(310 days)
No
The summary describes standard oscillometric and pulse wave analysis techniques for blood pressure measurement and does not mention the use of AI or ML. The performance studies focus on clinical validation against established standards and predicate devices, not on the training or testing of AI/ML models.
No.
The device is a non-invasive blood pressure measurement system for providing a derived ascending aortic blood pressure waveform and central arterial indices. It is not indicated for treatment or therapy.
Yes
This device provides medical measurements (blood pressure, central arterial indices) and alerts for irregular heartbeats, which are used to assess physiological states and can diagnose conditions like hypertension, classifying it as a diagnostic device.
No
The device description explicitly states it consists of two parts, one of which is based on the oscillometric method and silicon integrated pressure sensor technology, indicating a hardware component for blood pressure measurement.
Based on the provided information, the CONNEQT PULSE is not an In Vitro Diagnostic (IVD) device.
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening.
- CONNEQT PULSE Function: The CONNEQT PULSE is a non-invasive device that measures blood pressure and central arterial indices directly from the patient's upper arm using a cuff and oscillometric method. It does not analyze samples taken from the body.
The device's function is to measure physiological parameters directly from the patient, which falls under the category of a non-invasive medical device, not an IVD.
N/A
Intended Use / Indications for Use
CONNEQT PULSE is a non-invasive blood pressure measurement system that provides a derived ascending aortic blood pressure waveform and a range of central arterial indices. These measurements are provided non-invasively using a technique in which an inflatable cuff is wrapped around the upper arm. Additionally, the CONNEQT PULSE automatically provides brachial systolic and diastolic blood pressures and heart rate. The measurement range of the cuff circumference is 8.6''-12.6''(22cm-32cm) and 12.6''- 16.5''(32cm-42cm).
Product codes (comma separated list FDA assigned to the subject device)
DXN, DSK
Device Description
The CONNEQT PULSE is designed and manufactured according to IEC 80601 -2-30:2019and consists of the following two parts:
-
- Brachial systolic and diastolic blood pressure measurements:
The operational principle is based on the oscillometric method and silicon integrated pressure sensor technology for determining the brachial systolic and diastolic blood pressure. These blood pressure measurement results are classified for hypertension according to the American Heart Association (AHA) guidelines. The user is also alerted if an irregular heartbeat is detected.
- Brachial systolic and diastolic blood pressure measurements:
-
- Central blood pressure and cardiovascular indices measurement using Pulse Wave Analysis (PWA):
The central blood pressure measurement and calculation of corresponding central blood pressure parameters are a subset of the central blood pressure parameters provided by the predicate Atcor SphygmoCor XCEL (K122129).
- Central blood pressure and cardiovascular indices measurement using Pulse Wave Analysis (PWA):
The CONNEQT PULSE can be used on its own or with the optional CONNEQT App on the user's smartphone or CONNEQT PRO App on the healthcare provider's portal. Both Apps are used to transmit patient data from the device using paired Bluetooth Low Energy communication for the purpose of storing and displaying the daily blood pressure data and historical trends. Patient data can also be transmitted from the user's smartphone to their HCP to enable HCP monitoring of the user's cardiac health.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
upper arm
Indicated Patient Age Range
Adult
Intended User / Care Setting
Prescription Use (Rx) (Part 21 CFR 801 Subpart D) for professional setting or home-use setting.
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
The accuracies of the brachial systolic and diastolic measurements by the CONNEQT PULSE were validated in accordance with ISO 81060-2:2018, Non-invasive sphygmomanometers - Part 2: Clinical investigation of intermittent automated measurement type. This study included 90 adult subjects (54 female, 36 male) with a mean age of 43 years ± 17 years (range 18 to 75 years). The study test method conformed to the requirements of the ISO 81060-2 standard without deviations.
The accuracies of the central blood pressure parameters of the CONNEQT PULSE were validated under an internal protocol that compared the CONNEQT PULSE to the SphygmoCor CvMS (K070795) device using the same test method as was previously used to validate the predicate SphygmoCor XCEL device (K122129) in comparison to the SphygmoCor CvMS. Forty-one subjects (20 female/21 male, mean age 44 ± 19 years, range 20 to 85 years) distributed equally between three age groups:
§ 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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April 21, 2023
Atcor Medical PTY Ltd. Toni Hofhine, President c/o Sheila Hemeon-Heyer, MS,JD,FRAPS, Consultant Heyer Regulatory Solutions 125 Cherry Lane Amherst. MA 01002 USA
Re: K221742
Trade/Device Name: CONNEOT PULSE Regulation Number: 21 CFR 870.1130 Regulation Name: Noninvasive Blood Pressure Measurement System Regulatory Class: Class II Product Code: DXN, DSK Dated: March 12, 2023 Received: March 13, 2023
Dear Sheila Hemeon-Heyer:
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. 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.
