(83 days)
No
The description focuses on established navigation and robotic control technologies, with no mention of AI or ML.
No
The device aids the surgeon in planning and executing surgical procedures, and in controlling a surgical burr. It is not directly therapeutic; rather, it is a surgical navigation and assistance system.
No
The device is a computer-assisted surgical navigation and burring system. Its purpose is to assist the surgeon during orthopedic procedures by providing spatial boundaries and aiding in the execution of the surgical plan. 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" that uses a "passive infrared tracking camera" and adapts a "standard off-the-shelf surgical drill motor and bur". This indicates the system includes significant hardware components beyond just software.
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 during orthopedic procedures by providing spatial boundaries and reference information to anatomical structures. This is an in vivo application, meaning it is used within a living organism during surgery.
- Device Description: The device description details a computer-assisted surgical navigation and burring system used to aid in surgical planning and execution on bone. This is a surgical tool, not a device used to examine specimens in vitro (outside of the body).
- Lack of IVD Characteristics: There is no mention of the device being used to test or analyze biological specimens (blood, tissue, urine, etc.) to diagnose, monitor, or treat a medical condition.
IVD devices are specifically designed to perform tests on samples taken from the human body. The Navio system's function is to guide surgical procedures directly on the patient's anatomy.
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 (UKR), patellofemoral arthroplasty (PFA), and total knee arthroplasty (TKA).
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, JWH
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 both establishing a bone surface model for the target surgery and in planning the surgical implant location, based on intraoperatively-defined bone landmarks and known geometry 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 (Anspach eMax2 Plus System, cleared via K080802), which has been adapted using a tracking system.
The surgical bur is inserted into a handpiece, which allows the bur to move within the handpiece. The Navio system software controls the position 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. This is referred to as Exposure Control mode.
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 target 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 and fixation features.
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 each data line entry, patient and procedure ID, implant ID, step in process, and error messages received by the user during the procedure. This data can be archived to a CD upon demand at the end of the procedure and is anonymized.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Knee
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Intended for use 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)
Design verification tests were performed on the Blue Belt Technologies, Inc. Navio system to support total knee arthroplasty, as a result of the risk analysis and product requirements. Testing included software database reviews, bench testing, labeling inspection, drawing inspections, and a clinical simulation (usability testing). Simulated-use testing included simulated knee (sawbones) and cadaver laboratory testing. Users included surgeons, physician's assistants, and technical support personnel who were able to successfully use the Navio system to place total knee implant systems per Blue Belt Technologies' and implant manufacturer's specifications after being adequately trained.
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.
Navio® (K152574)
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.
K121936, K140596, K143668, K080802
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/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo is circular, with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter of the circle. In the center of the circle is a stylized image of three human profiles facing to the right, stacked on top of each other.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
May 19, 2016
Blue Belt Technologies, Incorporation Mr. Richard Confer Vice President of Regulatory Affairs 2905 Northwest Boulevard, Suite 40 Plymouth, Minnesota 55441
Re: K160537 Trade/Device Name: Navio® Regulation Number: 21 CFR 882.4560 Regulation Name: Stereotaxic instrument Regulatory Class: Class II Product Code: OLO, HSX, HRY, KRR, NPJ, JWH Dated: February 24, 2016 Received: February 26, 2016
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 Parts 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set
1
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
2
Indications for Use
510(k) Number (if known) K160537 XIXIXXXXXXX
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 (UKR), patellofemoral arthroplasty (PFA), and total knee arthroplasty (TKA).
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)
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Image /page/3/Picture/0 description: The image shows the logo for Blue Belt Technologies. The logo consists of a blue swirl design on the left, followed by the words "BLUE BELT" in large, blue, sans-serif font. Below "BLUE BELT" is the word "TECHNOLOGIES" in a smaller, gray, sans-serif font. The overall design is clean and modern.
2905 Northwest Boulevard, Suite 40, Plymouth, Minnesota 55441 USA Tel 763.452.4950 Fax 763.452.4675 www.bluebelttech.com
510(k) Summary
| 510(k) Owner | Blue Belt Technologies, Inc.
2905 Northwest Blvd Ste. 40
Plymouth, MN 55441 USA
Tel: (763) 452-4950
Fax: (763) 452-4675 |
|--------------------------|-------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person | Richard G. Confer
Vice President of Regulatory Affairs
Tel: (412) 683-3844 x 4106
Email: Rick.Confer@smith-nephew.com |
| Date of Submission | February 24, 2016 |
| Classification Reference | 21 CFR 882.4560 |
| Product Code | OLO |
| Supported Codes | HSX, HRY, KRR, NPJ, JWH |
| Common/Usual Name | Orthopedic Sterotaxic Instrument |
| Trade/Proprietary Name | Navio® |
| Predicate Device(s) | Navio® (K152574) |
| Reason for Submission | Expanded indications for use to include total knee
arthroplasty (TKA), which adds JWH as a supported
product code |
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Image /page/4/Picture/0 description: The image contains the logo for Blue Belt Technologies. The logo consists of a blue swirl design on the left, followed by the words "BLUE BELT" in large, bold, blue letters. Below "BLUE BELT" is the word "TECHNOLOGIES" in smaller, gray letters. The logo is clean and professional, with a focus on the company name.
