Who is the manufacturer of CAS-One IR?

Cascination AG filed the 510(k) submission for CAS-One IR (K232022).

What is the FDA product code for CAS-One IR?

JAK. It is classified under 21 CFR 892.1750 as a Class 2 device in the Radiology panel.

What is the regulatory pathway for CAS-One IR?

510(k) clearance (submission type: Traditional).

Does CAS-One IR use AI or machine learning?

Yes. CAS-One IR (K232022) is flagged as an AI/ML-enabled medical device in the FDA's AI/ML device list.

Who can help prepare an FDA 510(k) submission like CAS-One IR?

Innolitics — a medical-device software consultancy — provides regulatory and engineering support for FDA 510(k) submissions. See https://innolitics.com/services/510ks/ or contact https://innolitics.com/contact.

Can an AI/ML device like CAS-One IR get a guaranteed FDA 510(k) clearance?

Yes. Innolitics offers a guaranteed FDA 510(k) clearance engagement for AI/ML Software as a Medical Device — combining engineering and regulatory execution under one agreement with a guaranteed clearance outcome. Eligibility: the device must be an AI/ML Software as a Medical Device (SaMD), and its performance must meet the criteria Innolitics determines during an initial regulatory strategy engagement to be necessary for FDA clearance. See https://innolitics.com/services/end-to-end-samd/ or contact https://innolitics.com/contact.

CAS-One IR

K232022 · Cascination AG · JAK · Mar 13, 2024 · Radiology

Device Facts

Record ID	K232022
Device Name	CAS-One IR
Applicant	Cascination AG
Product Code	JAK · Radiology
Decision Date	Mar 13, 2024
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 892.1750
Device Class	Class 2
Attributes	AI/ML

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 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 relative 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. CAS-One IR is intended to be used for patients older than 18 years and eligible for CT-guided percutaneous interventions.

Device Story

CAS-One IR is a mobile stereotactic navigation platform used in radiology suites during CT-guided percutaneous interventions. The system comprises a mobile cart with touchscreens, a camera, and a computer; a guide arm; an aiming device; and a navigational pointer. The device ingests CT or MRI image data (DICOM) to assist physicians in planning needle trajectories, navigating instruments to targets, and verifying placement. During navigation, the system monitors respiratory levels and provides alignment guidance. Post-procedure, it overlays pre- and post-treatment images to verify instrument position and assess ablation performance (AblaSure). The system aids physicians in precise needle placement, potentially improving procedural accuracy and clinical outcomes for patients undergoing interventional CT procedures.

Clinical Evidence

No clinical data. Evidence consists of bench testing, including software verification and validation, and algorithm validation. Segmentation algorithms were validated against expert-annotated ground truth using DICE coefficients (Liver: 0.9, Tumor: 0.8, Effective Treatment Volume: 0.8, Kidney: 0.85, Lung: 0.9, Liver-Vessels: 0.6). Instrument detection reliability was assessed against ground truth positions. Electrical safety (ANSI AAMI ES60601-1) and EMC (ANSI AAMI IEC 60601-1-2) testing were performed.

Technological Characteristics

Mobile navigation platform with touchscreens, camera, and computer. Instruments (pointer, aiming device, guide arm) made of surgical stainless steel (1.4301/1.4305). Energy source: 110-230V, 50-60Hz. Software runs on Windows 10. Features include DICOM-based image fusion (CT/MRI), organ/lesion segmentation, and instrument detection. Moderate level of concern software.

Indications for Use

Indicated for patients >18 years old eligible for CT-guided percutaneous interventions, using rigid straight instruments (needles/probes) during CT-guided procedures performed by trained physicians.

Regulatory Classification

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.

