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.

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, 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.

AI/ML Overview

The provided text describes the ACIST Kodama Intravascular Ultrasound Catheter and ACIST HDi System, and cites a 510(k) submission for substantial equivalence to predicate devices. However, the document does not contain specific acceptance criteria or a dedicated study proving the device meets quantitative acceptance criteria for performance metrics like sensitivity, specificity, accuracy, or reader improvement.

Instead, the submission focuses on demonstrating substantial equivalence through:

Bench Testing: Evaluating physical and electrical performance characteristics.
Animal Study: Confirming imaging capabilities and usability in a peripheral vessel model.
Comparison to Predicate Devices: Highlighting similar indications for use, fundamental scientific technology, safety, and performance.

Therefore, many of the requested details cannot be extracted directly from this document.

Here's an attempt to answer the questions based on the available information:

1. A table of acceptance criteria and the reported device performance

No explicit quantitative acceptance criteria (e.g., specific accuracy thresholds, sensitivity/specificity targets) or corresponding reported performance values are provided in the document for the new device as compared to a predefined standard. The performance is assessed against specifications and compared to predicate devices qualitatively.

Acceptance Criteria (Type of Test)	Reported Device Performance (as described)
Bench Testing:
Trackability and Deliverability (insertion/retraction force, cross/re-cross force, kink resistance, torque strength)	"meet specifications and perform as intended."
Runtime	"meet specifications and perform as intended."
Non-Uniform Rotational Distortion (NURD)	"meet specifications and perform as intended."
Buckling force	"meet specifications and perform as intended."
Animal Study:
Imaging capabilities (in peripheral vessels)	"confirm the HDi System and Kodama Catheter imaging capabilities in the peripheral vessels."
Usability (catheter set-up, delivery, retraction)	"provided evaluation on the usability of Kodama catheter... device meets specification and performs as intended."

2. Sample size used for the test set and the data provenance

Bench Testing Test Set Sample Size: Not specified.
Animal Study Test Set Sample Size: "a porcine model" - the exact number of animals is not specified.
Data Provenance:
- Bench testing data provenance is implied to be from ACIST Medical Systems' internal testing.
- Animal study data provenance is "conducted by ACIST Medical Systems in a laboratory environment."

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Bench Testing: Ground truth is established by engineering specifications and direct measurements against those specifications. No external experts are mentioned for ground truth.
Animal Study: "The physician also provided evaluation on the usability of Kodama catheter." - This suggests at least one physician. Specific qualifications (e.g., years of experience, specialty) are not mentioned. The ground truth here appears to be the visual assessment of imaging capabilities and clinical usability by the physician.

4. Adjudication method for the test set

No specific adjudication method (like 2+1 or 3+1 consensus) is described for either the bench testing or the animal study. The animal study mentions a "physician also provided evaluation," implying a single observer or their primary findings rather than a multi-reader consensus process for ground truth.

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

No multi-reader multi-case (MRMC) comparative effectiveness study is mentioned, nor is there any mention of AI assistance in the context of this device. The device is an intravascular ultrasound system, not an AI-powered diagnostic tool in the sense of assisting human readers in interpretation.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

This is not applicable as the device is an imaging system (hardware and software) that produces images for human interpretation, not an algorithm providing a standalone diagnostic output.

7. The type of ground truth used

Bench Testing: Engineering specifications and direct physical/electrical measurements.
Animal Study: Visual assessment of imaging by a physician and their subjective evaluation of usability.

8. The sample size for the training set

No training set is mentioned as this is not an AI/machine learning device that requires a distinct training and test set for algorithm development in the traditional sense. The device is a medical imaging system.

9. How the ground truth for the training set was established

Not applicable, as no training set is mentioned.

Summary

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June 27, 2019

ACIST Medical Systems, Inc. Matt Stepanek Global Manager, Regulatory Affairs 7905 Fuller Rd. Eden Prairie, Minnesota 55344

Re: K191175

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: April 30, 2019 Received: May 1, 2019

Dear Matt Stepanek:

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/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.

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

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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 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)

K191175

Device Name

ACIST Kodama® Intravascular Ultrasound Catheter ACIST HDi® System

Indications for Use (Describe)

The ACIST Kodama Intravascular Ultrasound Catheter is intended for use with the ACIST HDi 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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Section 5