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.
Indications for Use
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 (UKR), patellofemoral arthroplasty (PFA), and total knee arthroplasty (TKA).
The Navio system is indicated for use with cemented implants only.
The Intended Use Statement is consistent with that of Navio®, the predicate device, cleared via K121936, K140596, K143668, and K152574. This expanded Indications for Use Statement includes the addition of total knee arthroplasty and support for product code JWH, per regulation number 888.3560.
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 both establishing a bone surface model for the target surgery and in planning the surgical implant location, based on intraoperatively-defined bone landmarks and known geometry 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 (Anspach eMax2 Plus System, cleared via K080802), which has been adapted using a tracking system.
The surgical bur is inserted into a handpiece, which allows the bur to move within the handpiece. The Navio system software controls the position 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. This is referred to as Exposure Control mode.
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 target 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 and fixation features.
5
Image /page/5/Picture/0 description: The image shows the logo for Blue Belt Technologies. The logo consists of a blue swirl design on the left, followed by the words "BLUE BELT" in large, blue, sans-serif font. Below "BLUE BELT" is the word "TECHNOLOGIES" in a smaller, gray, sans-serif font. The overall design is clean and modern.
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 each data line entry, patient and procedure ID, implant ID, step in process, and error messages received by the user during the procedure. This data can be archived to a CD upon demand at the end of the procedure and is anonymized.
The following diagram shows the primary workflow steps in each application: UKR, PFA, and TKA. The three procedures are mutually independent and cannot be planned or completed in parallel.
Note: The workflow for UKR and PFA procedures has not changed from the predicate device, cleared via K152574.
ReshapingMobility™
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Image /page/6/Picture/0 description: The image shows the logo for Blue Belt Technologies. The logo consists of a blue swirl design on the left, followed by the words "BLUE BELT" in large, blue, sans-serif font. Below "BLUE BELT" is the word "TECHNOLOGIES" in a smaller, gray, sans-serif font. The logo is clean and modern, with a focus on the company name.
2905 Northwest Boulevard, Suite 40, Plymouth, Minnesota 55441 USA Tel 763.452.4950 Fax 763.452.4675 www.bluebelttech.com
Figure 007-1a. Comparison of Workflows (Part 1 of 2)
Image /page/6/Figure/3 description: The image shows three flowcharts that describe the operative procedures for Navio-UKR, Navio-PFA, and Navio-TKA. Each flowchart lists the steps involved in the procedure, starting with hardware connection and ending with evaluating knee ROM. The Navio-UKR procedure includes steps such as malleoli point collection, femur kinematic axis, and gap planning, while the Navio-PFA procedure includes hip center calculation and prosthesis placement. The Navio-TKA procedure includes surgery options and a selection between femur first or tibia first.
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Image /page/7/Picture/0 description: The image shows the logo for Blue Belt Technologies. The logo consists of a blue swirl design on the left, followed by the words "BLUE BELT" in large, blue, sans-serif font. Below "BLUE BELT" is the word "TECHNOLOGIES" in a smaller, gray, sans-serif font. The overall design is clean and modern.
2905 Northwest Boulevard, Suite 40, Plymouth, Minnesota 55441 USA Tel 763.452.4950 Fax 763.452.4675 www.bluebelttech.com
Image /page/7/Figure/2 description: The image shows two flowcharts comparing the steps for Navio-TKA for femur first and tibia first. The femur first flowchart includes the following steps: Joint Laxity Extension/Flexion, Place Femur Implant, Place Tibia Implant, Gap Planning, Place Femur Cut Guide, Place Tibia Cut Guide, Checkpoint Verification, Femur Bone Removal, Checkpoint Verification, Tibia Bone Removal, and Evaluate Knee ROM. The tibia first flowchart includes the following steps: Place Tibia Implant, Place Tibia Cut Guide, Checkpoint Verification, Tibia Bone Removal, Joint Laxity Extension/Flexion, Place Femur Implant, Gap Planning, Place Femur Cut Guide, Checkpoint Verification, Femur Bone Removal, and Evaluate Knee ROM.
Figure 007-1b. Comparison of Workflows (Part 2 of 2)
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Image /page/8/Picture/0 description: The image shows the logo for Blue Belt Technologies. The logo consists of a blue circular design on the left, followed by the words "BLUE BELT" in blue, and the word "TECHNOLOGIES" in gray below. The circular design appears to be a stylized representation of a belt or a ring.
