(61 days)
The Curiteva Laminoplasty System is intended for use in the lower cervical and upper thoracic spine (C3 to T3) in laminoplasty procedures. The Curiteva Laminoplasty System is used to hold or buttress the allograft material in place in order to prevent the graft material from expulsion or impinging the spinal cord.
The Curiteva Laminoplasty System is an internal fixation device for spinal surgery that consists of various configurations of plates and screws. The implant configurations are available in different types and sizes so that adaptations can be made to take into account pathology and individual patient anatomy. The plates come preformed with holes to receive bone screws. Screws are used to attach the plates to bone. System plate configurations may be used with allograft or autograft material. A hinge plate is provided when additional stabilization is necessary. All system components are manufactured from Titanium alloy (Ti-6Al-4V ELI) that conforms to ASTM F136, or PEEK (Polyetheretherketone) as described by ASTM F2026.
The provided document is a 510(k) summary for a spinal implant device (Curiteva Laminoplasty System), not an AI/ML medical device. Therefore, it does not contain the information requested regarding acceptance criteria and performance studies for an AI/ML device.
Specifically, the document discusses:
- Acceptance Criteria & Performance: The performance data section (page 4, section F) states that "Non-clinical testing performed on the Curiteva Laminoplasty System supports substantial equivalence to predicate devices." The tests performed are:
- Static four-point bending per ASTM F2193
- Dynamic four-point bending per ASTM F2193
- Axial screw pullout per ASTM F543
It concludes that the strength and performance are sufficient for intended use and substantially equivalent to the primary predicate device (K032534). However, this refers to mechanical testing of a physical implant, not the performance of an AI/ML algorithm.
Therefore, I cannot extract the following information which is relevant to AI/ML device studies:
- Table of acceptance criteria and reported device performance (for AI/ML): Not applicable.
- Sample size, data provenance, number of experts, adjudication method, MRMC study, standalone performance, type of ground truth, training set size, ground truth establishment for training set: None of this information is present as the document describes a physical medical device, not an AI/ML algorithm.
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June 28, 2023
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Curiteva, Inc. Eric Linder Chief Technology Officer 25127 Will McComb Drive Tanner, Alabama 35671
Re: K231232
Trade/Device Name: Curiteva Laminoplasty System Regulation Number: 21 CFR 888.3050 Regulation Name: Spinal Interlaminal Fixation Orthosis Regulatory Class: Class II Product Code: NQW Dated: April 28, 2023 Received: April 28, 2023
Dear Eric Linder:
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 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
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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.
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Colin O'Neill, M.B.E. 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
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Indications for Use
510(k) Number (if known)
Device Name Curiteva Laminoplasty System
Indications for Use (Describe)
The Curiteva Laminoplasty System is intended for use in the lower cervical and upper thoracic spine (C3 to T3) in laminoplasty procedures. The Curiteva Laminoplasty System is used to hold or buttress the allograft material in place in order to prevent the graft material from expulsion or impinging the spinal cord.
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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Image /page/3/Picture/0 description: The image shows the logo for Curiteva. The logo consists of a geometric shape resembling a stylized flower or gear, with six petals or segments arranged in a circular pattern. Five of the segments are colored in a dark blue, while one segment is a lighter blue. Below the geometric shape, the word "CURITEVA" is written in a bold, sans-serif font, with the trademark symbol (™) next to it.
510(k) Summary
A. Submitter Information
| Submitter: | Curiteva, Inc.25127 Will McComb DriveTanner, AL 35671Phone: (256) 213-1057Fax: (256) 213-1058 |
|---|---|
| Contact Person: | Eric Linderregulatory@curiteva.com |
| Date Prepared: | April 28, 2023 |
B. Device Information
| Trade Name: | Curiteva Laminoplasty System |
|---|---|
| Common Name: | Spinal Interlaminal Fixation Orthosis |
| Classification Name: | Orthosis, Spine, Plate, Laminoplasty, Metal |
| Device Classification: | Class II (per 21 CFR 888.3050) |
| Product Code: | NQW |
| Classification Panel: | Division of Orthopedic Devices |
| Predicate Device(s): | Primary: Synthes Arch Fixation System (K032534)Additional: Choice Spine Laminoplasty Fixation System (K173215)Additional: Globus Medical Canopy Laminoplasty Fixation System (K121732)Additional: Nuvasive Laminoplasty System (K091623)Reference: Curiteva Cervical Interbody Fusion System (K181261) |
C. Device Description
The Curiteva Laminoplasty System is an internal fixation device for spinal surgery that consists of various configurations of plates and screws. The implant configurations are available in different types and sizes so that adaptations can be made to take into account pathology and individual patient anatomy. The plates come preformed with holes to receive bone screws. Screws are used to attach the plates to bone. System plate configurations may be used with allograft or autograft material. A hinge plate is provided when additional stabilization is necessary.
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Image /page/4/Picture/0 description: The image shows the logo for Corteva Agriscience. The logo features a stylized geometric shape resembling a flower or a stylized molecule, with several dark blue hexagonal elements arranged in a circular pattern. One of the hexagonal elements is colored in a lighter shade of blue. Below the geometric shape, the word "CURITEVA" is written in bold, sans-serif font, with a trademark symbol to the right of the word.
All system components are manufactured from Titanium alloy (Ti-6Al-4V ELI) that conforms to ASTM F136, or PEEK (Polyetheretherketone) as described by ASTM F2026.
D. Indications for Use
The Curiteva Laminoplasty System is intended for use in the lower cervical and upper thoracic spine (C3 to T3) in laminoplasty procedures. The Curiteva Laminoplasty System is used to hold or buttress the allograft or autograft material in place in order to prevent the graft material from expulsion or impinging the spinal cord.
E. Comparison of Technological Characteristics
As was established in this submission, the subject Curiteva Laminoplasty System is substantially equivalent to other predicate devices cleared by the FDA for commercial distribution in the United States. The subject device was shown to be substantially equivalent and to have similar technological characteristics to its predicate devices through comparison in areas including design, intended use, material composition, function, and range of sizes.
F. Performance Data
Non-clinical testing performed on the Curiteva Laminoplasty System supports substantial equivalence to predicate devices. The following testing was performed:
- Static four-point bending per ASTM F2193 ●
- Dynamic four-point bending per ASTM F2193
- Axial screw pullout per ASTM F543
The results of non-clinical testing demonstrate that the strength and performance of the Curiteva Laminoplasty System is sufficient for its intended use and is substantially equivalent to the legally marketed primary predicate device, K032534.
G. Conclusion
Based on the indications for use, technological characteristics, non-clinical performance testing, and comparison to predicate devices, the subject Curiteva Laminoplasty System has been shown to be substantially equivalent to legally marketed predicate devices.
§ 888.3050 Spinal interlaminal fixation orthosis.
(a)
Identification. A spinal interlaminal fixation orthosis is a device intended to be implanted made of an alloy, such as stainless steel, that consists of various hooks and a posteriorly placed compression or distraction rod. The device is implanted, usually across three adjacent vertebrae, to straighten and immobilize the spine to allow bone grafts to unite and fuse the vertebrae together. The device is used primarily in the treatment of scoliosis (a lateral curvature of the spine), but it also may be used in the treatment of fracture or dislocation of the spine, grades 3 and 4 of spondylolisthesis (a dislocation of the spinal column), and lower back syndrome.(b)
Classification. Class II.