PARI-PATH SURGICAL NAVIGATION SYSTEM

• K Number: K133901
• Device Name: PARI-PATH SURGICAL NAVIGATION SYSTEM
• Manufacturer: PARITIC INC
• Date Cleared: 2014-06-27 ( 189 days)
• Product Code: JAK
• Regulation Number: 892.1750

Intended Use

The pari-path surgical navigation system is a stereotactic accessory for Computed Tomography(CT) and Ultrasound imaging systems. It displays the simulated image of an interventional instrument ( a tracked insertion tool), such as a biopsy needle,an ablation needle ,or probe,on a computer monitor screen that shows an image model of the target organs and the current and the projected future path of the interventional instrument. Ultrasound imaging is incorporated with the pari-path surgical navigation system for the situation in which the target organs may move because of palients's respiratory. It is intended for treatment planning and intra-operative guidance for surgical procedures. It is intended for use in clinical interventionals and for anatomical structures where imaging is currently used for visualizing such procedures.

Device Description

The pari-path surgical navigation system is a stereotactic accessory for Computed Tomography(CT) and Ultrasound (US). It utilizes electromagnetic tracking technology to locate and navigate instruments relative to an image model of the patient anatomy. It displays the simulated image of an interventional instrument (a tracked insertion tool). such as a biopsy needle, an ablation needle, or probe, on a computer monitor screen that shows the image model of the patient anatomical target organs and the current and the projected future path of the interventional instrument. The image model of patient anatomical organs is derived from two-dimensional patient images (scan sets) via the navigation system. The interventional instrument can be located and navigated on the image model. Ultrasound imaging is incorporated with the system for the situation in which the target organs may move because of patient's respiratory. The system performs spatial mapping from CT image space to physical space ("registration") to correlate scan sets to the patient. It consists of a magnetic field transmitter, tracking sensors, system unit, monitor, keyboard, mouse, software, and an "off the shelf" ultrasound device (an optional, not supplied with the system).

Predicate Devices

K093146, K053610, K111818, K092619

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The summary describes a surgical navigation system using electromagnetic tracking and image registration. There is no mention of AI, ML, deep learning, or any related concepts in the intended use, device description, or performance studies. The system relies on established image processing and tracking techniques.

Therapeutic

No.
The device is described as a "stereotactic accessory" that provides "treatment planning and intra-operative guidance for surgical procedures" by displaying a simulated image of instruments and target organs. It helps locate and navigate instruments but does not itself provide therapy.

Diagnostic

No.
This device is for surgical navigation and intra-operative guidance for treatment planning and surgical procedures, not for diagnosis.

SaMD (Software as a Medical Device)

No

The device description explicitly lists hardware components such as a magnetic field transmitter, tracking sensors, system unit, monitor, keyboard, and mouse, in addition to software.

IVD (In Vitro Diagnostic)

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

Here's why:

• IVD Definition: In Vitro Diagnostics are devices intended for use in vitro for the examination of specimens, including blood, tissues, and urine, derived from the human body, solely or principally for the purpose of providing information concerning a physiological state, state of health, or disease or congenital abnormality.
• pari-path System Function: The pari-path surgical navigation system is a tool for surgical guidance and planning during procedures. It uses imaging data (CT and Ultrasound) to help physicians navigate instruments within the patient's body. It does not analyze biological specimens in vitro.
• Intended Use: The intended use clearly states "treatment planning and intra-operative guidance for surgical procedures." This is a clinical intervention, not an in vitro diagnostic test.

Therefore, the pari-path surgical navigation system falls under the category of surgical navigation or image-guided surgery systems, not In Vitro Diagnostics.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

The pari-path surgical navigation system is a stereotactic accessory for Computed Tomography(CT) and Ultrasound imaging systems.

It displays the simulated image of an interventional instrument ( a tracked insertion tool), such as a biopsy needle,an ablation needle ,or probe,on a computer monitor screen that shows an image model of the target organs and the current and the projected future path of the interventional instrument. Ultrasound imaging is incorporated with the pari-path surgical navigation system for the situation in which the target organs may move because of palients's respiratory.

It is intended for treatment planning and intra-operative guidance for surgical procedures. It is intended for use in clinical interventionals and for anatomical structures where imaging is currently used for visualizing such procedures.

Product codes

JAK

Device Description

The pari-path surgical navigation system is a stereotactic accessory for Computed Tomography(CT) and Ultrasound (US).

It utilizes electromagnetic tracking technology to locate and navigate instruments relative to an image model of the patient anatomy.

