(133 days)
The EUROPA™ Navigated Instruments are intended to be used in the preparation and placement of the EUROPA™ pedicle screws during spinal surgery to assist the surgeon in precisely locating anatomical structures in either open or minimally invasive procedures. These instruments are designed for use with the stereotactic navigation system 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.
The EUROPA™ Navigated Instruments is intended to be used with the EUROPA™ Pedicle Screw System. The EUROPA™ Navigated Instruments are non-sterile, re-usable instruments including probes, taps, and drivers that can be operated manually. These instruments are intended to be used with the Medtronic StealthStation ® System and are manufactured from Stainless Steel per ASTM F899.
The provided text does NOT include acceptance criteria or a study proving the device meets those criteria. The document is an FDA 510(k) clearance letter and a 510(k) summary for the "EUROPA™ Navigated Instruments."
This type of document primarily focuses on establishing substantial equivalence to already legally marketed predicate devices, rather than presenting a detailed clinical study with specific acceptance criteria, test sets, ground truth establishment, or human reader performance metrics. The information provided is high-level and generalized, stating that "Design validation testing included testing per ASTM F2554-18, and a one-to-one dimensional comparison to demonstrate substantially equivalent geometry that is critical to navigation accuracy. Testing, including anatomical and navigated simulated use and accuracy and reliability testing, has been conducted to verify that the EUROPA™ Navigated Instruments are appropriate for their intended use, to ensure functionality, accuracy, and compatibility with the Medtronic StealthStation® System using the NavLock Tracker, and to demonstrate substantial equivalence to the predicate instruments."
Therefore, I cannot fulfill your request for the specific details of acceptance criteria and the study that proves the device meets them from the provided text. The document does not contain the information required to construct the table or answer the specific questions about sample size, expert ground truth, adjudication, MRMC studies, standalone performance, or training set details.
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June 23, 2023
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MiRus LLC Jordan Bauman Vice President, Regulatory Affairs 1755 West Oak Parkway, Suite 100 Marietta. Georgia 30062
Re: K230369
Trade/Device Name: EUROPA™ Navigated Instruments Regulation Number: 21 CFR 882.4560 Regulation Name: Stereotaxic Instrument Regulatory Class: Class II Product Code: OLO Dated: February 10, 2023 Received: February 10, 2023
Dear Jordan Bauman:
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
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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 (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.
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 Ouality Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K230369
Device Name EUROPA™ Navigated Instruments
Indications for Use (Describe)
The EUROPA™ Navigated Instruments are intended to be used in the preparation and placement of the EUROPA™ pedicle screws during spinal surgery to assist the surgeon in precisely locating anatomical structures in either open or minimally invasive procedures. These instruments are designed for use with the stereotactic navigation system Medronic StealthStation® System, which is indical condition in which the use of stereotactic surgery may be appropriate, and where reference to a rigid anatomical structure, 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
This 510(k) summary is being submitted in accordance with the requirements of 21 CFR 807.92(c).
| I. SUBMITTER | MiRus™, LLC1755 West Oak ParkwaySuite 100Marietta, Georgia 30062Tel: (678) 324-6272Fax: (678) 401-5607 |
|---|---|
| II. OFFICIALCORRESPONDENT | Jordan BaumanVice President, Regulatory AffairsMiRus™, LLC1755 West Oak ParkwaySuite 100Marietta, Georgia 30062Tel: (678) 324-6272Fax: (678) 401-5607 |
| III. DATE PREPARED | May 22, 2023 |
| IV. DEVICE | |
| Name of Device | EUROPA™ Navigated Instruments |
| Common Name | Orthopedic Stereotaxic Instrument |
| Classification Name | 21 CFR 882.4560 |
| Regulatory Class | Class II |
| Product Codes | OLO |
| Submission Type | Traditional 510(k) |
| V. PREDICATE DEVICE | |
| Primary PredicateMedtronic Navigated Instruments - Medtronic Inc.(K140454) | |
| Additional PredicatesMedtronic Navigated Instruments - Medtronic Inc.(K143628, K143375) | |
| Reference DeviceEUROPA™ Pedicle Screw System - MiRus, LLC(K182970, K180337) |
VI. DEVICE DESCRIPTION
The EUROPA™ Navigated Instruments is intended to be used with the EUROPA™ Pedicle Screw System. The EUROPA™ Navigated Instruments are non-sterile, re-usable instruments including probes, taps, and drivers that can be operated manually. These
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instruments are intended to be used with the Medtronic StealthStation ® System and are manufactured from Stainless Steel per ASTM F899.
VII. INDICATIONS FOR USE
The EUROPA™ Navigated Instruments are intended to be used in the preparation and placement of the EUROPA™ pedicle screws during spinal surgery to assist the surgeon in precisely locating anatomical structures in either open or minimally invasive procedures. These instruments are designed for use with the stereotactic navigation system 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.
VIII. PREDICATE DEVICE COMPARISON
The EUROPA™ Navigated Instruments have similar technological characteristics as the predicate devices including design, intended use, material composition, function, and range of sizes.
IX. PERFORMANCE DATA
The mechanical performance profile of the EUROPA™ Navigated Instruments was assessed through design validation testing. Design validation testing included testing per ASTM F2554-18, and a one-to-one dimensional comparison to demonstrate substantially equivalent geometry that is critical to navigation accuracy. Testing, including anatomical and navigated simulated use and accuracy and reliability testing, has been conducted to verify that the EUROPA™ Navigated Instruments are appropriate for their intended use, to ensure functionality, accuracy, and compatibility with the Medtronic StealthStation® System using the NavLock Tracker, and to demonstrate substantial equivalence to the predicate instruments.
X. CONCLUSIONS
The EUROPA™ Navigated Instruments have similar intended use, indications for use, labeling, and technological characteristics as the predicate system, including design features, geometries, sizes, and materials. Performance data demonstrate that the EUROPA™ Navigated Instruments is substantially equivalent to legally marketed predicate systems.
§ 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).