(113 days)
Not Found
No
The document describes standard oscillometric blood pressure measurement and basic signal processing for pulse detection and irregular heartbeat warnings. There is no mention of AI or ML algorithms for data analysis, interpretation, or decision-making. The "Advanced Positioning Sensor" uses an accelerometer, which is a standard sensor, not an AI/ML technology. The optional smartphone app is for data display and archiving, not analysis.
No.
The device is a digital monitor for measuring blood pressure and pulse rate. It does not provide treatment or therapy, but rather monitors physiological parameters.
Yes
The device measures blood pressure and pulse rate, and it also detects and provides a warning signal for irregular heartbeats. While it doesn't provide a definitive diagnosis, the detection of irregular heartbeats serves as a diagnostic aid by alerting the user to a potential health issue that may require further medical evaluation.
No
The device description clearly outlines hardware components such as a battery, pump, electric valve, wrist cuff, and accelerometer, in addition to the software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens taken from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening.
- Device Function: The Omron HEM-6400T-Z Wrist Blood Pressure Monitor measures blood pressure and pulse rate directly from the patient's wrist using a non-invasive method (oscillometric). It does not analyze any biological specimens.
- Intended Use: The intended use is to measure blood pressure and pulse rate in adult patients, not to analyze samples for diagnostic purposes.
- Device Description: The description details a physical device that interacts with the patient's body (wrist cuff) and uses internal sensors and software to derive measurements. It does not mention any components for handling or analyzing biological samples.
Therefore, the device falls under the category of a non-invasive medical device for physiological measurement, not an In Vitro Diagnostic device.
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 6 inches to 8 inches (15.0 cm to 20.5 cm).
The device detects the appearance of irregular heartbeats during measurement and gives a warning signal with readings.
Product codes
DXN
Device Description
The Omron HEM-6400T-Z Wrist Blood Pressure Monitor is a battery-powered automatic non-invasive blood pressure system intended for home use. The device is powered by a rechargeable lithium-polymer battery. There is no connection to external power. The device inflates a wrist cuff with an integral pump, then deflates the cuff via an electric valve. During inflation, the wrist 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 blood pressure. The systolic and diastolic blood pressures are measured using the oscillometric method. The cuff pressure range is 0 to 299mmHg and the pulse rate range is 30 to 199 beats/min.
HEM-6400T-Z is intended for use in adult patient population with wrist circumference ranging from 6 inches to 8 inches (15.0 cm to 20.5 cm). The device also detects the appearance of irregular heartbeats during measurement and gives a warning signal with readings. The device displays the latest blood pressure reading, while up to 100 readings can be stored in memory. In addition, the device includes an Advanced Positioning Sensor (APS) as an aid to the user to determine if the wrist cuff is at the correct height in relation to the heart. It makes this determination based on the reading of an accelerometer (to measure the angle of the arm in relation to the table) integral to the device. The APS feature is similar to the predicate device. The operation of the device is intended for home use. 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 the BP and pulse measurement cycle, and charging the batteries as needed. As an optional feature, the user can also pair the HEM-6400T-Z to a smartphone when employing the "Omron connect" app. This app is an optional feature and is only intended to display trend graphs of measured systolic and diastolic blood pressure, and pulse rate. This app does not provide any diagnostic or measurement functions, and does not interpret or analyze the data for medical decision making. Unlimited readings can be stored in the app for archiving and review by the user. Aside from this optional app for smartphones, HEM-6400T-Z does not connect with other collateral 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
Intended User / Care Setting
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 HEM-6400T-Z to confirm acceptable performance of device features and functions
- Cleaning verification testing to confirm device retains its performance when cuff is exposed to surfactants as may be experienced in home use environment
- Usability testing with a representative population of study participants in a simulated 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 HEM-6400T-Z meet the established specifications necessary for consistent performance during its intended use. In addition, the collective bench testing demonstrates that HEM-6400T-Z does not raise different questions of safety or effectiveness for measurement of blood pressure and pulse 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 HEM-6400T-Z based on an oscillometric method as compared to an auscultation method using a calibrated sphygmomanometer by trained medical staff. The results demonstrated that HEM-6400T-Z performed equivalently to the auscultation method.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Accuracy of pressure indicator: Within ±3mmHg
Accuracy of pulse rate: Within ±5 % of reading
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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
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Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
February 21, 2017
Omron Healthcare, Inc. % Ronald S. Warren Senior Director, Regulatory Affairs Experien Group LLC 224 Airport Parkway Suite 250 San Jose, CA 95110 US
Re: K163045
Trade/Device Name: Omron HEM-6400T-Z Wrist Blood Pressure Monitor Regulation Number: 21 CFR 870.1130 Regulation Name: Noninvasive blood pressure measurement system Regulatory Class: Class II Product Code: DXN Dated: January 20, 2017 Received: January 23, 2017
Dear Ronald S. Warren:
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 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 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 devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in
1
the quality systems (OS) 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 Industry and Consumer Education 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.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 Industry and Consumer Education 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.htm.
