The AViTA Bluetooth Blood Pressure Monitor (Model no.: BPM656ZB) is intended to measure the blood pressure (systolic and diastolic) and pulse rate by oscillometric method. The measurements are conducted by using an cuff which is wrapped around the upper arm. At the end of each measurement, the results will be displayed on LCD. AViTA BPM656ZB through its Bluetooth wireless communication port can also transfer the measurement results to other electronic devices, such as a PC , a PDA or a printer.

The device is indicated for adult in home use. The arm circumference range shall be between 9 inches (23 cm) to 17 inches (43 cm). The end users should not have common arrhythmias, such as atrial or ventricular premature beats or atrial fibrillation.

Device Description

The AViTA Bluetooth Blood Pressure Monitor (Model no.: BPM656ZB) is designed to measure the systolic and diastolic blood pressure, and pulse rate (heart of an individual).

The device uses an inflated cuff which is wrapped around the upper arm. The cuff is inflated by an electrical air pump. The systolic and diastolic blood pressures are determined by oscillometric method. The deflation rate is controlled by a preset mechanical valve at a constant rate. At any moment of measurement, the user can deflate the cuff. The measurement results are displayed on the LCD and transmitted to a Bluetooth enabled devices, such as a PC, a PDA, a printer, or and access point.

AI/ML Overview

The provided text describes a 510(k) submission for the AViTA Bluetooth Blood Pressure Monitor. However, it does not contain the specific information required to complete the detailed acceptance criteria and study analysis table as requested.

The document primarily focuses on:

Identifying the submitter and device.
Classifying the device and its predicate.
Stating the intended use.
Giving a brief device description.
Concluding that the device is substantially equivalent to the predicate based on intended use, technological characteristics, and bench testing (without detailing the bench testing results or criteria).
The FDA's official acceptance letter.

Therefore, many of the requested fields cannot be filled from the provided text.

Here's a response based on the available information, with explanations for what is missing:

Acceptance Criteria and Device Performance Study Analysis

The provided 510(k) summary for the AViTA Bluetooth Blood Pressure Monitor (Model no.: BPM656ZB) states that the device conforms to applicable standards, including EN-1060-1, EN-1060-3, and ANSI/AAMI SP-10. These standards define the acceptance criteria for non-invasive sphygmomanometers. However, the specific reported device performance against these criteria is not detailed in the provided document. The 510(k) simply concludes that "bench testing contained in this submission demonstrate that any differences in their technological characteristics do not raise any new questions of safety or effectiveness."

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criterion (from EN-1060-1, EN-1060-3, ANSI/AAMI SP-10)	Description (General Standard Requirement)	Reported Device Performance (Specific values from study)
Accuracy (Mean Difference)	Sphygmomanometer must have a mean difference between device and reference measurement within ±5 mmHg.	Not specified in provided text.
Accuracy (Standard Deviation)	Sphygmomanometer must have a standard deviation between device and reference measurement within ≤8 mmHg.	Not specified in provided text.
Cuff Pressure Display Accuracy	Pressure display accuracy within ±3 mmHg.	Not specified in provided text.
Repeatability/Reproducibility	Consistency of measurements over multiple trials.	Not specified in provided text.
Safety & EMC	Conformance to IEC 60601-1 (electrical safety) and IEC 60601-1-2 (electromagnetic compatibility).	Conforms to IEC 60601-1 and IEC 60601-1-2.
Operating Specifications	Conformance to EN-1060-1 and EN-1060-3 (non-invasive sphygmomanometers).	Conforms to EN-1060-1 and EN-1060-3.
Software/Hardware Performance	Performance of the oscillometric method, display, and Bluetooth transmission.	Not specified in provided text beyond functional description.

2. Sample size used for the test set and the data provenance:

Sample Size for Test Set: Not specified in the provided text.
Data Provenance: Not specified (e.g., country of origin, retrospective or prospective). The text only mentions "bench testing contained in this submission" as the basis for performance claims.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

Number of Experts: Not specified.
Qualifications of Experts: Not specified. For blood pressure devices, reference measurements are typically taken by trained technicians, often using auscultation with a calibrated mercury or aneroid sphygmomanometer, according to standard protocols (e.g., AAMI/ISO standards). The "ground truth" for blood pressure accuracy studies is usually these simultaneous, expert-performed reference measurements.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:

Adjudication Method: Not specified. This typically refers to how discrepancies in expert readings are resolved, which would be relevant if multiple experts were performing initial ground truth measurements.