1
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 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/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); 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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). 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 (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely.
Robert T. Kazmierski -S
for
LCDR Stephen Browning Assistant Director Division of Cardiac Electrophysiology, Diagnostics, and Monitoring Devices Office of Cardiovascular Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K221742
Device Name CONNEOT PULSE
Indications for Use (Describe)
CONNEOT PULSE is a non-invasive blood pressure measurement system that provides a derived ascending aortic blood pressure waveform and a range of central arterial indices. These measurements are provided non-invasively using a technique in which an inflatable cuff is wrapped around the upper arm. Additionally, the CONNEQT PULSE automatically provides brachial systolic and diastolic blood pressures and heart rate. The measurement range of the cuff circumference is 8.6''-12.6''(22cm-32cm) and 12.6''- 16.5''(32cm-42cm).
| Type of Use (Select one or both, as applicable) |
|---|
| ------------------------------------------------- |
X Prescription Use (Part 21 CFR 801 Subpart D)
| Over-The-Counter Use (21 CFR 801 Subpart C)
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3
510(K) SUMMARY
(In accordance with 21 CFR 807.92)
1.0 Submitter's Information
| Name: | ATCOR Medical Pty Ltd. |
|---|---|
| Address: | 301/55 Lime Street Sidney, New South Wales, 2000 Australia |
| Contact | Toni Hofhine, President |
| Phone Number: | 1-608-354-6712 |
| thofhine@atcormedical.com | |
| Date of Preparation: | March 10, 2023 |
2.0 Device Information
| Device Name: | CONNEQT PULSE |
|---|---|
| Common Name: | Non-Invasive Blood Pressure Measurement System |
| Classification Name: | Non-Invasive Blood Pressure Measurement System |
3.0 Classification
| Product Code: | DXN, DSK |
|---|---|
| Regulation Number: | 21 CFR 870.1130, 21CFR870.1110 |
| Classification: | II |
| Review Panel: | 870 Cardiovascular |
4.0 Predicate Device Information
| Primary Predicate | Reference Predicate | |
|---|---|---|
| Manufacturer: | ATCOR Medical Pty Ltd | Andon Health Co. Ltd |
| Device: | SphygmoCor XCEL | iHealth Wireless Blood Pressure Monitor |
| 510(k) #: | K122129 | K162144 |
| Classification | Class II | II |
| Product Code | DXN, DSK | DXN |
5.0 Indications for Use Statement
CONNEQT PULSE is a non-invasive blood pressure measurement system that provides a derived ascending aortic blood pressure waveform and a range of central arterial indices. These measurements are provided non-invasively using a technique in which an inflatable cuff is wrapped around the upper arm. Additionally, the CONNEQT PULSE automatically provides brachial systolic and diastolic blood pressures and heart rate. The measurement range of the cuff circumference is 8.6''-12.6''(22cm-32cm) and 12.6''- 16.5''(32cm-42cm).
4
6.0 Device Description
The CONNEQT PULSE is designed and manufactured according to IEC 80601 -2-30:2019and consists of the following two parts:
-
- Brachial systolic and diastolic blood pressure measurements:
The operational principle is based on the oscillometric method and silicon integrated pressure sensor technology for determining the brachial systolic and diastolic blood pressure. These blood pressure measurement results are classified for hypertension according to the American Heart Association (AHA) guidelines. The user is also alerted if an irregular heartbeat is detected.
- Brachial systolic and diastolic blood pressure measurements:
-
- Central blood pressure and cardiovascular indices measurement using Pulse Wave Analysis (PWA):
The central blood pressure measurement and calculation of corresponding central blood pressure parameters are a subset of the central blood pressure parameters provided by the predicate Atcor SphygmoCor XCEL (K122129).
- Central blood pressure and cardiovascular indices measurement using Pulse Wave Analysis (PWA):
The CONNEQT PULSE can be used on its own or with the optional CONNEQT App on the user's smartphone or CONNEQT PRO App on the healthcare provider's portal. Both Apps are used to transmit patient data from the device using paired Bluetooth Low Energy communication for the purpose of storing and displaying the daily blood pressure data and historical trends. Patient data can also be transmitted from the user's smartphone to their HCP to enable HCP monitoring of the user's cardiac health.
