(86 days)
Not Found
No
The description focuses on established navigation technologies, spatial boundaries, and controlled burring based on predefined landmarks and surgical plans, without mentioning AI or ML.
No.
The device is a surgical navigation and burring system intended to assist the surgeon, not to achieve a therapeutic effect itself.
No
The Navio system is a surgical navigation and burring system intended to assist surgeons during orthopedic procedures by providing spatial boundaries and aiding in the execution of surgical plans. It does not diagnose medical conditions.
No
The device description explicitly states the Navio system is a "computer-assisted orthopedic surgical navigation and surgical burring system" and describes the use of a "passive infrared tracking camera" and an adapted "standard off-the-shelf surgical drill motor and bur" with a tracking system. These are hardware components integral to the device's function.
Based on the provided information, the Navio system is not an In Vitro Diagnostic (IVD) device.
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens (like blood, urine, or tissue) taken from the human body to provide information for diagnosis, monitoring, or screening.
- Navio System Function: The Navio system is a computer-assisted surgical navigation and burring system used during orthopedic procedures. It provides spatial guidance and assists the surgeon in preparing bone surfaces for implant placement. It does not analyze biological specimens.
- Intended Use: The intended use clearly states it's for assisting surgeons during orthopedic procedures by providing spatial boundaries and reference information to anatomical structures.
- Device Description: The description details its use of infrared tracking, bone surface modeling, surgical planning, and controlled burring – all related to surgical execution, not laboratory analysis of specimens.
Therefore, the Navio system falls under the category of a surgical navigation and robotic/assisted surgical system, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The Navio system is intended to assist the surgeon in providing software-defined spatial boundaries for orientation and reference information to anatomical structures during orthopedic procedures.
The Navio system is indicated for use in surgical knee procedures, in which the use of stereotactic surgery may be appropriate, and where reference to rigid anatomical bony structures can be determined. These procedures include unicondylar knee replacement and patellofemoral arthroplasty.
The Navio system is indicated for use with cemented implants only.
Product codes (comma separated list FDA assigned to the subject device)
OLO, HSX, HRY, KRR, NPJ
Device Description
The Navio system is a computer-assisted orthopedic surgical navigation and surgical burring system. The system uses established technologies of navigation via a passive infrared tracking camera to aid the surgeon in establishing a bone surface model for the target surgery and to plan the surgical implant location based on predefined bone landmarks and known configuration of the surgical implant. The Navio system then aids the surgeon in executing the surgical plan by using a standard off-the-shelf surgical drill motor and bur (eMax 2 Plus System -K080802), which has been adapted using a tracking system. The surgical bur is located in a handpiece, which allows the bur to move within the handpiece. In the Navio system the software controls the position of the tip of the surgical bur relative to the end of a guard attached to the handpiece and prohibits the bur from cutting bone as it approaches the planned target surface. As the planned surface is reached, the tip of the bur is fully retracted within the guard.
An alternate mode of operation is the speed control mode. In this mode the speed of the bur is controlled and the bur stops as the planned surface is reached. In this mode of operation the bur does not retract into the guard. This mode of operation is useful in shaping surfaces of the condyle as well as placing post holes.
The Navio computer system maintains a log of the patient data and procedure data. Each entry is date and time stamped. Data log entries include date and time stamp for data line entry, patient and procedure ID, implant ID, step in process, and error messages. This data can be archived to a CD upon demand at the end of the procedure.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found. The device uses "intraoperative data collection (image- free or non-CT data generation)".
Anatomical Site
knee, patellofemoral joint, femoral condyle, tibial plateau
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Used by trained orthopedic surgeons in an Orthopedic surgical suite.
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)
Nonclinical Testing: Design verification tests were performed on the Blue Belt Technologies Navio system to support inlay patellofemoral implant placement as a result of the risk analysis and product requirements. Testing included software data base reviews, bench verification testing, user manual/labeling inspection, drawing inspections, and a clinical simulation (usability testing). Simulated-use testing included testing in simulated knees (sawbones) and cadaver lab testing. Users included surgeons, physician's assistants, and technical support personnel who were able to successfully use the Navio system and place inlay patellofemoral implants per Blue Belt Technologies' specifications and implant manufacturer's specifications after being adequately trained.
