(24 days)
Not Found
No
The description focuses on standard ultrasound signal processing and image reconstruction, with no mention of AI, ML, or related concepts.
No.
The device is used for imaging assessment of coronary artery disease, which is a diagnostic purpose, not a direct therapeutic one. It provides imagery for physicians to make decisions, but it does not treat or cure the condition itself.
Yes
The device is intended for "intravascular ultrasound imaging assessment of coronary artery disease" and "ultrasound examination of coronary intravascular pathology," which are diagnostic purposes. It generates and displays images of internal structures to help physicians identify and evaluate disease or pathology.
No
The device description clearly outlines multiple hardware components including a Console, Patient Interface Module (PIM), Linear Translation System (LTS) (optional), and Kodama Catheter, all of which are integral to the device's function. While software is mentioned as being housed in the console for processing and control, the device is not solely software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices intended to be used in vitro for the examination of specimens, including blood and tissue samples, derived from the human body, in order to provide information for diagnostic, monitoring or compatibility purposes.
- Device Function: The ACIST HDi System and Kodama Catheter are used for intravascular ultrasound imaging. This is a technique that uses sound waves to create images of the inside of blood vessels within the body.
- Specimen Type: The device does not examine specimens derived from the human body. It directly images structures within the body.
- Intended Use: The intended use is for "intravascular ultrasound imaging assessment of coronary artery disease" and "ultrasound examination of coronary intravascular pathology." This is an imaging procedure performed in vivo, not an in vitro test on a sample.
Therefore, the ACIST HDi System and Kodama Catheter fall under the category of imaging devices used for diagnostic purposes in vivo, not In Vitro Diagnostics.
N/A
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. Intrasound imaging is indicated in patients who are candidates for transluminal coronary interventional procedures.
Product codes (comma separated list FDA assigned to the subject device)
OBJ, IYO
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.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
ultrasonic (sound) waves
Anatomical Site
coronary artery, inner vascular tissues
Indicated Patient Age Range
Not Found
Intended User / Care Setting
by or on the order of a physician
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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).
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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.
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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'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. |
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