(310 days)
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).
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).
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.
- Central blood pressure and cardiovascular indices measurement using Pulse Wave Analysis (PWA):
Here's a breakdown of the acceptance criteria and the study details for the CONNEQT PULSE device, based on the provided FDA 510(k) summary:
1. Acceptance Criteria and Reported Device Performance
The acceptance criteria are primarily defined by adherence to established standards for non-invasive sphygmomanometers and clinical agreement with a cleared reference device.
| Performance Metric | Acceptance Criteria (Standard / Comparator) | Reported Device Performance (CONNEQT PULSE) |
|---|---|---|
| Brachial Blood Pressure Accuracy | Met the acceptance criteria of ISO 81060-2:2018, "Non-invasive sphygmomanometers - Part 2: Clinical investigation of intermittent automated measurement type." (Details of specific criteria within the standard are not explicitly stated in the provided text, but the study "conformed to the requirements of the ISO 81060-2 standard without deviations"). This standard typically specifies mean difference and standard deviation between the device and a reference measurement (e.g., intra-arterial or auscultatory). | "The test results met the acceptance criteria of the standard and were considered passed." |
| Central Blood Pressure Parameters | Demonstrated high agreement with the SphygmoCor CvMS (K070795) device, which had previously shown high agreement with the predicate SphygmoCor XCEL (K122129). This implies that statistical tests confirmed equivalence between the CONNEQT PULSE and the SphygmoCor CvMS for central blood pressure parameters. The specific statistical metrics for "high agreement" are not detailed. | "The test results demonstrated high agreement between the central blood pressure parameters generated by the CONNEQT PULSE and the SphygmoCor CvMS..." |
| Heart Rate Accuracy | Within ±5 beats/min (Same as primary predicate device) | Within ±5 beats/min |
| Pressure Accuracy | Within ±3 mmHg (Same as reference predicate device) | Within ±3 mmHg |
2. Sample Sizes and Data Provenance
- Test Set for Brachial Blood Pressure:
- Sample Size: 90 adult subjects (54 female, 36 male)
- Data Provenance: Not explicitly stated, but clinical studies for FDA clearance are typically conducted in a controlled, prospective manner. The text does not specify the country of origin, but "clinical testing" implies a prospective study.
- Test Set for Central Blood Pressure Parameters:
- Sample Size: 41 subjects (20 female, 21 male)
- Data Provenance: Not explicitly stated, but described as an "internal protocol" for validation, suggesting a prospective clinical study. The country of origin is not specified.
- Training Set: Not specified in the provided document. The document focuses on the clinical validation of the device, not the development or training of its underlying algorithms.
3. Number of Experts and Qualifications for Ground Truth (Test Set)
- Brachial Blood Pressure: The ISO 81060-2:2018 standard typically specifies the use of trained observers for reference measurements (e.g., auscultatory) against which automated devices are compared. The exact number and qualifications of these observers are not detailed in this summary but would be specified within the standard's methodology.
- Central Blood Pressure Parameters: The SphygmoCor CvMS (K070795) device served as the comparator/reference standard. This device itself is cleared, and its output is considered the ground truth for this comparison. The summary doesn't mention human experts establishing ground truth for individual cases; rather, it relies on the output of a previously cleared device.
4. Adjudication Method (Test Set)
- Brachial Blood Pressure: The ISO 81060-2:2018 standard guides observer measurements for ground truth. This often involves multiple observers and a specific protocol to ensure accuracy and minimize bias (e.g., alternating observers, blind measurements). The summary does not provide specific details on the adjudication method used within that study, other than stating it conformed to the ISO standard.
- Central Blood Pressure Parameters: Adjudication is not applicable in the traditional sense here, as the comparison was against a device (SphygmoCor CvMS) rather than against expert human readings that might require adjudication.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
- No MRMC comparative effectiveness study was done to assess how much human readers improve with AI vs. without AI assistance. The CONNEQT PULSE is a device that provides blood pressure measurements and central arterial indices. It is not an AI-assisted diagnostic imaging or interpretation tool where human reader performance is typically evaluated.
