ANNE Chest

K240251 · Sibel Health, Inc. · DRG · Jun 3, 2024 · Cardiovascular

Device Facts

• Record ID: K240251
• Device Name: ANNE Chest
• Applicant: Sibel Health, Inc.
• Product Code: DRG · Cardiovascular
• Decision Date: Jun 3, 2024
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.2910
• Device Class: Class 2
• Attributes: Pediatric

Intended Use

The ANNE Chest is a wearable, wireless sensor intended for the measurement of electrocardiography (ECG) waveforms, heart rate, respiratory rate, activity, fall detection, body position, and skin temperature. The ANNE Chest sensor is not intended to monitor or measure respiratory rate while the patient undergoes significant motion or is active. The ANNE Chest sensor communicates with compatible software applications for the display, storage, and analysis of data. The device is intended to provide continuous physiological information as an aid to diagnosis and treatment by healthcare professionals in general care patients who are 12 years of age or older in clinical and home environments. The device is not intended for use on critical care patients.

Device Story

ANNE Chest is a skin-mounted, bio-integrated wearable sensor; collects real-time ECG, 3-axis accelerometry, and temperature data. Sensor transmits data via Bluetooth to Sibel SDK for integration into software applications; displays, stores, and analyzes physiological information. Used in clinical and home environments by healthcare professionals to aid diagnosis and treatment of general care patients (≥12 years). Provides continuous monitoring of heart rate, respiratory rate, activity, fall detection, body position, and skin temperature. ECG output is not for manual arrhythmia discrimination. Benefits include continuous physiological tracking without critical care requirements.

Clinical Evidence

Clinical validation study (n=40 healthy adult/adolescent subjects) evaluated respiratory rate accuracy against EtCO2 reference. Tested across demographics (age, gender, BMI), body positions, and motion activities. Mean absolute error (MAE) was 1.27 breaths per minute. Bench testing included electrical safety (IEC 60601-1), biocompatibility (ISO 10993), wireless coexistence (ANSI IEEE C63.27), and ECG performance (IEC 60601-2-27/47).

Technological Characteristics

Skin-mounted, bio-integrated sensor; Bluetooth connectivity. ECG sampling: 512 Hz (streaming 256 Hz), 18-bit resolution. 3-axis accelerometer for activity/posture. Biocompatible materials per ISO 10993. Powered by internal battery. Compliant with IEC 60601-1, 60601-1-2, 60601-1-11, 60601-2-27, 60601-2-47.

Indications for Use

Indicated for general care patients 12 years of age or older in clinical and home environments for continuous measurement of ECG, heart rate, respiratory rate, activity, fall detection, body position, and skin temperature. Not indicated for critical care patients or for respiratory rate monitoring during significant motion/activity.

Regulatory Classification

Identification

A radiofrequency physiological signal transmitter and receiver is a device used to condition a physiological signal so that it can be transmitted via radiofrequency from one location to another, e.g., a central monitoring station. The received signal is reconditioned by the device into its original format so that it can be displayed.

Predicate Devices

• ANNE One (K223711)
• Portrait Mobile Monitoring Solution (K230626)

Submission Summary (Full Text)

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June 3, 2024

Sibel Health Inc. Sarah Coughlin Regulatory Affairs Manager 2017 N Mendell Unit 2SE Chicago, Illinois 60614

Re: K240251

Trade/Device Name: ANNE Chest Regulation Number: 21 CFR 870.2910 Regulation Name: Radiofrequency Physiological Signal Transmitter And Receiver Regulatory Class: Class II Product Code: DRG, FLL, MWJ, KMI, BZQ, MWI Dated: May 10, 2024 Received: May 10, 2024

Dear Sarah Coughlin:

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" (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).

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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.

