(176 days)
Not Found
No
The summary describes a system that computes physiological parameters based on pressure measurements using embedded software and electronics, but there is no mention of AI or ML techniques being used for this computation or any other function.
No
The device is indicated for obtaining intravascular pressure measurements for use in the diagnosis and treatment of coronary and peripheral artery disease. It computes and displays physiological parameters (Fractional Flow Reserve), which are diagnostic information, not therapeutic interventions.
Yes
The device is indicated for "obtaining intravascular pressure measurements for use in the diagnosis and treatment of coronary and peripheral artery disease" and "will compute and display physiological parameters based on the output of an optically-based pressure measuring sensor" to provide "hemodynamic measurement information for use in the diagnosis and treatment." This directly indicates its use in the diagnostic process.
No
The device description explicitly states that the system consists of a single patient use, catheter-based sensing device, a hardware system containing embedded software, a user interface touchscreen, and electronics. This indicates the presence of significant hardware components beyond just software.
Based on the provided information, this device is not an In Vitro Diagnostic (IVD).
Here's why:
- Intended Use: The device is indicated for obtaining intravascular pressure measurements for use in the diagnosis and treatment of coronary and peripheral artery disease. This involves measurements taken within the body (intravascular).
- Device Description: The device measures physiological parameters based on an optically-based pressure measuring sensor within a catheter inserted into the body.
- IVD Definition: In Vitro Diagnostics (IVDs) are devices intended for use in the examination of specimens derived from the human body (such as blood, urine, or tissue) in vitro (outside the body) to provide information for diagnostic, monitoring, or compatibility purposes.
Since this device takes measurements directly within the patient's arteries, it falls under the category of an in vivo diagnostic or therapeutic device, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The ACIST Rapid Exchange (RXi) System is indicated for obtaining intravascular pressure measurements for use in the diagnosis and treatment of coronary and peripheral artery disease. The Navvus Catheter is intended for use with the ACIST RXi System.
Product codes (comma separated list FDA assigned to the subject device)
DXO, OBI
Device Description
The Rapid Exchange (RXi) System and Navvus Catheter are intended to provide hemodynamic measurement information for use in the diagnosis and treatment of coronary or peripheral artery disease. When used in catheterization and related cardiovascular specialty laboratories, the Rapid Exchange (RXi) System and Navvus Catheter will compute and display physiological parameters based on the output of an optically-based pressure measuring sensor.
The Rapid Exchange (RXi) System and Navvus Catheter consist of a single patient use, catheter-based sensing device, a hardware system containing embedded software, a user interface touchscreen, and electronics for converting measured pressure signals into Fractional Flow Reserve (FFR) measurements. The intravascular blood pressure sensor is optically-based and adhered to the end of a fiber optic. The sensor and fiber optic are integrated into a monorail catheter, which connects to the system to deliver the measured pressure data.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Coronary or peripheral artery
Indicated Patient Age Range
The average subject was a sixty-five (65) year old male (80%), ranging in age from 42-86 years.
Intended User / Care Setting
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
A prospective, observational, multi-center study was conducted. The primary objectives of the study were to assess the relationship in FFR measurements between the Navyus catheter and the Radi, including rate of device success defined as a valid FFR measurement by the Navvus Catheter where a valid FFR measurement was taken using the Radi. The study used paired measurements from the Navvus catheterand Radi within subjects as controls. Pressure measurements were assessed intra-operatively; subjects were evaluated for safety events through hospital discharge.
Three centers participated and enrolled 58 subjects. Patients with single or multi-vessel coronary artery disease indicated for FFR and a vessel reference diameter of >= 2.5 mm were eligible.
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Study Type: Non-clinical testing (Bench testing, Animal testing, Biocompatibility assessment), Clinical Testing (Prospective, observational, multi-center study)
Sample Size: Clinical: 58 subjects
AUC: Receiver Operator Curves, using the first measured Radi FFR measurement as the standard, created for both the Navvus catheter measured FFR and the last Radi FFR demonstrated very similar areas under the curve (87.4% and 88.1%, respectively).
MRMC: Not Found
Standalone Performance: Not Found
Key Results:
The RXI system was 100% successful in taking valid FFR measurements in all lesions in which the Radi was able to take valid FFR measurements.
The overall bias, as determined from a Bland-Altman analysis, was -0.01.
Using a Bland-Altman analysis, the observed 95% limits of agreement was -0.13 to 0.10.
The Kolmogorov-Smirnov test for linearity showed a cumulative p-value of 0.72, meeting success criteria of being > 0.1.
