The Panasonic wrist blood pressure meter, model EW280, 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 510(k) summary regarding the Panasonic Wrist Blood Pressure Meter, Model EW280, focusing on acceptance criteria and the study conducted.

Acceptance Criteria and Device Performance for Panasonic Wrist Blood Pressure Meter, Model EW280

The provided 510(k) summary focuses on demonstrating substantial equivalence to predicate devices, rather than establishing de novo performance acceptance criteria for a novel device. The performance data presented primarily addresses verification that modifications to the new model (EW280) did not negatively impact the safety and effectiveness compared to the cleared predicate devices.

1. Table of Acceptance Criteria and Reported Device Performance

Feature/Specification	Acceptance Criteria (from Predicate Device EW273)	Reported Device Performance (EW280)
Main body (w) x (h) x (d)	77 x 66 x 23 (mm)	67 x 67 x 26 (mm)
Display: during measurement	"▲" lights up under "MEAS"	"<3" lights up at the right side of display
Display: error indication; excessive pressurization; no pulse detection	"▲" lights up under "ERR"	"E" lights up at the center of diastolic blood pressure indication
Method for displaying blood pressure value and pulse rate	Alternative	Simultaneous (inherited from Model EW279)
Measurement range of pressure	20-300 mm Hg	0-300 mm Hg
Noise safety specification	Less than 65 dB at 50 cm from main unit	Less than 65 dB at 1 m from main unit
Error margin performance specification (Pulse rate)	± 2 beats/min	± 5 beats per min
Pressurization performance specification	Pressurization time from 0 to 150 shall be less than 10 seconds	Pressurization time from 0 to 180 shall be less than 20 seconds
Operational buttons	2 ("0/1", "start")	1 ("0/1")

Note on Acceptance Criteria: For most features, the "acceptance criteria" for the EW280 appear to be the specifications of the predicate device (EW273), or in some cases, an explicit modification that is still deemed acceptable (e.g., simultaneous display as seen in EW279). The performance of the EW280 is implicitly stated as meeting these modified specifications, as the document concludes that "All devices passed all tests and are qualified for use."

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

Sample Size for Test Set: The document does not specify the sample size used for the performance testing. It simply states that "Hardware and software testing was conducted".
Data Provenance: The manufacturer is Matsushita Electric Works, Ltd., Osaka, Japan, implying the testing likely occurred in Japan. The type of study is a verification and validation (V&V) study, not a clinical trial. It is an internal study by the manufacturer.

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

This information is not applicable and not provided in the document. The testing described is component/device-level performance testing, not human-read clinical evaluation that would require expert ground truth.

4. Adjudication Method for the Test Set

This information is not applicable and not provided. Adjudication methods are typically used in clinical studies involving interpretation of data, not in hardware/software performance verification.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This type of study is relevant for diagnostic imaging or similar devices where different human readers interpret cases. The document describes hardware and software performance verification.

6. If a Standalone Study (algorithm only without human-in-the-loop performance) was done

The document describes standalone performance testing of the device (EW280). While it doesn't use the term "algorithm only," the testing focuses on the device's inherent functional performance (e.g., measurement range, accuracy of beats per minute, pressurization time, noise safety) without a human-in-the-loop component for interpretation. The device itself is an automated measurement system.

7. The Type of Ground Truth Used

For the performance testing, the ground truth would be established through scientific measurement standards and calibrated equipment. For example, to verify the "Error margin performance specification" for pulse rate, a validated reference signal generator or a highly accurate reference device would be used. Similarly, a calibrated pressure gauge would be the ground truth for pressurization accuracy.

8. The Sample Size for the Training Set

This information is not applicable and not provided. This device is an electronic blood pressure meter, not an AI/ML-driven device that requires a "training set" in the context of machine learning.

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

This information is not applicable as there is no "training set" for this type of medical device as described in the 510(k) summary.

In summary, the 510(k) for the Panasonic Wrist Blood Pressure Meter, Model EW280, is a substantial equivalence submission. The "study" referenced is hardware and software testing designed to confirm that manufacturing changes and minor technical modifications to the EW280 do not adversely affect its safety and effectiveness when compared to previously cleared predicate devices. It is not a clinical study involving human subjects or AI/ML algorithms, and therefore many of the requested details related to those types of studies are not present in this document.

Summary

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3/3/99

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510(k) SUMMARY FOR PANASONIC CORPORATION'S WRIST BLOOD PRESSURE METER, MODEL EW280

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 Fax: (202) 626-3737

SYSTEM IDENTIFICATION II.

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 EW280

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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III. PREDICATE DEVICE

A. Name of Predicate Devices

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, EW277, EW278, and EW279 were cleared for market (K942422). Panasonic intends to market an additional device, model EW280. This model is substantially equivalent to Panasonic's previously cleared devices.

V. DEVICE DESCRIPTION

Model EW280 is a wrist blood pressure meter.

VI. INTENDED USE

Model EW280 is intended to measure systolic and diastolic blood pressure using a pressurized cuff worn around the wrist.

VII. SUBSTANTIAL EQUIVALENCE COMPARISON

Intended Use

The intended use for model EW280 is identical to that of Panasonic's 510(k) cleared wrist blood pressure meter models.

Technological Characteristics

The design of model EW280 is the same as previously cleared Panasonic 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. Differences between model EW280 and Panasonic's previously cleared devices are described in Table 1.

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TABLE 1 DIFFERENCES BETWEEN MODEL EW273 and MODEL EW280

FEATURE	EW273Predicatedevice	EW280
Main body(w) x (h) x (d)	77 x 66 x 23 (mm)	67 x 67 x 26 (mm)
Display: during measurement	"▲" lights up under"MEAS"	"<3" 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
Method for displaying bloodpressure value and pulse rate	Alternative	Simultaneous¹
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
Operational buttons	2²"0/1""start"	1"0/1"

1 Available in another predicate device (Model EW 279) which was cleared (K942422).

2 Use of one operational button was cleared in 1995.

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VIII. PERFORMANCE DATA

Hardware and software testing was conducted to verify that the changes made to model EW280 have not affected the safety and effectiveness of this device. All devices passed all tests and are qualified for use.

IX. CONCLUSIONS

The Panasonic Corporation wrist blood pressure meter, model EW280, is substantially equivalent to previously cleared Panasonic Wrist Blood Pressure Meter models EW273, EW277, EW278, and EW279.

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Image /page/4/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS). The seal features the department's name encircling an emblem. The emblem consists of a stylized caduceus, a symbol often associated with medicine and healthcare, with three intertwined serpents around a staff.

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

K981431 Re : Panasonic Wrist Blood Pressure Meter, Model EW280 Requlatory 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, 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 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 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.

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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.gov/cdrh/dsma/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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510(k) Number (if known): K981431

Àce Name: Panasonic Wrist Blood Pressure Meter, model EW280

Indications For Use:

The Panasonic wrist blood pressure meter, model EW280, is intended to measure systolic and diastolic blood pressure using a pressurized cuff worn around the wrist.

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Concurrence of CDRH, Office of Device Evaluation (ODE)

K981431

(Division Sign-Off) Division of Cardiovascular, Respiratory, and Neurological Devices 1-80 510(k) Number >>

Prescription Use (Per 21 CFR 801.109) OR

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).