(464 days)
The BP-2BHO Digital Blood Pressure Monitor is a device intended to measure the systolic, diastolic and pulse rate of an adult individual by using a non-invasive technique in which an inflatable cuff is wrapped around the upper arm.
The BP-2BHO Digital Blood Pressure Monitor is designed to measure the systolic, diastolic and pulse rate of an individual by using a non-invasive technique which an inflatable curr is wrapper als manufactory of the upper arm. Our technique which an infiatable curr is wrapper als similar to the auscultatory method but uses an electronic capactive sensor rather than stethoscope and mercury manonical. - no onnalyzing those signals to define the cuff pressure to electrical signals, by andryzing the subscripmarket so called "oscillometric method".
The MicroLife Automatic Blood Pressure Monitor, Model BP-2BHO, was evaluated for both non-clinical and clinical performance to demonstrate its safety and effectiveness.
1. Table of Acceptance Criteria and Reported Device Performance
| Test Category | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Non-Clinical Tests | ||
| General Functions | Meets requirements of "Reviewer Guidance for Premarket Notification Submissions", DCRND (Nov 1993) | Met all relevant requirements |
| Reliability (Operation Conditions) | Meets requirements of "Reviewer Guidance for Premarket Notification Submissions", DCRND (Nov 1993) | Met all relevant requirements |
| Reliability (Drop Testing) | Meets requirements of "Reviewer Guidance for Premarket Notification Submissions", DCRND (Nov 1993) | Met all relevant requirements |
| Reliability (Storage) | Meets requirements of "Reviewer Guidance for Premarket Notification Submissions", DCRND (Nov 1993) | Met all relevant requirements |
| Reliability (Vibration Testing) | Meets requirements of "Reviewer Guidance for Premarket Notification Submissions", DCRND (Nov 1993) | Met all relevant requirements |
| EMC | Meets requirements of "Reviewer Guidance for Premarket Notification Submissions", DCRND (Nov 1993) | Met all relevant requirements (EMC Test Report submitted) |
| EN1060 Regulations | Meets EN1060 Regulations | Met all relevant requirements (EN1060 Test Report and CE Certification submitted) |
| Clinical Tests | ||
| Blood Pressure Measurement Accuracy | Meets relevant sections of ANSI/AAMI SP-10-1992 "National Standard for Electronic or Automated Sphygmomanometers" | Met all relevant requirements of the standard |
2. Sample Size and Data Provenance
The document does not explicitly state the sample size used for the test set or training set.
The data provenance (e.g., country of origin, retrospective/prospective) for the clinical study is not specified in the provided text.
3. Number of Experts and Qualifications for Ground Truth Establishment
The document does not specify the number of experts used to establish ground truth for the test set or their qualifications. The clinical testing was performed according to ANSI/AAMI SP-10-1992, which typically involves comparison against reference measurements from trained observers.
4. Adjudication Method
The document does not describe the adjudication method used for the test set.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No multi-reader multi-case (MRMC) comparative effectiveness study evaluating the improvement of human readers with AI vs. without AI assistance was reported. The device is a standalone blood pressure monitor, not an AI-assisted diagnostic tool for human readers.
6. Standalone Performance Study
Yes, a standalone performance study was done for the device. The clinical testing against ANSI/AAMI SP-10-1992 demonstrates the algorithm-only performance of the MicroLife Automatic Blood Pressure Monitor.
7. Type of Ground Truth Used
For the clinical study, the ground truth was established by comparison to the "National Standard for Electronic or Automated Sphygmomanometers" (ANSI/AAMI SP-10-1992). This standard outlines procedures for accuracy testing, typically involving simultaneous measurements by the device and a trained human observer using a reference method (e.g., auscultation with a mercury sphygmomanometer). Therefore, the ground truth would be best described as expert consensus/reference method (as defined by the standard).
8. Sample Size for the Training Set
The document does not specify the sample size for the training set.
9. How Ground Truth for the Training Set was Established
The document does not provide details on how the ground truth for the training set was established. The device utilizes an "oscillometric method" based on a software algorithm to determine blood pressure. This implies that the algorithm itself might have been developed using various data, but the specifics of that development and ground truth establishment for training are not described in this summary.
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APR 3 0 1998
510(K) SUMMARY
This summary of 5lO(k) safety and effectiveness information is being submitted in
tell for and to the requirements of SMDA 1990 and 21 CFR 8807.92. This summary of 5lO(k) safety and enectiveliess information of the requirements of SMDA 1990 and 21 CFR 8807.92.
The assigned 510(k) number is:_KS) 10211
Submitter's Identification: 1 .
Micro Weiss Electronics 89 Bell Street West Babylon, NY 11704
Date Summary Prepared:
January 17, 1997
Name of the Device: 2.
MicroLife Automatic Blood Pressure Monitor, Model BP-2BHO
Predicate Device Information: ਤੇ .
The MicroLife Automatic Blood Pressure Monitor, Moolel BP-2BHO is The MicroLife Automatic Bioon Frestard World
substantially equivalent to the Omron Auto-Inflate Oscillometric Digital Blood
Substantially equivalent (1955) KBO2213 substantially our Model HEM-705C, K#903134.
Device Description: 4.
The BP-2BHO Digital Blood Pressure Monitor is designed to measure the The BP-2BHO Digital Blood Fressure Mindividual by using a non-invasive
systolic, diastolic and pulse rate of an individual by using a non-invasive systolic, diastolic and pulse face of an manufactory of the upper arm. Our technique which an infiatable curr is wrapper als similar to the auscultatory
method to define systolic and cia sansoutive sensor rather than method to define systolic and ulastonic pressure sensor sensor rather than method but uses an electronic capactive processor converts tiny alteration in stethoscope and mercury manonical. - no onnalyzing those signals to define the cuff pressure to electrical signals, by andryzing the subscripmarket so called "oscillometric method".