Clinical Testing: No human clinical tests were conducted to determine safety and effectiveness of the Navio system.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Onlay Patellofemoral component RMS placement error along any single axis averaged 0.884 mm and 1.013°.
Inlay Patellofemoral component RMS placement error along any single axis averaged 0.462 mm and 1.028°.
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.
Blue Belt Technologies Navio System (K140596)
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).
0
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is an abstract image of three faces in profile, stacked on top of each other, resembling a stylized human figure.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
March 20, 2015
Blue Belt Technologies, Incorporated Mr. Richard G. Confer Vice President of Regulatory Affairs 2828 Liberty Avenue, Suite 100 Pittsburgh, Pennsylvania 15222
Re: K143668
Trade/Device Name: Navio™M Regulation Number: 21 CFR 882.4560 Regulation Name: Stereotaxic instrument Regulatory Class: Class II Product Code: OLO, HSX, HRY, KRR, NPJ Dated: December 22, 2014 Received: December 24, 2014
Dear Mr. Confer:
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
1
Page 2 - Mr. Richard G. Confer
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.
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/Resourcesfor You/Industry/default.htm. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR 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 vours.
Lori A. Wiggins -S
for Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
510(k) Number (if known)
Device Name Navio
Indications for Use (Describe)
The Navio system is intended to assist the surgeon in providing software-defined spatial boundaries for orientation and reference information to anatomical structures during orthopedic procedures.
The Navio system is indicated for use in surgical knee procedures, in which the use of stereotactic surgery may be appropriate, and where reference to rigid anatomical bony structures can be determined. These procedures include unicondylar knee replacement and patellofemoral arthroplasty.
The Navio system is indicated for use with cemented implants only.
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)
PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.
FOR FDA USE ONLY
Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)
3
Section 6: 510(k) Summary
510(k) Summary
| 510(k) Owner | Blue Belt Technologies
2905 Northwest Blvd Ste. 40
Plymouth, MN 55441
UNITED STATES
Tel: (763) 452-4905
Fax: (763) 452-4675 |
|--------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person | Richard G. Confer
Vice President of Regulatory Affairs and Quality
Assurance
Tel: (412) 683-3844 x 4106
Email: rconfer@bluebelttech.com |
| Date of Submission | December 22, 2014 |
| Classification Reference | 21 CFR 882.4560 |
| Product Code | OLO |
| Supported Codes | HSX, HRY, KRR, NPJ |
| Common/Usual Name | Orthopedic Sterotaxic Instrument |
| Trade/Proprietary Name | NavioTM |
| Predicate Device(s) | Blue Belt Technologies Navio System (K140596) |
| Reason for Submission | Expanded Indications to add NPJ as a supported
product code |
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Intended Use
The Navio system is intended to assist the surgeon in providing software-defined spatial boundaries for orientation and reference information to anatomical structures during orthopedic procedures.
The Navio system is indicated for use in surgical knee procedures, in which the use of stereotactic surgery may be appropriate, and where reference to rigid anatomical bony structures can be determined. These procedures include unicondylar knee replacement and patellofemoral arthroplasty.
The Navio system is indicated for use with cemented implants only.
This intended use statement is the same as the predicate, Navio System per K140596, and adds product code NPJ per regulation 888.3560 as a supported product code.
Device Description
The Navio system is a computer-assisted orthopedic surgical navigation and surgical burring system. The system uses established technologies of navigation via a passive infrared tracking camera to aid the surgeon in establishing a bone surface model for the target surgery and to plan the surgical implant location based on predefined bone landmarks and known configuration of the surgical implant. The Navio system then aids the surgeon in executing the surgical plan by using a standard off-the-shelf surgical drill motor and bur (eMax 2 Plus System -K080802), which has been adapted using a tracking system. The surgical bur is located in a handpiece, which allows the bur to move within the handpiece. In the Navio system the software controls the position of the tip of the surgical bur relative to the end of a guard attached to the handpiece and prohibits the bur from cutting bone as it approaches the planned target surface. As the planned surface is reached, the tip of the bur is fully retracted within the guard.
