(7 days)
No
The summary describes a physical implant device and its mechanical properties, with no mention of software, algorithms, or data processing that would indicate AI/ML.
Yes
The device is indicated for intervertebral body fusion in patients with cervical disc degeneration and/or cervical spinal instability to alleviate radiculopathy, myelopathy, and/or pain. This clinical purpose aligns with the definition of a therapeutic device.
No
The device is an intervertebral body fusion device (an implant) used for treatment, not for diagnosis. It requires pre-existing imaging studies (radiographs, CT, MRI) for confirmation of conditions, but it does not perform diagnostic functions itself.
No
The device description clearly states it is an "additively manufactured interbody fusion device" made of "3D Porous Titanium," indicating it is a physical implant, not software.
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, tissue) to provide information for diagnosis, monitoring, or screening.
- Device Function: The uCerv Flux™-C 3D Porous Titanium Cervical Interbody is a surgical implant. Its purpose is to be surgically placed in the cervical spine to facilitate bone fusion and provide structural support.
- Intended Use: The intended use clearly describes a surgical procedure for treating cervical disc degeneration and instability, not analyzing biological samples.
- Device Description: The description details the physical characteristics of the implant, not a method for analyzing biological specimens.
- Performance Studies: The performance studies focus on mechanical testing of the implant's structural integrity, not the accuracy of a diagnostic test.
This device falls under the category of a surgical implant or medical device used in a surgical procedure, 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, and/or pain at multiple contiquous 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 and/or demineralized allograft bone with bone marrow aspirate to facilitate fusion. The hyperlordotic implants (>= 10°) are required to be used with an anterior cervical plate. Patients should have at least six (6) weeks of nonoperative treatment prior to treatment with an intervertebral caqe.
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
radiographs, CT, MRI
Anatomical Site
cervical disc, 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 Flux-C devices was relied upon in support of the original uCerv Flux™-C 3D Porous Titanium Cervical Interbody clearance. The testing included static and dynamic axial compression and static torsion according to ASTM F2077 and subsidence according to ASTM F2267. An engineering rationale was used to demonstrate that the additional cervical interbody sizes did not introduce a new worst case.
Mechanical testing of the worst case subject uCerv Flux™-C 3D Porous Titanium Cervical Interbody implants included dynamic torsion according to ASTM F2077 and expulsion tests.
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)
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
May 23, 2024
Image /page/0/Picture/1 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health and Human Services logo on the left and the FDA logo on the right. The FDA logo features the letters 'FDA' in a blue square, followed by the words 'U.S. FOOD & DRUG ADMINISTRATION' in blue text.
ulrich medical USA, Inc. Eric Lucas, Ph.D. Chief Operating Officer 3700 East Plano Parkway, Suite 200 Plano. Texas 75074
Re: K241396
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: May 14, 2024 Received: May 16, 2024
Dear Dr. Lucas:
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 (the 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 available 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.
Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
1
Your device is also subject to, among other requirements, the Quality System (OS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).
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 Part 803) for devices or postmarketing safety reporting (21 CFR Part 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 Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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,
Katherine D. Kavlock -S
for
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
2
Indications for Use
Submission 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 contiquous 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 and/or demineralized allograft bone with bone marrow aspirate to facilitate fusion. The hyperlordotic implants (≥ 10°) are required to be used with an anterior cervical plate. Patients should have at least six (6) weeks of nonoperative treatment prior to treatment with an intervertebral caqe.
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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510(k) Summary
Image /page/3/Picture/2 description: The image shows the logo for Ulrich Medical USA. The logo consists of the word "Ulrich" in a bold, sans-serif font, with the "U" stylized as a black square. Below the word "Ulrich" is the phrase "medical USA" in a smaller, sans-serif font.
| Date: | 14 May 2024 |
|---|---|
| Sponsor: | ulrich medical USA, Inc. |
| 3700 East Plano Pkwy. Suite 200 | |
| Plano, TX 75074 | |
| regulatory@ulrichmedicalusa.com | |
| Phone: 469.238.0800 | |
| Sponsor Contact: | Eric Lucas PhD, Chief Operating Officer |
| Proposed Trade | |
| Name: | uCerv Flux™-C 3D Porous Titanium Cervical Interbody |
| Common Name: | Cervical interbody fusion device |
| Device Classification: | Class II |
| Classification Name: | Intervertebral fusion device with bone graft, cervical |
| Regulation: | 888.3080 |
| Device Product Code: | ODP |
| Submission purpose: | A hyperlordotic implant option is added to the cleared components. |
| 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 and/or demineralized allograft | |
| bone with bone marrow aspirate to facilitate fusion. The hyperlordotic | |
| implants (≥ 10°) are required to be used with an anterior cervical plate. | |
| 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: | uCerv Flux™-C 3D Porous Titanium Cervical Interbody (ulrich medical USA |
- K220696) |
| Predicate/Reference: | Cascadia™ Interbody System (K2M, Inc. – K160125), LDR Spine Cervical
Interbody Fusion System (LDR Spine USA, K091088), INTEGRATE™-C
Interbody Fusion System (HAPPE Spine – K222004) |
| Performance Data: | Mechanical testing of the worst case Flux-C devices was relied upon in
support of the original uCerv Flux™-C 3D Porous Titanium Cervical
Interbody clearance. The testing included static and dynamic axial
compression and static torsion according to ASTM F2077 and subsidence
according to ASTM F2267. An engineering rationale was used to
demonstrate that the additional cervical interbody sizes did not introduce a
new worst case.
Mechanical testing of the worst case subject uCerv Flux™-C 3D Porous
Titanium Cervical Interbody implants included dynamic torsion according to
ASTM F2077 and expulsion tests.
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:
basic design (additively manufactured interbody 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. |
4