CONNEQT PULSE

K221742 · Atcor Medical · DXN · Apr 21, 2023 · Cardiovascular

Device Facts

• Record ID: K221742
• Device Name: CONNEQT PULSE
• Applicant: Atcor Medical
• Product Code: DXN · Cardiovascular
• Decision Date: Apr 21, 2023
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.1130
• Device Class: Class 2

Intended 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).

Device Story

CONNEQT PULSE is a non-invasive blood pressure measurement system; utilizes oscillometric method with inflatable arm cuff to determine brachial systolic/diastolic pressure and heart rate; employs Pulse Wave Analysis (PWA) to derive ascending aortic blood pressure waveform and central arterial indices. Device operates standalone or paired via Bluetooth Low Energy to smartphone/HCP portal apps for data storage, trend visualization, and remote monitoring. Used by patients or clinicians in home or professional settings. Output includes brachial BP, heart rate, and central hemodynamic parameters (e.g., central pulse pressure, augmentation index, SEVR). Enables HCPs to monitor cardiovascular health; provides hypertension classification per AHA guidelines; alerts for irregular heartbeats. Benefits include non-invasive assessment of central arterial health without invasive catheterization.

Clinical Evidence

Clinical validation included two studies: 1) Brachial BP accuracy validated per ISO 81060-2:2018 in 90 adults (mean age 43±17). 2) Central BP parameter accuracy validated in 41 adults (mean age 44±19) comparing CONNEQT PULSE to SphygmoCor CvMS (K070795). Results demonstrated high agreement between subject device and comparator, confirming substantial equivalence to predicate SphygmoCor XCEL.

Technological Characteristics

Oscillometric NIBP measurement; silicon integrated pressure sensor; Bluetooth Low Energy connectivity; 3.7V Li-ion 2200mAh battery; cuff circumference 22-42cm. Complies with IEC 60601-1, IEC 60601-1-2, IEC 60601-1-11, and IEC 80601-2-30. Software validation per IEC 62304.

Indications for Use

Indicated for adult patients requiring non-invasive measurement of brachial blood pressure, heart rate, derived ascending aortic blood pressure waveform, and central arterial indices. Intended for use in professional or home-use settings.

Regulatory Classification

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.

Predicate Devices

• SphygmoCor XCEL (K122129)
• iHealth Wireless Blood Pressure Monitor (K162144)

Reference Devices

• SphygmoCor CvMS (K070795)

Submission Summary (Full Text)

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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 ([e-mail]) or phone [phone] 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 |
| email | [e-mail] |
| 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:

- 1) 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.

- 2) 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.

