(86 days)
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No
The description details a standard oscillometric blood pressure measurement technique and classification based on established guidelines (JNC 7). There is no mention of AI or ML algorithms for data analysis, classification, or prediction.
No
Explanation: The device is intended to measure blood pressure and pulse rate, providing information. It is explicitly stated that the device is "not intended to be a diagnostic device." It does not provide any treatment or therapeutic intervention.
No
The "Intended Use / Indications for Use" section explicitly states, "The EW 3032 is not intended to be a diagnostic device."
No
The device description explicitly states it uses an inflatable cuff, a capacitive pressure sensor, and measures blood pressure using the oscillometric method, all of which are hardware components. The performance studies also include electrical, mechanical, and environmental testing, further indicating it is a hardware device.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD definition: In Vitro Diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device function: The Panasonic Wrist Blood Pressure Monitor measures blood pressure and pulse rate by using a non-invasive technique involving a cuff wrapped around the wrist. This is a physical measurement taken directly from the body, not a test performed on a sample outside the body.
- Intended Use statement: The Intended Use clearly states the device is for "measuring the systolic and diastolic blood pressure and pulse rate of an adult individual by using a non-invasive technique".
- Explicit statement: The description for the EW 3032 explicitly states, "The EW 3032 is not intended to be a diagnostic device." While this refers to it not being a diagnostic device in the clinical sense (meaning it doesn't definitively diagnose a condition), it further reinforces that it's not an IVD.
Therefore, based on the provided information, the Panasonic Wrist Blood Pressure Monitor is a non-invasive physiological monitoring device, not an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
The Panasonic Oscillometric Wrist Blood Pressure Monitors, Models EW3031 and EW 3032 are devices intended to measure systolic and diastolic blood pressure rate of an adult individual by using a pressurized cuff on the left wrist. The devices are not intended for use on infants or children. The devices are designed for home use only and not for ambulatory measurements.
The Panasonic Wrist Blood Pressure Monitor, Models EW 3031 and EW 3032 are devices intended to measure the systolic and diastolic blood pressure and pulse rate of an adult individual by using a non-invasive technique in which an inflatable cuff is wrapped around the wrist.
For the EW 3032, display of Normal (green), Prehypertensive (yellow) or Hypertensive (orange) are based on blood pressure values classified in the paper: "JNC Express, The Seventh Report of the Joint National Committee on Prevention, Detection, Evaluation, and Treatment of High Blood Pressure" , U.S. Department of Health and Human Services, National Institutes of Health, National Heart, Lung, and Blood Pressure Institute, National High Blood Pressure Education Program, NIH Publication No 03-5233, May 2003. The display values are generally known, but not proven, to be an indicator of your blood pressure.
The EW 3032 is not intended to be a diagnostic device. Contact your physician if prehypertensive or hypertensive values are indicated.
Product codes (comma separated list FDA assigned to the subject device)
DXN
Device Description
The Panasonic Wrist Blood Pressure Monitor, Models 3031/3032 are designed to measure the systolic and diastolic blood pressure and pulse rate of an individual by using a non-invasive technique in which an inflatable cuff is wrapped around the wrist. Our method to define systolic and diastolic pressure is similar to the auscultatory method but uses an electronic capacitive pressure sensor rather than a stethoscope and mercury manometer. The sensor converts tiny alterations in cuff pressure to electrical signals, by analyzing those signals to define the systolic and diastolic blood pressure and calculating pulse rate, which is a well - known technique in the market called the "oscillometric method".
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
wrist
Indicated Patient Age Range
adult individual, not intended for use on infants or children.
Intended User / Care Setting
Home use only, not for ambulatory measurements.
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)
Non-Clinical Tests:
Testing information demonstrating safety and effectiveness of the in the intended environment of use is supported by testing that was conducted in accordance with the FDA November 1993 Draft "Reviewer Guidance for Premarket Notification Submissions", DCRND, which outlines Electrical, Mechanical and Environmental Performance Requirements. The following testing was conducted:
a. Reliability Test Operation Conditions
b. Reliability Test Drop Testing
c. Reliability Test Storage
d. Reliability Test Vibrating Testing
e. EMC Test
f. IEC 60601-1 Safety Test
g. Evaluation of Pulse Rate Measurement
None of the testing demonstrated any design characteristics that violated the requirements of the Reviewer Guidance or resulted in any safety hazards. It was our conclusion that the Panasonic Wrist Blood Pressure Monitor, Models 3031/3032 tested met all relevant requirements of the aforementioned tests.
