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

Acist Medical Systems, Inc. filed the 510(k) submission for ACIST Kodama Intravascular Ultrasound Catheter, ACIST HDi System (K173063).

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

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 Kodama Intravascular Ultrasound Catheter, ACIST HDi System?

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

What are the predicate devices for ACIST Kodama Intravascular Ultrasound Catheter, ACIST HDi System?

HD-IVUS Ultrasound Imaging System (K122878); Kodama Intravascular Ultrasound Catheter (K113008).

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

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 Kodama Intravascular Ultrasound Catheter, ACIST HDi System

K173063 · Acist Medical Systems, Inc. · OBJ · Oct 23, 2017 · Cardiovascular

Device Facts

Record ID	K173063
Device Name	ACIST Kodama Intravascular Ultrasound Catheter, ACIST HDi System
Applicant	Acist Medical Systems, Inc.
Product Code	OBJ · Cardiovascular
Decision Date	Oct 23, 2017
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 the intravascular ultrasound imaging assessment of coronary artery disease. Intravascular ultrasound imaging is indicated in patients who are candidates for transluminal coronary interventional procedures. The ACIST Kodama Intravascular Ultrasound Catheter is a medical device for use by or on the order of a physician and is intended for ultrasound examination of coronary intravascular pathology only. Intrasound imaging is indicated in patients who are candidates for transluminal coronary interventional procedures.

Device Story

ACIST HDi System and Kodama Catheter provide real-time intravascular ultrasound (IVUS) imaging of coronary arteries. Catheter emits sound energy from distal transducer (40MHz/60MHz); reflected sound waves received by transducer; signals transmitted via coaxial cable to console. Console processes signals, reconstructs cross-sectional images, displays on touchscreen. System includes Console, Patient Interface Module (PIM), and optional Linear Translation System (LTS). PIM provides electromechanical interface, rotates imaging assembly. LTS enables automated, controlled linear pullback. Used in clinical settings by physicians for coronary pathology examination. Output assists clinicians in assessing coronary artery disease and guiding interventional procedures. Benefits include high-resolution visualization of vascular tissues to inform clinical decision-making.

Clinical Evidence

Bench testing only. Evidence includes operating environment testing, packaging verification, software verification, electrical safety testing (IEC 60601-1), electromagnetic compatibility testing (IEC 60601-1-2), and biocompatibility testing. No clinical data presented.

Technological Characteristics

IVUS imaging system; 40MHz/60MHz transducer frequencies. Components: Console, PIM, optional LTS. Connectivity: Digital recording, archival to removable media. Standards: IEC 60601-1 (electrical safety), IEC 60601-1-2 (EMC). Catheter features: imaging assembly, sheath with hydrophilic coating, telescope assembly. Software-based signal processing and image reconstruction.

Indications for Use

Indicated for patients who are candidates for transluminal coronary interventional procedures requiring intravascular ultrasound imaging assessment of coronary artery disease and coronary 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 (K122878)
Kodama Intravascular Ultrasound Catheter (K113008)

Related Devices

K191175 — ACIST Kodama Intravascular Ultrasound Catheter, ACIST HDi System · Acist Medical Systems, Inc. · Jun 27, 2019
K193183 — ACIST HDi System, ACIST Kodama Intravascular Ultrasound Catheter · Acist Medical Systems, Inc. · Mar 20, 2020
K112997 — HD-IVUS ULTRASOUND IMAGING SYSTEM · Silicon Vally Medical Instruments, Inc. · Dec 17, 2011
K122878 — HD-IVUS ULTRASOUND IMAGING SYSTEM · Silicon Vally Medical Instruments, Inc. · Jan 11, 2013
K113008 — KODAMA INTRAVASCULAR ULRASOUND CATHETER · Silicon Vally Medical Instruments, Inc. · Jun 14, 2012

