(140 days)
Not Found
No
The description focuses on image-guided surgery using tracked instruments and mapping them onto pre-operative images. There is no mention of AI, ML, or related concepts like training/test sets, performance metrics typically associated with AI/ML, or any algorithms that would suggest learning or adaptive capabilities. The technology described is consistent with traditional image-guided navigation systems.
No
The device is an image-guided surgery system designed to aid physicians in localizing tumors and anatomical structures during liver surgery, but it does not directly treat or cure the condition.
No
Explanation: The device is an image-guided surgery system used during surgical procedures to aid in the localization of tumors and anatomical structures. It does not diagnose conditions or diseases.
No
The device description explicitly lists multiple hardware components beyond just software, including an optical position sensor, tracked instruments (adapter, laser range scanner, localization probe), and an LCD display monitor.
Based on the provided information, the Explorer™ Liver device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections. They are used to provide information for diagnosis, monitoring, or screening.
- Explorer™ Liver Function: The Explorer™ Liver device is an image-guided surgery system. It uses pre-operative medical images (MRI or CT) and tracks the position of surgical instruments in real-time during open liver surgery. Its purpose is to help the surgeon navigate and localize structures within the liver during the surgical procedure.
- No Sample Analysis: The device does not analyze any biological samples taken from the patient. It works with existing medical images and the physical position of instruments.
Therefore, the Explorer™ Liver device falls under the category of a surgical navigation or image-guided surgery system, not an in vitro diagnostic device.
N/A
Intended Use / 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.
Product codes (comma separated list FDA assigned to the subject device)
OEW
Device Description
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)
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
MRI or CT
Anatomical Site
Liver
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Physicians / Open liver surgical procedures
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)
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.
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.
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
§ 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).
0
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: (615)-783-0094 Fax: (615) 783-0554 E-mail: craigh@pathsurg.com
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:
-
- Linasys Image Guided Liver Surgery System [K071063]
- Medtronic Navigation StealthStation with Advanced Contour Registration 2. Software Module [K954276 & K030106]
1
Kw93;494
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.
2
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 (800) 638-2041 or (301) 796-7100 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
4
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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