(117 days)
No
The description focuses on established navigation technologies (passive infrared tracking) and software control based on predefined landmarks and implant configurations. There is no mention of AI or ML in the device description, intended use, or performance studies.
No.
The device assists the surgeon in performing the procedure but does not directly provide therapy or treatment to the patient. It is a surgical navigation and burring system.
No
The Navio system is a computer-assisted orthopedic surgical navigation and surgical burring system intended to assist the surgeon during orthopedic procedures by providing spatial boundaries for orientation and reference information, and aiding in the execution of the surgical plan. It does not diagnose any medical conditions.
No
The device description explicitly states it is a "computer-assisted orthopedic surgical navigation and surgical burring system" and details the use of a "passive infrared tracking camera," a "standard off-the-shelf surgical drill motor and bur," and a "handpiece." These are all hardware components, indicating it is not a software-only device.
Based on the provided information, the Navio system is not an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use clearly states that 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." This describes a surgical navigation and assistance system used during a surgical procedure on a patient's body.
- Device Description: The description details a computer-assisted surgical navigation and surgical burring system that uses tracking technology to guide a surgical bur. This is a tool used directly on the patient's anatomy during surgery.
- Lack of In Vitro Activity: IVD devices are designed to examine specimens from the human body (like blood, urine, tissue) outside of the body to provide information for diagnosis, monitoring, or screening. The Navio system does not perform any such analysis of biological specimens.
- Anatomical Site: The anatomical site is the knee, indicating direct interaction with the patient's body during surgery.
In summary, the Navio system is a surgical navigation and assistance device used in vivo (within the living body) during orthopedic procedures, not an in vitro diagnostic device that analyzes specimens outside the body.
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
OLO, HSX, HRY, KRR
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
None preoperative.
Anatomical Site
Knee, femur, tibia, patellofemoral joint
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Surgeon, physician's assistants, and technical support personnel.
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 as a result of the risk analysis and product requirements. Testing included software code reviews, software unit testing, software integration testing, 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 implants per Blue Belt Technologies' 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.)
Not Found
Predicate Device(s)
Blue Belt Technologies, Inc. NavioPFS™ (K121936), MAKO Surgical Corp. Tactile Guidance System v2.0 (K081867)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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
JUL 0 2 2014
Traditional 510(k) 005_510(k) Summary
Navio™
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Company Control Concession Company Concession | .
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| 510(k) Owner | Blue Belt Technologies, Inc.
2828 Liberty Ave., Suite 100
Pittsburgh, PA 15222
Tel: (412) 683-3844
Fax: (412) 683-6447 |
|--------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person | Richard G. Confer
Vice President of Quality Assurance and Regulatory Affairs
Tel: (412) 683-3844 x 4106
Email: rconfer@bluebelttech.com |
| Date of Submission | June 27, 2014 |
| Classification Reference | 21 CFR 882.4560 |
| Product Code | OLO |
| Product Codes of Implants Supported by the Navio | HSX, HRY, KRR |
| Common/Usual Name | Orthopedic Sterotaxic Instrument |
| Trade/Proprietary Name | Navio™ |
| Predicate Device(s) | Blue Belt Technologies, Inc. NavioPFS™ (K121936)
MAKO Surgical Corp. Tactile Guidance System v2.0 (K081867) |
| Reason for Submission | Expanded Indications |
1
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, MAKO TGS (K081867) and expands the intended use statement of the NavioPFS (K121936) to include the patellofemoral knee replacement application.
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.
2
During Patient Registration, the user selects the operative procedure to be completed: Navio - UKR for Unicondylar Knee Replacement
Hardware Connection Handpiece Connection
Bur/Control Selection
Handpiece Retraction
Handpiece Calibration
Handpiece Home Position
Homing Validation
Bone Tracker Attachment
Camera Orientation Adjustment
Point Probe Verification
Checkpoint Definition
Malleoli Point Collection
Hip Center Calculation
Femur Neutral Postion
Femur Kinematic Axis
Stressed ROM Collection
Femur Landmark Point Selection
Femur Free Collection
Tibia Landmarks Collection
Tibia Free Collection
Prosthesis Placement
Gap Planning
Adjust Component ML Position
Checkpoint Verification
Bone Model Refinement
Bone Removal
Evaluate Knee ROM
During Patient Registration, the user selects the operative procedure to be completed: Navio - PFA for Patellofemoral Arthroplasty
Hardware Connection Handpiece Connection
Bur/Control Selection
Handpiece Retraction
Handpiece Calibration
Handpiece Home Position
Homing Validation
Bone Tracker Attachment
Camera Orientation Adjustment
Point Probe Verification
Checkpoint Definition
Hip Center Calculation
Femur Landmark Point Selection
Femur Free Collection
Prosthesis Placement
Checkpoint Verification Bone Model Refinement
Bone Removal
Blue Belt Technologies, Inc.
