ANNE View, Central Hub

K242842 · Sibel Health, Inc. · MSX · Jan 8, 2025 · Cardiovascular

Device Facts

• Record ID: K242842
• Device Name: ANNE View, Central Hub
• Applicant: Sibel Health, Inc.
• Product Code: MSX · Cardiovascular
• Decision Date: Jan 8, 2025
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.2300
• Device Class: Class 2
• Attributes: Software as a Medical Device

Intended Use

The ANNE View application is intended for the display of physiological data from the ANNE Chest and ANNE Limb devices. The application is also compatible with third-party, FDA-cleared devices for the display of noninvasive blood pressure, SpO2, pulse rate, and body temperature measurements. The ANNE View application notifies healthcare professionals when physiological data fall outside selected parameters. The ANNE View application displays the orientation of patients to aid in the prevention of pressure ulcers for at-risk patients. The system notifies the user when the patient's position has not changed for a preset threshold of time. The ANNE View application communicates to compatible central monitoring platforms, including the Central Hub, for the display and storage of multiple patients' physiological data. The Central Hub has the ability to notify healthcare professionals when physiological data fall outside selected parameters. The ANNE View and Central Hub are intended for use by trained, qualified healthcare professionals in the clinical or home healthcare environment. The device is not intended for use on critical care patients.

Device Story

ANNE View/Central Hub is a patient monitoring system. ANNE View (running on tablet) receives physiological data (ECG, SpO2, pulse, respiratory rate, temperature, position) via Bluetooth from ANNE Chest/Limb sensors and third-party devices. It displays real-time data, provides visual/auditory alarms for out-of-threshold parameters, and monitors patient orientation to prevent pressure ulcers. Data transmits via Wi-Fi/LAN to Central Hub, which aggregates data from up to 16 beds, provides 48-hour storage, and enables remote monitoring by healthcare professionals. System aids clinical decision-making by alerting staff to patient status changes. Intended for clinical or home use; not for critical care.

Clinical Evidence

Bench testing only. Evidence includes electromagnetic compatibility (IEC 60601-1-2:2020), wireless coexistence (ANSI IEEE C63.27-2017), software verification/validation (IEC 62304:2015), ECG waveform display verification (IEC 60601-2-27:2011, IEC 60601-2-47:2012), usability testing (IEC 62366-1:2020), cybersecurity evaluation, and alarm system verification (IEC 60601-1-8:2020).

Technological Characteristics

System comprises ANNE View application (Android 14.0) and Central Hub (Windows 11). Connectivity via Bluetooth (sensors), LAN/WLAN (Central Hub). Supports HL7 FHIR and IEEE 11073 SDC communication standards. Features include real-time physiological data display, alarm management, and patient position monitoring.

Indications for Use

Indicated for use by trained, qualified healthcare professionals in clinical or home settings for monitoring physiological data (ECG, SpO2, pulse rate, respiratory rate, temperature, body position) in non-critical care patients.

Regulatory Classification

Identification

A cardiac monitor (including cardiotachometer and rate alarm) is a device used to measure the heart rate from an analog signal produced by an electrocardiograph, vectorcardiograph, or blood pressure monitor. This device may sound an alarm when the heart rate falls outside preset upper and lower limits.

Predicate Devices

• Aulisa Multiple Patient Digital Vital Sign Monitoring System MP1000 (K202497)
• ANNE One (K223711)

Submission Summary (Full Text)

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January 8, 2025

Sibel Health Inc. Peter Xu Regulatory Affairs Consultant 2017 N Mendell St. Suite 2SE Chicago, Illinois 60614

Re: K242842

Trade/Device Name: ANNE View, Central Hub Regulation Number: 21 CFR 870.2300 Regulation Name: Cardiac Monitor (Including Cardiotachometer And Rate Alarm) Regulatory Class: Class II Product Code: MSX, MWI, KMI, DRG Dated: December 9, 2024 Received: December 9, 2024

Dear Peter Xu:

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 (the 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 available 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.

Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device"

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(https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).

Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30. Design controls; 21 CFR 820.90. Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review. the OS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).

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 Part 803) for devices or postmarketing safety reporting (21 CFR Part 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 Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.

