(19 days)
Not Found
No
The description focuses on standard oscillometric blood pressure measurement and data transmission/storage, with no mention of AI or ML algorithms for analysis, interpretation, or prediction.
No
The device is used for monitoring blood pressure and heart rate, which is a diagnostic function, not a therapeutic one. It does not provide any treatment or intervention.
Yes
The device monitors blood pressure and heart rate, which are diagnostic indicators used to assess a patient's health status.
No
The device description explicitly states it consists of a "table top monitor" in addition to the software application. This hardware component is essential for obtaining the blood pressure measurement.
No, 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. They are used to diagnose, monitor, or screen for various health issues.
- Device Function: The PMP BP Pro Blood Pressure Monitor measures blood pressure and heart rate directly from the upper arm using the oscillometric method. This is a non-invasive measurement of physiological parameters within the body, not a test performed on a sample taken from the body.
- Intended Use: The intended use is for monitoring blood pressure and heart rate, which are vital signs measured directly from the patient.
While the device collects and processes medical data, the core function of obtaining the data is not an in vitro diagnostic test.
N/A
Intended Use / Indications for Use
The PMP4 BP Pro is used for self-testing by patients and by healthcare professionals at home and at medical settings to monitor blood pressure (systolic and diastolic) and pulse rate from the upper arm. The device consists of a table top monitor and a receiving program - the PMP4 Medical Application. The table top monitor obtains the blood pressure measurement through the oscillometric method, i.e. the blood movement through the artery in the upper arm are detected and converted into digital readings. For evaluation, the stored measurement results can be transmitted by Bluetooth interface to wirelyss mobile platform, e.g. PDA or a static platform, i.e., PC with the PMP4 Medical Application installed. The PMP4 Medical Application interfaces to the table-top monitor and is used to receive for Pro the test results and other medical data, to process and save these test results, and to synchroized and test results with the PMP4 Medical Center.
The PMP4 Medical Application is also designed to receive ECG, spirometric, glucometric, and oximetric parameters from other Card Guard medical testing accessories in addition to BP+HR.
When the table top monitor is not used to measure blood pressure, it displays time and date. The intended product users are Non-Medical Persons (NMP), i.e. persons expected to understand only basic medical data.
The PMP BP Pro Blood Pressure Monitor is intended to be used for monitoring Blood Pressure (BP) and Heart Rate (HR) from the upper arm. BP and HR can be recorded and transferred to a remote hand held device/PC for viewing and processing.
Product codes
DXN
Device Description
The PMP4 BP Pro is used for self-testing by patients and by healthcare professionals at home and at medical settings to monitor blood pressure (systolic and diastolic) and pulse rate from the upper arm. The device consists of a table top monitor and a receiving program - the PMP4 Medical Application. The table top monitor obtains the blood pressure measurement through the oscillometric method, i.e. the blood movement through the artery in the upper arm are detected and converted into digital readings. For evaluation, the stored measurement results can be transmitted by Bluetooth interface to wirelyss mobile platform, e.g. PDA or a static platform, i.e., PC with the PMP4 Medical Application installed. The PMP4 Medical Application interfaces to the table-top monitor and is used to receive for Pro the test results and other medical data, to process and save these test results, and to synchroized and test results with the PMP4 Medical Center.
The PMP4 Medical Application is also designed to receive ECG, spirometric, glucometric, and oximetric parameters from other Card Guard medical testing accessories in addition to BP+HR.
When the table top monitor is not used to measure blood pressure, it displays time and date. The intended product users are Non-Medical Persons (NMP), i.e. persons expected to understand only basic medical data.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
upper arm
Indicated Patient Age Range
Not Found
Intended User / Care Setting
self-testing by patients and by healthcare professionals at home and at medical settings. The intended product users are Non-Medical Persons (NMP), i.e. persons expected to understand only basic medical data.
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)
K053395, K052556, K050853, K050940
Reference Device(s)
Not Found
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).
