(133 days)
No
The summary describes navigated surgical instruments that work with a separate navigation system. There is no mention of AI/ML in the description of the instruments or their function. The navigation system itself is not described in detail in this summary.
No
The device aids in the surgical placement of pedicle screws but does not directly treat or cure a disease or condition. Its function is to assist the surgeon, not provide therapy.
No
The device is described as "navigated instruments" intended to assist the surgeon "in precisely locating anatomical structures" during spinal surgery. Its function is to guide the placement of pedicle screws, not to diagnose a medical condition.
No
The device description explicitly states that the EUROPA™ Navigated Instruments are "non-sterile, re-usable instruments including probes, taps, and drivers" made from Stainless Steel. This indicates the device includes physical hardware components, not just software.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body, such as blood, urine, or tissue, to provide information about a person's health.
- Device Description and Intended Use: The description clearly states that the EUROPA™ Navigated Instruments are surgical instruments (probes, taps, drivers) used during spinal surgery to assist in the placement of pedicle screws. They are used directly on the patient's anatomy, not on samples taken from the patient.
- Function: Their function is to provide guidance and precision during a surgical procedure, not to analyze biological samples for diagnostic purposes.
The device is a surgical navigation instrument, which falls under a different category of medical devices.
N/A
Intended Use / 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.
Product codes (comma separated list FDA assigned to the subject device)
OLO
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 instruments are intended to be used with the Medtronic StealthStation ® System and are manufactured from Stainless Steel per ASTM F899.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
CT or MR based model, fluoroscopy images
Anatomical Site
Spinal, vertebra
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Surgeon, spinal surgery
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 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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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
June 23, 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 & 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.
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
1
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™, LLC
1755 West Oak Parkway
Suite 100
Marietta, Georgia 30062
Tel: (678) 324-6272
Fax: (678) 401-5607 |
|-------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| II. OFFICIAL
CORRESPONDENT | Jordan Bauman
Vice President, Regulatory Affairs
MiRus™, LLC
1755 West Oak Parkway
Suite 100
Marietta, Georgia 30062
Tel: (678) 324-6272
Fax: (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 Predicate
Medtronic Navigated Instruments - Medtronic Inc.
(K140454) |
| | Additional Predicates
Medtronic Navigated Instruments - Medtronic Inc.
(K143628, K143375) |
| | Reference Device
EUROPA™ 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
4
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.