(46 days)
Not Found
No
The description explicitly mentions "manual or semi-automatic segmentation" and does not include any terms related to AI, ML, or deep learning. The functions listed are standard image processing and visualization tools for surgical planning software.
No
The device is for preoperative planning and provides 3-D visualization and volume measurement, but it does not directly treat, diagnose, or mitigate a disease or condition. It is a tool to assist in surgical planning.
No
This device is intended for preoperative planning for liver surgery, providing 3D visualization, volume measurement, and tools for defining virtual resections. It does not diagnose diseases or conditions; rather, it helps plan surgical interventions based on existing medical image data.
Yes
The device description explicitly states it is a "self-contained, PC-based and noninvasive software application" and imports medical images. While it can output data for another device (SurgiSight Linasys), the core functionality described is purely software-based image processing and planning.
Based on the provided information, the PlaniSight Linasys™ 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.
- PlaniSight Linasys Function: The PlaniSight Linasys device is a software application that processes and analyzes medical images (CT and MRI scans) to assist in preoperative planning for liver surgery. It does not analyze biological samples from the patient.
- Focus on Imaging and Planning: The description clearly states its purpose is 3-D visualization, volume measurement, segmentation, modeling, and surgical analysis based on imaging data.
- No Mention of Biological Samples: There is no mention of the device interacting with or analyzing any biological samples.
Therefore, the PlaniSight Linasys device falls under the category of medical imaging software used for surgical planning, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The PlaniSight Linasys™ device is intended for liver surgery preoperative planning. The medical image data utilized is derived from various sources, including CT and MRI scanners. The software provides tools for 3-D visualization and volume measurement of structures in the liver following manual or semi-automatic segmentation of the liver organ, intrahepatic vessels, and physician-identified lesions. Preoperative evaluation of specific surgery strategies is supported by the feature to interactively define virtual resections that divide the liver and calculate margins around lesions. Data can be exported in a format suitable for image-guided surgery with the SurgiSight Linasys device. Typical users of the software are trained professionals, including physicians, nurses, and technicians.
Product codes (comma separated list FDA assigned to the subject device)
LLZ
Device Description
The PlaniSight Linasys 100 Liver Surgical Planning Software (LSPS) is a self-contained, PC-based and noninvasive software application that imports medical images (CT or MRI scans) in a DICOM format. Like the predicate devices, Linasys™ LSPS is used to analyze data for preoperative planning in liver surgery. It can also output the image and model data for the use of other device, such as SurgiSight Linasys™ Image Guided Liver Surgical System (IGLSS).
Linasys™ LSPS contains dedicated functions to prepare the image data and define fiducial points for use with the SurgiSight Linasys™ IGLSS system. The LSPS device also includes dedicated functions for segmentation and modeling of organ, tumor, intrahepatic vasculature, and surgical resection planes. Quantitative measurements of functional and residual liver volume allow surgeons analyze the case and make optimal liver surgical plans.
Linasys 100 LSPS consists of five (5) functions:
-
- Viewing image volumes & models
-
- Image volume conversion
-
- Anatomic fiducial point definition
-
- Segmentation & modeling
-
- Surgical analysis & planning
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
CT or MRI scans
Anatomical Site
Liver
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Typical users of the software are trained professionals, including physicians, nurses, and technicians.
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 Linasys™ LSPS. The results of these studies demonstrate that the device is capable of safely and accurately performing the stated indication for 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
§ 892.2050 Medical image management and processing system.
(a)
Identification. A medical image management and processing system is a device that provides one or more capabilities relating to the review and digital processing of medical images for the purposes of interpretation by a trained practitioner of disease detection, diagnosis, or patient management. The software components may provide advanced or complex image processing functions for image manipulation, enhancement, or quantification that are intended for use in the interpretation and analysis of medical images. Advanced image manipulation functions may include image segmentation, multimodality image registration, or 3D visualization. Complex quantitative functions may include semi-automated measurements or time-series measurements.(b)
Classification. Class II (special controls; voluntary standards—Digital Imaging and Communications in Medicine (DICOM) Std., Joint Photographic Experts Group (JPEG) Std., Society of Motion Picture and Television Engineers (SMPTE) Test Pattern).
0
PlaniSight Linasys 510K Summary
SEP 2 2 2008
Image /page/0/Picture/3 description: The image shows the logo for PTI Surgical Vision and Precision. The logo features a compass-like design on the left side. To the right of the compass is the text "PTI" in a bold, sans-serif font, with the words "SURGICAL VISION AND PRECISION" underneath in a smaller font.
