(350 days)
Not Found
No
The summary describes a standard oscillometric blood pressure monitor and does not mention any AI or ML components. The "PRECISE LOGIC™" term is likely a marketing phrase for their algorithm, but there's no indication it uses AI/ML.
No
The device is described as a blood pressure monitor intended for measurement and not for treating any condition.
Yes
The device is described as measuring systolic and diastolic blood pressure and pulse, and these measurements are used for diagnostic purposes in healthcare.
No
The device description explicitly states it is a "battery-operated, non-invasive, digital, electronic, arm blood pressure monitor," indicating it is a hardware device with integrated software, not a software-only device.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples such as blood, urine, or tissue that have been taken from the human body to detect diseases or other conditions.
- Device Function: The description clearly states that the device is an "arm blood pressure monitor" that uses an "oscillometric PRECISE LOGIC™ measurement" with a "pressurized cuff." This is a non-invasive method that measures physical parameters (blood pressure and pulse rate) directly from the body.
- Lack of Sample Analysis: There is no mention of analyzing any biological samples (blood, urine, etc.) taken from the patient.
Therefore, this device falls under the category of a non-invasive medical device, not an in vitro diagnostic.
N/A
Intended Use / 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.
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.
Product codes (comma separated list FDA assigned to the subject device)
DXN, 74 DXN
Device Description
MECA intends to market two battery-operated, non-invasive, digital, electronic, arm blood pressure monitors, model EW243 and model EW254.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Arm
Indicated Patient Age Range
Adults
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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
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.
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.
(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)