(85 days)
No
The summary describes a system of reusable surgical instruments used with a navigation system, focusing on positional accuracy and compatibility with existing navigation hardware and software. There is no mention of AI or ML in the intended use, device description, or performance studies.
No.
The documentation states that the device is a navigation system that assists surgeons in precisely locating anatomical structures during spinal surgery for the placement of screws. It is a tool to guide a procedure rather than to treat a disease/condition.
No
The Curiteva Navigation System is described as a system of instruments (awls, probes, taps, drills, and drivers) used in spinal surgery to assist the surgeon in precisely locating anatomical structures. While it uses imaging modalities (CT, MR, fluoroscopy) for reference, its primary function is guidance during a surgical procedure, not to diagnose a medical condition or disease. It aids in the placement of screws, which is a therapeutic intervention, not a diagnostic one.
No
The device description explicitly states that the Curiteva Navigation System includes reusable surgical instruments made of stainless steel (awls, probes, taps, drills, and drivers), which are hardware components.
Based on the provided text, the Curiteva Navigation System is not an IVD (In Vitro Diagnostic) device.
Here's why:
- IVD devices are used to examine specimens derived from the human body. The Curiteva Navigation System is a surgical navigation system used during surgery to assist in the placement of screws in the spine. It interacts directly with the patient's anatomy, not with specimens taken from the patient.
- The intended use and device description clearly state its purpose is for surgical guidance. It helps the surgeon locate anatomical structures and place implants.
- There is no mention of analyzing biological samples or providing diagnostic information. The system uses imaging data (CT, MR, fluoroscopy) to create a model for navigation, not to diagnose a condition based on biological markers.
Therefore, the Curiteva Navigation System falls under the category of a surgical navigation system, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The Curiteva Navigation System is intended to be used during the preparation and placement of Curiteva screws during spinal surgery to assist the surgeon in precisely locating anatomical structures in either open or minimally invasive procedures. The Curiteva Navigation System is specifically designed for use with the Medtronic StealthStation® System, which is indicated for any medical condition in which the use of stereotactic surgery may be appropriate, and where reference to a rigid anatomical structure, such as vertebra, can be identified relative to a CT or MR-based model, fluoroscopy images, or digitized landmarks of the anatomy.
Product codes
OLO, NKB, KWP, OUR
Device Description
The Curiteva Navigation System instruments are reusable surgical instruments for use with the Medtronic® StealthStation® Navigation System S7 v2.1.0 and S8 v1.2.0 (1.2.0-20) to assist surgeons in precisely locating anatomical structures in open or minimally invasive procedures for preparation and placement of Curiteva screws.
The Curiteva Navigation System includes awls, probes, taps, drills, and drivers. The Curiteva Navigation System instruments are to be used with the Curiteva Pedicle Screw System or the Curiteva Sacroiliac Joint Fusion System, as specified.
All instruments are made of stainless steel per ASTM F899. The Curiteva Navigation System instruments are not compatible with implants from other manufacturers and are designed for use only with Medtronic StealthStation Navigation System hardware and software.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
CT or MR-based model, fluoroscopy images
Anatomical Site
Vertebra (spinal surgery)
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Surgeons / Open or minimally invasive surgical procedures
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 Curiteva Navigation System instruments have been tested per ASTM F2554-18, "Standard Practice for Measurement of Positional Accuracy of Computer Assisted Surgical Systems". Dimensional comparisons were also made between the subject and predicate devices.
The results of this non-clinical testing show that the performance of the Curiteva Navigation System is sufficient for its intended use and is substantially equivalent to legally marketed predicate devices.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
K161210, K143628, K143375, K140454
Reference Device(s)
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 882.4560 Stereotaxic instrument.
(a)
Identification. A stereotaxic instrument is a device consisting of a rigid frame with a calibrated guide mechanism for precisely positioning probes or other devices within a patient's brain, spinal cord, or other part of the nervous system.(b)
Classification. Class II (performance standards).
0
January 6, 2023
Image /page/0/Picture/1 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health and 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.
