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.

Device Description

The device is an automatic non-invasive blood pressure system. The device is battery powered by 2 "AAA" batteries, there is no connection to external power. The device inflates a wrist cuff with an integral pump, then deflates the cuff via an electronically controllable valve. During inflation the cuff pressure is monitored and pulse waveform data is extracted. The extracted pulse waveform data is then analyzed by software which determines pulse rate, as well as systolic and diastolic pressure. The algorithm used to determine pulse rate, systolic and diastolic pressure is identical to the predicate. The device has a memory function that automatically stores up to 90 of the latest measurements. It can also display an average of the last three values. The device also detects the appearance of irregular heartbeats during measurement.

AI/ML Overview

Here's a summary of the acceptance criteria and the study proving the device meets them, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

Feature/Metric	Acceptance Criteria (from predicate/standards)	Reported Device Performance (HEM-6221)
Indications for Use	Measuring BP & pulse rate in adults, wrist circumference 5.25"-8.5" (13.5-21.5cm), irregular heartbeat detection.	Identical. Device is a digital monitor for 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) and detects irregular heartbeats.
Patient Population	Adult	Adult
Environment of Use	Home	Home
Accuracy of Pressure Indicator	+/- 3 mmHg (from predicate HEM-609N)	+/- 3 mmHg or 2% of reading (similar to predicate, and evaluated against ANSI/AAMI/ISO 81060-2)
Accuracy of Pulse Rate	+/- 5%	+/- 5%
Standards Compliance	IEC 60601-1, IEC 60601-1-2, AAMI SP10, ANSI/AAMI/ISO 81060-2	Met all requirements specifications and standards requirements; testing performed for all listed standards.
Biocompatibility (Cuff Materials)	ISO 10993-1 and FDA Guidance (Cytotoxicity, Sensitization, Intracutaneous Reactivity)	Tested in accordance with ISO 10993-1 and FDA Guidance; included Cytotoxicity, Sensitization, and Intracutaneous Reactivity.

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

Sample Size for Test Set: 85 patients (43 males and 42 females)
Data Provenance: Not explicitly stated, but the clinical accuracy testing was conducted "in accordance with ANSI/AAMI/ISO 81060-2." This standard outlines specific requirements for clinical validation of non-invasive sphygmomanometers, which typically involves prospective data collection under controlled clinical conditions. The text does not specify the country of origin, but given it's a 510(k) submission to the FDA, it could be conducted anywhere that meets these international standards. It can be inferred as prospective due to the nature of clinical accuracy studies.

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

Number of Experts: Not explicitly stated. The method used for reference blood pressure (BP) measurement was the "Standard auscultation method." This method in clinical studies typically involves trained observers (often physicians or nurses) with certified sphygmomanometers.
Qualifications of Experts: Not explicitly stated, but they would be expected to be qualified for the "Standard auscultation method," usually involving medical or clinical professionals trained in accurate blood pressure measurement.

4. Adjudication Method for the Test Set

Adjudication Method: Not explicitly detailed. The text states that "BP measurements were repeated alternatively with the device and auscultation in the same arm according to the sequence in AAMI." This typically implies comparison against the auscultation measurements. There's no mention of a specific expert adjudication process for discrepancies beyond the direct comparison to the reference method.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done

No. A MRMC comparative effectiveness study was not done. The study focused on the device's accuracy against a standard reference method (auscultation), not on how human readers' performance improved with or without AI assistance.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was Done

Yes. The clinical accuracy study evaluated the device's (and its embedded algorithm's) performance in measuring blood pressure and pulse rate compared to the standard auscultation method. This is a standalone performance evaluation of the device as it outputs the measurements directly.

7. The Type of Ground Truth Used

Type of Ground Truth: The ground truth for the clinical accuracy study was established using the Standard auscultation method (reference blood pressure). This is considered a gold standard for non-invasive blood pressure measurement in clinical validation studies.

8. The Sample Size for the Training Set

The document states that "The algorithm used to determine pulse rate, systolic and diastolic pressure is identical to the predicate." This implies that the algorithm itself was not newly trained for the HEM-6221 device but rather reused from a previously validated predicate device.
Therefore, a training set for this specific device's algorithm development is not applicable or provided in this submission, as the algorithm was pre-existing.

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

As mentioned above, the algorithm was identical to the predicate device. The document does not detail how the ground truth for the predicate's algorithm training (if any) was established. It's common for such algorithms to be developed and validated against extensive clinical datasets using reference methods like auscultation.

Summary

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K131749

510(k) Summary Page 1 of 4 9-Sep-13

Omron Healthcare, Inc.
1925 West Field Court
Lake Forest, IL 60045 USA

Official Contact:

Proprietary or Trade Name:

Common/Usual Name:

Classification Name/Code:

Device:

Predicate Device:

Page 1 of 4
9-Sep-13

Tel - 847-247-5626
Fax- 847-680-6269

Renee Thornborough - Director QA/RA

Model HEM-6221

Noninvasive blood pressure measurement system.

DXN - Noninvasive blood pressure measurement system.
21CFR 870.1130
Class II

Model HEM-6221

Omron - HEM-609N (HEM-6001-Z)-K042505
Omron - HEM-6131 - K131742

OCT 07 2013

Device Description:

The device has a memory function that automatically stores up to 90 of the latest measurements. It can also display an average of the last three values

The device also detects the appearance of irregular heartbeats during measurement.

Intended User Home user

Patient Population This device is intended for use on adults.

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 (13.5 cm to 21.5 cm).