Sincerely.
Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
| Form Approved: OMB No. | 0910-0120 |
|---|---|
| Expiration Date: | January 31, 2017 |
| See PRA Statement below. |
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
Indications for Use
| 510(k) Number (if known) | K163045 |
|---|---|
| Device Name | Omron HEM-6400T-Z Wrist Blood Pressure Monitor |
| 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 6 inches to 8 inches (15.0 cm to 20.5 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) |
| ------------------------------------------------- | ---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------- |
|---|
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FORM FDA 3881 (1/14)
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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: October 27, 2016
DEVICE INFORMATION
Trade Name:
Omron HEM-6400T-Z Wrist Blood Pressure Monitor
Generic/Common Name:
Noninvasive blood pressure measurement system
Classification:
Class II per 21CFR§870.1130
Product Code:
DXN
4
PREDICATE DEVICE(S)
The Omron HEM-6400T-Z Wrist Blood Pressure Monitor is substantially equivalent to the Omron BP652N (HEM-6300-Z) with APS (K142917).
DEVICE DESCRIPTION
The Omron HEM-6400T-Z Wrist Blood Pressure Monitor is a battery- powered automatic non-invasive blood pressure system intended for home use. The device is powered by a rechargeable lithium-polymer battery. There is no connection to external power. The device inflates a wrist cuff with an integral pump, then deflates the cuff via an electric valve. During inflation, the wrist 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 blood pressure. The systolic and diastolic blood pressures are measured using the oscillometric method. The cuff pressure range is 0 to 299mmHg and the pulse rate range is 30 to 199 beats/min.
HEM-6400T-Z is intended for use in adult patient population with wrist circumference ranging from 6 inches to 8 inches (15.0 cm to 20.5 cm). The device also detects the appearance of irregular heartbeats during measurement and gives a warning signal with readings. The device displays the latest blood pressure reading, while up to 100 readings can be stored in memory. In addition, the device includes an Advanced Positioning Sensor (APS) as an aid to the user to determine if the wrist cuff is at the correct height in relation to the heart. It makes this determination based on the reading of an accelerometer (to measure the angle of the arm in relation to the table) integral to the device. The APS feature is similar to the predicate device. The operation of the device is intended for home use. 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 the BP and pulse measurement cycle, and charging the batteries as needed. As an optional feature, the user can also pair the HEM-6400T-Z to a smartphone when employing the "Omron connect" app. This app is an optional feature and is only intended to display trend graphs of measured systolic and diastolic blood pressure, and pulse rate. This app does not provide any diagnostic or measurement functions, and does not interpret or analyze the data for medical decision making. Unlimited readings can be stored in the app for archiving and review by the user. Aside from this optional app for smartphones, HEM-6400T-Z does not connect with other collateral devices.
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 6 inches to 8 inches (15.0 cm to 20.5 cm).
The device detects the appearance of irregular heartbeats during measurement and gives a warning signal with readings.
