Model EW243 and model EW254 are intended to be used for the oscillometric PRECISE LOGIC™ measurement of systolic and diastolic blood pressure and pulse rate using a pressurized cuff.

These devices are designed for use by adults. These devices should not be used on infants or toddlers, for continuous monitoring medical emergencies or operations, or for any other purpose other than measuring blood pressure.

Blood pressure measurements determined with this device are equivalent to those obtained by a trained observer using the cuff/stethoscope auscultation method, within the limits prescribed by the American National Standard, Electronic or Automated Sphygmomanometers.

Device Description

MECA intends to market two battery-operated, non-invasive, digital, electronic, arm blood pressure monitors, model EW243 and model EW254.

AI/ML Overview

Here's a breakdown of the acceptance criteria and study information for the Matsushita Electric Corporation of America's Blood Pressure Monitors, Model EW243 and Model EW254, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The provided text does not explicitly state numerical acceptance criteria in a table format. However, it does state the overall performance claim for the device.

Acceptance Criteria (Implicit)	Reported Device Performance
Blood pressure measurements are equivalent to those obtained by a trained observer using the cuff/stethoscope auscultation method, within the limits prescribed by the American National Standard, Electronic or Automated Sphygmomanometers.	"This study demonstrates that MECA's arm blood pressure monitors can accurately measure blood pressure."

Important Note: The document refers to meeting the "limits prescribed by the American National Standard, Electronic or Automated Sphygmomanometers" as the benchmark for equivalence. The specific numerical limits of this standard are not detailed in the provided text.

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

Sample Size for Test Set: Not explicitly stated in the provided text. The text only mentions "a clinical study was conducted using model EW254."
Data Provenance: Not explicitly stated. There is no mention of the country of origin or whether the study was retrospective or prospective. Given the nature of a clinical study for device approval, it is highly likely to be prospective, but this is an inference, not a direct statement.

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

Number of Experts: Not explicitly stated. The text refers to "a trained observer using the cuff/stethoscope auscultation method" for ground truth establishment. It does not quantify how many such observers were used, nor does it specify their qualifications (e.g., years of experience).

4. Adjudication Method for the Test Set

Adjudication Method: Not explicitly stated. Given that the ground truth is established by a "trained observer using the cuff/stethoscope auscultation method," it implies a comparison to a widely accepted clinical standard. There is no mention of multiple observers or any specific adjudication process like 2+1 or 3+1.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

MRMC Study: No, there is no mention of a Multi-Reader Multi-Case (MRMC) comparative effectiveness study. The study described focuses on the device's accuracy against a standard human measurement, not on human readers improving with AI assistance.
Effect Size of Human Readers with AI: Not applicable, as no MRMC study involving AI assistance was mentioned.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study

Standalone Performance Study: Yes, a standalone performance study was done. The clinical study specifically evaluated the "arm blood pressure monitors" (EW254) to demonstrate their accuracy in measuring blood pressure independently. While "algorithm only" is a modern term, the described clinical study directly assesses the device's measurement capability without human intervention in the measurement process (beyond applying the cuff and starting the device). It states: "This study demonstrates that MECA's arm blood pressure monitors can accurately measure blood pressure."

7. Type of Ground Truth Used

Ground Truth Type: Expert consensus/clinical standard. The ground truth was established by "a trained observer using the cuff/stethoscope auscultation method." This is a widely accepted clinical standard for blood pressure measurement.

8. Sample Size for the Training Set

Sample Size for Training Set: Not explicitly stated. The document mentions that the devices "use the same blood pressure measurement algorithm" as the predicate device (EW277), but "the values for the matrix table and constants have been modified to account for differences in the volume and pressure in the arm." It does not provide details on a specific training set size for these modifications.

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

Ground Truth for Training Set: Not explicitly detailed. While the underlying algorithm is shared with the predicate device, it's inferred that the modifications to the "matrix table and constants" would have been informed by data reflecting arm measurements. However, the specific method for establishing ground truth for this "training" or adjustment phase is not described in the provided text.

Summary

{0}------------------------------------------------

K991458

510(k) SUMMARY FOR MATSUSHITA ELECTRIC CORPORATION OF AMERICA'S BLOOD PRESSURE MONITORS, MODEL EW243 AND MODEL EW254

I. SYSTEM SPONSOR

Sponsor Name and Address A.

Matsushita Electric Corporation of America (MECA) One Panasonic Way (4A-3) Secaucus, NJ 07094

Official Correspondent and Address B.

