(25 days)
Not Found
No
The description focuses on signal processing and conversion, with no mention of AI or ML terms or functionalities.
No.
The device is indicated for diagnosis (obtaining intravascular pressure measurements) and is not described as providing treatment.
Yes
The "Intended Use / Indications for Use" states that the device is "indicated for obtaining intravascular pressure measurements for use in the diagnosis and treatment of coronary and peripheral artery disease." This directly indicates a diagnostic purpose.
No
The device description explicitly states it consists of two hardware components (Navvus Interface and Processing Unit) and describes their physical connections and power source, indicating it is not software-only.
Based on the provided information, the ACIST RXi Mini is not an In Vitro Diagnostic (IVD) device.
Here's why:
- Intended Use: The intended use is to obtain intravascular pressure measurements for use in the diagnosis and treatment of coronary and peripheral artery disease. This is a measurement taken directly from within the body (in vivo), not from a sample of bodily fluid or tissue outside the body (in vitro).
- Device Description: The device receives a pressure signal sensed by a catheter inserted into the body and converts it into an analog signal for a hemodynamic system. This process is focused on real-time physiological measurement within the patient.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.) or performing tests on these samples outside the body, which are hallmarks of IVD devices.
Therefore, the ACIST RXi Mini is a medical device used for physiological monitoring and measurement in vivo, not an IVD device.
N/A
Intended Use / Indications for Use
The ACIST RXi Mini is indicated for obtaining intravascular pressure measurements for use in the diagnosis and treatment of coronary and peripheral artery disease. The ACIST Navvus Catheter is intended for use with the ACIST RXi Mini.
Product codes (comma separated list FDA assigned to the subject device)
DRQ
Device Description
ACIST RXi Mini consists of a 1.) Navvus Interface, which receives the pressure signal sensed by the Navvus Catheter, and a 2.) Processing Unit, which converts the optical sensor pressure signal into an analog pressure signal that can be read by a third party hemodynamic system in real-time. These two hardware components are intended to be located on or around a patient bed, and multiple mounting options are available to accommodate different workflows. Both components contain software.
The two modules are connected using the Navvus Interface cable, which contains both a fiber optic cable and an electrical signal (communication) cable. A hemodynamic cable is connected to the Processing Unit and is plugged into the appropriate channel programmed to accept the distal pressure in the hemodynamic system. The power cord is plugged into the Processing Unit and is then connected to the mains power source.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
coronary and peripheral artery
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
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)
Bench testing, including mechanical testing, electrical testing, bed mount testing, operating environment testing, and packaging verification testing was successfully performed. In addition, software verification, electrical safety testing (IEC 60601-1), electromagnetic compatibility testing (IEC 60601-1-2), and design validation was performed.
The results of these tests provide reasonable assurance that the proposed device has been designed and tested to assure conformance to the requirements for its intended use. No new safety or performance issues were raised during the testing and, therefore, ACIST RXi Mini may be considered substantially equivalent to the predicate device.
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
§ 870.2060 Transducer signal amplifier and conditioner.
(a)
Identification. A transducer signal amplifier and conditioner is a device used to provide the excitation energy for the transducer and to amplify or condition the signal emitted by the transducer.(b)
Classification. Class II (performance standards).
0
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 | 20 July 2017 |
| Trade or
Proprietary
Name | ACIST RXi® Mini™ System, which includes the following components:
• RXi Mini Processing Unit
• RXi Mini Navvus Interface
• RXi Mini Mounts
• RXi Mini Navvus Interface cable |
| Common or
Usual Name | Transducer System |
| Device
Classification | Class II |
| Product Code,
CFR Section | DRQ
21 870.2060 |
| Classification
Name | Transducer signal amplifier and conditioner |
| Classification
Panel | Cardiovascular |
| Predicate Device | ACIST RXi System and ACIST Navvus Catheter
K132474, cleared 30 January 2014 |
| Device
Description | ACIST RXi Mini consists of a 1.) Navvus Interface, which receives the
pressure signal sensed by the Navvus Catheter, and a 2.) Processing Unit,
which converts the optical sensor pressure signal into an analog pressure
signal that can be read by a third party hemodynamic system in real-time.
These two hardware components are intended to be located on or around a
patient bed, and multiple mounting options are available to accommodate
different workflows. Both components contain software. |
| | The two modules are connected using the Navvus Interface cable, which
contains both a fiber optic cable and an electrical signal (communication)
cable. A hemodynamic cable is connected to the Processing Unit and is
plugged into the appropriate channel programmed to accept the distal
pressure in the hemodynamic system. The power cord is plugged into the
Processing Unit and is then connected to the mains power source. |
| Intended
Use/Indications
for Use | The ACIST RXi Mini is indicated for obtaining intravascular pressure
measurements for use in the diagnosis and treatment of coronary and
peripheral artery disease. The ACIST Navvus Catheter is intended for use
with the ACIST RXi Mini. |
| Comparison of
Technological
Characteristics
to Predicate | The ACIST RXi Mini System is substantially equivalent to the predicate
device as it has the same intended operating environments, the same FISO
signal conditioner, and same fundamental technology as the predicate
device. |
| | The system contains similar components and similar accessories when
compared to the predicate device. The Navvus Catheter is intended to be
used with both the ACIST RXi Mini System and the predicate device.
Differences in software are supported by Software Verification testing. |
| Non-Clinical
Tests in Support
of Substantial
Equivalence | Bench testing, including mechanical testing, electrical testing, bed mount
testing, operating environment testing, and packaging verification testing was
successfully performed. In addition, software verification, electrical safety
testing (IEC 60601-1), electromagnetic compatibility testing (IEC 60601-1-2),
and design validation was performed. |
| | The results of these tests provide reasonable assurance that the proposed
device has been designed and tested to assure conformance to the
requirements for its intended use. No new safety or performance issues were
raised during the testing and, therefore, ACIST RXi Mini may be considered
substantially equivalent to the predicate device. |
| Conclusion | Based on the same indications for use, same fundamental technology, and
safety and performance testing, the ACIST RXi Mini System has been shown
to be appropriate for its intended use and is considered to be substantially
equivalent to the ACIST RXi System as submitted in K132474. |
1
2
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
ACIST Medical Systems, Inc. % Ms. Amber Luker Senior Regulatory Affairs Specialist 7905 Fuller Road Eden Prairie, Minnesota 55344
Re: K172216
Trade/Device Name: ACIST RXi Mini System Regulation Number: 21 CFR 870.2060 Regulation Name: Transducer Signal Amplifier And Conditioner Regulatory Class: Class II Product Code: DRQ Dated: July 20, 2017 Received: July 24, 2017
Dear Ms. 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, 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 vour 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 (reporting of medical devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in
3
the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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 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. 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 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,
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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