(214 days)
Measuring systolic and diastolic blood pressures and pulse rates in adult patients with arm circumference between 5 and 15 inches.
The Model BZ-576 Digital Blood Pressure Monitor uses the oscillometric method with Fuzzy arithmetic for measuring blood pressure, and the high accuracy and repeatability are achieved. The device is ideal for people who frequently monitor their own blood pressure, for its easy way to use at home, at work and during travel. The main components include a cuff, an integrated silicon pressure sensor, an electronic pump, an electronic valve, two buttons, a microcontroller and LCD display. The integrated silicon pressure sensor is used for detecting pressure within the cuff and the pulse wave component during the course of cuff pressure deflation, and guarantees the long period stability. The air pressure of inflation, deflation and rapid release are fully automatic by using an electronic pump and an electronic valve, and a constant deflation speed is controlled in the process of measurement for increasing the accuracy and reducing the measurement time. The blood pressure and pulse values are calculated, and are displayed with "mmHg" or "kPa" on LCD alternatively.
This document describes the premarket notification (510(k)) for the "BZ-576" Non-invasive Automatic Blood Pressure Monitor by The Buzz Group, LLC. It seeks to demonstrate substantial equivalence to the predicate device, the Omron HEM-757 Automatic Blood Pressure Monitor (K001670).
No specific acceptance criteria or a dedicated study proving the device meets said criteria are explicitly detailed in the provided text. The document primarily focuses on establishing substantial equivalence through a comparison of design, operating principles, and intended use, rather than presenting a standalone performance study with defined acceptance criteria and associated results.
However, based on the context of a 510(k) submission for a non-invasive blood pressure monitor, the implicit acceptance criteria would align with the performance standards for such devices, typically outlined in recognized consensus standards like ISO 81060-2 (Non-invasive sphygmomanometers - Part 2: Clinical investigation of automated measurement type). While the specific numerical acceptance criteria are not presented, regulatory bodies expect devices to meet accuracy and repeatability requirements for systolic and diastolic blood pressure measurements.
1. A table of acceptance criteria and the reported device performance
No explicit acceptance criteria table is provided. The document states that "The results of bench and user/clinical testing indicate that the new device is as safe and effective as the predicate devices," and mentions "high accuracy and repeatability are achieved" due to the oscillometric method with Fuzzy arithmetic. However, no specific performance metrics (e.g., mean difference, standard deviation) are quantified against defined acceptance thresholds.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document mentions "bench and user/clinical testing data" but does not specify the sample size for any clinical test sets. The data provenance (country of origin, retrospective or prospective) is also not stated.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
This information is not provided in the document. For blood pressure monitors, ground truth is typically established by trained clinical personnel (e.g., physicians, nurses) using a reference auscultatory method.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
The document does not describe any adjudication method.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
A Multi-Reader Multi-Case (MRMC) comparative effectiveness study is not applicable as this device is an automatic blood pressure monitor, not an AI-assisted diagnostic tool that involves human interpretation of images or data.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
The device is an automatic blood pressure monitor designed for standalone use, meaning it operates without human intervention in the measurement process itself, beyond placement and initiation. The document implies that the device's performance was evaluated in this standalone capacity, reporting "high accuracy and repeatability."
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The document does not explicitly state the type of ground truth used. However, for blood pressure monitors, the gold standard for clinical validation typically involves simultaneous or near-simultaneous measurements by trained observers using a mercury sphygmomanometer (auscultatory method) as the ground truth.
8. The sample size for the training set
No information is provided regarding a training set. While the device utilizes "Fuzzy arithmetic," suggesting an algorithm that might learn or be tuned, the document does not mention explicit training data or its size.
9. How the ground truth for the training set was established
Not applicable, as no training set or its ground truth establishment is described.
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EXHIBIT 2 Summary of Safety and Effectiveness
The Buzz Group, LLC 420 Lexington Avenue, Suite 2816 New York, NY 10170 Tel: (212) 375-2962 Fax: (212) 375-2918 Contact: David Ortiz, President
1. Identification of the device Proprietary-Trade Name: Model BZ-576 Automatic Blood Pressure Monitor Classification Names: DXN, SYSTEM, MEASUREMENT, BLOOD-PRESSURE, NON-INVASIVE, Common/Usual Name: Wrist blood pressure monitor/Body fat meter
Equivalent legally marketed devices 2.
This product is similar in function and design to the Omron HEM-757 Automatic Blood Pressure Monitor, K001670
3. Indications for Use (intended use)
Measuring systolic and diastolic blood pressures and pulse rates in adult patients with arm circumference between 5 and 15 inches.
Description of the Device 4.
