(123 days)
The ACIST HDi System is intended to be used for ultrasound examination of coronary and peripheral intravascular pathology. Intravascular ultrasound in indicated in patients who are candidates for transluminal interventional procedures.
The ACIST Kodama Intravascular Ultrasound Catheter is intended for use with the ACIST HD System.
The primary function of HDi System is to collect reflected ultrasonic (sound) waves from the Kodama catheter and render an intravascular image on the console touchscreen. The catheter emits sound energy from a transducer at the tip; sound waves reflected from the inner vascular tissues are received from the transducer and sent to the console where a high resolution, cross-sectional image is displayed on the touchscreen in real-time.
The main devices are the Console, Patient Interface Module (PIM), Linear Translation System (LTS) (optional), and Kodama Catheter.
The console houses hardware and software required to generate the energy used to excite the transducer in the Kodama catheter; it is the center of control and system architecture for how signals are acquired, processed, images constructed and presented, and overall power management and control of the PIM and LTS. The system digitally records case images, provides a review of recorded cases, and provides for the archival of recorded cases onto removable media.
The handheld PIM provides the electromechanical interface between the catheter and the console. It also provides the mechanical interface to secure the catheter, as well as the mechanical energy to rotate the catheter's imaging assembly. The LTS device provides automated, controlled linear translation of the catheter by providing mechanical coupling to the PIM and to the catheter's telescoping anchor as the PIM is pulled back along the longitudinal axis. The coupling between the LTS and PIM and LTS to catheter is strictly mechanical. The LTS device allows the user to perform automatic pullbacks and can be controlled via touchscreen buttons on the console or the buttons on the LTS. Manual pullbacks may be performed with or without the LTS, making the use of the LTS optional to the user.
The Kodama Catheter emits sound energy from its transducer at the distal tip, which is guided into the coronary and peripheral vasculature. The catheter can be operated at two different frequencies, 40MHz and/or 60MHz. The electrical energy from the catheter is transmitted, via the coaxial cable embedded in the drive cable, back to the HDi console for signal processing and image reconstruction.
The ACIST HDi System and Kodama Intravascular Ultrasound Catheter are intended for ultrasound examination of coronary and peripheral intravascular pathology in patients undergoing transluminal interventional procedures. The device's primary function is to collect reflected ultrasonic waves from the Kodama catheter and display an intravascular image on the console touchscreen in real-time. This submission focuses on software modifications to extend the field of view for larger peripheral vessels.
Here's an analysis of the acceptance criteria and the study that proves the device meets them:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| The Acquire screen is displayed during Imaging, Recording and Pullback and it has appropriate functional elements, including the new "Diameter" button. | Verified with passing results. |
| The Zoom/Decimation function allows the image to be magnified to the specified depth range in the extended field of view. | Verified with passing results. |
| The time gain compensation (TGC) control curve is controlled dynamically by the Diameter selection and covers the appropriate anatomical depth range. | Verified with passing results. |
| Users can utilize the new software features and interpret the resulting images correctly and that there were not new use errors identified. (Primary changes observed by the user are Graphical User Interface (GUI) changes to the "diameter" selection feature that sets the system field of view range and frequency). | All design validation testing was executed with passing results. |
| IVUS image quality generated by the HDi System with the modified system software is clinically useful at extended field of view diameters (12, 16, and 20 mm) and is equivalent to the current commercially available software within current field of view (6, 8, and 10 mm). | Physician assessment confirmed:• IVUS images generated with the modified system software at 10mm field of view are substantially equivalent to IVUS images generated by the current system software at 10 mm field of view.• All IVUS images generated by the modified system software at 20 mm field of view are clinically useful, especially for vessel lumen measurement and determining stent strut location.• All IVUS images generated by the modified system software which measured the lumen at 20 mm field of view do not show any differences between 1.0 mm/s pullback speed (30 f/s) and 10.0 mm/s pullback speed (60 f/s). |
| The device meets established performance specifications and performs as intended, with no new safety or performance issues raised. | Test results demonstrate the HDi System met the established performance specifications and performs as intended. No new safety or performance issues were raised during the testing. |
| The overall risk profile of the device has not changed. | One new use related risk was identified due to changes in the software user interface selection options; however, the overall risk profile of the device has not changed. |
2. Sample Size Used for the Test Set and Data Provenance
The document mentions an "animal study validation testing" to evaluate image quality. However, the specific sample size (number of animals or images) used for this test set is not provided. The provenance of this data is prospective as it was collected specifically for validation testing. The country of origin is not specified.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
The document mentions "Physician assessment" for confirming the clinical utility and equivalence of the IVUS images. However, the number of experts involved and their specific qualifications (e.g., cardiologist with X years of experience in IVUS) are not provided.
4. Adjudication Method for the Test Set
The document states "Physician assessment confirmed," implying that experts evaluated the images. However, the specific adjudication method (e.g., 2+1, 3+1, none) used to establish ground truth or resolve discrepancies among multiple expert opinions (if applicable) is not specified.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study comparing human readers with and without AI assistance was not done or mentioned in the provided text. The study focused on the performance of the modified device itself, not on its impact on human reader performance.