It displays the simulated image of an interventional instrument (a tracked insertion tool). such as a biopsy needle, an ablation needle, or probe, on a computer monitor screen that shows the image model of the patient anatomical target organs and the current and the projected future path of the interventional instrument.

The image model of patient anatomical organs is derived from two-dimensional patient images (scan sets) via the navigation system.

The interventional instrument can be located and navigated on the image model. Ultrasound imaging is incorporated with the system for the situation in which the target organs may move because of patient's respiratory.

The system performs spatial mapping from CT image space to physical space ("registration") to correlate scan sets to the patient.

It consists of a magnetic field transmitter, tracking sensors, system unit, monitor, keyboard, mouse, software, and an "off the shelf" ultrasound device (an optional, not supplied with the system).

Mentions image processing

Yes

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Computed Tomography (CT), Ultrasound (US)

Anatomical Site

anatomical structures where imaging is currently used for visualizing such procedures.

Indicated Patient Age Range

Not Found

Intended User / Care Setting

clinical interventions

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)

A set of software and bench testing were performed in order to demonstrate the performance and accuracy of the surgical navigation system and to verify that it does not raise any new safety and effectiveness issues in comparison to its predicate devices.

The testing included the following:

• Electrical safety and electromagnetic compatibility testing according to IEC 60601-1 . (and amendments), and IEC 60601-1-2 (and amendment) standards.
• Software verification and validation testing was conducted to evaluate the performance of the surgical navigation and to verify that it performs according to its specifications described in the Software Requirements Specifications (SRS) and Software Design Specifications (SDS).
• Bench test.

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Not Found

Predicate Device(s)

K093146, K053610, K111818, K092619

Reference Device(s)

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information

Not Found

Regulation Number and Section

§ 892.1750 Computed tomography x-ray system.

(a)
Identification. A computed tomography x-ray system is a diagnostic x-ray system intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data from the same axial plane taken at different angles. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.(b)
Classification. Class II.

Summary

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JUN 2 7 2014

KB33901
Page 1 of 8

Section 2 510(K) Summary

510 (k) Summary Paritic Inc Traditional 510 (k) pari-path surgical navigation system

Date Prepared: Dec. 10, 2013

Pari-Path

510(k) Applicant: PARITIC, INC 760 PARKSIDE AVENUE BROOKLYN NY 11226 TEL: [phone] Fax: [phone]

Premarket Notification 510(K) Submission

Contact name: Kevin Barrett, [e-mail]

Device Information

Trade Name: pari-path surgical navigation system Common Name: surgical navigation system Regulation/Classification Name: Computed Tomography X-ray System Regulation Number: 21 CFR 892.1750, Regulation Class: II Classification/Product Code: JAK

Device Description:

The pari-path surgical navigation system is a stereotactic accessory for Computed Tomography(CT) and Ultrasound (US).

It utilizes electromagnetic tracking technology to locate and navigate instruments relative to an image model of the patient anatomy.

It displays the simulated image of an interventional instrument (a tracked insertion tool). such as a biopsy needle, an ablation needle, or probe, on a computer monitor screen that

1

Section 2 510(K) Summary

shows the image model of the patient anatomical target organs and the current and the projected future path of the interventional instrument.

The image model of patient anatomical organs is derived from two-dimensional patient images (scan sets) via the navigation system.

The interventional instrument can be located and navigated on the image model. Ultrasound imaging is incorporated with the system for the situation in which the target organs may move because of patient's respiratory.

The system performs spatial mapping from CT image space to physical space ("registration") to correlate scan sets to the patient.

It consists of a magnetic field transmitter, tracking sensors, system unit, monitor, keyboard, mouse, software, and an "off the shelf" ultrasound device (an optional, not supplied with the system).

Indications for Use:

The pari-path surgical navigation system is a stereotactic accessory for Computed Tomography (CT) and Ultrasound (US).

It displays the simulated image of an interventional instrument (a tracked insertion tool), such as a biopsy needle, an ablation needle, or probe, on a computer monitor screen that shows an image model of the target organs and the current and the projected future path of the interventional instrument. Ultrasound imaging is incorporated with the pari-path surgical navigation system for the situation in which the target organs may move because of patient's respiratory.

It is intended for treatment planning and intra-operative guidance for surgical procedures. It is intended for use in clinical interventions and for anatomical structures where imaging is currently used for visualizing such procedures.

Paritic Inc

2

.

