(87 days)
Not Found
No
The summary describes a diagnostic computer that computes and displays physiological parameters based on input from transducers. There is no mention of AI, ML, or any related technologies like image processing, deep neural networks, or training/test sets for algorithms. The focus is on standard physiological parameter calculation and display.
No
The device is a diagnostic computer that computes, records, and displays physiological parameters for diagnosis and treatment planning, not for delivering therapy.
Yes
The "Intended Use / Indications for Use" section states that the device is "indicated to provide hemodynamic information for use in the diagnosis and treatment of patients". Additionally, the "Device Description" explicitly calls the device a "diagnostic computer".
No
The device description explicitly states that the RadiAnalyzer® Xpress is a "diagnostic computer" and lists several hardware components included in the standard configuration (remote control, monitor cables, adapter cable, mains cable). While it uses software for computation and display, it is not solely software.
Based on the provided information, the RadiAnalyzer® Xpress is not an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use describes the device as providing hemodynamic information for use in the diagnosis and treatment of patients undergoing physiological parameter measurements with a Pressure Wire®. It computes and displays physiological and blood flow parameters based on output from electrodes, transducers, or measuring devices. This involves analyzing signals from within the patient's body, not analyzing samples taken from the body (like blood, urine, or tissue).
- Device Description: The device description reinforces this by stating it computes, records, and displays information from a Pressure Wire® and other external transducers. It lists parameters like blood pressure, heart rate, and FFR, which are measured in vivo (within the living organism).
- Lack of IVD Characteristics: There is no mention of analyzing biological samples, reagents, or any of the typical components associated with in vitro diagnostics.
IVD devices are specifically designed to examine specimens derived from the human body to provide information for diagnostic purposes. The RadiAnalyzer® Xpress is designed to process and display physiological data obtained directly from within the patient.
N/A
Intended Use / Indications for Use
RadiAnalyzer® Xpress is intended for use in catheterization and related cardiovascular specialty laboratories to compute, and display various physiological and blood flow parameters based on the output from one or more electrodes, transducers or measuring devices.
RadiAnalyzer® Xpress is indicated to provide hemodynamic information for use in the diagnosis and treatment of patients that undergo measurement of physiological parameters with Pressure Wire®.
Product codes (comma separated list FDA assigned to the subject device)
DOK, DSK
Device Description
RadiAnalyzer® Xpress is a diagnostic computer designed to compute, record and display information from Pressure Wire® and other external transducers. The information is displayed as graphs as well as numerical values on the integrated screen and may also be transferred to a cardiac monitor, RadiAnalyzer® Printer and/or PC with external viewing software installed, such as RadiView® or PhysioMon™. Data includes: systolic, diastolic and mean blood pressure, heart rate, and Fractional Flow Reserve (FFR). RadiAnalyzer® Xpress can be upgraded with additional software, such as Thermo Option software to enable assessments of invasive temperature, Coronary Flow Reserve (CFR) or other physiological parameters such as first time derivative of pressure (dP/dt).
RadiAnalyzer® Xpress comes with one remote control, two monitor cables, one adapter cable, and one mains cable (standard configuration).
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
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
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
The software verification/validation conducted indicate that RadiAnalyzer® Xpress and its accessories PhysioMon™ and RadiView® satisfy safety and performance requirements of the device specifications and do not raise additional safety issues.
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.
RadiAnalyzer® Xpress (K042628), RadiView® (K013943)
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
§ 870.1425 Programmable diagnostic computer.
(a)
Identification. A programmable diagnostic computer is a device that can be programmed to compute various physiologic or blood flow parameters based on the output from one or more electrodes, transducers, or measuring devices; this device includes any associated commercially supplied programs.(b)
Classification. Class II (performance standards).
0
OCT - 9 2009
5 510(k) Summary of Safety and Effectiveness
This 510(k) summary of safety and effectiveness information is submitted in accordance with the requirements in the Safe Mcdical Device Act 1990 and 21 CFR §807.92.