7.0 Comparison of Technological Characteristics with Predicate Device
Primary:
The CONNEQT PULSE is substantially equivalent to the primary predicate device SphygmoCor XCEL as both the proposed and primary predicate devices use an arm cuff to measure and display brachial and central blood pressure. In addition, the central blood pressure parameters that are calculated and displayed by the proposed device are a subset of the central blood pressure parameters that are calculated and displayed by the predicate SphygmoCor XCEL.
Reference:
The technology used for the non-invasive blood pressure (NIBP) measurements by the CONNEOT PULSE, including the arm cuff, device electronics, and the wireless data transmission, is substantially equivalent to the reference predicate device, the iHealth Wireless Blood Pressure Monitor (K162144).
The following table provides a detailed comparison of the subject device to the primary and reference predicate devices,.
5
| Item | Subject Device | Primary Predicate
Device
(K122129) | Reference Predicate
Device
(K162144) | Comparison |
|---------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------|
| Trade Name | CONNEQT PULSE | SphygmoCor XCEL | iHealth Wireless Blood
Pressure Monitor | -- |
| Model | BPM1AT | XCEL | BPM1 | -- |
| Intended Use | CONNEQT PULSE is
that provides a derived
ascending aortic blood
pressure waveform and a
range of central arterial
indices. These
measurements are provided
non-invasively using a
technique in which an
inflatable cuff is wrapped
around the upper arm.
Additionally, the
CONNEQT PULSE
automatically provides
brachial systolic and
diastolic blood pressures.
The measurement range of
the cuff circumference is
8.6"-12.6" (22cm-32cm)
and 12.6"- 16.5" (32cm-
42cm). | The SphygmoCor XCEL
system provides a derived
ascending aortic blood
pressure waveform and a
range of central arterial
indices. These
measurements are
provided non-invasively
through the use of a
Brachial cuff.
It Is to be used on those
patients where information
related to ascending aortic
blood pressure is desired
but the risks of cardiac
catheterization procedure
or other invasive
monitoring may outweigh
the benefits.
Additionally, the
SphygmoCor' XCEL
System automatically
measures Systolic blood
pressure and Diastolic
blood pressure.
The SphygmoCor XCEL
Pulse Wave Velocity
(PWV) option is intended
to obtain PWV
measurements.
The PWV option is used
on adult patients only. | The BPM1 (Electronic
Sphygmomanometer) is
intended for use in a
professional setting or at
home and is a non-
invasive blood pressure
measurement system. It is
designed to measure the
systolic and diastolic
blood pressures and pulse
rate of an adult individual
by using a technique in
which an inflatable cuff is
wrapped around the upper
arm. The measurement
range of the cuff
circumference is 8.6"
to18.9" (22cm-48cm). | See Note 1 |
| Rx or OTC | Prescription Use
(Rx) | Prescription Use
(Rx) | OTC | Same as primary
predicate device
See Note 2 |
| Population | Adult | Adult | Adult | Same |
| Item | Subject Device | Primary Predicate
Device
(K122129) | Reference Predicate
Device
(K162144) | Comparison |
| Cuff Location | Arm | Arm (for PWA
Measurement)
Upper thigh
(for PWV Measurement) | Arm | See Note 3 |
| Physical Attributes | | | | |
| Weight
(exclude cuff) | About 350g | About 700g | About 350g | Same as
reference
predicate device |
| Dimensions | 119mm×118mm×51mm | 99mm x 190mm x 172mm | 119mm×118mm×51mm | |
| Memory | Extended storage on
CONNEQT APP
450 readings without
CONNEQT APP. | The data of the
measurements is not
stored in the EM4 device
itself, but in an external
SQL database installed in
the computer that runs the
SphygmoCor software. | 2×1000 times | See Note 4 |
| Displayed
Calculated
Parameters | 1) Brachial Blood
Pressure (SYS/DIA)
2) Heart Rate
3) Central Blood Pressure
4) Central Blood Pressure
Parameters (PWA):
– Central Pulse
Pressure (cPP)
– Augmentation
Pressure (AP)
– Augmentation Index
(Alx)
– Subendocardial
Viability Ratio
(SEVR)
– Average Central
Aortic Pressure
Waveform
– Central Diastolic
Pressure
– Central Mean
Arterial Pressure
(cMAP) | 1) Brachial Blood
Pressure (SYS/DIA)
2) Heart Rate
3) Central Blood Pressure
4) Central Blood Pressure
parameters (PWA):
– Central Pulse
Pressure (cPP)
– Augmentation
Pressure (AP)
– Augmentation Index
(Alx)
– Subendocardial
Viability Ratio
(SEVR)
– Average Central
Aortic Pressure
Waveform
– Central Diastolic
Pressure
– Central Mean
Arterial Pressure
(cMAP) | 1) Brachial Blood
Pressure (SYS/DIA)
2) Heart ate | Subject device
parameters are a
subset of those
provided by
primary
predicate device.
