(30 days)
No
The summary describes software calculations of standard hemodynamic parameters (CFR and FFR) and does not mention any AI or ML techniques.
No
The device is described as a tool for measuring hemodynamic status and providing clinical information for diagnosis and treatment, rather than directly treating a condition.
Yes
The "Intended Use / Indications for Use" section explicitly states that the device is used "during and after diagnostic procedures, such as angiography" and to "provide further clinical information in the diagnosis and treatment of both coronary and peripheral artery diseases." Additionally, the "Device Description" mentions it as a "tool for measuring coronary and peripheral vasculature hemodynamic status patterns during diagnostic and interventional procedures."
No
The device description explicitly states it is a "PC based system comprising of a full color display with a touchscreen... mounted in a shielded metal housing," indicating it includes hardware components beyond just software.
Based on the provided information, the SmartFlow® is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- SmartFlow® function: The SmartFlow® is described as a tool for measuring hemodynamic status patterns in vivo (within the living body) during diagnostic and interventional procedures. It uses pressure measurement devices and software calculations based on these measurements.
- Lack of sample analysis: There is no mention of the SmartFlow® analyzing samples taken from the patient's body. Its function is directly related to measurements taken within the vasculature.
Therefore, the SmartFlow® falls under the category of a medical device used for in vivo measurements and analysis, not an in vitro diagnostic device.
N/A
Intended Use / Indications 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.
Product codes
DQK
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
coronary and peripheral vasculature
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies
Not Found
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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).
0
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.
1
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.
2
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.
3
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:
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.
(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) | ✓ |
|---|---|
| ------------------------------------------ | --------------------------------------------------- |
OR
| Over the Counter Use | |
|---|---|
| ---------------------- | -------------------------------------------------- |
| Division of Cardiovascular & Respiratory Devices | |
|---|---|
| 510(k) Number | K020127 |