Predicate Devices

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The description focuses on computer-assisted navigation, tracking, and controlled burring based on predefined landmarks and surgical plans, without mentioning AI or ML algorithms for tasks like image analysis, prediction, or decision support.

Therapeutic

No

The device is a computer-assisted surgical navigation and burring system that aids surgeons in orthopedic procedures by providing orientation and reference information and assisting in executing surgical plans. It primarily assists the surgeon in the procedure and does not directly treat a disease or condition itself.

Diagnostic

No

The device is described as a computer-assisted orthopedic surgical navigation and surgical burring system that assists in planning and executing surgical procedures. While it collects data for the surgeon to determine implant fit, its primary function is surgical assistance, not diagnosing a medical condition.

SaMD (Software as a Medical Device)

No

The device description explicitly states it is a "computer-assisted orthopedic surgical navigation and surgical burring system" that uses 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.

IVD (In Vitro Diagnostic)

Based on the provided information, the NavioPFS™ System is not an In Vitro Diagnostic (IVD) device.

Here's why:

Intended Use: The intended use is to assist the surgeon during orthopedic procedures by providing spatial boundaries and reference information to anatomical structures. This is a surgical guidance and execution system, not a device used to examine specimens derived from the human body for the purpose of providing information for diagnosis, monitoring, or compatibility testing.
Device Description: The description details a computer-assisted surgical navigation and burring system that interacts directly with the patient's bone during surgery. It uses tracking technology and controls a surgical bur. This is a surgical tool, not a diagnostic test performed on a sample.
Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, tissue, etc.), performing tests on specimens, or providing diagnostic information based on laboratory analysis.

The NavioPFS™ System falls under the category of a surgical navigation and robotic/assisted surgical system, which is distinct from an IVD.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

The NavioPFS™ 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 NavioPFS™ 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.

Product codes (comma separated list FDA assigned to the subject device)

OLO

Device Description

The NavioPFS™ 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 targery and to plan the surgical implant location based on predefined bone landmarks and known configuration of the surgical implant. The NavioPFS™ System then aids the surgeon in executing the surgical plan by using a standard off-theshelf surgical drill motor and bur (Anspach/Synthes eMax2 plus (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 handbiece. In the NavioPFSM System the 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.

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 posterior surfaces of the condyle as well as placing post holes.

After the bone is prepared the surgeon is prompted to do a trial range of motion (ROM) test. Data collected using the tibial and femoral trackers is displayed as the knee and limb through a series of flexion, extension and rotational movements. Data is collected from the trackers and displayed in graphical formation is for use by the surgeon in determining fit of the implant (either the trial implant or the final implants after cementing) prior to finalization of the procedure.

The NavioPFS™ 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 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

Anatomical Site

Knee, femur, tibia

Indicated Patient Age Range

Not Found

Intended User / Care Setting

Surgeon

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 NavioPFS™ as a result of the risk analysis and product requirements. Testing included software code reviews, software unit testing, software integration testing, bench verification testing, biocompatibility 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 NavioPFS™ 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 NavioPFS™ System.

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.

MAKO Surgical Tactile Guidance System v2.0 ("MAKO RIO") (K081867), The Zimmer (ORTHOsoft) Navitrack® System - OS Unicondylar Knee Universal (K071714)

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

Regulation Number and Section

§ 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).

Summary

0

Traditional 510(k)
Tab 6 – 510(k) Summary_

NOV-3-0-2012-

Navio™ PFS

ـــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــ

TAB 6
510(K) SUMMARY
	K121936
Official Contact	Richard G. Confer
Vice President, Regulatory Affairs and Quality Assurance
Blue Belt Technologies
2828 Liberty Ave.
Pittsburgh, PA 15222
Email: rconfer@bluebelttech.com
412-683-3844 X 106
412-683-6447
Date of Submission	June 29, 2012
Classification Reference	21 CFR 882.4560
Product Code	OLO
Common/Usual Name	Orthopedic Sterotaxic Instrument
Proprietary Name	NavioPFSTM
Predicate Device(s)	MAKO Surgical Tactile Guidance System v2.0 ("MAKO RIO")
(K081867)
The Zimmer (ORTHOsoft) Navitrack® System - OS Unicondylar
Knee Universal (K071714)

Reason for submission

.

New Device

.

・

1

Indications for Use

The NavioPFS™ 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 NavioPFS™ 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.

Device Description

The NavioPFS™ 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 targery and to plan the surgical implant location based on predefined bone landmarks and known configuration of the surgical implant. The NavioPFS™ System then aids the surgeon in executing the surgical plan by using a standard off-theshelf surgical drill motor and bur (Anspach/Synthes eMax2 plus (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 handbiece. In the NavioPFSM System the 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.

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 posterior surfaces of the condyle as well as placing post holes.

After the bone is prepared the surgeon is prompted to do a trial range of motion (ROM) test. Data collected using the tibial and femoral trackers is displayed as the knee and limb through a series of flexion, extension and rotational movements. Data is collected from the trackers and displayed in graphical formation is for use by the surgeon in determining fit of the implant (either the trial implant or the final implants after cementing) prior to finalization of the procedure.

The NavioPFS™ 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 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.

