The 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 Pulse Transmission Coefficient 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.

AI/ML Overview

The provided text is a 510(k) summary for the SmartFlow® device, which is a programmable diagnostic computer for evaluating hemodynamic status. It primarily focuses on demonstrating substantial equivalence to previously cleared models. It does not contain information about acceptance criteria, detailed study designs, or specific performance metrics that would allow for a comprehensive response to all the requested points.

However, based on the available information, here's what can be inferred and what is missing:

Summary of Available Information from the Provided Text:

Device: SmartFlow® with Pulse Transmission Coefficient software.
Intended Use: To evaluate the hemodynamic status of diseased arteries in coronary and peripheral vasculature in conjunction with pressure measurement devices during diagnostic and interventional procedures.
Regulatory Status: Class II device (Product Code DQK), cleared via 510(k) process.
Substantial Equivalence: Claimed against previous SmartFlow® models (K003122 and K012947), with the current model being an improved version that includes calculation of transmission of high-frequency components of the pressure signal and Multiple Lesion case analysis. The FDA concurred with this claim.

Detailed Response to Requested Information (Based on Available Text and Inferences):

A table of acceptance criteria and the reported device performance

Acceptance Criteria Reported Device Performance
Not specified. Not specified.
- Explanation: The document is a 510(k) summary, which typically focuses on substantial equivalence rather than detailed performance study results with predefined acceptance criteria. For devices cleared through 510(k) based on substantial equivalence, the "acceptance criteria" are generally met if the device performs as well as, or better than, the predicate device in its intended use, and does not raise new questions of safety or effectiveness. Specific quantitative acceptance metrics are usually part of a full study report, not necessarily summarized in the 510(k) summary itself unless directly tied to the substantial equivalence claim for a novel feature. The text only states that it is an "improved model" with additional features for calculating pulse transmission coefficient and multiple lesion analysis.
Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample Size for Test Set: Not specified.
- Data Provenance: Not specified. The submitter is from Israel, but the location or nature of any data used for testing (if performed) is not mentioned.
- Retrospective or Prospective: Not specified.
- Explanation: As a 510(k) for an improved version of an already cleared device, detailed clinical study data (with test sets and provenance) might not have been required for substantial equivalence, or it might be presented in confidential sections of the full 510(k) submission, not in this public summary.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
- Number of Experts: Not specified.
- Qualifications of Experts: Not specified.
- Explanation: Ground truth establishment information is not present in this document. Given the device's function (calculating physiological parameters like CFR and FFR), ground truth would typically come from invasively measured pressure data, which is considered the clinical standard, rather than expert consensus on images.
Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Adjudication Method: Not specified.
- Explanation: No information on any adjudication method is provided.
If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
- MRMC Study: Not mentioned.
- Effect Size: Not applicable as no MRMC study is detailed.
- Explanation: This device is a diagnostic computer that processes physiological signals (pressure measurements), not an imaging AI that assists human readers in interpreting images. Therefore, a traditional MRMC study as understood in diagnostic imaging is unlikely to be relevant or performed for this type of device. The "AI" in this context refers to the algorithms for calculating hemodynamic parameters, which are presented to the clinician.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Standalone Performance Study: The text implies standalone performance. The device is described as "a tool for measuring coronary and peripheral vasculature hemodynamic status patterns" and performs "software calculations of the CFR and FFR parameters." This suggests the algorithm calculates these values directly from input data. However, a formal "standalone performance" study report (e.g., comparing algorithm output to a reference standard with metrics like accuracy, precision, recall) is not provided in this summary. Instead, the focus is on equivalence.
- Explanation: The device is the algorithm, providing calculations. The performance would be how accurately those calculations reflect the true physiological state, typically validated against invasively measured data. The summary does not provide details of such a validation study.
The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Type of Ground Truth: Not specified.
- Inferred Ground Truth: For devices measuring physiological parameters like Fractional Flow Reserve (FFR) and Coronary Flow Reserve (CFR), the gold standard or ground truth would typically be derived from direct invasive physiological measurements obtained in vivo.
The sample size for the training set
- Sample Size for Training Set: Not specified.
- Explanation: As an "improved model" of an existing device, it's possible that the core algorithms were developed and validated years prior, and this submission focuses on new features or software updates. Details on training sets are not typically included in 510(k) summaries, especially for updates to existing algorithms.
How the ground truth for the training set was established
- Ground Truth Establishment for Training Set: Not specified.
- Explanation: Similar to the test set, if a training set was used (e.g., for calibrating the pulse transmission coefficient algorithm), the ground truth would likely involve direct invasive measurements. This information is not in the summary.

Acceptance Criteria	Reported Device Performance
Not specified.	Not specified.

Conclusion:

The provided 510(k) summary for the SmartFlow® device is a regulatory document focused on demonstrating substantial equivalence to previously cleared predicate devices. It largely lacks the detailed scientific study information (acceptance criteria, sample sizes, ground truth methodology, expert qualifications, etc.) that would typically be found in a comprehensive clinical trial report or a full 510(k) submission. The FDA's clearance indicates they were satisfied that the device, with its new software features, was substantially equivalent to its predecessors and safe and effective for its stated indications for use, without the need for new, extensive clinical studies detailed in this summary.

Summary

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FEB 1 4 2002

510(k) Summary

Florence Medical Ltd.

SmartFlow®

510(k) Number K 0 20127

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:

Orly Maor 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 Pulse Transmission Coefficient software is substantially equivalent to the SmartFlow® (Florence Medical Ltd.) cleared under K003122 and K012947.

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Indication for use:

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:

Substantial Equivalence:

The SmartFlow® with the Pulse Transmission Coefficient software is substantially equivalent to the former cleared models of the SmartFlow®. In fact, it is an improved model of the SmartFlow® that includes application to calculate the transmission of high-frequency components of the pressure signal through a stenosis above the FFR/CFR and Multiple Lesion case analysis.

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Image /page/2/Picture/1 description: The image shows the seal of the U.S. Department of Health & Human Services. The seal is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is an abstract image of an eagle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

FEB 1 4 2002

Florence Medical Ltd c/o Mr. Orly Maor Vice President Push-med Ltd. 117 Ahuzah St. Ra'ananna 43373 ISRAEL

Re: K020127

Trade Name: Florence Medical Ltd. SmartFlow® device with Pulse Transmission Coefficient software Regulation Number: 21 CFR 870.1425 Regulation Name: Programmable Diagnostic Computer Regulatory Class: Class II (two) Product Code: DQK Dated: January 10, 2002 Received: January 15, 2002

Dear Mr. Maor:

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.

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Page 2 - Mr. Orly Maor

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. 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) 594-4646. 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 vours.

Donk Tell

am D. Zuckerman, M.D. Acting 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:

K020127

Device Name: SmartFlow®

Indications for Use:

(PLEASE DO NOT WRITE BELOW THIS LINE -CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use(Per 21 CFR 801.109)	✓
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Over the Counter Use
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Division of Cardiovascular & Respiratory Devices
510(k) Number	K020127

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).