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:

MRMC Study: No, this is not applicable for a standalone blood pressure monitor. MRMC studies are typically for image analysis or diagnostic support systems where human readers interpret data with or without AI assistance. This device simply provides blood pressure readings.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:

Standalone Performance: Yes, the device operates in a standalone mode, measuring and displaying blood pressure and heart rate. The performance indicated by conformance to standards like ANSI/AAMI SP-10 refers to the algorithm's accuracy in determining blood pressure from the oscillometric pulsations, without human interpretation of the underlying data.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):

Type of Ground Truth: Most likely, the ground truth for accuracy testing would be simultaneous, highly accurate measurements performed by a trained observer using a validated reference method (e.g., auscultatory measurements by a trained observer using a mercury sphygmomanometer) in accordance with the relevant international standards (e.g., ANSI/AAMI SP-10, ISO 81060-2). The expert's reading acts as the comparator.

8. The sample size for the training set:

Sample Size for Training Set: Not applicable/Not specified. For a traditional oscillometric blood pressure monitor, there isn't a "training set" in the machine learning sense. The device's algorithm is based on physiological principles and pre-defined mathematical models, rather than being "trained" on a dataset. The development and calibration would involve engineering and clinical validation rather than machine learning training.

9. How the ground truth for the training set was established:

Ground Truth for Training Set: Not applicable. As mentioned above, there isn't a training set in the machine learning context for this type of device. The algorithm's fundamental principles are established through engineering design and physiological understanding.

Summary

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510(K) SUMMARY

This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA and 21 CFR §807.92

1. Submitter's Name: AViTA Corporation

Address:	9F, No. 78, SEC. 1, Kwang-Fu Rd., San-Chung, TaipeiCounty., Taiwan, 241
Phone:	+886-2-8512-1568	DEC 07 2007
Fax:	+886-2-8512-1347
Contact:	Mr. Casper Chen / Vice President of R&D

2. Device Name :

Trade Name:	AVITA Bluetooth Blood Pressure Monitor ,
	Model no.: BPM656ZB
Common Name:	Non-Invasive Blood Pressure Monitor
Classification name	System , Measurement , Blood-Pressure , Non-Invasive

The AVITA Bluetooth Blood Pressure Monitor (Model 3. DEVICE CLASS no.: BPM656ZB) has been classified as Regulatory Class: II Panel: 74 Product Code: DXN Regulation Number: 2ICFR 870.1130
The predicate device is the A&D Medical UA-767PBT Digital 4. Predicate Device: Blood Pressure Monitor(K040371) marketed by A & D ENGINEERING, INC ..
The device is arm type Blood Pressure Monitor that applies 5. Intended Use: oscillometric method to measure human Systolic, Diastolic blood pressure and heart rate The measurement results are displayed on the LCD and transmitted to Bluetooth enabled devices, such as a PC , a PDA or a printer.

The devise is designed for adult.

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6. Device Description: The AViTA Bluetooth Blood Pressure Monitor (Model

no.: BPM656ZB} is designed to measure the systolic and diastolic blood pressure, and pulse rate (heart of an individual).

1. Performance In terms of operating specification, Safety & EMC Summary: requirements, the device conforms to applicable standards included EN-1060-1, EN-1060-3, ANSI/AAMI SP-10, IEC 60601-1 and IEC 60601-1-2 requirements.

8. Conclusions:

The_AViTA Bluetooth Blood Pressure Monitor (Model no.: BPM656ZB) has the same intended use and similar technological characteristics as the A&D Medical UA-767PBT Digital Blood Pressure Monitor(K040371) marketed by A & D ENGINEERING, INC.. Moreover, bench testing contained in this submission demonstrate that any differences in their technological characteristics do not raise any new questions of safety or effectiveness. Thus, The AVITA Bluetooth Blood Pressure Monitor (Model no.: BPM656ZB) is substantially equivalent to the predicate devices.

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Public Health Service

Image /page/2/Picture/2 description: The image is a circular seal for the Department of Health & Human Services - USA. The seal features the department's name encircling an emblem. The emblem is a stylized representation of a human figure, with three lines forming the head, torso, and legs, suggesting movement or progress.

DEC 0 7 2007

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

AViTA Corporation c/o Ms. Jennifer Reich 2904 Boldt Drive Flagstaff, AZ 86001

Re: K072137

Trade/Device Name: AViTA Bluetooth Blood Pressure Monitor Regulation Number: 21 CFR 870.1130 Regulation Name: Noninvasive Blood Pressure Measurement System Regulatory Class: Class II (two) Product Code: DXN, DRG Dated: November 6, 2007 Received: November 8, 2007

Dear Ms. Reich:

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 may publish further announcements concerning your device in the Federal Register.

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Page 2 - Ms. Jennifer Reich

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 Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

B.Zimmerman Jr

Bram 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): ___K072137

Device Name: AViTA Bluetooth Blood Pressure Monitor , Model no .: BPM656ZB AVITA Corporation

Indications For Use:

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)

Bllumema

(Division Sign-Off) Division of Cardiovascular Devices 510(k) Number

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Regulation Number and Section

§ 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).