Who is the manufacturer of ANNE One?

Sibel Health, Inc. filed the 510(k) submission for ANNE One (K223711).

What is the FDA product code for ANNE One?

DRG. It is classified under 21 CFR 870.2910 as a Class 2 device in the Cardiovascular panel.

What is the regulatory pathway for ANNE One?

510(k) clearance (submission type: Traditional).

Who can help prepare an FDA 510(k) submission like ANNE One?

Innolitics — a medical-device software consultancy — provides regulatory and engineering support for FDA 510(k) submissions. See https://innolitics.com/services/510ks/ or contact https://innolitics.com/contact.

ANNE One

K223711 · Sibel Health, Inc. · DRG · Aug 10, 2023 · Cardiovascular

Device Facts

Record ID	K223711
Device Name	ANNE One
Applicant	Sibel Health, Inc.
Product Code	DRG · Cardiovascular
Decision Date	Aug 10, 2023
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 870.2910
Device Class	Class 2

Intended Use

ANNE One is a wireless monitoring platform indicated for the measurement of electrocardiography (ECG) waveforms, heart rate, respiratory rate, functional oxygen saturation of arterial hemoglobin (SpO2), pulse rate, activity, body position, fall detection, skin temperature, and body temperature by qualified healthcare professionals in home and healthcare settings. ANNE One is compatible with third-party, FDA-cleared devices for noninvasive blood pressure, SpO2, pulse rate, and body temperature measurements. The device is indicated for monitoring ECG waveforms and heart rate on ambulatory patients. The device is not intended to monitor or measure respiratory rate, SpO2, pulse rate, or noninvasive blood pressure while the patient undergoes significant motion or is active. ANNE One continuously monitors the orientation of patients to aid in the prevention of pressure ulcers for at-risk patients. The system provides visual notification when the patient's position has not changed from a preset threshold of time. The device is intended for use on general care patients who are 12 years of age or older as a general patient monitor to provide continuous physiological information as an aid to diagnosis and treatment. The data from ANNE One are transmitted wirelessly for display, storage, and analysis. The device is not intended for use on critical care patients.

Device Story

ANNE One is a wireless, wearable monitoring platform for general care patients (12+ years). It utilizes two skin-mounted, bio-integrated sensors to capture ECG, PPG, 3-axis accelerometry, and temperature data. Inputs are processed to derive heart rate, respiratory rate, SpO2, pulse rate, activity, body position, and fall detection. The system transmits data wirelessly to the ANNE View software application for real-time display, storage, and analysis. It also supports integration with third-party, FDA-cleared devices for NIBP, SpO2, and body temperature. The device aids in pressure ulcer prevention by monitoring patient orientation and providing visual notifications for position changes. Operated by healthcare professionals, the system provides continuous physiological information to assist in diagnosis and treatment. It is not intended for critical care or automated arrhythmia detection; ECG waveforms are for manual interpretation and rhythm checks. The device benefits patients by enabling continuous, non-invasive monitoring in both home and clinical environments.

Clinical Evidence

Clinical validation included SpO2 accuracy testing in 12 healthy subjects (Fitzpatrick 2-5) compared to blood gas analysis, achieving an ARMS of 2.31% (range 70-100%). Respiratory rate accuracy was validated in 40 healthy adults compared to etCO2, with a mean absolute error within ±3 bpm. Bench testing covered electrical safety (IEC 60601-1), EMC, wireless coexistence (ANSI IEEE C63.27), biocompatibility (ISO 10993), and software verification/validation (IEC 62304).

Technological Characteristics

Wireless monitoring platform with two skin-mounted, bio-integrated sensors. Measures ECG (512 Hz sampling), PPG, 3-axis accelerometry, and temperature. Connectivity via Bluetooth to mobile device. Materials are biocompatible per ISO 10993. Software includes Pan-Tompkins algorithm for QRS detection. Compliant with IEC 60601-2-27 and IEC 60601-2-47 for ECG, and ISO 80601-2-61 for pulse oximetry.