6. Standalone Performance Study
- Yes, a standalone study was conducted for the CONNEQT PULSE device. The entire clinical testing section (Section 9.0) describes the validation of the device's accuracy for both brachial blood pressure and central blood pressure parameters as an algorithm/device-only system, without human interpretation being part of the primary measured outcome for its clearance.
- For brachial blood pressure, its measurements were validated against the ISO 81060-2:2018 standard.
- For central blood pressure parameters, its measurements were validated against the SphygmoCor CvMS device.
7. Type of Ground Truth Used (Test Set)
- Brachial Blood Pressure: Reference standard measurements as defined by ISO 81060-2:2018 (typically auscultatory measurements by trained observers or an intra-arterial reference).
- Central Blood Pressure Parameters: Measurements from a previously 510(k) cleared comparator device (SphygmoCor CvMS), which serves as the established reference for these parameters.
8. Sample Size for the Training Set
- The document does not provide information regarding the sample size for the training set. This summary focuses on the clinical validation of the final device for regulatory submission, not the developmental phase or the data used to train the underlying algorithms.
9. How the Ground Truth for the Training Set Was Established
- The document does not provide information on how the ground truth for the training set was established, as the training set details are not included in this 510(k) summary.
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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.
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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
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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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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).
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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,.
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| Item | Subject Device | Primary PredicateDevice(K122129) | Reference PredicateDevice(K162144) | Comparison |
|---|---|---|---|---|
| Trade Name | CONNEQT PULSE | SphygmoCor XCEL | iHealth Wireless BloodPressure Monitor | -- |
| Model | BPM1AT | XCEL | BPM1 | -- |
| Intended Use | CONNEQT PULSE isthat provides a derivedascending aortic bloodpressure waveform and arange of central arterialindices. Thesemeasurements are providednon-invasively using atechnique in which aninflatable cuff is wrappedaround the upper arm.Additionally, theCONNEQT PULSEautomatically providesbrachial systolic anddiastolic blood pressures.The measurement range ofthe cuff circumference is8.6"-12.6" (22cm-32cm)and 12.6"- 16.5" (32cm-42cm). | The SphygmoCor XCELsystem provides a derivedascending aortic bloodpressure waveform and arange of central arterialindices. Thesemeasurements areprovided non-invasivelythrough the use of aBrachial cuff.It Is to be used on thosepatients where informationrelated to ascending aorticblood pressure is desiredbut the risks of cardiaccatheterization procedureor other invasivemonitoring may outweighthe benefits.Additionally, theSphygmoCor' XCELSystem automaticallymeasures Systolic bloodpressure and Diastolicblood pressure.The SphygmoCor XCELPulse Wave Velocity(PWV) option is intendedto obtain PWVmeasurements.The PWV option is usedon adult patients only. | The BPM1 (ElectronicSphygmomanometer) isintended for use in aprofessional setting or athome and is a non-invasive blood pressuremeasurement system. It isdesigned to measure thesystolic and diastolicblood pressures and pulserate of an adult individualby using a technique inwhich an inflatable cuff iswrapped around the upperarm. The measurementrange of the cuffcircumference is 8.6"to18.9" (22cm-48cm). | See Note 1 |
| Rx or OTC | Prescription Use(Rx) | Prescription Use(Rx) | OTC | Same as primarypredicate deviceSee Note 2 |
| Population | Adult | Adult | Adult | Same |
| Item | Subject Device | Primary PredicateDevice(K122129) | Reference PredicateDevice(K162144) | Comparison |
| Cuff Location | Arm | Arm (for PWAMeasurement)Upper thigh(for PWV Measurement) | Arm | See Note 3 |
| Physical Attributes | ||||
| Weight(exclude cuff) | About 350g | About 700g | About 350g | Same asreferencepredicate device |
