(189 days)
No
The document describes image guidance and processing but does not mention AI, ML, or related terms.
No
The device is an image guidance system used during surgical procedures. It does not directly treat or cure a disease or condition, but rather aids the surgeon in performing the therapeutic procedure.
No
This device is described as an image-guided surgery system that visualizes instrument position relative to a 3D model of the liver in real-time during open liver surgical procedures. Its purpose is to assist in surgical navigation, not to diagnose a disease or condition. While it uses medical images (CT/MRI) for planning, it doesn't interpret them for diagnostic purposes.
No
The device description explicitly states it visualizes the position and pose of surgical instruments relative to a 3D model of the liver in real-time, implying the use of hardware for tracking and visualization in addition to software. The performance studies also mention bench testing for calibration, tracking, and registration, which are typically associated with hardware components.
Based on the provided information, the CAS-One Liver system is not an In Vitro Diagnostic (IVD).
Here's why:
- IVDs are used to examine specimens from the human body. The CAS-One Liver system is used during open liver surgical procedures to provide image guidance and visualize surgical instruments relative to the patient's liver. It does not analyze blood, tissue, or other bodily fluids or substances outside of the body.
- The intended use and device description clearly state its application in surgical procedures. The focus is on real-time image guidance during surgery, not on analyzing samples for diagnostic purposes.
- The input imaging modalities (CT and MRI) are used to create a 3D model of the liver for surgical planning and guidance. This is distinct from using imaging to analyze a specimen.
The CAS-One Liver system falls under the category of surgical navigation or image-guided surgery systems, which are considered medical devices but not IVDs.
N/A
Intended Use / Indications for Use
The CAS-One Liver system 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
OEW
Device Description
The CAS-One Liver system is indicated for open liver surgical procedures where image aujdance may be appropriate and where the patient can tolerate long apneic periods under general anesthesia. It visualizes the position and pose of surgical instruments relative to a three-dimensional model of the patients liver in real-time.
Step 1 - Preoperative Imaging
Preoperatively a bi- or tri-phasic CT scan or an MRI scan of the patient is acquired and processed using a virtual surgery planning tool (MeVis Medical Solutions, Bremen, Germany).
Step 2 - Virtual Surgery Planning
The processing includes segmentation of relevant anatomical structures of the liver (intrahepatic vessels, tumors, segments and the liver surface). The segmentation of patient-individual vascular territories for each vessel system and identification of vascular branches affected by different treatment strategies. The patient-individual 3D models provide support in analyzing the remaining functional liver volume and associated risks with different resection or ablation strategies towards an optimized patient-specific operative strategy.
Step 3 – Intraoperative Setup
Prior to the surgical procedure, all components of the system are set up close to the OR table. The 3D model is then loaded into the navigation software. Using the navigation system, the model can be zoomed, rotated and its different sub-models can be displays according to the surgeon's needs. Sterile draping of the device and assembly of the sterile instrumentation is performed. The computer displays a 3D model of the present anatomical situation, a plan of the surgical strategy and a view of the available ultrasound images.
Step 4 - Planning
After surgical preparation of the liver, a complete examination of the liver can be performed by palpation and intra-operative ultrasound. For preparation of the navigated procedure an area of interest for navigation or a set of anatomical landmarks is selected on the touch screen. The navigation system stores their positions and uses them for registration.
Step 5 - Registration
The reaistration procedure requires a few seconds and can be repeated whenever necessary. Registration is either based on navigated intra-operative ultrasound or on landmark points acquired surgical instruments.
Step 6 - Resection/Ablation Guidance
The computer system displays a 3D model of the liver anatomy, the resection/ablation plan, and a view of the available ultrasound images on a monitor near the operative field. This provided continuous real-time feedback and enables for the guidance of the surgical instruments towards the planned treations (resection planes or ablation targets).
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
CT scan, MRI scan, ultrasound
Anatomical Site
Liver
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Surgeons / open liver surgical procedures / OR table
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)
Bench Testing
Bench testing to show the accuracy and reproducibility was conducted and shown to meet the defined acceptance criteria for various functionality of the system (such as calibration, tracking and registration).
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
K132108, K082060, K083310, Exempt 878.4800
Predetermined Change Control Plan (PCCP) - All Relevant Information
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).
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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
April 28, 2015
CAScination AG Mr. Matthias Peterhans Chief Executive Officer Stauffacherstrasse 78 CH-3014 Bern Switzerland
Re: K143024
Trade/Device Name: CAS-One Liver system Regulation Number: 21 CFR 882.4560 Regulation Name: Stereotaxic instrument Regulatory Class: Class II Product Code: OEW Dated: March 19, 2015 Received: March 23, 2015
Dear Mr. Peterhans:
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 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
1
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 contact the Division of Industry and Consumer Education 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. 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/Safety/ReportaProblem/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 Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Jennifer R. Stevenson -S
For Binita S. Ashar, M.D., M.B.A., F.A.C.S. Director Division of Surgical Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K143024
Device Name CAS-One Liver system
Indications for Use (Describe)
The CAS-One Liver system 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
Type of Use (Select one or both, as applicable)
Prescription Use (Part 21 CFR 801 Subpart D)
_ Over-The-Counter Use (21 CFR 801 Subpart C)
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Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)
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Image /page/3/Picture/0 description: The image shows the word "CAScination" in green font. The letters are all capitalized except for the "c" in "CAScination". The font is sans-serif and the letters are spaced closely together. The background is white.
