(28 days)
Not Found
No
The document describes a PC-based system for calculating hemodynamic parameters (CFR and FFR) based on pressure measurements. There is no mention of AI, ML, image processing, or any other technology typically associated with AI/ML applications in medical devices. The description focuses on hardware components and software for calculation, not learning or adaptive algorithms.
No
The device is described as a tool for measuring hemodynamic status and providing clinical information for diagnosis and treatment, rather than actively treating a condition itself.
Yes
The device is described as providing "further clinical information in the diagnosis and treatment of both coronary and peripheral artery diseases" and being used "during and after diagnostic procedures, such as angiography." It also calculates parameters like CFR and FFR which are used for diagnostic purposes.
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" and includes accessories like a monitor interface and a hand-held remote, indicating it is a hardware system with integrated software, not software-only.
Based on the provided information, the Florence Medical Ltd. SmartFlow™ is not an In Vitro Diagnostic (IVD) device.
Here's why:
- Intended Use: The intended use describes the device as being used in conjunction with pressure measurement devices during and after diagnostic and interventional procedures to evaluate the hemodynamic status of arteries. This involves measuring physiological parameters (pressure) directly within the body.
- Device Description: The device is described as a PC-based system that calculates parameters like CFR and FFR based on these pressure measurements. It's a tool for analyzing in vivo physiological data.
- Lack of IVD Characteristics: IVD devices are typically used to examine specimens (like blood, urine, tissue) outside the body to provide information about a patient's health. The SmartFlow™ does not process or analyze biological specimens.
Therefore, the SmartFlow™ is a medical device used for in vivo physiological measurement and analysis, not an IVD.
N/A
Intended Use / 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.
Product codes (comma separated list FDA assigned to the subject device)
DQK
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.
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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
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.
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 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.
2
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
3
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)
OR
Over the Counter Use