(470 days)
K#903133
Not Found
No
The description explicitly states the device uses the "oscillometric method," a well-established technique for blood pressure measurement that does not inherently involve AI or ML. There are no mentions of AI, ML, or related terms in the document.
No
The device is a digital blood pressure monitor used for measurement, not for treatment or therapy.
Yes
Explanation: The device is intended to measure systolic and diastolic blood pressure and pulse rate, which are physiological parameters used to assess an individual's health status. This measurement provides information that can be used by healthcare professionals for diagnosis or monitoring purposes, fitting the definition of a diagnostic device.
No
The device description explicitly mentions an inflatable cuff, an electronic capacitive pressure sensor, and the oscillometric method, all of which are hardware components and physical measurement techniques, not solely software. The performance studies also detail hardware-related testing like drop testing and vibration testing.
Based on the provided information, the BP-2BIO Digital Blood Pressure Monitor is not an In Vitro Diagnostic (IVD) device.
Here's why:
- Intended Use: The intended use is to measure blood pressure and pulse rate by applying a cuff to the upper arm. This is a non-invasive measurement of physiological parameters within the body.
- Device Description: The device uses an electronic pressure sensor and the oscillometric method to measure blood pressure. This method involves analyzing pressure changes within the cuff, which is an external interaction with the body, not an analysis of samples taken from the body.
- Lack of IVD Characteristics: The description does not mention any analysis of biological samples (like blood, urine, tissue, etc.) or the use of reagents, which are hallmarks of IVD devices.
IVD devices are specifically designed to examine specimens derived from the human body to provide information for the diagnosis, monitoring, or treatment of diseases or conditions. The BP-2BIO measures a physiological parameter directly from the body's response to the cuff pressure.
N/A
Intended Use / Indications for Use
The BP-2BIO Digital Blood Pressure Monitor is a device intended to measure the systolic and diastolic blood pressure and pulse rate of an adult individual by using a non-invasive technique in which an inflatable cuff is wrapped around the upper arm.
Product codes
DPW
Device Description
The BP-2BIO Digital Blood Pressure Monitor is designed to measure the systolic and diastolic blood pressure and pulse rate of an individual by using a noninvasive technique which an inflatable cuff is wrapped around the upper arm. Our method to define systolic and diastolic pressures is similar to the auscultatory method but uses an electronic capacitive pressure sensor rather than stethoscope and mercury manometer. The sensor converts tiny alteration in cuff pressure to electrical signals; by analyzing those signals to define the systolic, diastolic and calculating pulse rate is a well known technique in the market so called "oscillometric method".
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
adult
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)
Non-Clinical Tests Performed:
Testing information demonstrating safety and effectiveness of the MicroLife Manual Blood Pressure Monitor (Manual Inflate) Model BP-2BIO) in the intended environment of use is supported by testing that was conducted in accordance with the FDA November 1993 Draft "Reviewer Guidance for Premarket Notification Submissions", DCRND, which outlines Electrical, Mechanical and Environmental Performance Requirements.
The following testing was conducted:
- General Functions Test
- Reliability Test-Operation Conditions
- Reliability Test-Drop Testing
- Reliability Test-Storage
- Reliability Test-Vibration Testing
- EMC Test Report
- EN1060 Regulations and Test Report
- CE Certification
None of the testing demonstrated any design characteristics that violated the requirements of the Reviewer Guidance or resulted in any safety hazards. It was our conclusion that the MicroLife Manual Blood Pressure Monitor (manual inflate), Model BP-2BIO tested met all relevant requirements of the aforementioned tests.
Clinical Tests Performed:
ANSI/AAMI SP-10-1992 "National Standard for Electronic or Automated Sphygmomanometers" testing was performed. All relevant sections were addressed and testing conducted. The BP-2BIO met all relevant requirements of this standard.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
K#903133
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 870.2100 Cardiovascular blood flowmeter.
(a)
Identification. A cardiovascular blood flowmeter is a device that is connected to a flow transducer that energizes the transducer and processes and displays the blood flow signal.(b)
Classification. Class II (performance standards).
0
APR 3 0 1998
ATTACHMENT #12b Page 1 of 3
510(K) SUMMARY
This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR §807.92.
The assigned 510(k) number is: K970139
1. Submitter's Identification:
Micro Weiss Electronics 89 Bell Street West Babvlon, NY 11704
Date Summary Prepared:
August 22, 1997
2. Name of the Device:
MicroLife Manual Blood Pressure Monitor, Model BP-2BIO
3. Predicate Device Information:
The MicroLife Manual Blood Pressure Monitor, Model BP-2BIO is substantially equivalent to the Omron Oscillometric Digital Blood Pressure Monitor, Model HEM-405C. K#903133.
4. . Device Description:
The BP-2BIO Digital Blood Pressure Monitor is designed to measure the systolic and diastolic blood pressure and pulse rate of an individual by using a noninvasive technique which an inflatable cuff is wrapped around the upper arm. Our method to define systolic and diastolic pressures is similar to the auscultatory method but uses an electronic capacitive pressure sensor rather than stethoscope and mercury manometer. The sensor converts tiny alteration in cuff pressure to electrical signals; by analyzing those signals to define the systolic, diastolic and calculating pulse rate is a well known technique in the market so called "oscillometric method".
