(168 days)
Not Found
No
The summary describes a physical implantable device (spinal cage) and its associated instruments. There is no mention of software, algorithms, image processing, AI, ML, or any data analysis components that would suggest the use of AI/ML. The performance studies are bench tests of the physical device's mechanical properties.
Yes
The device is described as an "interbody body fusion" device used in patients with degenerative disc disease to facilitate fusion, which is a therapeutic intervention.
No
The device is described as an intervertebral body fusion system (a "cage") designed to facilitate fusion in patients with degenerative disc disease, functioning as an implant. Its purpose is therapeutic (fusion), not diagnostic.
No
The device description clearly states it is an implantable cage made of PEEK and tantalum markers, and is implanted using stainless steel instruments. These are physical hardware components, not software.
Based on the provided information, 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™ PEEK Cervical/Lumbar Cage Function: The Velofix™ PEEK Cervical/Lumbar Cage is an implantable medical device designed for intervertebral body fusion in the spine. It is a physical structure intended to facilitate bone growth and stabilize the spine.
- Lack of Specimen Analysis: The description of the device and its intended use does not involve the analysis of any biological specimens from the patient. It is surgically implanted directly into the body.
Therefore, the Velofix™ PEEK Cervical/Lumbar Cage falls under the category of an implantable surgical device, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The VelofixTM PEEK Cervical Cage is intervertebral body fusion in skeletally mature patients with degenerative disc disease (DDD) of the cervical spine with accompanying radicular symptoms at one disc level from the C2-C3 disc to the C7-T disc. DDD is defined as discogenic pain with degeneration of the disc confirmed by history and radiographic studies. The device system is designed for use with supplemental fixation and with autograft to to facilitate fusion. Patients should have at least six weeks of nonoperative treatment prior to treatment with an intervertebral cage.
The VelofixTM PEEK Lumbar Cage is indicated for use with autogenous with degenerative disc disease(DD) at one or two levels for L2 to S1. These DDD patients may also have up w Grade I Spondylolisthesis at the involved levels. DDD is defined as back pain of discongenic origin with degeneration of the disc confirmed by history and radiographic studies. These patients should be skeletally mature and six months of non-operative treasment. These devices are intended to be used with supplemental fixation.
Product codes (comma separated list FDA assigned to the subject device)
ODP, MAX
Device Description
The Velofix™ Interbody Fusion System consists of implants available in various heights, width and angle with an open architecture to accept packing of bone graft material.
And consist of:
-
- Cervical Interbody Fusion Device (Velofix™ PEEK Cervical Cage), which may be implanted as a single device via an anterior approach.
-
- Lumbar Interbody Fusion Device (Velofix™ PEEK Lumbar Cage), which may be implanted.
- o Bilaterally via a posterior(PLIF) approach;
- o As a single device via a transforaminal(TLIF) approach;
The implants are made of radiolucent polymer polyether-ether-ketone(PEEK-
OPTIMA LT 1, ASTM F2026) body with the x-ray markers made of tantalum markers (ASTM F560).
The Velofix™ PEEK(Cervical and Lumbar) 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
Cervical spine, L2 to S1 (lumbar)
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)
The Velofix™ Interbody Fusion System was tested in a non clinical setting (bench testing) to assess that to no new safety and efficiency issues were raised with this device. The testing met all acceptance criteria and verifies that performance of the Velofix Interbody Fusion System is substantially equivalent to the predicate devices.
The following tests were performed:
-
- Velofix™ PEEK Cervical Cage
- (1) Static compression test according to ASTM F2077
- (2) Static torsion test according to ASTM F2077
- (3) Dynamic compression test according to ASTM F2077
- (4) Dynamic torsion test according to ASTM F2077
- (5) Subsidence test according to ASTM F2267
2) Velofix™ PEEK Lumbar Cage
- (1) Static compression test according to ASTM F2077
- (2) Dynamic compression test according to ASTM F2077
- (3) Subsidence test according to ASTM F2267
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.
K122872, P980048, K092336, K082342
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
MAR 0 5 2014
510(k) Summary
| Manufacturer: | U & I Corporation
20, Sandan-ro 76beon-gil(Rd), Uijeongbu-si, Gyeonggi-do,
Korea, 480-859 |
|----------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Sponsor: | U & I Corporation
20, Sandan-ro 76beon-gil(Rd), Uijeongbu-si, Gyeonggi-do,
Korea, 480-859 |
| Sponsor Contact: | Gyeong-Je Kwon, Regulatory Affairs Specialist
+82 31 852 0102 (ext.610)
kkjane@youic.com |
| Date Prepared: | February 28, 2014 |
| Device Name: | Trade Name: Velofix™ Interbody Fusion System |
| Classification Name: | Spinal Intervertebral Body Fusion Device, Cervical
Spinal Intervertebral Body Fusion Device, Lumbar
. per 21 CFR 888.3080 |
| Common Name: | Intervertebral Body Fusion Device, IBF Device |
| Product Code: | ODP, MAX |
| Predicate Devices: | Galaxy (ACIF, PLIF, TLIF) PEEK Cage (K122872)
BAK/Cervical Interbody Fusion System (P980048)
C-Thru™ Anterior Spinal System (K092336)
Capstone Spinal System (K082342) |
Description of Device:
The Velofix™ Interbody Fusion System consists of implants available in various heights, width and angle with an open architecture to accept packing of bone graft material.
And consist of:
-
- Cervical Interbody Fusion Device (Velofix™ PEEK Cervical Cage), which may be implanted as a single device via an anterior approach.
-
- Lumbar Interbody Fusion Device (Velofix™ PEEK Lumbar Cage), which may be implanted.
