(27 days)
Not Found
No
The description focuses on the oscillometric method and manual inflation, with no mention of AI/ML terms or related concepts like image processing, training/test sets, or performance metrics typically associated with AI/ML algorithms.
No.
The "Intended Use" explicitly states that the device is "not intended to be a diagnostic device" and advises users to "Contact your physician if hypertensive values are indicated," implying it does not provide therapy. Its purpose is for measurement, not treatment or diagnosis.
No
The "Intended Use / Indications for Use" section explicitly states, "The Omron HEM-4030 is not intended to be a diagnostic device."
No
The device description explicitly states it is a non-invasive blood pressure monitor with a cuff, squeeze bulb, and battery power, indicating it is a hardware device, not software-only.
Based on the provided information, the HEM-4030 is not an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use clearly states it's for "measuring systolic and diastolic blood pressure and pulse rate in adults." This is a physiological measurement taken directly from the body, not a test performed on a sample (like blood, urine, or tissue) outside the body.
- Explicit Statement: The document explicitly states, "The Omron HEM-4030 is not intended to be a diagnostic device." While not specifically stating "IVD," this reinforces that its purpose is measurement, not in vitro diagnosis.
- Device Description: The description details a non-invasive blood pressure monitor using the oscillometric method, which is a physical measurement technique.
- Lack of IVD Characteristics: The description does not mention any components or processes typically associated with IVD devices, such as reagents, sample handling, or analysis of biological samples.
Therefore, the HEM-4030 falls under the category of a non-invasive physiological monitoring device, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The HEM-4030 is a digital monitor intended for measuring systolic and diastolic blood pressure and pulse rate in adults.
The Omron HEM-4030 is not intended to be a diagnostic device. Contact your physician if hypertensive values are indicated.
Product codes (comma separated list FDA assigned to the subject device)
DXN
Device Description
The HEM-4030 is a non-invasive blood pressure monitor that determines blood pressure by the oscillometric method. The cuff is manually inflated by the user with a squeeze bulb. The device is powered by 2 "AAA" batteries. It is a minor modification of the Omron - HEM-405C - 510(k) K903133 non-invasive blood pressure monitor.
The modifications to the device and labeling do not change the intended use of the predicate device. The modifications to the device do not alter the fundamental scientific technology. As there are no changes in hardware or software that will impact performance there is no need to validate the changes through a clinical investigation.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
adults
Intended User / Care Setting
Home
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)
Verification activities, as required by the risk analysis, for the modification were performed by the designated individual(s) and the results demonstrated that the predetermined acceptance criteria were met.
Table 5.1 summarizes the testing:
Parameter
- Pressure Measurement Performance
- Blood Pressure Measurement Accuracy
- Re-inflation
- Drift Correction
- Battery Indicator Testing
- Automatic Power Off
- Clear and Display Memory
- Memory Error Detection
- Average Values
- Indication of High Blood Pressure
- Setting of pressure units of measure
- Pressure unit of measure conversion
- Saving units of measure
- Communication Errors
- RAM Testing
- ROM Testing
- No Blood Pressure determined
- Blood Pressure out of range
- Pulse Rate out of range
- Pulse rate can't be determined
- Deflation rate error
- Cannot inflate cuff
- Artifact
- Unstable sensor
- No arm
- Measurement time exceeded
- Pressure sensor errors
- Test mode
- Waveform checks
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
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.
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.
Not Found
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).
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
K110501
Pi/3
MAR 2 1 2011
510(k) Summary Page 3 of 3 3/14/2011
| Omron Healthcare, Inc.
1200 Lakeside Drive
Bannockburn, IL 60015 USA | Tel - 847-247-5626
Fax - 847-680-6269 |
|----------------------------------------------------------------------------|-------------------------------------------------------------------------|
| Official Contact: | Mirna DiPano - Director, Quality & Regulatory |
| Proprietary or Trade Name: | Model HEM-4030 |
| Common/Usual Name: | Noninvasive blood pressure measurement system. |
| Classification Name/Code: | DXN -
Noninvasive blood pressure measurement system.