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510(k) Summary Page 2 of 4 9-Sep-13

The device detects the appearance of irregular heartbeats during measurement and gives a warning signal with readings.

Environment of Use: Home

Home

Contraindications: There are no known contraindications.

Predicate Device Comparison:

The HEM-6221 was compared to the predicate HEM-609N (K042505) in the device comparison table below.

Differences Between Other Legally Marketed Predicate Devices:

The Omron HEM-6221 is viewed as substantially equivalent to the predicate device because: The HEM-6221 uses the exact same technology and has identical indications for use. The differences that exist between the devices are insignificant in the terms of safety or effectiveness.

Indications -

The indications for use 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.

Discussion - These indications are identical to the predicate Omron HEM-609N (K042505).

Prescriptive - The HEM-6221 and predicate are both OTC.

Design and Technology - The HEM-6221 has equivalent design and features as the predicate and has the identical technology to the predicate K 131742 - Omron HEM-6131.

Performance and Specifications - The HEM-6221 has equivalent specifications of performance as the predicates.

Compliance with standards - The HEM-6221 and predicate device declare compliance with SP10, IEC 60601-1 and IEC 60601-1-2.

Materials -

The patient contacting materials of the cuffs has been tested in accordance with ISO 10993-1 and FDA Guidance. The tests included Cytotoxicity, Sensitization, and Intracutaneous Reactivity.

Patient Population -

The HEM-6221 and predicate are indicated for adults.

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510(k) Summary

evice Compariso

	Omron HEM-6221	Omron HEM-609N 510(k) K042505	Comment
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.	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.	Identical
Patient Population	Adult	Adult	Identical
Environment of Use	Home	Home	Identical
rescriptive	OTC	No	Identical
Patient Connection	Yes via cuff	Yes via cuff	Identical
Technology	Oscillometric	Oscillometric	Identical
Measurement range	Pressure: 0-299 mmHgPulse rate: 40 to 180 bpm	Pressure: 0-299 mmHgPulse rate: 40 to 180 bpm	Identical
Accuracy or pressure indicator	+/- 3 nmmllg or 2% of reading	+/-3 mmHg	Similar
Pressure sensor	Piezo resistance sensor	Silicone capacitive sensor	Identical to K131742 - Omron HEM-6131
Accuracy Pulse Rate	+/-5%	+/-5%	Identical
Inflation Method	Electric pump	Electric pump	Identical
Deflation Method	Internal valve	Internal valve	Identical
Display Type	LCD	LCD	Identical
Irregular pulse detection	Yes	Yes	Identical
Power Source	AAA batteries	AAA batteries	Identical
Operating Conditions	Temperature: 10° to 40° CHumidity: 30 to 85% RH	Temperature: 10° to 40° CHumidity: 30 to 85% RH	Similar
Storage Conditions	Temperature: -20° to 60° CHumidity: 10 to 95% RH	Temperature: -20° to +60°CHumidity: 10 to 95% RH	Identical
Dimensions	87(W) x 14(D) x 64(H) mm	70(W) x 54(D) x 37(H) mm	Similar
Weight	Approximately 85g	110g	Similar

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510(k) Summary Page 4 of 4 9-Sep-13

Non-Clinical Testing Summary:

We have performed bench tests and found that the HEM-6221 met all requirements specifications and standards requirements and were found to be equivalent in comparison to the predicate. Testing includes the following:

. Verification Testing
Testing for compliance to IEC 60601-1 .
Testing for compliance to IEC 60601-1-2 .
. Testing for compliance to AAMI SP10
Comparative Testing to the Predicate .

Testing to insure clinical accuracy of the device in accordance with ANSI/AAMI/ISO 81060-2.

Clinical Testing Summary:

Testing to insure clinical accuracy of the device in accordance with ANSI/AAMI/ISO 81060-2 as documented in Section 20.

Eighty five patients (43 males and 42 females) were recruited for the study.

Standard auscultation method was used as the reference blood pressure (BP) measuring in the left arm. BP measurements were repeated alternatively with the device and auscultation in the same arm according to the sequence in AAMI.

Substantial Equivalence Conclusion

Omron maintains that the HEM-6221 is substantially equivalent to the predicate HEM-609N (K042505) in indications for use, patient population, and environment for use, technology characteristics, specifications / performance and compliance with international standards.

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Image /page/4/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized depiction of an eagle or bird with three wing-like lines, representing health and human services. The bird is encircled by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES U.S.A."

Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

October 7, 2013

Omron Healthcare, Inc. % Paul Dryden ProMedic, Inc. 24301 Woodsage Drive Bonita Springs, FL 34134 US

Re: K131749

Trade/Device Name: HEM-6221 Regulation Number: 21 CFR 870.1130 Regulation Name: Noninvasive Blood Pressure Measurement System Regulatory Class: Class II Product Code: DXN Dated: September 9, 2013 Received: September 11, 2013

Dear Mr. Paul 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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you. however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into cither class 11 (Special Controls) or class 111 (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 - 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 contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.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/Resourcesfor You/Industry/default.htm.

Sincerely yours.

Owen P. Faris -S

for

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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Indications for Use Statement

Page 1 of 1

510(k) Number: K131749

Device Name:

Omron HEM-6221

Indications for Use:

The device detects the appearance of irregular heartbeats during measurement and gives a warning signal with readings.

Environments of Use: Home Patient Population: Adult

Prescription Use
(Part 21 CFR 801 Subpart D)

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

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Digital
Owen:
Date: 3
16:12:

Digitally signed by Owen P. Faris -S Date: 2013.10.07 16:12:13 -04'00'

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).