(24 days)
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.
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.
This document is a 510(k) summary for the ACIST Kodama Intravascular Ultrasound Catheter and ACIST HDi System. It describes the device, its intended use, and how it compares to predicate devices to establish substantial equivalence.
Based on the provided text, the device is an intravascular ultrasound imaging system. The document does not describe an AI/Algorithm-based device, but rather a traditional medical imaging device. Therefore, many of the requested details such as sample size for test sets, expert involvement, adjudication methods, MRMC studies, or training set information are not applicable or available in this specific document.
The "acceptance criteria" and "study that proves the device meets the acceptance criteria" in the context of this document refer to demonstrating substantial equivalence to predicate devices, primarily through non-clinical performance and safety testing, rather than an AI model's performance on a specific task.
Here's an attempt to answer the questions based only on the provided text, acknowledging that most questions relate to AI/algorithm performance which is not the subject of this submission:
1. A table of acceptance criteria and the reported device performance
Since this is not an AI/algorithm device submission, the acceptance criteria are not in terms of traditional performance metrics like sensitivity, specificity, or AUC against a ground truth for an AI task. Instead, the acceptance criteria are implicitly demonstrating that the device is as safe and effective as its predicate devices. The "reported device performance" in this context refers to the outcomes of non-clinical tests that support substantial equivalence.
| Acceptance Criteria (Implicit from 510(k)) | Reported Device Performance (Summary of Non-Clinical Tests) |
|---|---|
| Safety and Effectiveness equivalent to Predicate Devices | - Bench Testing: Supports cumulative changes. |
| Conformance to standards (e.g., electrical safety, EMC) | - Operating Environment Testing: Supports cumulative changes. |
| Functionality as an Intravascular Ultrasound System | - Packaging Verification: Supports cumulative changes. |
| Software functionality and reliability | - Software Verification: Supports cumulative changes. |
| Biocompatibility of patient-contacting components | - Electrical Safety Testing (IEC 60601-1): Results provide reasonable assurance of conformance. |
| No new safety or performance issues compared to predicate devices | - Electromagnetic Compatibility Testing (IEC 60601-1-2): Results provide reasonable assurance of conformance. |
| - Biocompatibility Testing: Results provide reasonable assurance of conformance. | |
| - Conclusion: "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." |
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
Not applicable, as this is a traditional medical device submission based on non-clinical engineering and safety testing. There is no "test set" in the context of an algorithm's performance on patient data. The tests performed are bench, operating environment, packaging, software, electrical safety, EMC, and biocompatibility testing. The data provenance is not specified beyond being generated through these tests.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
Not applicable. The ground truth for engineering and safety tests is based on established scientific principles, standards, and regulatory requirements, not expert consensus on medical images. A "Medical Advisory Board" supported labeling changes, but their role was not to establish ground truth for an algorithm's performance.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. There is no test set requiring adjudication in the context of an AI algorithm's performance.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
Not applicable. This device is not an AI-assisted diagnostic tool; it is an intravascular ultrasound imaging system.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
Not applicable. This is not an AI algorithm.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)
For the non-clinical tests conducted, the "ground truth" refers to compliance with engineering specifications, recognized standards (e.g., IEC 60601-1 and IEC 60601-1-2), and established safety and performance benchmarks for intravascular ultrasound systems. The goal was to prove substantial equivalence to predicate devices, implying that the device performs as expected and safely.
8. The sample size for the training set
Not applicable. This is not an AI algorithm requiring a training set.
9. How the ground truth for the training set was established
Not applicable. This is not an AI algorithm.
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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.
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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
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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)
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| 510(k) Summary per 21 CFR 807.92 | |||||
|---|---|---|---|---|---|
| ---------------------------------- | -- | -- | -- | -- | -- |
| Submitter'sName andAddress | ACIST Medical Systems, Inc.7905 Fuller RoadEden Prairie, MN 55344USA |
|---|---|
| Contact Nameand Information | Amber R. Luker, RACSenior Regulatory Affairs SpecialistACIST Medical Systems, Inc.952-995-9317 (office)952-941-4648 (fax)amber.luker@acistmedical.com |
| Date Prepared | 28 September 2017 |
| Trade orProprietaryName | ACIST Kodama® Intravascular Ultrasound CatheterACIST HDi® System |
| Common orUsual Name | Catheter, ultrasound, intravascularSystem, imaging, pulsed echo, ultrasonic |
| DeviceClassification | Class II |
| Product Code,CFR Section | OBJ, 21 870.1200IYO, 21 892.1560 |
| ClassificationName | Catheter, ultrasound, intravascularSystem, imaging, pulsed echo, ultrasonic |
| ClassificationPanel | CardiovascularRadiology |
| PredicateDevices | HD-IVUS Ultrasound Imaging System, K122878 (cleared 11 January 2013)Kodama Intravascular Ultrasound Catheter, K113008 (cleared 14 June 2012) |
| 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 arteries of the heart. The catheter canbe operated at two different frequencies, 40MHz and/or 60MHz, dependingon user preference. The catheter design includes an imaging assembly (withtransducer, drive cable, coaxial cable, and rotor), sheath assembly (whichincludes the femoral marker and hydrophilic coating), telescope assembly,and catheter hub assembly. The electrical energy from the catheter istransmitted, via the transmission line embedded in the drive cable, back tothe HDi console for signal processing and image reconstruction. | |
| IntendedUse/Indicationsfor Use | The ACIST HDi System is intended to be used for the intravascularultrasound imaging assessment of coronary artery disease.Intravascular ultrasound imaging is indicated in patients who are candidatesfor transluminal coronary interventional procedures.The ACIST Kodama Intravascular Ultrasound Catheter is a medical devicefor use by or on the order of a physician and is intended for ultrasoundexamination of coronary intravascular pathology only.Intravascular ultrasound imaging is indicated in patients who are candidatesfor transluminal coronary interventional procedures. |
| Comparison ofTechnologicalCharacteristicsto Predicate | The proposed devices are substantially equivalent to the predicate devices(K113008 & K122878) based on the same indications for use as described inthe labeling, the same fundamental scientific technology, safety, andperformance testing. The system contains similar components and similaraccessories when compared to the predicate device. |
| Non-ClinicalTests in Supportof SubstantialEquivalence | The Medical Advisory Board supports the proposed changes to the labelingcontraindications and adverse events.Cumulative changes are supported by bench testing, operating environmenttesting, packaging verification, software verification, electrical safety testing(IEC 60601-1), electromagnetic compatibility testing (IEC 60601-1-2), andbiocompatibility testing. The results of these tests provide reasonableassurance that the proposed devices have been designed and tested toassure 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 consideredsubstantially equivalent to the predicate devices. |
| Conclusion | Based on the same indications for use, same fundamental technology, andsafety and performance testing, the HDi System and the Kodama Catheterhave been shown to be appropriate for their intended use and are |
| considered to be substantially equivalent to the predicate devices submittedin K122878 and K113008. |
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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).