Clinical Tests:
ANSI/AAMI SP10-1992 "National Standard for Electronic or Automated Sphygmomanometers" testing was performed. All relevant sections were addressed and testing conducted. The EW 3031 and EW 3032 met all relevant requirements of this standard.
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).
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K033894
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EXHIBIT # 1
510(K) SUMMARY
This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR §807.92.
The assigned 510(k) number is:
1. Submitter's Identification:
Matsushita Electric Works, Ltd. 33 Okamachi Hikone, Shiga 522-85 Japan TEL: +81-(0) 749-27-2963 FAX: +81-(0)-749-23-0349
Date Summary Prepared: December 15, 2003
Name of the Device: 2.
Panasonic Wrist Blood Pressure Monitor, Models EW 3031/EW 3032
3. Predicate Device Information:
The Panasonic Wrist Blood Pressure Monitor, Models 3031/3032 are substantially equivalent to the MECA Blood Pressure Meter, Model EW 243/254, K991458.
4. Device Description:
The Panasonic Wrist Blood Pressure Monitor, Models 3031/3032 are designed to measure the systolic and diastolic blood pressure and pulse rate of an individual by using a non-invasive technique in which an inflatable cuff is wrapped around the wrist. Our method to define systolic and diastolic pressure is similar to the auscultatory method but uses an electronic capacitive pressure sensor rather than a stethoscope and mercury manometer. The sensor converts tiny alterations in cuff pressure to electrical signals, by analyzing those signals to define the systolic and diastolic blood pressure and calculating pulse rate, which is a well - known technique in the market called the "oscillometric method".
Intended Use: 5.
The Panasonic Oscillometric Wrist Blood Pressure Monitors, Models EW3031 and EW 3032 are devices intended to measure systolic and diastolic blood
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K033894.
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pressure rate of an adult individual by using a pressurized cuff on the left wrist. The devices are not intended for use on infants or children. The devices are designed for home use only and not for ambulatory measurements.
Comparison to Predicate Devices: 6.
Both devices use the well known oscillometric method within the software algorithm to determine the systolic and diastolic blood pressure and pulse rate. A wrist cuff is inflated automatically; deflate rate is controlled but a factory set bleed valve and the deflation pressures are transferred via tubing to a sensor in both units. Each device uses a similar capacitance-type pressure sensor to translate the pressure variations to electrical signals that can be interpreted by an integrating circuit. Once the reading is determined each unit operates a solenoid valve to release the pressure to zero. Our Wrist Blood Pressure Monitor, Model EW 3031/3032 , differs from the predicate device in the cuff application part, display function, and memory function.
Discussion of Non-Clinical Tests Performed for Determination of 7. Substantial Equivalence are as follows:
Testing information demonstrating safety and effectiveness of the in the intended environment of use is supported by testing that was conducted in accordance with the FDA November 1993 Draft "Reviewer Guidance for Premarket Notification Submissions", DCRND, which outlines Electrical, Mechanical and Environmental Performance Requirements. The following testing was conducted:
- Reliability Test Operation Conditions a.
- Reliability Test Drop Testing b.
- Reliability Test Storage C.
- Reliability Test Vibrating Testing ದೆ.
- EMC Test e.
- IEC 60601-1 Safety Test f.
- Evaluation of Pulse Rate Measurement g.
None of the testing demonstrated any design characteristics that violated the requirements of the Reviewer Guidance or resulted in any safety hazards. It was our conclusion that the Panasonic Wrist Blood Pressure Monitor, Models 3031/3032 tested met all relevant requirements of the aforementioned tests.
8. Discussion of Clinical Tests Performed:
ANSI/AAMI SP10-1992 "National Standard for Electronic or Automated Sphygmomanometers" testing was performed. All relevant sections were addressed and testing conducted. The EW 3031 and EW 3032 met all relevant requirements of this standard.
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