(24 days)
The uNion MAX Cervical Plate System is intended for anterior fixation of the cervical spine (C2 to T1). The system is to be used to provide stabilization of the anterior cervical spine as an adjunct to fusion for the treatment of degenerative disc disease (defined as neck pain of discogenic origin with the degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, trauma (i.e., fractures or dislocations), tumors, spinal stenosis, deformity (i.e., kyphosis, lordosis or scoliosis), pseudarthrosis or failed previous fusion.
uNion MAX is an anterior cervical plate and screw system used to provide mechanical support across implanted level(s) in the cervical spine until fusion is achieved. The components include Ø4.0mm and Ø4.5mm fixed and variable screws having self-tapping, self-drilling or self-drilling/self-tapping tips and one- through four-level plates having lengths from 8mm to 84mm. The plates incorporate a pivoting locking mechanism which functions to block screw backout. The devices are sold non-sterile.
The provided document is a 510(k) Premarket Notification from the FDA for a medical device called the uNion® MAX Cervical Plate System. It describes the device and its intended use, and importantly, declares that the device is "substantially equivalent" to legally marketed predicate devices based on performance data.
However, the document does not contain any information about acceptance criteria or a study that proves the device meets those criteria in the context of AI/ML performance. This document pertains to the regulatory clearance of a physical medical implant, not a software or AI-driven diagnostic or treatment device.
Therefore, I cannot provide the requested information. The concepts of "acceptance criteria," "reported device performance," "sample size for test set," "data provenance," "experts to establish ground truth," "adjudication method," "MRMC study," "standalone performance," "type of ground truth," "sample size for training set," and "ground truth for training set" as typically applied to AI/ML devices, are not applicable to this document.
The "Performance Data" section in the 510(k) summary refers to "ASTM F1717 mechanical testing of the worst case uNion MAX constructs included static and dynamic compression bending and static torsion." This testing is for the mechanical properties of the cervical plate system itself, ensuring its structural integrity and safety. It tests the physical attributes of the device, not its analytical or interpretive capabilities.
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March 18, 2024
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Ulrich Medical USA, Inc. Eric Lucas Vice President of Technology 3700 East Plano Parkway Suite 200 Plano, Texas 75074
Re: K240515
Trade/Device Name: uNion® MAX Cervical Plate System Regulation Number: 21 CFR 888.3060 Regulation Name: Spinal Intervertebral Body Fixation Orthosis Regulatory Class: Class II Product Code: KWQ Dated: January 23, 2024 Received: February 23, 2024
Dear Eric 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).
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Your device is also subject to, among other requirements, the Quality System (QS) 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 OS 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,
Image /page/1/Picture/7 description: The image contains the text "Colin O'neill -S" in a simple, sans-serif font. The text is arranged vertically, with "Colin" on the top line and "O'neill -S" on the bottom line. The text is black, and the background is white. There is a faint FDA logo in the background.
Colin O'Neill, M.B.E. Assistant Director DHT6B: Division of Spinal Devices OHT6: Office of Orthopedic Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
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Indications for Use
510(k) Number (if known) K240515
Device Name uNion® MAX Cervical Plate System
Indications for Use (Describe)
The uNion MAX Cervical Plate System is intended for anterior fixation of the cervical spine (C2 to T1). The system is to be used to provide stabilization of the anterior cervical spine as an adjunct to fusion for the treatment of degenerative disc disease (defined as neck pain of discogenic origin with the degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, trauma (i.e., fractures or dislocations), tumors, spinal stenosis, deformity (i.e., kyphosis, lordosis or scoliosis), pseudarthrosis or failed previous fusion.
| 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
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| Date: | 23 January 2024 |
|---|---|
| Sponsor: | ulrich medical USA, Inc.3700 East Plano Pkwy. Suite 200 |
| Plano, TX 75074regulatory@ulrichmedicalusa.com | |
| Phone: 469.238.0800 | |
| Sponsor Contact: | Eric Lucas PhD, Vice President of Technology |
| Proposed TradeName: | uNion® MAX Cervical Plate System |
| Common Name: | Anterior cervical plate system |
| Device Classification: | Class II |
| Classification Name: | Spinal intervertebral body fixation orthosis |
| Regulation: | 888.3060 |
| Device Product Code: | KWQ |
| Device Description: | uNion MAX is an anterior cervical plate and screw system used to providemechanical support across implanted level(s) in the cervical spine until fusionis achieved. The components include Ø4.0mm and Ø4.5mm fixed andvariable screws having self-tapping, self-drilling or self-drilling/self-tappingtips and one- through four-level plates having lengths from 8mm to 84mm.The plates incorporate a pivoting locking mechanism which functions to blockscrew backout. The devices are sold non-sterile. |
| Indications for Use: | The uNion MAX Cervical Plate System is intended for anterior fixation of thecervical spine (C2 to T1). The system is to be used to provide stabilization ofthe anterior cervical spine as an adjunct to fusion for the treatment ofdegenerative disc disease (defined as neck pain of discogenic origin with thedegeneration of the disc confirmed by history and radiographic studies),spondylolisthesis, trauma (i.e., fractures or dislocations), tumors, spinalstenosis, deformity (i.e., kyphosis, lordosis or scoliosis), pseudarthrosis orfailed previous fusion. |
| Materials: | uNion MAX components are manufactured from Ti-6Al-4V ELI titanium alloy(ASTM F136). |
| Primary Predicate: | uNion Cervical Plate System (ulrich medical USA - K150666) |
| Predicate/Reference: | MaxAn® Anterior Cervical Plate System (Biomet Spine - K133518) |
| Performance Data: | ASTM F1717 mechanical testing of the worst case uNion MAX constructsincluded static and dynamic compression bending and static torsion. Themechanical test results demonstrate that uNion MAX performance issubstantially equivalent to the predicate devices. |
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| TechnologicalCharacteristics: | uNion MAX Cervical Plate System possesses similar technologicalcharacteristics as one or more of the predicate devices. These include:basic design (plates and screws configuration), material (titanium alloy) and sizes (dimensions are comparable to those offered by the predicate systems) The fundamental scientific technology of the uNion MAX system is the same as previously cleared devices. |
|---|---|
| Conclusion: | The uNion MAX Cervical Plate System possesses the same intended useand similar technological characteristics as the predicate devices. ThereforeuNion MAX is substantially equivalent for its intended use. |
§ 888.3060 Spinal intervertebral body fixation orthosis.
(a)
Identification. A spinal intervertebral body fixation orthosis is a device intended to be implanted made of titanium. It consists of various vertebral plates that are punched into each of a series of vertebral bodies. An eye-type screw is inserted in a hole in the center of each of the plates. A braided cable is threaded through each eye-type screw. The cable is tightened with a tension device and it is fastened or crimped at each eye-type screw. The device is used to apply force to a series of vertebrae to correct “sway back,” scoliosis (lateral curvature of the spine), or other conditions.(b)
Classification. Class II.