SMARTFLOW

K012947 · Florence Medical , Ltd. · DQK · Oct 2, 2001 · Cardiovascular

Device Facts

• Record ID: K012947
• Device Name: SMARTFLOW
• Applicant: Florence Medical , Ltd.
• Product Code: DQK · Cardiovascular
• Decision Date: Oct 2, 2001
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 870.1425
• Device Class: Class 2

Intended 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 Story

SmartFlow™ is a PC-based diagnostic system for evaluating hemodynamic status in coronary and peripheral arteries. It receives pressure measurement data during/after diagnostic or interventional procedures. The system performs software-based calculations of Coronary Flow Reserve (CFR) and Fractional Flow Reserve (FFR) parameters. It features a touchscreen display in a shielded metal housing, with optional infrared remote control. Used in clinical settings by healthcare providers to assess diseased arteries; output provides quantitative hemodynamic data to assist clinical decision-making during procedures. The device supports analysis of both single and multiple lesion cases.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

PC-based system; shielded metal housing; touchscreen interface; infrared remote control; monitor interface. Software performs hemodynamic calculations (CFR, FFR).

Indications for Use

Indicated for patients undergoing diagnostic or interventional procedures (e.g., angiography, angioplasty) in coronary and peripheral vasculature to evaluate hemodynamic status and assist in diagnosis and treatment of artery disease.

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)

Submission Summary (Full Text)

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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.: [phone] Fax: [phone] SmartFlow(@florence.co.il

### Contact Person:

Shoshana Friedman, RAC 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 Multiple Lesion software is substantially equivalent to the SmartFlow™ (Florence Medical Ltd.) cleared under K003122.

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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 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.

#### 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 [phone]. Iffice 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 Outer general mionnation or your 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 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)

OR

Over the Counter Use