Stauffacherstrasse 78 CH-3014 Bern Switzerland
510(k) Summary
| Manufacturer: | CAScination AG |
|---|---|
| Contact: | Matthias Peterhans |
| CEO | |
| Stauffacherstrasse 78 | |
| CH-3014 Bern | |
| Switzerland | |
| Tel: +41 31 832 5182 | |
| Email: matthias.peterhans@cascination.ch | |
| Date Prepared: | 2015-04-28 |
| Trade Name: | CAS-One Liver system |
| Common Name: | A navigation system for open liver surgery |
| Classification Name: | Stereotaxic Instrument (21 CFR 882 4560) |
Description:
The CAS-One Liver system is indicated for open liver surgical procedures where image aujdance may be appropriate and where the patient can tolerate long apneic periods under general anesthesia. It visualizes the position and pose of surgical instruments relative to a three-dimensional model of the patients liver in real-time.
Step 1 - Preoperative Imaging
Preoperatively a bi- or tri-phasic CT scan or an MRI scan of the patient is acquired and processed using a virtual surgery planning tool (MeVis Medical Solutions, Bremen, Germany).
Step 2 - Virtual Surgery Planning
The processing includes segmentation of relevant anatomical structures of the liver (intrahepatic vessels, tumors, segments and the liver surface). The segmentation of patient-individual vascular territories for each vessel system and identification of vascular branches affected by different treatment strategies. The patient-individual 3D models provide support in analyzing the remaining functional liver volume and associated risks with different resection or ablation strategies towards an optimized patient-specific operative strategy.
Step 3 – Intraoperative Setup
Prior to the surgical procedure, all components of the system are set up close to the OR table. The 3D model is then loaded into the navigation software. Using the navigation system, the model can be zoomed, rotated and its different sub-models can be displays according to the surgeon's needs. Sterile draping of the device and assembly of the sterile instrumentation is performed. The computer displays a 3D model of the present anatomical situation, a plan of the surgical strategy and a view of the available ultrasound images.
Step 4 - Planning
After surgical preparation of the liver, a complete examination of the liver can be performed by palpation and intra-operative ultrasound. For preparation of the navigated procedure an area of interest for navigation or a set of anatomical landmarks is selected on the touch screen. The navigation system stores their positions and uses them for registration.
Step 5 - Registration
The reaistration procedure requires a few seconds and can be repeated whenever necessary. Registration is either based on navigated intra-operative ultrasound or on landmark points acquired surgical instruments.
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Image /page/4/Picture/0 description: The image shows the word "CAScINATION" in green font. The letters are all capitalized except for the "c" in the middle of the word. The font is sans-serif and the letters are evenly spaced. The word is centered and there is no background.
Step 6 - Resection/Ablation Guidance
The computer system displays a 3D model of the liver anatomy, the resection/ablation plan, and a view of the available ultrasound images on a monitor near the operative field. This provided continuous real-time feedback and enables for the guidance of the surgical instruments towards the planned treations (resection planes or ablation targets).
Indications for Use:
The CAS-One Liver system 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.
Substantial Equivalence:
CAS-One Liver system exhibits characteristics that are similar or the selected predicate device. The following predicate device was selected:
-
Pathfinder Therapeutics, Inc. EXPLORER Liver Passive Tracking [K101979] -
The predicate device was shown to have the same indications for use and intended use. A comparison of the following key technological characteristics was also performed between the predicate and subject devices: -
Marker Shields: Attaches to surgical instruments to passively track them for navigation -
-
-Instrument Sensing: This is the method in which the system detects the surgical instruments
-
-Instrument Navigation: This shows the position and orientation of the instruments with respect to the preoperative 3D patient model
-
Calibration: The means of calibrating the surgical tools to the preoperative patient 3D model.
-
Registration: The method of aligning the preoperative patient data with the patient organ.
-
Fusion Ultrasound: This technology overlays preoperative patient data with other views of data. —
-
-3D Patient Preoperative Data: A visual representation in 3D of the patient preoperative data.
-
-Ultrasound: An ultrasound device, integrated or externally connected, which provides ultrasound images of the patient.
This analysis identified the following minor technological characteristic differences between the subject and predicate devices:
- -Method of sterilization
- Materials used for attachments —
- Fusion Ultrasound
- Use of simulated ablation volume
- -Registration method with pointing device
- -Materials used for shields
As these differences related to technology implementation choices, reference devices were selected for further comparison analysis:
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Image /page/5/Picture/0 description: The image shows the word "CAScination" in green font. The letters are all capitalized except for the "c" in "CAScination". The font is sans-serif and the letters are evenly spaced. The word is centered in the image and the background is white.
- Brainlab AG Image guided Surgery System [K083310] -
- Symmetry Surgical Universal Ring Deaver Retractor Blade [Exempt 878.4800] -
- _
Performance data was also submitted to further demonstrate safety and effectiveness.
An evaluation of the above information concluded that the CAS-One Liver system is substantially equivalent.
Biocompatibility
All devices of the CAS-One Liver system have the following patient contacting characteristics:
- -External Communicating Devices
- -Blood path indirect
- -Limited (