(163 days)
Not Found
No
The 510(k) summary describes a passive, additively manufactured interbody fusion device. There is no mention of AI, ML, image processing for analysis, or any software component that would suggest the use of such technologies. The performance studies focus on mechanical testing, not algorithmic performance.
Yes
The device is described as an intervertebral body fusion device indicated for treating cervical disc degeneration and/or spinal instability, which are medical conditions, and therefore falls under the definition of a therapeutic device.
No
This device is an implantable intervertebral body fusion device used for treatment, not for diagnosing a condition. It facilitates fusion of the cervical spine but does not analyze or interpret medical images or patient data to make a diagnosis.
No
The device description clearly states it is an "additively manufactured interbody fusion device for cervical implantation," which is a physical implant, 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, tissue) to provide information for diagnosis, monitoring, or screening.
- Device Description and Intended Use: The uCerv Flux™-C 3D Porous Titanium Cervical Interbody is a surgical implant designed to be placed within the body to facilitate spinal fusion. It is a physical device used for structural support and to promote bone growth, not for analyzing biological samples.
- Lack of IVD Characteristics: The description does not mention any components or processes related to analyzing biological specimens. The input imaging modalities (radiographs, CT, MRI) are used for visualizing the anatomy and condition, not for analyzing biological markers.
Therefore, the uCerv Flux™-C 3D Porous Titanium Cervical Interbody is a surgical implant, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The uCerv Flux™-C 3D Porous Titanium Cervical Interbody is indicated for intervertebral body fusion in skeletally mature patients with cervical disc degeneration and/or cervical spinal instability, as confirmed by imaging studies (radiographs, CT, MRI), that results in radiculopathy, myelopathy, and/or pain at multiple contiguous levels from C2-T1. The device system is designed for use with supplemental fixation cleared for use in the cervical spine and with autogenous and/or allogeneic bone graft comprised of cancellous and/or corticocancellous bone to facilitate fusion. Patients should have at least six (6) weeks of non-operative treatment prior to treatment with an intervertebral cage.
Product codes
ODP
Device Description
The uCerv Flux™-C 3D Porous Titanium Cervical Interbody implants are additively manufactured interbody fusion devices for cervical implantation. The implants are designed having porous surfaces to provide surgical stabilization of the spine. Each interbody has a central cavity that can be packed with autogenous and/or allogeneic bone graft comprised of cancellous and/or corticocancellous bone graft material and lateral windows for radiographic visualization. The implants are available in a variety of height, length, width and lordotic angulation combinations to accommodate the patient specific anatomy and clinical circumstances.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Cervical spine, C2-T1
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)
Mechanical testing of the worst case uCerv Flux™-C 3D Porous Titanium Cervical Interbody implants included static and dynamic axial compression and static and dynamic torsion according to ASTM F2077. In addition, subsidence according to ASTM F2267 and expulsion tests were performed. The mechanical test results demonstrate that the uCerv Flux™-C 3D Porous Titanium Cervical Interbody performance is substantially equivalent to the predicate devices.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
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
Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food & Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
August 19, 2022
ulrich medical USA, Inc. Hans Stover President & CEO 18221 Edison Avenue Chesterfield, Missouri 63005
Re: K220696
Trade/Device Name: uCerv Flux™-C 3D Porous Titanium Cervical Interbody Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral body fusion device Regulatory Class: Class II Product Code: ODP Dated: July 18, 2022 Received: July 19, 2022
Dear Hans Stover:
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
1
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 (OS) 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 Ouality Center for Devices and Radiological Health
Enclosure
2
Form Approved: OMB No. 0910-0120
Expiration Date: 06/30/2020
See PRA Statement below.