6. If a Standalone Performance (Algorithm Only Without Human-in-the-Loop Performance) Was Done
Yes, in part. The "Design verification testing" and "Design validation testing" focused on the software and system's technical and functional performance, including the display of functional elements, zoom/decimation, and TGC control. This can be considered a form of standalone performance assessment as it evaluated the algorithm's output (images) and user interface functionality directly. The animal study also tested the system's ability to generate clinically useful images.
7. The Type of Ground Truth Used
The ground truth for the image quality assessment in the animal study was established through expert consensus/assessment by physicians. They confirmed the clinical utility and equivalence of the IVUS images.
8. The Sample Size for the Training Set
The document primarily describes validation and verification testing of modifications to existing software. It does not mention a separate "training set" or sample size for training an artificial intelligence or machine learning algorithm. This suggests that the device's image generation and display capabilities are based on established algorithms rather than a newly trained AI model.
9. How the Ground Truth for the Training Set Was Established
As no separate training set for an AI/ML algorithm is explicitly mentioned for this modification, the method for establishing its ground truth is not applicable based on the provided text. The modifications appear to be primarily functional extensions of existing software and firmware, rather than the introduction of a new learnable model.
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March 20, 2020
ACIST Medical Systems, Inc. Angela Johnson Regulatory Affairs Specialist II 7905 Fuller Rd Eden Prairie, Minnesota 55344
Re: K193183
Trade/Device Name: ACIST HDi System, ACIST Kodama Intravascular Ultrasound Catheter Regulation Number: 21 CFR 870.1200 Regulation Name: Diagnostic Intravascular Catheter Regulatory Class: Class II Product Code: OBJ, IYO Dated: February 18, 2020 Received: February 20, 2020
Dear Angela Johnson:
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. 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 located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmp/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.
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 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see
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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 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about medical devices and radiation-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,
Mark Fellman Assistant Director DHT2A: Division of Cardiac Electrophysiology, Diagnostics and Monitoring Devices OHT2: Office of Cardiovascular Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K193183
Device Name
ACIST HDi® System and Kodama® Intravascular Ultrasound Catheter
Indications for Use (Describe)
The ACIST HDi System is intended to be used for ultrasound examination of coronary and peripheral intravascular pathology. Intravascular ultrasound in indicated in patients who are candidates for transluminal interventional procedures.
The ACIST Kodama Intravascular Ultrasound Catheter is intended for use with the ACIST HD System.
| 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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Image /page/3/Picture/0 description: The image shows the ACIST logo. The logo consists of a cube made of three squares in green, blue, and purple, followed by the text "ACIST" in blue. Below the text is the tagline "the power to" in a smaller font.
Section 1
510(k) Summary per 21 CFR 807.92
| Submitter'sName andAddress | ACIST Medical Systems, Inc.7905 Fuller RoadEden Prairie, MN 55344USA |
|---|---|
| Contact Nameand Information | Angela K. JohnsonRegulatory Affairs Specialist IIACIST Medical Systems, Inc.952-253-4571 (office)952-941-4648 (fax)Angela.Johnson@acistmedical.com |
| Date Prepared | 18 February 2020 |
| Trade orProprietaryName | ACIST HDi® SystemACIST Kodama® Intravascular Ultrasound Catheter |
| Common orUsual Name | System, imaging, pulsed echo, ultrasonicCatheter, ultrasound, intravascular |
| DeviceClassification | Class II |
| Product Code,CFR Section | IYO, 21 892.1560OBJ, 21 870.1200 |
| ClassificationName | System, imaging, pulsed echo, ultrasonicCatheter, ultrasound, intravascular |
| ClassificationPanel | RadiologyCardiovascular |
| PredicateDevices | HD-IVUS Ultrasound Imaging System and Kodama Catheter, K191175(cleared 27 June 2019) |
| DeviceDescription | The primary function of HDi System is to collect reflected ultrasonic (sound)waves from the Kodama catheter and render an intravascular image on theconsole touchscreen. The catheter emits sound energy from a transducer atthe tip; sound waves reflected from the inner vascular tissues are receivedfrom the transducer and sent to the console where a high resolution, cross-sectional image is displayed on the touchscreen in real-time.The main devices are the Console, Patient Interface Module (PIM), LinearTranslation System (LTS) (optional), and Kodama Catheter.The console houses hardware and software required to generate the energyused to excite the transducer in the Kodama catheter; it is the center ofcontrol and system architecture for how signals are acquired, processed,images constructed and presented, and overall power management andcontrol of the PIM and LTS. The system digitally records case images, |
| provides a review of recorded cases, and provides for the archival ofrecorded cases onto removable media. | |