Section 2 510(K) Summary

Comparison chart

| | Subject
Device | Predicate
Device | Predicate
Device | Predicate
Device | Predicate
Device |
|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Product
Name | Pari-Path
surgical
navigation
system | ig4TM Image
Guided
System | ABARIS
Computer
assisted,
image-guided
surgery
system | SonixGPS
Needle
Sensor | Electro
magnetic
Tracking
System |
| 510(k)
Number | K123720 | K093146 | K053610 | K111818 | K092619 |
| Manufacture | Paritic Inc | Veran
Medical
Technologies
Inc | Traxtal
Technologies
Inc | Ultrasonix
Medical
Corporation | CIVCO
Medical
Instruments
Co. |
| Intended Use | The Pari-Path
surgical
navigation
system is a
stereotactic
accessory for
Computed
Tomography(
CT) and
Ultrasound
(US).
It displays the
simulated
image of an
interventional
instrument (a
tracked
insertion tool),
such as a
biopsy needle,
an ablation | The ig4TM
Image Guided
System is a
stereotactic
accessory for
Computed
Tomography
(CT) or 3D
fluoroscopic
x-ray systems.
The ig4
System is
indicated for
displaying an
interventional
instrument
such as a
biopsy needle,
an aspiration
needle, or
ablation | ABARIS is a
stereotaxic
accessory for
Computed
Tomography(
CT),
Magnetic
Resonance
(MR),
Ultrasound
(US), Positron
Emission
Tomography
(PET), Single
Photon
Emission
Computed
Tomography
(SPECT),
Fluoroscopy,
Endoscopy | The device
is intended
to provide
physicians
with tools
for electro
magnetic
tracking of
instruments
with respect
to image
data. The
device is
available in
two models
0.55mm
and 0.9mm
in diameter. | The device is
intended to
provide
physicians
with tools for
electro
magnetic
tracking of
instruments
with respect
to image
data. |
| Pari-Path | | | Section 2 510(K) Summary | | |
| needle, or
probe, on a
computer
monitor
screen that
shows an
image model
of the target
organs and the
current and
the projected
future path of
the
interventional
instrument.
Ultrasound
imaging is
incorporated
with the
Pari-path
surgical
navigation
system for the
situation in
which the
target organs
may move
because of
patient's
respiratory.
It is intended
for treatment
planning and
intra-operative
guidance for
surgical
procedures. It
is intended for
use in clinical
interventions
and for | needle
on a computer
monitor that
also displays a
CT-based or
3D
fluoroscopic
x-ray-based
model of the
target
organ(s). The
ig4 TM System
compensates.
for the
patient's
respiratory
phases.
The ig4 TM
System is
intended for
use in clinical
interventions
and for
anatomical
structures
where
computed
tomography
or 3D
fluoroscopic
x-ray are
currently used
for visualizing
such
procedures. | and other
imaging
systems. It
displays the
simulated
image of a
tracked
insertion tool
such as a
biopsy
needle, guide
wire or probe
on a computer
monitor
screen that
shows images
of the target
organs and the
current and
the projected
future path of
the
interventional
instrument
taking
into account
movements of
the patient.
This is
intended for
treatment
planning and
intra-
operative
guidance for
surgical
procedures.
The device
also supports
an image-free
mode in | | | |
| | | | | Section 2 510(K) Summary | |
| | anatomical
structures
where
imaging is
currently used
for visualizing
such
procedures. | | which the
proximity of
the
interventional
device is
displayed
relative to
another
device.
The device is
intended to be
used in
clinical
interventions
and for
anatomical
structures
where
imaging is
currently used
for visualizing
such
procedures.
The device is
also intended
for use in
clinical
interventions
to determine
the proximity
of one device
relative to
another. | | |
| Tracking
technology | Electro
magnetic
tracking
technology | Same | Same | Same | Same |
| Instrument
images | Displaying
dynamically
the simulated | Same | Same | Same | N/A |

Paritic Inc

2-3

.

.

3

. . .

:

・

:

Paritic Inc

.

・

2-4

:

.

.

・

4

·

,

Paritic Inc

,

2-5

5

Pari-Path				Section 2 510(K) Summary
	images of
tracked
instruments.
Patient
imaging	Use of
acquired
patient
imaging for
anatomy
structure	Same	Same	Same	Same
Combining
two kind of
Images	Combining
the simulated
images of
tracked
instruments
with the
acquired
patient
imaging.	Same	Same	Same	N/A
Respiratory
Concern	Use
ultrasound
imaging to
monitor the
real-time
target organs'
movement
caused by
patient's
respiratory,
and display
updated
spatial
positions of
the simulated
insertion
instrument
with respect to
the ultrasound
image in real
time.	N/A
(ig4TM
System does
not use
ultrasound)	Same
(when used in
conjunction
with
an ultrasound
system)	Same	N/A

Paritic Inc

:

:

2-6

:

·

·

6

Section 2 510(K) Summary

The intended use among new device and predicate devices is same.