An alternate mode of operation is the speed control mode. In this mode the speed of the bur is controlled and the bur stops as the planned surface is reached. In this mode of operation the bur does not retract into the guard. This mode of operation is useful in shaping surfaces of the condyle as well as placing post holes.
The Navio computer system maintains a log of the patient data and procedure data. Each entry is date and time stamped. Data log entries include date and time stamp for data line entry, patient and procedure ID, implant ID, step in process, and error messages. This data can be archived to a CD upon demand at the end of the procedure.
The following diagram shows the primary workflow steps in each application, UKR and PFA. Though the two procedures are very similar, they are mutually independent and cannot be planned or completed in parallel.
Note: The workflow has not changed from the predicate, Navio per K140596.
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Figure 6-1
Image /page/5/Figure/2 description: The image shows two flowcharts outlining the steps for two different operative procedures: Navio-UKR for Unicondylar Knee Replacement and Navio-PFA for Patellofemoral Arthroplasty. Both procedures start with hardware and handpiece connections, followed by bur/control selection, handpiece retraction, calibration, and homing validation. The UKR procedure includes steps like malleoli point collection, femur neutral position, tibia landmarks collection, gap planning, and evaluate knee ROM. The PFA procedure includes hip center calculation and skips the tibia-related steps and gap planning.
6
| Devices | Blue Belt Technologies
Navio | Predicate A
Blue Belt Technologies
Navio (K14059) |
|-----------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Indications for use | The same as Predicate | The Navio system is intended to assist
the surgeon in providing software-
defined spatial boundaries for
orientation and reference information
to anatomical structures during
orthopedic procedures.
The Navio System is indicated for use in
surgical knee procedures in which the
use of stereotactic surgery may be
appropriate, and where reference to
rigid anatomical bony structures can be
determined.
These procedures include unicondylar
knee replacement and patellofemoral
arthroplasty.
The Navio system is indicated for use
with cemented implants only. |
| Supported Product
Code | Supported Product
Codes:
HSX, HRY, KRR, NPJ | Supported Product Codes:
HSX, HRY, KRR |
| Environment of Use | Same as Predicate | Used by trained orthopedic surgeons in
an Orthopedic surgical suite. |
| Technological
Characteristics | Same as Predicate | The Navio system uses established
technologies to prepare bone for
attachment of implant components.
Navio uses intraoperative data
collection (image- free or non-CT data
generation) to create a model of the
patient's femur and/or tibia,
dependent on the procedure being
performed, and allows the surgeon to
prepare a surgical plan.
The Navio system uses predefined
boundaries generated during the
planning process to control the motion
of the surgical bur and limit the amount
of bone removed in order to shape the |
| Devices | Blue Belt Technologies
Navio | Predicate A
Blue Belt Technologies
Navio (K14059) |
| Construction | Same as Predicate | patellofemoral joint in preparation for
placement of the surgical implant.
Bur cutting is controlled either by
retracting the bur in a guard, or by
controlling the speed of the bur as the
target surface is approached. |
| Pre-Surgical Planning
Method | Same as Predicate | Consists of an IR image system
(Northern Digital Polaris), reflective
trackers, computer, user interface
display, various probes, a surgical bur,
bur guards, bone screws, and clamps. |
| Imaging
Requirements | Same as Predicate | Uses data collected intra-operatively by
surgeon during the initial surgical
procedure to generate a real-time plan
of cut surfaces. |
| Tool manipulation | Same as Predicate | None preoperative.
Possible post-operative to verify
implant placement after surgeon
finalizes placement. |
| Feedback that
boundary has been
reached | Same as Predicate | Controlled by retracting surgical bur
into a guard as a function of proximity
of bur to planned cut surface. Also,
speed of bur changes as a function of
proximity to planned cut surface.
