(82 days)
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Not Found
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 used for measurement and checking personal health conditions, not for treating or alleviating a disease or condition.
Yes
The device is described as a "Blood Pressure Meter" that performs "oscillometric measurement of systolic and diastolic blood pressure and pulse." These measurements provide information about a patient's health condition, which can be used for diagnosis or monitoring.
No
The device is described as a "Blood Pressure Meter" and its intended use is for "oscillometric measurement". Oscillometric measurement of blood pressure typically requires hardware components like a cuff and pressure sensor. The summary does not mention any software-only functionality or exclude hardware.
Based on the provided information, the Model CH-432 Blood Pressure Meter is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device function: The description states the device is a "Blood Pressure Meter" intended for "oscillometric measurement of systolic and diastolic blood pressure and pulse". This is a non-invasive measurement taken directly from the body (typically the arm), not a test performed on a sample outside the body.
- Intended Use: The intended use is for "checking personal health condition at home". This aligns with a general health monitoring device, not a diagnostic test performed on a sample.
Therefore, the Model CH-432 Blood Pressure Meter falls under the category of a general medical device for physiological measurement, not an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
Model CH-432 Blood Pressure Meter intended use is intended to be used for oscillometric measurement of systolic and diastolic blood pressure and pulse 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
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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
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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).
0
Image /page/0/Picture/1 description: The image shows the seal of the Department of Health and Human Services (HHS) of the United States. The seal features an abstract eagle design, with three stylized lines forming the body and wings of the eagle. The words "DEPARTMENT OF HEALTH AND HUMAN SERVICES. USA" are arranged in a circular pattern around the eagle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
OCT 1 9 2005
:
Citizen Watch Company. Ltd. c/o Mr. Tamas Borsai Division Manager, Medical Division TUV Rheinland of North America 12 Commerce Road Newtown, CT 06470
Re: K052046
Trade Name: Blood Pressure Meter, Model CII-432 Regulation Number: 21 CFR 870.1130 Regulation Name: Noninvasive Blood Pressure Measurement System Regulatory Class: Class II (two) Product Code: DXN Dated: October 06, 2005 Received: October 11, 2005
Dear Mr. Borsai:
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 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. I'DA may publish further announcements concerning your device in the Federal Register.
1
Page 2 - Mr. Tamas Borsai
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 sct 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) 276-0295. 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 may be obtained 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/cdrh/dsma/dsmamain.html
Sincerely yours,
Mesayng
for R. Zadeh, M.D.
Zuckerma Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
052046/s
Indications for Use
K052046 510(k) Number (if known):
Devise Name: Model CH-432 Blood Pressure Meter
Indications For Use: Model CH-432 Blood Pressure Meter intended use is intended to be used for oscillometric measurement of systolic and diastolic blood pressure and pulse 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
CITIZEN
AND/OR
Over-The-Counter Use
Use
(PLEASE DP NOPT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostic Devices (ODE)
Maces Aop
(Signature)
(Division Sign-Off)
Division of Cardiovascular Devices
Page 1 of 1
510(k) Number K052046
11/4/1