Who is the manufacturer of ACIST HDi System, ACIST Kodama Intravascular Ultrasound Catheter?

Acist Medical Systems, Inc. filed the 510(k) submission for ACIST HDi System, ACIST Kodama Intravascular Ultrasound Catheter (K193183).

What is the FDA product code for ACIST HDi System, ACIST Kodama Intravascular Ultrasound Catheter?

OBJ. It is classified under 21 CFR 870.1200 as a Class 2 device in the Cardiovascular panel.

What is the regulatory pathway for ACIST HDi System, ACIST Kodama Intravascular Ultrasound Catheter?

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

Who can help prepare an FDA 510(k) submission like ACIST HDi System, ACIST Kodama Intravascular Ultrasound Catheter?

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.

ACIST HDi System, ACIST Kodama Intravascular Ultrasound Catheter

K193183 · Acist Medical Systems, Inc. · OBJ · Mar 20, 2020 · Cardiovascular

Device Facts

Record ID	K193183
Device Name	ACIST HDi System, ACIST Kodama Intravascular Ultrasound Catheter
Applicant	Acist Medical Systems, Inc.
Product Code	OBJ · Cardiovascular
Decision Date	Mar 20, 2020
Decision	SESE
Submission Type	Special
Regulation	21 CFR 870.1200
Device Class	Class 2

Intended Use

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.

Device Story

ACIST HDi System performs intravascular ultrasound (IVUS) imaging for coronary and peripheral vasculature. System components include console, Patient Interface Module (PIM), optional Linear Translation System (LTS), and Kodama IVUS catheter. Catheter transducer emits sound energy; reflected waves received and processed by console to render real-time cross-sectional images on touchscreen. PIM provides electromechanical interface and catheter rotation; LTS enables automated linear pullbacks. Used in clinical settings by physicians during interventional procedures. Output allows visualization of vessel lumen and stent strut location, aiding clinical decision-making during procedures. Modified software extends field of view (FOV) to 12, 16, and 20 mm, with automatic frequency selection for optimal image quality. Benefits include improved visualization of larger peripheral vessels.

Clinical Evidence

Animal study validation conducted to assess image quality at extended FOV (12, 16, 20 mm). Physician assessment confirmed images are clinically useful for vessel lumen measurement and stent strut location, and equivalent to predicate software at 10 mm FOV. No differences observed between 1.0 mm/s and 10.0 mm/s pullback speeds. Bench testing included software/system-level verification and end-user validation with passing results.

Technological Characteristics

System uses pulsed echo ultrasonic imaging. Catheter operates at 40MHz and 60MHz. Hardware includes console, PIM, and optional LTS. Software-controlled FOV (6, 8, 10, 12, 16, 20 mm) with automatic frequency selection. Connectivity includes digital recording and archival to removable media. Software is Moderate Level of Concern.

Indications for Use

Indicated for patients who are candidates for transluminal interventional procedures requiring ultrasound examination of coronary and peripheral intravascular pathology.

Regulatory Classification

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.

Predicate Devices

HD-IVUS Ultrasound Imaging System and Kodama Catheter (K191175)

Related Devices

K173063 — ACIST Kodama Intravascular Ultrasound Catheter, ACIST HDi System · Acist Medical Systems, Inc. · Oct 23, 2017
K191175 — ACIST Kodama Intravascular Ultrasound Catheter, ACIST HDi System · Acist Medical Systems, Inc. · Jun 27, 2019
K122878 — HD-IVUS ULTRASOUND IMAGING SYSTEM · Silicon Vally Medical Instruments, Inc. · Jan 11, 2013
K112997 — HD-IVUS ULTRASOUND IMAGING SYSTEM · Silicon Vally Medical Instruments, Inc. · Dec 17, 2011
K170385 — CORE M2 Vascular System · Volcano Corporation · Apr 6, 2017

Submission Summary (Full Text)