See Note 5 |
| Item | Subject Device | Primary Predicate Device
(K122129) | Reference Predicate Device
(K162144) | Comparison |
| | Pulse Pressure
Amplification (PP
Amplification)
- Augmentation Index
75 (AIx75) | - Pulse Pressure
Amplification (PP
Amplification) - Augmentation Index
75 (AIx75) - Ejection Duration
- SphygmoCor
Reference Age
PWV - Measures velocity
of pressure pulse between
carotid and femoral
arterial sites. | | |
| Other
Displayed
Information | 1) Date and Time
- Battery low indicator
- Pressure in cuff
- Blood pressure
classification - Averages (7 and 30 day
measurement
averages/trends) | Patient's personal data
including Patient ID,
Gender, Date of Birth and
Age, and Height | Date
Time
Memory
Battery usage
Blood pressure
classification | See Note 6 |
| Data
Transmission | Transmit data to iOS
device or Android device
with Bluetooth | The SphygmoCor XCEL
device is connected to PC
using the USB cable | Transmit data to iOS
device or Android device
via WIFI | See Note 7 |
| Electrical Power | | | | |
| DC Mains | 5V | Input: 100-240 VAC, 50-
60Hz
Output: 15VDC at 2A | 5V | Same as
reference
predicate device |
| Battery | 13.7VLi-ion 2200mAh | N/A | 13.7VLi-ion 2200mAh | |
| Environmental Operation | | | | |
| Temperature | 1040°C | 1540°C | 1040°C | Same as the50°C | -20°C to 65°C | -20~50°C | Same as
reference
predicate device |
| Humidity | ≤85% | 15% to 95% non-
condensing | ≤85% | |
| Environmental Storage | | | | |
| Temperature | -20
reference
predicate device |
| Humidity | ≤85% | 20% to 90% non-
condensing | ≤85% | |
| Item | Subject Device | Primary Predicate
Device
(K122129) | Reference Predicate
Device
(K162144) | Comparison |
| Performance NIBP/PWA | | | | |
| Heart Rate Range | 40 -180 times/min | 30-220 times/min | 40 -180 times/min | Same as reference
predicate device |
| Heart Rate Accuracy | Within ±5 beats/min | Within ±5 beats/min | Within ±5% | Same as primary
predicate device |
| Technique/
Method | Oscillometric | Oscillometric | Oscillometric | Same |
| Measure
process | Measure during inflating | Measure during inflating | Measure during inflating | Same |
| Pressure
Accuracy | Within ±3 mmHg | Within ±5 mmHg | Within ±3 mmHg | Same as
reference
predicate device |
| Cuff Pressure
Range | 0-300 mmHg | 0-300 mmHg | 0 - 300 mmHg | Same |
| Overpressure
Limit | 300 mmHg | 300 mmHg | 300 mmHg | Same |
| Algorithm | Amplitude (Brachial)
PWA Transfer Function
(Central) | Amplitude (Brachial)
PWA Transfer Function
(Central) | Amplitude (Brachial) | Same as primary
predicate device |
| NIBP Pressure
Ranges | Sys: 60-260 mmHg
Dia: 40-199 mmHg | Sys: 50 - 260 mmHg
Dia: 40 – 200 mmHg | Sys: 60-260 mmHg
Dia: 40-199 mmHg | Same as
reference
predicate device |
| Central blood
pressure ranges | 40 – 260 mmHg | 40 – 260 mmHg | N/A | Same as primary
predicate device |
6
7
8
9
DISCUSSION OF DIFFERENCES:
| Note
| Difference | Justification |
|-----------|---------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 1 | Indications for Use | The indications for use statement for the CONNEQT PULSE is
substantially equivalent to that of the primary predicate SphygmoCor
XCEL. Both the subject and primary predicate devices are used to obtain
both brachial and central blood pressure information to enable a HCP to
monitor the patient's cardiovascular health. These functions of the subject
and primary predicate devices are both derived using pulse-wave analysis
(PWA). The accuracy of these parameters for both systems was confirmed
in clinical testing using the SphygmoCor CvMS as the comparator, which
was 5109k) cleared under K070795 and was the predicate device for the
SphygmoCor XCEL.
