(146 days)
The Navigated Instrument System is indicated for use during the preparation and placement of Orthofix screws during spinal surgery to assist the surgeon in precisely locating anatomical structures in either open or minimally invasive procedures. The Navigated Instruments are specifically designed for use with the BrainLab Vector Vision system and the Medronic StealthStation System which are 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 a skull, a long bone, or vertebra can be identified relative to a CT or MR based model, fluoroscopy images, or digitized landmarks for the anatomy.
The Navigated Instrument System is comprised of manual surgical instruments for use with the BrainLab VectorVision System and the Medtronic StealthStation Navigation System to assist surgeons in precisely locating anatomical structures in either open, minimally invasive, or percutaneous procedures for preparation and placement of pedicle screw system implants. This surgical imaging technology provides surgeons visualization for complex and MIS procedures and confirms the accuracy of advanced surgical procedures. Use of these navigation systems provides the surgeon access to real-time, multi-plane 3D images (and 2D images) providing confirmation of hardware placement. Use of the Navigated Instrument System is limited to Taps ranging in sizes of 4.5mm to 8.5mm and bone screws ranging from 4.5mm to 8.5mm with length ranging from 25mm to 55mm.
The Navigated Instrument System Medtronic compatible instruments are comprised of Bone Awl, Bone Taps, and Bone Probes only.
The Navigated Instrument System BrainLab compatible instruments are comprised of Bone Awl. Bone Taps, Bone Probes and a variety of Screw Drivers.
The provided text is a 510(k) summary for a medical device called the "Navigated Instrument System." This document aims to demonstrate substantial equivalence to predicate devices, not necessarily to prove a device meets specific performance acceptance criteria through clinical studies in the typical sense (e.g., diagnostic accuracy on a test set).
Here's an attempt to answer your questions based on the available information, noting that much of it is not explicitly stated in this type of regulatory document:
1. A table of acceptance criteria and the reported device performance
The document does not explicitly state quantitative acceptance criteria or detailed performance results in the format of a table. Instead, it makes a general statement about substantial equivalence based on "compatibility, accuracy, function and performance."
| Acceptance Criteria (Implied) | Reported Device Performance (Implied) |
|---|---|
| Compatibility with BrainLab VectorVision and Medtronic StealthStation systems. | Demonstrated compatibility with both systems. |
| Accuracy (specific numerical target not provided). | "Accuracy" demonstrated through engineering analysis. |
| Functionality in spinal surgery (preparation and placement of Orthofix screws). | "Function" demonstrated through engineering analysis. |
| Performance during spinal surgery (assisting in locating anatomical structures in open or MIS procedures). | "Performance" demonstrated through engineering analysis. |
| Substantial equivalence to predicate devices (K153442 and K070106). | Concluded to be substantially equivalent based on engineering analysis and non-clinical tests. |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document mentions "Engineering analysis and performance data" and "non-clinical test." This implies in-vitro or bench testing rather than studies involving patient data. Therefore:
- Sample size for the test set: Not specified, but likely refers to a set of instruments/fixtures used for bench testing, not human subjects or patient data.
- Data provenance: Not explicitly stated, but given it's a 510(k) submission from Orthofix Inc. in Lewisville, Texas, the testing was likely conducted in the US or by an affiliated entity. The data would be non-clinical/bench testing data, not clinical in retrospect or prospect.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
This information is not applicable or not provided in the context of this 510(k) summary. "Ground truth" in this context would typically refer to clinical data or expert consensus on diagnoses, which is not what was used given the "engineering analysis and performance data" for a surgical instrument system. The ground truth for bench testing would be defined by metrology standards or physical measurements.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable or not provided. This usually refers to how disagreements among expert readers are resolved in diagnostic image interpretation studies. Since this device relates to surgical instrumentation and its performance was assessed via engineering analysis, such a method would not be used.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
No. This is a surgical instrument system, not an AI-powered diagnostic device. Therefore, an MRMC study assessing human reader improvement with AI assistance is not relevant and was not performed.
6. If a standalone (i.e. algorithm only, without human-in-the-loop performance) was done
Not applicable. This device is an instrument system, not an algorithm. Its function is to assist a human surgeon. Standalone performance as an algorithm would not be relevant.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The ground truth for the "engineering analysis and performance data" would be based on physical measurements and engineering specifications. For example, the accuracy of instrument tip localization might be verified against known physical coordinates or measurements of a phantom. It is not clinical ground truth like pathology reports or patient outcomes.
8. The sample size for the training set
The concept of a "training set" is primarily relevant for machine learning or AI models. This device is a traditional mechanical/navigated instrument system. Therefore, there is no training set in the AI sense. The "training" for the system would involve calibration procedures and design verification.
9. How the ground truth for the training set was established
As there is no training set in the AI context, this question is not applicable. The design and performance were validated against engineering principles and predicate device characteristics.
