(88 days)
Not Found
No
The description mentions "software algorithms within the microprocessor" for determining blood pressure and pulse rate, and detecting irregular heartbeats. However, it does not use terms like AI, ML, deep learning, or neural networks, nor does it describe any training or testing of models on data sets, which are characteristic of AI/ML systems. The methods described (oscillometric) are standard for blood pressure monitors and do not inherently involve AI/ML.
No
The device is described as a monitor intended for measuring blood pressure and pulse rate, and it provides warning signals for irregular heartbeats. It does not perform any therapeutic function.
No
A diagnostic device is used to identify a disease, condition, or medical problem. While this device measures blood pressure and heart rate and detects irregular heartbeats, it explicitly states its intended use is to "measure blood pressure and pulse rate," not to diagnose a condition. The detection of irregular heartbeats serves as a "warning signal with readings," which can prompt further medical consultation but does not, in itself, constitute a diagnosis.
No
The device description clearly states it is a "wrist-worn blood pressure measurement system" with an "electric pump within the main unit" and a "wrist cuff," indicating it is a hardware device with embedded software.
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 body (in vitro).
- Device Function: The described device is a blood pressure monitor. It measures blood pressure and pulse rate by applying pressure to the wrist and analyzing the resulting oscillations. This is a non-invasive measurement performed on the body, not on a sample taken from the body.
- Intended Use: The intended use is to measure blood pressure and pulse rate in adult patients. This is a physiological measurement, not a diagnostic test performed on a biological sample.
Therefore, based on the provided information, the Wrist Blood Pressure Monitor (BPM) Model BP6100 is a non-invasive medical device for physiological measurement, 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 5.3 inches to 8.5 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 (comma separated list FDA assigned to the subject device)
DXN
Device Description
The Wrist Blood Pressure Monitor (BPM) Model BP6100 ("BP6100") is an automatic, non-invasive, wrist-worn blood pressure measurement system for over-the-counter (OTC) home use. During measurements, an electric pump within the main unit slowly inflates the wrist cuff, generating cuff pressure which is monitored and from which pulse waveform data is extracted. This waveform data is analyzed by software algorithms within the microprocessor to determine pulse rate, systolic pressure, and diastolic pressure. The systolic and diastolic pressures are determined via the oscillometric cuff method. The cuff pressure range is 0 to 299mmHg and the pulse rate range is 40 to 180 beats/min.
The BP6100 is intended for use in the adult patient population, in wrist circumferences ranging between 5.3 - 8.5 inches (13.5 - 21.5 cm). During measurement, the device also detects the appearance of irregular heartbeat rhythms. BP6100 further includes administrative functions for automatic storage of the 60 most recent readings taken by the device. The device also provides an "average" function, which can calculate an average reading based on the latest two (2) or three (3) readings, when taken within a 10-minute span.
The operations of BP6100 are primarily through use of buttons. Functions and other features that are controlled by the end user include applying the wrist cuff to the wrist, powering on/off the system, starting or stopping measurements, and installing and changing batteries as needed. It has no potential connection to external power. There are no additional parts or accessories to the BP6100. The BP6100 does not connect to any other devices.
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 patient population
Intended User / Care Setting
Over-The-Counter Use / home 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)
Nonclinical Testing Summary:
The nonclinical, bench testing included:
- Comparative blood pressure and pulse rate testing to the predicate device.
- Performance verification testing of BP6100 to confirm acceptable performance of device features and functions
- Cleaning verification testing to confirm device retains its performance when cuff is cleaned with household detergents as may be required in home use environment
Other nonclinical safety testing included:
- Biocompatibility of patient-contacting materials per ISO 10993-1 requirements
- Electrical safety, electromagnetic compatibility, and electrostatic discharge testing
- Software verification and validation
The collective results of the nonclinical testing demonstrate that the materials chosen, the manufacturing processes, and design of the BP6100 meet the established specifications necessary for consistent performance during its Intended Use. In addition, the collective bench testing results demonstrate that the BP6100 does not raise different questions of safety or effectiveness for blood pressure and pulse rate measurement in a home use environment when compared to the predicate device.
