RADIANALYZER, MODEL 12710, RADIVIEW (PC-SOFTWARE ACCESSORY), MODEL 12720

K013943 · Radi Medical Systems AB · DSK · Dec 18, 2001 · Cardiovascular

Device Facts

• Record ID: K013943
• Device Name: RADIANALYZER, MODEL 12710, RADIVIEW (PC-SOFTWARE ACCESSORY), MODEL 12720
• Applicant: Radi Medical Systems AB
• Product Code: DSK · Cardiovascular
• Decision Date: Dec 18, 2001
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 870.1110
• Device Class: Class 2

Intended 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.

Device Story

RadiAnalyzer™ System functions as a blood pressure computer for cardiovascular diagnostic use. It accepts real-time pressure signal inputs from a PressureWire™ Sensor and an External Pressure Transducer (EPT). The device processes these signals to calculate systolic, diastolic, and mean blood pressure, heart rate, and Fractional Flow Reserve (FFR). Outputs are presented on an integrated graphic display or transmitted to a cardiac monitor. The system is operated via remote control in catheterization or cardiovascular laboratories by physicians. It supports data transfer to a printer or a PC running RadiView™ software for recording purposes. The device assists clinicians in assessing vascular status to inform diagnostic decision-making.

Clinical Evidence

No clinical data provided; substantial equivalence is based on identical mechanical, electrical, and signal properties to the predicate device.

Technological Characteristics

Blood pressure computer; inputs from PressureWire™ Sensor and External Pressure Transducer (EPT); outputs to integrated display, cardiac monitor, printer, or PC via RadiView™ software; remote control operation; identical mechanical/electrical/signal properties to predicate.

Indications for Use

Indicated for use under the direction of a licensed physician in catheterization and cardiovascular laboratories to calculate, display, and record vascular data (systolic, diastolic, mean blood pressure, heart rate, and FFR) acquired from PressureWire sensors and external pressure transducers.

Regulatory Classification

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.

Predicate Devices

• RadiAnalyzer™ System (K002067)

Submission Summary (Full Text)

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## 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<br>Palmbladsgatan 10<br>SE-754 50 Uppsala, Sweden<br>Phone:[phone] |
|----------------------|---------------------------------------------------------------------------------------------------|
| 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.

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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.

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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 [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. 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 [phone] or [phone] 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

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### Attachment 2

# Indication for Use Statement

K013943

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.

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#### 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)