### 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 Predicate<br>Device<br>(K122129) | Reference Predicate<br>Device<br>(K162144) | Comparison |
|---------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------|
| Trade Name | CONNEQT PULSE | SphygmoCor XCEL | iHealth Wireless Blood<br>Pressure Monitor | -- |
| Model | BPM1AT | XCEL | BPM1 | -- |
| Intended Use | CONNEQT PULSE is<br>that provides a derived<br>ascending aortic blood<br>pressure waveform and a<br>range of central arterial<br>indices. These<br>measurements are provided<br>non-invasively using a<br>technique in which an<br>inflatable cuff is wrapped<br>around the upper arm.<br>Additionally, the<br>CONNEQT PULSE<br>automatically provides<br>brachial systolic and<br>diastolic blood pressures.<br>The measurement range of<br>the cuff circumference is<br>8.6"-12.6" (22cm-32cm)<br>and 12.6"- 16.5" (32cm-<br>42cm). | The SphygmoCor XCEL<br>system provides a derived<br>ascending aortic blood<br>pressure waveform and a<br>range of central arterial<br>indices. These<br>measurements are<br>provided non-invasively<br>through the use of a<br>Brachial cuff.<br>It Is to be used on those<br>patients where information<br>related to ascending aortic<br>blood pressure is desired<br>but the risks of cardiac<br>catheterization procedure<br>or other invasive<br>monitoring may outweigh<br>the benefits.<br>Additionally, the<br>SphygmoCor' XCEL<br>System automatically<br>measures Systolic blood<br>pressure and Diastolic<br>blood pressure.<br>The SphygmoCor XCEL<br>Pulse Wave Velocity<br>(PWV) option is intended<br>to obtain PWV<br>measurements.<br>The PWV option is used<br>on adult patients only. | The BPM1 (Electronic<br>Sphygmomanometer) is<br>intended for use in a<br>professional setting or at<br>home and is a non-<br>invasive blood pressure<br>measurement system. It is<br>designed to measure the<br>systolic and diastolic<br>blood pressures and pulse<br>rate of an adult individual<br>by using a technique in<br>which an inflatable cuff is<br>wrapped around the upper<br>arm. The measurement<br>range of the cuff<br>circumference is 8.6"<br>to18.9" (22cm-48cm). | See Note 1 |
| Rx or OTC | Prescription Use<br>(Rx) | Prescription Use<br>(Rx) | OTC | Same as primary<br>predicate device<br>See Note 2 |
| Population | Adult | Adult | Adult | Same |
| Item | Subject Device | Primary Predicate<br>Device<br>(K122129) | Reference Predicate<br>Device<br>(K162144) | Comparison |
| Cuff Location | Arm | Arm (for PWA<br>Measurement)<br>Upper thigh<br>(for PWV Measurement) | Arm | See Note 3 |
| Physical Attributes | | | | |
| Weight<br>(exclude cuff) | About 350g | About 700g | About 350g | Same as<br>reference<br>predicate device |
| Dimensions | 119mm×118mm×51mm | 99mm x 190mm x 172mm | 119mm×118mm×51mm | |
| Memory | Extended storage on<br>CONNEQT APP<br>450 readings without<br>CONNEQT APP. | The data of the<br>measurements is not<br>stored in the EM4 device<br>itself, but in an external<br>SQL database installed in<br>the computer that runs the<br>SphygmoCor software. | 2×1000 times | See Note 4 |
| Displayed<br>Calculated<br>Parameters | 1) Brachial Blood<br>Pressure (SYS/DIA)<br>2) Heart Rate<br>3) Central Blood Pressure<br>4) Central Blood Pressure<br>Parameters (PWA):<br>– Central Pulse<br>Pressure (cPP)<br>– Augmentation<br>Pressure (AP)<br>– Augmentation Index<br>(Alx)<br>– Subendocardial<br>Viability Ratio<br>(SEVR)<br>– Average Central<br>Aortic Pressure<br>Waveform<br>– Central Diastolic<br>Pressure<br>– Central Mean<br>Arterial Pressure<br>(cMAP) | 1) Brachial Blood<br>Pressure (SYS/DIA)<br>2) Heart Rate<br>3) Central Blood Pressure<br>4) Central Blood Pressure<br>parameters (PWA):<br>– Central Pulse<br>Pressure (cPP)<br>– Augmentation<br>Pressure (AP)<br>– Augmentation Index<br>(Alx)<br>– Subendocardial<br>Viability Ratio<br>(SEVR)<br>– Average Central<br>Aortic Pressure<br>Waveform<br>– Central Diastolic<br>Pressure<br>– Central Mean<br>Arterial Pressure<br>(cMAP) | 1) Brachial Blood<br>Pressure (SYS/DIA)<br>2) Heart ate | Subject device<br>parameters are a<br>subset of those<br>provided by<br>primary<br>predicate device.<br>See Note 5 |
| Item | Subject Device | Primary Predicate Device<br>(K122129) | Reference Predicate Device<br>(K162144) | Comparison |
| | Pulse Pressure<br>Amplification (PP<br>Amplification)<br>- Augmentation Index<br>75 (AIx75) | - Pulse Pressure<br>Amplification (PP<br>Amplification)<br>- Augmentation Index<br>75 (AIx75)<br>- Ejection Duration<br>- SphygmoCor<br>Reference Age<br>PWV - Measures velocity<br>of pressure pulse between<br>carotid and femoral<br>arterial sites. | | |
| Other<br>Displayed<br>Information | 1) Date and Time<br>2) Battery low indicator<br>3) Pressure in cuff<br>4) Blood pressure<br>classification<br>5) Averages (7 and 30 day<br>measurement<br>averages/trends) | Patient's personal data<br>including Patient ID,<br>Gender, Date of Birth and<br>Age, and Height | Date<br>Time<br>Memory<br>Battery usage<br>Blood pressure<br>classification | See Note 6 |
| Data<br>Transmission | Transmit data to iOS<br>device or Android device<br>with Bluetooth | The SphygmoCor XCEL<br>device is connected to PC<br>using the USB cable | Transmit data to iOS<br>device or Android device<br>via WIFI | See Note 7 |
| Electrical Power | | | | |
| DC Mains | 5V | Input: 100-240 VAC, 50-<br>60Hz<br>Output: 15VDC at 2A | 5V | Same as<br>reference<br>predicate 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 the<br>reference<br>predicate device |
| Humidity | ≤85% | 15% to 95% non-<br>condensing | ≤85% | |
| Environmental Storage | | | | |
| Temperature | -20~50°C | -20°C to 65°C | -20~50°C | Same as<br>reference<br>predicate device |
| Humidity | ≤85% | 20% to 90% non-<br>condensing | ≤85% | |
| Item | Subject Device | Primary Predicate<br>Device<br>(K122129) | Reference Predicate<br>Device<br>(K162144) | Comparison |
| Performance NIBP/PWA | | | | |
| Heart Rate Range | 40 -180 times/min | 30-220 times/min | 40 -180 times/min | Same as reference<br>predicate device |
| Heart Rate Accuracy | Within ±5 beats/min | Within ±5 beats/min | Within ±5% | Same as primary<br>predicate device |
| Technique/<br>Method | Oscillometric | Oscillometric | Oscillometric | Same |
| Measure<br>process | Measure during inflating | Measure during inflating | Measure during inflating | Same |
| Pressure<br>Accuracy | Within ±3 mmHg | Within ±5 mmHg | Within ±3 mmHg | Same as<br>reference<br>predicate device |
| Cuff Pressure<br>Range | 0-300 mmHg | 0-300 mmHg | 0 - 300 mmHg | Same |
| Overpressure<br>Limit | 300 mmHg…