(214 days)
No
The description focuses on hardware components, signal processing, and a software package ("BeatScope") that performs calculations based on a "Modelflow-based computation" of hemodynamic parameters. There is no mention of AI, ML, or any learning algorithms.
No
The device is strictly for monitoring blood pressure and pulse rate, and it provides computational data without directly treating or diagnosing any condition.
Yes
The device provides continuous, non-invasive blood pressure and pulse rate monitoring, and its accompanying software computes real-time and beat-to-beat blood pressure as well as hemodynamic parameters. These measurements and computations are used to assess a patient's physiological state, which is a key function of a diagnostic device.
No
The device description clearly outlines multiple hardware components including a waist belt, pump unit, wrist unit, finger cuff, pressure transducer, and hydrostatic height correction unit. While software is mentioned (BeatScope), it is used in conjunction with data from the hardware device.
Based on the provided information, this device 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.
- Device Function: The Portapres device measures blood pressure and pulse rate non-invasively by interacting with the patient's finger. It does not analyze samples taken from the body.
- Intended Use: The intended use is for continuous, non-invasive blood pressure and pulse rate monitoring, and the computation of hemodynamic parameters from the pressure waveform. This is a physiological measurement, not an in vitro diagnostic test.
The device is a physiological monitoring device, not an IVD.
N/A
Intended Use / Indications for Use
The Portapres Ambulatory Continuous Non-Invasive Blood Pressure Monitor is intended to provide the user with continuous, noninvasive blood pressure and pulse rate monitoring. The Portapres enables 24-hour continuous ambulatory measurements.
The PC-based BeatScope software used with the data from the device provides Modelflow-based computation of real-time and beat-to-beat blood pressure as well as hemodynamic parameters from the pressure waveform, including, cardiac output and total peripheral resistance.
Product codes
DXN
Device Description
Portapres is a portable, battery-powered device to record continuous non-invasive arterial blood pressure. Portapres is intended for 24-hour continuous recordings in ambulatory subjects. The device includes a Neoprene belt to be worn around the waist, with compartments for the Main Unit with electronics and memory card, a Pump Unit with an air pump, and a NiCd or Li battery pack. Connected to the waist belt Main Unit and Pump Unit is a Wrist Unit, used to interface with the signals from the electronics and air supply in the waist belt to the finger cuffs. The Wrist Unit then connects to a finger cuff, which consists of an inflatable air bladder and an infrared photoplethysmograph. The plethysmograph measures the finger arterial volume which varies with the patient's blood pressure. The Wrist Unit controls the pressure in the cuff bladder so as to keep the arterial volume constant at a level (the setpoint) determined during startup. The Wrist Unit contains a pressure transducer that measures the cuff pressure as an indirect measure of the patient's blood pressure. Also connected to the Wrist Unit is a hydrostatic height correction unit that compensates for the hydrostatic component of the blood pressure in the finger when this is not at heart level. This allows the patient free hand movement in ambulatory applications.
Pressure and volume signals from the finger cuffs are routed from the Wrist Unit to the Main Unit microprocessor for pump control and data acquisition purposes. The microprocessor has an internal flash memory card for storage of blood pressure wave form data.
The Main Unit is equipped with an RS232 serial interface to transfer the data stored in the flash memory card via a Control Unit to a PC and to allow remote control of the Portapres.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
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)
Reference Device(s)
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 870.1130 Noninvasive blood pressure measurement system.
(a)
Identification. A noninvasive blood pressure measurement system is a device that provides a signal from which systolic, diastolic, mean, or any combination of the three pressures can be derived through the use of tranducers placed on the surface of the body.(b)
Classification. Class II (performance standards).
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510(k) SUMMARY FMS PORTAPRES AMBULATORY NONINVASIVE BLOOD PRESSURE MONITOR
This 510(k) summary is being submitted in accordance with the requirements of SMDA and 21CFR § 807.92
I. NAME OF SUBMITTER
FMS, Finapres Medical Systems BV Simon Stevinweg 48 NL-6827 BT Arnhem The Netherlands
Phone Number: +31 26 384 9080
Contact Person: Gerard J. Langewouters, PhD. General Manager FMS
U. S Agent for FMS: Richard Meissel Propel Biomedical Consulting 15500 Rockfield Boulevard, Suite A-1 Irvine, CA 92618 Phone Number: 949-768-0444 Fax Number: 949-768-8400
Date Prepared:
9/27/02
II. DEVICE NAME AND CLASSIFICATION
| Proprietary Name: | Portapres Ambulatory Continuous Non Invasive Blood
Pressure Monitor |
|-----------------------|------------------------------------------------------------------------|
| Common or Usual Name: | Continuous Non-Invasive Blood Pressure Monitor |
| Classification: | Class II; CFR 870.1130, Product Code DXN |
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III. PREDICATE DEVICES
The Portapres is substantially equivalent in design (methodology) and indications for use to the following devices that have been or still are in commercial distribution:
- Ohmeda 2300 Finapres® Blood Pressure Monitor, Ohmeda Medical, Englewood, . CO 80112-5810, K822055
- Ohmeda 2350 Finapres® Blood Pressure Monitor, Ohmeda Medical, Englewood, ● CO 80112-5810, K880572
- Task Force Monitor 3040, CNSystems Medizintechnik GMBH, Europe, AU, ● K014063
- (BeatScope software): RODA Monitoring System, Metracor Technologies, Inc., San Diego, CA 921221, K011238
Portapres and Finapres are substantially equivalent in design, methodology, software, manufacture, materials, intended use and principle of operation. The Portapres, the Finapres, and the Task Force Monitor devices are intended for use for continuous monitoring of finger arterial blood pressure, the Portapres in an ambulatory model and the Finapres and Task Force Monitor in stationary models. FMS considers the use of the Portapres to be substantially equivalent to its predicate devices, the Ohmeda 2300 and 2350 Finapres and the CNSystems Task Force Monitor, and considers the BeatScope software cardiac output technology to be equivalent to the RODA Monitoring System cardiac output technology.