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Image /page/0/Picture/1 description: The image is a black and white logo for the Department of Health & Human Services - USA. The logo consists of a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" written around it. Inside the circle is a stylized symbol that resembles three human profiles facing to the right, with flowing lines beneath them.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
March 13, 2017
Orthofix Inc. % Jacki Koch Regulatory Affairs Specialist, II 3451 Plano Parkway Lewisville, Texas 75056
Re: K162921
Trade/Device Name: Navigated Instrument System Regulation Number: 21 CFR 882.4560 Regulation Name: Stereotaxic Instrument Regulatory Class: Class II Product Code: OLO Dated: February 8, 2017 Received: February 9, 2017
Dear Jacki Koch:
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. 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 (reporting of medical devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely,
Lori A. Wiggins -S
for Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K162921
Device Name Navigated Instrument System
Indications for Use (Describe)
The Navigated Instrument System is indicated for use during the preparation and placement of Orthofix screws during spinal surgery to assist the surgeon in precisely locating anatomical structures in either open or minimally invasive procedures. The Navigated Instruments are specifically designed for use with the BrainLab Vector Vision system and the Medronic StealthStation System which are 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 a skull, a long bone, or vertebra can be identified relative to a CT or MR based model, fluoroscopy images, or digitized landmarks for 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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Image /page/3/Picture/0 description: The image shows the logo for Orthofix. The logo consists of a blue abstract shape on the left, followed by the word "ORTHOFIX" in black, sans-serif font. The "ORTHOFIX" text is all capitalized and has a registered trademark symbol after it.
510(k) SUMMARY
Navigated Instrument System
| 510(k) Owner InformationName:Address: | Orthofix Inc.3451 Plano ParkwayLewisville, TX 75056 |
|---|---|
| Telephone Number:Fax Number:Email: | 214-937-2100214-937-3322jackikoch@orthofix.com |
| Registration Number: | 2183449 |
| Contact Person: | Jacki Koch, Senior Regulatory Affairs Specialist |
| Date Prepared: | March 10, 2017 |
| Name of DeviceTrade Name / ProprietaryName: | Navigated Instrument System |
| Common Name: | Instrument, Stereotaxic |
| Product Code: | OLO |
| Regulatory Classification: | Class II - 21 CFR § 882.4560 |
| Review Panel: | Orthopedic Device Panel |
| Predicate Devices: | K153442 - Medtronic Navigated Instrument System - NavigatedReusable Instruments for Use with StealthStationK070106 - BrainLab Navigated Instruments for use with theVectorVision System (Individually/Manual Calibrated) |
| Reference Devices: | K140927 - Depuy Universal Navigation Instruments for EXPEDIUMand VIPER MIS Spine System. |
Reason for 510(k) Submission:
Orthofix is submitting this Traditional 510(k) premarket notification for the introduction of the new Navigated Instrument System.
Device Description
The Navigated Instrument System is comprised of manual surgical instruments for use with the BrainLab VectorVision System and the Medtronic StealthStation Navigation System to assist surgeons in precisely locating anatomical structures in either open, minimally invasive, or percutaneous procedures for preparation and placement of pedicle screw system implants. This surgical imaging technology provides surgeons visualization for complex and MIS procedures and confirms the accuracy of advanced surgical procedures. Use of these navigation systems provides the surgeon access to real-time, multi-plane 3D images (and 2D
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Image /page/4/Picture/1 description: The image shows the logo for Orthofix. The logo consists of a blue, stylized leaf-like shape on the left, followed by the word "ORTHOFIX" in bold, black letters. A registered trademark symbol is present to the right of the word "ORTHOFIX". A black line is present underneath the logo.
images) providing confirmation of hardware placement. Use of the Navigated Instrument System is limited to Taps ranging in sizes of 4.5mm to 8.5mm and bone screws ranging from 4.5mm to 8.5mm with length ranging from 25mm to 55mm.
The Navigated Instrument System Medtronic compatible instruments are comprised of Bone Awl, Bone Taps, and Bone Probes only.
The Navigated Instrument System BrainLab compatible instruments are comprised of Bone Awl. Bone Taps, Bone Probes and a variety of Screw Drivers.
Intended Use / Indications for Use
The Navigated Instrument System is indicated for use during the preparation and placement of Orthofix screws during spinal surgery to assist the surgeon in precisely locating anatomical structures in either open or minimally invasive procedures. The Navigated Instrument System reusable instruments are specifically designed for use with the BrainLab Vector Vision system and the Medtronic StealthStation System which are 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 a skull, a long bone, or vertebra can be identified relative to a CT or MR based model, fluoroscopy images, or digitized landmarks for the anatomy.
Summary of the Technological Characteristics of the Device Compared to the Selected Predicate Devices
The technological characteristics of the subject Navigated Instrument System were compared to the predicate devices in indications for use, intended use, design, technology, materials, function and performance. It was demonstrated that the subject Navigated Instrument System technology is substantially equivalent to the predicate devices.
PERFORMANCE DATA – Summary of Non-Clinical Test Conducted for Determination of Substantial Equivalence
Engineering analysis and performance data demonstrate that the subject Navigated Instrument System is substantially equivalent to the predicate devices in compatibility, accuracy, function and performance. Engineering analysis includes dimensional measurements of both the predicate devices and subject devices.
Therefore, it can be concluded that the compatibility, accuracy, function, and performance of the subject Navigated Instrument System are substantially equivalent to the predicate device when used with the Medtronic Navigated Instrument System (K153442) and the predicate BrainLab Navigated Instruments for use with the VectorVision System (K070106).
Conclusion
Based upon the information provided in this Traditional 510(k) submission, it has been demonstrated that the subject Navigated Instrument System is substantially equivalent to the legally marketed predicate devices in regards to indications for use, intended use, design, technology, functionality and performance.
§ 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).