The surgeon has control of the tool at
all times. Position of the bur is based
on navigated guidance and planning of
desired cut surface. |
| Visual indicator | Same as Predicate | Visual (color-coded surface on GUI) and
audio indicators as feedback that the
boundary has been reached.
Withdrawal of bur or reduced bur
speed. |
| | Same as Predicate | Color changes as surgical bur
approaches planned cut boundary.
Magenta (purple) is the starting bone
surface (>3 mm from target surface).
Intermediate colors (blue and green)
indicate bone to be removed. Blue
indicates 2 mm to target surface.
Green indicates 1 mm to target surface.
Colors are correlated to the distance. |
| Devices | Blue Belt Technologies
Navio | Predicate A
Blue Belt Technologies
Navio (K14059) |
| | | from planned cut surface in 1mm
increments. Red indicates over cut
exceeding 0.5 mm. |
| User Override | Same as Predicate | Surgeon has full control of handpiece
at all times. Cutting bur operation
speed is enabled by surgeon operated
footswitch. The computer program
only modifies the speed up to the limit
set by the surgeon pressing the
footswitch.
The surgeon always has the ability to
move the handpiece away from the cut
surface or disable the footswitch. |
| Accuracy of
placement of
implant | Same placement
accuracies as Predicate
for patellofemoral knee
replacements
(algorithms have not
changed).
Onlay Patellofemoral
component RMS
placement error along
any single axis averaged
0.884 mm and 1.013°.
Inlay Patellofemoral
component RMS
placement error along
any single axis averaged
0.462 mm and 1.028°. | Onlay Patellofemoral component RMS
placement error along any single axis
averaged 0.884 mm and 1.013°. |
Table 6-1: Summary of Technological Similarities with Predicates
7
8
Nonclinical Testing
Design verification tests were performed on the Blue Belt Technologies Navio system to support inlay patellofemoral implant placement as a result of the risk analysis and product requirements. Testing included software data base reviews, bench verification testing, user manual/labeling inspection, drawing inspections, and a clinical simulation (usability testing). Simulated-use testing included testing in simulated knees (sawbones) and cadaver lab testing. Users included surgeons, physician's assistants, and technical support personnel who were able to successfully use the Navio system and place inlay patellofemoral implants per Blue Belt Technologies' specifications and implant manufacturer's specifications after being adequately trained.
9
Discussion of Similarities and Differences
The Navio system uses established technologies to prepare bone for attachment of implant components. Navio uses intraoperative data collection (image-free or non-CT data generation) to create a model of the patient's femur and tibia and allow the surgeon to prepare a surgical plan. The Navio uses predefined boundaries generated during the planning process to control the motion of the surgical bur and limit the amount of bone removed in order to shape the condyles, tibial plateau, or patellofemoral joint in preparation for placement of the surgical implant. This is equivalent to the methodology used by the NavioPFS™ system except for the Navio's additional capability to prepare the patellofemoral joint for implant.
The Navio uses predefined boundaries generated during the planning process to control the motion of the surgical bur and limit the amount of bone removed in order to shape the condyles, tibial plateau, and/or the patellofemoral joint in preparation for placement of the surgical implant.
This submittal supports the expanded indication for use of the Navio system to place inlay patellofemoral implants using the same techniques used in the predicate Navio system.
Though the UKR and PFA procedures are very similar, they are mutually independent and cannot be planned or completed in parallel. If the user is completing a bicompartmental knee joint replacement in which a patellofemoral arthroplasty and a unicondylar knee replacement are both being performed, preparation of the patellofemoral joint must be completed independently of the preparations of the femoral condyle and tibial plateau surfaces.
Clinical Testing
No human clinical tests were conducted to determine safety and effectiveness of the Navio system.
Summary and Conclusions
The Navio system described in this submittal has the same intended use and the same technological characteristics as the Navio system (K140596). Non-clinical testing was completed to verify that the use of the Navio system to assist with the placement of inlay patellofemoral implants does not raise any new issues of safety or effectiveness. The information presented in this 510(k) notification demonstrates that the Navio, when used to place an inlay patellofemoral implant, is as safe and effective as Navio™ (K140596).