(139 days)
No
The summary describes a mechanical expandable spacer and its associated inserter. There is no mention of software, algorithms, image processing, or any terms related to AI/ML. The performance studies are mechanical tests.
Yes.
The device is a medical implant used in intervertebral body fusion procedures to treat degenerative disc disease, which clearly falls under the definition of a therapeutic intervention.
No
The device is an expandable intervertebral body fusion device used for treatment, not for diagnosis. It is intended to be implanted with bone graft and supplemental fixation to treat degenerative disc disease.
No
The device description clearly states it is an "expandable lumbar intervertebral body fusion device manufactured from unalloyed commercially pure titanium" and includes a "reusable surgical instrument" for expansion. This indicates a physical hardware device, not software only.
Based on the provided information, 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 Leva® Anterior Expandable Spacer System is a physical implant designed to be surgically placed in the lumbar spine. It is used for intervertebral body fusion procedures.
- Intended Use: The intended use clearly describes a surgical procedure to treat degenerative disc disease by fusing vertebrae, not a diagnostic test performed on a sample.
The device is a surgical implant used in a therapeutic procedure, not a diagnostic test.
N/A
Intended Use / Indications for Use
The Leva® Anterior Expandable Spacer System is indicated for intervertebral body fusion procedures in skeletally mature patients with degenerative disc disease (DDD) of the lumbar spine at one or two contiguous levels from L2-S1. Degenerative disc disease is defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies. These DDD patients may have up to Grade I spondylolisthesis at the involved level(s). The Leva® Anterior Expandable Spacer System is to be used with autogenous bone graft and with supplemental fixation. Patients should have at least six (6) months of non-operative treatment with an intervertebral body fusion device.
Product codes
MAX
Device Description
The Leva® Anterior Expandable Spacer is an expandable lumbar intervertebral body fusion device manufactured from unalloyed commercially pure titanium per ASTM F67. The Leva® Anterior Expandable Inserter, a reusable surgical instrument, expands the spacer (which is provided in a collapsed form) in situ to a predefined height. To accommodate the anatomical needs of a variety of patients, the spacer is available in a range of sizes. The superior and inferior surfaces of the spacer are convex with a lordotic angle to conform to the vertebral endplates, and ridges on both surfaces help resist expulsion. The spacer is designed to accommodate autogenous bone graft material.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
lumbar spine at one or two contiguous levels from 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
Spine Wave performed the following testing to demonstrate that the Leva® Anterior Expandable Spacer System is substantially equivalent to its predicate:
- o Static and dynamic axial compression (per ASTM F2077)
- Static and dynamic compression shear (per ASTM F2077)
- Subsidence (per ASTM F2267)
- Cadaveric validation o
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
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
Spine Wave, Inc. Amy Noccioli Regulatory Affairs Specialist 3 Enterprise Drive, Suite 210 Shelton, Connecticut 06484
Re: K163246
Trade/Device Name: Leva® Anterior Expandable Spacer System Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral Body Fusion Device Regulatory Class: Class II Product Code: MAX Dated: March 2, 2017 Received: March 3, 2017
Dear Ms. Noccioli:
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 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/Resourcesfor You/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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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
510(k) Number (if known)
Device Name
Leva® Anterior Expandable Spacer System
Indications for Use (Describe)
The Leva® Anterior Expandable Spacer System is indicated for intervertebral body fission procedures in skeletally mature patients with degenerative disc disease (DDD) of the lumbar spine at one or two contiguous levels from L2-S1. Degenerative disc disease is defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies. These DDD patients may have up to Grade I spondylolisthesis at the involved level(s). The Leva® Anterior Expandable Spacer System is to be used with autogenous bone graft and with supplemental fixation. Patients should have at least six (6) months of non-operative treatment with an intervertebral body fusion device.
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 Leva® Anterior Expandable Spacer System
1. Submitter Information
| Submitter: | Spine Wave, Inc. |
|---|---|
| Address: | Three Enterprise Drive |
| Suite 210 | |
| Shelton, CT 06484 | |
| Telephone: | 203-712-1842 |
| Telefax: | 203-944-9493 |
| Contact: | Amy Noccioli |
| Date Prepared: | November 16, 2016 |
2. Device Information
| Trade Name: | Leva® Anterior Expandable Spacer System |
|---|---|
| Common Name: | Intervertebral Body Fusion Device |
| Classification: | Class II (special controls) per 21 CFR 888.3080 |
| Classification Name: | Intervertebral Fusion Device with Bone Graft, Lumbar |
| Product Code: | MAX |
3. Purpose of Submission
The purpose of this submission is to gain clearance for a new intervertebral body fusion device.
4. Predicate Device Information
The Leva® Anterior Expandable Spacer System described in this submission is substantially equivalent to the following predicates:
| Primary Predicate Device | Manufacturer | 510(k) No. |
|---|---|---|
| Leva® Spacer System | Spine Wave, Inc. | K141980 |
| Reference Predicate Devices | Manufacturer | 510(k) No. |
|---|---|---|
| MAGNIFYTM Spacer | Globus Medical, Inc. | K142498 |
| PATRIOT® Spacer | Globus Medical, Inc. | K072970 |
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5. Device Description
The Leva® Anterior Expandable Spacer is an expandable lumbar intervertebral body fusion device manufactured from unalloyed commercially pure titanium per ASTM F67. The Leva® Anterior Expandable Inserter, a reusable surgical instrument, expands the spacer (which is provided in a collapsed form) in situ to a predefined height. To accommodate the anatomical needs of a variety of patients, the spacer is available in a range of sizes. The superior and inferior surfaces of the spacer are convex with a lordotic angle to conform to the vertebral endplates, and ridges on both surfaces help resist expulsion. The spacer is designed to accommodate autogenous bone graft material.
6. Indications for Use
The Leva® Anterior Expandable Spacer System is indicated for intervertebral body fusion procedures in skeletally mature patients with degenerative disc disease (DDD) of the lumbar spine at one or two contiguous levels from L2-S1. Degenerative disc disease is defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies. These DDD patients may have up to Grade I spondylolisthesis or retrolisthesis at the involved level(s). The Leva® Anterior Expandable Spacer System is to be used with autogenous bone graft and with supplemental fixation. Patients should have at least six (6) months of non-operative treatment prior to treatment with an intervertebral body fusion device.
7. Comparison of Technological Characteristics
The Leva® Anterior Expandable Spacer System has technological characteristics similar to the predicate devices, including intended use, performance, design, material composition, and range of sizes.
8. Performance Data
Spine Wave performed the following testing to demonstrate that the Leva® Anterior Expandable Spacer System is substantially equivalent to its predicate:
- o Static and dynamic axial compression (per ASTM F2077)
- Static and dynamic compression shear (per ASTM F2077)
- Subsidence (per ASTM F2267)
- Cadaveric validation o
9. Conclusion
The indications for use, technological characteristics, performance testing, and comparison to the predicates show that the Leva® Anterior Expandable Spacer System is substantially equivalent to the predicate devices identified in this submission and does not present any new issues of safety or effectiveness.