2

Summary of technological similarities with predicates

| Summary of Similarities and Differences

NavioPFS™, MAKO RIO and Navitrack System - OS Unicondylar Knee Universal
Devices	Blue Belt Technologies
NavioPFS™	Predicate A.
MAKO Surgical Tactile
Guidance System v2.0
("MAKO RIO") (K081867)	Predicate B.
The Zimmer (Orthosoft)
Navitrack® System -
OS Unicondylar Knee
Universal (K071714)
Technological
Characteristics	The NavioPFS™ System
uses a combination of two
established technologies
to prepare bone for
attachment of implant
components. 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.
This is equivalent to the
methodology used by the
Navitrack system.
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 motion is controlled
either by retracting the
bur in a guard, or by
controlling the speed of
the bur.	The MAKO RIO uses
preoperative CT imaging
to create a model of the
patient's femur and tibia
which allows the surgeon
to prepare a surgical plan.
The plan is then verified
intra-operatively during
the procedure.
The MAKO RIO uses
predefined boundaries
generated during the
above described 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.
The motion is controlled
by a robotic arm which
provides resistance to
movement as the target
boundary is approached.	The Navitrack System -
OS Unicondylar Knee
Universal device
consists of software, a
computer workstation,
an optical tracking
system, surgical
instruments, and
tracking accessories,
designed to assist the
surgeon in the
placement of
unicondylar knee
replacement
components.
Tracking devices are
incorporated with given
surgical instruments, as
well as on fixation
bases that attach to
each of the femur and
tibia, such to allow the
ability to track and
display to the user their
respective positions
intra-operatively. The
femur and tibia are
displayed to the user in
the form of their main .
alignment axes. The
alignment axes are
determined and
recorded intra-
operatively by
identifying the key
anatomical references
that are used clinically
to align and position the
components. The
Navitrack system does
not require a
preoperative CT scan.
Summary of Similarities and Differences
NavioPFS™, MAKO RIO and Navitrack System - OS Unicondylar Knee Universal
Devices	Blue Belt Technologies
NavioPFS™	Predicate A.
MAKO Surgical Tactile
Guidance System v2.0
("MAKO RIO") (K081867)	Predicate B.
The Zimmer (Orthosoft)
Navitrack® System -
OS Unicondylar Knee
Universal (K071714)
Construction	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.	Consists of an IR image
system (Northern Digital
Polaris), reflective
trackers, computer,
user interface display,
various probes, bone
screws and clamps.
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 DICOM data
imported from pre-
operative CT scans.	Uses data collected
intra-operatively by
surgeon during initial
surgical procedure to
generate real time plan
of cut surfaces. Does
not require a pre-
operative CT scan.
Imaging
Requirements	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.	None preoperative.
Possible post-operative
to verify implant
placement after
surgeon finalizes
placement

.

06/29/2012

3

Nonclinical testing:

Design verification tests were performed on the Blue Belt Technologies NavioPFS™ as a result of the risk analysis and product requirements. Testing included software code reviews, software unit testing, software integration testing, bench verification testing, biocompatibility 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 NavioPFS™ system, and place implants per Blue Belt Technologies' specifications after being adequately trained.

In addition to the bench and simulated use testing cited above, compliance testing to the following standards was completed.

IEC 60601-1:2005 Medical Electrical Equipment Part 1: General Requirements for Safety .
. IEC 60601-1-2 Edition 3:2007-03, Medical Electrical Equipment - Part 1-2: General Requirements for Basic Safety and Essential Performance - Collateral Standard: Electromagnetic compatibility - Requirements and tests.
AAMI/ANSI/ISO 11607-1:2006 Packaging for terminally sterilized medical devices Part 1: . Requirements for materials, sterile barrier systems and packaging systems
ISO 11607-2:2006 Packaging for terminally sterilized medical devices Part 2: Validation .

4

requirements for forming, sealing and assembly processes

ISO 10993-1 Biological Evaluation of Medical Devices Part 1: Evaluation and Testing within a . risk management system
ANSI/AAMI/ISO 11137-2:2006 Sterilization of health care products Radiation Part 2: . Establishing the sterilization dose

Discussion of similarities and differences

The NavioPFS™ System uses a combination of two established technologies to prepare bone for
attachment of implant components. The NavioPFS™ uses intraoperative data collectio non-CT data generation) to create a model of the patient's femur and tibia and allows the surgeon to prepare a surgical plan. This is equivalent to the methodology used by the Navitrack system.

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. This is similar to the methods used by the Mako TGS (RIO) system, although the Mako TGS (RIO) system uses a preoperative CT scan in addition to intraoperatively acquired data to plan the position of implant components.

Clinical testing

No human clinical tests were conducted to determine safety and effectiveness of the NavioPFS™ System.

Summary and Conclusions

In summary, based on the results of the clinical and non-clinical testing, the NavioPFS™ is as safe and effective and preforms as well as to the MAKO Surgical Robotic Arm Interactive Orthopedic System ("MAKO RIO") (K081867) and The Zimmer (ORTHOsoft) Navitrack® System - OS Unicondylar Knee Universal (K071714).

{End of tab)

5

Image /page/5/Picture/0 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized eagle with three stripes representing the three levels of government: federal, state, and local. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle.

DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-002

Blue Belt Technologies, Incorporated % Mr. Richard G. Confer Vice President, Regulatory Affairs and Quality Assurance 2828 Liberty Avenue, Suite 100 Pittsburgh, Pennsylvania 15222

Re: K121936

Trade/Device Name: NavioPFS™ Regulation Number: 21 CFR 882.4560 Regulation Name: Stereotaxic instrument Regulatory Class: Class II Product Code: OLO Dated: October 28, 2012 Received: November 01, 2012

November 30, 2012

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

6

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 go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. 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 Small Manufacturers, International and Consumer Assistance 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,

Peter D. Rumm -S

Mark N. Melkerson Acting Director Division of Surgical Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

7

Traditional 510(k)

Tab 5 - Indication for Use Statement

ISE

510(k) Number (if known): Device Name:

K121936 NavioPFs™

Indications for Use:

The NavioPFS™ 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 NavioPFS™ 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.

Prescription Use × (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use (21 CFR 807 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Dwight Yen 2012.11.30 11:09:16 -05'00'

(Division Sign-off) Division of Surgical Devices 510(k) Number_ K121936