(61 days)
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No
The summary does not mention AI, ML, or any related concepts like image processing, training sets, or performance metrics typically associated with AI/ML devices. The description points to a standard oscillometric blood pressure meter.
No
The device is described as a "Blood Pressure Meter" intended for "measurement of systolic and diastolic blood pressure and pulse" and "checking personal health condition". It measures a physiological parameter but does not state any therapeutic function like treating or curing a disease.
Yes
The device is intended for oscillometric measurement of systolic and diastolic blood pressure and pulse, which are measurements used to assess personal health conditions, making it a diagnostic device.
No
The device description explicitly states "Model CH-311B Blood Pressure Meter," which implies a physical hardware device for measuring blood pressure. The summary does not mention any software-only components or functions.
Based on the provided information, the Model CH-311B Blood Pressure Meter is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to examine specimens taken from the human body (like blood, urine, or tissue) to provide information about a person's health. This testing is done outside of the body.
- Device Function: The description states the device is a "Blood Pressure Meter" used for "oscillometric measurement of systolic and diastolic blood pressure and pulse." This is a non-invasive measurement taken on the body (typically on the arm or wrist).
- Intended Use: The intended use is for "checking personal health condition at home." This aligns with a general health monitoring device, not a device used for laboratory testing of biological samples.
Therefore, the function and intended use of the Model CH-311B Blood Pressure Meter clearly place it outside the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
Model CH-311B Blood Pressure Meter is intended to be used for oscillometric measurement of systolic and diastolic blood pressure and pulse and are intended to be sold at a retail shop and 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
Blood Pressure Monitor, Model CH-311B
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
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Indicated Patient Age Range
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Intended User / Care Setting
personal health condition at home, and not primarily under the order or direction of a physician.
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 for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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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 is a seal or logo. It features a circular design with text around the perimeter. The text reads "DEPARTMENT OF HEALTH AND HUMAN SERVICES, USA". Inside the circle is a stylized emblem that resembles a bird or abstract wings, composed of three curved lines stacked on top of each other.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUN 2 6 2006
Citizen Watch Co., Ltd c/o Nathan A. Beaver Attorney Foley & Larder 3000 K. Street, NW, Suite 500 Washington DC 20007
Re: K061161
Trade Name: Blood Pressure Monitor, Model CH-311B Regulation Number: 21 CFR 870.1130 Regulation Name: Noninvasive Blood Pressure Measurement System Regulatory Class: II (two) Product Code: DXN Dated: June 14, 2006 Received: June 15. 2006
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. Iisting 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
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); 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. 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) 276-0120. 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrl/industry/support/index.html.
Sincerely yours,
D. Permuta for
Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Image /page/2/Picture/0 description: The image shows the word "CITIZEN" in large, bold, sans-serif font. Below the word "CITIZEN" is a black bar with the words "Micro HumanTech" in a smaller font. The words "Micro HumanTech" are white and appear to be in a sans-serif font as well.
CITIZEN WATCH CO., LTD.
6-1-12, Tanashi-cho, Nishi-Tokyo-Shi, Tokyo 188-8511, Japan Tel : +81-424-68-4712 Fax : +B1-424-68-4644
Date : June 14, 2006
Indications for Use
KOGITE I 510(k) Number (if known):
Device Name: Model CH-311B Blood Pressure Meter
Indications For Use: Model CH-311B Blood Pressure Meter is intended to be used for oscillometric measurement of systolic and diastolic blood pressure and pulse and are intended to be sold at a retail shop and to be used for checking personal health condition at home, and not primarily under the order or direction of a physician.
Prescription Use _
AND/OR
Over-The-Counter Use
er Use 8
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostic Devices (ODE)
Bluminia
llovascular Devices