(108 days)
No
The summary describes a mechanical implant and instrumentation, with no mention of AI/ML in the intended use, device description, or performance studies.
Yes
The device is used for intervertebral body fusion at one or two contiguous levels in the lumbar spine in patients with degenerative disc disease, which directly addresses a medical condition to alleviate back pain and promote healing.
No.
The device is an intervertebral body fusion implant, indicated for surgical use in the lumbar spine to promote fusion, not to diagnose a condition.
No
The device description explicitly states it consists of "medical grade titanium alloy (Ti-6AL-4V, ELI) cages and implantation instrumentation," which are physical hardware components.
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 intervertebral body fusion in the lumbar spine. This is a therapeutic device, not a diagnostic one.
- Device Description: The device is described as a physical implant (cages) and associated instrumentation for surgical implantation. This aligns with a surgical device, not a diagnostic test.
- Lack of Diagnostic Elements: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting specific markers, or providing diagnostic information about a patient's condition.
- Performance Studies: The performance studies focus on mechanical testing of the implant's structural integrity and biocompatibility, which are relevant for surgical devices. There are no studies related to diagnostic accuracy or performance.
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
Elite™ Expandable implants are intervertebral body fusion devices indicated for intervertebral body fusion at one level or two contiguous levels in the lumbar spine from L2 to S1 in patients with degenerative disc disease (DDD) with up to Grade 1 spondylolisthesis at the involved level(s). DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies. These patients should be sketally mature and have had six months of non-operative treatment.
Elite™ Expandable implants are designed for use with autograft comprised of cancellous and/or corticocancellous bone graft as an adjunct to fusion and are intended for use with supplemental fixation systems cleared by the FDA for use in the lumbar spine.
Product codes
MAX
Device Description
The Elite™ Expandable Interbody Fusion System is designed for use as a lumbar intervertebral body fusion device and consists of medical grade titanium alloy (Ti-6AL-4V, ELI) cages and implantation instrumentation. The cages are available in various geometries and sizes to accommodate patient anatomy. The cages have ridges or teeth that resist rotation and migration and have cavities to accept packing of bone graft. Components of the Elite™ IBF Expandable Lumbar Fusion System should not be used with components of any other system or manufacturer.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
lumbar spine from L2 to S1
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
The following mechanical testing was conducted in accordance with FDA's Class II Special Controls Guidance Document: Intervertebral Fusion Device (2007) and applicable American Society for Testing and Materials (ASTM) standards:
ASTM F2077
- Static and Dynamic Axial Compression
- Subsidence
- Static and Dynamic Compression Shear
- Expulsion
- Static Torsion
Bacterial endotoxin testing (BET) was conducted in accordance with ANSI/AAMI ST-72:2011.
Key Metrics
Not Found
Predicate Device(s)
K133459, K160906, K102293, K113527
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.
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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
January 27, 2017
Spineology Inc. Ms. Jacqueline Hauge Regulatory Affairs Manager 7800 3rd Street North, Suite 600 St. Paul. Minnesota 55127
Re: K162879
Trade/Device Name: Elite™ Expandable Interbody Fusion Device Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral Body Fusion Device Regulatory Class: Class II Product Code: MAX Dated: December 21, 2016 Received: December 22, 2016
Dear Ms. Hauge:
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 devicerelated 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.
1
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/ResourcesforYou/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,
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
510(k) Number (if known)
Device Name
Elite™Expandable Interbody Fusion Device
Indications for Use (Describe)
Elite™ Expandable implants are intervertebral body fusion devices indicated for intervertebral body fusion at one level or two contiguous levels in the lumbar spine from L2 to S1 in patients with degenerative disc disease (DDD) with up to Grade 1 spondylolisthesis at the involved level(s). DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies. These patients should be sketally mature and have had six months of non-operative treatment.
Elite™ Expandable implants are designed for use with autograft comprised of cancellous and/or corticocancellous bone graft as an adjunct to fusion and are intended for use with supplemental fixation systems cleared by the FDA for use in the lumbar spine.
