(107 days)
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Not Found
No
The description focuses on standard blood pressure measurement and classification based on established guidelines (JNC 7), with no mention of AI or ML algorithms for data processing, analysis, or prediction.
No
This device is intended to measure blood pressure and pulse rate, not to treat any condition. It explicitly states it is not intended to be a diagnostic device, further indicating it's not therapeutic.
No
The document explicitly states, "The EW 3037 is not intended to be a diagnostic device."
No
The device description explicitly states it is a "Panasonic Wrist Blood Pressure Monitor Models EW3003 and EW3037," which are hardware devices with an inflatable cuff. The description of the EW 3037's display features is a function of the hardware device, not a standalone software application.
Based on the provided information, 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 using a non-invasive technique involving a cuff on the wrist. This is a physical measurement taken directly from the body, not a test performed on a sample outside the body.
- Explicit statement: The intended use section for the EW 3037 explicitly states, "The EW 3037 is not intended to be a diagnostic device." While this doesn't directly say it's not an IVD, it reinforces that its purpose is not for in-vitro diagnostic testing.
Therefore, the device's function and the explicit statement in the intended use clearly indicate that it is not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The Panasonic Wrist Blood Pressure Monitor, Models EW 3003 and EW 3037 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 3037, 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 3037 is not intended to be a diagnostic device. Contact your physician if prehypertensive or hypertensive values are indicated.
Product codes
DXN
Device Description
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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
Intended User / Care Setting
Over-The-Counter Use
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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Predicate Device(s)
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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
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/0/Picture/11 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an emblem featuring a stylized eagle with three stripes extending from its wing.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JAN 2 7 2005
Matsushita Electric Works, Ltd. c/o Ms. Carolann Kotula MDI Consultants, Inc. 55 Northern Blvd. Suite 200 Great Neck, NY 11021
Re: K042818
Trade Name: Panasonic Wrist Blood Pressure Monitor Models EW3003 and EW3037 Regulation Number: 21 CFR 870.1130 Regulation Name: Non-invasive Blood Pressure Measurement System Regulatory Class: II (two) Product Code: DXN Dated: December 23, 2004 Received: December 27, 2004
Dear Ms. Kotula:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for are caraction to May 28, 1976, the enactment date of the Medical Device Amendments, or 10 devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). 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 (PMA), 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 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
1
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set Of It in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. This letter will allow you to begin marketing your device as described in your Section 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), please contact the Office of Compliance at (240) 276-2190. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrl/industry/support/index.html.
Sincerely yours,
Bhimuma for
B. Zuber MD
Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Attachment 2
Page -1
510(k) Number (if known): __KO42818 / S / S
Device Name: Panasonic Wrist Blood Pressure Monitor, Models EW 3003 and EW 3037
Indications For Use: The Panasonic Wrist Blood Pressure Monitor, Models EW 3003 and EW 3037 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 3037, 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 3037 is not intended to be a diagnostic device. Contact your physician if prehypertensive or hypertensive values are indicated.
Prescription Use (Per 21 CFR 801.109)
OR
Over-The-Counter Use X (Optional Format 1-2-96)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
B. Ammann
Division Sign-Off) Division of Cardiovascular Devices 510(k) Number