(204 days)
No
The summary does not mention AI, ML, deep learning, or any related terms, and the description focuses on standard image-guided navigation techniques.
No
The device aids surgeons in precisely locating anatomical structures and spatially positioning tools for surgical procedures. It does not directly provide therapy.
No
The device is an image-guided surgical navigation system intended to assist surgeons in precisely locating anatomical structures and positioning surgical tools during spinal procedures. It does not diagnose medical conditions.
No
The device description explicitly states it is comprised of a computer workstation, software, a trajectory system (including a targeting platform), a Camera, and various image guided instruments, indicating it includes significant hardware components beyond just software.
Based on the provided information, the Practical Navigation Surgical Guidance System 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 (like blood, urine, tissue) to provide information about a person's health. These tests are performed outside the body.
- Device Function: The Practical Navigation Surgical Guidance System is a surgical guidance system used during surgery to help surgeons navigate and position instruments within the patient's body. It uses imaging and tracking technology to assist in the surgical procedure itself.
- Intended Use: The intended use clearly states it's for "precisely locating anatomical structures and for the spatial positioning and orientation of a tool holder or Guide Tube to be used by surgeons for navigating and/or guiding compatible surgical instruments in open or percutaneous spinal procedures." This is an in vivo (within the living body) application, not an in vitro one.
Therefore, the device's function and intended use fall outside the scope of In Vitro Diagnostics.
N/A
Intended Use / Indications for Use
The Practical Navigation Surgical Guidance System is intended for use as an aid for precisely locating anatomical structures and for the spatial positioning and orientation of a tool holder or Guide Tube to be used by surgeons for navigating and/or guiding compatible surgical instruments in open or percutaneous spinal procedures in rigid patient anatomy and fiducials that can be identified on an O-arm scan. The Practical Navigation Surgical Guidance System is indicated for assisting the surgeon in placing pedicle in the posterior lumbar region (1-S1).
The system is designed for lumbar pedicle screw placement with the prone position and is compatible with the Integrity LineSider Pedicle Spinal System.
Product codes (comma separated list FDA assigned to the subject device)
OLO
Device Description
The Practical Navigation Surgical Guidance System (PNSGS) is an image guided system primarily comprised of a computer workstation, software, a trajectory system, including a targeting platform, a Camera, and various image guided instruments intended for assisting the surgeon in placing screws in the pedicles of the lumbar spine. The PNSGS system allows for registration of the patient's anatomy to O-arm images. Once the patient anatomy is registered, a surgical plan can be created and optically-tracked surgical instruments can be used to follow the surgical plan. The system is used in the following manner:
-
- The patient is placed in the appropriate position on the OR table.
- The compact tracking Camera is rigidly affixed to the OR table using a multi-2. functional mechanical support arm in the appropriate position to track the surgical site.
-
- The Camera is also affixed to a pin placed in the patient's iliac to provide a fixed location relative to the patient's spinal anatomy.
-
- The Targeting Platform is affixed to the OR Table using a multi-functional mechanical support arm, ensuring that the Targeting Platform has sufficient range of motion to be placed over the surgical site.
-
- The Registration Array is affixed to planned surgical site.
- The appropriate area of spine is scanned with an O-arm. 6.
-
- The scans are transferred to the PNSGS workstation, which reconstructs the images and uses the registration array image to register the patient's spine relative to the Camera location.
-
- The registration is confirmed by placing an image guided instrument with a Tracking Array at various points in the surgical field.
-
- The surgical paths are planned on the workstation.
-
- The Targeting Platform is gross-positioned manually close to the first surgical plan location.
-
- The Targeting Platform is activated to set the fine location and the trajectory based on the surgical plan.
-
- Instruments with tracking arrays are used through the tool guide of the Targeting Platform to prepare the pedicle and place a pedicle screw.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
3D Intraoperative images
Anatomical Site
Spinal, posterior lumbar region (L1-S1)
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Surgeons, OR table
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)
Non-clinical system, software, and instrument verification and validation.
Cadaver and simulated-use testing under clinically relevant scenarios.
ASTM F2554-10 Standard Practice for Measurement of Positional Accuracy of . Computer Assisted Surgical Systems.
ANSI/AAMI ES60601-1:2005/(R)2012 And A1:2012Medical Electrical ● Equipment - Part 1: General Requirements for Basic Safety and Essential Performance.
IEC 60601-1-2:2014 Medical Electrical Equipment Part 1-2: General ● Requirements for Basic Safety and Essential Performance - Collateral Standard: Electromagnetic Disturbances - Requirements and Testing.
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
February 24, 2021
Image /page/0/Picture/1 description: The image contains 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.