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) |
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510(k) Summary
| Date Prepared: | December 21, 2016 | |||
|---|---|---|---|---|
| Submitter: | Spineology Inc. | |||
| 7800 3rd Street North, Suite 600 | ||||
| Saint Paul, MN 55128 | ||||
| Establishment Registration Number: 2135156 | ||||
| Contact Person: | Jacqueline A. Hauge | |||
| Regulatory Affairs Manger | ||||
| Phone: 651.256.8534 Fax: 651.256.8505 | ||||
| Email: jhauge@spineology.com | ||||
| Device Name and Classification | ||||
| Trade Name: | Elite™ Expandable Interbody Fusion Device | |||
| Common Name: | Spinal implant | |||
| Classification Name: | Intervertebral body fusion device | |||
| Product Codes: | MAX | |||
| Regulatory Class: | Class II | |||
| Regulation Number: | 21 CFR 888.3080 |
Orthopedic
| Predicate Devices
| Primary: | K133459 | Elite™ Interbody Fusion Device (Innova Spinal Technologies, LLC) |
|---|---|---|
| Additional: | K160906 | Rampart™ O Lumbar Interbody Fusion Device (Spineology Inc.); |
| Rampart™ T Lumbar Interbody Fusion Device (Spineology Inc.); | ||
| Rampart™ A Lumbar Interbody Fusion Device (Spineology Inc.) | ||
| K102293 | Caliber® Spacer (Globus Medical Inc.) | |
| K113527 | Opticage® Expandable Interbody Fusion Device (Interventional Spine, Inc.) |
I. Purpose
Panel:
The purpose of this submission is to obtain FDA clearance of the Spineology Elite™ Expandable Interbody Fusion Device which is comprised of 10mm and 12mm Elite™ Expandable implantable devices and associated surgical instrumentation.
II. Previous Submissions
| 510(k) # | Device Name | Purpose of 510(k) |
|---|---|---|
| K133459 | 12mm Elite™ Interbody Fusion Device | Initial Clearance |
| K150954 | 12mm Elite™ L Interbody Fusion Device | Added Device |
No previous submissions have been submitted for the 10mm Elite™ Expandable device.
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K162879 page 2 of 2
510(k) Summary
III. Device Description
The Elite™ Expandable Interbody Fusion System is designed for use as a lumbar intervertebral body fusion device and consists of medical grade titanium alloy (Ti-6AL-4V, ELI) cages and implantation instrumentation. The cages are available in various geometries and sizes to accommodate patient anatomy. The cages have ridges or teeth that resist rotation and migration and have cavities to accept packing of bone graft. Components of the Elite™ IBF Expandable Lumbar Fusion System should not be used with components of any other system or manufacturer.
IV. Indications for Use
Elite™ Expandable implants are intervertebral body fusion devices indicated for intervertebral body fusion at one level or two contiguous levels in the lumbar spine from L2 to S1 in patients with degenerative disc disease (DDD) with up to Grade 1 spondylolisthesis at the involved level(s). DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies. These patients should be skeletally mature and have had six months of non-operative treatment.
Elite™ Expandable implants are designed for use with autograft and/or allograft comprised of cancellous and/or corticocancellous bone graft as an adjunct to fusion and are intended for use with supplemental fixation systems cleared by the FDA for use in the lumbar spine.
V. Technological Characteristics
Elite™ Expandable implants have the same technological characteristics as the predicate Elite Interbody Fusion Device, including design, intended use, material composition, and function.
VI. Non-Clinical Testing
The following mechanical testing was conducted in accordance with FDA's Class II Special Controls Guidance Document: Intervertebral Fusion Device (2007) and applicable American Society for Testing and Materials (ASTM) standards:
ASTM F2077
- ASTM F2267 • Static and Dynamic Axial Compression · Subsidence • Static and Dynamic Compression Shear
- Expulsion • Static Torsion
Bacterial endotoxin testing (BET) was conducted in accordance with ANSI/AAMI ST-72:2011.
VII. Conclusion
Based on the indications for use, technological characteristics, and comparison to the predicate devices, the Elite™ Expandable Interbody Fusion System has been shown to be substantially equivalent to legally marketed predicate devices.