IV. DESCRIPTION
Portapres is a portable, battery-powered device to record continuous non-invasive arterial blood pressure. Portapres is intended for 24-hour continuous recordings in ambulatory subjects. The device includes a Neoprene belt to be worn around the waist, with compartments for the Main Unit with electronics and memory card, a Pump Unit with an air pump, and a NiCd or Li battery pack. Connected to the waist belt Main Unit and Pump Unit is a Wrist Unit, used to interface with the signals from the electronics and air supply in the waist belt to the finger cuffs. The Wrist Unit then connects to a finger cuff, which consists of an inflatable air bladder and an infrared photoplethysmograph. The plethysmograph measures the finger arterial volume which varies with the patient's blood pressure. The Wrist Unit controls the pressure in the cuff bladder so as to keep the arterial volume constant at a level (the setpoint) determined during startup. The Wrist Unit contains a pressure transducer that measures the cuff pressure as an indirect measure of the patient's blood pressure. Also connected to the Wrist Unit is a hydrostatic height correction unit that compensates for the hydrostatic component of the blood pressure in the finger when this is not at heart level. This allows the patient free hand movement in ambulatory applications.
Pressure and volume signals from the finger cuffs are routed from the Wrist Unit to the Main Unit microprocessor for pump control and data acquisition purposes. The
2
microprocessor has an internal flash memory card for storage of blood pressure wave form data.
The Main Unit is equipped with an RS232 serial interface to transfer the data stored in the flash memory card via a Control Unit to a PC and to allow remote control of the Portapres.
V. INTENDED USE
The Portapres Ambulatory Continuous Non-Invasive Blood Pressure Monitor is intended to provide the user with continuous, noninvasive blood pressure and pulse rate monitoring. The Portapres enables 24-hour continuous ambulatory measurements.
The PC-based BeatScope software used with the data from the device provides Modelflow-based computation of real-time and beat-to-beat blood pressure as well as hemodynamic parameters from the pressure waveform, including, cardiac output and total peripheral resistance.
VI. TECHNOLOGICAL CHARACTERISTICS
No new technology, materials, or change in efficacy have been introduced by FMS in the manufacture of the FMS Portapres Ambulatory Continuous Noninvasive Blood Pressure Monitor. The design, form, and materials of the monitor are equivalent to its predicate devices.
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Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" arranged around the perimeter. Inside the circle is an abstract symbol resembling an eagle or bird in flight, with the negative space forming a human profile.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAY - 9 2003
FMS, Finapres Medical Systems BV c/o Ms. Christine Emanuel TECSA Technical Services 1205 De La Vina Street Santa Barbara, CA 93101
Re: K023338
Trade Name: Portapres Ambulatory Continuous Non Invasive Blood Pressure Monitor Regulation Number: 21 CFR 870.1130 Regulation Name: Noninvasive blood pressure measurement system Regulatory Class: Class II (two) Product Code: DXN Dated: March 5, 2003 Received: March 10, 2003
Dear Ms. Emanuel:
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 annùal registration, listing of devices, good manufacturing 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 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
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Page 2 - Ms. Christine Emanuel
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), please contact the Office of Compliance at (301) 594-4646. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act 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 yours,
Bram D. Zuckerman, M.D.
Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Include the following "Indications For Use" page that contains the applicant's name, name of the device and the intended use of the device. The information, data and labeling claims in the entire the 510(k) submission must support and agree with the "indications for use" statement.
*For a new submission, do NOT fill in the 510(k) number blank.
INDICATIONS FOR USE
Applicant: FMS, Finapres Medical Systems BV
510(k) Number (if known): N/A*
Device Name: Portapres Ambulatory Continuous Non-Invasive Blood Pressure Monitor
Indications For Use:
The Portapres Ambulatory Continuous Non-Invasive Blood Pressure Monitor is intended to provide the user with continuous, noninvasive blood pressure and pulse rate monitoring. The Portapres enables 24-hour continuous ambulatory measurements.
The PC-based BeatScope software used with the data from the device provides Modelflowbased computation of real-time and beat-to-beat blood pressure as well as hemodynamic parameters from the pressure waveform, including, cardiac output and total peripheral resistance.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH Office of Device Evaluation (ODE)
(Division Sign-Off)
Division of Cardiovascular Devices
Prescription Use ✗
Per 21 CFR 801.109
510(k) Number K023338
OR
Over-the-Counter _