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.

AI/ML Overview

Here's an analysis of the provided text regarding the Omron HEM-4030, focusing on acceptance criteria and study details.

Important Note: The provided document is a 510(k) Summary for a modified medical device. This typically means that a full clinical trial for performance is often not required if the changes do not impact the fundamental scientific technology or performance. The document explicitly states this: "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." and "There are no changes to the blood pressure or pulse rate algorithms." Therefore, the "study that proves the device meets the acceptance criteria" in the traditional sense of a clinical performance study may not be present for this specific submission. Instead, the focus is on verification activities for the modifications.

1. Table of Acceptance Criteria and Reported Device Performance

The document lists "Performance Testing" but does not explicitly provide the quantitative acceptance criteria for each and the specific reported performance values for the new HEM-4030 against those criteria. It states that "the results demonstrated that the predetermined acceptance criteria were met."

However, we can infer some general performance areas from the "Performance Testing Performed" table. For a non-invasive blood pressure monitor, the primary acceptance criteria would typically relate to the accuracy of blood pressure and pulse rate measurements. Since the blood pressure and pulse rate algorithms were not changed from the predicate device (Omron HEM-405C - K903133), it is implied that the performance of these key metrics is considered equivalent to the predicate.

Parameter	Acceptance Criteria (Implied/General)	Reported Device Performance (Implied from submission)
Pressure Measurement Accuracy	Likely, adherence to recognized standards (e.g., AAMI, ISO) for blood pressure measurement accuracy.	The modifications do not alter the fundamental scientific technology or the blood pressure/pulse rate algorithms. Implied to meet the predicate's performance.
Blood Pressure Measurement Accuracy	(Same as above)	(Same as above)
Pulse Rate Accuracy	Adherence to recognized standards for pulse rate measurement accuracy.	(Same as above)
Re-inflation	Functional re-inflation as intended to achieve a valid measurement.	Functionality verified; meets predetermined acceptance criteria.
Drift Correction	Proper functioning of drift correction mechanism.	Functionality verified; meets predetermined acceptance criteria.
Battery Indicator Testing	Accurate indication of battery level.	Functionality verified; meets predetermined acceptance criteria with new battery configuration.
Automatic Power Off	Device powers off automatically as per specification.	Functionality verified; meets predetermined acceptance criteria.
Clear and Display Memory	Memory functions (clear, display) operate correctly.	Functionality verified; meets predetermined acceptance criteria for storing 21 measurements.
Memory Error Detection	System detects and indicates memory errors if they occur.	Functionality verified; meets predetermined acceptance criteria.
Average Values	Calculation and display of average values are accurate.	Functionality verified; meets predetermined acceptance criteria.
Indication of High Blood Pressure	Indicator illuminates/displays correctly when blood pressure exceeds limits.	Functionality verified; meets predetermined acceptance criteria.
Setting of pressure units of measure	Users can set and save desired pressure units.	Functionality verified; meets predetermined acceptance criteria.
Pressure unit of measure conversion	Accurate conversion between pressure units.	Functionality verified; meets predetermined acceptance criteria.
Saving units of measure	Device retains chosen unit settings.	Functionality verified; meets predetermined acceptance criteria.
Communication Errors	System detects and indicates communication errors.	Functionality verified; meets predetermined acceptance criteria.
RAM Testing	RAM functions correctly for device operation.	Functionality verified; meets predetermined acceptance criteria.
ROM Testing	ROM functions correctly for device operation.	Functionality verified; meets predetermined acceptance criteria.
No Blood Pressure determined	Device indicates when BP cannot be determined (e.g., artifact).	Functionality verified; meets predetermined acceptance criteria.
Blood Pressure out of range	Device indicates when BP is outside measurement range.	Functionality verified; meets predetermined acceptance criteria.
Pulse Rate out of range	Device indicates when pulse rate is outside measurement range.	Functionality verified; meets predetermined acceptance criteria.
Pulse rate can't be determined	Device indicates when pulse rate cannot be determined.	Functionality verified; meets predetermined acceptance criteria.
Deflation rate error	System detects and indicates deflation rate errors.	Functionality verified; meets predetermined acceptance criteria.
Cannot inflate cuff	Device indicates when cuff cannot be inflated.	Functionality verified; meets predetermined acceptance criteria.
Artifact	Device detects and indicates measurement artifacts.	Functionality verified; meets predetermined acceptance criteria.
Unstable sensor	Device detects and indicates unstable sensor conditions.	Functionality verified; meets predetermined acceptance criteria.
No arm	Device indicates when no arm is detected (e.g., during inflation attempt).	Functionality verified; meets predetermined acceptance criteria.
Measurement time exceeded	Device indicates when measurement time is exceeded.	Functionality verified; meets predetermined acceptance criteria.
Pressure sensor errors	Device detects and indicates pressure sensor errors.	Functionality verified; meets predetermined acceptance criteria.
Test mode	Test mode functions correctly for manufacturing/service.	Functionality verified; meets predetermined acceptance criteria.
Waveform checks	Internal waveform analysis/checks are performed correctly.	Functionality verified; meets predetermined acceptance criteria.