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EXHIBIT #1 Page 2 of 4
- 2 -
5. Intended Use:
The BP-2BHO Digital Blood Pressure Monitor is a device intended to measure the systolic, diastolic and pulse rate of an adult individual by using a noninvasive technique in which an inflatable cuff is wrapped around the upper arm.
6. 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 blean। curr and the deflation pressures are transferred via tubing to a sensor in both voits. Each device uses a similar capacitance-type pressure sensor to translater 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. Qur Digital Blood Pressure Monitor, Model BP-2BHO, 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-2BHO, 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 200mmHg) (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.
In addition to battery power, the Digital Blood Pressure Monitor Model No, BP-2BHO includes a socket to receive 6 volt DC power from an AC adapter.
The Digital Blood Pressure Monitor Model BP-B2HO 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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EXHIBIT #1 Page 3 of 4
Between the pump and the air channel that connects the tubing, leakage valve, solenoid valve, and sensor a check valve is included to prevent pressure leakage through the pump.
Discussion of Non-Clinical Tests Performed for Determination of Substantial 7. Equivalence are as follows:
Testing information demonstrating safety and effectiveness of the MicroLife Automatic Blood Pressure Monitor (Auto Inflate) Model BP-2BHO) 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 Automatic Blood Pressure Monitor (Auto Inflate), Model BP-2BHO tested met all relevant requirements of the aforementioned tests.
Discussion of Clinical Tests Performed: 8.
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-2BHO met all relevant requirements of this standard.
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EXHIBIT #1 Page 4 of 4
- 4 -
Conclusions: 9.
We have demonstrated that the MicroLife Automatic Blood Pressure Monitor, Model
and Pressure State Schools offective, as , the , predicate, the Omron Auto-Inflate We have demonstrated that the Microche Automatic Broom Auto-Inflate BP-2BHO is as safe and effective as the predication of the bear Oscillometric Digital Blood Pressure Monitor, Model Fine FDA DCRND November
mechanical and environmental testing results as well as the FDA DCRND November mechanical and environmental testing results as well as tho Parrown on Parties on Submissions," and, the
1993 Draft "Reviews Caracterd CD 10,1992 testing results. 1993 Draft "Reviewer Guldanet Tor Promants"
ANSI/AAMI Voluntary Standard, SP-10-1992 testing results.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/4/Picture/1 description: The image shows a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the edge. Inside the circle is an abstract image of an eagle with its wings spread. The eagle is facing to the right. There is a small square above the eagle.
Public Health Service
MAR 3 0 1999
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
K970211 Re : K970211
MicroLife Automatic Blood Pressure Monitor Regulatory Class: II (Two) Product Code: DXN Dated: April 13, 1998 Received: April 15, 1998
Dear Ms. Goldstein-Falk:
This letter corrects our substantially equivalent letter of This letter corrects can .
April 30, 1998, regarding the incorrect product code.
We have reviewed your section 510(k) notification of intent to We have reviewed your beceien beve and we have determined the market the device felefenced abore the indications for used device Is substancially oquality marketed predicate devices stated in the encrosulery of the may 28, 1976, the marketed in Interstate Commerce provide mendments on to devices that have been reclassified in accordance with the provisions of the nave been recrassifica in accomment (Act). You may, therefore, market the device, subject to the general controls provisions of e device, burgentrols provisions of the Act include the Act. the Act. The general belowing for a requirements TOF annual 1998 and prohibitions against misbranding and adulteration.
If your device is classified (see above) into either class III If your device is clabbilion (1997) (Premarket Approval) it may be (Special Controls) or Clabo -------------------------------------------------------------------------------------------------------------------------------------------------subject to back evice can be found in the Code of Federal arrecting your devros sail to 895. A substantially Regulations, frees as , a lease compliance with the Cood equivalent decemination assimments, as set forth in the Quality Manufacturing Fractice for Medical Devices: General (QS) System Regulation (Q27 200) and that, through periodic QS
regulation (21 CFR Part 820) and that, through periodic to regulation (2) Crk Farc (20) and assumptions. Failure to comply inspections, IDA will result in regulatory action.
with the GMP regulation may result in regulation may publ III with the GMP regulacion may rebure in the first in (FDA) may publish
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Page 2 - Ms. Susan D. Goldstein-Falk
further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might houriederon basmission about 542 of the Act for devices under nave under Bectronic one sinces.
The Electronic Product Radiation Control provisions, or other Federal laws or regulations.
This letter will allow you to continue marketing your device as Ills lecter will arew for any and ification. The FDA finding described in your in four device to a legally marketed of subscancial equivalism 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 II you desire speciese and additionally 809.10 for in xilro regulation (21 CM rais over contact the Office of Compliance at diagnostic devices), proads online on the promotion and (301) 594 1010. Historice, please contact the Office of advertibility on your box 639. Other general information on your Compilance at (301) 354 4057. Ochez generalized from the Division reportibliation and their toll free number (800) or bmarr (301) 443-6597 or at its internet address "http://www.fda.gov/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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ЕХНІВІТ В Page I of 1
<970211 510(k) Number (if known):
Device Name:_ MicroLife_Automatic_Blood Pressure Monitor, Auto Inflate, Model BP-2BHO
Indications For Use:
The BP-2BHO Digital Blood Pressure Monitor is a device intended to measure the systolic, diastolic 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)
Lee R. Kompera
Division Sign-Om)
Division of Cardiovascular, Respiratery,
and Neurological Devices
510(k) Number K970214
OR Over-The-Counter Use
Prescription Use (Per 21 CFR 801.109)
(Optional Format 1-2-96)
§ 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).