Florence Medical Ltd. SmartFlow™ is intended for use in coronary and peripheral vasculature in conjunction with pressure measurement devices during and after diagnostic procedures, such as angiography, or interventional procedures, such as angioplasty, to evaluate the hemodynamic status of the diseased arteries and to provide further clinical information in the diagnosis and treatment of both coronary and peripheral artery diseases.

Device Description

The SmartFlow™ with the Multiple Lesion software is a tool for measuring coronary and peripheral vasculature hemodynamic status patterns during diagnostic and interventional procedures.

The SmartFlow™ is a PC based system comprising of a full color display with a touchscreen for patient data entry and control, and software calculations of the CFR and FFR parameters. The display and touchscreen are mounted in a shielded metal housing.

The SmartFlow™ may be operated through its touchscreen or through an Infrared receiver port which allows the use of a hand-held remote.

There are two defined accessories for use with the device: Monitor interface for standard medical monitors and hand-held Infrared remote control which activates function keys and acts as a mouse.

AI/ML Overview

This document describes the SmartFlow™M device, a diagnostic tool for evaluating the hemodynamic status of coronary and peripheral vasculature. The information provided is from a 510(k) summary, which is a premarket notification for a medical device to demonstrate that it is substantially equivalent to a legally marketed predicate device.

Note: The provided text does not contain a detailed study report with specific acceptance criteria, sample sizes, and detailed methodology for a clinical or performance study of the SmartFlow™M device itself. Instead, it describes the device, its intended use, and its substantial equivalence to a previously cleared device. Therefore, the response below will extrapolate and make assumptions based on standard FDA 510(k) submissions where such details are usually found in the performance data section, which is missing from this excerpt.

Here's an analysis based on the provided text, highlighting what is present and what is missing:

1. Table of Acceptance Criteria and Reported Device Performance

This information is not explicitly provided in the given 510(k) summary. A 510(k) summary typically includes a table comparing the performance of the new device to the predicate device, often using metrics like accuracy, sensitivity, specificity, and potentially precision or agreement for quantitative measurements such as CFR (Coronary Flow Reserve) and FFR (Fractional Flow Reserve), which the SmartFlow™ calculates.

Since the device "enables analysis of multiple lesion cases as well as single lesion cases," a key performance metric would likely revolve around its ability to accurately measure CFR and FFR for multiple lesions and its agreement with established methods or the predicate device.

Hypothetical Acceptance Criteria (based on common practice in this field, not from the document):

Performance Metric	Acceptance Criteria (Hypothetical)	Reported Device Performance (Not in document, would be based on studies)
Agreement for FFR measurement	Mean difference (new vs. predicate/gold standard) within ± 0.02, with 95% limits of agreement within ± 0.05	Not provided in excerpt
Agreement for CFR measurement	Mean difference (new vs. predicate/gold standard) within ± 0.5 units, with 95% limits of agreement within ± 1.0 unit	Not provided in excerpt
Accuracy for lesion identification (for multiple lesion cases)	Sensitivity > 90%, Specificity > 85% for identifying relevant lesions in simulated or clinical data	Not provided in excerpt
Reproducibility/Precision	Coefficient of Variation (CV) < 5%	Not provided in excerpt

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

This information is not provided in the given 510(k) summary. For a device like SmartFlow, a test set would typically involve a cohort of patients undergoing coronary or peripheral procedures where hemodynamic measurements are taken.

Sample Size (Test Set): Not provided. This would depend on the statistical power needed to demonstrate equivalence or performance.
Data Provenance: Not provided. Often, data provenance includes details like the country/countries where the study was conducted, the number of clinical sites, and whether the data was collected retrospectively or prospectively. Given the submitter's location (Kfar-Saba, Israel), it's possible some data originated there, but this is speculative without explicit mention.

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

This information is not provided in the given 510(k) summary. For a device that measures FFR and CFR, the "ground truth" often involves established invasive pressure wire measurements, potentially correlated with imaging (e.g., angiography) interpreted by experienced interventional cardiologists or radiologists.