Regarding the "Study that proves the device meets the acceptance criteria":

For this specific 510(k) submission (K110501), the "study" is described as "Verification activities, as required by the risk analysis, for the modification were performed..."

The core argument for not requiring a new clinical investigation is that:

The device is a minor modification of a previously cleared device (Omron HEM-405C - K903133).
The modifications do not change the intended use or alter the fundamental scientific technology.
There are no changes to the blood pressure or pulse rate algorithms.

Therefore, the "proof" is based on engineering verification testing to ensure the specific modifications (e.g., changes to environmental specs, physical dimensions, memory, battery, software to support changes, cuff material, high BP indicator) function as intended and do not negatively impact the performance of the core blood pressure/pulse rate measurement functionality, which is inherited from the predicate device.

2. Sample Size Used for the Test Set and Data Provenance

Sample Size for Test Set: The document does not specify a sample size for the verification tests listed in Table 5.1. Given that these are primarily engineering verification activities for modifications rather than a clinical performance study, the "sample size" might refer to the number of units tested or specific test cases rather than a patient cohort.
Data Provenance: The document does not specify the country of origin for the data or whether it was retrospective or prospective. Typically for engineering verification, data is generated internally through controlled testing environments.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications

Number of Experts: This information is not provided.
Qualifications of Experts: This information is not provided.

For engineering verification, "ground truth" is often established by adherence to product specifications, industry standards, and internal quality control processes, rather than through expert clinical consensus in the way a diagnostic AI device might. As the blood pressure algorithm itself was not changed, the "ground truth" for its accuracy would refer back to the predicate device's clearance and underlying studies, which are not detailed here.

4. Adjudication Method for the Test Set

Adjudication Method: This information is not provided. Given the nature of engineering verification tests, a clinical adjudication method (like 2+1, 3+1) is generally not applicable. Test results are typically compared against predefined specifications.

5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size

MRMC Study: No, an MRMC comparative effectiveness study was not done. The document explicitly states that "there is no need to validate the changes through a clinical investigation" and that "There are no changes to the blood pressure or pulse rate algorithms." Therefore, there is no AI component, and no study comparing human readers with and without AI assistance.

6. If a Standalone Study (Algorithm Only Without Human-in-the-Loop Performance) Was Done

Standalone Study: No, a standalone study on a new blood pressure or pulse rate algorithm was not done. The submission explicitly states "There are no changes to the blood pressure or pulse rate algorithms." The device relies on the performance of the algorithm from its predicate device. The verification activities focus on ensuring the modified hardware/software supports this existing algorithm correctly.

7. The Type of Ground Truth Used

Type of Ground Truth: For the performance tests (e.g., pressure measurement accuracy, blood pressure measurement accuracy, pulse rate accuracy), the ground truth for blood pressure and pulse rate would typically be established against a reference standard (e.g., sphygmomanometer readings by trained observers, ECG for pulse rate) as per recognized clinical measurement protocols (like AAMI or ISO standards) for the predicate device. For the verification of the modifications (e.g., memory, display, indicators, battery), the ground truth would be the device specifications themselves (i.e., does the feature work as designed/specified?).

8. The Sample Size for the Training Set

Sample Size for Training Set: This information is not applicable/not provided. This device is a non-AI, non-diagnostic blood pressure monitor. It uses an oscillometric algorithm, which is a pre-programmed method, not a machine learning model that requires a "training set" in the AI sense. The algorithms are inherited from the predicate device and were not changed.

9. How the Ground Truth for the Training Set Was Established

How Ground Truth for Training Set was Established: This information is not applicable/not provided. As explained above, the device does not use an AI/machine learning model in the sense that it requires a "training set" with established ground truth. The algorithms are based on established oscillometric principles.

Summary

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K110501
Pi/3

MAR 2 1 2011

510(k) Summary Page 3 of 3 3/14/2011

Omron Healthcare, Inc.1200 Lakeside DriveBannockburn, IL 60015 USA	Tel - 847-247-5626Fax - 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 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

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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

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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

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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.

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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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<110501

Indications for Use Statement

Page 1 of 1

K110201 510(k) Number:

HEM-4030 Device Name:

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.

Prescription Use or (Part 21 CFR 801 Subpart D)

Over-the-counter use X (21 CFR 807 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

(Division Sign-Off)

/RD Zuckermar

3/21/204

Division of Cardiovascular Devices

Division of Cardiovascular Devices
510(k) Number K116501

Regulation Number and Section

§ 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).