(198 days)
Not Found
No
The document describes a system for measuring intravascular pressure and calculating FFR and resting Pd/Pa based on these pressure measurements. There is no mention of AI or ML being used in the data processing or calculation. The technology described is based on optical sensing and pressure ratio calculations.
No
The device is indicated for obtaining intravascular pressure measurements for the diagnosis and treatment of coronary and peripheral artery disease. It computes and displays FFR and resting Pd/Pa to assess lesion severity. It is used for diagnosis, not therapy.
Yes
Explanation: The "Intended Use / Indications for Use" section explicitly states that the system is used "for obtaining intravascular pressurements for use in the diagnosis and treatment of coronary and peripheral artery disease." Additionally, the "Device Description" states it is "designed to provide hemodynamic information for the diagnosis and treatment of coronary and peripheral artery disease." It computes and displays Fractional Flow Reserve (FFR) and resting Pd/Pa, which "supplement the visual data provided by angiography and provides an assessment of the lesion severity." These are all diagnostic functions.
No
The device description explicitly details hardware components, including a microcatheter with a pressure sensor and the ACIST RXi family of system hardware.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are devices intended for use in the collection, preparation, and examination of specimens taken from the human body (such as blood, urine, or tissue) to provide information for the diagnosis, treatment, or prevention of disease.
- Device Function: The ACIST RXi System and Navvus II MicroCatheter are used to obtain intravascular pressure measurements directly within the coronary and peripheral arteries. This is an in vivo measurement (within the living body), not an in vitro examination of a specimen outside the body.
- Intended Use: The intended use is to obtain pressure measurements for use in the diagnosis and treatment of coronary and peripheral artery disease. While this information is used for diagnosis and treatment, the method of obtaining the information is not through the analysis of a bodily specimen.
Therefore, the ACIST RXi System and Navvus II MicroCatheter fall under the category of medical devices used for in vivo measurements and procedures, not In Vitro Diagnostics.
N/A
Intended Use / Indications for Use
The ACIST RXi System is indicated for obtaining intravascular pressure measurements for use in the diagnosis and treatment of coronary and peripheral artery disease. The ACIST Navvus II MicroCatheter is intended for use with the ACIST RXi System.
Product codes
DXO, OBI
Device Description
Navvus II 1.
The ACIST Navvus II MicroCatheter is a single-lumen monorail catheter designed to be used with standard 0.014 in (0.36 mm) guidewires in the arterial vasculature. The MicroCatheter is compatible with the ACIST RXi family of system hardware which includes the RXi System and RXi Mini. Features unique to each system are denoted specifically.
The Navvus II MicroCatheter distal shaft is 26 cm in length with a pressure sensor located 5 mm from the distal tip. The elliptical distal shaft is 1.68 x 1.91F (0.020 in x 0.025 in) up to 10 mm from the distal tip; a maximum profile of 2.7F (0.036 in) occurs at the pressure sensor. The distal shaft smoothly tapers over the pressure sensor and down to the tip accepting the guidewire. A radiopaque marker band is located 2.5 mm from the distal tip.
The shaft proximal to the monorail section is 2.4F, allowing use in 5F or larger guide catheters. Two white positioning markers are located at 80 cm and 100 cm from the distal tip. The pressure sensor on the catheter utilizes optical sensing technology. Both the optical pressure signal and information for auto calibration are transmitted from the catheter to the RXi hardware.
2. RXi System
The ACIST RXi System is designed to provide hemodynamic information for the diagnosis and treatment of coronary and peripheral artery disease. The system is intended for use in catheterization and related cardiovascular specialty laboratories to compute and display fractional flow reserve (FFR) and resting Pd/Pa.
FFR and resting Pd/Pa supplement the visual data provided by angiography and provides an assessment of the lesion severity.
Measurement of FFR and resting Pd/Pa requires simultaneously monitoring the blood pressures proximal and distal to a lesion. The ACIST RXi System includes a single-use MicroCatheter with a pressure sensor for acquisition of the distal pressure. The proximal pressure is acquired via the guide catheter which is monitored by the ACIST RXi System via an interface to the hospital's hemodynamic monitor.
