RADIANALYZER, MODEL 12710

K022188 · Radi Medical Systems AB · DQK · Oct 3, 2002 · Cardiovascular

Device Facts

• Record ID: K022188
• Device Name: RADIANALYZER, MODEL 12710
• Applicant: Radi Medical Systems AB
• Product Code: DQK · Cardiovascular
• Decision Date: Oct 3, 2002
• 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 specially laboratories to compute, and display various physiological parameters based on the output from one or more electrodes, transducers or measuring devices.

Device Story

RADIAnalyzer™ is a diagnostic computer for catheterization labs; operated by clinical staff. Inputs include signals from PressureWire™ sensors and external pressure transducers. Device computes, records, and displays hemodynamic parameters: systolic/diastolic/mean blood pressure, heart rate, Fractional Flow Reserve (FFR), Coronary Flow Reserve (CFR), and temperature. Outputs displayed on integrated screen; data transferable to cardiac monitors, printers, or PCs running RADIView™. Provides real-time physiological data to assist clinicians in diagnosing and treating coronary or peripheral artery disease.

Clinical Evidence

Bench testing only. No clinical data provided. Performance verified through requirements specification review, code inspection, software/hardware testing, safety testing, environmental testing, and final validation.

Technological Characteristics

Programmable diagnostic computer (21 CFR 870.1425). Electrical and signal properties identical to predicates. Integrated screen display; connectivity to external monitors, printers, and PCs. Software-based computation of hemodynamic parameters.

Indications for Use

Indicated for patients undergoing diagnosis or treatment of coronary or peripheral artery disease in catheterization or cardiovascular 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 (K013943)
• RADIAnalyzer (K002067)
• SmartFlow (K020127)
• Thermometer Models ST8631 (K021048)

Submission Summary (Full Text)

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OCT 03 2002

#### 510(K) SUMMARY OF SAFETY AND EFFECTIVENESS 3

## Submitter's Information:

Name: Address: Phone/Fax: Contact Person: Date of Preparation: RADI Medical Systems AB Palmbladsgatan 10, SE-754 50 Uppsala, Sweden [phone] / [phone] Mats Granlund July 1, 2002

## Device Name:

Trade Names: Common Name: Classification Name: RADIAnalyzer™ Programmable Diagnostic Computer 8870.1425

Predicate Device Names:

RADIAnalyzer (K013943 / K002067) SmartFlow (K020127) Thermometer Models ST8631 (K021048)

## Device Description:

RADIAnalyzer™ is a diagnostic computer designed to compute, record and display information, based on the input from PressureWire™ Sensor and other External Pressure Transducer. 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 RADIView™ installed. Data includes: systolic, diastolic and mean blood pressure, heart rate, Fractional Flow Reserve (FFR), Coronary Flow Reserve (CFR) and temperature.

## 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 specially laboratories to compute, and display various physiological parameters based on the output from one or more electrodes, transducers or measuring devices.

## Technical Characteristic:

The mechanical, electrical and signal properties of RADIAnalyzer™ are identical to the predicate device.

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KO22188 p212

#### Performance Data:

The RADIAnalyzer™ complies with the voluntary standards as detailed in section 7 of this submission. The following quality assurance measures were applied to the development of the RADIAnalyzer™.

- . Requirements specification review
- Code inspection .
- Software and hardware testing .
- . Safety testing
- Environmental testing .
- . Final validation

#### Conclusions:

The results of these measures demonstrate that the RADIAnalyzer™ is as safe, as effective, and performs as well as the predicate devices.

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Public Health Service

Image /page/2/Picture/2 description: The image shows the logo for the U.S. Department of Health & 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 symbol featuring three abstract human profiles facing to the right, stacked on top of each other.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

OCT 03 2002

RADI Medical Systems AB c/o Mr. Mats Granlund Ouality and Regulatory Affairs Manager Palmbladsgatan 10 SE-754 50 Uppsala, Sweden

Re: K022188 Trade Name: RADIAnalyzer™ Model 12710 Regulation Number: 21 CFR 870.1425 Regulation Name: Programmable Diagnostic Computer Regulatory Class: Class II (two) Product Code: DQK Dated: July 1, 2002 Received: July 5, 2002

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 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 (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.

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,

K. Oelker

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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#### Statement of Indications for Use 2

| 510(k) Number: | K022188 |
|----------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Device Name: | RADIAnalyzer™ |
| Indications for Use: | RADIAnalyzer™ is indicated to provide hemodynamic<br>information for use in the diagnosis and treatment of coronary or<br>peripheral artery disease.<br>RADIAnalyzer™ is intended for use in catheterization and related<br>cardiovascular specially laboratories to compute, and display<br>various physiological parameters based on the output from one or<br>more electrodes, transducers or measuring devices. |

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## CONCURRENCE OF CDRH, OFFICE OF DEVICE EVALUATION (ODE)

Over-The-Counter Use _________________________________________________________________________________________________________________________________________________________ OR Prescription Use (Per 21 CFR 801.109)

(Optional Format 1/2/96)
Division of Cardiovascular & Respiratory Devices
510(k) Number K022188