0
APR 4 2006
CARD GUADD
PMP4 BP Pro Blood Pressure Monitor 510(k) Summary of Safety and Effectiveness
1. General
| Submitter | Card Guard Scientific Survival Ltd., |
|---|---|
| Address | 2 Pekeris St. P.O.B. 527 Rehovot 76100, Israel |
| Contact: | Alex Gonorovsky, RA Manager |
| Phone: | 972-8-9484019 Fax: 972-8-9484044 |
| E-mail: | galex@cardguard.com |
| Device | |
| Trade Name: | PMP4 BP Pro Blood Pressure Monitor |
| Classification: | Noninvasive Blood Pressure Measurement System |
| Product Code: | DXN |
| Regulation No: | 21 CFR 870.1130 |
| Class: | II |
2. Definition and Intended Use
The PMP4 BP Pro is used for self-testing by patients and by healthcare professionals at home and at medical settings to monitor blood pressure (systolic and diastolic) and pulse rate from the upper arm. The device consists of a table top monitor and a receiving program - the PMP4 Medical Application. The table top monitor obtains the blood pressure measurement through the oscillometric method, i.e. the blood movement through the artery in the upper arm are detected and converted into digital readings. For evaluation, the stored measurement results can be transmitted by Bluetooth interface to wirelyss mobile platform, e.g. PDA or a static platform, i.e., PC with the PMP4 Medical Application installed. The PMP4 Medical Application interfaces to the table-top monitor and is used to receive for Pro the test results and other medical data, to process and save these test results, and to synchroized and test results with the PMP4 Medical Center.
The PMP4 Medical Application is also designed to receive ECG, spirometric, glucometric, and oximetric parameters from other Card Guard medical testing accessories in addition to BP+HR.
When the table top monitor is not used to measure blood pressure, it displays time and date. The intended product users are Non-Medical Persons (NMP), i.e. persons expected to understand only basic medical data.
3. Referenced Standards
- MDD 93/42/EEC Medical Device Directive Council Directive 93/42/EEC; June 14, 1993 -
- MPG The Act on Medical Devices (Medizinproduktegesetz), rev 2; Germany; Dec 2001 2.
- EN 475: Medical devices Electrically-generated alarm signals ; April 1995 నా
- EN 980: Graphical symbols for use in the labeling of medical devices; August 2003 র্বা
- EN 1041: Terminology, Symbols and Information provided with Medical Devices; Information supplied by the 5. manufacturer with medical devices; April 1998
- EN 1060: Non-invasive sphygmomanometers, Part 1: General requirements, Dec. 95 (EN 1060-1/A1: Changes, Sept. 02), 6. Part 3: Supplements for electro-mechanical blood pressure measuring systems; Sept. 1997. Change
- EN ISO 9001 : Quality management systems Requirements; December 2000 7.
- EN ISO 13485: Quality systems Medical devices; August 2000 8.
- EN ISO 14971: Medical devices application of risk management to medical devices, March 2001 9.
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- EN ISO 10993 Biological evaluation of medical devices Part 1. Evaluation and testing; Dec. 1997
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- EN 60601-1: Medical electrical equipment; Part 1: General requirements for safety; Boo. 2002
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- EN 60601-1-2: Medical electrical equipment; Part 1: 2. Collateral standard: EMC ; requirements and tests; 2001
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- EN 60601-1-4: Medical electrical equipment; Part 1: 4. Collateral Std. Programmable electric medical systems; Apr. 01
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- AAMI/ANSI SP10: Electronic or automated sphygmomanometers; October 1992
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Image /page/1/Figure/0 description: The image shows the logo for "CARD GUARD Scientific Survival LTD". The text is in bold, sans-serif font. To the right of the text is a graphic that resembles an EKG readout.
PMP4BP Pro Blood Pressure Monitor 510(k) Summary of Safety and Effectiveness
60703
4. Method of Operation
Inflating the Cuff
To lessen patient discomfort, the cuff does not always inflate to a defined predetermined value, but by means of an approximation of the envelope curve during the inflation phase attempts to inflate only up to a value just above the systolic pressure. To do this the pressure is increased in defined predetermined pressure steps (85, 100, 120, 140, 160 ... mmHg) and a single pressure pulse is measured at each stage. An increase in pulse amplitude to a maximum and the subsequent decrease is determined during this type of inflation. The systolic pressure is then regarded as definitely attained and the inflation terminated when a pulse amplitude of