Pd/Pa is the ratio of distal coronary arterial pressure to aortic pressured at resting conditions. The physician may then use the resting Pd/Pa value, along with knowledge of patient history, medical expertise and clinical judgment to determine if an additional measurement of FFR during hyperemia or therapeutic intervention is indicated.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
coronary and peripheral artery, arterial vasculature, coronary and peripheral vasculature
Indicated Patient Age Range
adult patients
Intended User / Care Setting
Physician, catheterization and related cardiovascular specialty laboratories
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)
Non-Clinical Bench Testing:
- Dimensional and Visual Inspections
- Static Accuracy
- Tortuous Path
- Durability
- Tensile Strength
Pd/Pa Clinical Post-Market Analysis and Supported Literature:
A meta-analysis by Maini et al. reported on 14 studies of resting Pd/Pa diagnostic accuracy compared to FFR. Optimal cutpoints ranged from 0.875 to 0.96, with 12 of 14 studies showing cutpoints from 0.91 to 0.93.
The ACIST-FFR Pd/Pa Post-hoc Sub-Group Analysis identified an optimal cutpoint of 0.91, derived from a post-hoc receiver operating characteristic (ROC) curve analysis using an FFR cutoff value of
§ 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).
0
Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services seal on the left and the FDA acronym and name on the right. The FDA acronym is in a blue square, and the full name "U.S. Food & Drug Administration" is in blue text.
September 13, 2019
ACIST Medical Systems, Inc. Sherri Mellingen Principal Regulatory Affairs Specialist 7905 Fuller Road Eden Prairie, Minnesota 55344
Re: K190473
Trade/Device Name: ACIST Rapid Exchange (RXi) System and Navvus II MicroCatheter Regulation Number: 21 CFR 870.2870 Regulation Name: Catheter Tip Pressure Transducer Regulatory Class: Class II Product Code: DXO, OBI Dated: August 13, 2019 Received: August 14, 2019
Dear Sherri Mellingen:
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 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
1
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.
Stephen Browning Assistant Director Division of Cardiac Electrophysiology, Diagnostics and Monitoring Devices Office of Cardiovascular Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K190473
Device Name
ACIST Rapid Exchange (RXi) System and Navvus II MicroCatheter
Indications for Use (Describe)
The ACIST RXi System is indicated for obtaining intravascular pressurements for use in the diagnosis and treatment of coronary and peripheral artery disease. The ACIST Navvus II MicroCatheter is intended for use with the ACIST RXi System
X Prescription Use (Part 21 CFR 801 Subpart D)
| Over-The-Counter Use (21 CFR 801 Subpart C)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
3
Image /page/3/Picture/0 description: The image shows the logo for ACIST. The logo consists of a cube made up of three diamond shapes in green, blue, and purple, followed by the word "ACIST" in blue. Below the word "ACIST" is the phrase "the power to" in a smaller font.
Premarket Notification - Traditional 510(k)
RXi System and Navvus II Catheter
510(k) Summary
Date Prepared: 2/26/2019
Submitters Name / Contact Person
510k Submitter Address
ACIST Medical 7905 Fuller Road Eden Prairie, MN 55344 Phone - (952) 995 - 9300
Contact for Official/Routine Correspondence
Sherri Mellingen Senior Regulatory Affairs Specialist 7905 Fuller Road Eden Prairie, MN 55344 Phone - (952) 995 - 9381 Email: sherri.mellingen@acistmedical.com
| General Information | ||||
|---|---|---|---|---|
| Trade Name: | ACIST Rapid Exchange (RXi) System and Navvus II MicroCatheter | |||
| Common / Usual Name: | Cardiovascular Pressure Measurement System and Navvus Catheter | |||
| Classification: | Class 2 per 21 CFR 870.2870 | |||
| Product Code: | OBI, DXO | |||
| Predicate Device: | ACIST RXi® System and Navvus Catheter |
Device Description
Navvus II 1.
