(336 days)
K11123, P980048
Not Found
No
The summary describes a mechanical interbody fusion device and does not mention any software, algorithms, or data processing capabilities that would suggest the use of AI or ML.
Yes.
The device is used to facilitate intervertebral body fusion in the cervical spine to treat degenerative disc disease and radicular symptoms. This falls under the definition of a therapeutic device as it treats a medical condition.
No
Explanation: The Wenzel Spine VariLift® Cervical Interbody Fusion System is described as a device used to facilitate intervertebral body fusion, meaning it is a therapeutic device implanted to treat degenerative disc disease, not to diagnose a condition.
No
The device description explicitly states the device is composed of Titanium-6Al-4V ELI alloy and is a physical implant (expandable device with an interior sliding wedge). This indicates it is a hardware medical 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 medical devices used to perform tests on samples taken from the human body (like blood, urine, tissue) to provide information about a person's health.
- Device Description and Intended Use: The Wenzel Spine VariLift® Cervical Interbody Fusion System is a surgical implant designed to be placed directly into the cervical spine to facilitate bone fusion. It is a physical device used in a surgical procedure, not a test performed on a sample outside the body.
- Lack of IVD Characteristics: The description does not mention any testing of biological samples, analysis of biomarkers, or any other activity typically associated with IVDs.
Therefore, the Wenzel Spine VariLift® Cervical Interbody Fusion System is a surgical implant/device, not an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
The Wenzel Spine VariLift® Cervical Interbody Fusion System is indicated use in skeletally mature patients with degenerative disc disease (DDD) of the cervical spine with accompanying radicular symptoms at one disc level. DDD is defined as discogenic pain with degeneration of the disc confirmed by patient history and radiographic studies. These DDD patients may have up to Grade 1 spondylolisthesis or retrolisthesis at the involved level.
The Wenzel Spine VariLift Cervical Interbody Fusion System is used to facilitate intervertebral body fusion in the cervical spine and is placed in a unilateral fashion via an anterior approach at the C3 to C7 disc levels using autograft bone. The Wenzel Spine VariLift Cervical Interbody Fusion System may be used with or without supplemental fixation. Patients should have at least six (6) weeks of non-operative treatment prior to treatment with an intervertebral fusion device.
Product codes
ODP
Device Description
The Wenzel Spine VariLift Cervical Interbody Fusion System is self-tapping, expandable devices with an interior sliding wedge. 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 VariLift Cervical device is grooved and fluted with large fenestrations (graft windows) positioned between each of its four quadrants that provide bony contact with the endplates.
The device is supplied in an appropriately labeled sterile packaging.
The instrument case is 10 inch X 20 inch. All instruments for VariLift-C fit on a single tray.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
cervical spine, C3 to C7 disc levels
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
Whereas the only change submitted for this Premarket Notification is a change in the Indications for Use, no new performance data is being submitted.
Key Metrics
Not Found
Predicate Device(s)
K11123, P980048
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.
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510(k) SUMMARY Wenzel Spine's VariLift-C
| Date: | February 10, 2012 | ||
|---|---|---|---|
| Contact: | Wenzel Spine, LLC | ||
| Sourabh Mishra | |||
| JAN 2 9 2013 | |||
| Chief Technical Officer | |||
| 206 Wild Basin Road | |||
| Building A, Suite 203 | |||
| 512-501-4017 | |||
| Austin, TX 78746 | |||
| Trade Name: | |||
| Common Name: | |||
| Product Class: | |||
| Classification: | VariLift® Cervical Interbody Fusion Device | ||
| Intervertebral body fusion device | |||
| Class II | |||
| 21 CFR §888.3080 Orthosis, intervertebral body fusion device | |||
| Product Code: | |||
| Panel Code: | ODP | ||
| 87 | |||
| Name of Device and Name/Address of Sponsor |
Wenzel Spine, LLC
206 Wild Basin Road Building A, Suite 203 Austin, TX 78746 512-501-4017
Device Description
The Wenzel Spine VariLift Cervical Interbody Fusion System is self-tapping, expandable devices with an interior sliding wedge. 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 VariLift Cervical device is grooved and fluted with large fenestrations (graft windows) positioned between each of its four quadrants that provide bony contact with the endplates.
The device is supplied in an appropriately labeled sterile packaging.
The instrument case is 10 inch X 20 inch. All instruments for VariLift-C fit on a single tray.
Predicate Devices
The VariLift-C was shown to be substantially equivalent to legally marketed predicate device. The predicate devices are the VariLift Cervical Interbody Fusion System (K11123) and the BAK/C Interbody Fusion Device (P980048).