{0}------------------------------------------------ Image /page/0/Picture/0 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 is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue. 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 {1}------------------------------------------------ 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 {2}------------------------------------------------ ## 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) | | |----------------------------------------------------------------------------------|--| | <div> Prescription Use (Part 21 CFR 801 Subpart D) </div> | | | <div> Over-The-Counter Use (21 CFR 801 Subpart C) </div> | | 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 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's Name and Address | ACIST Medical Systems, Inc. 7905 Fuller Road Eden Prairie, MN 55344 USA | |-------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Contact Name and Information | Angela K. Johnson Regulatory Affairs Specialist II ACIST Medical Systems, Inc. 952-253-4571 (office) 952-941-4648 (fax) Angela.Johnson@acistmedical.com | | Date Prepared | 18 February 2020 | | Trade or Proprietary Name | ACIST HDi® System ACIST Kodama® Intravascular Ultrasound Catheter | | Common or Usual Name | System, imaging, pulsed echo, ultrasonic Catheter, ultrasound, intravascular | | Device Classification | Class II | | Product Code, CFR Section | IYO, 21 892.1560 OBJ, 21 870.1200 | | Classification Name | System, imaging, pulsed echo, ultrasonic Catheter, ultrasound, intravascular | | Classification Panel | Radiology Cardiovascular | | Predicate Devices | HD-IVUS Ultrasound Imaging System and Kodama Catheter, K191175 (cleared 27 June 2019) | | Device Description | 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. | | Intended Use/Indications for Use | The ACIST HDi System is intended to be used for ultrasound examination of coronary and peripheral intravascular pathology. Intravascular ultrasound imaging is indicated in patients who are candidates for transluminal interventional procedures. The ACIST Kodama Intravascular Ultrasound Catheter is intended for use with the ACIST HDi System. | | Comparison of Technological Characteristics to Predicate | The HDi System software has been modified to extend the field of view for larger peripheral vessels. The predicate device provides the option to use standard 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 in 12, 16, and 20 mm field of view and automatically selects the highest definition available for the field of view selected by the user. The HDi system contains identical hardware components and accessories when compared to the predicate device. No changes were made to the Kodama Catheter associated with this change. The Kodama Catheter and HDi System are substantially equivalent to the predicate devices (K191175) in intended use, design, performance, and technological characteristics. | | Substantial Equivalence and Summary of Studies | No device modifications were made to the Kodama Catheter or HDi System hardware and accessories for this change. Testing was limited to the safety and effectiveness of the HDi System software and firmware. The HDi System was subjected to design verification and validation activities, including software and system level verification testing, end user software validation, and animal study validation, to ensure the software modifications did not affect the safety and effectiveness of the device. Design verification testing included verifying all testing for the application software and FPGA firmware. Specifically, the following items were directly correlated to the extended field of view change and were verified: The Acquire screen is displayed during Imaging, Recording and Pullback and it has appropriate functional elements, including the new "Diameter" button.The Zoom/Decimation function allows the image to be magnified to the specified depth range in the extended field of view | | | • The time gain compensation (TGC) control curve is controlled dynamically by the Diameter selection and covers the appropriate anatomical depth range. | | | All software and system verification testing were executed with passing results. | | | Design validation testing was conducted to ensure 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. | | | Animal study validation testing was conducted to demonstrate that the 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 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 systems 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). | | | 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. 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. Results of design verification and validation testing on the HDi System demonstrate that the device is as safe, as effective, and performs equivalently to the predicate device. | | | Software documentation for a Moderate Level of Concern software per FDA's Guidance document "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices" (issued May 11, 2005) is included in this premarket notification. | {4}------------------------------------------------ Image /page/4/Picture/0 description: The image shows the ACIST logo. The logo consists of a cube made up of three different colored squares, green, purple, and blue. To the right of the cube is the word "ACIST" in blue, with a registered trademark symbol in the upper right corner. Below the word "ACIST" is the phrase "the power to" in a smaller font. {5}------------------------------------------------ Image /page/5/Picture/0 description: The image shows the logo for ACIST. The logo consists of a cube made up of three different colored squares, green, blue, and purple. To the right of the cube is the word "ACIST" in blue, with the words "the power to" underneath.