PLANISIGHT LINASYS™ LIVER SURGICAL PLANNING SOFTWARE 510(k) SUMMARY [as required by 21 CFR 807.92(c)]
]. Submitted by:
Pathfinder Therapeutics, Inc. 2969 Armory Drive, Suite #100A Nashville, TN 37204
Establishment Registration Number: 3006587863
ll. Contact Person:
James Stefansic, PhD, MBA Chief Technology Officer Telephone: (615) 783-0094 Fax: (615) 783-0554 E-mail: jds@2pti.com
lll. Date Summary Prepared:
July 31, 2008
IV. Name of the Device:
Proprietary Name: PlaniSight Linasys™ Common / Usual Name: Liver Surgical Planning Software (LSPS) Classification Name: Radiological Image Processing System (per 21 CFR 892.2050) [Class II, Product Code LLZ]
and the contraction of the contribution
and the commend of the comments of
1
V. · Substantial Equivalence:
The characteristics and indications for use of the PlaniSight Linasys™ device are the same or similar to those found in the predicate device is substantially equivalent to the following FDA cleared Radiological Image Processing Systems:
- IQQA Liver Software (EDDA Technology, K061696) 1.
-
- MeVis Liver Analyzer / Liver Viewer Software (MeVis-Center for Medical Diagnostic Systems and Visualization, K051528)
VI. Device Description:
The PlaniSight Linasys 100 Liver Surgical Planning Software (LSPS) is a self-contained, PC-based and noninvasive software application that imports medical images (CT or MRI scans) in a DICOM format. Like the predicate devices, Linasys™ LSPS is used to analyze data for preoperative planning in liver surgery. It can also output the image and model data for the use of other device, such as SurgiSight Linasys™ Image Guided Liver Surgical System (IGLSS).
Linasys™ LSPS contains dedicated functions to prepare the image data and define fiducial points for use with the SurgiSight Linasys™ IGLSS system. The LSPS device also includes dedicated functions for segmentation and modeling of organ, tumor, intrahepatic vasculature, and surgical resection planes. Quantitative measurements of functional and residual liver volume allow surgeons analyze the case and make optimal liver surgical plans.
Linasys 100 LSPS consists of five (5) functions:
-
- Viewing image volumes & models
-
- Image volume conversion
-
- Anatomic fiducial point definition
-
- Segmentation & modeling
-
- Surgical analysis & planning
VII. Performance Data:
Validation and verification studies were conducted to evaluate the performance characteristics of the Linasys™ LSPS. The results of these studies demonstrate that the device is capable of safely and accurately performing the stated indication for use.
VIII. Indications For Use:
The PlaniSight Linasys™ device is intended for liver surgery preoperative planning. The medical image data utilized is derived from various sources, including CT and MRI scanners. The software provides tools for 3-D visualization and volume measurement of structures in the liver following manual or semiautomatic segmentation of the liver organ, intrahepatic vessels, and physician-identified lesions. Preoperative evaluation of specific surgery strategies is supported by the feature to interactively define virtual resections that divide the liver and calculate margins around lesions. Data can be exported in a format suitable for image-guided surgery with the SurgiSight Linasys device. Typical users of the software are trained professionals, including physicians, nurses, and technicians.
2
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 an eagle with its wings spread, with three wavy lines below the eagle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
SEP 2 2 2008
James D. Stefansic, Ph.D., MBA Chief Technology Officer Pathfinder Therapeutics, Inc. 2969 Armory Drive Suite 100A NASHVILLE TN 37204
Re: K082228
Trade/Device Name: PlaniSight Linasys™ Liver Surgical Planning Software (LSPS) Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: II Product Code: LLZ Dated: August 5, 2008 Received: August 7, 2008
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, listing 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.
3
Page 2
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.
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 Office of Compliance at one of the following numbers, based on the regulation number at the top of this letter:
| 21 CFR 876.xxx | (Gastroenterology/Renal/Urology) | 240-276-0115 |
|---|---|---|
| 21 CFR 884.xxx | (Obstetrics/Gynecology) | 240-276-0115 |
| 21 CFR 894.xxx | (Radiology) | 240-276-0120 |
| Other | 240-276-0100 |
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 Biometrics' (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 vours.
forque M. Whang
Joyce M. Whang, Ph.D. Acting Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Indications for Use
510(k) Number (if known): Kos zzz z
Device Name: PlaniSight Linasys™ Liver Surgical Planning Software (LSPS)
Indications For Use:
The PlaniSight Linasys™ device is intended for liver surgery preoperative planning. The medical image data utilized is derived from various sources, including CT and MRI scanners. The software provides tools for 3-D visualization and volume measurement of structures in the liver following manual or semi-automatic segmentation of the liver organ, intrahepatic vessels, and physician-identified lesions. Preoperative evaluation of specific surgery strategies is supported by the feature to interactively define virtual resections that divide the liver and calculate margins around lesions. Data can be exported in a format suitable for image-guided surgery with the SurgiSight Linasys device. Typical users of the software are trained professionals, including physicians, nurses, and technicians.
Prescription Use X CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(Part 21
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
concurrence of CDRH, Office of Device Evaluation (ODE)
(Division Sign-Off) Division of Reproductive. Abdominal and Radiological Devices KO 8222 510(k) Number ________________________________________________________________________________________________________________________________________________________________
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