(140 days)
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.
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)
The provided text is a 510(k) summary for the Explorer™ Liver system. It describes the device, its indications for use, and states that performance data from validation and verification studies demonstrate the device's safety and accuracy. However, this document does not contain explicit acceptance criteria or the details of a study that proves the device meets those criteria.
The "Performance Data" section (VII) is very brief and only states: "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." It does not provide any specific metrics, thresholds, sample sizes, or methodologies for these studies.
Therefore, I cannot fulfill your request for a table of acceptance criteria, device performance, sample sizes, data provenance, expert qualifications, adjudication methods, MRMC study details, standalone study details, types of ground truth, or training set information based solely on the provided text.
The document is a high-level summary for regulatory submission, not a detailed technical report of the studies themselves. To answer your questions, one would need access to the actual validation and verification study reports mentioned.
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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: (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]
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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 (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
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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
Page 1 of 1
§ 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).