Submitter's Information:
| Name: | Radi Medical Systems AB |
|---|---|
| Address: | Palmbladsgatan 10, |
| SE-754 50 Uppsala, Sweden | |
| Phone/Fax: | +46-18-16 10 00 / +46-18-16 10 99 |
| Contact Person: | Mats Granlund |
| Date of Preparation: | July 8, 2009 |
| Device Name: | |
| Trade Name: | RadiAnalyzer® Xpress |
| Common Name: | Diagnostic computer |
| Classification Name: | Programmable Diagnostic Computer §870.1425 |
| Blood pressure computer § 870.1110 | |
| Predicate Device Names: | RadiAnalyzer® Xpress (K042628) |
| RadiView® (K013943) |
Device Description:
RadiAnalyzer® Xpress is a diagnostic computer designed to compute, record and display information from Pressure Wire® and other external transducers. The information is displayed as graphs as well as numerical values on the integrated screen and may also be transferred to a cardiac monitor, RadiAnalyzer® Printer and/or PC with external viewing software installed, such as RadiView® or PhysioMon™. Data includes: systolic, diastolic and mean blood pressure, heart rate, and Fractional Flow Reserve (FFR). RadiAnalyzer® Xpress can be upgraded with additional software, such as Thermo Option software to enable assessments of invasive temperature, Coronary Flow Reserve (CFR) or other physiological parameters such as first time derivative of pressure (dP/dt).
RadiAnalyzer® Xpress comes with one remote control, two monitor cables, one adapter cable, and one mains cable (standard configuration).
Intended Use:
RadiAnalyzer® Xpress is intended for use in catheterization and related cardiovascular specialty laboratories to compute, and display various physiological and blood flow parameters based on the output from one or more electrodes, transducers or measuring devices.
1
The indication has been modified to address that the device is not only suitable for usage for diagnosis and treatment of coronary or peripheral artery disease but for patients that undergo measurement of physiological parameters with PressureWire®.
Indication for Use:
RadiAnalyzer® Xpress is indicated to provide hemodynamic information for use in the diagnosis and treatment of patients that undergo measurement of physiological parameters with Pressure Wire®.
Technical Characteristic:
The mechanical, clectrical and signal properties of RadiAnalyzer® Xpress are identical to the predicate device with the addition of the algorithm for calculation of the first time derivative of pressure and with the addition of the IMR (Index of Microcirculatory Resistance) calculation in the accessory RadiView®.
Functional/Safety testing:
The software verification/validation conducted indicate that RadiAnalyzer® Xpress and its accessories PhysioMon™ and RadiView® satisfy safety and performance requirements of the device specifications and do not raise additional safety issues.
Conclusion:
On the basis of the testing conducted, it may be concluded that RadiAnalyzer® Xpress and its accessories PhysioMon™ and RadiView® satify specificd safety and performance
requirements and are substantially equivalent to predicate devices.
2
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows the logo for the United States Department of Health and Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of an eagle with its wings spread, symbolizing the department's mission to protect the health of all Americans.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room W-066-0609 Silver Spring, MD 20993-0002
Radi Medical Systems AB Mr. Mats Granlund Director, Quality & Regulatory Affairs Palmbladsgatan 10, SE-754 50 Uppsala SWEDEN
OCT ~ 9 2009
Re: K092105
Trade/Device Name: RadiAnalyzer® Xpress Regulation Number: 21 CFR 870.1425 Regulation Name: Programmable Diagnostic Computer Regulatory Class: Class II (two) Product Codes: DOK, DSK Dated: July 8, 2009 Received: July 14, 2009
Dear Mr. Granlund:
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.
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.
3
Page 2 -- Mr. Mats Granlund
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 (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) 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 go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR 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 vours.
M. A. Hillebrenner
for Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Indications for Use
510(k) Number:
Kogzios
Device Name:
RadiAnalyzer® Xpress
Indications for Use:
RadiAnalyzer® Xpress is indicated to provide hemodynamic information for use in the diagnosis and treatment of patients that undergo measurement of physiological parameters with Pressure Wire®.
RadiAnalyzer® Xpress is intended for use in catheterization and related cardiovascular specialty laboratories to compute, and display various physiological and blood flow parameters based on the output from one or more electrodes, transducers or measuring devices.
Prescription Use X (Per 21 CFR 801.Subpart D)
'
.. .
Over-The-Counter Use AND/OR (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
M. A. Hillhem
Page 1 of _
ivision Sian-Off) Division of Cardiovascular Devices
09 2105 510(k) Number