The electrical safety report, EMC report, performance testing and clinical
testing submitted in this 510(k) confirmed that the subject device is as safe
and effective as the primary (K122129) and reference (K162144) predicate
devices. |
| 2 | Rx or OTC | Both the subject and primary predicate devices are intended for
prescription use only. The primary predicate device is intended for use in
a professional setting only, while the subject device can be used in a
professional or home-use setting.
The operation of the subject device is the same as for the reference
predicate device, which is sold OTC and is intended for home use. Blood
pressure measurement data obtained using the reference predicate device
can also be wirelessly transmitted to the user's smartphone. These
similarities in operation of the subject device and reference predicate
device support the substantial equivalence of the subject device for use as
a prescription device in the home setting as well as the professional
setting. |
| 3 | Cuff Location | The subject device and both the primary and reference predicate devices
all use an arm cuff to obtain the blood pressure measurements for pulse
wave analysis (PWA). The primary predicate also uses a thigh cuff for
pulse wave velocity (PWV) measurements. The subject device does not
do PWV and so does not come with a thigh cuff. |
| 4 | Memory | The memory for the subject device is different from predicate devices, but
the software validation confirmed that the subject device is as safe and
effective as the predicate devices. |
| 5 | Displayed
Calculated
Parameters | The displayed calculated parameters for the subject device are a subset of
those offered on the primary predicate device. The software validation and
clinical testing confirmed that the subject device is as safe and effective as
the primary predicate device. |
| Note
| Difference | Justification |
| 6 | Other Displayed
Information | The other displayed parameters for the subject device are different from the
predicate devices, but the performance testing, clinical testing report and
software validation report confirmed that the subject device is as safe and
effective as the predicate devices. |
| 7 | Data Transmission | Although the method used to transmit data from the subject device to the
user's smartphone is via Bluetooth as compared to Wi-fi in the reference
predicate device, the electrical safety report, EMC report and software
validation report confirmed that the data transmission in the subject device
is as safe and effective as the reference predicate device. |
10
8.0 Discussion of Non-Clinical Testing
Non-clinical tests were conducted to verify that the subject device met all of its design specifications. The test results demonstrated that the subject device complies with the following standards:
- IEC 60601-1:2005/(R)2012 And A1:2012, C1:2009/(R)2012 And A2:2010/(R)2012 (Consolidated Text) Medical Electrical Equipment - Part 1: General Requirements For Basic Safety And Essential Performance (IEC 60601-1:2005, MOD)
- IEC 60601-1-2:2014,Medical Electrical Equipment -- Part 1-2: General Requirements ● For Basic Safety And Essential Performance -- Collateral Standard: Electromagnetic Disturbances -- Requirements And Tests
- . IEC 60601-1-11 Edition 2.0 2015-01 Medical electrical equipment - Part 1-11: General requirements for basic safety and essential performance - Collateral Standard: Requirements for medical electrical equipment and medical electrical systems used in the home healthcare environment
- IEC 80601-2-30: Edition 2.0 2018-03. Medical Electrical Equipment Part 2-30: . Particular Requirements For The Basic Safety And Essential Performance Of Automated Non-invasive Sphygmomanometers
The software verification and validation were conducted according to IEC 62304:2015. The 510(k) was supported by software documentation appropriate for Moderate level of concem software in compliance with FDA's Guidance for Industry and FDA Staff, "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices", dated May 11, 2005.
All test results were passed and support that the CONNEQT PULSE does not raise new questions of safety and effectiveness compared to the primary and reference predicate devices.
11
9.0 Clinical Test
Clinical equivalence testing was conducted to verify the accuracies of the brachial and central blood pressure parameters of the CONNEOT PULSE.
- The accuracies of the brachial systolic and diastolic measurements by the CONNEQT 1. PULSE were validated in accordance with ISO 81060-2:2018, Non-invasive sphygmomanometers - Part 2: Clinical investigation of intermittent automated measurement type. This study included 90 adult subjects (54 female, 36 male) with a mean age of 43 years ± 17 years (range 18 to 75 years). The study test method conformed to the requirements of the ISO 81060-2 standard without deviations, and the test results met the acceptance criteria of the standard and were considered passed.
-
- The accuracies of the central blood pressure parameters of the CONNEQT PULSE were validated under an internal protocol that compared the CONNEOT PULSE to the SphygmoCor CvMS (K070795) device using the same test method as was previously used to validate the predicate SphygmoCor XCEL device (K122129) in comparison to the SphygmoCor CvMS. Forty-one subjects (20 female/21 male, mean age 44 ± 19 years, range 20 to 85 years) distributed equally between three age groups: