Who is the manufacturer of PARI-PATH SURGICAL NAVIGATION SYSTEM?

Paritic, Inc. filed the 510(k) submission for PARI-PATH SURGICAL NAVIGATION SYSTEM (K133901).

What is the FDA product code for PARI-PATH SURGICAL NAVIGATION SYSTEM?

JAK. It is classified under 21 CFR 892.1750 as a Class 2 device in the Radiology panel.

What is the regulatory pathway for PARI-PATH SURGICAL NAVIGATION SYSTEM?

510(k) clearance (submission type: Traditional).

What are the predicate devices for PARI-PATH SURGICAL NAVIGATION SYSTEM?

ig4TM Image Guided System (K093146); ABARIS Computer assisted, image-guided surgery system (K053610); SonixGPS Needle Sensor (K111818); Electro magnetic Tracking System (K092619).

Who can help prepare an FDA 510(k) submission like PARI-PATH SURGICAL NAVIGATION SYSTEM?

Innolitics — a medical-device software consultancy — provides regulatory and engineering support for FDA 510(k) submissions. See https://innolitics.com/services/510ks/ or contact https://innolitics.com/contact.

PARI-PATH SURGICAL NAVIGATION SYSTEM

K133901 · Paritic, Inc. · JAK · Jun 27, 2014 · Radiology

Device Facts

Record ID	K133901
Device Name	PARI-PATH SURGICAL NAVIGATION SYSTEM
Applicant	Paritic, Inc.
Product Code	JAK · Radiology
Decision Date	Jun 27, 2014
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 892.1750
Device Class	Class 2

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 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.

Device Story

Pari-Path is a stereotactic surgical navigation system using electromagnetic tracking to guide interventional instruments (biopsy needles, ablation needles, probes). The system inputs include CT scan sets and real-time ultrasound data. It performs spatial registration to correlate CT image space with physical patient space. The system tracks instruments and displays a simulated image of the tool overlaid on the patient's anatomical model on a computer monitor, showing current and projected paths. Ultrasound integration compensates for respiratory-induced organ movement. Used in clinical settings by physicians for treatment planning and intra-operative guidance. The output assists clinicians in navigating instruments to target organs, potentially improving procedural accuracy and patient outcomes.

Clinical Evidence

No clinical data. Substantial equivalence is supported by bench testing and software verification and validation. Testing included electrical safety and electromagnetic compatibility per IEC 60601-1 and IEC 60601-1-2, and verification that the system performs according to Software Requirements Specifications (SRS) and Software Design Specifications (SDS).

Technological Characteristics

Electromagnetic tracking system; consists of magnetic field transmitter, tracking sensors, system unit, monitor, keyboard, mouse, and software. Integrates with third-party ultrasound devices. Performs spatial registration (CT to physical space). Software-based navigation and visualization. Electrical safety/EMC per IEC 60601-1 and IEC 60601-1-2.

Indications for Use

Indicated for use as a stereotactic accessory for CT and ultrasound imaging systems to provide treatment planning and intra-operative guidance for surgical procedures, including biopsy, ablation, or probing, in clinical interventions where imaging is used for visualization, including cases involving respiratory-induced organ movement.

Regulatory Classification

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.

Predicate Devices

ig4TM Image Guided System (K093146)
ABARIS Computer assisted, image-guided surgery system (K053610)
SonixGPS Needle Sensor (K111818)
Electro magnetic Tracking System (K092619)

Related Devices

K170716 — PercuNav Image Fusion and Interventional Navigation · Philips Ultrasound, Inc. · Apr 21, 2017
K162314 — IMACTIS CT-Navigation system · Imactis, Sas · Apr 24, 2018
K121498 — PERCUNAV · Philips Health Care · Dec 14, 2012
K151414 — IQQA Guide · Edda Technology · Nov 20, 2015
K093995 — IG 4 IMAGE GUIDED SYSTEM · Veran Medical Technologies, Inc. · Jan 27, 2010

Submission Summary (Full Text)

{0}------------------------------------------------ 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: 718-3042236 Fax: 718-3042233 Premarket Notification 510(K) Submission Contact name: Kevin Barrett, kevinb@paritic.com ## 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 (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" (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 (800) 638-2041 or (301) 796-7100 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) This section applies only to requirements of the Paperwork Reduction Act of 1995. # *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW." The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete time to review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to: > Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov "An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

PARI-PATH SURGICAL NAVIGATION SYSTEM

Device Facts

Intended Use

Device Story

Clinical Evidence

Technological Characteristics

Indications for Use

Regulatory Classification

Identification

Predicate Devices

Related Devices

Submission Summary (Full Text)

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PARI-PATH SURGICAL NAVIGATION SYSTEM

Device Facts

Intended Use

Device Story

Clinical Evidence

Technological Characteristics

Indications for Use

Regulatory Classification

Identification

Predicate Devices

Related Devices

Submission Summary (Full Text)

Panel 1

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Product Code Matches

Special Control Matches

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