(128 days)
No
The summary describes a physical implant (a spinal cage) and its materials. There is no mention of software, algorithms, image processing, or any terms related to AI/ML.
Yes.
The Velofix™ TLIF Cage is indicated for intervertebral body fusion to treat degenerative disc disease, which is a therapeutic intervention.
No
The Velofix™ TLIF Cage is an implantable device used for intervertebral body fusion, not for diagnosis. Its description and intended use clearly define it as a therapeutic and structural support device, not one that gathers or analyzes data for diagnostic purposes.
No
The device description clearly states it is an implantable cage made of PEEK and/or Titanium alloy, which are hardware components.
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, or tissue) to provide information for diagnosis, monitoring, or screening.
- Velofix™ TLIF Cage Function: The Velofix™ TLIF Cage is a surgical implant designed to be placed within the human body to facilitate spinal fusion. It is a structural device, not a diagnostic tool that analyzes biological samples.
The provided text clearly describes a medical device intended for surgical implantation, not for in vitro diagnostic testing.
N/A
Intended Use / Indications for Use
The Velofix™ TLIF Cage is indicated for intervertebral body fusion at one level or two contiguous levels in the lumbar spine from L2 to S1 in patients with degenerative disc disease (DDD) with up to Grade I spondylolisthesis at the involved level(s). DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies. These patients should be skeletally mature and have had six months of non-operative treatment. The Velofix™ TLIF Cage is to be used with supplemental internal spinal fixation. Additionally, the Velofix™ TLIF Cage is to be used with autogenous bone graft material.
Product codes
MAX
Device Description
The Velofix™ TLIF Cage consists of implants available in various heights, width, length and angle with an open architecture to accept packing of auto bone graft material. The Velofix™ TLIF Cage may be implanted a single device via a transforaminal approach and adopted to the anterior anatomy of the vertebral endplates.
The Velofix™ TLIF Cage device has two types: the one is consisted of cage body (PEEK), articulating component (Ti Alloy) and radiographic markers (Tantalum); the other is consisted of cage body and articulating component made of Ti Alloy. The articulating component is for attachment to the inserter instrument to allow the cage to pivot to the final positioning.
The Velofix™ TLIF Cage implant is manufactured from either
- Polyetheretherketone (PEEK) with a titanium alloy for articulating component (Ti6Al4V ELI), and tantalum radiographic markers for spinal applications, or
- Titanium alloy (Ti6Al4V ELI) for cage body and articulating component for spinal applications.
The Velofix™ TLIF Cage is implanted by using the instruments manufactured from stainless steel materials that conform to ASTM F899.
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
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)
Any mechanical test in non clinical setting (bench testing) was not conducted on the Velofix™ TLIF Cage. However, the mechanical strength evaluation was conducted to compare data of proposed device of the Velofix "" TLIF Cage (K172419) and to verify there are no new safety and effectiveness issues were not raised by the proposed device. The Velofix™ TLIF Cage is substantially equivalent to predicate devices.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Velofix™ TLIF Cage (K172419), Altus Spine Titanium Interbody Fusion System (K170512)
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
November 14, 2018
Image /page/0/Picture/1 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left, there is a symbol representing the Department of Health & Human Services. To the right, the FDA logo is displayed in blue, with the words "U.S. FOOD & DRUG" stacked above the word "ADMINISTRATION".
U&I Corporation Jee-Ae Bang RA Specialist 20, Sandan-ro 76beon-gil(Rd) Uijeongbu-si. Gyeonggi-do. 11781 Korea
Re: K181829
Trade/Device Name: Velofix™ TLIF Cage Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral Body Fusion Device Regulatory Class: Class II Product Code: MAX Dated: October 19, 2018 Received: October 23, 2018
Dear Jee-Ae Bang:
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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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 of medical device-related adverse events) (21 CFR 803) for
1
devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.html; good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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 comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Katherine D. Kavlock -S
for Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2020 See PRA Statement below.
