(204 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 is limited to basic digital monitoring of blood pressure and pulse rate.
No
The device is described as a monitor intended for measuring blood pressure and pulse rate, which are diagnostic or monitoring functions, not therapeutic ones. It does not exert any direct treatment or intervention.
No
Explanation: The device is described as a "digital monitor intended for use in measuring blood pressure and pulse rate," which are measurements, not a diagnosis. It does not state that it identifies or detects a disease, condition, or state of health.
No
The description explicitly states the device is a "digital monitor" intended for measuring blood pressure and pulse rate, which implies a hardware component is necessary for these measurements. The summary does not mention any software-only functionality or a reliance on external hardware for data acquisition.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD devices are used to examine specimens derived from the human body (like blood, urine, tissue) to provide information about a physiological state, health, or disease.
- This device measures blood pressure and pulse rate directly from the patient's arm. It does not analyze any biological specimens.
Therefore, this device falls under the category of a non-invasive physiological monitoring device, not an IVD.
N/A
Intended Use / Indications for Use
The device is a digital monitor intended for use in measuring blood pressure and pulse rate in adult patient population with arm circumference ranging from 9 inches to 17 inches (from 22 cm to 42 cm).
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
arm
Indicated Patient Age Range
adult
Intended User / Care Setting
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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
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Key Metrics
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Predicate Device(s)
Not Found
Reference Device(s)
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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).
0
Image /page/0/Picture/0 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 a stylized image of three human profiles facing to the right, with three bars above them.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
DEC 12 2002
Omron Healthcare, Inc. c/o Mr. Iwao Kojima Director of Technology 300 Lakeview Parkway Vernon Hills, Illinois 60061
Re: K021682
Trade Name: Omron Automatic Blood Pressure Monitor with IntelliSense™, Model HEM-773AC
Regulation Number: 21 CFR 870.1130
Regulation Name: Noninvasive Blood Pressure Measurement System Regulatory Class: Class II (two) Product Code: DXN Dated: September 11, 2002 Received: September 13, 2002
Dear Mr. Kojima:
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, 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 forth in the quality systems (OS) 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 (301) 594-4646. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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,
Bram D. Zuckerman, M.D.
1 Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Indication for use statement a.
Following is the new indication for use statement for the HEM-773AC
Applicant: 510(k) Number: Device Name:
OMRON HEALTHCARE, INC.
OMRON AUTOMATIC BLOOD PRESSURE MONITOR WITH INTELLISENSE™, Model HEM-773AC
Indication for Use:
The device is a digital monitor intended for use in measuring blood pressure and pulse rate in adult patient population with arm circumference ranging from 9 inches to 17 inches (from 22 cm to 42 cm).
(Division Sign-Off) Division of Cardiovascular and Respiratory Devices
510(k) Number K021682
Non-prescription use ✓