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 consists of a blue square with the letters "FDA" in white, followed by the words "U.S. FOOD & DRUG" in blue, and the word "ADMINISTRATION" in a smaller font size below that. October 23, 2017 ACIST Medical Systems, Inc. Amber Luker Senior Regulatory Affairs Specialist 7905 Fuller Road Eden Prairie, Minnesota 55344 Re: K173063 Trade/Device Name: ACIST Kodama Intravascular Ultrasound Catheter, ACIST HDi System Regulation Number: 21 CFR 870.1200 Regulation Name: Diagnostic Intravascular Catheter Regulatory Class: Class II Product Code: OBJ, IYO Dated: September 28, 2017 Received: September 29, 2017 Dear Amber Luker: 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. Iisting 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); good manufacturing practice requirements as set forth in the quality systems (OS) 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 (DICE) at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevicesforYou/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 (DICE) 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, M.A. Willehemen for Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {2}------------------------------------------------ ## Indications for Use 510(k) Number (if known) K173063 Device Name ACIST Kodama® Intravascular Ultrasound Catheter ACIST HDi® System ## Indications for Use (Describe) The ACIST HDi System is intended to be used for the intravascular ultrasound imaging assessment of coronary artery disease. Intravascular ultrasound imaging is indicated in patients who are candidates for transluminal coronary interventional procedures. The ACIST Kodama Intravascular Ultrasound Catheter is a medical device for use by or on the order of a physician and is intended for ultrasound examination of coronary intravascular pathology only. Intrasound imaging is indicated in patients who are candidates for transluminal coronary interventional procedures. 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}------------------------------------------------ | 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 | Amber R. Luker, RAC Senior Regulatory Affairs Specialist ACIST Medical Systems, Inc. 952-995-9317 (office) 952-941-4648 (fax) amber.luker@acistmedical.com | | Date Prepared | 28 September 2017 | | Trade or Proprietary Name | ACIST Kodama® Intravascular Ultrasound Catheter ACIST HDi® System | | Common or Usual Name | Catheter, ultrasound, intravascular System, imaging, pulsed echo, ultrasonic | | Device Classification | Class II | | Product Code, CFR Section | OBJ, 21 870.1200 IYO, 21 892.1560 | | Classification Name | Catheter, ultrasound, intravascular System, imaging, pulsed echo, ultrasonic | | Classification Panel | Cardiovascular Radiology | | Predicate Devices | HD-IVUS Ultrasound Imaging System, K122878 (cleared 11 January 2013) Kodama Intravascular Ultrasound Catheter, K113008 (cleared 14 June 2012) | | 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 arteries of the heart. The catheter can be operated at two different frequencies, 40MHz and/or 60MHz, depending on user preference. The catheter design includes an imaging assembly (with transducer, drive cable, coaxial cable, and rotor), sheath assembly (which includes the femoral marker and hydrophilic coating), telescope assembly, and catheter hub assembly. The electrical energy from the catheter is transmitted, via the transmission line 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 the intravascular ultrasound imaging assessment of coronary artery disease. Intravascular ultrasound imaging is indicated in patients who are candidates for transluminal coronary interventional procedures. The ACIST Kodama Intravascular Ultrasound Catheter is a medical device for use by or on the order of a physician and is intended for ultrasound examination of coronary intravascular pathology only. Intravascular ultrasound imaging is indicated in patients who are candidates for transluminal coronary interventional procedures. | | Comparison of Technological Characteristics to Predicate | The proposed devices are substantially equivalent to the predicate devices (K113008 & K122878) based on the same indications for use as described in the labeling, the same fundamental scientific technology, safety, and performance testing. The system contains similar components and similar accessories when compared to the predicate device. | | Non-Clinical Tests in Support of Substantial Equivalence | The Medical Advisory Board supports the proposed changes to the labeling contraindications and adverse events. Cumulative changes are supported by bench testing, operating environment testing, packaging verification, software verification, electrical safety testing (IEC 60601-1), electromagnetic compatibility testing (IEC 60601-1-2), and biocompatibility testing. The results of these tests provide reasonable assurance that the proposed devices have been designed and tested to assure conformance to the requirements for their intended use. No new safety or performance issues were raised during the testing and, therefore, the HDi System and Kodama Catheter may be considered substantially equivalent to the predicate devices. | | Conclusion | Based on the same indications for use, same fundamental technology, and safety and performance testing, the HDi System and the Kodama Catheter have been shown to be appropriate for their intended use and are | | | considered to be substantially equivalent to the predicate devices submitted in K122878 and K113008. | {4}------------------------------------------------ {5}------------------------------------------------