| The handheld PIM provides the electromechanical interface between thecatheter and the console. It also provides the mechanical interface to securethe catheter, as well as the mechanical energy to rotate the catheter'simaging assembly. The LTS device provides automated, controlled lineartranslation of the catheter by providing mechanical coupling to the PIM andto the catheter's telescoping anchor as the PIM is pulled back along thelongitudinal axis. The coupling between the LTS and PIM and LTS tocatheter is strictly mechanical. The LTS device allows the user to performautomatic pullbacks and can be controlled via touchscreen buttons on theconsole or the buttons on the LTS. Manual pullbacks may be performed withor without the LTS, making the use of the LTS optional to the user.The Kodama Catheter emits sound energy from its transducer at the distaltip, which is guided into the coronary and peripheral vasculature. Thecatheter can be operated at two different frequencies, 40MHz and/or 60MHz.The electrical energy from the catheter is transmitted, via the coaxial cableembedded in the drive cable, back to the HDi console for signal processingand image reconstruction. | |
| IntendedUse/Indicationsfor Use | The ACIST HDi System is intended to be used for ultrasound examination ofcoronary and peripheral intravascular pathology. Intravascular ultrasoundimaging is indicated in patients who are candidates for transluminalinterventional procedures.The ACIST Kodama Intravascular Ultrasound Catheter is intended for usewith the ACIST HDi System. |
| Comparison ofTechnologicalCharacteristicsto Predicate | The HDi System software has been modified to extend the field of view forlarger peripheral vessels. The predicate device provides the option to usestandard definition (40MHz) or high definition (60MHz) imaging with a 6, 8,and 10 mm field of view. The proposed device adds the ability to image in12, 16, and 20 mm field of view and automatically selects the highestdefinition available for the field of view selected by the user. The HDi systemcontains identical hardware components and accessories when compared tothe predicate device. No changes were made to the Kodama Catheterassociated with this change. The Kodama Catheter and HDi System aresubstantially equivalent to the predicate devices (K191175) in intended use,design, performance, and technological characteristics. |
| SubstantialEquivalence andSummary ofStudies | No device modifications were made to the Kodama Catheter or HDi Systemhardware and accessories for this change. Testing was limited to the safetyand effectiveness of the HDi System software and firmware.The HDi System was subjected to design verification and validationactivities, including software and system level verification testing, end usersoftware validation, and animal study validation, to ensure the softwaremodifications did not affect the safety and effectiveness of the device.Design verification testing included verifying all testing for the applicationsoftware and FPGA firmware. Specifically, the following items were directlycorrelated to the extended field of view change and were verified:The Acquire screen is displayed during Imaging, Recording andPullback and it has appropriate functional elements, including thenew "Diameter" button.The Zoom/Decimation function allows the image to be magnified tothe specified depth range in the extended field of view |
| • The time gain compensation (TGC) control curve is controlleddynamically by the Diameter selection and covers the appropriateanatomical depth range. | |
| All software and system verification testing were executed with passingresults. | |
| Design validation testing was conducted to ensure users can utilize the newsoftware features and interpret the resulting images correctly and that therewere not new use errors identified. Primary changes observed by the userare Graphical User Interface (GUI) changes to the "diameter" selectionfeature that sets the system field of view range and frequency. All designvalidation testing was executed with passing results. | |
| Animal study validation testing was conducted to demonstrate that the IVUSimage quality generated by the HDi System with the modified systemsoftware is clinically useful at extended field of view diameters (12, 16, and20 mm) and is equivalent to the current commercially available softwarewithin current field of view (6, 8, and 10 mm). Physician assessmentconfirmed: | |
| • IVUS images generated with the modified system software at 10mmfield of view are substantially equivalent to IVUS images generatedby current system software at 10 mm field of view. | |
| • All IVUS images generated by the modified system software at 20mm field of view are clinically useful, especially for vessel lumenmeasurement and determining stent strut location. | |
| • All IVUS images generated by the modified systems software whichmeasured the lumen at 20 mm field of view do not show anydifferences between 1.0 mm/s pullback speed (30 f/s) and 10.0mm/s pullback speed (60 f/s). | |
| Test results demonstrate the HDi System met the established performancespecifications and performs as intended. No new safety or performanceissues were raised during the testing. One new use related risk wasidentified due to changes in the software user interface selection options;however, the overall risk profile of the device has not changed. Results ofdesign verification and validation testing on the HDi System demonstrate thatthe device is as safe, as effective, and performs equivalently to the predicatedevice. | |
| Software documentation for a Moderate Level of Concern software perFDA's Guidance document "Guidance for the Content of PremarketSubmissions for Software Contained in Medical Devices" (issued May 11,2005) is included in this premarket notification. |
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§ 870.1200 Diagnostic intravascular catheter.
(a)
Identification. An intravascular diagnostic catheter is a device used to record intracardiac pressures, to sample blood, and to introduce substances into the heart and vessels. Included in this generic device are right-heart catheters, left-heart catheters, and angiographic catheters, among others.(b)
Classification. Class II (performance standards).