The intercept determined by a Passing-Bablok linear regression between FFR measurements made using RXi system and that made using Radi had a 95% confidence interval of -0.15 to 0.19, meeting success criteria of the interval containing 0.
The slope determined by a Passing-Bablok linear regression between FFR measurements made using RXi system and that made using Radi showed a 95%. confidence interval of 0.76 to 1.17, meeting success criteria of the interval containing 1.
The RXi System demonstrated a statistically significant lower rate of drift compared to the Radi system, both for mean drift (0.02 +/- 0.02 for RXi vs. 0.06 +/- 0.12 for Radi) and clinically relevant drift (13% vs. 33% rate of occurrence).
No serious adverse events were related to the RXi system. None of the 17 reported adverse events were device related.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Overall bias (Bland-Altman analysis): -0.01
95% limits of agreement (Bland-Altman analysis): -0.13 to 0.10
Kolmogorov-Smirnov test for linearity cumulative p-value: 0.72 (> 0.1 success criteria)
Intercept (Passing-Bablok linear regression, 95% CI): -0.15 to 0.19 (contains 0 success criteria)
Slope (Passing-Bablok linear regression, 95% CI): 0.76 to 1.17 (contains 1 success criteria)
AUC for Navvus catheter FFR: 87.4%
AUC for last Radi FFR: 88.1%
Mean drift for RXi: 0.02 +/- 0.02
Mean drift for Radi: 0.06 +/- 0.12
Clinically relevant drift rate for RXi: 13%
Clinically relevant drift rate for Radi: 33%
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
§ 870.2870 Catheter tip pressure transducer.
(a)
Identification. A catheter tip pressure transducer is a device incorporated into the distal end of a catheter. When placed in the bloodstream, its mechanical or electrical properties change in relation to changes in blood pressure. These changes are transmitted to accessory equipment for processing.(b)
Classification. Class II (performance standards).
0
JAN 30 2014
Section 6
510(k) Summary [21 CFR 807.92]
| Date the Summary was Prepared |
|---|
| January 28, 2014 |
| 510(k) Submitter's Name and Address |
| ACIST Medical Systems |
| 7905 Fuller Road |
| Eden Prairie, MN 55344 |
| 952-253-4519 (telephone) |
| 952-941-4648 (fax) |
| matt.stepanek@acistmedical.com |
| Owner/Operator |
| ACIST Medical Systems |
| 7905 Fuller Road |
| Eden Prairie, MN 55344 |
| 952-995-9300 (telephone) |
| 952-941-4648 (fax) |
| matt.stepanek@acistmedical.com |
| Primary Contact |
| Matthew D. Stepanek |
| Principal Regulatory Affairs Specialist |
| ACIST Medical Systems |
| 7905 Fuller Road |
| Eden Prairie, MN 55344 |
| 952-253-4519 (telephone) |
| 952-941-4648 (fax) |
| matt.stepanek@acistmedical.com |
| Alternative Contact |
| Dennis Crane |
| Director of Regulatory and Clinical Affairs |
| ACIST Medical Systems |
| 7905 Fuller Road |
| Eden Prairie, MN 55344 |
| (952) 253 4515 (telephone) |
| 952-941-4648 (fax) |
| dennis.crane@acistmedical.com |
1
| Sterilization Facility |
|---|
| Sterigenics US, Inc. |
| 7775 S Quincy St. |
| Willowbrook, IL 60527 |
| Establishment Registration Number: 1450293 |
| Console Manufacturing Facility |
| ACIST Medical Systems, Inc. |
| 7905 Fuller Road |
| Eden Prairie, MN 55344 |
| Establishment Registration Number: 2134243 |
| Catheter Manufacturing Facility |
| MedVenture |
| 2301 Centennial Blvd. |
| Jeffersonville, IN 47130 |
| Establishment Registration Number: 1222140 |
| Device Classification Names |
| Transducer, Pressure, Catheter Tip and Catheter, Pressure Monitoring, Cardiac |
| Device Common/Usual Name |
| Catheter Tip Pressure Transducer and Diagnostic Intravascular Catheter |
| Device Trade/Proprietary Name |
| Rapid Exchange (RXi) System and Navvus Catheter |
| Product Codes |
| DXO and OBI |
| Classification of Device |
| Class II |
| 21 CFR 870.2870 and 870.1200 |
2
| Predicate Device(s) | ||
|---|---|---|
| Device Name | Submission Number. | Clearance Date |
| Radi Analyzer® and PressureWire® Sensor | ||
| (RADI Medical Systems, St. Jude Medical, Minnesota, USA) | K062769 | December 4, 2006 |
Device Description
The Rapid Exchange (RXi) System and Navvus Catheter are intended to provide hemodynamic measurement information for use in the diagnosis and treatment of coronary or peripheral artery disease. When used in catheterization and related cardiovascular specialty laboratories, the Rapid Exchange (RXi) System and Navvus Catheter will compute and display physiological parameters based on the output of an optically-based pressure measuring sensor.