Indications for Use

Indicated for general care patients aged 12+ in home and healthcare settings. Measures ECG, heart rate, respiratory rate, SpO2, pulse rate, activity, body position, fall detection, skin/body temperature. Not for critical care patients. Not for respiratory rate, SpO2, pulse rate, or NIBP 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 (K211305)

Reference Devices

ANNE Sleep (K220095)
BioSticker System (K191614)
Leaf Patient Monitoring System (K141877)
Eclipse Mini (K212317)

Related Devices

K240251 — ANNE Chest · Sibel Health, Inc. · Jun 3, 2024
K211305 — ANNE One · Sibel, Inc. · Sep 14, 2021
K242842 — ANNE View, Central Hub · Sibel Health, Inc. · Jan 8, 2025
K150361 — ViSi Mobile Monitoring System · Sotera Wireless, Inc. · Apr 30, 2015
K223498 — Radius VSM and Accessories · Masimo Corporation · Jun 1, 2023

Submission Summary (Full Text)

{0}------------------------------------------------ Image /page/0/Picture/0 description: The image contains the logos of the Department of Health and Human Services and the Food and Drug Administration (FDA). The Department of Health and Human Services logo is on the left, and the FDA logo is on the right. The FDA logo includes the letters "FDA" in a blue square, followed by the words "U.S. Food & Drug Administration" in blue text. August 10, 2023 Sibel Health Inc. Sarah Coughlin Senior Regulatory Affairs and Quality Assurance Engineer 6650 W Touhv Ave. Niles, Illinois 60714 Re: K223711 Trade/Device Name: ANNE One Regulation Number: 21 CFR 870.2910 Regulation Name: Radiofrequency Physiological Signal Transmitter And Receiver Regulatory Class: Class II Product Code: DRG, MWI, FLL, DQA, MWJ, KMI Dated: July 6, 2023 Received: July 10, 2023 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 (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. 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 {1}------------------------------------------------ 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 (OS) 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 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 (DICE@fda.hhs.gov) or phone (1-800-638-2041 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 Enclosure {2}------------------------------------------------ # Indications for Use 510(k) Number (if known) K223711 Device Name ANNE One # Indications for Use (Describe) ANNE One is a wireless monitoring platform indicated for the measurement of electrocardiography (ECG) waveforms. heart rate, respiratory rate, function of arterial hemoglobin (SpO2), pulse rate, activity, body position, fall detection, skin temperature by qualified healthcare professionals in home and healthcare settings. ANNE One is compatible with third-party, FDA-cleared devices for noninvasive blood pressure, SpO2, pulse rate, and body temperature measurements. The device is indicated for monitoring ECG waveforms and heart rate on ambulatory patients. The device is not intended to monitor or measure respiratory rate. SpO2, pulse rate, or noninvasive blood pressure while the patient undergoes significant motion or is active. ANNE One continuously monitors the orients to aid in the prevention of pressure ulcers for at-risk patients. The system provides visual notification when the pation has not changed from a preset threshold of time. The device is intended for use on general care patients who are 12 years of age or older as a general patient monitor to provide continuous physiological information as an aid to diagnosis and treatment. The data from ANNE One are transmitted wirelessly for display, storage, and analysis. The device is not intended for use on critical care patients. Type of Use (*Select one or both, as applicable*) | <div> X Prescription Use (Part 21 CFR 801 Subpart D) </div> | <div> ☐ Over-The-Counter Use (21 CFR 801 Subpart C) </div> | |-------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------| |-------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------| CONTINUE ON A SEPARATE PAGE IF NEEDED. This section applies only to requirements of the Paperwork Reduction Act of 1995# *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.* The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to: > Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov "An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number." {3}------------------------------------------------ # 510(K) Summary #### -Submitter: Sibel Health Inc. 2017 N Mendell St. Suite 2SE Chicago, IL 60614 Tel: (224) 251-8859 Official Correspondent: Sarah Coughlin, Regulatory Affairs Manager 2017 N Mendell St. Suite 2SE Chicago, IL 60614 Tel: (224) 251-8859 Date Prepared: 08/10/2023 #### II. Device Information Name of Device: ANNE One 510K Number: K223711 Classification Name: Radiofrequency Physiological Signal Transmitter and Receiver Regulation: 21 CFR §870.2910 Regulatory Class: Class II Product Classification Code: DRG, MWI, FLL, DQA, MWJ, KMI #### lll. Predicate Device Trade Name: ANNE One 510(k): K211305 Device Manufacturer: Sibel Health Inc. #### IV. Reference Devices Trade Name: ANNE Sleep 510(k): K220095 Device Manufacturer: Sibel Health Inc. Trade Name: BioSticker System 510(k): K191614 Device Manufacturer: BioIntelliSense Inc. Trade