| Dimensions | 119mm×118mm×51mm | 99mm x 190mm x 172mm | 119mm×118mm×51mm | |
| Memory | Extended storage onCONNEQT APP450 readings withoutCONNEQT APP. | The data of themeasurements is notstored in the EM4 deviceitself, but in an externalSQL database installed inthe computer that runs theSphygmoCor software. | 2×1000 times | See Note 4 |
| DisplayedCalculatedParameters | 1) Brachial BloodPressure (SYS/DIA)2) Heart Rate3) Central Blood Pressure4) Central Blood PressureParameters (PWA):– Central PulsePressure (cPP)– AugmentationPressure (AP)– Augmentation Index(Alx)– SubendocardialViability Ratio(SEVR)– Average CentralAortic PressureWaveform– Central DiastolicPressure– Central MeanArterial Pressure(cMAP) | 1) Brachial BloodPressure (SYS/DIA)2) Heart Rate3) Central Blood Pressure4) Central Blood Pressureparameters (PWA):– Central PulsePressure (cPP)– AugmentationPressure (AP)– Augmentation Index(Alx)– SubendocardialViability Ratio(SEVR)– Average CentralAortic PressureWaveform– Central DiastolicPressure– Central MeanArterial Pressure(cMAP) | 1) Brachial BloodPressure (SYS/DIA)2) Heart ate | Subject deviceparameters are asubset of thoseprovided byprimarypredicate device.See Note 5 |
| Item | Subject Device | Primary Predicate Device(K122129) | Reference Predicate Device(K162144) | Comparison |
| Pulse PressureAmplification (PPAmplification)- Augmentation Index75 (AIx75) | - Pulse PressureAmplification (PPAmplification)- Augmentation Index75 (AIx75)- Ejection Duration- SphygmoCorReference AgePWV - Measures velocityof pressure pulse betweencarotid and femoralarterial sites. | |||
| OtherDisplayedInformation | 1) Date and Time2) Battery low indicator3) Pressure in cuff4) Blood pressureclassification5) Averages (7 and 30 daymeasurementaverages/trends) | Patient's personal dataincluding Patient ID,Gender, Date of Birth andAge, and Height | DateTimeMemoryBattery usageBlood pressureclassification | See Note 6 |
| DataTransmission | Transmit data to iOSdevice or Android devicewith Bluetooth | The SphygmoCor XCELdevice is connected to PCusing the USB cable | Transmit data to iOSdevice or Android devicevia WIFI | See Note 7 |
| Electrical Power | ||||
| DC Mains | 5V | Input: 100-240 VAC, 50-60HzOutput: 15VDC at 2A | 5V | Same asreferencepredicate device |
| Battery | 1*3.7VLi-ion 2200mAh | N/A | 1*3.7VLi-ion 2200mAh | |
| Environmental Operation | ||||
| Temperature | 10~40°C | 15~40°C | 10~40°C | Same as thereferencepredicate device |
| Humidity | ≤85% | 15% to 95% non-condensing | ≤85% | |
| Environmental Storage | ||||
| Temperature | -20~50°C | -20°C to 65°C | -20~50°C | Same asreferencepredicate device |
| Humidity | ≤85% | 20% to 90% non-condensing | ≤85% | |
| Item | Subject Device | Primary PredicateDevice(K122129) | Reference PredicateDevice(K162144) | Comparison |
| Performance NIBP/PWA | ||||
| Heart Rate Range | 40 -180 times/min | 30-220 times/min | 40 -180 times/min | Same as referencepredicate device |
| Heart Rate Accuracy | Within ±5 beats/min | Within ±5 beats/min | Within ±5% | Same as primarypredicate device |
| Technique/Method | Oscillometric | Oscillometric | Oscillometric | Same |
| Measureprocess | Measure during inflating | Measure during inflating | Measure during inflating | Same |
| PressureAccuracy | Within ±3 mmHg | Within ±5 mmHg | Within ±3 mmHg | Same asreferencepredicate device |
| Cuff PressureRange | 0-300 mmHg | 0-300 mmHg | 0 - 300 mmHg | Same |
| OverpressureLimit | 300 mmHg | 300 mmHg | 300 mmHg | Same |
| Algorithm | Amplitude (Brachial)PWA Transfer Function(Central) | Amplitude (Brachial)PWA Transfer Function(Central) | Amplitude (Brachial) | Same as primarypredicate device |
| NIBP PressureRanges | Sys: 60-260 mmHgDia: 40-199 mmHg | Sys: 50 - 260 mmHgDia: 40 – 200 mmHg | Sys: 60-260 mmHgDia: 40-199 mmHg | Same asreferencepredicate device |
| Central bloodpressure ranges | 40 – 260 mmHg | 40 – 260 mmHg | N/A | Same as primarypredicate device |
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DISCUSSION OF DIFFERENCES:
| Note# | Difference | Justification |
|---|---|---|
