2182.
Key Metrics
Not Found
Predicate Device(s)
Globus CALIBER® K102293, CAPSTONE® Spinal System K073291, CAPSTONE® Spinal System K123027, CRESCENT® Spinal System K094025, Globus PATRIOT® K072970, SOVEREIGN® Spinal System K122037, Globus RISE® Spacer K113447, WAVE™ D Cage K083626, WAVE™ D Cage K121333
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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
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" arranged around the perimeter. Inside the circle is a stylized image of three faces in profile, stacked one behind the other, representing people. The faces are rendered in a simple, abstract style.
June 9, 2015
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
Medtronic Sofamor Danek USA, Incorporated Ms. Becky Ronner Senior Regulatory Affairs Specialist 1800 Pyramid Place Memphis, Tennessee 38132
Re: K142559
Trade/Device Name: ELEVATE™ Spinal System Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral body fusion device Regulatory Class: Class II Product Code: MAX Dated: May 8, 2015 Received: May 11, 2015
Dear Ms. Ronner:
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 of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set
1
Page 2 - Ms. Becky Ronner
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 vours.
Mark N. Melkerson -S
Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Indications for Use
Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below.
Page 1 of 1
510(k) Number (if known) K142559
Device Name ELEVATE™ Spinal System
Indications for Use (Describe)
The ELEVATE™ Spinal System Expandable Interbody Fusion Device is indicated for interbody fusion 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 1 Spondylolisthesis 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. These implanted via an open or a minimally invasive posterior approach. These implants are to be used with autogenous bone graft. These devices are intended to be used with supplemental fixation instrumentation, which has been cleared by the FDA for use in the lumbar spine.
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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FOR FDA USE ONLY
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510(k) SUMMARY
MEDTRONIC Sofamor Danek ELEVATE™ Spinal System
May 2015
| I. | Submitter | Medtronic Sofamor Danek, USA Inc.
1800 Pyramid Place
Memphis, Tennessee 38132
Telephone: (901)396-3133
Fax: (901) 346-9738 |
|------|-----------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | Contact: | Becky Ronner
Senior Regulatory Affairs Specialist
Direct Telephone: (901)399-2757 |
| | Date Prepared: | September 5, 2014 |
| II. | Device | |
| | Name of Device: | ELEVATE™ Spinal System |
| | Classification Names: | Intervertebral Body Fusion Device
(21 CFR 888.3080) |
| | Class: | II |
| | Product Code: | MAX |
| III. | Predicate Devices: | Globus CALIBER® K102293(Primary)
(S.E. January 5th, 2011)
CAPSTONE® Spinal System K073291 & K123027
(S.E. April 24th, 2008 & July 25th, 2013)
CRESCENT® Spinal System K094025
(S.E. April 26th, 2010)
Globus PATRIOT® K072970
(S.E. January 18th, 2008)
SOVEREIGN® Spinal System K122037
(S.E. March 22nd, 2013) |
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Globus RISE® Spacer K113447 (S.E. January 26, 2012) WAVE™ D Cage K083626 & K121333 (S.E. October 17, 2009 & S.E. June 29, 2012) The predicates have not been subject to a design related recall.
IV. Description:
The ELEVATE™ Spinal System consists of polyetheretherketone (PEEK) with tantalum markers and titanium expandable cages of various length and heights, which can be surgically implanted between two lumbar or lumbarsacral vertebral bodies to give support and correction during lumbar intervertebral body fusion. The hollow geometry of the implants allows them to be packed with autogenous bone graft. This system also includes stainless steel and silicone instruments used to facilitate the implantation of the subject cages. Finally, the subject system includes case, trays, and lids used to package, ship and can be used to sterilize the non-sterile instruments in the subject system. The case, trays, and lids are manufactured from aluminum with either silicone or nylon coated brackets.
The ELEVATE™ Spinal System will be available in similar sizes as the predicate systems.
V. Indications for Use:
The ELEVATE™ Spinal System Expandable Interbody Fusion Device is indicated for interbody fusion 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 1 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. These implants may be implanted via an open or a minimally invasive posterior approach. These implants are to be used with autogenous bone graft. These devices are intended to be used with supplemental fixation instrumentation, which has been cleared by the FDA for use in the lumbar spine.
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VI. Comparison of Technological Characteristics with the Predicate Devices:
The ELEVATE™ Spinal System has the same fundamental technology, PEEK material with tantalum markers as the predicate devices. The predicate and subject devices are intended to be surgically implanted between two lumbar or lumbosacral vertebral bodies to give support and correction during lumbar intervertebral body fusion. The subject and predicates implants include a bullet nose and were designed to contain graft material to facilitate a fusion between two vertebral bodies.
- Globus CALIBER® Spinal System (Primary) .
