(238 days)
Not Found
No
The description focuses on manual surgical instruments used with existing navigation systems (Brainlab Vector Vision and Medtronic StealthStation) for precise anatomical location based on imaging data. There is no mention of AI or ML in the device description, intended use, or performance studies. The navigation systems themselves are not described as using AI/ML in this summary.
No.
The device is a surgical navigation system and instruments designed to assist surgeons in precisely locating anatomical structures during spinal surgery, rather than directly treating a medical condition or providing therapy.
No
This device is described as a system of manual surgical instruments used during spinal surgery to assist in precisely locating anatomical structures for the preparation and placement of screws. It is a surgical navigation aid, not a device used for diagnosing medical conditions.
No
The device description explicitly states the system is comprised of "manual surgical instruments" which are hardware components.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are devices used to examine specimens taken from the human body (like blood, urine, tissue) to provide information about a person's health.
- Device Function: The Navigated Instrument System is a set of surgical instruments used during spinal surgery to assist the surgeon in precisely locating anatomical structures and placing implants. It works in conjunction with navigation systems that use imaging data.
- Lack of Specimen Analysis: The description focuses on surgical guidance and instrument use within the body, not on analyzing biological specimens.
The device is a surgical navigation accessory, not a diagnostic tool that analyzes samples outside the body.
N/A
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 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.
Use of the Navigated Instrument System is limited to use only with the Firebird Spinal Fixation System / Phoenix MIS Spinal Fixation Systems.
Product codes (comma separated list FDA assigned to the subject device)
OLO
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 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 and Brainlab compatible instruments are comprised of Bone Awl, Bone Taps, Bone Probes and a variety of Screw Drivers.
The Navigated Instrument System instruments were tested for compatibility utilizing the Medtronic StealthStation S7 Orange, Violet, and Gray Navlock Tracker (Part Numbers 9734683, 9733482, 9734590 and 9732353), Medtronic Navigation Instrument Driver (Part Number 9734279) and the Navlock Reference Frame (Part Number 9732353) while utilizing the Navigated CD Horizon Solera Operative Technique with control number PMD016466-1.0 31441.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
CT or MR based model, fluoroscopy images, or digitized landmarks
Anatomical Site
rigid anatomical structure such as a skull, a long bone, or 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)
Engineering analysis and performance data demonstrate that the subject Navigated Instruments are 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 and geometrical comparisons to currently marketed Orthofix Instruments. Validation testing includes physical testing with all Navigated Instrument System Screwdrivers to ensure compatibility with the system software and 1:1 accuracy and performance testing of the subject and predicate device in a simulated surgical navigation use environment.
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.
K153442, K070106, K162921, K153428
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.
Not Found
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).
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Image /page/0/Picture/0 description: The image shows the logos of the Department of Health & Human Services and the Food and Drug Administration (FDA). The Department of Health & Human Services logo is on the left and features a stylized human figure. The FDA logo is on the right and consists of the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.
March 8, 2018
Orthofix Inc. Jacki Koch Senior Regulatory Affairs Specialist 3451 Plano Parkway Lewisville, Texas 75056
Re: K172115
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 1, 2018 Received: February 6, 2018
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 of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
1
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.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Mark N. Melkerson -S
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) K172115
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 Instrument System reusable 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.
Use of the Navigated Instrument System is limited to use only with the Firebird Spinal Fixation System / Phoenix MIS Spinal Fixation Systems.
| Type of Use (Select one or both, as applicable) |
|---|
| ------------------------------------------------- |
X 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, bold letters. The abstract shape is a stylized design, possibly representing movement or connection. The word "ORTHOFIX" is the main element of the logo, clearly indicating the brand name.
510(k) SUMMARY
Navigated Instrument System
| 510(k) Owner Information | |
|---|---|
| Name: | Orthofix Inc. |
| Address: | 3451 Plano Parkway |
| Lewisville, TX 75056 | |
| Telephone Number: | 214.937.2100 |
| Fax Number: | 214-937-3322 |
| Email: | jackikoch@orthofix.com |
| Registration Number: | 2183449 |
| Contact Person: | Jacki Koch, Senior Regulatory Affairs Specialist |
| Date Prepared: | March 7, 2018 |
| Name of Device | |
| Trade Name / Proprietary Name: | 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 – Navigatec |
| Reusable Instruments for Use with StealthStation | |
| K070106 - Brainlab Navigated Instruments for use with the | |
| VectorVision System (Individually/Manual Calibrated) | |
| K162921 - Navigated Instrument System - Orthofix | |
| K153428 – Firebird Spinal Fixation System / Phoenix MIS Spinal | |
| Fixation System - Orthofix |
Reason for 510(k) Submission:
Due to the advancements in surgical techniques and surgeon requests, Orthofix is submitting this Special 510(k) request for the following:
-
- Addition of Navigated MDT Screw Drivers
- a. Modular Screw Driver, Firebird Navigated MDT
- b. Multi-Axial Screw Driver, Firebird Navigated MDT
- c. Mono-Axial Screw Driver, Firebird Navigated MDT
- d. Multi-Axial Screw Driver, Phoenix Navigated MDT
- e. Reduction Screw Driver, Firebird Navigated MDT
-
- Addition of Navigated MDT and BL Duckbill Probes with depth markings
-
- Modification of Navigated MDT and BL Straight Probes to add depth markings
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Image /page/4/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, bold letters. The "®" symbol is located to the right of the word "ORTHOFIX".
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 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 and Brainlab compatible instruments are comprised of Bone Awl, Bone Taps, Bone Probes and a variety of Screw Drivers.
The Navigated Instrument System instruments were tested for compatibility utilizing the Medtronic StealthStation S7 Orange, Violet, and Gray Navlock Tracker (Part Numbers 9734683, 9733482, 9734590 and 9732353), Medtronic Navigation Instrument Driver (Part Number 9734279) and the Navlock Reference Frame (Part Number 9732353) while utilizing the Navigated CD Horizon Solera Operative Technique with control number PMD016466-1.0 31441.
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.
Use of the Navigated Instrument System is limited to use only with the Firebird Spinal Fixation System / Phoenix MIS Spinal Fixation Systems.
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 Instruments are 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 and geometrical comparisons to currently marketed Orthofix Instruments. Validation testing includes physical testing with all Navigated Instrument System Screwdrivers to ensure compatibility with the system software and 1:1 accuracy and performance testing of the subject and predicate device in a simulated surgical navigation use environment.
Therefore, it can be concluded that the compatibility, accuracy, function, and performance of the subject Navigated Instrument System are substantially equivalent to the predicate devices.
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Image /page/5/Picture/1 description: The image shows the word "ORTHOFIX" in bold, black letters. To the left of the word is a blue, curved shape. A small, circled R is located to the upper right of the word.
Conclusion
Based upon the information provided in this Special 510(k) submission, it has been demonstrated that the subject Navigated Instrument System subject devices are substantially equivalent to the legally marketed predicate devices in regards to indications for use, intended use, design, technology, functionality and performance.