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 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.

AI/ML Overview

The provided text describes the regulatory clearance for the RADIAnalyzer™ device and details its function and intended use. However, it does not contain any information regarding specific acceptance criteria, a study that proves the device meets those criteria, sample sizes, data provenance, expert qualifications, or ground truth methods.

The document states that the RADIAnalyzer™ complies with voluntary standards and that quality assurance measures were applied, including:

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

It concludes that "The results of these measures demonstrate that the RADIAnalyzer™ is as safe, as effective, and performs as well as the predicate devices." This implies that the device was compared to predicate devices for safety and effectiveness, but no details of such a comparison (e.g., performance metrics, statistical analysis) are provided.

Therefore, I cannot populate the table or answer the specific questions you've posed based on the given input. The information required (acceptance criteria, study details, sample sizes, ground truth methodology, etc.) is not present in the provided 510(k) summary.

Summary

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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 +46-18-161000 / +46-18-161099 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:

Intended Use:

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 (301) 594-4646. 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,

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 hemodynamicinformation for use in the diagnosis and treatment of coronary orperipheral artery disease.RADIAnalyzer™ is intended for use in catheterization and relatedcardiovascular specially laboratories to compute, and displayvarious physiological parameters based on the output from one ormore electrodes, transducers or measuring devices.

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)

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

Regulation Number and Section

§ 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).