5
COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE PREDICATE DEVICES
The proposed HEM-6400T-Z has similar technological characteristics as compared to the predicate BP652N device. Both devices are intended for home use and employ the cuff oscillometric method for measuring blood pressure and pulse rate from the wrist. Both devices have the same cuff pressure range of 0 to 299mmHg. The pulse rate range is similar between the two devices with a range of 30 to 199 beats/min for HEM-6400T-Z and range of 40 to 180 beats/min for the predicate BP652N. The devices accommodate similar sized wrists. HEM-6400T-Z is intended for a wrist circumference of 6 to 8 inches (15.0 cm to 20.5 cm) while the BP652N is intended for a wrist circumference of 5.25 to 8.5 inches (13.5 cm to 21.5 cm). The accuracy of pressure reading is ±3mmHg for both devices, and accuracy of pulse rate is ±5% in both devices. Both devices include detection of irregular heartbeats and give a warning signal with readings. In addition, both devices include an APS as an aid to the user to determine if the wrist cuff is at the correct height in relation to the heart. Both devices utilize a piezoelectric pump for wrist cuff inflation. Both the proposed device and the predicate device employ a semiconductor pressure sensor, and utilize an active electronic control valve that performs cuff air bleeding and release.
There are minor differences between HEM-6400T-Z and BP652N but these do not raise different questions of safety or effectiveness. The HEM-6400T-Z uses a rechargeable lithium-polymer battery as the power source, whereas BP652N uses 2 "AAA" batteries. On the device display, HEM-6400T-Z adds time and date as compared to BP652N display, and the HEM-6400T-Z control buttons have been updated for user convenience. Specifically, the HEM-6400T-Z has a secondary "mini display" on the bottom of the device which also serves as the start/stop button. During the BP measurement, this mini display cycles through a display of systolic pressure, diastolic pressure, and then pulse rate. At the conclusion of the BP measurement, the mini display goes blank and the final results are shown on the main display screen on the top of the device. The BP652N only has a single display screen and start/stop button located on the top of the device. The HEM-6400T-Z wrist cuff main components include an elastomer strap, air bag and metal buckle, while the BP652N wrist cuff main components are a cloth bag, air bag, and hookand-loop strap (aka Velcro). See Table 5.1 for a summary of the comparison between the proposed device and the predicate device.
6
| Feature | Proposed Device
Omron HEM-
6400T-Z
K | Predicate Device
Omron BP652N
K142917 | Analysis of Technological
Differences |
|-------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Classification-
Regulation | 21 CFR§870.1130,
Noninvasive blood
pressure
measurement
system. | 21 CFR§870.1130,
Noninvasive blood
pressure
measurement system. | No difference. Proposed device and
predicate device have the same
medical device classification
number |
| Classification -
Product Code | DXN - Noninvasive
blood pressure
measurement | DXN - Noninvasive
blood pressure
measurement | No difference. Proposed device and
predicate device have the same
medical device product code |
| 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 6
inches to 8 inches
(15.0 cm to 20.5
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 (13.5cut to
21.5 cm). The device
detects the
appearance of
irregular heartbeats
during measurement
and gives a warning
signal with readings. | No difference of intended purpose.