Predicate Devices

CAS-One IR (K152473)

Related Devices

K152473 — CAS-One IR · Cascination AG · Jan 20, 2016
K223758 — Epione · Quantum Surgical Sas · May 3, 2023
K132108 — MAXIO · Perfint Healthcare Pvt, Ltd. · May 19, 2014
K162314 — IMACTIS CT-Navigation system · Imactis, Sas · Apr 24, 2018
K221116 — XACT ACE Robotic System · Xact Robotics, Ltd. · May 13, 2022

Submission Summary (Full Text)

{0}------------------------------------------------ March 13, 2024 Image /page/0/Picture/1 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which consists of the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG" in blue, with the word "ADMINISTRATION" underneath. Cascination AG % Andreas Meschberger Senior Regulatory & Clinical Affairs Manager Steigerhubelstrasse 3 BERN. 3008 SWITZERLAND Re: K232022 Trade/Device Name: CAS-One IR Regulation Number: 21 CFR 892.1750 Regulation Name: Computed Tomography X-Ray System Regulatory Class: Class II Product Code: JAK Dated: February 14, 2024 Received: February 14, 2024 Dear Andreas Meschberger: 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 (the 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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database available at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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. Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download). {1}------------------------------------------------ Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181). 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 of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems. For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100). Sincerely, Smita Kakar for Lu Jiang Assistant Director DHT8B: Division of Radiologic Imaging Devices and Electronic Products OHT8: Office of Radiological Health Office of Product Evaluation and Quality Center for Devices and Radiological Health Enclosure {2}------------------------------------------------ ### Indications for Use 510(k) Number (if known) K232022 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 relative 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. CAS-One IR is intended to be used for patients older than 18 years and eligible for CT-guided percutaneous interventions. 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) #### CONTINUE ON A SEPARATE PAGE IF NEEDED. This section applies only to requirements of the Paperwork Reduction Act of 1995. #### *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.* The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to: > Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov "An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number." {3}------------------------------------------------ Image /page/3/Picture/0 description: The image shows the word "CASCINATION" in green font. To the right of the word is a red square with a white cross in the center. The cross is a symbol of Switzerland. Steigerhubelstrasse 3 CH-3008 Bern Switzerland # 510(K) SUMMARY # K232022 This summary of 510(k) safety and effectiveness information is submitted in accordance with the requirements of 21 CFR §807.92. ### I. SUBMITTER | Manufacturer: | CASCINATION AG | |-----------------|----------------------------------------------| | | Steigerhubelstrasse 3 | | | CH-3008 Bern | | | Switzerland | | | Tel: +41 31 306 26 26 | | Contact Person: | Andreas Meschberger | | | Senior Regulatory & Clinical Affairs Manager | | Date Prepared: | March 08, 2024 | ### II. SUBJECT DEVICE | Device Name: | CAS-One IR | |----------------------|-------------------------------------| | Classification Name: | Computed tomography x-ray system | | Regulation: | 892.1750 | | Common Name: | System, X-Ray, Tomography, Computed | | Regulatory Class: | Class II | | Product Code: | JAK | The Subject Device is an updated version of the Predicate Device. {4}------------------------------------------------ # III. PREDICATE DEVICE | Primary Predicate Device | | |--------------------------|------------------------------------------------------------------| | Company: | CASCINATION AG, Steigerhubelstrasse 3, CH-3008 Bern, Switzerland | | Device name: | CAS-One IR | | 510(k) number: | K152473 | | Classification Name: | Computed tomography x-ray system | | Regulation: | 892.1750 | | Common Name: | System, X-Ray, Tomography, Computed | | Regulatory Class: | Class II | | Product Code: | JAK | # IV. 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 relative 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. CAS-One IR is intended to be used for patients older than 18 years and eligible for CT-guided percutaneous interventions. # V. DEVICE DESCRIPTION The system consists of the following main components: - . A mobile navigation platform: this 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. - . Instruments: The instrument set comprises a guide arm, aiming device and a navigational pointer that are connected to each other and assist the user in aligning and positioning a needle trajectory relative to the patient. After positioning the aiming device using the guide arm, the {5}------------------------------------------------ aiming device is aligned with respect to the desired entry point (translational alignment) and rotationally oriented to the desired insertion angle. - 