Clinical Testing Summary:
A clinical investigation was conducted with the objective of validating the accuracy of blood pressure measurements by BP6100 based on an oscillometric method as compared to an auscultation method using a calibrated sphygmomanometer by trained medical staff. This study was conducted in accordance with guideline per ANSI/AAMI/ISO 81060-2:2013 Non-invasive sphygmomanometers — Part 2: Clinical investigation of automated measurement type. The results demonstrated that BP6100 performed equivalently to the auscultation method and is in conformance with ANSVAAMI/ISO 81060-2:2013.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Accuracy:
Blood Pressure: Within ±3mmHg
Pulse Rate: Within ±5 % of reading
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
Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
November 2, 2018
Omron Healthcare, Inc. % Ronald Warren Senior Director, Regulatory Affairs Experien Group, LLC 224 Airport Pkwy.. Ste. 250 San Jose, California 95110
Re: K182127
Trade/Device Name: Wrist Blood Pressure Monitor Model BP6100 Regulation Number: 21 CFR 870.1130 Regulation Name: Noninvasive Blood Pressure Measurement System Regulatory Class: Class II Product Code: DXN Dated: August 3, 2018 Received: August 6, 2018
Dear Ronald Warren:
We have reviewed vour 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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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 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.
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
1
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 of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.html; good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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 comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Shawn W. Forrest -A
Digitally signed by Shawn W. Forrest -A N: c=US, o=U.S. Government, ou=HHS Qu=FDA ou=People. 0.9.2342.19200300.100.1.1=1300403341 cn=Shawn W. Forrest -A Date: 2018.11.02 10:07:35 -04'00'
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
510(k) Number (if known)
Device Name
Wrist Blood Pressure Monitor Model BP6100
Indications for Use (Describe)
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 5.3 inches to 8.5 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.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| Prescription Use (Part 21 CFR 801 Subpart D) | Over-The-Counter Use (21 CFR 801 Subpart C) |
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
3
510(k) Notification K
GENERAL INFORMATION [807.92(a)(1)]
Applicant:
Omron Healthcare, Inc. 1925 West Field Court Lake Forest, IL 60045 USA Phone: 847-247-5626 FAX: 847-680-6269
Contact Person:
Ronald S. Warren Senior Director, Regulatory Affairs Experien Group, LLC 224 Airport Parkway, Suite 250 San Jose, CA 95110 USA Phone: 408-505-3926 FAX: 408-400-0856
Date Prepared: August 3, 2018
DEVICE INFORMATION [807.92(a)(2)]
Trade Name:
Wrist Blood Pressure Monitor Model BP6100
Generic/Common Name:
Noninvasive blood pressure measurement system
Classification:
Class II per 21 CFR §870.1130
Product Code:
DXN
PREDICATE DEVICE(S) [807.92(a)(3)]
The Wrist Blood Pressure Monitor Model BP6100 is substantially equivalent to the Omron Healthcare, Inc. HEM-6131 non-invasive blood pressure measurement system (K131742).
DEVICE DESCRIPTION [807.92(a)(4)]
The Wrist Blood Pressure Monitor (BPM) Model BP6100 ("BP6100") is an automatic, non-invasive, wrist-worn blood pressure measurement system for over-the-counter (OTC) home use. During measurements, an electric pump within the main unit slowly inflates the wrist cuff, generating cuff pressure which is monitored and from which pulse waveform data is extracted. This waveform data is analyzed by software algorithms
4
510(k) SUMMARY
within the microprocessor to determine pulse rate, systolic pressure, and diastolic pressure. The systolic and diastolic pressures are determined via the oscillometric cuff method. The cuff pressure range is 0 to 299mmHg and the pulse rate range is 40 to 180 beats/min.