510(k) Number (if known)
K181829
Device Name Velofix™ TLIF Cage
Indications for Use (Describe)
The Velofix™ TLIF Cage is indicated for intervertebral body fusion at one level or two contiguous levels in the lumbar spine from L2 to S1 in patients with degenerative disc disease (DDD) with up to Grade I spondylolisthesis at the involved level(s). DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies. These patients should be skeletally mature and have had six months of non-operative treatment. The Velofix™ TLIF Cage is to be used with supplemental internal spinal fixation. Additionally, the Velofix™ TLIF Cage is to be used with autogenous bone graft material.
| 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) |
|---|---|
| ------------------------------------------------- | -------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------- |
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DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
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6. 510(k) Summary
| Manufacturer: | U & I Corporation
20, Sandan-ro 76beon-gil(Rd), Uijeongbu-si, Gyeonggi-do,
11781, Korea, |
|----------------------|------------------------------------------------------------------------------------------------|
| Sponsor: | U & I Corporation
20, Sandan-ro 76beon-gil(Rd), Uijeongbu-si, Gyeonggi-do,
11781, Korea, |
| Sponsor Contact: | Jee-Ae Bang, RA Specialist
+82 31 860 6846
bbangzhi@youic.com |
| Date Prepared: | July 06, 2018 |
| Device Name: | Trade Name: VelofixTM TLIF Cage |
| Classification Name: | Spinal Intervertebral Body Fusion Device, Lumbar
, per 21 CFR 888.3080 |
| Common Name: | Intervertebral Body Fusion Device, IBF Device |
| Product Code: | MAX |
Predicate Device:
Primary - Velofix™ TLIF Cage (K172419) Additional - Altus Spine Titanium Interbody Fusion System (K170512)
Purpose of submission:
This submission is to introduce a titanium alloy (per ASTM F136) of the Velofix™ TLIF Cage.
Description of Device:
The Velofix™ TLIF Cage consists of implants available in various heights, width, length and angle with an open architecture to accept packing of auto bone graft material. The Velofix™ TLIF Cage may be implanted a single device via a transforaminal approach and adopted to the anterior anatomy of the vertebral endplates.
The Velofix™ TLIF Cage device has two types: the one is consisted of cage body (PEEK), articulating component (Ti Alloy) and radiographic markers (Tantalum); the other is consisted of cage body and articulating component made of Ti Alloy. The articulating component is for attachment to the inserter instrument to allow the cage to pivot to the final positioning.
4
The Velofix™ TLIF Cage implant is manufactured from either
-
Polyetheretherketone (PEEK) with a titanium alloy for articulating component (Ti6Al4V ELI), and tantalum radiographic markers for spinal applications, or
-
Titanium alloy (Ti6Al4V ELI) for cage body and articulating component for spinal applications.
The Velofix™ TLIF Cage is implanted by using the instruments manufactured from stainless steel materials that conform to ASTM F899.
Indications for Use:
The Velofix™ TLIF Cage is indicated for intervertebral body fusion at one level or two contiguous levels in the lumbar spine from L2 to S1 in patients with degenerative disc disease (DDD) with up to Grade I spondylolisthesis at the involved level(s). DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies. These patients should be skeletally mature and have had six months of non-operative treatment.
The Velofix™ TLIF Cage is to be used with supplemental internal spinal fixation. Additionally, the Velofix™ TLIF Cage is to be used with autogenous bone graft material.
Substantial Equivalence:
Velofix™ TLIF Cage is substantially equivalent to Velofix™ TLIF Cage (K172419) and Altus Spine Titanium Interbody Fusion System (K170512) in design, material, mechanical performance, function and intended use.
-
- Comparison Technological Characteristics
The predicate and proposed devices have the same intended use and basic fundamental scientific technology and share the following similarities;
- Comparison Technological Characteristics
-
The same indications for use ●
-
Similar design features ●
- . Pyramidal teeth on superior and inferior surfaces.
- Self-distracting nose which allows for insertion. .
- . Articulation mechanism which allows the cage to pivot to final positioning.
- Large graft cavity for bone graft packing to help aid in the fusion process. •
- . Anterior and posterior side holes.
- . Various lordosis angles(0°, 5°, 8°).
-
Incorporate the same or similar materials
-
The equivalent mechanical performance
5
2. Performance Testing
Any mechanical test in non clinical setting (bench testing) was not conducted on the Velofix™ TLIF Cage. However, the mechanical strength evaluation was conducted to compare data of proposed device of the Velofix "" TLIF Cage (K172419) and to verify there are no new safety and effectiveness issues were not raised by the proposed device. The Velofix™ TLIF Cage is substantially equivalent to predicate devices.
3. Conclusion
The data and information provided in this submission support the conclusion that the Velofix™ TLIF Cage is substantially equivalent to predicate devices with respect to indications for use and technological characteristics.