(266 days)
No
The device description and intended use focus on the physical components and surgical procedure for a cervical cage. There is no mention of software, algorithms, or any features that would suggest the use of AI or ML. The performance studies are mechanical evaluations, not related to data analysis or image processing.
Yes
The device is a cervical cage indicated for anterior cervical interbody fusion procedures to treat cervical disc disease, which involves modifying the body's structure or function for a therapeutic purpose.
No
The Velofix™ SA Cervical Cage is an implant used for anterior cervical interbody fusion procedures, not for diagnosing conditions. Its purpose is to treat cervical disc disease by providing stability and promoting fusion, not to identify or characterize the disease itself.
No
The device description clearly outlines physical components made of titanium alloy and PEEK, indicating it is a hardware device for surgical implantation, not software.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to examine specimens taken from the human body (like blood, urine, or tissue) to provide information for diagnosis, monitoring, or screening.
- Velofix™ SA Cervical Cage Function: The Velofix™ SA Cervical Cage is a surgical implant designed to be placed within the body to facilitate bone fusion in the cervical spine. It is a structural device, not a diagnostic tool that analyzes biological samples.
- Intended Use: The intended use clearly describes a surgical procedure for treating cervical disc disease by providing structural support and promoting bone growth. It does not involve the analysis of biological specimens.
- Device Description: The description details the physical components of the implant (spacers, screws, plates) and their materials, not reagents or analytical components typical of IVDs.
The device is a surgical implant used in a therapeutic procedure, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The Velofix™ SA Cervical Cage is indicated for anterior cervical interbody fusion procedures in skeletally mature patients with cervical disc disease at one level from the C2-C3 disc to the C7-T1 disc. Cervical disc disease is defined as intractable radiculopathy and/or myelopathy with herniated disc and/or osteophyte formation on posterior vertebral endplates producing symptomatic nerve root and/or spinal cord compression confirmed by radiographic studies. The Velofix™ SA Cervical Cage implants are to be used with either autogenous bone graft and/or allogenic bone graft comprised of cancellous and/or corticocancellous bone graft, and implanted via an open, anterior approach. The Velofix™ SA Cervical Cage must be used with the internal screw fixation provided by screws of the Velofix™ SA Cervical Cage. This cervical device is to be used in patients who have had six weeks of non-operative treatment.
Product codes
OVE
Device Description
The Velofix™ SA Cervical Cage consists of spacers, screws, locking plate and set screw.
The spacers are available in various heights, width and have only 7° lordotic angle with an open architecture to accept packing of autograft or autogenous bone graft, while the medical grade titanium alloy screws have various diameters and length for fixing the spacers. The locking plate, made of radiolucent PEEK and titanium alloy, is to prevent screw loosening. The medical grade titanium alloy set screw is intended for fixation of the locking plate.
The Velofix™ SA Cervical Cage has three types:
-
- All PEEK Type
The spacer which is made of radiolucent PEEK spacer (polymer polyetherether-ketone, ASTM F2026) with the tantalum markers (ASTM F560).
- All PEEK Type
-
- Ti plate Type
The spacer which is a combination of radiolucent PEEK spacer with the x-ray markers and medical grade titanium alloy plate (Ti6Al4V ELI, ASTM F136).
- Ti plate Type
-
- Ti plate-N type
The spacer which is a combination of radiolucent PEEK spacer with the x-ray markers and medical grade titanium alloy plate (Ti6Al4V ELI, ASTM F136). Before surgery, the user can choice and assemble PEEK spacers and titanium alloy plates in order to size through patient's bone condition.
- Ti plate-N type
The Velofix™ SA Cervical Cage is implanted as a single device via an anterior approach.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Radiographic studies
Anatomical Site
Cervical spine, one level from the C2-C3 disc to the C7-T1 disc.