The BP6100 is intended for use in the adult patient population, in wrist circumferences ranging between 5.3 - 8.5 inches (13.5 - 21.5 cm). During measurement, the device also detects the appearance of irregular heartbeat rhythms. BP6100 further includes administrative functions for automatic storage of the 60 most recent readings taken by the device. The device also provides an "average" function, which can calculate an average reading based on the latest two (2) or three (3) readings, when taken within a 10-minute span.
The operations of BP6100 are primarily through use of buttons. Functions and other features that are controlled by the end user include applying the wrist cuff to the wrist, powering on/off the system, starting or stopping measurements, and installing and changing batteries as needed. It has no potential connection to external power. There are no additional parts or accessories to the BP6100. The BP6100 does not connect to any other devices.
INDICATIONS FOR USE [807.92(a)(5)]
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 5.3 inches to 8.5 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.
COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE PREDICATE DEVICES [807.92(a)(6)]
The proposed BP6100 device and the HEM-6131 predicate device have similar technological characteristics. Both devices are battery-operated wrist blood pressure monitors intended for home use and employ the oscillometric method for measuring blood pressure and pulse rate. Both devices have the same cuff pressure range of 0 to 299mmHg and pulse rate range of 40 to 180 beats/min. The devices are intended for the same wrist circumference range of 13.5 cm to 21.5 cm. The devices share the same accuracy range of pressure reading of ±3 mmHg and the same accuracy range for pulse rate reading of ± 5%.
There are minor differences in technical specifications and features between the BP6100 proposed device and HEM-6131 predicate device. These differences relate primarily to user convenience and simplicity of operation. The BP6100 is slightly smaller in dimension and weighs slightly less than the HEM-6131 predicate device. The BP6100 has a different user interface configuration from the HEM-6131; however, the displayed information is the same between the two devices. The BP6100 software also differs slightly from the HEM-6131 software in processing workflow; however, the underlying principle of operation for the algorithms are the same.
5
SUBSTANTIAL EQUIVALENCE
The proposed Indications for Use for the Wrist Blood Pressure Monitor Model BP6100 is substantially equivalent to the Indications for Use for the predicate HEM-6131 device. Comparison testing demonstrated that the proposed device is equivalent to the predicate device with regard to measurement of blood pressure in a pulse wave generator test. Minor differences in the technological features relate mostly to convenience considerations or routine performance updates and do not impact the safety or performance of blood pressure or pulse rate measurements. Any differences in the technological characteristics between the devices do not raise any different questions of safety or effectiveness. Thus, the BP6100 is substantially equivalent to the predicate HEM-6131 device.
Please refer to the table below for a comparison of Indications for Use and technological characteristics between the BP6100 and the HEM-6131 predicate device.
| Feature | BP6100
(K____) | HEM-6131
(K131742) | Comparison |
|---------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------|
| Classification | 21 CFR§870.1130,
Noninvasive blood
pressure measurement system | 21 CFR§870.1130,
Noninvasive blood
pressure measurement system | Same |
| Product Code | DXN - Noninvasive blood
pressure
measurement | DXN - Noninvasive blood
pressure
measurement | Same |
| 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 5.3 inches to 8.5 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 5¼ inches to 8½ inches
(13.5cm to 21.5cm).
