(135 days)
Not Found
No
The summary describes a mechanical interbody fusion device made of titanium alloy. There is no mention of software, algorithms, or data processing that would indicate the use of AI or ML. The performance studies are based on mechanical testing and clinical trial results, not AI/ML model performance metrics.
Yes
The device is intended for intervertebral body fusion to treat degenerative disc disease and is implanted in the body.
No
The device is an interbody fusion system designed for surgical implantation to treat degenerative disc disease, not to diagnose it.
No
The device description clearly states that the device is composed of physical components made of Titanium-6AI-4V ELI alloy, which are implanted into the lumbar spine. This indicates a hardware-based medical device, not a software-only one.
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 Wenzel Spine VariLift Interbody Fusion System is a physical implant designed to be surgically placed in the lumbar spine to facilitate fusion. It is a medical device used in vivo (within the body), not a test performed in vitro (outside the body).
- Lack of IVD Characteristics: The description does not mention any analysis of biological samples, reagents, or laboratory procedures, which are characteristic of IVDs.
Therefore, the Wenzel Spine VariLift Interbody Fusion System is a surgical implant, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The Wenzel Spine VariLift Interbody Fusion System (VariLift-L and VariLift-A) is indicated for intervertebral body fusion of the lumbar spine, from L2 to Sl, in skeletally mature patients who have had six months of non-operative treatment. The device is intended for use at either one level or two contiguous levels 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.
VariLift-L is designed to be implanted bi-laterally via a posterior (PLIF) approach or as a single device via a transverse (TLIF) approach. VariLift-A is designed to be implanted bi-laterally via an anterior (ALIF) approach. VariLift-L and VariLift-A may be implanted with or without supplemental fixation and are intended for use with autograft to facilitate fusion.
Product codes (comma separated list FDA assigned to the subject device)
MAX
Device Description
The proposed Wenzel Spine VariLift Interbody Fusion System will be offered in two (2) configurations of various sizes that are designed based on indicated spinal implant level and surgical approach, and consist of:
-
- VariLift-L, which may be implanted bi-laterally via a posterior lumbar (PLIF) approach or as a single device via a transverse (TLIF) approach.
-
- VariLift-A, which may be implanted bi-laterally via an anterior (ALIF) approach.
The VariLift-L and VariLift-A are grooved and fluted devices with large fenestrations (araft windows) positioned between each of its four quadrants that provide bony contact with the endplates. The VariLift-L and VariLift-A are self-tapping, expandable devices with an interior sliding wedge and a posterior end cap. The devices are cylindrical-ovoid in shape, which is adapted to the general shape of the vertebral end plates. All components are composed of Titanium-6AI-4V ELI alloy that conforms to ASTM F136.
- VariLift-A, which may be implanted bi-laterally via an anterior (ALIF) approach.
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)
Non-Clinical Testing:
- Static and dynamic compression testing, conducted in accordance with ASTM -F2077-03
- Static shear testing, conducted in accordance with ASTM F2077-03
- Dynamic torsion testing, conducted in accordance with ASTM F2077-03
- Subsidence testing, conducted in accordance with ASTM F2267-04
- Expulsion testing, conducted in accordance with ASTM Draft Standard F--04.25.02.02
Results: Substantially equivalent results of non-clinical testing relative to static and dynamic testing (per ASTM F2077-03), subsidence (per ASTM F2267-04), and expulsion (per ASTM Draft Standard F-04.25.02.02).
Clinical Testing:
Clinical data were also submitted, the results of which demonstrate that the Wenzel Spine VariLift Interbody Fusion System is substantially equivalent to the predicate(s). The clinical trial was conducted solely without the use of supplemental fixation.
Results: Substantially equivalent results of clinical testing, conducted solely without supplemental fixation.
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.