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

SYSTEM IDENTIFICATION II.

A. Classification Name

Non-invasive blood pressure measurement system

B. Common/Usual Name

Electronic blood pressure monitor

C. Trade/Proprietary Name of the System

Panasonic blood pressure monitor, model EW243 Panasonic blood pressure monitor, model EW254

D. Classification

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

Classification Panel: Circulatory Systems Device Panel

Product code: 74 DXN

{1}------------------------------------------------

III. PREDICATE DEVICE

In 1995, MECA's wrist blood pressure monitor model EW277 was cleared for market (K942422).

A. Name of Predicate Devices

Panasonic wrist blood pressure monitor, model EW277.

B. Intended Use

The wrist blood pressure monitor is intended to measure systolic and diastolic blood pressure using a pressurized cuff.

C. Device Description

The blood pressure monitor is a battery-operated, non-invasive, digital, electronic blood pressure monitor.

IV. DEVICE DESCRIPTION

MECA intends to market two battery-operated, non-invasive, digital, electronic, arm blood pressure monitors, model EW243 and model EW254.

V. INTENDED USE

Model EW243 and model EW254 are intended to measure systolic and diastolic blood pressure using a pressurized cuff.

VI. SUBSTANTIAL EQUIVALENCE COMPARISON

A. Intended Use

The intended use for model EW243 and model EW254 is identical to that of MECA's 510(k)-cleared blood pressure monitor model EW277.

B. Technological Characteristics

l. Similarities between Model EW277, EW243, and EW254
MECA modified its existing, previously-cleared blood pressure monitor model EW277, to create model EW243 and model EW254. Therefore, these device models share many of the same features, functions, and components.

{2}------------------------------------------------

2. Differences between Model EW277, EW243, and EW254

Model EW277 is a blood pressure monitor that has a cuff that is worn around the wrist, while both model EW243 and EW254 have cuffs that are worn around the upper arm. The cuff circumference for model EW277 is smaller than the cuff circumference for models EW243 and EW254 (135-195 mm for EW277 to 200-400 mm for EW243 and EW254). The size and weight for these devices are also different. While these devices use the same blood pressure measurement algorithm, the values for the matrix table and constants have been modified to account for differences in the volume and pressure in the arm.

VII. PERFORMANCE DATA

Hardware and software testing was conducted to verify that the changes made to model EW234 and EW254 do not affect the safety and effectiveness of these devices. Model EW243 and model EW254 passed all tests. Additionally, a clinical study was conducted using model EW254. This study demonstrates that MECA's arm blood pressure monitors can accurately measure blood pressure.

CONCLUSIONS VIII.

MECA's arm blood pressure monitors, model EW243 and model EW254, are substantially equivalent to MECA's previously-cleared wrist blood pressure monitor model EW277.

{3}------------------------------------------------

Image /page/3/Picture/1 description: The image is a black and white logo for the Department of Health & Human Services - USA. The logo features a stylized image of an eagle with three lines representing its wings. The eagle is facing to the right. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

APR 1 0 2000

Matsushita Electric Corporation of America c/o Mr. Edward M. Basile King & Spalding 1730 Pennsylvania Avenue, N.W. Washington, D.C. 20006-0500

510(K) K991458 Re: MECA Blood Pressure Meter, Model EW243 and Model EW254 Requlatory Class: II Product Code: DXN Dated: January 19, 2000 Received: January 19, 2000

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, 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 requlation (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 requlatory action. In addition, FDA may publish 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 have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

{4}------------------------------------------------

Page 2 - Mr. Edward M. Basile

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 regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4639. 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.gov/cdrh/dsma/dsmamain.html".

Sincerely yours,

for Nina & Simperle

James E. Dillard III Director Division of Cardiovascular and Respiratory Devices Office of Device Evaluation Center for Devices and Radiological Health

{5}------------------------------------------------

Page of

510(k) Number (if known): K991458

Device Name: MECA arm blood pressure meters, model EW243 and model EW254

Indications For Use:

Model_EW243 and model EW254 are intended to be used for the oscillometric PRECISE LOGIC™ measurement of systolic and diastolic blood pressure and pulse rate using a pressurized cuff.

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

and Neurological Devices

510(k) Number

Concurrence of CDRH, Office of Device Evaluation (ODE)

(Division Sign-Off)
Division of Cardiovascular, Respiratory,

(Optional Format 3-10-98)

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).