• All predicate and new devices have the same intended use for physicians to tr ack and display the simulated instrument with respect to images of the target organs of a patient on a computer monitor screen.
• Like the predicate devices: SonixGPS Needle Sensor (K111818) and ABARIS ● Computer assisted, image-guided surgery system (K053610), the new subject d evice. Pari-path surgical navigation system incorporates ultrasound imaging whi ch can observe the movement of anatomy structures caused by the patient's re spiration in real time, and displays the spatial position of the simulated inserti on instrument with respect to the ultrasound image in real time.

The new device presents no new issues of safety and effectiveness and the features of intended use are substantially equivalent between the new and predicate devices.

Furthermore, the new device has the same technological characteristics as predicate devices. The new device and predicate devices are substantially equivalent with respect to the design and technology.

The subject device has different software interface than predicate devices. The software interface does not affect performance and functionality. The software interface does not raise different questions of safety and effectiveness than the predicate devices.

The differences for subject device in sensor diameter, length and connection type compared to the predicate devices do not affect performance and functionality. The differences do not raise different questions of safety and effectiveness than the predicate devices.

The device labeling includes an instruction manual which provides technical description, intended use, cautions, warnings, contraindications and instructions to ensure safe and effective use of the device.

Testing and Performance Data:

A set of software and bench testing were performed in order to demonstrate the performance and accuracy of the surgical navigation system and to verify that it does not raise any new safety and

effectiveness issues in comparison to its predicate devices.

The testing included the following:

Paritic Inc

7

K133901
Page 8 of 8

Section 2 510(K) Summary

• Electrical safety and electromagnetic compatibility testing according to IEC 60601-1 . (and amendments), and IEC 60601-1-2 (and amendment) standards.
• . Software verification and validation testing was conducted to evaluate the performance of the surgical navigation and to verify that it performs according to its specifications described in the Software Requirements Specifications (SRS) and Software Design Specifications (SDS).
• . Bench test.

Conclusions

The pari-path surgical navigation system has the same intended uses and similar indications, technological characteristics, and principles of operation as its predicate devices. Based on the performance testing results. including software validation, bench testing, it has been established that the pari-path system is substantially equivalent to its predicate devices.

Reference:

1. Guidance for Industry and FDA Staff: Format for Traditional and Abbreviated 510(k)s, CDHR, ODE August 12,2005

2. Guidance for the Content of Premarket Submission for Software Contained in Medical Devices, CDRH ODE May 11, 2005

8

DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/8/Picture/1 description: The image shows the logo for the U.S. Department of Health and 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 a stylized symbol that resembles an abstract human figure with three flowing lines representing the body and arms.

Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

June 27, 2014

PARITIC INC KEVIN BARRETT VICE PRESIDENT 760 PARKSIDE AVENUE BROOKLYN NY 11226

Re: K133901

Trade/Device Name: Pari-path Surgical Navigation System Regulation Number: 21 CFR 892.1750 Regulation Name: Computed tomography x-ray system Regulatory Class: II Product Code: JAK Dated: June 15, 2014 Received: June 18, 2014

Dear Mr. Barrett:

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 or any routh 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 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.

9

Page 2-Mr. Barrett

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 [phone] or [phone] 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" (21 CFR 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 [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours.

Smh.p)

for

Janine M. Morris Director Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health

Enclosure

10

Indications for Use

510(k) Number (if known) K133901

Device Name Pari-path Surgical Navigation System

Indications for Use (Describe)

The pari-path surgical navigation system is a stereotactic accessory for Computed Tomography(CT) and Ultrasound imaging systems.

It displays the simulated image of an interventional instrument ( a tracked insertion tool), such as a biopsy needle,an ablation needle ,or probe,on a computer monitor screen that shows an image model of the target organs and the current and the projected future path of the interventional instrument. Ultrasound imaging is incorporated with the pari-path surgical navigation system for the situation in which the target organs may move because of palients's respiratory.

It is intended for treatment planning and intra-operative guidance for surgical procedures. It is intended for use in clinical interventionals and for anatomical structures where imaging is currently used for visualizing such procedures.

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.

FOR FDA USE ONLY

Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)

Sm.h.7)

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