| 1 | Indications for Use | The indications for use statement for the CONNEQT PULSE issubstantially equivalent to that of the primary predicate SphygmoCorXCEL. Both the subject and primary predicate devices are used to obtainboth brachial and central blood pressure information to enable a HCP tomonitor the patient's cardiovascular health. These functions of the subjectand primary predicate devices are both derived using pulse-wave analysis(PWA). The accuracy of these parameters for both systems was confirmedin clinical testing using the SphygmoCor CvMS as the comparator, whichwas 5109k) cleared under K070795 and was the predicate device for theSphygmoCor XCEL.The electrical safety report, EMC report, performance testing and clinicaltesting submitted in this 510(k) confirmed that the subject device is as safeand effective as the primary (K122129) and reference (K162144) predicatedevices. |
| 2 | Rx or OTC | Both the subject and primary predicate devices are intended forprescription use only. The primary predicate device is intended for use ina professional setting only, while the subject device can be used in aprofessional or home-use setting.The operation of the subject device is the same as for the referencepredicate device, which is sold OTC and is intended for home use. Bloodpressure measurement data obtained using the reference predicate devicecan also be wirelessly transmitted to the user's smartphone. Thesesimilarities in operation of the subject device and reference predicatedevice support the substantial equivalence of the subject device for use asa prescription device in the home setting as well as the professionalsetting. |
| 3 | Cuff Location | The subject device and both the primary and reference predicate devicesall use an arm cuff to obtain the blood pressure measurements for pulsewave analysis (PWA). The primary predicate also uses a thigh cuff forpulse wave velocity (PWV) measurements. The subject device does notdo PWV and so does not come with a thigh cuff. |
| 4 | Memory | The memory for the subject device is different from predicate devices, butthe software validation confirmed that the subject device is as safe andeffective as the predicate devices. |
| 5 | DisplayedCalculatedParameters | The displayed calculated parameters for the subject device are a subset ofthose offered on the primary predicate device. The software validation andclinical testing confirmed that the subject device is as safe and effective asthe primary predicate device. |
| Note# | Difference | Justification |
| 6 | Other DisplayedInformation | The other displayed parameters for the subject device are different from thepredicate devices, but the performance testing, clinical testing report andsoftware validation report confirmed that the subject device is as safe andeffective as the predicate devices. |
| 7 | Data Transmission | Although the method used to transmit data from the subject device to theuser's smartphone is via Bluetooth as compared to Wi-fi in the referencepredicate device, the electrical safety report, EMC report and softwarevalidation report confirmed that the data transmission in the subject deviceis as safe and effective as the reference predicate device. |
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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.
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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: <30 years (N=13, 6 female/7 male); 30 to 60 years (N=17, 10 female/7 male); above 60 years (N=11, 4 female/7 male) participated in the investigation. Statistical tests were conducted to measure the equivalence between the results of the CONNEQT PULSE device and the 510(k) cleared comparator device. The test results demonstrated high agreement between the central blood pressure parameters generated by the CONNEQT PULSE and the SphygmoCor CvMS, which was also previously shown to have high agreement with the predicate SphygomoCor XCEL, thus confirming substantial equivalence.[0]
10. Comparison to the Predicate Devices and Conclusion
The conclusion drawn from the nonclinical testing demonstrate that the CONNEOT PULSE is substantially equivalent to the primary predicate SphygmoCor XCEL device in its indications for use and performance in measuring brachial and central blood pressure and calculating central blood pressure parameters. In addition, the technology and operation of the CONNEOT PULSE is the same as the reference predicate iHealth Wireless Blood Pressure device. Therefore, the subject device is substantially equivalent to the legally marketed predicate devices (K122129 and K162144).
§ 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).