(308 days)
Not Found
No
The summary describes a standard digital blood pressure meter and does not mention any AI or ML capabilities.
No
The device is intended to measure blood pressure, which is a diagnostic function, not a therapeutic one. It does not treat or alleviate any condition.
No
The device measures blood pressure, which is a physiological parameter. It does not diagnose a disease or condition; it provides data that can be used by a healthcare professional for diagnosis or monitoring.
No
The device description explicitly states it is a "digital electronic blood pressure meter" and mentions a "pressurized cuff worn around the wrist," indicating hardware components are integral to its function. The performance studies also mention "Hardware and software testing."
Based on the provided information, the Panasonic wrist blood pressure meter, model EW 284, is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD devices are used to examine specimens taken from the human body (like blood, urine, or tissue) to provide information about a person's health.
- The description of the Panasonic wrist blood pressure meter clearly states its intended use is to measure systolic and diastolic blood pressure using a pressurized cuff worn around the wrist. This is a non-invasive measurement taken directly from the body, not from a specimen.
Therefore, this device falls under the category of a non-invasive medical device used for physiological measurement, not an in vitro diagnostic device.
N/A
Intended Use / 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.
Product codes
74 DXN
Device Description
Model EW284 is a wrist blood pressure meter. 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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Wrist
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies
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.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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).
0
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
1
PREDICATE DEVICE
Name of Predicate Devices A.
Panasonic wrist blood pressure meter, models EW273, EW277, EW278, and EW279.
B. 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.
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.
2
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.
3
TABLE 1 DIFFERENCES BETWEEN MODEL EW279 and MODEL EW284
| FEATURE | EW279
Predicate
device | 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 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 |
| 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 | ± 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 |
| Data memory and retention | Memory function
for 30 readings.
Device retains up to
30 readings in
memory. | Memory function for 60 readings.
Device retains up to 60 readings
in memory. |
| Additional operational
buttons/switches | Not applicable | Recall button
Memory button
Memory clear button
"▲" switch |
4
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.
5
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
6
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)
OR
Over-The Counter Use
(Optional Format 1-2-96)