(317 days)
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No
The summary describes a standard digital blood pressure meter and does not mention any AI or ML capabilities.
No
Explanation: The device is intended to measure blood pressure, not to treat any condition. While it can be used in a therapeutic context (e.g., monitoring blood pressure during treatment), its primary function as described is measurement, not therapy.
No
Explanation: The device measures blood pressure, which is a physiological parameter, but the provided text does not state that it is used to diagnose a medical condition. It is a measurement device, not a diagnostic one.
No
The device description explicitly states it is a "digital electronic blood pressure meter" and mentions a "pressurized cuff worn around the wrist," indicating it includes hardware components for measurement.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD devices are used to examine specimens derived from the human body (like blood, urine, or tissue) in vitro (outside the body) to provide information for diagnosis, monitoring, or screening.
- This device measures blood pressure in vivo (within the body) by applying a cuff to the wrist. It does not analyze any bodily fluids or tissues.
The description clearly states its purpose is to measure blood pressure using a cuff worn around the wrist, which is a non-invasive, in vivo measurement.
N/A
Intended Use / 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.
Product codes
74 DXN
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.
Model EW280 is a wrist blood pressure meter.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
wrist
Indicated Patient Age Range
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Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies
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.
Key Metrics
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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
Image /page/0/Picture/1 description: The image shows a handwritten string of characters. The string starts with the letter 'K', followed by the numbers '981431'. The characters are written in a simple, slightly slanted style, and the image has a clean, white background.
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
1
III. PREDICATE DEVICE
A. Name of Predicate Devices
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, 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.
2
TABLE 1 DIFFERENCES BETWEEN MODEL EW273 and MODEL EW280
| FEATURE | EW273
Predicate
device | 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" | ">
Prescription Use (Per 21 CFR 801.109) OR
Over-The-Counter Use
(Optional Format 1-2-96)