The proposed indication for use is
the same as the cleared indication
for use of the predicate device. The
wrist circumference is slightly
different between the two devices,
but this difference does not affect
safety or effectiveness. |
| Environment of
Use | Home Use | Home Use | No difference. The proposed
device and predicate device have
the same environment of use. |
| Patient Population | Adults | Adults | No difference. Intended for same
population. |
| Contraindications/
Warnings/
Precautions | There are no known
contraindications. | There are no known
contraindications. | No difference. Proposed device
and predicate device have no
known contraindications |
| Single Use | No | No | No difference. Proposed and
predicate devices are durable
medical equipment intended for
multiple uses |
| Sterility | External contacting
device, nonsterile | External contacting
device, nonsterile | No difference. Proposed and
predicate device are provided
nonsterile |
| Label Information | Labeled for OTC
(Home Use) | Labeled for OTC
(Home Use) | No difference, Label information
provided as required by US medical
device regulations for home use. |
| Feature | Proposed Device
Omron HEM-
6400T-Z
K | Predicate Device
Omron BP652N
K142917 | Analysis of Technological
Differences |
| Specifications/Features | | | |
| Measurement
method/Principle
of operation | Cuff oscillometric
method | Cuff oscillometric
method | No difference |
| Measurement
range | Pressure: 0 to
299mmHg
Pulse Rate: 30 to 199
beats/min. | Pressure: 0 to
299mmHg
Pulse Rate: 40 to 180
beats/min. | This minor difference in pulse rate
range does not impact safety and
effectiveness of the device. |
| Pressure senor | Semiconductor
pressure sensor | Semiconductor
pressure sensor | No difference |
| Applicable cuff
(Wrist
Circumference) | 15.0 to 20.5cm | 13.5 to 21.5cm | This minor difference does not
impact safety and effectiveness of
the device. |
| Accuracy of
pressure
indicator | Within ±3mmHg | Within ±3mmHg or
2% of reading | There is no difference in the
accuracy range based on mmHg
scale |
| Accuracy of
pulse rate | Within ±5 % of
reading | Within ±5 % of
reading | No difference |
| Inflation method | Automatic inflation
with piezoelectric
pump | Automatic inflation
by piezoelectric pump | No difference |
| Deflation
method | Automatic rapid
deflation valve | Automatic rapid
deflation valve | No difference |
| Display | Organic
electroluminescent
display | LCD digital display | Similar. Both devices provide
digital display of BP and pulse. |
| Power source | Rechargeable
lithium-polymer
battery | Two (2) "AAA"
batteries | HEM-6400T-Z includes
rechargeable battery for user
convenience and reduced
environmental impact |
| Operating
conditions | 5 to 40 °C (41 to 104
°F)
15 to 85 %RH (non-
condensing)
800 to 1060 hPa | 10 to 40 °C (50 to
104 °F)
15 to 85 %RH | Similar. HEM-6400T-Z operating
conditions specified to comply with
IEC60601-1 requirements. |
| Charging/Data
transmission
conditions | 10 to 35 °C (+50 to
95 °F)
15 to 85 %RH(non-
condensing) | NA | HEM-6400T-Z has specific battery
charging conditions for recharging
lithium-ion battery. |
| Storage
conditions | -20 to 40 °C (-4 to
104 °F)
10 to 90 %RH(non-
condensing) | -20 to 60 °C (-4 to
140 °F)
10 to 95 %RH | Similar. HEM-6400T-Z has specific
storage conditions since lithium-ion
battery requires specific storage
conditions. |
| Transporting
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. HEM-6400T-Z has specific
transporting conditions since
lithium-ion battery requires specific
transporting conditions. |
| Feature | Proposed Device
Omron HEM-
6400T-Z
K | Predicate Device
Omron BP652N
K142917 | Analysis of Technological
Differences |
| Dimensions
(mm) | 54 (W) × 63 (D) × 16
(H) mm | 89 (W) × 61 (D) × 13
(H) mm | Similar. HEM-6400T-Z has smaller
dimensions for added convenience
in home use. |
| Weight | Approx. 110g (3 7/8
oz.)
(including batteries) | Approx. 80g (2 7/8
oz.)