All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rue"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-devices/device-advicecomprehensive-regulatory-assistance/unique-device-identification-system-udi-system.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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 mediation-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).

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Sincerely,

# Jennifer W. Shih -S

Jennifer Kozen 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

Submission Number (if known)

K242842

Device Name

ANNE View, Central Hub

### Indications for Use (Describe)

The ANNE View application is intended for the display of physiological data from the ANNE Chest and ANNE Limb devices. The application is also compatible with third-party, FDA-cleared devices for the display of noninvasive blood pressure, SpO2, pulse rate, and body temperature measurements. The ANNE View application notifies healthcare professionals when physiological data fall outside selected parameters. The ANNE View application displays the orientation of patients to aid in the prevention of pressure ulcers for at-risk patients. The system notifies the user when the patient's position has not changed for a preset threshold of time. The ANNE View application communicates to compatible central monitoring platforms, including the Central Hub, for the display and storage of multiple patients' physiological data. The Central Hub has the ability to notify healthcare professionals when physiological data fall outside selected parameters.

The ANNE View and Central Hub are intended for use by trained, qualified healthcare professionals in the clinical or home healthcare environment. The device is not intended for use on critical care patients.

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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# 510(K) Summary

#### -Submitter:

Sibel Health Inc. 2017 N Mendell St. Suite 2SE Chicago, IL 60614 Tel: [phone]

Official Correspondent: Peter Xu, Regulatory Affairs Consultant 2017 N Mendell St. Suite 2SE Chicago, IL 60614 Tel: [phone]

Date Prepared: 12/06/2024

#### . Device Information

Name of Device: ANNE View, Central Hub

510K Number: K242842

Classification Name: Cardiac monitor (including cardiotachometer and rate alarm)

Requlation: 21 CFR §870.2300

Regulatory Class: Class II

Product Classification Code: MSX, MWI, KMI, DRG

#### 111. Predicate Device

Primary Predicate

Trade Name: Aulisa Multiple Patient Digital Vital Sign Monitoring System MP1000 510(k): K202497 Device Manufacturer: Taiwan Aulisa Medical Devices Technologies Inc.

Secondary Predicate

Trade Name: ANNE One 510(k): K223711 Device Manufacturer: Sibel Health Inc.

#### IV. Device Description

The ANNE View application is a bedside patient monitoring device that receives vital signs and physiological data from compatible devices for display and transmission to the Central Hub. The ANNE View application operates on the ANNE Tablet. When connected to the ANNE Chest Sensor, the ANNE View application displays electrocardiography (ECG), skin temperature, heart rate, respiratory rate, and body position data. When connected to the ANNE Limb Sensor, the ANNE View application displays photoplethysmography (PPG), SpO2, pulse rate, and skin temperature data. The ANNE View application is also compatible with optional third-party

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devices for SpO2, non-invasive blood pressure, and body temperature measurements. The ANNE View application alarms when physiological data are outside of the configured thresholds.

When the ANNE Tablet is connected to Wi-Fi, the vital signs and physiological data are uploaded from the ANNE View application to the Central Hub. The Central Hub allows healthcare professionals to view vitals data from up to 16 beds on one screen and provides storage of up to 48 hours of data from each patient. Alarm conditions are communicated to the Central Hub from the ANNE View application for visual and audio alarms on the Central Hub.

#### V. Indications for Use

The ANNE View application is intended for the display of physiological data from the ANNE Chest and ANNE Limb devices. The application is also compatible with third-party. FDA-cleared devices for the display of noninvasive blood pressure, SpO2, pulse rate, and body temperature measurements. The ANNE View application notifies healthcare professionals when physiological data fall outside selected parameters. The ANNE View application displays the orientation of patients to aid in the prevention of pressure ulcers for at-risk patients. The system notifies the user when the pation has not changed for a preset threshold of time. The ANNE View application communicates to compatible central monitoring platforms, including the Central Hub. for the display and storage of multiple patients' physiological data. The Central Hub has the ability to notify healthcare professionals when physiological data fall outside selected parameters.

The ANNE View and Central Hub are intended for use by trained, qualified healthcare professionals in the clinical or home healthcare environment. The device is not intended for use on critical care patients.

#### VI. Performance Data

The following consensus standards and bench testing were used to evaluate the safety and effectiveness of ANNE View, Central Hub as compared to the predicate:

- Electromagnetic compatibility testing according to IEC 60601-1-2:2020. .
- Wireless coexistence testing according to ANSI IEEE C63.27-2017. ●
- Software verification and validation testing according to IEC 62304:2015 and the FDA quidance document, Content of Premarket Submissions for Software Contained in Medical Devices.
- Verification of the ECG waveform display per IEC 60601-2-27:2011 and IEC . 60601-2-47:2012.
- . Usability testing in accordance with the FDA guidance document, Applying Human Factors and Usability Enqineering to Medical Devices and IEC 62366-1:2020.
- Cybersecurity evaluation according to the FDA guidance document, Cybersecurity in Medical Devices: Quality System Considerations and Content of Premarket Submissions
- Verification of the alarm system to IEC 60601-1-8:2020.
- . Performance evaluation of the HL7 FHIR and IEEE 11073 SDC communication.

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#### VII. Conclusion

The results of the substantial equivalence assessment below, taken together with safety and performance testing data, demonstrate that ANNE View, Central Hub's performance characteristics are substantially equivalent to the predicate device in both technology and intended use.

| | Subject Device<br>Sibel Health Inc. | Primary Predicate<br>Device<br>Taiwan Aulisa<br>Medical Devices<br>Technologies Inc. | Secondary<br>Predicate Device<br>Sibel Health Inc | Variances /<br>Equivalences |
|----------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Trade Name | ANNE View, Central<br>Hub | Aulisa Multiple<br>Patient Digital Vital<br>Sign Monitoring<br>System MP1000 | ANNE One | |
| 510(k) Number | K242842 | K202497 | K223711 | |
| Class | II | II | II | Equivalent |
| Product Code | MSX, MWI, KMI | MSX, MWI | DRG, MWI, FLL,<br>DQA, MWJ, KMI | Equivalent |
| Regulation<br>Number and<br>Name | 870.2300<br>Cardiac monitor<br>(including<br>cardiotachometer<br>and rate alarm) | 870.2300<br>Cardiac monitor<br>(including<br>cardiotachometer<br>and rate alarm) | 870.2910<br>Radiofrequency<br>physiological signal<br>transmitter and<br>receiver | Equivalent |
| Indications for<br>Use | The ANNE View<br>application is<br>intended for the<br>display of<br>physiological data<br>from the ANNE Chest<br>and ANNE Limb<br>devices. The<br>application is also<br>compatible with<br>third-party,<br>FDA-cleared devices<br>for the display of<br>noninvasive blood<br>pressure, SpO2,<br>pulse rate, and body<br>temperature<br>measurements. The<br>ANNE View<br>application notifies<br>healthcare<br>professionals when<br>physiological data fall<br>outside selected<br>parameters. The | The Aulisa Multiple<br>Patient Digital Vital<br>Sign Monitoring<br>System, MP1000, is<br>intended to provide<br>remote central<br>monitoring and<br>display of information<br>as recorded by<br>multiple Aulisa<br>single-patient<br>monitoring systems,<br>on a central remote<br>screen. The system<br>can be used in a<br>hospital type and<br>clinic environment. | ANNE One is a<br>wireless monitoring<br>platform indicated for<br>the measurement of<br>electrocardiography<br>(ECG) waveforms,<br>heart rate, respiratory<br>rate, functional<br>oxygen saturation of<br>arterial hemoglobin<br>(SpO2 ), pulse rate,<br>activity, body<br>position, fall<br>detection, skin<br>temperature, and<br>body temperature by<br>qualified healthcare<br>professionals in<br>home and healthcare<br>settings. ANNE One<br>is compatible with<br>third-party,<br>FDA-cleared devices<br>for noninvasive blood<br>pressure, SpO2, | Equivalent<br>Both devices are<br>intended to display<br>real-time<br>physiological data for<br>patient monitoring by<br>healthcare<br>professionals. |