BAK® Cage (P950002), RAY® Threaded Fusion Cage (P950019), Lumbar I/F Cage (P960025), Asfora Bullet Cage System (K090048), Paramount (K072120), L-Varlock (K080537)
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
Wenzel Spine VariLift Interbody Fusion System (VariLift-L and VariLift-A)
510(k) Summary of Safety and Effectiveness
| SUBMITTED BY | Wenzel Spine
206 Wild Basin Rd
Building A, Suite 203
Austin, TX 78746 |
|--------------------------------------|----------------------------------------------------------------------------------------|
| | AUG 05 2011 |
| ESTABLISHMENT
REGISTRATION NUMBER | 3008009850 |
| CONTACT PERSON | Sourabh Mishra
Chief Technology Officer
Phone: 512-501-4017
Fax: 512-469-0604 |
| SUBMISSION PREPARED BY | Lisa Peterson
QA Consulting, Inc.
Phone: 512-507-0746 |
| DATE PREPARED | March 10, 2010 |
| CLASSIFICATION NAME | MAX 888.3080- Intervertebral Fusion Device with
Bone Graft, Lumbar |
| COMMON NAME | Intervertebral Body Fusion Device (MAX) |
| PROPRIETARY NAME | VariLift Interbody Fusion System (VariLift-L and
VariLift-A) |
| IDENTIFICATION OF PREDICATES | -
BAK® Cage (P950002)
RAY® Threaded Fusion Cage (P950019) |
| - BAK® Cage (P950002) |
|---|
| - RAY® Threaded Fusion Cage (P950019) |
| - Lumbar I/F Cage (P960025) |
| - Asfora Bullet Cage System (K090048) |
| - Paramount (K072120) |
| - L-Varlock (K080537). |
DEVICE DESCRIPTION
1
The proposed Wenzel Spine VariLift Interbody Fusion System will be offered in two (2) configurations of various sizes that are designed based on indicated spinal implant level and surgical approach, and consist of:
-
- VariLift-L, which may be implanted bi-laterally via a posterior lumbar (PLIF) approach or as a single device via a transverse (TLIF) approach.
1
-
- VariLift-A, which may be implanted bi-laterally via an anterior (ALIF) approach.
The VariLift-L and VariLift-A are grooved and fluted devices with large fenestrations (araft windows) positioned between each of its four quadrants that provide bony contact with the endplates. The VariLift-L and VariLift-A are self-tapping, expandable devices with an interior sliding wedge and a posterior end cap. The devices are cylindrical-ovoid in shape, which is adapted to the general shape of the vertebral end plates. All components are composed of Titanium-6AI-4V ELI alloy that conforms to ASTM F136.
- VariLift-A, which may be implanted bi-laterally via an anterior (ALIF) approach.
INDICATIONS:
The Wenzel Spine VariLift Interbody Fusion System (VariLift-L and VariLift-A) is indicated for intervertebral body fusion of the lumbar spine, from L2 to Sl, in skeletally mature patients who have had six months of non-operative treatment. The device is intended for use at either one level or two contiguous levels 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.
VariLift-L is designed to be implanted bi-laterally via a posterior (PLIF) approach or as a single device via a transverse (TLIF) approach. VariLift-A is designed to be implanted bi-laterally via an anterior (ALIF) approach. VariLift-L and VariLift-A may be implanted with or without supplemental fixation and are intended for use with autograft to facilitate fusion.
SUMMARY OF TECHNOLOGICAL CHARACTERISTICS
The purpose of this premarket notification is to obtain clearance to market the Wenzel Spine VariLift Interbody Fusion System (VariLift-L and VariLift-A), which mav be implanted with or without supplemental fixation and is intended for use with autograft to facilitate fusion. The Wenzel Spine VariLift Interbody Fusion System is offered in two (2) configurations of various sizes that are designed based on surgical approach, and consist of:
-
- VariLift-L, which may be implanted bi-laterally via a posterior lumbar (PLIF) approach or as a single device via a transverse (TLIF) approach.
-
- VariLift-A, which may be implanted bi-laterally via an anterior (ALIF) approach.
The VariLift-L and VariLift-A are self-tapping, expandable devices with an interior sliding wedge and a posterior end cap. The devices are cylindrical-ovoid in shape, which is adapted to the general shape of the vertebral end plates. All components are composed of Titanium-6Al-4V ELI alloy that conforms to ASTM F136.