SUBSTANTIAL EQUIVALENCE CLAIMED TO PREDICATE DEVICES
The VariLift Cervical Interbody Fusion System is substantially equivalent to the VariLift-C device previously cleared and the BAK®/C Vista Cage in terms of intended use, design, and materials used. The table below compares the features and characteristics of the VariLift Cervical Interbody Fusion System to these predicate devices.
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K120603
| Items | VariLift Cervical
Interbody Fusion
System | VariLift Cervical
Interbody Fusion
System | BAK®/C-Vista Interbody
Fusion System |
|-----------------------|-------------------------------------------------|-------------------------------------------------|------------------------------------------|
| Sponsor | Wenzel Spine | Wenzel Spine | Zimmer |
| 510(K) Number | N/A | K111123 | P980048 S003 |
| Indications for Use | Per FDA Guidance | Per FDA Guidance | Per FDA Guidance |
| Material | Ti-6Al-4V alloy per
ASTM F136 | Ti-6Al-4V alloy per
ASTM F136 | PEEK Optima LT1 |
| Implant Levels | One Level | One Level | One Level |
| # Implants per level | Single or Pairs | Single or Pairs | Single or Pairs |
| Supplemental Fixation | With or Without
Supplemental Fixation | With Supplemental
Fixation | With or Without
Supplemental Fixation |
Intended Use / Indications for Use
The Wenzel Spine VariLift® Cervical Interbody Fusion System is indicated use in skeletally mature patients with degenerative disc disease (DDD) of the cervical spine with accompanying radicular symptoms at one disc level. DDD is defined as discogenic pain with degeneration of the disc confirmed by patient history and radiographic studies. These DDD patients may have up to Grade 1 spondylolisthesis or retrolisthesis at the involved level.
The Wenzel Spine VariLift Cervical Interbody Fusion System is used to facilitate intervertebral body fusion in the cervical spine and is placed in a unilateral fashion via an anterior approach at the C3 to C7 disc levels using autograft bone. The Wenzel Spine VariLift Cervical Interbody Fusion System may be used with or without supplemental fixation. Patients should have at least six (6) weeks of non-operative treatment prior to treatment with an intervertebral fusion device.
Performance Data
Whereas the only change submitted for this Premarket Notification is a change in the Indications for Use, no new performance data is being submitted.
Summary:
The VariLift-C Interbody Fusion Device and predicate devices have the same intended use, to provide mechanical stability in the cervical disc space to facilitate biologic fusion. The indications for use of the VariLift-C Interbody Fusion Device are exactly the same as one of the predicate devices. Moreover, the device is very similar in its size to the predicate device. The materials used are also the same as in the predicate device. There are no significant differences in technological characteristics compared to the predicate devices, and the minor differences that do exist do not raise any new types of safety or efficacy issues. Furthermore, clinical data presented demonstrates that these differences do not adversely impact device performance, as discussed below.
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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
January 29, 2013
Wenzel Spine, LLC % Mr. Sourabh Mishra Chief Technical Officer 206 Wild Basin Road Building A. Suite 203 Austin, Texas 78746
Re: K120603
Trade/Device Name: VariLift-C® Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral body fusion device Regulatory Class: Class II Product Code: ODP Dated: January 8, 2013 Received: January 11, 2013
Dear Mr. 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.
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
3
Page 2 – Mr. Sourabh Mishra
forth in the quality systems (OS) 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,
Mark N. Melkerson
Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use Statement
510(k) Number (if known): K120603
Device Name: VariLift-C
Indications for Use:
The Wenzel Spine VariLift® Cervical Interbody Fusion System is indicated use in skeletally mature patients with degenerative disc disease (DDD) of the cervical spine with accompanying radicular symptoms at one disc level. DDD is defined as discogenic pain with degeneration of the disc confirmed by patient history and radiographic studies. These DDD patients may have up to Grade 1 spondylolisthesis or retrolisthesis at the involved level.
The Wenzel Spine VariLift Cervical Interbody Fusion System is used to facilitate intervertebral body fusion in the cervical spine and is placed in a unilateral fashion via an anterior approach at the C3 to C7 disc levels using autograft bone. The Wenzel Spine VariLift Cervical Interbody Fusion System may be used with or without supplemental fixation. Patients should have at least six (6) weeks of non-operative treatment prior to treatment with an intervertebral fusion device.
Prescription Use V (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Stephanie; Bechtold -S 2013.01.29 15:43:40 -05'00'
Concurrence of CDRH, Office of Device Evaluation (ODE)
(Division Sign-Off) Division of Orthopedic Devices 510 (k) Number: K120603
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