MODIFICATION TO: RADIANALYZER, MODEL 12711

K042628 · Radi Medical Systems AB · DQK · Jan 19, 2005 · Cardiovascular

Device Facts

• Record ID: K042628
• Device Name: MODIFICATION TO: RADIANALYZER, MODEL 12711
• Applicant: Radi Medical Systems AB
• Product Code: DQK · Cardiovascular
• Decision Date: Jan 19, 2005
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.1425
• Device Class: Class 2

Intended Use

RadiAnalyzer® is indicated to provide hemodynamic information for use in the diagnosis and treatment of coronary or peripheral artery disease. RadiAnalyzer® is intended for use in catheterization and related cardiovascular specialty laboratories to compute, and display various physiological parameters based on the output from one or more electrodes, transducers, or measuring devices.

Device Story

Diagnostic computer for hemodynamic monitoring; inputs include signals from PressureWire® Sensor and Aortic Pressure Transducer (AO). Device computes, records, and displays physiological parameters including systolic, diastolic, and mean blood pressure, heart rate, Fractional Flow Reserve (FFR), Coronary Flow Reserve (CFR), and temperature. Used in catheterization and cardiovascular specialty labs by clinicians. Output displayed on integrated screen; data transferable to cardiac monitors, printers, or PCs via RADIView® software. Assists clinicians in assessing coronary/peripheral artery disease to guide treatment decisions.

Clinical Evidence

No clinical data provided; substantial equivalence based on technological and functional similarity to the predicate device.

Technological Characteristics

Programmable diagnostic computer; smaller and lighter form factor than predicate. Inputs: pressure sensors/transducers. Outputs: hemodynamic parameters (BP, HR, FFR, CFR, temperature). Connectivity: integrated screen, cardiac monitor, printer, and PC interface. Electrical and signal properties equivalent to predicate.

Indications for Use

Indicated for patients undergoing diagnosis and treatment of coronary or peripheral artery disease in catheterization and cardiovascular specialty laboratories.

Regulatory Classification

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.

Predicate Devices

• RADIAnalyzer®System (K022188)

Submission Summary (Full Text)

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# Attachment 4

### 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: | Helene Ekstrand |
| Date Prepared: | September 23th, 2004 |
| Proprietary Name: | RADIAnalyzer® |
| Common Name: | Programmable diagnostic computer |
| Classification Name: | §870.1425, Programmable diagnostic computer |
| Predicate Device: | RADIAnalyzer®System 510(k) # K022188 |

#### Description of the Device:

RADIAnalyzer® is a diagnostic computer designed to compute, record and display information, based on the input from PressureWire® Sensor and an Aortic Pressure Transducer (AO). 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 vicwing software installed such as RADIView® Software. Data includes: systolic, diastolic and mean blood pressure, heart rate, Fractional Flow Reserve (FFR), Coronary Flow Reserve (CFR) and temperature.

#### Intended Use of the Device:

RADIAnalyzer® is indicated to provide hemodynamic information for use in the diagnosis and treatment of coronary or peripheral artery disease.

RADIAnalyzer® is intended for use in catheterization and related cardiovascular specialty laboratories to compute, and display various physiological parameters based on the output from one or more electrodes, transducers or measuring devices.

#### Technical Characteristics:

The subject device, RADIAnalyzen®, version Xpress, is smaller and lighter version of the predicate device. Electrical and signal properties are equivalent to the predicate device.

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Image /page/1/Picture/1 description: The image shows the seal of the Department of Health & Human Services - USA. The seal is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is a stylized image of an eagle.

Public Health Service

JAN 1 9 2005

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Radi Medical Systems AB c/o Ms. Helene Ekstrand Regulatory Affairs Officer Palmbladsgatan 10 SE-754 50 Uppsala SWEDEN

Re: K042628

> Trade Name: RadiAnalyzer®Xpress Regulation Number: 21 CFR 870.1425 Regulation Name: Programmable Diagnostic Computer Regulatory Class: Class II (two) Product Code: 74 DQK Dated: November 12, 2004 Received: November 15, 2004

Dear Ms. Ekstrand:

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 accession 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 r ou may, merers, mains 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 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 - Ms. Helene Ekstrand

Please be advised that FDA's issuance of a substantial equivalence determination does not mean Flease oc advised that I Dri 3 issualles or our device complies with other requirements of the Act that I DA has made a actornments administered by other Federal agencies. You must or any it catal statutes and registents, including, but not limited to: registration and listing (21 Comply with an the Her 8 requirements)01); good manufacturing practice requirements as set CITY and 007); adoling (21 OS) regulation (21 CFR Part 820); and if applicable, the electronic forth in the quality by sions (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) I mis letter whilanow you to organ maing of substantial equivalence of your device to a legally premaince notification. "The 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), please If you desire operio darroliance at [phone]. Also, please note the regulation entitled, Comaci the Office of Companyers market notification" (21CFR Part 807.97). You may obtain Millsbraining of Yorerence to pur responsibilities under the Act from the Division of Small other general informational and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

B. Somimer for

Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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## Indication for Use

| 510(k) Number: | K042628 |
|----------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Device Name: | RadiAnalyzer® |
| Indications for Use: | RadiAnalyzer® is indicated to provide hemodynamic information for use in the diagnosis and treatment of coronary or peripheral artery disease.<br>RadiAnalyzer® is intended for use in catheterization and related cardiovascular specialty laboratories to compute, and display various physiological parameters based on the output from one or more electrodes, transducers, or measuring devices. |

Prescription Use _____________________________________________________________________________________________________________________________________________________________

(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)

Blumner

(Division Sign-Off) Division of Cardiovascular Devices 510(k) Number KOYA(No

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