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 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,

# Jennifer W. Shih -S

Jennifer Shih 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

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## Indications for Use

Submission Number (if known)

K240251

Device Name

ANNE Chest

Indications for Use (Describe)

The ANNE Chest is a wearable, wireless sensor intended for the measurement of electrocardioaraphy (ECG) waveforms, heart rate, respiratory rate, activity, fall detection, body position, and skin temperature. The ANNE Chest sensor is not intended to monitor or measure respiratory rate while the patient undergoes significant motion or is active. The ANNE Chest sensor communicates with compatible software applications for the display, storage, and analysis of data. The device is intended to provide continuous physiological information as an aid to diagnosis and treatment by healthcare professionals in general care patients who are 12 years of age or older in clinical and home environments. 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: Sarah Coughlin, Regulatory Affairs Manager 2017 N Mendell St. Suite 2SE Chicago, IL 60614 Tel: [phone]

Date Prepared: 05/09/2024

#### . Device Information

Name of Device: ANNE Chest 510K Number: K240251 Classification Name: Radiofrequency Physiological Signal Transmitter and Receiver Regulation: 21 CFR §870.2910 Regulatory Class: Class II Product Classification Code: DRG, FLL, MWJ, KMI, BZQ, MWI

#### lll. Predicate Device

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

Secondary Predicate

Trade Name: Portrait Mobile Monitoring Solution 510(k) Number: K230626 Manufacturer: GE Medical Systems Information Technologies, Inc.

#### IV. Device Description

The ANNE Chest Sensor is a skin-mounted, bio-integrated sensor that collects real-time biosignals including electrocardiography (ECG), 3-axis accelerometry, and temperature to measure vital signs such as heart rate, respiratory rate, body position, fall detection, and skin temperature. The sensor communicates via Bluetooth to the Sibel SDK, which may be integrated within software applications for the display and storage of data. The ECG signal

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obtained by the ANNE Chest sensor is not intended for manual discrimination of any arrhythmias or cardiac conditions.

#### V. Indications for Use

The ANNE Chest is a wearable, wireless sensor intended for the measurement of electrocardiography (ECG) waveforms, heart rate, respiratory rate, activity, fall detection, body position, and skin temperature. The ANNE Chest sensor is not intended to monitor or measure respiratory rate while the patient undergoes significant motion or is active. The ANNE Chest sensor communicates with compatible software applications for the display, storage, and analysis of data. The device is intended to provide continuous physiological information as an aid to diagnosis and treatment by healthcare professionals in general care patients who are 12 years of age or older in clinical and home environments. 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 substantial equivalence of ANNE Chest:

- Electrical safety and electromagnetic compatibility testing according to ANSI/AAMI . ES60601-1:2005/(R) 2020 and IEC 60601-1-2:2014 standards. Electrical safety testing in the home healthcare environment per IEC 60601-1-11:2015.
- Biocompatibility testing according to ISO 10993-5:2009, ISO 10993-10:2021, and ISO 10993-23:2021 for patient contacting materials.
- Wireless coexistence testing according to ANSI IEEE C63.27-2017.
- . Software verification and validation testing according to IEC 62304:2015 and the FDA guidance document, Content of Premarket Submissions for Software Contained in Medical Devices.
- Safety and performance testing of ECG per IEC 60601-2-27:2011 and IEC . 60601-2-47:2012.
- . Defibrillation testing according to Section 8.5.5 of ANSI/AAMI ES60601-1:2005/(R)2012
- Shelf life testing of the adhesive to demonstrate performance over the intended device life cycle.
- Bench testing to demonstrate the mechanical durability of the sensors.
- Usability testing in accordance with the FDA guidance document, Applying Human Factors and Usability Engineering to Medical Devices.
- Performance testing of heart rate, respiratory rate, skin temperature, activity, and posture. ●
- Cybersecurity evaluation according to the FDA guidance document, Cybersecurity in ● Medical Devices: Quality System Considerations and Content of Premarket Submissions

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#### VII. Clinical Studies

Respiratory Rate Accuracy: A clinical validation study was conducted in n=40 healthy adult and adolescent subjects to evaluate respiratory rate measurements with the ANNE Chest sensor against an End Tidal Carbon Dioxide (EtCO2) monitor reference. Testing encompassed a range of patient demographics including age, gender, and BMI. Participants were asked to breathe along with a metronome at 8, 13, 23, 27, and 35 breaths per minute. The test also evaluated respiratory rate at different body positions and after motion activities. The mean absolute error (MAE) between the ANNE Chest sensor and capnography was 1.27 breaths per minute.

