(25 days)
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.
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.
The provided text describes a 510(k) submission for the ACIST RXi Mini System, a medical device for measuring intravascular pressure. However, the document focuses on non-clinical tests (bench testing, electrical, software verification) to demonstrate substantial equivalence to a predicate device. It does not present clinical study data or specific acceptance criteria for device performance.
Therefore, many of the requested sections (e.g., sample size for test set, number of experts for ground truth, MRMC study, training set details) cannot be populated from the provided information.
Here's a summary based on the available text:
Acceptance Criteria and Study to Prove Device Meets Acceptance Criteria
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Specific Criteria (Implicitly met by testing) | Reported Device Performance |
|---|---|---|
| Mechanical Performance | - Electrical Safety (IEC 60601-1) | Successfully performed |
| - Electromagnetic Compatibility (IEC 60601-1-2) | Successfully performed | |
| - Bed Mount compatibility | Successfully performed | |
| - Operating Environment compatibility | Successfully performed | |
| - Packaging Integrity | Successfully performed | |
| Software Performance | - Software Verification | Successfully performed |
| Overall Performance | - Design Validation | Successfully performed |
| Safety and Performance | - No new safety or performance issues raised | Achieved |
| Substantial Equivalence | - Same intended operating environments | Confirmed |
| - Same FISO signal conditioner | Confirmed | |
| - Same fundamental technology | Confirmed | |
| - Similar components and accessories | Confirmed | |
| - Performance appropriate for intended use | Confirmed |
2. Sample size used for the test set and the data provenance
- Sample Size for Test Set: Not specified. The document refers to "bench testing," "electrical testing," "software verification," and "design validation" which are non-clinical and do not typically involve human patient "test sets" in the context of diagnostic accuracy.
- Data Provenance: The tests were non-clinical, likely conducted at the manufacturer's facilities or accredited labs. Country of origin for data is not applicable as it's not patient data. Retrospective/Prospective: Not applicable as it's non-clinical testing.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Not applicable. As this was non-clinical engineering and software testing, there was no "ground truth" established by medical experts in the context of patient diagnosis. Performance was assessed against engineering specifications and regulatory standards.
4. Adjudication method for the test set
- Not applicable. There was no clinical imagery or patient data requiring expert adjudication.
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. This device is a transducer system for measuring intravascular pressure, not a diagnostic imaging AI system. Therefore, an MRMC study or AI assistance evaluation is not relevant.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Yes, in a sense. The "standalone" performance refers to the device's ability to accurately convert the optical sensor pressure signal into an analog pressure signal. This performance was validated through non-clinical testing (bench testing, electrical testing, software verification, design validation) to show it functions as intended by itself, without human interpretation of its output beyond ensuring it meets specifications.
7. The type of ground truth used
- The "ground truth" for the non-clinical tests would have been engineering specifications, established standards (e.g., IEC 60601-1, IEC 60601-1-2), and design requirements. The device’s output was measured against these predefined technical benchmarks rather than against a medical outcome or expert consensus on clinical data.
8. The sample size for the training set
- Not applicable. This device is a hardware and software system for signal processing, not a machine learning or AI model that requires a "training set" of data in the typical sense.
9. How the ground truth for the training set was established
- Not applicable, as there was no training set in the context of machine learning.
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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 | 20 July 2017 |
| Trade orProprietaryName | 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 orUsual Name | Transducer System |
| DeviceClassification | Class II |
| Product Code,CFR Section | DRQ21 870.2060 |
| ClassificationName | Transducer signal amplifier and conditioner |
| ClassificationPanel | Cardiovascular |
| Predicate Device | ACIST RXi System and ACIST Navvus CatheterK132474, cleared 30 January 2014 |
| DeviceDescription | ACIST RXi Mini consists of a 1.) Navvus Interface, which receives thepressure signal sensed by the Navvus Catheter, and a 2.) Processing Unit,which converts the optical sensor pressure signal into an analog pressuresignal 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 apatient bed, and multiple mounting options are available to accommodatedifferent workflows. Both components contain software. |
| The two modules are connected using the Navvus Interface cable, whichcontains both a fiber optic cable and an electrical signal (communication)cable. A hemodynamic cable is connected to the Processing Unit and isplugged into the appropriate channel programmed to accept the distalpressure in the hemodynamic system. The power cord is plugged into theProcessing Unit and is then connected to the mains power source. | |
| IntendedUse/Indicationsfor Use | The ACIST RXi Mini is indicated for obtaining intravascular pressuremeasurements for use in the diagnosis and treatment of coronary andperipheral artery disease. The ACIST Navvus Catheter is intended for usewith the ACIST RXi Mini. |
| Comparison ofTechnologicalCharacteristicsto Predicate | The ACIST RXi Mini System is substantially equivalent to the predicatedevice as it has the same intended operating environments, the same FISOsignal conditioner, and same fundamental technology as the predicatedevice. |
| The system contains similar components and similar accessories whencompared to the predicate device. The Navvus Catheter is intended to beused with both the ACIST RXi Mini System and the predicate device.Differences in software are supported by Software Verification testing. | |
| Non-ClinicalTests in Supportof SubstantialEquivalence | Bench testing, including mechanical testing, electrical testing, bed mounttesting, operating environment testing, and packaging verification testing wassuccessfully performed. In addition, software verification, electrical safetytesting (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 proposeddevice has been designed and tested to assure conformance to therequirements for its intended use. No new safety or performance issues wereraised during the testing and, therefore, ACIST RXi Mini may be consideredsubstantially equivalent to the predicate device. | |
| Conclusion | Based on the same indications for use, same fundamental technology, andsafety and performance testing, the ACIST RXi Mini System has been shownto be appropriate for its intended use and is considered to be substantiallyequivalent 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 (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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§ 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).