- CAPSTONE® Spinal System o
- CRESCENT® PEEK Spinal System ●
- Globus PATRIOT® Spinal System o
- SOVEREIGN® Spinal System ●
- Globus RISE® Spacer ●
- WAVE™ D Cage o
Additionally, like Globus CALIBER® Spinal System, the subject ELEVATE™ Spinal System is an expandable interbody device design and includes titanium alloy.
VII. Performance Data:
The following performance data were provided in support of substantial equivalence.
Biocompatibility
The biocompatibility evaluation for the ELEVATE™ Spinal System devices was conducted in accordance with FDA's Draft Guidance for Industry and FDA Staff "Use of International Standard ISO-10993, Biological Evaluation of Medical Devices Part 1: Evaluation and Testing" issued April, 23, 2013
The subject ELEVATE™ Spinal System implants are permanent implants and will be classified as permanent , >30 day body contact according to with FDA's Draft Guidance for Industry and FDA Staff "Use of International Standard ISO-10993, Biological Evaluation of Medical Devices Part 1: Evaluation and Testing". The subject implants are manufactured from identical materials as the predicate devices, in accordance with the following ASTM standards:
- ASTM F2026: Standard Specifications for Poletheretherketone Polymers . for Surgical Implant Applications
6
- ASTM F 560: Standard Specification for Unalloyed Tantalum for Surgical ● Implant Applications
- ASTM F136: Standard Specification for Wrought Ti-6Al-4V ELI Alloy . for Surgical Implant
The ELEVATE™ Spinal System instruments are external communicating devices and are classified as limited, up to 24 hours of body contact according to with FDA's Draft Guidance for Industry and FDA Staff "Use of International Standard ISO-10993, Biological Evaluation of Medical Devices Part 1: Evaluation and Testing". These instruments are manufactured from the same medical grade stainless steel and silicone as the predicate devices in accordance with the following ASTM standards:
- ASTM F899 Standard Specification for Wrought Stainless Steels for . Surgical Instruments
- ASTM A564 Standard Specification for Hot Rolled and Cold Finished . Age Hardening Stainless Steel Bars and Shapes
- ASTM A693 Standard Specification for Precipitation-Hardening Stainless . and Heat Resisting Steel Plate, Sheet and Strip
The case, trays, and lids used to for shipment and sterilization of instruments are manufactured from aluminum with either silicone or nylon coated brackets and are not patient contacting and do not require biocompatiblity testing.
The PEEK, tantalum, titanium alloy, medical grade stainless steel and silicone have a long history of safe and effective use in predicate spinal implants and instruments; based on this it was determined that biocompatibility testing is not required. No biocompatibility testing was conducted on the subject devices.
Mechanical Testing
In accordance with, Guidance for Industry and FDA Staff – Spinal System 510(k)'s", Medtronic has evaluated the subject devices to demonstrate substantial equivalence to the predicate devices.
Design verification testing was completed on the subject ELEVATE™ Spinal System in accordance with ASTM F2077-11 "Test Methods for Intervertebral Body Fusion Devices" and ASTM F2267-4 (2011) "Standard Test Method for Measuring Load Induced Subsidence of Intervertebral Body Fusion Device Under Static Axial Compression". The following testing was completed and tests met the predetermined acceptance criteria.
- . Static Compression
7
- Compression Fatigue ●
- Static Compression-Shear ●
- Compression-Shear Fatigue o
- Subsidence ●
Additional radiographic verification testing was completed demonstrating the substantial equalivence of the subject device to the predicates included in this submission.
In accordance with the FDA Guidance "Establishing Safety and Compatibility of Passive Implants in the Magnetic Resonance (MR) Environment" the subject ELEVATE™ Spinal System was evaluated for MR-safety in accordance with the following standards:
- ASTM F2052:2006 "Standard test method for measurement of . magnetically induced displacement force on passive implants in the magnetic resonance environment"
- ASTM F2213:2006 "Standard test method for measurement of ● magnetically induced torque on medical devices in the magnetic resonance environment"
- ASTM F2119:2007(R13) "Standard test method for evaluation of MR ● image artifacts from passive implants"
- ASTM F2182:2002a, 2011, 2011a "Standard test method for 0 measurement of radio frequency induced heating on or near passive implant during magnetic resonance imaging"
VIII. Conclusion:
Based on the risk analysis, test results, and additional supporting documentation provided in the pre-market notification, the subject ELEVATE™ Spinal System are as safe and effective as the following predicates:
- o Globus CALIBER® K102293 (S.E. January 5th, 2011)
- CAPSTONE® Spinal System K073291 & K123027 (S.E. April 24th, 2008 o & July 25th, 2013)
- CRESCENT® Spinal System K094025 (S.E. April 26th, 2010) O
- Globus PATRIOT® K072970 (S.E. January 18th, 2008) O
- SOVEREIGN® Spinal System K122037 (S.E March 22nd, 2013) o
- Globus RISE® Spacer K113447 (S.E. January 26, 2012) O
- WAVE™ D Cage K083626 & K121333 (S.E. October 17, 2009 & S.E. O June 29, 2012)