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)
The mechanical strength evaluation was conducted to compare data of proposed device of the Velofix™ SA Cervical Cage (K172424) and Galaxy ACIF Cage (K122872) and to verify there are no new safety and effectiveness issues were not raised by the proposed device. The mechanical performance of Velofix™ SA Cervical Cage met the acceptance criteria which have been established from the predicate devices.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Velofix™ SA Cervical Cage (K172424), Galaxy (ACIF, PLIF, TLIF and ALIF) Peek cage (K122872)
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
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November 19, 2021
U&I Corporation Young-eun Lee RA Specialist 20, Sandan-ro 76beon-gil(Rd) Uijeongbu-si, Gyeonggi-do 11781 South Korea
Re: K210573
Trade/Device Name: Velofix™ SA Cervical Cage Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral body fusion device Regulatory Class: Class II Product Code: OVE Dated: October 13, 2021 Received: October 18, 2021
Dear Young-eun Lee:
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
1
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 devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); 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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). 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 (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Brent Showalter, Ph.D. Assistant Director DHT6B: Division of Spinal Devices OHT6: Office of Orthopedic Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K210573
Device Name Velofix™ SA Cervical Cage
Indications for Use (Describe)
The Velofix™ SA Cervical Cage is indicated for anterior cervical interbody fusion procedures in skeletally mature patients with cervical disc disease at one level from the C2-C3 disc to the C7-T1 disc. Cervical disc disease is defined as intractable radiculopathy and/or myelopathy with herniated disc and/or osteophyte formation on posterior vertebral endplates producing symptomatic nerve root and/or spinal cord compression confirmed by radiographic studies. The Velofix™ SA Cervical Cage implants are to be used with either autogenous bone graft and/or allogenic bone graft comprised of cancellous and/or corticocancellous bone graft, and implanted via an open, anterior approach. The Velofix™ SA Cervical Cage must be used with the internal screw fixation provided by screws of the Velofix™ SA Cervical Cage. This cervical device is to be used in patients who have had six weeks of non-operative treatment.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| X Prescription Use (Part 21 CFR 801 Subpart D) | Over-The-Counter Use (21 CFR 801 Subpart C) |
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510(k) Summary K210573
| 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: | Young-eun Lee, RA Specialist
+82 31 860 6927
youngeun@youic.com |
| Date Prepared: | October 13, 2021 |
| Device Name: | Trade Name: Velofix™ SA Cervical Cage |
| Classification Name: | Intervertebral Fusion Device With Integrated Fixation, Cervical
, per 21 CFR 888.3080 |
| Common Name: | Intervertebral Body Fusion Device, IBF Device |
| Product Code: | OVE |
Predicate Devices:
Primary - Velofix™ SA Cervical Cage (K172424) Additional - Galaxy (ACIF, PLIF, TLIF and ALIF) Peek cage (K122872)
Purpose of submission:
This submission is to add new device to the original device, which the assembly method of spacers and plates with the increased length is different from the original device.
Description of Device:
The Velofix™ SA Cervical Cage consists of spacers, screws, locking plate and set screw.
The spacers are available in various heights, width and have only 7° lordotic angle with an open architecture to accept packing of autograft or autogenous bone graft, while the medical grade titanium alloy screws have various diameters and length for fixing the spacers. The locking plate, made of radiolucent PEEK and titanium alloy, is to prevent screw loosening. The medical grade titanium alloy set screw is intended
Velofix™ SA Cervical Cage
Image /page/3/Picture/11 description: The image shows the logo for U&I Group PLC. The logo consists of the letters "U" and "i" in a stylized font. The "U" is in black, and the "i" is also in black, but with a red dot above it. The ampersand symbol is placed between the "U" and the "i".
4
for fixation of the locking plate.
The Velofix™ SA Cervical Cage has three types:
-
- All PEEK Type
The spacer which is made of radiolucent PEEK spacer (polymer polyetherether-ketone, ASTM F2026) with the tantalum markers (ASTM F560).
- All PEEK Type
-
- Ti plate Type
The spacer which is a combination of radiolucent PEEK spacer with the x-ray markers and medical grade titanium alloy plate (Ti6Al4V ELI, ASTM F136).
- Ti plate Type
-
- Ti plate-N type
The spacer which is a combination of radiolucent PEEK spacer with the x-ray markers and medical grade titanium alloy plate (Ti6Al4V ELI, ASTM F136). Before surgery, the user can choice and assemble PEEK spacers and titanium alloy plates in order to size through patient's bone condition.
- Ti plate-N type
The Velofix™ SA Cervical Cage is implanted as a single device via an anterior approach.
Indications For Use:
The Velofix™ SA Cervical Cage is indicated for anterior cervical interbody fusion procedures in skeletally mature patients with cervical disc disease at one level from the C2-C3 disc to the C7-T1 disc. Cervical disc disease is defined as intractable radiculopathy and/or myelopathy with herniated disc and/or osteophyte formation on posterior vertebral endplates producing symptomatic nerve root and/or spinal cord compression confirmed by radiographic studies. The Velofix™ SA Cervical Cage implants are to be used with either autogenous bone graft and/or allogenic bone graft comprised of cancellous and/or corticocancellous bone graft, and implanted via an open, anterior approach. The Velofix™ SA Cervical Cage must be used with the internal screw fixation provided by screws of the Velofix™ SA Cervical Cage. This cervical device is to be used in patients who have had six weeks of non-operative treatment.
Substantial Equivalence:
The Velofix™ SA Cervical Cage is substantially equivalent to Velofix™ SA Cervical Cage (K172424) and Galaxy ACIF Cage (K122872) in design, material, mechanical performance, function and intended use.
The mechanical performance of Velofix™ SA Cervical Cage met the acceptance criteria which have been established from the predicate devices.
- Comparison Technological Characteristics
Velofix™ SA Cervical Cage
5
The predicate and proposed devices have the similar intended use and basic fundamental scientific technology and share the following similarities;
- The similar indications for use ●
- Similar design features ●
- Incorporate the same or similar materials
- The equivalent mechanical performance ●
2. Performance Testing
The mechanical strength evaluation was conducted to compare data of proposed device of the Velofix™ SA Cervical Cage (K172424) and Galaxy ACIF Cage (K122872) and to verify there are no new safety and effectiveness issues were not raised by the proposed device.
3. Conclusion
The data and information provided in this submission support the conclusion that the Velofix™ SA Cervical Cage is substantially equivalent to its predicate devices with respect to indications for use and technological characteristics.
Velofix™ SA Cervical Cage
Image /page/5/Picture/13 description: The image shows the logo for U&I. The logo is black with a red square on the top right corner of the I. The U is lowercase and the I is uppercase.