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 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.

AI/ML Overview

This submission, KD13943, is a 510(k) summary for the RadiAnalyzer™ System, a blood pressure computer. The manufacturer, RADI Medical Systems AB, is seeking clearance for a device that is "identical to the predicate devices" in its mechanical, electrical, and signal properties, with the only stated new feature being a "new PC-software for digital transfer of RadiAnalyzer™ physiological recordings."

Given the nature of a 510(k) submission for a device largely identical to a predicate and the provided document content, it is highly unlikely that a comprehensive standalone study with extensive performance metrics, ground truth establishment, or comparative effectiveness studies (MRMC) were conducted or are detailed in this summary. 510(k) submissions typically focus on demonstrating substantial equivalence to a legally marketed predicate device rather than conducting new, elaborate clinical performance studies unless the device introduces significant new technology, intended uses, or raises new questions of safety and effectiveness. This case appears to be a modification of an existing cleared device (K002067).

Therefore, the information regarding acceptance criteria and performance studies will be limited to what can be inferred or directly stated in the provided text, which primarily focuses on substantial equivalence based on technical characteristics rather than a new performance validation study as might be seen for novel AI algorithms.

Here's an analysis based on the provided text, acknowledging the limitations inherent in a 510(k) summary for a substantially equivalent device:

1. Table of Acceptance Criteria and Reported Device Performance

Based on the provided text, there are no explicit "acceptance criteria" or a detailed "reported device performance" table as one might expect for a novel device or AI algorithm. The core of this 510(k) is to demonstrate substantial equivalence to its predicate device (RadiAnalyzer™ System 510(k) # K002067). The key "performance" criterion for this submission is that the device's technical characteristics are identical to the predicate, apart from the new software component.

Acceptance Criteria (Inferred from Substantial Equivalence)	Reported Device Performance (Inferred from Submission)
Technical Characteristics: Mechanical, electrical, and signal properties are equivalent to the predicate device (K002067).	The submission explicitly states: "The mechanical, electrical and signal properties of RadiAnalyzer™ are identical to the predicate devices." This implies that the device meets this criterion by being identical in these core aspects.
Intended Use: The device performs the same intended use as the predicate (calculates, displays, and records vascular data including systolic, diastolic, mean BP, HR, and FFR, acquired from PressureWire Sensor and EPT, for use in catheterization labs).	The "Intended Use" section for the new device is essentially the same as that of the predicate, indicating it fulfills the same functions.
Safety and Effectiveness: No new questions of safety or effectiveness are raised compared to the predicate device.	The FDA's clearance implicitly means they determined that the device, given its substantial equivalence to the predicate and the limited new features (PC software for data transfer), does not raise new questions of safety or effectiveness. No specific study data is presented to prove safety or effectiveness beyond the assertion of technical equivalence and the addition of a data transfer utility, which would likely have been assessed for basic functionality and data integrity rather than medical performance.
Functionality of New PC-software: The RadiView™ software effectively transfers digital physiological recordings.	While not explicitly detailed, the "Technical Characteristics" mention RadiView as "a new PC-software for digital transfer of RadiAnalyzer™ physiological recordings." This implies that its functionality is limited to data transfer and not
to deriving new diagnostic information or altering the core FFR calculation. Any specific acceptance criteria for this software (e.g., data integrity, transfer speed, compatibility) would be internal to the manufacturer's development and verification testing and not typically detailed in a 510(k) summary if it doesn't impact diagnostic performance.

2. Sample Size Used for the Test Set and Data Provenance

The provided text does not contain any information about a specific test set, its sample size, or data provenance (e.g., country of origin, retrospective/prospective). This is consistent with a 510(k) submission largely based on substantial equivalence to an existing device rather than a new performance study. The "test set" for this type of submission would primarily involve engineering verification and validation that the new device (or its modified component, the software) continues to function as intended and comparably to the predicate.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

There is no mention of expert involvement for establishing ground truth as there is no specific performance test set described in the provided document. For a blood pressure computer, the "ground truth" for its core function (measuring and calculating pressures and FFR) would typically be the physical fluid dynamics and pressure readings themselves, validated through bench testing and, for the predicate, potentially prior clinical studies to correlate with clinical outcomes.

4. Adjudication Method for the Test Set

As no specific test set or clinical study is detailed for this 510(k) submission, there is no information regarding an adjudication method.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size of How Much Human Readers Improve with AI vs without AI Assistance

No, an MRMC comparative effectiveness study was not conducted or described in this document. This device is a blood pressure computer that directly measures and calculates physiological parameters (BP, HR, FFR). It does not involve "human readers" interpreting images or data in a way that would lend itself to an MRMC study or "AI assistance" in the sense of an interpretive algorithm. Its function is to provide raw and calculated numerical data.

6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) Was Done

The device itself, the RadiAnalyzer, is a standalone instrument in that it performs calculations (Fractional Flow Reserve, systolic, diastolic, mean blood pressure, heart rate) based on sensor inputs without human intervention in the calculation process. However, the term "standalone performance" often refers to the performance of an algorithm in generating a diagnostic output without human interpretation or modification.

Since the device's function is to directly measure and calculate established physiological parameters from sensor data, its "standalone performance" is embedded in its engineering validation for accuracy, precision, and consistency of these measurements and calculations. The 510(k) relies on the fact that these core mechanical, electrical, and signal properties are identical to the predicate device. Therefore, the standalone performance, as recognized and cleared in the predicate device, is considered to be maintained. There is no new standalone algorithm described that would warrant a separate performance study of its own.

7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)

Given that this is a blood pressure computer measuring physical values, the ground truth for its core functions (blood pressure, heart rate, FFR calculations) would primarily be based on:

Physical Reference Measurements: Comparison to highly accurate reference pressure transducers and flow models during design and verification.
Physiological Principles: The FFR calculation itself is based on established physiological principles and equations.
Prior Clinical Validation (of the predicate): The predicate device would have undergone validation to ensure its measurements correlate with clinical understanding and possibly patient outcomes, although specific details are not in this summary.

No human expert consensus, pathology, or outcomes data is explicitly mentioned as being used for ground truth in this specific 510(k) submission.

8. The Sample Size for the Training Set

There is no mention of a training set or its sample size. This device is not an AI/ML algorithm that requires training data in the typical sense. It is a hardware and software system for measuring and calculating physiological parameters.

9. How the Ground Truth for the Training Set Was Established

As there is no training set described, there is no information on how ground truth for a training set was established.

Summary

{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 ABPalmbladsgatan 10SE-754 50 Uppsala, SwedenPhone:(+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

K013943

Device Name:

510(k) Number:

RadiAnalyzer™ System

Indications for Use:

(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 /

Over-The-Counter Use

(Per 21 CFR 801.109)

Regulation Number and Section

§ 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).