(126 days)
No
The summary describes a mechanical interbody fusion device and its materials, with no mention of AI/ML capabilities or related performance metrics.
Yes
The device is described as a "stand-alone system indicated for intervertebral body fusion procedures" for treating "degenerative disc disease (DDD) of the lumbar spine," which directly addresses a medical condition to restore function.
No
This device is an intervertebral body fusion system, indicated for surgical implantation to treat degenerative disc disease, not for diagnosing conditions.
No
The device description explicitly states it is a family of stand-alone lumbar intervertebral body fusion devices fabricated from Ti-6A1-4V and Ti-6A1-4V ELI, which are metallic materials used for physical implants. The performance studies also describe mechanical testing of these physical devices.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens taken from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening.
- Leva® Anterior Interbody System Function: The Leva® Anterior Interbody System is a surgical implant designed to be placed within the human body to facilitate bone fusion in the lumbar spine. It is a therapeutic device, not a diagnostic one.
- Intended Use: The intended use clearly states it's for "intervertebral body fusion procedures" and is a "stand-alone system indicated for intervertebral body fusion procedures." This describes a surgical intervention, not a diagnostic test.
- Device Description: The description details the materials and design of a physical implant, not a device for analyzing biological samples.
- Performance Studies: The performance studies focus on the mechanical properties and safety of the implant itself (compression, shear, push-out, subsidence, bacterial endotoxin), not on the accuracy or reliability of a diagnostic test.
The mention of "radiographic studies" in the "Input Imaging Modality" section refers to the imaging used to diagnose the patient's condition (DDD) and potentially guide the surgical procedure, but the Leva® device itself does not perform or process these images for diagnostic purposes.
N/A
Intended Use / Indications for Use
The Leva® Anterior Interbody System is a stand-alone system 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 Interbody System is intended to be filled with autogenous bone graft material and used with the bone screws provided. Patients should have at least six (6) months of non-operative treatment with an intervertebral body fusion device.
Product codes
OVD
Device Description
The Leva® Anterior Interbody System is family of stand-alone lumbar intervertebral body fusion devices fabricated from Ti-6A1-4V per ASTM F1472 and Ti-6A1-4V ELI per ASTM F136. The device includes integrated plate/screw fixation available in two configurations. In both device configurations, the surgeon inserts the bone screws through the anterior plate screw holes to provide fixation to the vertebral bodies. The device is intended to be filled with autogenous bone graft material. Both implant configurations are provided in various dimensions to accommodate the anatomical needs for a range of patients. The implants have convex endplates to conform to the bony endplates of the patient and ridges on the endplates to resist expulsion.
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
Spine Wave performed the following testing to demonstrate the Leva® Anterior Interbody System is substantially equivalent to its predicate:
- Static and dynamic axial compression (per ASTM F2077)
- Static and dynamic compression shear (per ASTM F2077)
- Static push-out (per ASTM Draft F-04.25.02.02)
- Subsidence (per ASTM F2267)
Bacterial endotoxin testing (BET) was conducted in accordance with ANSI/AAMI ST-72:2011.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
K130445, K122168, K120101, K133947, K142487, K073109
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 features the department's name in a circular arrangement around a symbol. The symbol consists of a stylized caduceus, which is a staff with two snakes entwined around it, often used as a symbol of medicine. The logo is simple and recognizable, representing the department's mission to protect the health of all Americans.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
November 22, 2016
Spine Wave, Inc. Sanja Jahr Regulatory Affairs Specialist 3 Enterprise Drive, Suite 210 Shelton, Connecticut 06484
Re: K161993
Trade/Device Name: Leva® Anterior Interbody System Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral body fusion device Regulatory Class: Class II Product Code: OVD Dated: October 27, 2016 Received: October 28, 2016
Dear Sanja Jahr:
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, Vincent J. Devlin -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)
K161993
Device Name Leva® Anterior Interbody System
Indications for Use (Describe)
The Leva® Anterior Interbody System is a stand-alone system 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 Interbody System is intended to be filled with autogenous bone graft material and used with the bone screws provided. 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)
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."
Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below.
3
Image /page/3/Picture/1 description: The image shows the words "Spine Wave" in a bold, sans-serif font. The word "Spine" is on the left, and the word "Wave" is on the right. A blue wave design is underneath the word "Wave" and extends to the left, under the word "Spine."
510(k) Summary Leva® Anterior Interbody System
1. Submitter Information
| Submitter: | Spine Wave, Inc. |
|---|---|
| Address: | Three Enterprise Drive |
| Suite 210 | |
| Shelton, CT 06484 | |
| Telephone: | 203-712-1870 |
| Telefax: | 203-944-9493 |
| Contact: | Sanja Jahr |
| Date Prepared: | October 27, 2016 |
2. Device Information
| Trade Name: | Leva® Anterior Interbody System |
|---|---|
| Common Name: | Intervertebral Body Fusion Device |
| Classification: | Class II (special controls) per 21 CFR 888.3080 |
| Classification Name: | Intervertebral Fusion Device with Integrated Fixation, Lumbar |
| Product Code: | OVD |
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 Interbody System described in this submission is substantially equivalent to the following predicates:
| Primary Predicate Device | Manufacturer | 510(k) No. |
|---|---|---|
| Zuma System | SeaSpine | K082926 |
| Reference Predicate Devices | Manufacturer | 510(k) No. |
| Vault ALIF System | Precision Spine | K130445 |
| VisuALIF | SpineSmith | K122168 |
| Independence | Globus | K120101 |
| Irix-A | X-Spine | K133947 |
| Chesapeake Stabilization System | K2M | K142487 |
| The STALIF TTTM | Surgicraft Spine | K073109 |
4
5. Device Description
The Leva® Anterior Interbody System is family of stand-alone lumbar intervertebral body fusion devices fabricated from Ti-6A1-4V per ASTM F1472 and Ti-6A1-4V ELI per ASTM F136. The device includes integrated plate/screw fixation available in two configurations. In both device configurations, the surgeon inserts the bone screws through the anterior plate screw holes to provide fixation to the vertebral bodies. The device is intended to be filled with autogenous bone graft material. Both implant configurations are provided in various dimensions to accommodate the anatomical needs for a range of patients. The implants have convex endplates to conform to the bony endplates of the patient and ridges on the endplates to resist expulsion.
6. Indications for Use
The Leva® Anterior Interbody System is a stand-alone system 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 Interbody System is intended to be filled with autogenous bone graft material and used with the bone screws provided. 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 Interbody System has the same technological characteristics as 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 the Leva® Anterior Interbody System is substantially equivalent to its predicate:
- Static and dynamic axial compression (per ASTM F2077) ●
- Static and dynamic compression shear (per ASTM F2077) ●
- Static push-out (per ASTM Draft F-04.25.02.02)
- Subsidence (per ASTM F2267)
Bacterial endotoxin testing (BET) was conducted in accordance with ANSI/AAMI ST-72:2011.
9. Conclusion
Based on the indications for use, technological characteristics, performance testing and comparison to the predicates, the Leva® Anterior Interbody System has been shown to be substantially equivalent to the predicate devices identified in this submission and does not present any new issues of safety or effectiveness.