(25 days)
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No
The summary describes a standard oscillometric blood pressure monitor with irregular heartbeat detection, which is a common feature in such devices and does not inherently require AI/ML. There are no mentions of AI, ML, or related concepts in the provided text.
No
The device is described as a blood pressure meter intended for measurement and checking personal health conditions, not for treating or providing therapy.
No
The device measures blood pressure and pulse, and detects irregular heartbeats, but it explicitly states it's "not primarily under the order or direction of a physician" and is for "checking personal health condition at home." It provides a warning for irregular heartbeat but does not diagnose a medical condition.
No
The device description explicitly states it is a "blood pressure meter" that uses an "inflatable cuff wrapped around the wrist," indicating it includes hardware components for measurement.
Based on the provided information, the Citizen Model CH-658 blood pressure meter 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 Citizen Model CH-658 measures blood pressure and pulse using a non-invasive technique (a cuff around the wrist). It does not analyze samples taken from the body.
- Intended Use: The intended use describes the device as being used for "oscillometric measurement of systolic and diastolic blood pressure and pulse" and "checking personal health condition at home." This aligns with a non-IVD medical device.
Therefore, the Citizen Model CH-658 blood pressure meter falls under the category of a non-invasive medical device, not an in vitro diagnostic.
N/A
Intended Use / Indications for Use
The Citizen Model CH-658 blood pressure meter is intended to be used for oscillometric measurement of systolic and diastolic blood pressure and pulse by using a non-invasive technique in which an inflatable cuff is wrapped around the wrist. The device detects the appearance of irregular heartbeat during measurement, and gives a warning signal with the reading once the irregular heartbeat is detected. The device is intended to be used for checking personal health condition at home, and not primarily under the order or direction of a physician.
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
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Intended User / Care Setting
personal health condition at home
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)
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Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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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.
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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.
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Predetermined Change Control Plan (PCCP) - All Relevant Information
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§ 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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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized caduceus symbol, which is a staff with two snakes coiled around it. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the caduceus symbol. The logo is black and white.
Food and Drug Administration 10903 New Hampshire Avenue Document Mail Center - WO66-0609 Silver Spring, MD 20993-0002
SEP 1 0 2010
Citizen Systems Japan Co. Ltd. c/o Mr. Nathan A. Beaver Foley & Lardner LLP 3000 K Street NW, Suite 600 Washington, DC 20007
Re: K102303
Trade/Device Name: Model CH-658 Blood Pressure Meter Regulatory Number: 21 CFR 870.1130 Regulation Name: Noninvasive Blood Pressure Measurement System Regulatory Class: Class II (Two) Product Code: DXN Dated: August 16, 2010 Received: August 16, 2010
Dear Mr. Beaver:
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 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) 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 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
Page 2 - Mr. Nathan A. Beaver
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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth 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.
- If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
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) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.
Sincerely yours,
Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Indications for Use
SEP 1 0 2010
| 510(k) Number: | K102303 |
|---|---|
| Device Name: | Model CH-658 Blood Pressure Meter |
| Indications For Use: | The Citizen Model CH-658 blood pressure meter is intended to be used for oscillometric measurement of systolic and diastolic blood pressure and pulse by using a non-invasive technique in which an inflatable cuff is wrapped around the wrist. |
| The device detects the appearance of irregular heartbeat during measurement, and gives a warning signal with the reading once the irregular heartbeat is detected. | |
| The device is intended to be used for checking personal health condition at home, and not primarily under the order or direction of a physician. |
Prescription Use
(Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use X
(21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF
NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)Page 1 of _
(Division Sign-Off)
Division of Cardiovascular Devices
510(k) Number K102303