Number of Experts: Not provided. Usually, multiple experts (e.g., 2-3 independent readers/interpreters) are involved, especially if subjective interpretation is part of the ground truth establishment.
Qualifications of Experts: Not provided. Experts would typically be interventional cardiologists with significant experience (e.g., 5-10+ years of experience) in performing and interpreting these procedures.

4. Adjudication Method for the Test Set

This information is not provided in the given 510(k) summary. If multiple experts were involved in establishing ground truth (which is common for these types of devices), an adjudication method would be used to resolve discrepancies. Common methods include:

Consensus: Experts discuss and reach a joint decision.
Majority Vote: If three experts, 2 out of 3 determines the ground truth.
Senior Expert Adjudication: A designated senior expert makes the final decision in case of disagreement.
Adjudication Method: Not provided.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size of Human Readers Improving with AI vs. Without AI Assistance

This information is not provided in the given 510(k) summary.

MRMC Study: The document describes SmartFlow™ as a "tool for measuring" and "software calculations of the CFR and FFR parameters." It's a system to provide quantitative data. It is not presented as an "AI-assisted interpretation" device for human readers. Therefore, an MRMC study measuring human reader improvement with vs. without AI assistance is unlikely to have been the primary study performed for this device, as it doesn't appear to be an AI diagnostic aid in the context of improving human interpretation of images. The device calculates parameters directly.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done

Yes, the nature of the device suggests a standalone performance evaluation. The SmartFlow™ performs "software calculations of the CFR and FFR parameters." This implies that the algorithm itself takes input (likely pressure measurements) and outputs CFR and FFR values. The performance of these calculations, relative to a gold standard (e.g., highly accurate reference pressure wire systems or established formulas), would be a standalone evaluation of the algorithm's accuracy and precision.

Standalone Study: Based on the description, yes, a standalone evaluation of the algorithm's performance in calculating CFR and FFR would be central to its clearance.

7. The Type of Ground Truth Used

The ground truth for a device calculating CFR and FFR would typically be:

Established Invasive Measurements: Direct, invasive pressure wire measurements considered the clinical gold standard for FFR and CFR. These measurements are taken by highly accurate transducers during the diagnostic or interventional procedure.
Correlation with Clinical Outcomes: While not the primary ground truth for algorithm accuracy, studies might also correlate the device's outputs with patient outcomes (e.g., recurrence of angina, need for revascularization) to demonstrate clinical utility.
Ground Truth Type: Established Invasive Measurements (e.g., from an independent, highly accurate pressure measurement system) would be the most relevant ground truth for validating CFR and FFR calculations.

8. The Sample Size for the Training Set

This information is not provided in the given 510(k) summary. SmartFlow is described as a system that performs "software calculations" of CFR and FFR. While the software might incorporate algorithms, the term "training set" strongly implies a machine learning or AI component. The description doesn't explicitly state that the calculations are based on a machine learning model that requires a training set in the conventional sense. It could be based on well-established physiological models and mathematical equations.

Sample Size (Training Set): Not provided. If the underlying algorithms are purely deterministic (based on physics and physiology equations), a "training set" in the AI sense wouldn't be applicable. If there are data-driven models, then a training set would be used, but its size is not mentioned.

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

This information is not provided and is dependent on whether a training set, as typically understood in machine learning, was even used.

Ground Truth Establishment (Training Set): Not provided. If a training set was used, the ground truth would typically be established similarly to the test set: using established invasive measurements performed by expert clinicians.

In summary, the provided 510(k) excerpt focuses on the device description, indications for use, and substantial equivalence to a predicate device. It lacks the detailed performance study results, including specific acceptance criteria, sample sizes, and methodology for ground truth establishment that would typically be found in the "Performance Data" section of a full 510(k) submission.

Summary

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510(k) Summary

Florence Medical Ltd.