Practical Navigation, LLC % Roger White President Phiama, Inc 236 McKinley Park Lane Louisville, Colorado 80027
Re: K202184
Trade/Device Name: Practical Navigation Surgical Guidance System Regulation Number: 21 CFR 882.4560 Regulation Name: Stereotaxic Instrument Regulatory Class: Class II Product Code: OLO Dated: January 22, 2021 Received: January 25, 2021
Dear Roger White:
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,
For: Shumaya Ali, MPH 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) K202184
Device Name
Practical Navigation Surgical Guidance System
Indications for Use (Describe)
The Practical Navigation Surgical Guidance System is intended for use as an aid for precisely locating anatomical structures and for the spatial positioning and orientation of a tool holder or Guide Tube to be used by surgeons for navigating and/or guiding compatible surgical instruments in open or percutaneous spinal procedures in rigid patient anatomy and fiducials that can be identified on an O-arm scan. The Practical Navigation Surgical Guidance System is indicated for assisting the surgeon in placing pedicle in the posterior lumbar region (1-S1).
The system is designed for lumbar pedicle screw placement with the prone position and is compatible with the Integrity LineSider Pedicle Spinal System.
| 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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3
510(k) Summary Practical Navigation Surgical Guidance System
1. Submitter Information
| Submitter: | Practical Navigation, LLC |
|---|---|
| Address: | 720 E. Wiggins Street |
| Superior, CO 80027 | |
| Telephone: | (303) 517-0506 |
| Telefax: | N/A |
- Roger N. White Contact: rwhite@phiama.com (303) 550-2451
Date Prepared: February 24, 2021
2. Device Information
| Trade Name: | Practical Navigation Surgical Guidance System |
|---|---|
| Common Name: | Stereotaxic Instrument |
| Classification: | Class II per 21 CFR 882.4560 |
| Classification Name: | Stereotaxic Instrument |
| Product Code: | OLO |
3. Purpose of Submission
The purpose of this submission is to gain clearance for a new Image Guided System, the Practical Navigation Surgical Guidance System.
4. Predicate Device Information
The Practical Navigation Surgical Guidance System described in this submission is substantially equivalent to the following predicate:
| Predicate Device | Manufacturer | 510(k) No. |
|---|---|---|
| Excelsius GPS | Globus Medical, Inc. | K171651 |
The following device is referenced in this submission:
| Reference Device | Manufacturer | 510(k) No. |
|---|---|---|
| LineSider™ Spinal System | Integrity Implants, Inc. | K203367 |
4
5. Device Description
The Practical Navigation Surgical Guidance System (PNSGS) is an image guided system primarily comprised of a computer workstation, software, a trajectory system, including a targeting platform, a Camera, and various image guided instruments intended for assisting the surgeon in placing screws in the pedicles of the lumbar spine. The PNSGS system allows for registration of the patient's anatomy to O-arm images. Once the patient anatomy is registered, a surgical plan can be created and optically-tracked surgical instruments can be used to follow the surgical plan. The system is used in the following manner:
-
- The patient is placed in the appropriate position on the OR table.
- The compact tracking Camera is rigidly affixed to the OR table using a multi-2. functional mechanical support arm in the appropriate position to track the surgical site.
-
- The Camera is also affixed to a pin placed in the patient's iliac to provide a fixed location relative to the patient's spinal anatomy.
-
- The Targeting Platform is affixed to the OR Table using a multi-functional mechanical support arm, ensuring that the Targeting Platform has sufficient range of motion to be placed over the surgical site.
-
- The Registration Array is affixed to planned surgical site.
- The appropriate area of spine is scanned with an O-arm. 6.
-
- The scans are transferred to the PNSGS workstation, which reconstructs the images and uses the registration array image to register the patient's spine relative to the Camera location.
-
- The registration is confirmed by placing an image guided instrument with a Tracking Array at various points in the surgical field.
-
- The surgical paths are planned on the workstation.
-
- The Targeting Platform is gross-positioned manually close to the first surgical plan location.
-
- The Targeting Platform is activated to set the fine location and the trajectory based on the surgical plan.
-
- Instruments with tracking arrays are used through the tool guide of the Targeting Platform to prepare the pedicle and place a pedicle screw.
6. Indications for Use
The Practical Navigation Surgical Guidance System is intended for use as an aid for precisely locating anatomical structures and for the spatial positioning and orientation of a tool holder or Guide Tube to be used by surgeons for navigating and/or guiding compatible surgical instruments in open or percutaneous spinal procedures in reference to rigid patient anatomy and fiducials that can be identified on an O-arm scan. The Practical Navigation Surgical Guidance System is indicated for assisting the surgeon in placing pedicle screws in vertebrae in the posterior lumbar region (L1-S1).