Curiteva, Inc. Eric Linder Chief Technology Officer 25127 Will McComb Drive Tanner, Alabama 35671
Re: K223200
Trade/Device Name: Curiteva Navigation System Regulation Number: 21 CFR 882.4560 Regulation Name: Stereotaxic Instrument Regulatory Class: Class II Product Code: OLO Dated: September 30, 2022 Received: October 13, 2022
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
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,
Shumaya Ali-S
Shumaya Ali, M.P.H. Assistant Director DHT6C: Division of Restorative, Repair and Trauma Devices OHT6: Office of Orthopedic Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K223200
Device Name Curiteva Navigation System
Indications for Use (Describe)
The Curiteva Navigation System is intended to be used during the preparation and placement of Curiteva screws during spinal surgery to assist the surgeon in precisely locating anatomical structures in either open or minimally invasive procedures. The Curiteva Navigation System is specifically designed for use with the Medtronic StealthStation® System, which is indicated for any medical condition in which the use of stereotactic surgery may be appropriate, and where reference to a rigid anatomical structure, such as vertebra, can be identified relative to a CT or MR-based model, fluoroscopy images, or digitized landmarks of the anatomy.
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 - K223200
| Submitter's Name: | Curiteva, Inc. |
|---|---|
| Submitter's Address: | 25127 Will McComb Dr. |
| Tanner, Alabama 35671 | |
| Submitter's Telephone: | (256) 213-1057 |
| Contact Person: | Eric Linder |
| regulatory@curiteva.com | |
| Date Summary was Prepared: | January 5, 2023 |
| Trade or Proprietary Name: | Curiteva Navigation System |
| Common or Usual Name: | Orthopedic Stereotaxic Instrument |
| Classification: | Class II per 21 CFR §882.4620 |
| Product Code: | OLO |
| Classification Panel: | Division of Orthopedic Devices |
DESCRIPTION OF THE DEVICE SUBJECT TO PREMARKET NOTIFICATION:
The Curiteva Navigation System instruments are reusable surgical instruments for use with the Medtronic® StealthStation® Navigation System S7 v2.1.0 and S8 v1.2.0 (1.2.0-20) to assist surgeons in precisely locating anatomical structures in open or minimally invasive procedures for preparation and placement of Curiteva screws.
The Curiteva Navigation System includes awls, probes, taps, drills, and drivers. The Curiteva Navigation System instruments are to be used with the Curiteva Pedicle Screw System or the Curiteva Sacroiliac Joint Fusion System, as specified.
All instruments are made of stainless steel per ASTM F899. The Curiteva Navigation System instruments are not compatible with implants from other manufacturers and are designed for use only with Medtronic StealthStation Navigation System hardware and software.
INDICATIONS FOR USE
The Curiteva Navigation System is intended to be used during the preparation and placement of Curiteva screws during spinal surgery to assist the surgeon in precisely locating anatomical structures in either open or minimally invasive procedures. The Curiteva Navigation System is specifically designed for use with the Medtronic StealthStation® System, which is indicated for
4
any medical condition in which the use of stereotactic surgery may be appropriate, and where reference to a rigid anatomical structure, such as vertebra, can be identified relative to a CT or MR-based model, fluoroscopy images, or digitized landmarks of the anatomy.
TECHNOLOGICAL CHARACTERISTICS
The subject and predicate devices have nearly identical technological characteristics and the minor differences do not raise any new issues of safety and effectiveness. Specifically, the following characteristics are similar between the subject, predicate, and reference devices:
- Indications for use
- . Materials of manufacture
- Principles of operation
- . Design
Table 1 - Predicate Devices
| 510k Number | Trade or Proprietary or
Model Name | Manufacturer | Product
Code |
|-------------------------------------------------------------|---------------------------------------|---------------------------------------|-----------------|
| K161210
(PRIMARY) /
K143628 /
K143375 /
K140454 | Medtronic Navigated
Instruments | Medtronic Sofamore
Danek USA, Inc. | OLO |
Table 2 - Reference Devices
| 510k Number | Trade or Proprietary or
Model Name | Manufacturer | Product
Code |
|-------------|--------------------------------------------|----------------|-----------------|
| K191810 | Curiteva Pedicle Screw
System | Curiteva, Inc. | NKB, KWP |
| K210402 | Curiteva Sacroiliac Joint
Fusion System | Curiteva, Inc. | OUR |
PERFORMANCE DATA
The Curiteva Navigation System instruments have been tested per ASTM F2554-18, "Standard Practice for Measurement of Positional Accuracy of Computer Assisted Surgical Systems". Dimensional comparisons were also made between the subject and predicate devices.
5
The results of this non-clinical testing show that the performance of the Curiteva Navigation System is sufficient for its intended use and is substantially equivalent to legally marketed predicate devices.
CONCLUSION
The overall technology characteristics and mechanical performance data lead to the conclusion that the Curiteva Navigation System is substantially equivalent to the predicate device.