Navio™
3
Navio™
| Summary of Similarities and Differences
| Navio, NavioPFS™, and Tactile Guidance System v2.0 | |||
|---|---|---|---|
| Devices | Premarket Notification | ||
| Subject Device | Predicate A | Predicate B | |
| Blue Belt Technologies | |||
| Navio™ | Blue Belt Technologies | ||
| NavioPFS™ | |||
| (K121936) | MAKO Surgical Corp. | ||
| Tactile Guidance System v2.0 | |||
| (K081867) | |||
| Technological | |||
| Characteristics | The Navio system uses | ||
| established technologies, | |||
| as described for the | |||
| NavioPFS, 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. | |||
| This is equivalent to the | |||
| methodology used by the | |||
| NavioPFS. | |||
| 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. | |||
| 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. | The NavioPFS™ uses | ||
| intraoperative data | |||
| collection (image free or | |||
| non-CT data generation) | |||
| to create a model of the | |||
| patient's femur and tibia | |||
| and allows the surgeon to | |||
| prepare a surgical plan. |
The NavioPFS™ 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 and tibial
plateau 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. |
| Construction | Consists of an IR image
system (Northern Digital
Polaris), reflective trackers,
computer, user interface
display, various probes, a
surgical bur, reusable bur
guards, bone screws and
clamps | Consists of an IR image
system (Northern Digital
Polaris), reflective
trackers, computer, user
interface display, various
probes, a surgical bur,
sterile bur guards, bone
screws and clamps | Consists of an IR image
system (Northern Digital
Polaris), reflective trackers,
computer, user interface
display, various probes, a
surgical bur, bone screws and
clamps. |
| | clamps. | | |
| Summary of Similarities and Differences | | | |
| Navio, NavioPFSTM, and Tactile Guidance System v2.0 | | | |
| Devices | Premarket Notification
Subject Device | Predicate A | Predicate B |
| | Blue Belt Technologies
NavioTM | Blue Belt Technologies
NavioPFSTM
(K121936) | MAKO Surgical Corp.
Tactile Guidance System v2.0
(K081867) |
| Pre-Surgical
Planning
Method | Uses data collected intra-
operatively by surgeon
during the initial surgical
procedure to generate a
real time plan of cut
surfaces. | Uses data collected intra-
operatively by surgeon
during the initial surgical
procedure to generate a
real time plan of cut
surfaces. | Uses DICOM data imported
from pre-operative CT scans. |
| Imaging
Requirements | None preoperative.
Possible post-operative to
verify implant placement
after surgeon finalizes
placement | None preoperative.
Possible post-operative to
verify implant placement
after surgeon finalizes
placement | CT Scans required
preoperatively.
Possible post-operative scans
to confirm implant placement
after surgeon finalizes
placement. |
Summary of Technological Similarities with Predicates:
Blue Belt Technologies, Inc.
4
Navio™
Nonclinical testing:
Design verification tests were performed on the Blue Belt Technologies Navio system as a result of the risk analysis and product requirements. Testing included software code reviews, software unit testing, software integration testing, 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 implants per Blue Belt Technologies' specifications after being adequately trained.
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 allows the surgeon to prepare a surgical plan. The Navio uses predefined boundaries generated during the planning process to control 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 is similar to the methods used by the MAKO TGS system to prepare the condyles, tibial plateau, and patellofemoral joint, although the MAKO TGS system uses a preoperative CT scan in addition to intra-operatively acquired data to plan the position of implant components.
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 bi-compartmental 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.
Blue Belt Technologies, Inc.
5
Clinical testing
No human clinical tests were conducted to determine safety and effectiveness of the Navio system.
Summary and Conclusions
The Navio system has the same intended use as the MAKO TGS system (K081867) and has the same technological characteristics as the NavioPFS system (K121936). Non clinical testing was completed to verify that the differences in technological characteristics and workflow do not raise any new issues of safety or effectiveness. The information presented in this 510(k) notification demonstrates that the Navio is as safe and effective and performs as well as the Blue Belt Technologies NavioPFS™ (K121936) or the MAKO Surgical Corp. Tactile Guidance System v2.0 (K081867).
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6
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/6/Picture/1 description: The image shows the logo for the Department of Health & Human Services (HHS) in the United States. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" around the perimeter. Inside the circle is an emblem featuring a stylized eagle with three lines representing its wings and body. The eagle is facing left, and the overall design is simple and iconic.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
Blue Belt Technologies, Incorporated Mr. Richard G. Confer Vice President of Quality Assurance and Regulatory Affairs 2828 Liberty Avenue, Suite 100 Pittsburgh, Pennsylvania 15222
July 2, 2014
Re: K140596
Trade/Device Name: Navio Regulation Number: 21 CFR 882.4560 Regulation Name: Stereotaxic instrument Regulatory Class: Class II Product Code: OLO, HSX, HRY, KRR Dated: June 5, 2014 Received: June 6. 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. Iisting 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 he advised that FDA`s issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complics 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 device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set
7
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/ResourcesforYou/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 yours,
Mark N. Melkerson -S
- Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
8
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement on last page.
510(k) Number (if known) unknown
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)
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.
... のお店での中国の一部に、採用・保育・保育・FOR FOR FOR FOR FOR FOR FOR FOR MAN Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)
Casey L. Hanley, Ph.D.
Division of Orthopedic Devices