CFR 870.1130 |
| Device: | HEM-4030 |
| Modified Device: | Omron - HEM-405C - K903133 |
Device Description:
The HEM-4030 is a non-invasive blood pressure monitor that determines blood pressure by the oscillometric method. The cuff is manually inflated by the user with a squeeze bulb. The device is powered by 2 "AAA" batteries. It is a minor modification of the Omron - HEM-405C - 510(k) K903133 non-invasive blood pressure monitor.
The modifications to the device and labeling do not change the intended use of the predicate device. The modifications to the device do not alter the fundamental scientific technology. As there are no changes in hardware or software that will impact performance there is no need to validate the changes through a clinical investigation.
Indications for Use:
The HEM-4030 is a digital monitor intended for measuring systolic and diastolic blood pressure and pulse rate in adults.
The Omron HEM-4030 is not intended to be a diagnostic device. Contact your physician if hypertensive values are indicated
Environment of Use: Home
1
510(k) Summary Page 2 of 3 3/14/2011
Contraindications
None
Summary of Modifications
The modifications to the device and labeling do not change the intended use of the predicate device. The modifications to the device do not alter the fundamental scientific technology. As there are no changes in hardware or software that will impact performance, there is no need to validate the changes through a clinical investigation.
Modifications:
- Minor changes to environmental specifications .
- . Changes to physical dimensions
- Change to packaging for the physical characteristics of the new device. .
- Change in pulse rate specification .
- . Change in pressure range
- . Change in operating humidity
- Change in weight .
- Minor changes to hardware .
- Minor changes to software in support of new pulse rate and pressure range .
- Change in cuff material .
- Stores up 21 measurements in memory .
- Electrical and mechanical changes to support change to operation on 2 "RO3" . ("AAA") batteries instead of 4 "AA" batteries.
- Indicator if blood pressure is above certain limits .
There are changes in the instructions for use to update and support the new model name and characteristics. Note there is no change in intended use, including patient population and environment of use. There is no change in contraindications.
Change to packaging for the physical characteristics of the new device.
There are no changes to the blood pressure or pulse rate algorithms.
Performance Testing
Verification activities, as required by the risk analysis, for the modification were performed by the designated individual(s) and the results demonstrated that the predetermined acceptance criteria were met. Table 5.1 summarizes the testing.
10501
2
10501 p 3/3
510(k) Summary
Table 5.1 – Performance Testing Performed
| Parameter |
|---|
| Pressure Measurement Performance |
| Blood Pressure Measurement Accuracy |
| Re-inflation |
| Drift Correction |
| Battery Indicator Testing |
| Automatic Power Off |
| Clear and Display Memory |
| Memory Error Detection |
| Average Values |
| Indication of High Blood Pressure |
| Setting of pressure units of measure |
| Pressure unit of measure conversion |
| Saving units of measure |
| Communication Errors |
| RAM Testing |
| ROM Testing |
| No Blood Pressure determined |
| Blood Pressure out of range |
| Pulse Rate out of range |
| Pulse rate can't be determined |
| Deflation rate error |
| Cannot inflate cuff |
| Artifact |
| Unstable sensor |
| No arm |
| Measurement time exceeded |
| Pressure sensor errors |
| Test mode |
| Waveform checks |
3
Image /page/3/Picture/1 description: The image shows the seal for the Department of Health & Human Services USA. The seal is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" around the perimeter. In the center of the seal is an abstract image of an eagle.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
Omron Healthcare, Inc. c/o Mr. Paul Dryden President ProMedic, Inc. 24301 Woodsage Drive Bonita Springs, FL 34134
MAR 2 1 2011
Re: K110501
Trade/Device Name: Omron HEM-4030 Regulatory Number: 21 CFR 870.1130 Regulation Name: Non-invasive Blood Pressure Measurement System Regulatory Class: II (two) Product Code: DXN Dated: February 19, 2011 Received: February 22, 2011
Dear Mr. Dryden:
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 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.
4
Page 2 – Mr. Paul Dryden
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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); 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.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.lda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
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 (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.hum.
Sincerely yours,
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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