#### VIII. Conclusion

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

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| | Subject device<br>Sibel Health Inc. | Primary Predicate device<br>Sibel Health Inc. | Secondary Predicate<br>GE Medical Systems<br>Information<br>Technologies, Inc. | Variances / Equivalence | |
|---------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Trade<br>Name | ANNE Chest | ANNE One | Portrait Mobile Monitoring<br>Solution | | |
| 510(k)<br>Number | K240251 | K223711 | K230626 | | |
| Class | II | II | II | Equivalent | |
| Product<br>Code | DRG, FLL, KMI, MWJ,<br>BZQ, MWI | DRG, MWI, FLL, DQA,<br>MWJ, KMI | MHX, MSX, DRG, BZQ,<br>DQA | Equivalent<br>BZQ is a product code in<br>the subject device that<br>was not present in the<br>predicate device.<br>However, the predicate<br>device did monitor<br>breathing frequency. The<br>K230626 secondary<br>predicate is used to<br>support the BZQ product<br>code. | |
| Regulation<br>Number<br>and<br>Regulation<br>Name | 870.2910<br>Transmitters and<br>Receivers, Physiological<br>Signal, Radiofrequency | 870.2910<br>Transmitters and<br>Receivers, Physiological<br>Signal, Radiofrequency | 870.1025<br>Arrhythmia Detector and<br>Alarm (Including<br>ST-Segment Measurement<br>and Alarm) | Equivalent | |
| Indications<br>for Use | The ANNE Chest is a<br>wearable, wireless sensor<br>intended for the<br>measurement of<br>electrocardiography (ECG)<br>waveforms, heart rate,<br>respiratory rate, activity,<br>fall detection, body<br>position, and skin<br>temperature. The ANNE<br>Chest sensor is not<br>intended to monitor or<br>measure respiratory rate<br>while the patient<br>undergoes significant<br>motion or is active. The<br>ANNE Chest sensor<br>communicates with<br>compatible software<br>applications for the display.<br>storage, and analysis of<br>data. The device is<br>intended to provide<br>continuous physiological<br>information as an aid to<br>diagnosis and treatment | ANNE One is a wireless<br>monitoring platform<br>indicated for the<br>measurement of<br>electrocardiography (ECG)<br>waveforms, heart rate,<br>respiratory rate, functional<br>oxygen saturation of<br>arterial hemoglobin<br>(SpO2), pulse rate, activity,<br>body position, fall<br>detection, skin<br>temperature, and body<br>temperature by qualified<br>healthcare professionals in<br>home and healthcare<br>settings. ANNE One is<br>compatible with third-party,<br>FDA-cleared devices for<br>noninvasive blood<br>pressure, SpO2, pulse<br>rate, and body<br>temperature<br>measurements. The<br>device is indicated for<br>monitoring ECG | Portrait Mobile Monitoring<br>Solution: The Portrait<br>Mobile Monitoring Solution<br>is intended to acquire,<br>store, calculate, display<br>and export patient<br>monitoring data as well as<br>provide real time alarming<br>for monitoring adult and<br>pediatric patients (3 years<br>of age and older, and<br>weighing more than 10<br>kg).<br>Physiological parameters<br>and waveforms supported<br>are:<br>• Pulse oximetry<br>(SpO2/pulse rate)<br>• Respiration rate (RR)<br>Continuous pulse oximetry<br>and respiration rate<br>monitoring may be used<br>for patients at risk of | Similar<br>The subject device utilizes<br>the same ANNE Chest<br>sensor for the monitoring<br>of ECG, heart rate,<br>respiratory rate, body<br>position, activity, and skin<br>temperature as the<br>predicate device ANNE<br>One. The ANNE One<br>predicate has additional<br>outputs including SpO2,<br>pulse rate, body<br>temperature, and<br>non-invasive blood<br>pressure. This difference<br>does not affect safety or<br>effectiveness of the output<br>parameters indicated for<br>use in the subject device. | |
| | | | | | |