| | ANNE View<br>application displays<br>the orientation of<br>patients to aid in the<br>prevention of<br>pressure ulcers for<br>at-risk patients. The<br>system notifies the<br>user when the<br>patient's position has<br>not changed for a<br>preset threshold of<br>time. The ANNE View<br>application<br>communicates to<br>compatible central<br>monitoring platforms,<br>including the Central<br>Hub, for the display<br>and storage of<br>multiple patients'<br>physiological data.<br>The Central Hub has<br>the ability to notify<br>healthcare<br>professionals when<br>physiological data fall<br>outside selected<br>parameters.<br>The ANNE View and<br>Central Hub are<br>intended for use by<br>trained, qualified<br>healthcare<br>professionals in the<br>clinical or home<br>healthcare<br>environment. The<br>device is not<br>intended for use on<br>critical care patients. | | pulse rate, and body<br>temperature<br>measurements. The<br>device is indicated for<br>monitoring ECG<br>waveforms and heart<br>rate on ambulatory<br>patients. The device<br>is not intended to<br>monitor or measure<br>respiratory rate,<br>SpO2, pulse rate, or<br>noninvasive blood<br>pressure while the<br>patient undergoes<br>significant motion or<br>is active. ANNE One<br>continuously<br>monitors the<br>orientation of patients<br>to aid in the<br>prevention of<br>pressure ulcers for<br>at-risk patients. The<br>system provides<br>visual notification<br>when the patient's<br>position has not<br>changed from a<br>preset threshold of<br>time. The device is<br>intended for use on<br>general care patients<br>who are 12 years of<br>age or older as a<br>general patient<br>monitor to provide<br>continuous<br>physiological<br>information as an aid<br>to diagnosis and<br>treatment. The data<br>from ANNE One are<br>transmitted wirelessly<br>for display, storage,<br>and analysis. The<br>device is not<br>intended for use on<br>critical care patients. | |
| Environment of<br>Use | Home and healthcare<br>settings | Hospitals or hospital<br>type and clinic<br>environment | Home and healthcare<br>settings | Equivalent<br>The subject device<br>and K223711<br>predicate are both<br>intended for use in<br>home and healthcare<br>settings. Regardless<br>of environment, all |
| | | | | three devices are<br>intended to be used<br>solely by healthcare<br>professionals. |
| Alarms | Visual and auditory<br>alarms | Visual and auditory<br>alarms | No alarming | Equivalent |
| Operating<br>System | ANNE View - Android<br>14.0<br>Central Hub Desktop<br>- Windows 11 | Windows 10 | ANNE View - Android<br>8.0 or above | Equivalent |
| Communication<br>Method | The ANNE View<br>application<br>communicates with<br>compatible medical<br>devices over<br>Bluetooth. The<br>Central Hub receives<br>data from ANNE<br>View over LAN or<br>WLAN. | LAN and WLAN | The ANNE View<br>application<br>communicates with<br>compatible medical<br>devices over<br>Bluetooth. | Equivalent |
| Monitoring type | The ANNE View<br>application provides<br>real time monitoring.<br>The Central Hub<br>provides real time<br>monitoring and data<br>storage for later<br>analysis. | Real time monitoring<br>and data storage. | The ANNE View<br>application provides<br>real time monitoring<br>and data storage for<br>later analysis. | Equivalent |
| Interoperability | The ANNE View<br>application is<br>interoperable with the<br>ANNE Chest Sensor<br>and the ANNE Limb<br>Sensor. The ANNE<br>View application is<br>also interoperable<br>with third party<br>compatible devices<br>for non-invasive<br>blood pressure,<br>SpO2, pulse rate,<br>and body<br>temperature<br>monitoring.<br>The ANNE View<br>application is<br>interoperable with<br>central monitoring<br>platforms including<br>the Central Hub. | The Aulisa Multiple<br>Patient Digital Vital<br>Sign Monitoring<br>System is<br>interoperable with<br>Aulisa single-patient<br>monitoring systems. | The ANNE View<br>application is<br>interoperable with the<br>ANNE Chest Sensor<br>and the ANNE Limb<br>Sensor. The ANNE<br>View application is<br>also interoperable<br>with third party<br>compatible devices<br>for non-invasive<br>blood pressure,<br>SpO2, pulse rate,<br>and body<br>temperature<br>monitoring. | Equivalent |

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