- o Bilaterally via a posterior(PLIF) approach;
- o As a single device via a transforaminal(TLIF) approach;
The implants are made of radiolucent polymer polyether-ether-ketone(PEEK-
Image /page/0/Picture/12 description: The image shows the logo for U&I Corporation. The logo is in black and white. The letters U&I are stacked on top of each other, with the "U" on top and the "I" on the bottom. The word "CORPORATION" is to the right of the letters U&I.
Velofix™ Interbody Fusion System
1
OPTIMA LT 1, ASTM F2026) body with the x-ray markers made of tantalum markers (ASTM F560).
The Velofix™ PEEK(Cervical and Lumbar) Cage is implanted by using the instruments manufactured from stainless steel materials that conform to ASTM F899.
Intended Use:
The Velofix 110 PEEK Cervical Cage is indicated for intervertebral body fusion in skeletally mature patients with degenerative disc disease (DDD) of the cervical spine with accompanying radicular symptoms at one disc level from the C2-C3 disc to the C7-T1 disc. DDD is defined as discogenic pain with degeneration of the disc confirmed by history and radiographic studies. The device system is designed for use with supplemental fixation and with autograft to to facilitate fusion. Patients should have at least six weeks of non-operative treatment prior to treatment with an intervertebral cage.
The Velofix™ PEEK Lumbar Cage is indicated for use with autogenous bone graft in patients with degenerative disc disease(DDD) at one or two levels for L2 to S1. These DDD patients may also have up to Grade 1 Spondylolisthesis or retrolisthesis at the involved levels. DDD is defined as back pain of discongenic 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 devices are intended to be used with supplemental fixation.
Substantial Equivalence:
The Velofix™ Interbody Fusion System is substantially equivalent to Galaxy (ACIF, PLIF, TLIF) PEEK Cage (K122872), BAK/Cervical Interbody Fusion System (P980048), C-Thru™ Anterior Spinal System (K092336), Capstone Spinal System (K082342) in design, material, mechanical performance, function and intended use.
The mechanical performance of Velofix 110 Interbody Fusion System met the acceptance criteria which have been established from the predicate devices.
-
- Comparison Technological Characteristics
The predicate and proposed devices have the similar intended use and basic fundamental scientific technology and share the following similarities;
- Comparison Technological Characteristics
-
The similar indications for use
-
Similar design features
Velofix™ Interbody Fusion System
U&i CORPORATION
2
- Incorporate the same or similar materials .
- The equivalent mechanical performance
2. Performance Testing
The Velofix™ Interbody Fusion System was tested in a non clinical setting (bench testing) to assess that to no new safety and efficiency issues were raised with this device. The testing met all acceptance criteria and verifies that performance of the Velofix Interbody Fusion System is substantially equivalent to the predicate devices.
The following tests were performed:
-
- Velofix™ PEEK Cervical Cage
- (1) Static compression test according to ASTM F2077
- (2) Static torsion test according to ASTM F2077
- (3) Dynamic compression test according to ASTM F2077
- (4) Dynamic torsion test according to ASTM F2077
- (5) Subsidence test according to ASTM F2267
2) Velofix™ PEEK Lumbar Cage
- (1) Static compression test according to ASTM F2077
- (2) Dynamic compression test according to ASTM F2077
- (3) Subsidence test according to ASTM F2267
-
- Conclusion
The data and information provided in this submission support the conclusion that the Velofix "Interbody Fusion System is substantially equivalent to its predicate devices with respect to indications for use and technological characteristics.
U&i CORPORATION
Velofix™ Interbody Fusion System
3
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol that resembles a stylized caduceus or a bird-like figure with three wing-like shapes.
Public Health Service
Food and Drug Administration 0903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring MD 20993-0002
March 5, 2014
U & I Corporation Gyeong Je-Kwon Regulatory Affairs Specialist 20. Sandan-ro 76beon-gil(Rd), Uijeongbu-si, Gyeonggi-do Korea, 480-859
Re: K132926
Trade/Device Name: Velofix™ Interbody Fusion System Regulation Number: 21 CFR 888.3080 Regulation Name: Spinal intervertebral body fusion device Regulatory Class: Class II Product Code: ODP, MAX Dated: January 24, 2014 Received: January 27, 2014
Dear Mr. Gyeong Je-Kwon:
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 oonly war an an 2011, labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set
4
Page 2 - Mr. Gyeong Je-Kwon
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 Small Manufacturers, International and Consumer Assistance at its tollfree number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/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 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,
Vincent 同 golin -S
for
Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
5
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement on last page.
510(k) Number (if known) KI32926
Device Name
VelofixTM Interbody Fusion System
Indications for Use (Describe)
The VelofixTM PEEK Cervical Cage is intervertebral body fusion in skeletally mature patients with degenerative disc disease (DDD) of the cervical spine with accompanying radicular symptoms at one disc level from the C2-C3 disc to the C7-T disc. DDD is defined as discogenic pain with degeneration of the disc confirmed by history and radiographic studies. The device system is designed for use with supplemental fixation and with autograft to to facilitate fusion. Patients should have at least six weeks of nonoperative treatment prior to treatment with an intervertebral cage.
The VelofixTM PEEK Lumbar Cage is indicated for use with autogenous with degenerative disc disease(DD) at one or two levels for L2 to S1. These DDD patients may also have up w Grade I Spondylolisthesis at the involved levels. DDD is defined as back pain of discongenic origin with degeneration of the disc confirmed by history and radiographic studies. These patients should be skeletally mature and six months of non-operative treasment. These devices are intended to be used with supplemental fixation.
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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Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)
FORM FDA 3881 (1/14)
PSC Database Service TOOL INSTALLATION UF
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