The Rapid Exchange (RXi) System and Navvus Catheter consist of a single patient use, catheter-based sensing device, a hardware system containing embedded software, a user interface touchscreen, and electronics for converting measured pressure signals into Fractional Flow Reserve (FFR) measurements. The intravascular blood pressure sensor is optically-based and adhered to the end of a fiber optic. The sensor and fiber optic are integrated into a monorail catheter, which connects to the system to deliver the measured pressure data.
Proposed Intended Use & Indication for Use
The Intended Use/Indication for Use of the Rapid Exchange (RXi) System and Navvus Catheter is as follows:
The ACIST Rapid Exchange (RXi) System is indicated for obtaining intravascular pressure measurements for use in the diagnosis and treatment of coronary and peripheral artery disease. The Navvus Catheter is intended for use with the ACIST RXi System.
3
Summary of the Technological Characteristics to the Predicate Device(s)
The Rapid Exchange (RXi) System and Navvus Catheter employs many of the same technology characteristics as the predicate device to perform coronary pressure and fractional flow reserve (FFR) measurements. The Rapid Exchange (RXi) System and Navvus Catheter includes an intracoronary pressure measurement system that would allow the physician to use the best guidewire for the patient's anatomy and would facilitate access to coronary lesions. Using the Rapid Exchange (RXi) System and Navvus Catheter could avoid multiple guidewire exchanges if the patient went on to PCI after the FFR measurement, because the physician could use the same quidewire for the PCI.
The Rapid Exchange (RXi) System and Navvus Catheter and the predicate are intended for obtaining intravascular pressure measurements for use in the diagnosis and treatment of coronary and peripheral artery disease. The Rapid Exchange (RXi) System. Navvus Catheter and predicate are designed to fit inside a percutaneous guiding catheter for the purpose of directing the catheter through a vessel. The signal output from the sensor is used for calculation and presentation of any physiological parameters, functions or indices based on pressure e.g. Fractional Flow Reserve (FFR).
The predicate devices are 0.014" guidewires with an integrated pressure sensor, together with a detachable cable for connection to a diagnostic computer.
The devices are for single use and are not to be re-sterilized.
The Rapid Exchange (RXi) System and Navvus Catheter device modifications are deemed substantially equivalent to the RAD! PressureWire Sensor, as there are no differences in the product performance, device indications for use/intended use and/or device functional scientific technology. The subject device uses the same surgical approach procedures as the predicate device.
ACIST Medical Systems considers the Rapid Exchange (RXi) System and Navvus Catheter product performance to be significantly equivalent to the predicate device, Radi Analyzer and PressureWire Sensor.
ACIST Medical Systems Traditional 510(k) Notification Rapid Exchange (RXi) System and Navvus Catheter Page 4 of 9
4
| Characteristic | Radi Analyzer® and PressureWire®
(RADI Medical Systems, St. Jude
Medical, Minnesota, USA) (K062769) | ACIST Rapid Exchange (RXi) System and
Navvus Catheter |
|-------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended Use | PressureWire is designed to fit inside a
percutaneous catheter for the purpose of
directing the catheter through a vessel. The
signal output from the sensor is used for
calculation and presentation of any
physiological parameters, functions or
indices based on pressure or temperature,
e.g. Fractional Flow Reserve (FFR). | The ACIST Rapid Exchange (RXi) System is
indicated for obtaining intravascular pressure
measurements for use in the diagnosis and
treatment of coronary and peripheral artery
disease. The Navvus Catheter is intended for
use with the ACIST RXi System. |
| Conditions of
Use | • Operating temperature 15°C to 30°C
(59°F to 86°F)
• Transport temperature -40°C to 70°C (-
40°F to 158°F)
• Storage temperature: Room temperature
• Relative humidity operating 30-75% | • Operating temperature 18°C to 30°C
• Transport temperature -29°C to 60°C
• Storage temperature: Room temperature
• Relative humidity operating 10-95% non-
condensing |
| Specifications
and
Properties | • Pressure Accuracy: +/-1mmHg plus +/-1%
of reading (over the pressure range -30 to
50mmHg); +/-3% of reading (over the
range 50 to 300mmHg)
• Pressure range: -30 to 300mmHg
• Frequency response: 0-25 Hz
• Zero thermal effect: 0.3 mmHg/degC
• Sensitivity thermal effect: 0.3%/degC