(not including
batteries) | This minor difference does not
impact safety and effectiveness of
the device. |
| Irregular Heart
Beat Feature | Yes | Yes | No difference |
| Body movement
detection | Yes | Yes | No difference |
| Hypertension
indicator | No | Yes | Hypertension Indicator not included
in HEM-6400T-Z. Device not
intended to make diagnosis of
hypertension. Instruction Manual
includes statement that only a
physician is qualified to diagnose
and treat high blood pressure. |
| Advanced
positioning
sensor (APS) | Yes | Yes | No difference |
| Technology/Features Comparison | | | |
| Power supply | Regulates power
voltage regardless of
battery voltage. | Regulates power
voltage regardless of
battery voltage. | No difference |
| Microprocessor | • determines blood
pressure and pulse
rate
• controls the pump,
the valve, and the
display
• detects switch
operations
• stores
measurement results
• manages date and
time | • determines blood
pressure and pulse
rate
• controls the pump,
the valve, and the
display
• detects switch
operations
• stores measurement
results
• manages date and
time | No difference |
| Pressure sensor | Semiconductor
pressure sensor. | Semiconductor
pressure sensor | No difference |
| Rapid exhaust
Valve | Active electronic
control valve that
performs cuff air
bleeding and release | Active electronic
control valve that
performs cuff air
bleeding and release | No difference |
| Inflation source | Piezoelectric pump | Piezoelectric pump | No difference |
| Feature | Proposed Device
Omron HEM-
6400T-Z
K | Predicate Device
Omron BP652N
K142917 | Analysis of Technological
Differences |
| Display | Organic
electroluminescent
display
• current cuff
pressure
• systolic blood
pressure
• diastolic blood
pressure
• pulse rate
• error messages
• time and date
• latest results in
the memory | LCD (Liquid Crystal
Display) displays;
• current cuff
pressure
• systolic blood
pressure
• diastolic blood
pressure
• pulse rate
• error messages
• measurement
results in the
memory | Different technology for digital
display. Similar information
displayed. |
| Controls | • START/STOP
Button
• Connection Button
• Memory
• Home Button | • START/STOP
Button
• Date/Time setting
Button
• Up/Down Button
• User ID Selections
Button | Similar. Minor differences relate to
user convenience. |
| Cuff | Wrist Cuff,
Composed of
elastomer belt, air
bag and metal buckle | Wrist Cuff,
Composed of cloth
bag, air bag and
hook-and-loop
fastener | Similar. Difference in method to
apply device to wrist was evaluated
in usability study and found
acceptable. |
| Materials | Patient contact
materials of the cuff
have been tested in
accordance with ISO
10993 and FDA
guidance | Patient contact
materials of the cuff
have been tested in
accordance with ISO
10993 and FDA
guidance | No difference |
Table 5.1: Substantial Equivalence Table
7
Table 5.1: Substantial Equivalence Table (cont.)
8
Table 5.1: Substantial Equivalence Table (cont.)
9
Tablo 5 1: Substantial Equivolonco Tablo (cont )
SUBSTANTIAL EQUIVALENCE
The indications for use statement for HEM-6400T-Z is identical to that of the predicate BP652N. 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 technological features relate to convenience considerations for home use but do not impact safety or performance of blood pressure or pulse rate measurements. These minor differences in the technological characteristics between the devices do not raise different questions of safety or effectiveness. Thus, HEM-6400T-Z is substantially equivalent to the predicate BP652N device.
10
PERFORMANCE DATA [807.92(b)]
All necessary bench and clinical testing was conducted on HEM-6400T-Z to support a determination of substantial equivalence to the predicate device.
Nonclinical Testing Summary:
The nonclinical, bench testing included:
- Comparative blood pressure and pulse rate testing to the predicate device
- Performance verification testing of HEM-6400T-Z to confirm acceptable performance of device features and functions
- Cleaning verification testing to confirm device retains its performance when cuff is exposed to surfactants as may be experienced in home use environment
- Usability testing with a representative population of study participants in a ● simulated 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 HEM-6400T-Z meet the established specifications necessary for consistent performance during its intended use. In addition, the collective bench testing demonstrates that HEM-6400T-Z does not raise different questions of safety or effectiveness for measurement of blood pressure and pulse 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 HEM-6400T-Z based on an oscillometric method as compared to an auscultation method using a calibrated sphygmomanometer by trained medical staff. The results demonstrated that HEM-6400T-Z performed equivalently to the auscultation method.
Conclusions
Based on the results from the nonclinical and clinical tests performed in support of HEM-6400T-Z, it is concluded that that the proposed device is safe, is effective, and performs at least as safely and effectively as the legally marketed predicate device.
Summarv
HEM-6400T-Z and BP652N are designed for the measurement of blood pressure, pulse rate and detection of irregular pulses in adult population for home use. These devices have the same indications for use. Performance characteristics related to BP measurement and pulse rate are comparable between the two devices. The minor differences in labeling and technological characteristics between the proposed device and the predicate devices have been evaluated and determined to not raise any different issues of safety or effectiveness. As such, the proposed HEM-6400T-Z is substantially equivalent to the predicate device.