ACIST RXi Mini System

K172216 · Acist Medical Systems, Inc. · DRQ · Aug 18, 2017 · Cardiovascular

Device Facts

• Record ID: K172216
• Device Name: ACIST RXi Mini System
• Applicant: Acist Medical Systems, Inc.
• Product Code: DRQ · Cardiovascular
• Decision Date: Aug 18, 2017
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 870.2060
• Device Class: Class 2

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.

Device Story

ACIST RXi Mini System is a transducer signal amplifier and conditioner. It receives optical pressure signals from the Navvus Catheter via the Navvus Interface; the Processing Unit converts these optical signals into analog pressure signals. The system is used in clinical settings (e.g., near patient beds) to provide real-time pressure data to third-party hemodynamic systems. The output allows clinicians to monitor distal pressure, aiding in the diagnosis and treatment of coronary and peripheral artery disease. The system includes mounting options for workflow flexibility and connects to mains power.

Clinical Evidence

Bench testing only. Testing included mechanical, electrical, bed mount, and operating environment verification. Software verification, electrical safety (IEC 60601-1), electromagnetic compatibility (IEC 60601-1-2), and design validation were performed to support substantial equivalence.

Technological Characteristics

Transducer signal amplifier and conditioner. Uses FISO (Fiber Optic) signal conditioning technology. Components include a Processing Unit, Navvus Interface, and Navvus Interface cable (fiber optic and electrical). Connectivity includes a hemodynamic cable for third-party system integration and mains power connection. Software-based signal processing.

Indications for Use

Indicated for patients requiring intravascular pressure measurements for the diagnosis and treatment of coronary and peripheral artery disease.

Regulatory Classification

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.

Predicate Devices

• ACIST RXi System and ACIST Navvus Catheter (K132474)

Submission Summary (Full Text)

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## 510(k) Summary per 21 CFR 807.92

| Submitter's<br>Name and<br>Address | ACIST Medical Systems, Inc.<br>7905 Fuller Road<br>Eden Prairie, MN 55344<br>USA |
|-------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Name<br>and Information | Amber R. Luker, RAC<br>Senior Regulatory Affairs Specialist<br>ACIST Medical Systems, Inc.<br>952-995-9317 (office)<br>952-941-4648 (fax)<br>[e-mail] |
| Date Prepared | 20 July 2017 |
| Trade or<br>Proprietary<br>Name | ACIST RXi® Mini™ System, which includes the following components:<br>• RXi Mini Processing Unit<br>• RXi Mini Navvus Interface<br>• RXi Mini Mounts<br>• RXi Mini Navvus Interface cable |
| Common or<br>Usual Name | Transducer System |
| Device<br>Classification | Class II |
| Product Code,<br>CFR Section | DRQ<br>21 870.2060 |
| Classification<br>Name | Transducer signal amplifier and conditioner |
| Classification<br>Panel | Cardiovascular |
| Predicate Device | ACIST RXi System and ACIST Navvus Catheter<br>K132474, cleared 30 January 2014 |
| Device<br>Description | ACIST RXi Mini consists of a 1.) Navvus Interface, which receives the<br>pressure signal sensed by the Navvus Catheter, and a 2.) Processing Unit,<br>which converts the optical sensor pressure signal into an analog pressure<br>signal that can be read by a third party hemodynamic system in real-time.<br>These two hardware components are intended to be located on or around a<br>patient bed, and multiple mounting options are available to accommodate<br>different workflows. Both components contain software. |
| | The two modules are connected using the Navvus Interface cable, which<br>contains both a fiber optic cable and an electrical signal (communication)<br>cable. A hemodynamic cable is connected to the Processing Unit and is<br>plugged into the appropriate channel programmed to accept the distal<br>pressure in the hemodynamic system. The power cord is plugged into the<br>Processing Unit and is then connected to the mains power source. |
| Intended<br>Use/Indications<br>for Use | The ACIST RXi Mini is indicated for obtaining intravascular pressure<br>measurements for use in the diagnosis and treatment of coronary and<br>peripheral artery disease. The ACIST Navvus Catheter is intended for use<br>with the ACIST RXi Mini. |
| Comparison of<br>Technological<br>Characteristics<br>to Predicate | The ACIST RXi Mini System is substantially equivalent to the predicate<br>device as it has the same intended operating environments, the same FISO<br>signal conditioner, and same fundamental technology as the predicate<br>device. |
| | The system contains similar components and similar accessories when<br>compared to the predicate device. The Navvus Catheter is intended to be<br>used with both the ACIST RXi Mini System and the predicate device.<br>Differences in software are supported by Software Verification testing. |
| Non-Clinical<br>Tests in Support<br>of Substantial<br>Equivalence | Bench testing, including mechanical testing, electrical testing, bed mount<br>testing, operating environment testing, and packaging verification testing was<br>successfully performed. In addition, software verification, electrical safety<br>testing (IEC 60601-1), electromagnetic compatibility testing (IEC 60601-1-2),<br>and design validation was performed. |
| | The results of these tests provide reasonable assurance that the proposed<br>device has been designed and tested to assure conformance to the<br>requirements for its intended use. No new safety or performance issues were<br>raised during the testing and, therefore, ACIST RXi Mini may be considered<br>substantially equivalent to the predicate device. |
| Conclusion | Based on the same indications for use, same fundamental technology, and<br>safety and performance testing, the ACIST RXi Mini System has been shown<br>to be appropriate for its intended use and is considered to be substantially<br>equivalent to the ACIST RXi System as submitted in K132474. |

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## 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

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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 [phone] or [phone] 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 [phone] or [phone] 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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