The subject and predicate devices have similar technological characteristics and the minor differences do not raise any new issues of safety and effectiveness. Specifically, the following characteristics support this conclusion:
- Intended for use at either one level or two contiguous levels for the treatment of । degenerative disc disease (DDD) with up to Grade I spondylolisthesis
- Threaded and expandable implant design -
- Implant material: Titanium-6Al-4V ELI alloy that conforms to ASTM F136 -
- Substantially equivalent results of non-clinical testing relative to static and dynamic testing (per ASTM F2077-03), subsidence (per ASTM F2267-04), and expulsion (per ASTM Draft Standard F-04.25.02.02).
2
- Substantially equivalent results of clinical testing, conducted solely without supplemental fixation.
DISCUSSION OF NON-CLINICAL TESTING
The following non-clinical tests were conducted:
- Static and dynamic compression testing, conducted in accordance with ASTM -F2077-03
- Static shear testing, conducted in accordance with ASTM F2077-03 ー
- Dynamic torsion testing, conducted in accordance with ASTM F2077-03 -
- Subsidence testing, conducted in accordance with ASTM F2267-04 -
- Expulsion testing, conducted in accordance with ASTM Draft Standard F--04.25.02.02
DISCUSSION OF CLINICAL TESTING
Clinical data were also submitted, the results of which demonstrate that the Wenzel Spine VariLift Interbody Fusion System is substantially equivalent to the predicate(s). The clinical trial was conducted solely without the use of supplemental fixation.
CONCLUSIONS
The subject and predicate devices share the same intended use, implant design and material of manufacture. The non-clinical and clinical test results demonstrate that any minor differences do not impact device performance as compared to the predicates. The non-clinical and clinical test results demonstrate that the VariLift System is substantially equivalent to the predicate devices and support the use of VariLift with or without supplemental fixation.
3
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/3/Picture/1 description: The image shows the logo for the Department of Health & Human Services USA. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" around the perimeter. Inside the circle is a stylized image of an eagle.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
Wenzel Spine % Sourabh Mishra, Ph.D. Chief Technology Officer 206 Wild Basin Road Building A. Suite 203 Austin, Texas 78746
AUG 0 5 2010
Re: K100820
Trade/Device Name: Wenzel Spine VariLift Interbody Fusion System Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral body fusion device Regulatory Class: Class II Product Code: MAX Dated: July 14, 2010 · Received: July 23, 2010
Dear Dr. Mishra:
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.
4
Page 2 - Sourabh Mishra, Ph.D.
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 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 go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. 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 Small Manufacturers, International and Consumer Assistance 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 yours.
Sincerely yours,
Mark McMullen
Mark N. Melkerson Director Division of Surgical, Orthopedic And Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
5
INDICATIONS FOR USE
510(k) Number (if known): K100820 -
Device Name:
Wenzel Spine VariLift Interbody Fusion System
Indications for Use:
The Wenzel SpineVariLift Interbody Fusion System (VariLift-L and VariLift-A) is indicated for intervertebral body fusion of the lumbar spine, from L2 to SI, in skeletally mature patients who have had six months of nonoperative treatment. The device is intended for use at either one level or two contiguous levels 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.
VariLift-L is designed to be implanted bi-laterally via a posterior (PLIF) approach or as a single device via a transverse (TLIF) approach. VariLift-A is designed to be implanted bi-laterally via an anterior (ALIF) approach. VariLift-L and VariLift-A may be implanted with or without supplemental fixation and are intended for use with autograft to facilitate fusion.
Prescription Use × (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (21 CFR 807 Subpart C)
AUG 0 5 2010
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
signature
(Division Sign-Off) Division of Surgical, Orthopedic, and Restorative Devices
KIOO820 510(k) Number_
2720 Bee Cave Road Austin, Texas 78746 Wenzel Spine
Phone: 512-501-4017 Fax: 512-469-0604