PMP4 BP PRO BLOOD PRESSURE MONITOR
Device Facts
| Record ID | K060703 |
|---|---|
| Device Name | PMP4 BP PRO BLOOD PRESSURE MONITOR |
| Applicant | Card Guard Scientific Survival , Ltd. |
| Product Code | DXN · Cardiovascular |
| Decision Date | Apr 4, 2006 |
| Decision | SESE |
| Submission Type | Special |
| Regulation | 21 CFR 870.1130 |
| Device Class | Class 2 |
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.
Device Story
PMP4 BP Pro is an oscillometric blood pressure monitor for upper arm use. Device detects arterial blood movement, converts to digital readings; transmits data via Bluetooth to mobile platforms (PDA) or PCs running PMP4 Medical Application. Application processes, stores, and synchronizes data with PMP4 Medical Center; also supports ECG, spirometry, glucometry, and oximetry data from other accessories. Inflation logic uses envelope curve approximation to minimize discomfort, inflating to just above systolic pressure; subsequent measurements use auto-feedback logic (previous systolic + 15 mmHg). Used by patients (self-testing) or healthcare professionals in home/clinical settings. Output allows providers to review historical data, facilitating clinical decision-making and patient monitoring.
Clinical Evidence
No clinical data provided; bench testing only.
Technological Characteristics
Oscillometric blood pressure measurement system. Features Bluetooth wireless connectivity for data transmission to mobile/static platforms. Software-controlled inflation logic with auto-feedback. Complies with EN 1060 (non-invasive sphygmomanometers), AAMI/ANSI SP10, and EN 60601-1/1-2/1-4 safety and EMC standards. Quality management per ISO 9001/13485.
Indications for Use
Indicated for monitoring blood pressure and heart rate from the upper arm in patients, including non-medical persons, for home or clinical use.
Regulatory Classification
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.
Predicate Devices
Submission Summary (Full Text)
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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.
- 10. EN ISO 10993 Biological evaluation of medical devices Part 1. Evaluation and testing; Dec. 1997
- 11. EN 60601-1: Medical electrical equipment; Part 1: General requirements for safety; Boo. 2002
- 12. EN 60601-1-2: Medical electrical equipment; Part 1: 2. Collateral standard: EMC ; requirements and tests; 2001
- 13. EN 60601-1-4: Medical electrical equipment; Part 1: 4. Collateral Std. Programmable electric medical systems; Apr. 01
- 14. 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 <52% of the maximum is measured after exceeding the maximum.
### Inflation with Auto Feedback Logic
After the first measurement, the device recognizes the systolic pressure. During the next inflation, the cuff inflates up to the most recent systolic value plus ~ 1 5mmHg instead of inflating stepwise to a predefined value. The advantage is the reduced pumping time and therefore the reduced discomfort for the patient.
#### Substantial Equivalence 5.
Substantial equivalence (SE) is claimed to the following predicate devices:
- Card Guard's BP Pro K053395 for physical and functional identity and close similarity in IU. 1.
- 2. Card Guard's CG-7000DX-BT K052556 - for the remote communication functionality,
- Card Guard's PMP Spiro Pro K050853 for including the PMP4 Medical Application. 3.
- Card Guard's PMP* Medical Web Center K050940 for multiple-format medical data feature. 4.
#### 6. PMP4 Medical Application
The PMP4 Medical Application is designed for wireless mobile platforms, e.g. PDA and for static platforms, i.e., PC. It is used to receive from the BP Pro and other Card Guard's medical testing accessories, the test results and other medical data, to process and save these test results, and synchronize data and test results with the PMP4 Medical Center. The Application is a part of a personal medical system solution. The PMP4 Medical Application performs the following activities:
- Receives medical test inputs from the external accessories. 1.
- Collects medical test data and other related information as defined for each test. 2.
- 3. Accesses historical test and related data stored on the device.
- Transmits medical test data and additional information to Center for professional evaluation or backup. বা
- ડાં Receives data from Center.
- Enables configuring GPRS data connection (based on mobile phone GPRS/CDMA capabilities), 6. changing user name and password.
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Image /page/2/Picture/1 description: The image shows a logo with a circular border containing text, surrounding a stylized symbol. The symbol consists of three abstract human figures in profile, arranged in a row. The figures are depicted with simple, curved lines, giving them a modern and minimalist appearance. The text in the circular border is small and difficult to read, but it appears to be arranged in a clockwise direction around the symbol.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
4 2006
APR
Card Guard Scientific Survival Ltd. c/o Mr. Alex Gonorovsky Regulatory Affairs Manager 2 Pekeris St. P. O. Box 527 Rehevot 76100 ISRAEL
Re: K060703
Trade Name: PMP4 BP Pro 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: February 21, 2006 Received: March 16, 2006
Dear Mr. Gonorovsky:
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.
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 mav publish further announcements concerning your device in the Federal Register.
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Page 2 -- Mr. Alex Gonorovsky
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), please contact the Office of Compliance at (240) 276-0120. 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/industry/support/index.html.
Sincerely yours,
Blumuman for
Bran D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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# Indications for Use
510(k) Number (if known): Device Name: PMP4 BP Pro Blood Pressure Monitor
Indications for Use:
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.
Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use _ 区 AND/OR (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Page 1 of 1
(Posted November 13, 2003)
Bhumanna
510(k) Nu
