(248 days)
The Linasys device is indicated for open liver surgical procedures where imageguidance may be appropriate and where the patient can tolerate long apneic periods under general anesthesia.
The Linasys (Liver Navigation 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 Linasys system consists of six (6) components which are listed below:
(1) An image-guided surgery software platform installed on a personal computer (PC)
(2) A three lens active-based optical position sensor that can accurately localize the tracked devices listed below
(3) A tracked localization probe
(4) A tracked fixed reference emitter used to define 3-D surgical space
(5) A tracked laser range scanner
(6) An LCD display monitor.
The provided 510(k) summary for the Linasys Image-Guided Liver Surgery System does not contain detailed information about specific acceptance criteria or a study proving the device meets those criteria in a quantitative sense.
It broadly states: "Validation and verification studies were conducted to evaluate the performance characteristics of the Linasys Image-Guided Liver Surgery System. The results of these studies demonstrate that the device is capable of safely and accurately performing the stated intended use."
Without specific performance metrics from a study, it's not possible to create the requested table or answer most of the detailed questions.
However, based on the limited information provided, here's what can be inferred or stated about the device and its assessment:
1. Table of Acceptance Criteria and Reported Device Performance:
- Acceptance Criteria: Not explicitly stated in the document. For a medical device, these would typically include quantifiable metrics for accuracy, precision, reliability, and safety.
- Reported Device Performance: Not explicitly stated in terms of specific numerical outcomes or metrics. The summary only gives a general statement of capability.
2. Sample size used for the test set and the data provenance:
- Sample Size: Not mentioned.
- Data Provenance: Not mentioned (e.g., country of origin, retrospective or prospective).
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Number of Experts: Not mentioned.
- Qualifications of Experts: Not mentioned.
4. Adjudication method for the test set:
- Not mentioned.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, if so, what was the effect size of how much human readers improve with AI vs without AI assistance:
- No, an MRMC comparative effectiveness study is not mentioned. The Linasys is described as an image-guided surgery system for assisting physicians, not an AI diagnostic tool for "human readers." Therefore, this type of study would not be directly applicable as described.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- The document implies the device is an assistance tool for physicians during surgery ("to aid physicians," "used as a guide by the physician"). It is not described as a standalone algorithm performing tasks without human interaction. Therefore, a standalone performance study in the context of an "algorithm only" would be unlikely or not explicitly mentioned here. The "performance characteristics" studies likely refer to the system's accuracy in mapping positions, not an AI's standalone diagnostic capability.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- Not mentioned. For a navigation system, ground truth would likely involve highly precise measurements of physical locations and their correlation with imaging data.
8. The sample size for the training set:
- Not mentioned.
9. How the ground truth for the training set was established:
- Not mentioned.
Summary of what is known from the provided text:
- Device Name: Linasys Image-Guided Liver Surgery System
- Intended Use: To aid physicians during open liver procedures by mapping the current surgical position of tracked instruments onto preoperative, patient-specific MRI or CT medical images, guiding localization of tumors and other structures.
- Performance Claim: "Validation and verification studies were conducted to evaluate the performance characteristics... The results... demonstrate that the device is capable of safely and accurately performing the stated intended use."
- Predicate Devices: Several other FDA-cleared frame stereotaxic systems (Medtronic Navigation StealthStation, BrainLAB VectorVision2, J&J ACUSTAR I). This implies the Linasys system's performance metrics, though not detailed, would likely be compared to or fall within the established performance ranges of these predicate devices.
To provide the requested details, additional information from the actual validation and verification study reports would be necessary. This 510(k) summary is a high-level overview.
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71063
Page 1 of 2
510(k) Summary [as required by 21 CFR 807.92(c)]
Submitted by: I.
Pathfinder Therapeutics, Inc. 2969 Armory Dr. Suite #100A Nashville, TN 37204
DEC 2 0 2007
at and the comments of the comments of
II. Contact Person:
James Stefansic, PhD, MBA Chief Technology Officer Telephone: (615) 783-0094 Fax: (615) 783-0554 E-mail: jds@2pti.com
III. Date Initial Summary Prepared:
March 5, 2007
IV. Name of the Device:
Proprietary Name: Linasys Image-Guided Liver Surgery System Common / Usual Name: Computer-assisted, image-guided stereotaxic system Classification Name: Stereotaxic Instrument (per 21 CFR 882.4560)
V. Substantial Equivalence:
The technological characteristics and indications for use of the Linasys Image-Guided Liver Surgery System are the same or similar to those found in the predicate devices. The patient contact 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 Linasys system is substantially equivalent to the following FDA cleared frame stereotaxic systems:
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K07/0563
Page 2 of 2
- J&J ACUSTAR I Advanced Surgical Navigation System [K944612]
VI. Device Description:
The Linasys (Liver Navigation 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 Linasys system consists of six (6) components which are listed below:
(1) An image-guided surgery software platform installed on a personal computer (PC) (2) A three lens active-based optical position sensor that can accurately localize the tracked devices listed below
(3) A tracked localization probe
(4) A tracked fixed reference emitter used to define 3-D surgical space
(5) A tracked laser range scanner
(6) An LCD display monitor.
VII. Performance Data:
Validation and verification studies were conducted to evaluate the performance characteristics of the Linasys Image-Guided Liver Surgery 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 Linasys 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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Image /page/2/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS) of the United States. The seal features an eagle with its wings spread, symbolizing protection and strength. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
DEC 2 0 2007
Pathfinder Therapeutics, Inc. % James D. Stefansic, PhD, MBA Chief Technology Officer 2969 Armory Drive, Suite 100A Nashville, Tennessee 37204-3717
Re: K071063
Trade/Device Name: Linasys Image-Guided Liver Surgery System Regulation Number: 21 CFR 882.4560 Regulation Name: Stereotaxic instrument Regulatory Class: II Product Code: OEW Dated: November 20, 2007 Received: November 21, 2007
Dear Dr. Stefansic:
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. Iisting of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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 comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); 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.
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Page 2 -- James D. Stefansic, PhD, MBA
This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at (240) 276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at (240) 276-3464. 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours.
Mark N Milkerson
Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known): K071063
Device Name: Linasys Image-Guided Liver Surgery System
Indications For Use:
The Linasys device is indicated for open liver surgical procedures where imageguidance may be appropriate and where the patient can tolerate long apneic periods under general anesthesia.
Prescription Use X (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)
(Division Sign-)
Division of General, Restorative, Page 1 of 1
and Neurological Devices
510(k) Number 1071063
§ 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).