(142 days)
Not Found
No
The summary describes a stereotactic navigation system based on mechanical alignment and image overlay, with no mention of AI or ML in the device description, intended use, or performance studies.
No
Explanation: This device is a surgical navigation system that assists physicians in planning, navigating, and verifying instrument positions during CT-guided interventional procedures. It does not directly provide therapy or treatment to a patient.
No
The device is described as a "stereotactic accessory intended to assist in planning, navigation and manual advancement of one or more instruments, as well as in verification of instrument position and performance during Computed Tomography (CT) guided procedures." This indicates it is for guiding interventions, not for diagnosing conditions.
No
The device description explicitly lists multiple hardware components including a mobile navigation platform with touch screens, camera, and computer, an aiming device with a mechanical arm, and an instrument adapter clamp. While software is a component, it is part of a larger hardware system.
Based on the provided information, no, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that CAS-One IR is a "stereotactic accessory intended to assist in planning, navigation and manual advancement of one or more instruments, as well as in verification of instrument position and performance during Computed Tomography (CT) guided procedures." This describes a system used during a medical procedure to guide instruments within the body, not a device used to examine specimens outside the body to obtain diagnostic information.
- Device Description: The description details hardware components like a mobile navigation platform, aiming device, and instrument adapter clamp, along with software for planning and navigation. These are all consistent with a surgical or interventional guidance system, not an IVD.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, tissue, urine, etc.), reagents, or providing diagnostic information based on the analysis of such samples.
In summary, CAS-One IR is a medical device used for image-guided intervention, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
CAS-One IR is a user controlled, stereotactic accessory intended to assist in planning, navigation and manual advancement of one or more instruments, as well as in verification of instrument position and performance during Computed Tomography (CT) guided procedures.
In planning, the desired needle configuration and performance is defined relative to the target anatomy.
In navigation, the instrument position is displayed telative to the patient and guidance for needle alignment is provided while respiratory levels are monitored.
In verification, the achieved instrument configuration and performance are displayed relative to the previously defined plan through an overlay of the pre- and post- treatment image data.
CAS-One IR is indicated for use with rigid straight instruments such as needles and probes used in CT guided interventional procedures performed by physicians trained for CT procedures.
Product codes (comma separated list FDA assigned to the subject device)
JAK
Device Description
The system consists of three main components:
- A mobile navigation platform can be moved in and out of radiology rooms and is positioned next to the patient in front of the CT scanner. The platform includes two touch screens, a camera and a computer.
- Aiming device with trackable aiming insert: To aim the needles to their correct locations, the system uses an aiming device. The aiming device is attached to a multi-axis mechanical arm that can align the position of the aiming device around the expected needle entry position. The aiming device is first aligned to the desired entry point (translational alignment) and then alignment to the desired needle insertion angle is performed using a remote center of rotation principle (rotational alignment). There are two possible configurations of the aiming device.
- Instrument adapter clamp with trackable marker shield: As an alternative to the aiming device, trackable markershields can be attached directly to rigid needles by means of an instrument adapter. Calibration of the needle geometry is performed with a calibration unit supplied by CAScination.
- CAS-One IR software: The software provides the step-by-step workflow assistance for needle navigation. It provides a means for users to precisely plan a single or multiple needle trajectories, navigate a needle to this exact position and validate the inserted needle's position to the planned position.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Computed Tomography (CT)
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Physicians trained for CT 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)
- Positional accuracy bench test: conducted between the real-time tracking system used in the predicate device and CAS-One IR to show that the two technologies were substantially equivalence.
- Patient registration method performance evaluation: evaluated and shown to be a safe and effective method of registering.
- Integrated clinical workflow benchmarking: benchmarked against the predicate devices and CAS-One IR was shown to be safe and effective.
- Accuracy test: evaluated all needle insertion configurations of CAS-One IR was conducted on a phantom within the context of clinical use and each method was shown to be accurate and as safe and effective as the predicate devices.
- Post-clinical evaluation: of interventions conducted with CAS-One IR showed the system to be accurate and as safe and effective on patients within a clinical context as the predicate devices.
- Usability studies: with qualified users of varying degrees of experience was conducted in terms of both risk management and human factors. CAS-One IR was shown to be easy and accurate to use for both novice and experienced users.
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
§ 892.1750 Computed tomography x-ray system.
(a)
Identification. A computed tomography x-ray system is a diagnostic x-ray system intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data from the same axial plane taken at different angles. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.(b)
Classification. Class II.
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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
January 20, 2016
CAScination AG % Mr. Matthias Peterehans CEO Steigerhubelstrasse 3 CH-3008 Bern SWITZERLAND
Re: K152473
Trade/Device Name: CAS-One IR Regulation Number: 21 CFR 892.1750 Regulation Name: Computed tomography x-ray system Regulatory Class: II Product Code: JAK Dated: November 20, 2015 Received: November 27, 2015
Dear Mr. Peterehans:
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 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.
1
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" (21 CFR 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.
