(245 days)
Not Found
No
The summary describes a mechanical implant for spinal fusion and does not mention any software, algorithms, or data processing that would indicate the use of AI/ML. The performance studies are mechanical tests, not algorithmic performance evaluations.
Yes.
The device is used to treat degenerative disc disease and provide structural stability in spinal fusion procedures, which are therapeutic interventions.
No
The device is an implantable medical device used for spinal fusion procedures, not for diagnosing conditions.
No
The device description clearly states it is a physical implant (lumbar interbody fusion device) made of material and designed for surgical insertion, not a software program.
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.
- Device Description: The Zavation Posterior LEIF is a surgical implant designed to be placed inside the body to provide structural support for spinal fusion. It is a physical device used in a surgical procedure, not a test performed on a sample outside the body.
- Intended Use: The intended use describes a surgical procedure for treating a specific condition (degenerative disc disease) by fusing vertebrae. It does not involve analyzing biological samples for diagnostic purposes.
Therefore, based on the provided information, the Zavation Posterior LEIF is a surgical implant, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The Zavation Posterior LEIF(Lateral Expandable Interbody Fusion) implants are indicated for spinal fusion procedures to be used with autogenous bone graft in skeletally mature patients. The Zavation Posterior LEIF implants are intended for use at either one level or two contiguous levels in the lumbar spine, from L2 to S1, for the treatment of degenerative disc disease (DDD) with up to Grade I spondylolisthesis. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. The device is intended to be used in patients who have had six months of non-operative treatment.
The Zavation Posterior LEIF implants are intended to be used with supplemental internal fixation appropriate for the implanted level, including Zavation Spinal System.
Product codes (comma separated list FDA assigned to the subject device)
MAX
Device Description
The Zavation Posterior LEIF(Lateral Expandable Interbody Fusion) devices are lumbar interbody fusion devices used to provide structural stability in skeletally mature individuals following discectomy. The implants are provided in a shape that accommodates a posterior or transforaminal approach to the lumbar spine. After insertion the implant can be expanded to a larger footprint. The devices are available in various heights and geometric options to fit the anatomical needs of a wide variety of patients. These implants are to be filled with autogenous bone graft material. Serrations on the superior and inferior surfaces of each device grip the endplates of the adjacent vertebrae to resist expulsion.
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 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)
Mechanical test results demonstrated that the Zavation Posterior LEIF 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): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Zavation IBF System (K120576), Vertebral Technologies InterFuse T (K110226)
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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 is a stylized representation of three human profiles facing right, layered on top of each other. The profiles are white against a dark background.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
April 29, 2015
Zavation, LLC Mr. Lawrence Walker Engineering Manager 400 Liberty Park Flowood, Mississippi 39232
Re: K142392
Trade/Device Name: Zavation Posterior LEIF Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral body fusion device Regulatory Class: Class II Product Code: MAX Dated: March 27, 2015 Received: March 30, 2015
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) K142392
Device Name Zavation Posterior LEIF
Indications for Use (Describe)
The Zavation Posterior LEIF(Lateral Expandable Interbody Fusion) implants are indicated for spinal fusion procedures to be used with autogenous bone graft in skeletally mature patients. The Zavation Posterior LEIF implants are intended for use at either one level or two contiguous levels in the lumbar spine, from L2 to S1, for the treatment of degenerative disc disease (DDD) with up to Grade I spondylolisthesis. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. The device is intended to be used in patients who have had six months of non-operative treatment.
The Zavation Posterior LEIF implants are intended to be used with supplemental internal fixation appropriate for the implanted level, including Zavation Spinal System.
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)
PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.
FOR FDA USE ONLY
Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)
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."
3
510K Summary
| Date: | March 27, 2015 |
|---|---|
| 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 Posterior LEIF |
| Common name: | Intervertebral Body Fusion Device |
| Classification regulation: | 21 CFR 888.3080 Intervertebral body fusion device |
| Device classification: | Class II |
| Classification Panel: | Orthopedic |
| Product code: | MAX |
| Basis for submission: | New device |
Device Description:
The Zavation Posterior LEIF(Lateral Expandable Interbody Fusion) devices are lumbar interbody fusion devices used to provide structural stability in skeletally mature individuals following discectomy. The implants are provided in a shape that accommodates a posterior or transforaminal approach to the lumbar spine. After insertion the implant can be expanded to a larger footprint. The devices are available in various heights and geometric options to fit the anatomical needs of a wide variety of patients. These implants are to be filled with autogenous bone graft material. Serrations on the superior and inferior surfaces of each device grip the endplates of the adjacent vertebrae to resist expulsion.
4
Intended Use:
The Zavation Posterior LEIF(Lateral Expandable Interbody Fusion) implants are indicated for spinal fusion procedures to be used with autogenous bone graft in skeletally mature patients. The Zavation Posterior LEIF implants are intended for use at either one level or two contiguous levels in the lumbar spine, from L2 to S1, for the treatment of degenerative disc disease (DDD) with up to Grade I spondylolisthesis. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. The device is intended to be used in patients who have had six months of non-operative treatment.
The Zavation Posterior LEIF implants are intended to be used with supplemental internal fixation appropriate for the implanted level, including Zavation Spinal System.
Materials:
The spacer component is manufactured from medical grade PEEK Zeniva ZA-500 (ASTM F2026) with a Tantalum alloy position marker (ASTM F560). And pins per titanium alloy (ASTM F136).
Predicate Devices:
Zavation IBF System (K120576) Primary Vertebral Technologies InterFuse T (K110226)
Performance Data:
Mechanical test results demonstrated that the Zavation Posterior LEIF 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 o
- Dynamic Axial Compression o
- 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.
Comparison of Technological Characteristics:
The Zavation Posterior LEIF possesses the same technological characteristics as both predicates with one exception. They are the same in heights, lengths, widths, insertion method, and material construction. The one exception is that the footprint of the Zavation Posterior LEIF and the Vertebral Technologies InterFuse can both be expanded wider than their insertion width, but the Zavation IBF devices are only available in a fixed footprint.
Basis for Substantial Equivalence:
The Zavation Posterior LEIF devices are similar to the predicate systems with respect to technical characteristics, performance and intended use. The information provided within this premarket notification supports substantial equivalence of the subject spacers to the predicate devices.