(115 days)
Not Found
No
The document explicitly states that the algorithm used is identical to the predicate device and there is no mention of AI, DNN, or ML. The testing described is standard clinical validation against a reference method, not training or testing of an AI/ML model.
No
Explanation: The device is a monitor used for measuring blood pressure and pulse rate, not for treating a condition.
Yes
The device is described as measuring blood pressure and pulse rate, and detecting irregular heartbeats, which are all diagnostic indicators.
No
The device description explicitly states it is an "automatic non-invasive blood pressure system" that is "battery powered," "inflates a wrist cuff with an integral pump," and "deflates the cuff via an electronically controllable valve." These are all hardware components, indicating it is not a software-only device.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections. These tests are performed outside of the living body (in vitro).
- Device Function: The description clearly states that this device is a "digital monitor intended for use in measuring blood pressure and pulse rate." It is an "automatic non-invasive blood pressure system."
- Method of Measurement: The device measures blood pressure and pulse rate by inflating a cuff on the wrist and analyzing the pressure and pulse waveform data. This is a physical, non-invasive measurement performed on the body, not a test on a sample taken from the body.
Therefore, based on the provided information, this device falls under the category of a non-invasive physiological monitoring device, not an In Vitro Diagnostic.
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 (13.5 cm to 21.5 cm).
The device detects the appearance of irregular heartbeats during measurement and gives a warning signal with readings.
Environments of Use: Home Patient Population: Adult
Product codes (comma separated list FDA assigned to the subject device)
DXN
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.
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
Home user / 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)
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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Accuracy or pressure indicator: +/- 3 nmmllg or 2% of reading
Accuracy Pulse Rate: +/-5%
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
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 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.
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).
1
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.
2
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 mmHg | ||
| Pulse rate: 40 to 180 bpm | Pressure: 0-299 mmHg | ||
| Pulse 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° C | ||
| Humidity: 30 to 85% RH | Temperature: 10° to 40° C | ||
| Humidity: 30 to 85% RH | Similar | ||
| Storage Conditions | Temperature: -20° to 60° C | ||
| Humidity: 10 to 95% RH | Temperature: -20° to +60°C | ||
| Humidity: 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 |
3
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.
4
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.
5
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
6
Indications for Use Statement
Page 1 of 1
510(k) Number: K131749
Device Name:
Omron HEM-6221
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.
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:
or
Digitally signed by Owen P. Faris -S Date: 2013.10.07 16:12:13 -04'00'