The ACIST Navvus II MicroCatheter is a single-lumen monorail catheter designed to be used with standard 0.014 in (0.36 mm) guidewires in the arterial vasculature. The MicroCatheter is compatible with the ACIST RXi family of system hardware which includes the RXi System and RXi Mini. Features unique to each system are denoted specifically.
The Navvus II MicroCatheter distal shaft is 26 cm in length with a pressure sensor located 5 mm from the distal tip. The elliptical distal shaft is 1.68 x 1.91F (0.020 in x 0.025 in) up to 10 mm from the distal tip; a maximum profile of 2.7F (0.036 in) occurs at the pressure sensor. The distal shaft smoothly tapers over the pressure sensor and down to the tip accepting the guidewire. A radiopaque marker band is located 2.5 mm from the distal tip.
The shaft proximal to the monorail section is 2.4F, allowing use in 5F or larger guide catheters. Two white positioning markers are located at 80 cm and 100 cm from the distal tip. The pressure sensor on the catheter utilizes optical sensing technology. Both the optical pressure signal and information for auto calibration are transmitted from the catheter to the RXi hardware.
4
Image /page/4/Picture/1 description: The image shows the logo for ACIST. The logo consists of a cube made up of three diamond shapes in green, blue, and purple, followed by the word "ACIST" in blue. Below the word "ACIST" are the words "the power to" in a smaller font.
2. RXi System
The ACIST RXi System is designed to provide hemodynamic information for the diagnosis and treatment of coronary and peripheral artery disease. The system is intended for use in catheterization and related cardiovascular specialty laboratories to compute and display fractional flow reserve (FFR) and resting Pd/Pa.
FFR and resting Pd/Pa supplement the visual data provided by angiography and provides an assessment of the lesion severity.
Measurement of FFR and resting Pd/Pa requires simultaneously monitoring the blood pressures proximal and distal to a lesion. The ACIST RXi System includes a single-use MicroCatheter with a pressure sensor for acquisition of the distal pressure. The proximal pressure is acquired via the guide catheter which is monitored by the ACIST RXi System via an interface to the hospital's hemodynamic monitor.
Pd/Pa is the ratio of distal coronary arterial pressure to aortic pressured at resting conditions. The physician may then use the resting Pd/Pa value, along with knowledge of patient history, medical expertise and clinical judgment to determine if an additional measurement of FFR during hyperemia or therapeutic intervention is indicated.
Intended Use / Indications
The ACIST RXi System is indicated for obtaining intravascular pressure measurements for use in the diagnosis and treatment of coronary and peripheral artery disease. The ACIST Navvus II MicroCatheter is intended for use with the ACIST RXi System.
Comparison of Technological Characteristics
The RXi System is identical to the predicate as there have been no design changes since the device was originally cleared. The PdPa function has always existed on the device as this change is simply to include it in the labeling. The Navvus II differs from the predicate device with regard to the tip OD (0.06mm difference) and the distance from the distal end of the sensor to the marker band (0.10 difference). Design verification testing demonstrated that these two small differences did not affect the performance of the device and that the subject device and the predicate device were substantially equivalent. The Navvus II Catheter is substantially equivalent to the legally marketed predicate device in design, intended use, intended population, principles of use, materials, size and sterility.
5
Image /page/5/Picture/0 description: The image is a logo for ACIST. The logo features a geometric shape on the left, composed of three diamond shapes in green, blue, and purple. To the right of the shape is the word "ACIST" in blue, with a registered trademark symbol in the upper right corner. Below the word "ACIST" are the words "the power to" in a smaller, lighter font.
