(202 days)
Not Found
None
No
The summary describes a standard digital blood pressure monitor with irregular heartbeat detection, and there are no mentions of AI, ML, or related concepts.
No.
The device is a digital monitor for measuring blood pressure and pulse rate, which is a diagnostic function, not a therapeutic one. It does not actively treat or alleviate a medical condition.
Yes
Explanation: The device measures blood pressure and pulse rate and also detects and warns about irregular heartbeats, which are diagnostic indicators.
No
The description explicitly states the device is a "digital monitor" intended for measuring blood pressure and pulse rate, implying a hardware component is necessary for these physical measurements. The lack of a "Device Description" section prevents confirmation, but the intended use strongly suggests hardware is involved.
Based on the provided information, 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 human body, such as blood, urine, or tissue, to provide information about a person's health.
- Device Function: The description clearly states the device is a digital monitor intended for measuring blood pressure and pulse rate. This is a direct measurement of physiological parameters from the body, not an analysis of a specimen taken from the body.
- Lack of Specimen Analysis: There is no mention of collecting or analyzing any biological specimens.
Therefore, this device falls under the category of 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 with wrist circumference ranging from 5 1/4 inches to 8 1/2 inches (13.5 cm to 21.5 cm). The device detects the appearance of irregular heartbeats during measurement and gives a warning signal with readings.
Product codes
DXN
Device Description
Not Found
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Wrist
Indicated Patient Age Range
Adult
Intended User / Care Setting
Over-The-Counter Use
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Not Found
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
APR 5 2005
Omron Healthcare, Inc. c/o Mr. Iwao Kojima Director of Technology 1200 Lakeside Drive Bannockburn, IL 60015
Re: K042505
Trade Name: OMRON DIGITAL Wrist Blood Pressure Monitor HEM-609N Regulation Number: 21 CFR 870.1130 Regulation Name: Non-invasive blood pressure measurement system Regulatory Class: Class II (two) Product Code: DXN Dated: February 7, 2005 Received: February 8, 2005
Dear Mr. Kojima:
We have reviewed your Section 510(k) premarket notification of intent to market the device wt nave reviewed your becamed the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for use stated in the encrosure) to regally to regally the Medical Device American procession in the commerce proof to May 20, 1776, the encordance with the provisions of the Federal Food, Drug, devices that have been recuire approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The r va may, therefore, manov of the Act include requirements for annual registration, listing of general controls provisions of the line, and prohibitions against misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it If your device is classified (500 abor 0) ins existing major regulations affecting your device can
may be subject to such additional controls. Existing major regulations FDA may oc subject to suell additions, Title 21, Parts 800 to 898. In addition, ITDA may be found in the Obat in the Obacerning your device in the Federal Register.
1
Page 2 – Mr. Iwao Kojima
Please be advised that FDA's issuance of a substantial equivalence determination does not mean I least be advised that I Dri i losaantes syour device complies with other requirements of the Act that I DA has made a associations administered by other Federal agencies. You must of any I cacial statutes and regulanents, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set CI K Part 607); adoning (21 CFR Part 820); and if applicable, the electronic form in the quality bystems (Sections 531-542 of the Act); 21 CFR 1000-1050. product lauditori control provisions (sevice as described in your Section 510(k) This icitel will anow you to begin maing of substantial equivalence of your device to a legally prematication. The Pice 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 If you desire specific advice 101-704-2011) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain Misoralianing of reference to presensibilities under the Act from the Division of Small other general 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/cdrl/dsma/dsmamain.html
Sincerely yours,
Bzimmerma for
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
K042505 510(k) Number:
OMRON Device Name: DIGITAL WRIST BLOOD PRESSURE MONITOR MODEL: HEM-609N
Indications For Use:
The device is a digital monitor intended for use in measuring blood pressure and pulse rate in adult patient population with wrist circumference ranging from 5 1/4 inches to 8 1/2 inches (13.5 cm to 21.5 cm).
The device detects the appearance of irregular heartbeats during measurement and gives a warning signal with readings.
Prescription Use (Part 21 CFR 801 Subpart D) AND/OR
X 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)
Blammana
Page 1 of _ I
(Division Sign-Off) Division of Cardioyascular Devices 510(k) Number 042505