(30 days)
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No
The summary describes a standard digital blood pressure monitor with irregular heartbeat detection, which is a common feature in such devices and does not inherently indicate the use of AI/ML. There are no mentions of AI, ML, or related concepts like training/test sets.
No
The device is a monitor for measuring blood pressure and pulse rate. While it can detect irregular heartbeats, its primary function is measurement and warning, not the active treatment or therapy of a condition.
No
The device measures blood pressure and pulse rate and warns of irregular heartbeats, which are monitoring functions. While it provides information that can be used for diagnosis, it doesn't diagnose a specific medical condition itself.
No
The device description explicitly states "OMRON Automatic Blood Pressure Monitor, Model: HEM-741CRELN", which is a hardware device. The summary does not mention any software component as the primary or sole medical device.
No, this device 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 body (like blood, urine, tissue) to provide information about a person's health. This testing is done outside the body (in vitro).
- Device Function: The description clearly states the device is a "digital monitor intended for use in measuring blood pressure and pulse rate in adult patient population." This is a direct measurement of physiological parameters on the body (in vivo).
- Lack of Specimen Analysis: There is no mention of analyzing any bodily fluids or tissues.
Therefore, based on the provided information, the OMRON Automatic Blood Pressure Monitor, Model: HEM-741CRELN, is a non-IVD medical device.
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.
The device detects the appearance of irregular heartbeats during measurement and gives a warning signal with readings.
Product codes
DXN
Device Description
The device is a digital monitor intended for use in measuring blood pressure and pulse rate. It also detects the appearance of irregular heartbeats during measurement and provides a warning.
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
Adult patient population
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 (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).
0
Image /page/0/Picture/2 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized eagle with three lines representing its body and wings. The eagle is facing right. The text "DEPARTMENT OF HEALTH AND HUMAN SERVICES. USA" is arranged in a circle around the eagle.
SEP - 8 2005
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Omron Healthcare, Inc. c/o Ms. Silvia Ankova Senior Project Engineer Underwriters Laboratories Inc. 333 Pfingsten Road Northbrook, IL 60062
Re: K052153
Trade Name: Omron Automatic Blood Pressure Monitor, Model HEM-741CRELN Regulation Number: 21 CFR 870.1130 Regulation Name: Noninvasive Blood Pressure Measurement System Regulatory Class: Class II (two) Product Code: DXN Dated: August 24, 2005 Received: August 25, 2005
Dear Ms. Ankova:
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
Page 2 – Ms. Silvia Ankova
Please be advised that FDA's issuance of a substantial equivalence determination does not mean r lease oc davilsou that I Dr o retain that your device complies with other requirements of the Act that I Drinas Intacted and regulations administered by other Federal agencies. You must or any I each blacked the requirements, including, but not limited to: registration and listing compry with and not 110 110 110 Part 801); good manufacturing practice requirements as set (21 CFR Part 801); asseming (21 CFR Part 820); and if applicable, the electronic rorduct radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. product radiation only of to begin marketing your device as described in your Section 510(k) I ms letter will and in your your e FDA finding of substantial equivalence of your device to a legally prematication. The Presults 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 it you attire 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 from the Division of Small other general informational 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/industry/support/index.html.
Sincerely yours,
Brimmer for
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
Applicant:
omron healthcare, Inc.
510(k) Number:
K
Device Name:
OMRON Automatic Blood Pressure Monitor, Model: HEM-741CRELN
(OMRON Internal Model Name: HEM-7041-W)
Indication for Use:
The device is a digital monitor intended for use in measuring blood pressure and pulse rate in adult patient population.
detects the appearance of irregular The device heartbeats during measurement and gives a warning signal with readings.
Prescription Use (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
B. Hammermor
(Division Sign-Off) Division of Cardiovascular Devices 510(k) Number K 05 215
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