| Table 1: Comparison with Predicate | |||
|---|---|---|---|
| Subject Device | Predicate Device | Comparison of | |
| K132474 to Subject | |||
| Device | |||
| 510(k) # | TBD | K132474 | |
| Intended Use / | |||
| Indications | The ACIST RXi System is indicated for obtaining intravascular pressure measurements for use in the diagnosis and treatment of coronary and peripheral artery disease. The ACIST Navvus MicroCatheter is intended for use with the entire family of ACIST RXi Systems. | Same | |
| Principles of Use | Calculates FFR and Pd/Pa based on simultaneous acquisition of pressure from two transducers: | ||
| The flexible distal tip of the catheter that contains the optical pressure sensor is advanced over the proximal end of the 0.014 in (0.36 mm) guidewire that is already in place in the distal vasculature. The Navvus catheter is advanced over the wire and positioned with the radiopaque marker in the coronary ostium, 3 mm outside the tip of the guide catheter. Equalization must take place with the Navvus Catheter distal tip just outside the tip of the guide catheter. Pressure is measured less than 3 mm proximal from the marker band visible under fluoroscopy. The guide catheter is flushed with saline solution. Then the Navvus Catheter sensor is advanced past the lesion under study. | Same | ||
| Display Features | Navvus distal (Pd) and proximal/aortic (Pa) pressure, Pd/Pa, and FFR | Same | |
| Intended | |||
| Anatomical | |||
| Location | Coronary and peripheral vasculature | Same | |
| Configuration | Navvus Catheter is a 0.022" catheter with and integrated pressure sensor that is used in the real-time calculation of FFR and Pd/Pa together with a detachable cable for connection to a diagnostic computer. | Same | |
| Coating | No | Same | |
| Marker Band? | Yes - 2.5mm from distal tip | Same | |
| Maximum Tip | |||
| OD | Tip OD 0.75mm MAX | Tip OD 0.69mm MAX | Differs 0.06mm |
| Table 1: Comparison with Predicate | |||
| Subject Device | Predicate Device | Comparison of K132474 to Subject Device | |
| Distal End of Sensor to Markerband | 2.31+/- 0.25mm | 2.41+/- 0.25mm | Differs by 0.10mm |
| Effective (Working) Length | 145 cm to 155 cm | Same | |
| Compatible Guidewire Diameter (max) | 0.014" | Same | |
| Single use, sterile? | Yes | Same | |
| Sterilization method | Ethylene Oxide | Same | |
| Intended Population | This product is designed for use in adult patients identified by a physician as suitable candidates for vascular pressure measurement after taking into consideration the patient's anatomy and health status. | Same |
6
Image /page/6/Picture/0 description: The image shows the ACIST logo. The logo consists of a cube made up of three squares in the colors blue, green, and purple. To the right of the cube is the word "ACIST" in blue, with the registered trademark symbol next to the "T". Below the word "ACIST" are the words "the power to" in a smaller font.
Non-Clinical Bench Testing
The following non-clinical bench testing was completed on the Navvus II MicroCatheter:
Dimensional and Visual Inspections Static Accuracy Tortuous Path
Durability Tensile Strength
Pd/Pa Clinical Post-Market Analysis and Supported Literature
The expected FFR value in a normal vessel without a stenotic lesion or obstruction to blood flow is a value of 1.0. Based on clinical evidence, a threshold or cutpoint value of ≤ 0.80 is commonly considered for treatment with a therapeutic intervention, while a value > 0.80 is commonly considered for deferment. An established, clinically evident Pd/Pa threshold or cutpoint such as this is indeterminate, but guidance for use of PdPa for clinical decision making may be considered by referring to the existing, supportive clinical evidence from multiple diagnostic accuracy studies performed on resting Pd/Pa.
A recent meta-analysis was reported by Maini et al., based on published resting Pd/Pa diagnostic accuracy studies which examined the overall diagnostic accuracy of Pd/Pa compared to FFR. The meta-analysis reported on 14 studies with an optimal cutpoint ranging from 0.875 to 0.96 and resulted in cutpoints from 0.91 to 0.93 in 12 of the 14 studies in the meta-analysis.
The ACIST-FFR Pd/Pa Post-hoc Sub-Group Analysis' identified an optimal cutpoint of 0.91. The cutpoint was derived from a post-hoc receiver operating characteristic (ROC) curve analysis using an FFR cutoff value of ≤0.80 measured with the Navvus MicroCatheter to define stenosis. The 0.91 cutpoint is within the range of 0.91 to 0.93 as was reported in 12 of the 14 studies in the Maini et al., meta-analysis.
