The Panasonic wrist blood pressure meter, model EW 284, is intended to measure systolic and diastolic blood pressure using a pressurized cuff worn around the wrist.

Device Description

The wrist blood pressure meter is a battery-charged non-invasive digital electronic blood pressure meter manufactured by Matsushita Electric Works, Ltd., (MEW) Osaka, Japan. The wrist blood pressure meter is intended to measure systolic and diastolic blood pressure using a pressurized cuff worn around the wrist.

AI/ML Overview

Here's an analysis of the provided text regarding the Panasonic wrist blood pressure meter, model EW284, focusing on acceptance criteria and supporting studies:

I. Acceptance Criteria and Reported Device Performance

The document reports several performance specifications for the EW284 and notes changes from the predicate device (EW279). It does not explicitly state acceptance criteria in the sense of pass/fail thresholds for a study, but rather specifications of the device's design and operation. The study mentioned generally states that the device "passed all tests" to verify that changes haven't affected safety and effectiveness.

Feature	Acceptance Criteria (as per specifications, for EW284)	Reported Device Performance (Implied from "passed all tests")
Measurement Range of Pressure	0-300 mm Hg	Met (implied)
Noise Safety Specification	Less than 65 dB at 1 m from main unit	Met (implied)
Error Margin Performance	± 5 beats per min	Met (implied)
Pressurization Performance	From 0 to 180 shall be less than 20 seconds	Met (implied)
Data Memory and Retention	Memory function for 60 readings	Met (implied)

II. Sample Size Used for the Test Set and Data Provenance

The document states: "Hardware and software testing was conducted to verify that the changes made to model EW284 have not affected the safety and effectiveness of this device."

Sample Size for Test Set: Not specified. The document does not provide details about the number of devices tested or the number of measurements taken.
Data Provenance: Not specified, but the device is manufactured by Matsushita Electric Works, Ltd., Osaka, Japan, suggesting the testing likely occurred in Japan. The study is retrospective in the sense that it's performed on the completed device for regulatory submission, but the data itself could be prospectively collected during the testing phase.

III. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications

Number of Experts: Not applicable. The "ground truth" for blood pressure measurements in this context would typically be established by a reference method (e.g., a mercury sphygmomanometer calibrated against known standards) rather than by expert consensus. The document does not describe the specific methodology for establishing measurement accuracy (e.g., comparison to a trained observer using a stethoscope and sphygmomanometer).
Qualifications of Experts: Not applicable, as expert consensus is not the stated method for determining ground truth in blood pressure device testing.

IV. Adjudication Method for the Test Set

Adjudication Method: Not applicable. The document describes technical performance testing rather than studies involving human interpretation or subjective assessment that would require adjudication.

V. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done

MRMC Study: No, an MRMC comparative effectiveness study was not done. This type of study is typically used for diagnostic imaging devices where human interpretation is a key component, not for an automated measurement device like a blood pressure monitor.
Effect Size of Human Readers Improvement with AI vs. without AI Assistance: Not applicable, as no MRMC study was performed and the device is not an AI-assisted diagnostic tool for human readers.

VI. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was Done

Standalone Performance: Yes, the described "Hardware and software testing" would inherently be a standalone performance evaluation of the device's ability to measure blood pressure according to its specifications. The document implies that the device operates independently to perform its measurement function.

VII. The Type of Ground Truth Used

Type of Ground Truth: The document does not explicitly state the type of ground truth used. For blood pressure monitors, the ground truth for accuracy testing is typically obtained through a reference standard measurement, such as simultaneous measurement by a trained observer using a calibrated mercury sphygmomanometer or an oscillometric device that has been independently validated to a recognized standard (e.g., ISO 81060-2, AAMI, BHS). The "Error margin performance specification" of "± 5 beats per min" refers to pulse rate, not blood pressure accuracy directly, but it still implies comparison to a known standard.

VIII. The Sample Size for the Training Set

Sample Size for Training Set: Not applicable. This device is a hardware-based electronic blood pressure meter, not a machine learning or AI-based system that requires a "training set" in the computational sense. Its operation is based on predefined algorithms and physical principles, not learned patterns from a dataset.

IX. How the Ground Truth for the Training Set Was Established

How Ground Truth for Training Set Was Established: Not applicable, as there is no "training set" in the context of this device.

Summary

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3/3/99

981542

510(k) SUMMARY FOR PANASONIC CORPORATION'S WRIST BLOOD PRESSURE METER, MODEL EW284

SYSTEM SPONSOR I.

Sponsor Name and Address A.