The Model BZ-576 Digital Blood Pressure Monitor uses the oscillometric method with Fuzzy arithmetic for measuring blood pressure, and the high accuracy and repeatability are achieved. The device is ideal for people who frequently monitor their own blood pressure, for its easy way to use at home, at work and during travel. The main components include a cuff, an integrated silicon pressure sensor, an electronic pump, an electronic valve, two buttons, a microcontroller and LCD display. The integrated silicon pressure sensor is used for detecting pressure within the cuff and the pulse wave component during the course of cuff pressure deflation, and guarantees the long period stability. The air pressure of inflation, deflation and rapid release are fully automatic by using an electronic pump and an electronic valve, and a constant deflation speed is controlled in the process of measurement for increasing the accuracy and reducing the measurement time. The blood pressure and pulse values are calculated, and are displayed with "mmHg" or "kPa" on LCD alternatively.
Safety and Effectiveness, comparison to predicate device క.
The results of bench and user/clinical testing indicate that the new device is as safe and effective as the predicate devices.
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| Designation | Omron HEM-757 Automatic BloodPressure Monitor, K001670 | Buzz Group BZ-576 |
|---|---|---|
| Operating Principle | Oscillometric automated bloodpressure monitoring | SAME |
| Display | LCD: Systolic, Diastolic, Pulse,Low Batt. | LCD: Systolic, Diastolic, Pulse,Low Batt. (SAME) PLUS dateand time. |
| Controls | ON/OFFSTARTM (Memory) | POWERSTARTMEM AMEM B |
| Power supply | 4-AA batteries; AC Adaptor | SAME except no AC Adaptoravailable |
| External dimensions | Approx. 4.5" L x 7" W x 2.8" H | Approx. 3.8" L x 5.2" W x1.5" H. |
| Memory | 14 measurements | SAME |
| Weight | 19 oz, 530 g. not includingbatteries | 10.2 oz with batteries (unit)4.4 oz: cuff |
| Accessories | Arm cuff, carrying case,instruction manual | SAME |
Comparison matrix -- new vs. Predicate device 6.
7. Conclusion
After analyzing both bench and clinical testing data, it is the conclusion of The Buzz Group that that the "BZ-576" Automated Blood Pressure Monitor is as safe and effective as the predicate device, has few technological differences, and has no new indications for use, thus rendering it substantially equivalent to the predicate devices.
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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized eagle with three stripes forming its body and wing. The eagle is enclosed in a circle with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES-USA" written around the circumference of the circle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAY - 4 2004
The Buzz Group, LLC c/o Mr. Daniel Kamm Kamm & Associates PO Box 7007 Deerfield IL 60015
Re: K033216
Trade/Device Name: "BZ-576" Non-invasive Automatic Blood Pressure Monitor Regulation Number: 21 CFR 870.1130 Regulation Name: Noninvasive Blood Pressure Measurement System Regulatory Class: II (two) Product Code: DXN Dated: September 30, 2003 Received: October 03, 2003
Dear Mr. Kamm:
We have reviewed your Section 510(k) premarket notification of intent to market the indication We have reviewed your Section 9 ro(x) [remained is substantially equivalent (for the indications feterenced above and nave determined the marketed predicate devices marketed in interstate for use stated in the encrosule) to regally manated to of the Medical Device Americans, or to connineree prior to May 20, 1978, the excordance with the provisions of the Federal Food, Drug. devices that have been recuire approval of a premarket approval application (PMA). alla Cosment Act (Act) that to hot require appear a controls provisions of the Act. The You may, therefore, market the devices, bacterements for annual registration, listing of general controls provisions of tactice, 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 If your device is classified ($60 a0070) als. Existing major regulations affecting your device can inay be subject to such additions, 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 I hat FDA has made a determination that your device complics with other requirements of the Act that I DT has made a actual regulations administered by other Federal agencies. You must
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Page 2 – Mr. Daniel Kamm
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 CI IC rate 677, adoling (21 CFR Part 820); and if applicable, the electronic forth in the quant) by sions (Sections 531-542 of the Act); 21 CFR 1000-1050. product launtion control pro no begin (2001) (2006) 100 marketing your Section 510(k) I mis letter with and w yourse only and inding of substantial equivalence of your device to a legally premaired predicated. The PDF interessification 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 If you desire specific acritories for your as (301) 594-4648. 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 other general 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,
Dma R. Lachner
( Bram D. Zuckerman, M.D. Division Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Page 4 – Mr. Daniel Kamm
Indications for Use
510(k) Number: K033216
Device Name: "BZ-576" Non-Invasive Automatic Blood Pressure Monitor
Indications For Use:
Measuring systolic and diastolic blood pressures and pulse rates in adult patients with arm circumference between 5 and 15 inches.
Prescription Use (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use _ V __ (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
R. lochner
(Division Sign-Off) Division of Cardiovascular Devices
510(K) Number LA33216
Page 1 of 1 .
§ 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).