5
The system is designed for lumbar pedicle screw placement with the patient in the prone position and is compatible with the Integrity LineSider Pedicle Spinal System.
7. Comparison of Technological Characteristics
The substantial equivalence of the Practical Navigation Surgical Guidance System to the predicate devices is shown by the similarity in intended use, indications for use, mechanism of action, mode of operation, and performance. The table below provides a comparison of technological characteristics and principles of operation of the PNSGS and the predicate system:
| Feature | Practical Navigation Surgical Guidance
System
(Subject Device) | Globus Medical, Inc.
Excelsius GPS
(K171651) |
|--------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Indications for Use: | The Practical Navigation Surgical Guidance
System is intended for use as an aid for precisely
locating anatomical structures and for the spatial
positioning and orientation of a tool holder or
Guide Tube to be used by surgeons for navigating
and/or guiding compatible surgical instruments in
open or percutaneous spinal procedures in
reference to rigid patient anatomy and fiducials
that can be identified on an O-arm scan. The
Practical Navigation Surgical Guidance System is
indicated for assisting the surgeon in placing
pedicle screws in vertebrae in the posterior
lumbar region (L1-S1). | The EXCELSIUS GPSTM is intended for use as an aid
for precisely locating anatomical structures and for the
spatial positioning and orientation of an instrument
holder or Guide Tube to be used by surgeons for
navigating and/or guiding compatible surgical
instruments in open or percutaneous procedures
provided that the required fiducial markers and rigid
patient anatomy can be identified on CT scans or
fluoroscopy. The system is indicated for the placement
of spinal and orthopedic bone screws. |
| Principles of
Operation | - Intraoperative/
preoperative images
- Patient registration
- Surgical planning
- Real-time tracking of
navigated instruments - Guidance of instruments | - Intraoperative/
preoperative images - Patient registration
- Surgical planning
- Real-time tracking of
navigated instruments - Guidance of instruments |
| Input Images | 3D Intraoperative images | 3D Pre-operative images
3D Intraoperative images
2D Intraoperative images |
| Integrated Planning
Software | PNSGS Planning and Navigation Software | Excelsius™ GPS Planning and Navigation Software |
| Save/load Planning | Yes | Yes |
| Image Merging | No | Yes |
| Trajectory planning
parameters | Entry point, target point, length of the instrument,
diameter | Entry point, target point, length of the instrument,
diameter |
| Localization method | Optical System (infrared Camera) | Optical System (infrared Camera) |
| Camera system | Monocular | Stereo |
| Image-guided
Controller | Yes
Manual macro adjustments
Force-controlled movement of Targeting
platform | Yes
Force-controlled movement allowing robotic arm
positioning |
| Patient Registration
Method | Registration fixture in place during 3D
intraoperative images | Registration fixture during 3D intraoperative images.
Fluoroscopic merge to pre-op CT
Registration fixture in place during fluoroscopy |
| Accuracy
verification on
anatomical
landmarks | Yes | Yes |
| Real time display of
instrument position | Yes | Yes |
| Instrument
Guidance | Trajectory and location set by Targeting
platform. Instruments are manually | Trajectory and location set by the robotic arm.
Instruments are manually positioned by the |
| Feature | Practical Navigation Surgical Guidance
System
(Subject Device) | Globus Medical, Inc.
Excelsius GPS
(K171651) |
| | positioned by the surgeon through the
Guide Tube on the Targeting Platform. | surgeon through the Guide Tube on the robotic
arm. |
| Patient fixation | Tracking Camera is fixed to OR table and to
the patient's iliac crest. | Dynamic reference system is fixed to patient's
bony structure such as a long bone, iliac crest,
spinous process, vertebra, etc. |
6
8. Performance Data
Practical Navigation Surgical Guidance System was tested in accordance with the design requirements. Testing included the following:
- Non-clinical system, software, and instrument verification and validation.
- Cadaver and simulated-use testing under clinically relevant scenarios.
- ASTM F2554-10 Standard Practice for Measurement of Positional Accuracy of . Computer Assisted Surgical Systems.
- ANSI/AAMI ES60601-1:2005/(R)2012 And A1:2012Medical Electrical ● Equipment - Part 1: General Requirements for Basic Safety and Essential Performance.
- IEC 60601-1-2:2014 Medical Electrical Equipment Part 1-2: General ● Requirements for Basic Safety and Essential Performance - Collateral Standard: Electromagnetic Disturbances - Requirements and Testing.
9. Conclusion
Based on the indications for use, technological characteristics, performance results, and comparison to the predicates, the Practical Navigation Surgical Guidance System has been shown to be substantially equivalent to the predicate devices identified in this submission and does not present any new issues of safety or effectiveness.