Michael D'Hara
For
Robert Ochs, Ph.D. Director Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K152473
Device Name CAS-One IR
Indications for Use (Describe)
CAS-One IR is a user controlled, stereotactic accessory intended to assist in planning, navigation and manual advancement of one or more instruments, as well as in verification of instrument position and performance during Computed Tomography (CT) guided procedures.
In planning, the desired needle configuration and performance is defined relative to the target anatomy.
In navigation, the instrument position is displayed telative to the patient and guidance for needle alignment is provided while respiratory levels are monitored.
In verification, the achieved instrument configuration and performance are displayed relative to the previously defined plan through an overlay of the pre- and post- treatment image data.
CAS-One IR is indicated for use with rigid straight instruments such as needles and probes used in CT guided interventional procedures performed by physicians trained for CT procedures.
Type of Use (Select one or both, as applicable)X Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
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Steigerhubelstrasse 3 CH-3008 Bern Switzerland
5: 510(k) Summary
ID: CASC-11-228 Version: 3.0 Valid from: Tuesday January 12, 2015
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Contents
| Intended Use: | 3 |
|---|---|
| Description: | 3 |
| Substantial Equivalence: | 4 |
| Biocompatibility | 4 |
| Electrical Safety | 4 |
| Software Verification and Validation | 5 |
| Performance Data | 5 |
| Conclusion | 5 |
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510(k) Summary
| Manufacturer: | CAScination AG |
|---|---|
| Contact: | Matthias Peterhans |
| CEO | |
| Steigerhubelstrasse 3 | |
| CH-3008 Bern | |
| Switzerland | |
| Tel: +41 31 552 0440 | |
| Date Prepared: | 12 January 2016 |
| Trade Name: | CAS-One IR |
| Common Name: | Navigated system for CT guided interventions |
| Classification Number: | 21 CFR 892.1750, Computed Tomography X-Ray system |
| Product Code: | JAK, System, X-ray, Tomography, Computed |
| Predicate device(s): | ig4 Image Guided System [K060903] (JAK, 21 CFR 892.1750) |
| MAXIO [K132108] (JAK, 21 CFR 892.1750) |
Intended Use:
CAS-One IR is a user controlled, stereotactic accessory intended to assist in planning, navigation and manual advancement of one or more instruments, as well as in verification and performance during Computed Tomography (CT) guided procedures.
In planning, the desired needle configuration and performance is defined relative to the target anatomy.
In navigation, the instrument position is displayed relative to the patient and guidance for needle alignment is provided while respiratory levels are monitored.
In verification, the achieved instrument contiguration and performance are displayed relative to the previously defined plan through an overlay of the pre- and post- treatment image data.
CAS-One IR is indicated for use with rigid straight instruments such as needles and probes used in CT guided interventional procedures performed by physicians trained for CT procedures.
Description:
The system consists of three main components:
- A mobile navigation platform can be moved in and out of radiology rooms and is positioned next to the patient in front of the CT scanner. The platform includes two touch screens, a camera and a computer.
- Aiming device with trackable aiming insert: To aim the needles to their correct locations, the system uses an aiming device. The aiming device is attached to a multi-axis mechanical arm that can align the position of the aiming device around the expected needle entry position. The aiming device is first aligned to the desired entry point (translational alignment) and then alignment to the desired needle insertion angle is performed using a remote center of rotation principle (rotational alignment). There are two possible configurations of the aiming device.
6
Image /page/6/Picture/0 description: The image shows the word "CAScination" in green font. The letters are all capitalized, and the font is sans-serif. The word is written in a single line, and the letters are evenly spaced. The image is simple and clean, with no other elements present.
- Instrument adapter clamp with trackable marker shield: As an alternative to the aiming device, trackable markershields can be attached directly to rigid needles by means of an instrument adapter. Calibration of the needle geometry is performed with a calibration unit supplied by CAScination.
- CAS-One IR software: The software provides the step-by-step workflow assistance for needle navigation. It provides a means for users to precisely plan a single or multiple needle trajectories, navigate a needle to this exact position and validate the inserted needle's position to the planned position.
Substantial Equivalence:
CAS-One IR has been shown to be equivalent to:
- MAXIO (Perfint Healthcare, Pvt. Ltd.) [K132108] |
- ig4 Image Guided System (Veran Medical Technologies) [K060903]
CAS-One IR was compared and evaluated to the predicate devices with respect to the following characteristics:
- Planning
- Needle configuration and performance -
- Navigation ー
- Respiratory motion control -
- -Intra-interventional verification
- Post treatment verification —
- -Interventional instruments
- -User
- lmaging modality |
The above characteristics were evaluated and found to have the same intended use as the predicate devices. Where technological differences were identified, performance data was supplied to support the conclusion that CAS-One IR does not raise different questions of safety and effectiveness.
CAS-One IR is shown to be substantially equivalent to the predicate devices.
Biocompatibility
All devices of CAS-One IR have the following patient contacting characteristics:
- Surface Devices
- -Skin
- -Limited (