| | | by healthcare<br>professionals in general<br>care patients who are 12<br>years of age or older in<br>clinical and home<br>environments. The device<br>is not intended for use on<br>critical care patients. | waveforms and heart rate<br>on ambulatory patients.<br>The device is not intended<br>to monitor or measure<br>respiratory rate, SpO2,<br>pulse rate, or noninvasive<br>blood pressure while the<br>patient undergoes<br>significant motion or is<br>active.<br>ANNE One continuously<br>monitors the orientation of<br>patients to aid in the<br>prevention of pressure<br>ulcers for at-risk patients.<br>The system provides<br>visual notification when the<br>patient's position has not<br>changed from a preset<br>threshold of time.<br>The device is intended for<br>use on general care<br>patients who are 12 years<br>of age or older as a<br>general patient monitor to<br>provide continuous<br>physiological information<br>as an aid to diagnosis and<br>treatment. The data from<br>ANNE One are transmitted<br>wirelessly for display,<br>storage, and analysis. The<br>device is not intended for<br>use on critical care<br>patients. | cardiorespiratory and<br>infectious complications.<br>The Portrait Mobile<br>Monitoring Solution is<br>intended for use under the<br>direct supervision of a<br>licensed practitioner, or by<br>personnel trained in proper<br>use of the equipment in a<br>professional healthcare<br>facility.<br>This device is not an<br>Apnea monitor (i.e., do not<br>rely on the device for<br>detection or alarm for the<br>cessation of breathing).<br>This device should not be<br>used for life<br>sustaining/supporting<br>purposes. The Portrait<br>Mobile Monitoring Solution<br>is not intended for use in a<br>controlled Magnetic<br>Resonance (MR)<br>environment. | |
| | Target<br>Population | 12 years of age and older | 12 years of age and older | 3 years of age and older,<br>weighing more than 10 kg | Equivalent |
| | Use<br>Environment | Home and healthcare<br>settings | Home and healthcare<br>settings | Professional healthcare<br>facility | Equivalent |
| | Reprocessing | Multiple patient reusable | Single patient reusable | Semi-disposable | Different<br>The subject device is<br>reusable on multiple<br>patients. Validation of the<br>cleaning process and<br>mechanical testing<br>demonstrate that this<br>difference does not impact<br>safety or effectiveness. |
| | Sensor<br>Placement | Chest | Finger and Chest | Portrait Wearable<br>Respiration Rate Sensor<br>and Portrait RR Electrode<br>Patch: | Equivalent<br>Placement location of the<br>ANNE Chest sensor is the<br>same between the subject |
| | | | Chest | and predicate devices.<br>The predicate device<br>includes an additional<br>sensor, the ANNE Limb<br>Sensor, that is worn on the<br>finger. The ANNE Limb<br>Sensor is not part of the<br>scope of the subject<br>device. | |
| Heart Rate | 30 - 270 bpm<br>(the greater of ±10% or<br>±5bpm) | 30-270 bpm<br>(the greater of ± 10% or ±<br>5 bpm) | N/A | Equivalent | |
| Respiratory<br>Rate | Accelerometer and ECG<br>derived<br>8 - 35 bpm (±3 bpm<br>RMSE) | Accelerometer-derived<br>8 - 30 bpm (± 3 bpm<br>RMSE) | Derived from impedance<br>and biopotential signals<br>Accuracy range from 4 to<br>60 breaths/minute (± 3<br>bpm RMSE) | Similar<br>The range for respiratory<br>rate has been extended in<br>the subject device from the<br>K223711 predicate. The<br>range is less than the<br>K230626 secondary<br>predicate. Respiratory rate<br>over the output range for<br>the subject device meets<br>the same accuracy<br>specification as both<br>predicates. | |
| Skin<br>Temperatur<br>e | 73.4°F - 109.4°F (±0.54°F)<br>23°C - 43°C (±0.3°C) | 73.4°F - 109.4°F (±0.54°F)<br>23°C - 43°C (±0.3°C) | N/A | Equivalent | |
| Body<br>Temperatur<br>e | Not Applicable | ± 0.05 °C ( ± 0.1 °F )<br>during 35.00 °C ~38.00°C<br>(95.00 °F ~100.40°F) ±<br>0.1°C ( ± 0.2 °F ) during<br>T<35.00°C (95.00°F) or<br>T>38.00°C (100.40°F)<br>with use of an optional<br>compatible thermometer | N/A | Different<br>The subject device does<br>not have body temperature<br>functionality. | |
| SpO2 | Not Applicable | ARMS ≤ 3% (range<br>70-100%) | ARMS ≤ 2% (range<br>70-100%)<br>Low perfusion: ARMS ≤ 3%<br>With motion: ARMS ≤ 3% | Different<br>The subject device does<br>not have SpO2<br>functionality. | |
| Pulse Rate | Not Applicable | 30-300 bpm<br>(the greater of ± 10% or ±<br>5 bpm) | 30-250 bpm<br>≤ 2bpm (30 to 250 bpm)<br>With motion: ≤5bpm | Different<br>The subject device does<br>not have pulse rate<br>functionality. | |
| Activity | Accelerometer | Accelerometer | N/A…