SMARTFLOW PULSE TRANSMISSION COEFFICIENT

K020127 · Florence Medical , Ltd. · DQK · Feb 14, 2002 · Cardiovascular

Device Facts

• Record ID: K020127
• Device Name: SMARTFLOW PULSE TRANSMISSION COEFFICIENT
• Applicant: Florence Medical , Ltd.
• Product Code: DQK · Cardiovascular
• Decision Date: Feb 14, 2002
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 870.1425
• Device Class: Class 2

Intended Use

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 Story

SmartFlow® is a PC-based diagnostic system used in clinical settings during or after coronary/peripheral vascular procedures. It interfaces with external pressure measurement devices to acquire pressure signals. The system processes these signals using Pulse Transmission Coefficient software to calculate hemodynamic parameters, including CFR (Coronary Flow Reserve), FFR (Fractional Flow Reserve), and high-frequency components of pressure signals through stenoses. It also performs multiple lesion case analysis. The device features a touchscreen display for data entry and control, housed in a shielded metal enclosure. Clinicians use the output to assess hemodynamic status, aiding in the diagnosis and treatment planning for coronary and peripheral artery diseases.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

PC-based system; shielded metal housing; touchscreen interface. Software-based calculation of hemodynamic parameters (CFR, FFR, Pulse Transmission Coefficient). Connectivity with external pressure measurement devices. Class II programmable diagnostic computer.

Indications for Use

Indicated for patients undergoing diagnostic or interventional procedures (e.g., angiography, angioplasty) in coronary or peripheral vasculature to evaluate hemodynamic status of diseased arteries.

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

• SmartFlow® (K003122)
• SmartFlow® (K012947)

Submission Summary (Full Text)

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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.: [phone] Fax: [phone] [e-mail]

#### Contact Person:

Orly Maor Push-Med Ltd. 117, Ahuza St., Ra'ananna 43373, Israel Tel: [phone] Fax: [phone]

### 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:

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.

#### 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 [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 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:

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.

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Concurrence of CDRH, Office of Device Evaluation (ODE)

| Prescription Use<br>(Per 21 CFR 801.109) | <span style="text-decoration: overline;">✓</span> |
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| Division of Cardiovascular & Respiratory Devices | |
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| 510(k) Number | <span style="text-decoration: overline;">K020127</span> |