SmartFlow™M

510(k) Number K_012947

Submitter's Name:

Florence Medical Ltd. Sharona Center 12 Derech Hasharon Kfar-Saba, Israel Tel.: 972-9-7431975 Fax: 972-9-7452323 SmartFlow(@florence.co.il

Contact Person:

Shoshana Friedman, RAC Push-Med Ltd. 117, Ahuza St., Ra'ananna 43373, Israel Tel: 972-9-7718130 Fax: 972-9-7718131

Trade Name:

SmartFlow™

Classification Name:

Computer, Diagnostic, Programmable

Classification:

Computer, Diagnostic, Programmable are class II devices (Product Code DQK).

Predicate Device:

The SmartFlow™ with the Multiple Lesion software is substantially equivalent to the SmartFlow™ (Florence Medical Ltd.) cleared under K003122.

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Indication for use:

Device Description:

The SmartFlow™ with the Multiple Lesion software is a tool for measuring coronary and peripheral vasculature hemodynamic status patterns during diagnostic and interventional procedures.

The SmartFlow™ may be operated through its touchscreen or through an Infrared receiver port which allows the use of a hand-held remote.

There are two defined accessories for use with the device: Monitor interface for standard medical monitors and hand-held Infrared remote control which activates function keys and acts as a mouse.

Substantial Equivalence:

The SmartFlow™ with the Multiple Lesion software is substantially equivalent to the SmartFlow™ In fact, it is an improved model of the SmartFlow™ that enables analysis of multiple lesion cases as well as single lesion cases.

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Image /page/2/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS) of the United States. The seal features a stylized eagle with three stripes representing the department's mission. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged in a circular pattern around the eagle.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

OCT - 2 2001

Mr. Shoshana Friedman Managing Director Florence Medical Ltd. c/o Push-Med Ltd. 117 Ahuzah Street Ra'ananna 43373, Israel

K012947 Re:

Trade Name: SmartFlow™ Regulation Number: 21 CFR 870.1425 Regulation Name: Programmable dianostic computer. Regulatory Class: II Product Code: DQK Dated: August 25, 2001 Received: September 4, 2001

Dear Mr. Friedman,

We have reviewed your Section 510(k) premarket notification of intent to market the device we nave reviewed your becaon 3 ro(t) premised is substantially equivalent (for the indications felerenced above and nave colorizes ally marketed predicate devices marketed in interstate for use stated in the encroours) to regard cate of the Medical Device Amendments, or to Connices that have been reclassified in accordance with the provisions of the Federal Food, Drug, devices that have been recuire approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The I ou may, dicrorore, market are act include requirements for annual registration, listing of golloral oonly of of of acturing 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 is elassinod (600 a croppos. Existing major regulations affecting your device can may or subject to basil adades a legulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

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 or any I with all the Act's requirements, including, but not limited to: registration and listing (21

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Page 2 - Mr. Shoshana Friedman

CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set CITY at 807); adomig (21 OF RT R1000); government (20); and if applicable, the electronic form in also quality by solisions (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 premarket notincation: THP PDF miraling of cation 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 If you desire specific arra 809.10 for in vitro diagnostic devices), please contact the Office of additionally 21 CF N Furt 607.10 for questions on the promotion and advertising of Compliance at (301) 594-1999. Iffice 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 Outer general mionnation or your 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,

signature

James E. Dillard III Director Division of Cardiovascular and Respiratory Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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INDICATIONS FOR USE STATEMENT

510(k) Number:

K 012947

SmartFlow™ Device Name:

Indications for Use:

The SmartFlow™ is intended for use in coronary and peripheral vasculature in The Onlart 10 w - aresure measurement devices during and after diagnostic procedures, such as angiography, or interventional procedures, such as angioplasty, to evaluate the hemodynamic status of the diseased arteries and to provide further clinical information in the diagnosis and treatment of both coronary and peripheral artery diseases.

(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 K012947

Prescription Use
(Per 21 CFR 801.109)

Over the Counter Use

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).