(19 days)
No
The description focuses on calculating, displaying, and recording standard vascular data (blood pressure, heart rate, FFR) from sensors. There is no mention of AI, ML, image processing, or any learning/adaptive capabilities. The device appears to be a data acquisition and display system.
No
The device is described as a "diagnostic tool" that calculates, displays, and records vascular data for diagnosis, rather than providing or supporting a therapy.
Yes
Explanation: The "Device Description" explicitly states, "The RadiAnalyzer™ is a blood pressure computer, to be used as a diagnostic tool when the diagnosis is based on patient blood pressures." Additionally, the "Intended Use / Indications for Use" section details its use to "calculate, display and record vascular data" and specifically mentions "Fractional Flow Reserve (FFR)," which is a diagnostic measurement.
No
The device description explicitly states it comprises a graphic display, remote control, and entries/outlets for pressure signals and connections, indicating it includes hardware components beyond just software.
Based on the provided information, the RadiAnalyzer is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- RadiAnalyzer's function: The RadiAnalyzer directly measures and processes physiological data (blood pressure, heart rate, FFR) from within the patient's vascular system using a PressureWire Sensor and External Pressure Transducer. This is an in vivo measurement, not an in vitro test on a sample.
- Intended Use: The intended use clearly states it's for calculating, displaying, and recording vascular data acquired from sensors placed within the body.
Therefore, the RadiAnalyzer falls under the category of a medical device used for physiological monitoring and data analysis, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The RadiAnalyzer is intended for use under the direction of a licensed physician to calculate, display and record vascular data. Data is acquired from a PressureWire Sensor and an External Pressure Transducer (EPT). The information is displayed on the integrated screen and/or transferred to a cardiac monitor. Data includes: systolic, diastolic and mean blood pressure, heart rate, and Fractional Flow Reserve (FFR). The RadiAnalyzer is intended for use in catheterization and related cardiovascular specially laboratories.
Product codes
DSK
Device Description
The RadiAnalyzer™ is a blood pressure computer, to be used as a diagnostic tool when the diagnosis is based on patient blood pressures. The device comprises a graphic display that presents real-time pressure curves as well as numerical values, and is operated via a remote control. The device has two entries for pressure signals, one for a PressureWire™ Sensor, and another for an External Pressure Transducer (EPT) and corresponding outlets for connection to a cardiac monitor. The RadiAnalyzer™ could also be connected to a RadiAnalyzer™-Printer or to a PC with the RadiView™ software installed.
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
licensed physician, catheterization and related cardiovascular specially 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)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 870.1110 Blood pressure computer.
(a)
Identification. A blood pressure computer is a device that accepts the electrical signal from a blood pressure transducer amplifier and indicates the systolic, diastolic, or mean pressure based on the input signal.(b)
Classification. Class II (performance standards).
0
Attachment 4
KD13943
510(k) Summary
This 510(k) summary is submitted in accordance with the requirements in 21 CFR §807.92
| Submitted by: | RADI Medical Systems AB
Palmbladsgatan 10
SE-754 50 Uppsala, Sweden
Phone:(+46) 18161000 |
|----------------------|---------------------------------------------------------------------------------------------------|
| Contact Person: | Mats Granlund |
| Date Prepared: | November 27, 2001 |
| Proprietary Name: | RadiAnalyzer™ System |
| Common Name: | Blood Pressure Computer |
| Classification Name: | §870.1110 Blood Pressure Computer |
| Predicate Device: | RadiAnalyzer™ System 510(k) # K002067 |
The RadiAnalyzer™ is a blood pressure computer, to be Description of the Device: used as a diagnostic tool when the diagnosis is based on patient blood pressures. The device comprises a graphic display that presents real-time pressure curves as well as numerical values, and is operated via a remote control.
The device has two entries for pressure signals, one for a PressureWire™ Sensor, and another for an External Pressure Transducer (EPT) and corresponding outlets for connection to a cardiac monitor. The RadiAnalyzer™ could also be connected to a RadiAnalyzer™-Printer or to a PC with the RadiView™ software installed.
Intended Use of the Device: The RadiAnalyzer is intended for use under the direction of a licensed physician to calculate, display and record vascular data. Data is acquired from a PressureWire Sensor and an External Pressure Transducer (EPT).
The information is displayed on the integrated screen and/or transferred to a cardiac monitor. Data includes: systolic. diastolic and mean blood pressure, heart rate, and Fractional Flow Reserve (FFR).
The RadiAnalyzer is intended for use in catheterization and related cardiovascular specially laboratories.
The mechanical, electrical and signal properties of Technical Characteristics: RadiAnalyzer™ are identical to the predicate devices. RadiView is a new PC-software for digital transfer of RadiAnalyzer™ physiological recordings.
1
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
DEC 1 82001
Mr. Mats Granlund Quality & Regulatory Affairs Manager RADI Medical Systems AB Palmbladsgatan 10 SE-754 52 Uppsala SWEDEN
Re: K013943
Trade Name: RadiAnalyzer™ System Regulation Number: 21 CFR 870.1110 Regulation Name: Blood Pressure Computer Regulatory Class: Class II (two) Product Code: DSK Dated: November 27, 2001 Received: November 29, 2001
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 for do cance 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 If your device to such 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.
2
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); 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.
This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 21 CFR Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4645. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely yours,
D. Darlene Tiller, MP
ram D. Zuckerman, M.D. Acting Director Division of Cardiovascular and Respiratory Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
3
Attachment 2
Indication for Use Statement
Device Name:
510(k) Number:
RadiAnalyzer™ System
Indications for Use:
The RadiAnalyzer is intended for use under the direction of a licensed physician to calculate, display and record vascular data. Data is acquired from a PressureWire Sensor and an External Pressure Transducer (EPT). The information is displayed on the integrated screen and/or transferred to a cardiac monitor. Data includes: systolic, diastolic and mean blood pressure, heart rate, and Fractional Flow Reserve (FFR). The RadiAnalyzer is intended for use in catheterization and related cardiovascular specially laboratories.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
CONCURRENCE OF CDRH, OFFICE OF DEVICE EVALUATION (ODE)
Division of Cardiovascular & Respiratory Devices
510(k) Number K013943
Prescription Use /
OR
Over-The-Counter Use
(Per 21 CFR 801.109)