Currently supported implants include:
| Implant Model Name | Manufacturer | 510(k) number |
|---|---|---|
| NEO Total Knee System | New Era Orthopedics | K142388 |
| Journey II CR | Smith and Nephew | K121443 |
Table 007-1. Summary of Technological Similarities with Predicate
| Devices | Subject Device | Predicate Device |
|---|---|---|
| Navio with Total Knee | ||
| Arthroplasty Application | Navio [K152574] | |
| Intended use | 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. | ||
| Indications for Use | 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, | ||
| patellofemoral arthroplasty, and | ||
| total knee arthroplasty. | 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. |
| | The Navio system is indicated
for use with cemented implants
only. | |
| Supported Product Code(s) | HSX, HRY, KRR, NPJ, JWH | HSX, HRY, KRR, NPJ |
| Devices | Subject Device | Predicate Device |
| | Navio with Total Knee
Arthroplasty Application | Navio [K152574] |
| Environment of Use | Same as Predicate | Intended for use by trained
orthopedic surgeons in an
orthopedic surgical suite. |
| Technological Characteristics | The Navio system uses
established technologies to
prepare bone for attachment of
implant components, or in the
case of a total knee
arthroplasty, the bone surface is
prepared to receive the femoral
and tibial cutting guides. | 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. | 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 pre-
defined 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, or in the case of a total
knee arthroplasty, the bone
surface is prepared to receive
the femoral and tibial cutting
guides.
Bone surface for
receiving the implant is | The Navio system uses pre-
defined 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. |
| Devices | Subject Device | Predicate Device |
| | Navio with Total Knee
Arthroplasty Application | Navio [K152574] |
| | prepared using a standard
surgical saw. | |
| | 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. | 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. |
ReshapingMobility™
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Image /page/9/Picture/0 description: The image contains the logo for Blue Belt Technologies. The logo consists of a blue swirl design on the left, followed by the words "BLUE BELT" in large, bold, blue letters. Below "BLUE BELT" is the word "TECHNOLOGIES" in smaller, gray letters.
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Image /page/10/Picture/0 description: The image shows the logo for Blue Belt Technologies. The logo consists of a blue swirl design on the left, followed by the words "BLUE BELT" in large, bold, blue letters. Below "BLUE BELT" is the word "TECHNOLOGIES" in smaller, gray letters. The logo is simple and modern, and the use of blue and gray gives it a professional look.
Non-Clinical Testing (Bench)
Design verification tests were performed on the Blue Belt Technologies, Inc. Navio system to support total knee arthroplasty, as a result of the risk analysis and product requirements. Testing included software database reviews, bench testing, labeling inspection, drawing inspections, and a clinical simulation (usability testing). Simulateduse testing included simulated knee (sawbones) and cadaver laboratory testing. Users included surgeons, physician's assistants, and technical support personnel who were able to successfully use the Navio system to place total knee implant systems per Blue Belt Technologies' and implant manufacturer's specifications after being adequately trained.
Clinical Testing
No human clinical testing was conducted to determine safety and effectiveness of the Navio system.
Discussion of Similarities and Differences
The predicate, Navio, uses established technologies to prepare bone for attachment of implant components. The predicate uses intraoperative data collection (image-free or non-CT data generation) to create a model of the patient's femur and/or tibia and allow the surgeon to prepare a surgical plan. The predicate uses pre-defined 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 methodology is equivalent to what is used by the Navio, the subject of this 510(k), with the exception of the Navio's expanded indication to prepare the knee for a total
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Image /page/11/Picture/0 description: The image shows the logo for Blue Belt Technologies. The logo consists of a blue swirl design on the left, followed by the words "BLUE BELT" in large, blue, sans-serif font. Below "BLUE BELT" is the word "TECHNOLOGIES" in a smaller, gray, sans-serif font. The logo is clean and modern, with a focus on the company name.
knee arthroplasty. During a total knee arthroplasty procedure, the Navio controls the cutting action of the bur during the placement of the cutting guides. The surgeon then uses the Navio-placed cutting guides to finish the preparation of the bone surface using standard surgical saws and the manual instrumentation technique established by each implant's manufacturer to prepare the remainder of the bone surface to receive the total knee implant components.
The Navio surgical system uses pre-defined 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, or in the case of a total knee arthroplasty, the bone surface is prepared to receive the femoral and tibial cutting guides. This submission supports the expanded indication for use of the Navio system to place total knee implants using the same techniques used in the predicate Navio system.
The UKR, PFA, and TKA applications are mutually independent and cannot be planned or completed in parallel.
Conclusions
The Navio system described in this submission has the same intended use and the same technological characteristics as the Navio system, cleared per K121936, K140596, K143668, and K152574, with the additional indication of total knee arthroplasty. Nonclinical testing was completed to verify that the use of the Navio system to assist with placement of total knee implants does not raise any new issues of safety or effectiveness. The information presented in this 510(k) premarket notification demonstrates that the Navio, when used to place total knee implants, is as safe and effective as the currently cleared Navio system.