LINASYS IMAGE-GUIDED LIVER SURGERY SYSTEM

K093494 · Pathfinder Therapeutics, Inc. · OEW · Mar 30, 2010 · Neurology

Device Facts

• Record ID: K093494
• Device Name: LINASYS IMAGE-GUIDED LIVER SURGERY SYSTEM
• Applicant: Pathfinder Therapeutics, Inc.
• Product Code: OEW · Neurology
• Decision Date: Mar 30, 2010
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 882.4560
• Device Class: Class 2

Indications for Use

The Explorer™ Liver device is indicated for open liver surgical procedures where image-guidance may be appropriate and where the patient can tolerate long apneic periods under general anesthesia.

Device Story

Explorer™ Liver is an image-guided surgery system for open liver procedures. It maps the position of tracked surgical instruments onto preoperative patient-specific MRI or CT images. The system comprises a PC-based software platform, a three-lens active optical position sensor, an LCD monitor, and tracked accessories including a multi-tool adapter, laser range scanner, and localization probe. Used in the OR by physicians, the system provides real-time visualization of surgical instruments relative to tumors and anatomical structures. This guidance assists in accurate localization during surgery, potentially improving surgical precision and patient outcomes.

Clinical Evidence

No clinical data. Performance was established through bench-level validation and verification studies demonstrating the system's ability to accurately map surgical instruments to preoperative images.

Technological Characteristics

PC-based image-guided surgery platform; three-lens active optical position sensor; tracked instruments (adapter, laser scanner, probe); LCD display. System utilizes preoperative MRI/CT data for registration. Sterilization methods and materials are equivalent to predicate devices.

Indications for Use

Indicated for patients undergoing open liver surgery who can tolerate long apneic periods under general anesthesia.

Regulatory Classification

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.

Predicate Devices

• Linasys Image Guided Liver Surgery System (K071063)
• Medtronic Navigation StealthStation with Advanced Contour Registration Software Module (K954276 & K030106)

Submission Summary (Full Text)

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# 510(k) Summary (as required by 21 CFR 807.92(c)]

#### Submitted by: l.

MAR 3 0 2010

Pathfinder Therapeutics, Inc. 2969 Armory Dr. Suite #100A Nashville, TN 37204

#### Contact Person: II.

Craig A. Henderson Quality and Regulatory Manager Telephone: [phone] Fax: [phone] E-mail: [e-mail]

#### 111. Date 510(k) Summary Prepared:

November 5, 2009

#### IV. Name of the Device:

Explorer™ Liver (previously known as Linasys Image Guided Liver Surgery Proprietary Name: System) Common / Usual Name: Computer-assisted, image-guided stereotaxic system Stereotaxic Instrument (per 21 CFR 882.4560) Classification Name:

#### V. Substantial Equivalence:

The technological characteristics and indications for use of the Explorer™ Liver System are the same or similar to those found in the predicate devices. The patient components and component materials in both the new and predicate devices are equivalent. The packaging materials, packaging configurations, sterilization methods, and sterility assurance levels are also equivalent. The Explorer™ Liver system is substantially equivalent to the following FDA cleared frame stereotaxic systems:

- 1. Linasys Image Guided Liver Surgery System [K071063]
- Medtronic Navigation StealthStation with Advanced Contour Registration 2. Software Module [K954276 & K030106]

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#### Device Description: VI.

The Explorer™ Liver system is an image-guided surgery medical device specifically designed to aid physicians during open liver procedures. The device is capable of mapping the current surgical position of tracked instruments onto preoperative, patient-specific MRI or CT medical images. These images can then be used as a guide by the physician for more accurate localization of tumors and other surrounding anatomic structures during liver surgery. The Explorer™ Liver system consists of six (6) components which are listed below:

- An image-guided surgery software platform installed on a personal computer (PC) (1)
- A three lens active-based optical position sensor that can accurately localize the tracked devices (2) listed below
- A tracked adapter multi tool (used for localization of rigid surgical instruments and to (a) define 3-D surgical space)
- A tracked laser range scanner (b)
- A tracked Localization Probe (c)
- An LCD display monitor. (3)

#### Performance Data: VII.

Validation and verification studies were conducted to evaluate the performance characteristics of the Explorer™ Liver system. The results of these studies demonstrate that the device is capable of safely and accurately performing the stated intended use.

#### VIII. Indications For Use:

The Explorer™ Liver device is indicated for open liver surgical procedures where image guidance may be appropriate and where the patient can tolerate long apneic periods under general anesthesia.

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## DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of a bird-like figure, possibly representing an eagle or another national symbol. The logo is presented in black and white.

### Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room W-O66-0609 Silver Spring, MD 20993-0002

Pathfinder Therapeutics, Inc. % Craig A. Henderson Quality and Regulatory Manager 2969 Armory Drive, Suite 100A Nashville, Tennessee 37204

MAR 3 0 2010

Re: K093494

Trade/Device Name: Explorer™ Liver (previously known as Linasys Image-Guided Liver Surgery System) Regulation Number: 21 CFR 882.4560 Regulation Name: Stereotaxic instrument Regulatory Class: Class II Product Code: OEW Dated: March 05, 2010 Received: March 08, 2010

Dear Mr. Henderson:

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

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Page 2 - Mr. Craig A. Henderson

comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set 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/SafetyReportaProblem/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 [phone] or [phone] or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

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

Sincerely yours,

Mark A. Milkerg

Mark N. Melkerson Director Division of Surgical, Orthopedic And Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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093494

## Indications for Use

510(k) Number (if known): K093494

Device Name: Explorer™ Liver (previously known as Linasys Image Guided Liver Surgery System)

Indications For Use:

The Explorer™ Liver device is indicated for open liver surgical procedures where image-guidance may be appropriate and where the patient can tolerate long apneic periods under general anesthesia.

Prescription Use × (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use (21 CFR 801 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Nil R. Ogden forman

Division of Surgical, Orthopedic, and Restorative Devices

510(k) Number K093494

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