Panasonic Corporation (Panasonic) One Panasonic Way (4A-3) Secaucus, NJ 07094

B. Official Correspondent and Address

Edward M. Basile, Esq. King & Spalding 1730 Pennsylvania Avenue, N.W. Washington, D.C. 20006 Phone: (202) 737-0500 (202) 626-3737 Fax:

II. SYSTEM IDENTIFICATION

A. Classification Name

Non-invasive blood pressure measurement system

B. Common/Usual Name

Electronic blood pressure meter

C. Trade/Proprietary Name of the System

Panasonic wrist blood pressure meter, model EW284

D. Classification

Regulatory Class: II (two); 21 C.F.R. § 870.1130

Classification Panel: Circulatory Systems Device Panel

Product code: 74 DXN

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PREDICATE DEVICE

Name of Predicate Devices A.

Panasonic wrist blood pressure meter, models EW273, EW277, EW278, and EW279.

B. Device Description

IV. BACKGROUND

In 1995, the Panasonic wrist blood pressure meter models EW273, EW278, and EW279 were cleared for market (K942422). Panasonic intends to market an additional device, model EW284. This model is substantially equivalent to Panasonic's previously cleared devices.

DEVICE DESCRIPTION V.

Model EW284 is a wrist blood pressure meter.

VI. INTENDED USE

Model EW284 is intended to measure systolic and diastolic blood pressure using a pressurized cuff worn around the wrist.

SUBSTANTIAL EQUIVALENCE COMPARISON VII.

Intended Use

The intended use for model EW284 is identical to that of Panasonic's 510(k) cleared wrist blood pressure meter models.

Technological Characteristics

The design of model EW284 is the same as Panasonic's previously cleared wrist blood pressure meter models EW273, EW277, EW278, and EW279. Minor modifications were made to product specifications to harmonize with Japan Industry Standards (JIS). The measurement range, display functionality, and device dimensions were also modified for ease of use. Data memory and retention have increased from 30 to 60 readings. Three buttons and a switch were added. The recall, memory, and memory clear buttons can be

III.

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used to obtain or delete pulse rate information that is stored in memory. The "♪" switch allows the user to control whether audible tones are provided during measurement, when an error occurs, and at the conclusion of the measurement. Differences between model EW284 and Panasonic's previously cleared devices are described in Table 1.

VIII. PERFORMANCE DATA

Hardware and software testing was conducted to verify that the changes made to model EW284 have not affected the safety and effectiveness of this device. All devices passed all tests and are qualified for use.

CONCLUSIONS IX.

The Panasonic Corporation wrist blood pressure meter, model EW284, is substantially equivalent to previously cleared Panasonic Wrist Blood Pressure Meter models EW273, EW277, EW278, and EW279.

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TABLE 1 DIFFERENCES BETWEEN MODEL EW279 and MODEL EW284

FEATURE	EW279Predicatedevice	EW284
Main body(w) x (h) x (d)	7 x 3 x 7 (inches)	3 x 3 x 1 (mm)
Display: during measurement	"▲" lights up under"MEAS"	"◇" lights up at the right side ofdisplay
Display:error indication;excessive pressurization;no pulse detection	"▲" lights up under"ERR"	"E" lights up at the center ofdiastolic blood pressureindication
Measurement range ofpressure	20-300 mm Hg	0-300 mm Hg
Noise safety specification	Less than 65 dB at50 cm from mainunit	Less than 65 dB at1 m from main unit
Error margin performancespecification	± 2 beats/min	± 5 beats per min
Pressurization performancespecification	Pressurization timefrom 0 to 150 shallbe less than 10seconds	Pressurization time from 0 to 180shall be less than 20 seconds
Data memory and retention	Memory functionfor 30 readings.Device retains up to30 readings inmemory.	Memory function for 60 readings.Device retains up to 60 readingsin memory.
Additional operationalbuttons/switches	Not applicable	Recall buttonMemory buttonMemory clear button"▲" switch

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Image /page/4/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized caduceus symbol, which is a staff with two snakes coiled around it, often used as a symbol of medicine. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" are arranged in a circular pattern around the caduceus symbol.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAR - 3 1999

Panasonic Corporation c/o Mr. Edward M. Basile, Esq. King & Spalding 1730 Pennsylvania Avenue, N.W. Washington, DC 20006-4706

K981542 Re : Panasonic Wrist Blood Pressure Meter, Model EW284 Regulatory Class: II (Two) Product Code: 74 DXN February 12, 1999 Dated: Received: February 12, 1999

Dear Mr. Basile:

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 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, Druq, 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 Regulations, 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 - Mr. Edward M. Basile, Esq.

This letter will allow you to begin 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 requlation (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 regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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/dsma/dsmamain.html".

Sincerely yours,

Thomas J. Callehan

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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510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________

nce Name: Panasonic Wrist Blood Pressure Meter, model EW 284

Indications For Use:

The Panasonic wrist blood pressure meter, model EW 284, is intended to measure systolic and diastolic blood pressure using a pressurized cuff worn around the wrist.

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRR, Office of Device Evaluation (ODE)

Sue R. Campbell

(Division Sign-Off) (Division Sign Oly, Oly and Neurological Devices

510(k) Number .

Prescription Use (Per 21 CFR 801.109)

Over-The Counter Use

(Optional Format 1-2-96)

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).