(126 days)
None
No
The summary describes a mechanical implant (interbody fusion device) and its components. There is no mention of software, algorithms, image processing, or any terms related to AI/ML. The performance studies are mechanical tests, not algorithmic performance evaluations.
Yes
The device is indicated for use in patients with degenerative disc disease, which is a medical condition, making it a therapeutic device designed to treat or alleviate a disease.
No
This device is an anterior interbody fusion device (a PEEK spacer, titanium interbody plate and screws) used for treatment of degenerative disc disease, not for diagnosis. Its purpose is to physically fuse vertebrae, not to identify or assess medical conditions.
No
The device description explicitly details physical components made of PEEK and titanium, including a spacer, plate, and screws. The performance studies also focus on mechanical testing of these physical components. There is no mention of software as a component or function of the device.
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 and Intended Use: The Zavation Z-Link Lumbar is a physical implantable device (a spinal fusion device) used in surgery to treat degenerative disc disease. It is not a test performed on a sample outside the body.
- Lack of IVD Characteristics: The description does not mention any analysis of biological samples, reagents, or laboratory procedures, which are hallmarks of IVD devices.
Therefore, the Zavation Z-Link Lumbar is a surgical implant, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The Zavation Z-Link Lumbar is a stand-alone anterior interbody fusion device indicated for use in patients with degenerative disc disease (DDD) at one or two contiguous levels from L2 to S 1. DDD is defined as back pain of discogenic origin 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 DDD patients may also have up to Grade I spondylolisthesis at the involved level(s). The interior of the spacer component of the Z-Link Lumbar is to be filled with autogenous bone graft material.
Product codes
OVD
Device Description
The Zavation Z-Link Lumbar includes a PEEK spacer, titanium interbody plate and screws. The spacer component is assembled to an interbody plate and implanted anteriorly. The endplate contacting surfaces of the spacer component include serrations, and the plate component includes four holes for inserting two bone screws in each vertebral body. The plate component also includes a screw lock at each hole. The bone screws are available in a variety of diameters and lengths. The interbody plate components are available in a variety of heights. The spacer components are available in a variety of depths, widths, and heights.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
L2 to S1 (lumbar spine)
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, sample size, AUC, MRMC, standalone performance, key results)
Mechanical test results demonstrated that the Zavation Z-Link Lumbar is substantially equivalent to the predicate devices. Testing was performed in accordance with:
- ASTM F2077, Test Methods for Intervertebral Body Fusion Devices
- Static Axial Compression
- Dynamic Axial Compression
- Static Shear
- Dynamic Shear
- ASTM F2267, Standard Test Method for Measuring Load Induced Subsidence of an Intervertebral Body Fusion Device Under Static Axial Compression
- ASTM Draft F04.25.02.02, Static Pushout Test Method for Intervertebral Body Fusion Devices.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Synthes SynFix-LR (K072253), Zavation IBF System (K120576)
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
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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
December 19, 2014
Zavation, LLC Mr. Lawrence Walker Engineering Manager 400 Liberty Park Flowood, Mississippi 39232
Re: K142271
Trade/Device Name: Zavation Z-Link Lumbar Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral Body Fusion Device Regulatory Class: Class II Product Code: OVD Dated: November 25, 2014 Received: November 26, 2014
Dear Mr. Walker:
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
Page 2 - Mr. Lawrence Walker
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
510(k) Number (if known) K142271
Device Name Zavation Z-Link Lumbar
Indications for Use (Describe)
The Zavation Z-Link Lumbar is a stand-alone anterior interbody fusion device indicated for use in patients with degenerative disc disease (DDD) at one or two contiguous levels from L2 to S 1. DDD is defined as back pain of discogenic origin 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 DDD patients may also have up to Grade I spondylolisthesis at the involved level(s). The interior of the spacer component of the Z-Link Lumbar is to be filled with autogenous bone graft material.
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
Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)
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510K Summary
| Date: | December 19, 2014 |
|---|---|
| Submitter: | Zavation LLC |
| 400 Liberty Park Drive | |
| Flowood, MS 39232 | |
| Phone: 601-919-1119 | |
| Fax: 800-447-1302 | |
| Contact person: | Lawrence Walker |
| Type of 510(k) submission: | Traditional |
| Trade name: | Zavation Z-Link Lumbar |
| Common name: | Intervertebral Fusion Device with Integrated Fixation, Lumbar |
| Classification regulation: | 21 CFR 888.3080 Intervertebral body fusion device |
| Device classification: | Class II |
| Classification Panel: | Orthopedic |
| Product code: | OVD |
| Basis for submission: | New device |
Device Description:
The Zavation Z-Link Lumbar includes a PEEK spacer, titanium interbody plate and screws. The spacer component is assembled to an interbody plate and implanted anteriorly. The endplate contacting surfaces of the spacer component include serrations, and the plate component includes four holes for inserting two bone screws in each vertebral body. The plate component also includes a screw lock at each hole. The bone screws are available in a variety of diameters and lengths. The interbody plate components are available in a variety of heights. The spacer components are available in a variety of depths, widths, and heights.
4
Intended Use:
The Zavation Z-Link Lumbar is a stand-alone anterior interbody fusion device indicated for use in patients with degenerative disc disease (DDD) at one or two contiguous levels from L2 to S 1. DDD is defined as back pain of discogenic origin 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 DDD patients may also have up to Grade I spondylolisthesis at the involved level(s). The interior of the spacer component of the Z-Link Lumbar is to be filled with autogenous bone graft material.
Materials:
The spacer component is manufactured from medical grade PEEK Zeniva ZA-500 (ASTM F2026) with a Tantalum alloy position marker (ASTM F560). The plate and screws are titanium alloy (ASTM F136).
Predicate Devices:
Synthes SynFix-LR (K072253) - Primary Zavation IBF System (K120576)
Performance Data:
Mechanical test results demonstrated that the Zavation Z-Link Lumbar is substantially equivalent to the predicate devices. Testing was performed in accordance with:
- ASTM F2077, Test Methods for Intervertebral Body Fusion Devices .
- o Static Axial Compression
- o Dynamic Axial Compression
- Static Shear o
- Dynamic Shear O
- . ASTM F2267, Standard Test Method for Measuring Load Induced Subsidence of an Intervertebral Body Fusion Device Under Static Axial Compression
- . ASTM Draft F04.25.02.02, Static Pushout Test Method for Intervertebral Body Fusion Devices.
Summary of Technological Characteristics:
The Zavation Z-link Lumbar device is substantially equivalent to the cited predicate(s) in design, material, and intended use.
Conclusions:
The device description and testing completed demonstrate that the device is substantially equivalent to the cited predicates for the stated intended use.