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ATTACHMENT #12b Page 2 of 3
5. Intended Use:
The BP-2BIO Digital Blood Pressure Monitor is a device intended to measure the systolic and diastolic blood pressure and pulse rate of an adult individual by using a non-invasive technique in which an inflatable cuff is wrapped around the upper arm.
ଚ. Comparison to Predicate Devices:
Both devices use the well known oscillometric method within the software algorithm to determine the systolic, diastolic and pulse rate. A similar arm cuff is inflated automatically, deflate rate is controlled but a factory set bleed valve and the deflation pressures are transferred via tubing to a sensor in both units. Each device uses a similar capacitance-type pressure sensor to translate the pressure variations to electrical signals that can be interpreted by an integrating circuit. Once the reading is determined each unit operates a solenoid valve to release the pressure to zero. Our Digital Blood Pressure Monitor, Model BP-B21O, differs from the predicate device in the software interface to the sensor which determines the system accuracy.
The interface between the sensor and the microprocessor determines the system's accuracy. For our Digital Blood Pressure Monitor, Model BP-B2IO, the software is capable of a split slope resolution to improve accuracy over the entire range. Since the range is "split" into three sections (0 to 100mmHg) (100 to 200mmHq) (200 to 300mmHg) error due to nonlinearity is reduced by the ability to adjunct the slope to best fit the output curve. A nonlinearity of 1 % is reduced to .33% by splitting the span into three separate linear relations. This way the sensor is matched to the software by using a series of jumpers that profile the slopes to the output of the sensor.
The Digital Blood Pressure Monitor Model BP-B210 has field calibration access; this mode is initiated by depressing both the start and the on button for over 5 seconds. A sleeve on the input tube fitting can be removed so that the fitting can be inserted into the unit in a manner to bypass the pressure bleed valve to close the pressure system and enable it to respond to the input pressure for calibration check.
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ATTACHMENT #12b Page 3 of 3
Discussion of Non-Clinical Tests Performed for Determination of Substantial 7. Equivalence are as follows:
Testing information demonstrating safety and effectiveness of the MicroLife Manual Blood Pressure Monitor (Manual Inflate) Model BP-2BIO) in the intended environment of use is supported by testing that was conducted in accordance with the FDA November 1993 Draft "Reviewer Guidance for Premarket Notification Submissions", DCRND, which outlines Electrical, Mechanical and Environmental Performance Requirements.
The following testing was conducted:
- General Functions Test a.
- Reliability Test-Operation Conditions b.
- Reliability Test-Drop Testing C.
- Reliability Test-Storage d.
- Reliability Test-Vibration Testing e.
- EMC Test Report f.
- EN1060 Regulations and Test Report g.
- CE Certification h.
None of the testing demonstrated any design characteristics that violated the requirements of the Reviewer Guidance or resulted in any safety hazards. It was our conclusion that the MicroLife Manual Blood Pressure Monitor (manual inflate), Model BP-2BIO tested met all relevant requirements of the aforementioned tests.
8. Discussion of Clinical Tests Performed:
ANSI/AAMI SP-10-1992 "National Standard for Electronic or Automated Sphygmomanometers" testing was performed. All relevant sections were addressed and testing conducted. The BP-2BIO met all relevant requirements of this standard.
9. Conclusions:
We have demonstrated that the MicroLife Manual Blood Pressure Monitor, Model BP-2BIO is as safe and effective as the predicate, the Omron Oscillometric Digital Blood Pressure Monitor, Model HEM-405C based on electrical, mechanical and environmental testing results as well as the FDA DCRND November 1993 Draft "Reviewer Guidance for Premarket Notification Submissions," and, the ANSI/AAMI Voluntary Standard, SP-10-1992 testing results.
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Public Health Service
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APR 3 0 1998
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Ms. Susan D. Goldstein-Falk Official Correspondent for Micro Weiss Electronics 89 Bell Street W. Babylon, NY 11704
K970139 Re:
MicroLife Manual Blood Pressure Monitor (Manual Inflate) Regulatory Cľass: II (Two) Product Code: DPW Dated: April 13, 1998 Received: April 15, 1998
Dear Ms. Goldstein-Falk:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). 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 (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Requlations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Reqister. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
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Page 2 - Ms. Susan Goldstein-Falk
This letter will allow you to beqin marketing your device as described in your 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 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4648. 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 requlation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.qov/cdrh/dsmamain.html."
Sincerely yours,
Thomas J. Callahan
Thomas J. Callahan, Ph.D. Director Division of Cardiovascular, Respiratory, and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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ATTACHMENT #12a Page_1________________________________________________________________________________________________________________________________________________________________________
510(k) Number (if known): K970139
MicroLife Manual Blood Pressure Monitor, Device Name: Manual Inflate, Model BP-2BIO
Indications For Use:
The BP-2BIO Digital Blood Pressure Monitor is a device intended to measure the systolic and diastolic blood pressure and pulse rate of an adult individual by using a non-invasive technique in which an inflatable cuff is wrapped around the upper arm.
(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, Respiratory,
and Neurological Devices
510(k) Number. K970139
ription Use OR Over-The-Counter Use
Prescription Use (Per 21 CFR 801.109)
. .
OR
Over-The-Counter Use
(Optional Format 1-2-96)