The device detects the
appearance of irregular
heartbeats during measurement
and gives a warning signal with
readings. | Equivalent |
| Environment of
Use | Home Use | Home Use | Same |
| Patient Population | Adults | Adults | Same |
| Over-The-Counter
(OTC) | Yes | Yes | Same |
| Measurement
method | Cuff oscillometric method | Cuff oscillometric method | Same |
| Measurement
Range | Cuff pressure range 0 to 299
mmHg
Pulse Rate: 40 to 180
beats/min. | Pressure: 0 to 299 mmHg
Pulse Rate: 40 to 180
beats/min. | Same |
| Accuracy | Blood Pressure: Within
±3mmHg
Pulse Rate: Within ±5 % of
reading | Blood Pressure: Within
±3mmHg or 2% of reading
Pulse Rate: Within ±5 % of
reading | Equivalent |
| Pressure Sensor | Piezo resistance sensor | Piezo resistance sensor | Same |
6
510(k) SUMMARY
| Feature | BP6100
(K____) | HEM-6131
(K131742) | Comparison |
|---------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------|------------|
| Inflation Method | Automatic inflation with
electric pump | Automatic inflation with
electric pump | Same |
| Deflation Method | Automatic rapid deflation valve | Automatic rapid deflation valve | Same |
| Display Type | LCD digital display | LCD digital display | Same |
| Additional
Functionalities | Irregular heartbeat feature
Averaging value
Body movement detection
Hypertension indicator
Cuff wrap guide
Storage of readings | Irregular heartbeat feature
Averaging value
Body movement detection
Hypertension indicator
Cuff wrap guide
Storage of readings | Same |
| Power Source | Two "AAA" batteries | Two "AAA" batteries | Same |
| Operating
Conditions | 10 to 40 °C (50 to 104 °F)
15 to 90 %RH (non-condensing)
800 to 1060 hPa | 10 to 40 °C (50 to 104 °F)
15 to 85 %RH | Similar |
| Storage/Transport
Conditions | -20 to 60 °C (-4 to 140 °F)
10 to 90 %RH (non-condensing) | -20 to 60 °C (-4 to 140 °F)
10 to 95 %RH | Similar |
| Dimensions | 93 (W) × 20 (D) × 62 (H) mm | 78 (W) × 60 (D) × 21 (H) mm | Similar |
| Weight | Approx. 86g (3.0 oz) (not
including battery) | Approx. 101g (not including
battery) | Similar |
PERFORMANCE DATA [807.92(b)]
All necessary bench and clinical testing was conducted on the Wrist Blood Pressure Monitor Model BP6100 to support a determination of substantial equivalence to the predicate device.
[807.92(b)(1)] Nonclinical Testing Summary:
The nonclinical, bench testing included:
- Comparative blood pressure and pulse rate testing to the predicate device
- . Performance verification testing of BP6100 to confirm acceptable performance of device features and functions
- Cleaning verification testing to confirm device retains its performance when . cuff is cleaned with household detergents as may be required in home use environment
Other nonclinical safety testing included:
- Biocompatibility of patient-contacting materials per ISO 10993-1 . requirements
- Electrical safety, electromagnetic compatibility, and electrostatic discharge ● testing
- Software verification and validation ●
7
510(k) SUMMARY
The collective results of the nonclinical testing demonstrate that the materials chosen, the manufacturing processes, and design of the BP6100 meet the established specifications necessary for consistent performance during its Intended Use. In addition, the collective bench testing results demonstrate that the BP6100 does not raise different questions of safety or effectiveness for blood pressure and pulse rate measurement in a home use environment when compared to the predicate device.
[807.92(b)(2)] Clinical Testing Summary:
A clinical investigation was conducted with the objective of validating the accuracy of blood pressure measurements by BP6100 based on an oscillometric method as compared to an auscultation method using a calibrated sphygmomanometer by trained medical staff. This study was conducted in accordance with guideline per ANSI/AAMI/ISO 81060-2:2013 Non-invasive sphygmomanometers — Part 2: Clinical investigation of automated measurement type. The results demonstrated that BP6100 performed equivalently to the auscultation method and is in conformance with ANSVAAMI/ISO 81060-2:2013.
CONCLUSIONS [807.92(b)(3)]
The conclusions drawn from the nonclinical and clinical tests performed in support of BP6100 demonstrate that the device is safe and effective, and performs at least as safely and effectively as the legally marketed HEM-6131 predicate device.
SUMMARY
The Wrist Blood Pressure Monitor Model BP6100 is substantially equivalent to the Omron Model HEM-6131 predicate device.