7
Image /page/7/Picture/0 description: The image shows the ACIST logo. The logo consists of a cube made of three squares in green, blue, and purple, followed by the word "ACIST" in blue. Below the word "ACIST" are the words "the power to" in a smaller font.
RXi System and Navvus II Catheter
Standards
The following is a summary of the standards used in testing for the RXi System and Navvus II MicroCatheter:
| Table 3: Standards used in non-clinical bench testing | ||
|---|---|---|
| Test | Industry Standards | FDA Recognition Number, Version and Date |
| Design Verification | EN ISO 13485:2016, Medical Devices, Quality Management Systems | Not recognized by FDA |
| Device Performance | EN ISO 13485:2016, Medical Devices, Quality Management Systems | Not recognized by FDA |
| ISO 10555-1, Sterile and Single Use Intravascular Catheters General Requirements | 6-301 | |
| 8/14/2015 | ||
| Risk Management | EN ISO 14971, Application of Risk Management to Medical Devices | 5-40 |
| 6/27/2016 | ||
| Medical Electrical Equipment | IEC 60601-1-2:2014, Medical Electrical Equipment | 19-8 |
| 9/17/2018 | ||
| Animal Model | FDA 21 CFR: Part 58 Good Laboratory Practice Regulations | N/A |
| Packaging & Shelf Life | ISO 11607-1:2006/2010, 11607-2:2006 Packaging for Sterilized Medical Devices | 14-454, 14-455 |
| 1/27/2015 | ||
| Biocompatibility | ISO 10993-1: 2009 Biological Evaluation of Medical Devices | 2-220 |
| 7/26/2016 | ||
| Sterilization | ISO 11135:2014 Medical Devices - Validation of Routine Control of Ethylene Oxide Sterilization | 14-452 |
| 4/4/2016 |
Product Codes
The following product codes are similar to the predicate and subject device (product code OBI) as the devices are classified in accordance with regulation 870.1200: DQO, NLI, NUI, OBJ, OES, OFN, OGZ, ORD. The secondary product code, DXO, is regulated in accordance with regulation 870.2870 and has no similar product codes.
8
Image /page/8/Picture/0 description: The image shows the ACIST logo. The logo consists of a cube made of three diamond shapes in green, blue, and purple, followed by the word "ACIST" in blue. Below the word "ACIST" is the phrase "the power to" in a smaller font.
Results of design verification testing on the Navus II MicroCatheter demonstrate that the device is substantially equivalent to the predicate device. The subject device has been evaluated through bench testing. All test results met documented acceptance criteria and demonstrated the Navvus II MicroCatheter is substantially equivalent to the predicate device. Finally, the ACIST-FFR Pd/Pa Sub-Group Post-Hoc Analysis, in which all pressure tracings were acquired by the ACIST Navvus MicroCatheter, gave additional information on the clinical use of PdPa and provided further information as compared to the cutpoint range presented in the Maini meta-analysis.
1 Thackery, Lisa,, Rorke, Becky., Larson, Janet A., PdPa, Sub-Group, Post-hoc analysis of data from the ACIST-FFR clinical study which assessed catherrogation and standard techniques for Fractional Flow Reserve Measurement. Original data set analysis published in: Circ Cardiovasc Interv. 2017 Dec; 10 (12). e005905
2 Maini R, Moscona J, Sidhu G, et al. Pooled diagnostic accuracy of resting distal to aortic coronary pressure referenced to fractional flow reserve: The importance of resting coronary physiology. Journal of Interventional Cardiology. 2018;31(5):588-598. doi:10.1111/joic.12517.
3 Lighart Jurgen, Masdjedi Kaneshka, Witberg Karen, et al. Validation of Resure Ratio Calculated by a Novel Algorithm and Its Correlation With Distal Coronary Artery Pressure to Aortic Pressure, Instantaneous Wave-Free Ratio, and Fractional Flow Reserve. Circulation: Cardiovascular Interventions. 2018;11(12):e006911. doi:10.1161/CIRCINTERVENTIONS.118.006911.