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. # VI. SUBSTANTIAL EQUIVALENCE The following characteristics were compared between the subject device and the predicate device in order to demonstrate substantial equivalence: | Item | Subject Device (CAS-One IR) | Predicate Device (CAS-One IR) K152473 | Conclusion | |----------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Regulation Number | Regulation Number: 21 CFR 892.1750 Product Code: JAK | Regulation Number: 21 CFR 892.1750 Product Code: JAK | ⇒ Same Both the subject and predicate devices have the same product code and regulation number | | Item | Subject Device (CAS-One IR) | Predicate Device (CAS-One IR) K152473 | Conclusion | | Indications For Use Statement | 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 relative 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. CAS-One IR is intended to be used for patients older than 18 years and eligible for CT-guided percutaneous interventions. | 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 relative 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. | ⇒ Same, but more specific Both the subject and predicate devices have the same general indications for use statement and the subject device has an additional specificity regarding the target population | | User | physicians trained for interventional CT procedures | physicians trained for interventional CT procedures | ⇒ Same Both the subject and predicate devices have the same user | | Item | Subject Device (CAS-One IR) | Predicate Device (CAS-One IR) K152473 | Conclusion | | | | System | | | System | Consists of: • Platform • Pointer, Aiming device, Guide Arm • CAS-One IR software | Consists of: • Platform • Pointer, Aiming device, Guide Arm • CAS-One IR software | ⇒ Same There was no change in the system concept | | Compatibility | The system is compatible with needle-shaped devices used in percutaneous interventional procedures that have the following physical properties: • Cylindrical, straight shape • Design that allows the placement of instruments in the Guide | The system is compatible with needle-shaped devices used in percutaneous interventional procedures that have the following physical properties: • Cylindrical, straight shape • Design that allows the placement of instruments in the Guide | ⇒ Same There was no change in the system compatibility | | | | Hardware | | | Navigation Platform | Same: Camera, Rack, Screen Arms, Camera Arms Updated: Touch screens, Graphic Cards, Mother board and Power Supplier | Same: Camera, Rack, Screen Arms, Camera Arms Predicate: Touch screens, Graphic Cards, Mother board and Power Supplier | ⇒ Same The updated components have the same technical principles and just represent an updated technical state. The parts are covered by the Electrical Safety and EMC Testing, and System Validation | | Pointer (Aiming Insert and Marker Shield), Aiming Device, Guide Arm. | Surgical Stainless Steel 1.4301 & 1.4305 Slight mechanical design improvements. | Surgical Stainless Steel 1.4301 | ⇒ Same Both devices use a surgical stainless steel of a slightly different type. Minor mechanical design improvements. | | Patient Fixation | Vacuum cushion on top of carbon baseplate. | Vacuum cushion on top of carbon baseplate. | ⇒ Same | | Energy Source | 110-230V, 50-60Hz, single phase | 110-230V, 50-60Hz, single phase | ⇒ Same | | Item | Subject Device (CAS-One IR) | Predicate Device (CAS-One IR) K152473 | Conclusion | | Software | | | | | Operating System | Windows 10 | Windows 7 | ⇒ Same Both devices run on Microsoft Windows, installed on the platform. Programming language and software architecture remain the same. Full Software V&V has been executed and passed | | Image datasets | DICOM file format: • CT or MRI image modality | DICOM file format: • CT image modality | ⇒ Same The subject device allows to import MRI images, but they must also comply to the DICOM standard | | Data Management | Function to import image datasets. | Function to import image datasets. | ⇒ Same | | DICOM Viewer | Function to view, pan, zoom, adjust brightness and insensitivity, and carry out measurements in image data and to overlay image data | Function to view, pan, zoom, adjust brightness and insensitivity, and carry out measurements in image data and to overlay image data | | | Module Plan | Trajectory Planning Single / Multiple needles Display of manufacturer ablation parameters Point-based image fusion CT to CT or MR. Segmentation of organs (liver tissue, portal vein, hepatic vein, liver lesions, kidney tissue, lung tissue, and lung airway) | Trajectory Planning Single / Multiple needles Display of manufacturer ablation parameters Point-based image fusion CT to CT | ⇒ Different Technological characteristic "Segmentation of organs and lesions" which does not raise any concern about safety and effectiveness. The Point-based registration MRI to CT images of the subject device is similar to the Point-based registration CT to CT images of the predicate device and does not represent a technological difference | | Item | Subject Device (CAS-One IR) | Predicate Device (CAS-One IR) K152473 | Conclusion | | Navigation | Module Name "Place" | Module Name "Navigation" | ⇒ Same | | | Supports Instrument Guide | Supports Instrument Guide and Freehand | The module was renamed but the functionality remains the same | |…