• Zero drift: 0.1. The intercept determined by a Passing-Bablok linear regression between FFR measurements made using RXi system and that made using Radi had a 95% confidence interval of -0.15 to 0.19, meeting success criteria of the interval containing 0. The slope determined by a Passing-Bablok linear regression between FFR measurements made using RXi system and that made using Radi showed a 95%. confidence interval of 0.76 to 1.17, meeting success criteria of the interval containing 1. Receiver Operator Curves, using the first measured Radi FFR measurement as the standard, created for both the Navvus catheter measured FFR and the last Radi FFR demonstrated very similar areas under the curve (87.4% and 88.1%, respectively). The RXi System demonstrated a statistically significant lower rate of drift compared to the Radi system, both for mean drift (0.02 ± 0.02 for RXi vs. 0.06 ± 0.12 for Radi) and clinically relevant drift (13% vs. 33% rate of occurrence). This clinical study also demonstrated a very good safety profile. Although serious adverse events occurred during five subject's hospitalization none of these events were related to the RXi system. In a similar fashion, none of the 17 reported adverse events were device related. Eleven of the 17 were related to the procedure, including: hematomas, mild hemorrhage, elevated cardiac enzymes, nausea, vasovagal reaction, headache, hypokalemia, temporary rhythm disturbances and wheeze. All of the adverse events were mild to moderate in nature. |
| ------------------------------------ | ---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------- |
|---|
8
Substantial Equivalence
The proposed Rapid Exchange (RXi) System and Navvus Catheter device uses the same surgical approach procedures as the predicate device.
The proposed Rapid Exchange (RXi) System and Navvus Catheter device and the predicate device have similar indications for use/intended use, similar implant materials, similar sterilization methods; and similar delivery characteristics.
The device performance and fundamental scientific technology remains unchanged. The differences between the proposed device and the predicate device do not have any negative effect on the safety and effectiveness of the device.
The non-clinical test and clinical results conclude that the Rapid Exchange (RXi) System and Navyus Catheter to be substantially equivalent to the predicate device, Radi Analyzer and PressureWire Sensor.
Conclusion
Based on ACIST Medical Systems assessment of the Rapid Exchange (RXi) System, Navus Catheter and predicate device, we conclude that the Rapid Exchange (RXi) System and Navvus Catheter contains technological features that do not differ significantly from the currently marketed device. Bench testing completed according to the Verification and Validation Test Plans confirms that the design specifications for the Rapid Exchange (RXi) System and Navvus Catheter have been met and that the device meets the applicable requirements for the safety and performance standards cited. Therefore, ACIST Medical Systems concludes that the Rapid Exchange (RXi) System and Navvus Catheter are substantially equivalent to the legally marketed predicate device subject to this 510(k) based on design, performance, characteristics, and indication for use and does not introduce any new questions regarding safety or effectiveness of the product for its proposed intended use.
9
Image /page/9/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized symbol that resembles an abstract human figure or a caduceus, with three wavy lines extending upwards.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
January 30, 2014
Acist Medical Systems Matthew Stepanek Principal Regulatory Affairs Specialist 7905 Fuller Road Eden Prairie, MN 55344 US
Re: K132474
Trade/Device Name: Rapid Exchange (RXi) System and Navvus Catheter Regulation Number: 21 CFR 870.2870 Regulation Name: Catheter Tip Pressure Transducer, Diagnostic Intravascular Catheter Regulatory Class: Class II Product Code: DXO, OBI Dated: December 19, 2013 Received: December 20, 2013
Dear Mr. Stepanek:
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 your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies.
10
Page 2 - Matthew Stepanek
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 device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in 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 Small Manufacturers, International and Consumer Assistance at its tollfree 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 Small Manufacturers, International and Consumer Assistance 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 yours,
Owen P. Faris -S
for
Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
11
Section 5
Statement of Indications for Use
510(k) Number: K132474
Device Name: Rapid Exchange (RXi) System and Navvus Catheter
Indications for Use: The ACIST Rapid Exchange (RXi) System is indicated for obtaining intravascular pressure measurements for use in the diagnosis and treatment of coronary and peripheral artery disease. The Navvus Catheter is intended for use with the ACIST RXi System.
Prescription Use × (Per 21 CFR 801 Subpart D) AND/OR
Over-The Counter Use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Digitally signed by Owen P.
Faris-S
Date: 2014.01.30 15:14:14
-05:00
ACIST Medical Systems Traditional 510(k) Notification Rapid Exchange (RXI) System and Navvus Catheler Page 1 of 1