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
510(k) Number (if known)
Device Name
uCerv Flux™-C 3D Porous Titanium Cervical Interbody
Indications for Use (Describe)
The uCerv Flux™-C 3D Porous Titanium Cervical Interbody is indicated for intervertebral body fusion in skeletally mature patients with cervical disc degeneration and/or cervical spinal instability, as confirmed by imaging studies (radiographs, CT, MRI), that results in radiculopathy, and/or pain at multiple contiguous levels from C2-T1. The device system is designed for use with supplemental fixation cleared for use in the cervical spine and with autogenous and/or allogeneic bone graft comprised of cancellous bone to facilitate fusion. Patients should have at least six (6) weeks of non-operative treatment with an intervertebral cage.
| 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) |
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services
Food and Drug Administration
Office of Chief Information Officer
Paperwork Reduction Act (PRA) Staff
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
3
K220696
Page 1 of 2
510(k) Summary
Image /page/3/Picture/2 description: The image shows the logo for Ulrich medical USA. The logo consists of a black square on the left, followed by the word "Ulrich" in a stylized font. Below "Ulrich" is the text "medical USA" in a smaller, sans-serif font. The logo is simple and professional, suggesting a company in the medical field.
| Date: | 8 March 2022 |
|---|---|
| Sponsor: | ulrich medical USA, Inc. 18221 Edison Avenue Chesterfield, MO 63005 (636) 519-0268 Office (636) 519-0271 Fax |
| Sponsor Contact: | Hans Stover, President & CEO |
| 510(k) Contact: | Karen E. Warden, PhD BackRoads Consulting Inc. PO Box 566 Chesterland, OH 44026 Office: 440.729.8457 |
| Proposed Trade Name: | uCerv Flux™-C 3D Porous Titanium Cervical Interbody |
| Common Name: | Cervical interbody fusion device |
| Device Classification: | Class II |
| Regulation Name, Regulation Number, Product Code: | Intervertebral fusion device with bone graft, cervical, 888.3080, ODP |
| Device Description: | The uCerv Flux™-C 3D Porous Titanium Cervical Interbody implants are additively manufactured interbody fusion devices for cervical implantation. The implants are designed having porous surfaces to provide surgical stabilization of the spine. Each interbody has a central cavity that can be packed with autogenous and/or allogeneic bone graft comprised of cancellous and/or corticocancellous bone graft material and lateral windows for radiographic visualization. The implants are available in a variety of height, length, width and lordotic angulation combinations to accommodate the patient specific anatomy and clinical circumstances. |
| Indications for Use: | The uCerv Flux™-C 3D Porous Titanium Cervical Interbody is indicated for intervertebral body fusion in skeletally mature patients with cervical disc degeneration and/or cervical spinal instability, as confirmed by imaging studies (radiographs, CT, MRI), that results in radiculopathy, myelopathy, and/or pain at multiple contiguous levels from C2-T1. The device system is designed for use with supplemental fixation cleared for use in the cervical spine and with autogenous and/or allogeneic bone graft comprised of cancellous and/or corticocancellous bone to facilitate fusion. Patients should have at least six (6) weeks of non-operative treatment prior to treatment with an intervertebral cage. |
| Materials: | The uCerv Flux™-C 3D Porous Titanium Cervical Interbody implants are manufactured from Ti-6Al-4V ELI titanium alloy (ASTM F3001). The instrumentation for implantation is manufactured from medical grade stainless steel per ASTM F899. |
| Primary Predicate: | Cascadia™ Interbody System (K2M Inc. - K160125) |
4
| Performance Data: | Mechanical testing of the worst case uCerv Flux™-C 3D Porous Titanium
Cervical Interbody implants included static and dynamic axial compression
and static and dynamic torsion according to ASTM F2077. In addition,
subsidence according to ASTM F2267 and expulsion tests were performed.
The mechanical test results demonstrate that the uCerv Flux™-C 3D
Porous Titanium Cervical Interbody performance is substantially equivalent
to the predicate devices. |
|-----------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Technological
Characteristics: | The uCerv Flux™-C 3D Porous Titanium Cervical Interbody possesses the
same technological characteristics as one or more of the predicate devices.
These include:
• intended use (as described above)
• basic design (additively manufactured structure),
• material (titanium alloy) and
• sizes (dimensions are comparable to those offered by the predicate
systems)
The uCerv Flux™-C 3D Porous Titanium Cervical Interbody is the same as
previously cleared devices. |
| Conclusion: | The uCerv Flux™-C 3D Porous Titanium Cervical Interbody possesses the
same intended use and technological characteristics as the predicate
devices. Therefore the uCerv Flux™-C 3D Porous Titanium Cervical
Interbody is substantially equivalent for its intended use. |