Name: Leaf Patient Monitoring System 510(k): K141877 Device Manufacturer: Leaf Healthcare Incorporated {4}------------------------------------------------ Trade Name: Eclipse Mini 510(k): K212317 Device Manufacturer: Spacelabs ## V. Device Description ANNE One is a wireless monitoring platform that streams and stores real-time biosignals including electrocardiography (ECG), photoplethysmography (PPG), 3-axis accelerometry, and temperature to measure vital signs such as heart rate, respiratory rate, SpO2, pulse rate, skin temperature, and body temperature. The ECG signal is not intended for automated arrhythmia detection or classification; rather it is intended for manual interpretation, and the automated computation of heart rate through QRS identification using the well-known Pan-Tompkins beat detection algorithm. The displayed waveform is only intended for display as a check for normal ECG rhythm. The waveform is not intended for manual discrimination of any arrhythmias or cardiac conditions. The system features two skin-mounted, bio-integrated sensors that pair with the ANNE View software application for the continuous display, storage, and analysis of vital sign measurements and physiological waveforms. The system is also compatible with optional FDA-cleared third-party devices for SpO2, non-invasive blood pressure, and body temperature measurements. # VI. Indications for Use ANNE One is a wireless monitoring platform indicated for the measurement of electrocardiography (ECG) waveforms, heart rate, respiratory rate, functional oxygen saturation of arterial hemoglobin (SpO-), pulse rate, activity, body position, fall detection, skin temperature, and body temperature by qualified healthcare professionals in home and healthcare settings. ANNE One is compatible with third-party, FDA-cleared devices for noninvasive blood pressure, SpO2, pulse rate, and body temperature measurements. The device is indicated for monitoring ECG waveforms and heart rate on ambulatory patients. The device is not intended to monitor or measure respiratory rate, SpO2, pulse rate, or noninvasive blood pressure while the patient undergoes significant motion or is active. ANNE One continuously monitors the orientation of patients to aid in the prevention of pressure ulcers for at-risk patients. The system provides visual notification when the patient's position has not changed from a preset threshold of time. The device is intended for use on general care patients who are 12 years of age or older as a general patient monitor to provide continuous physiological information as an aid to diagnosis and treatment. The data from ANNE One are transmitted wirelessly for display, storage, and analysis. The device is not intended for use on critical care patients. {5}------------------------------------------------ # VII. Performance Data The following consensus standards and bench testing were used to evaluate the substantial equivalence of ANNE One: - Electrical safety and electromagnetic compatibility testing according to ANSI/AAMI ● ES60601-1:2005/(R)2012 and IEC 60601-1-2:2014 standards. Electrical safety testing in the home healthcare environment per IEC 60601-1-11:2015. - Safety and performance testing of pulse oximeter per ISO 80601-2-61:2017. . - . Biocompatibility testing according to ISO 10993-1:2018, ISO 10993-5:2009, and ISO 10993-10:2010 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 safe and effective 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, body temperature, activity, and posture, - . Cybersecurity evaluation according to the requirements of the FDA draft guidance document, Content of Premarket Submissions for Management of Cybersecurity in Medical Devices. - Assessment of Software of Unknown Provenance per the FDA quidance document. ● Off-The-Shelf Software Use in Medical Devices. ### VIII. Clinical Studies SpO2 Accuracy: Sibel validated the accuracy of SpO2 measurements compared to blood gas analysis in n=12 healthy subjects over the range of 70-100% oxygen saturation according to Section 201.12.1 of ISO 80601-2-61 and Pulse Oximeters - Premarket Notification Submissions [510(k)s]: Guidance for Industry and Food and Drug Administration Staff, Issued March 2013. Enrolled subjects had skin tones varying from Fitzpatrick 2-5, with two subjects having darker skin pigmentation (Fitzpatrick 5). The average root mean square error (Agus) was 2.31%, meeting the requirements of the above-mentioned standard. Respiratory Rate Accuracy: Sibel validated the accuracy of respiratory rate measurements compared to etCO2 in n=40 healthy adult subjects over the output range of 8-30 breaths per {6}------------------------------------------------ minute. The mean absolute error of respiratory rate measurements with ANNE One was within ±3bpm of the reference device, meeting the defined performance criteria. ## IX. Conclusion The results of the substantial equivalence assessment, taken together with safety and performance testing data, demonstrate that ANNE One's performance characteristics are substantially equivalent to the predicate device in both technology and intended use. {7}------------------------------------------------ | | Subject device Sibel Health Inc. | Predicate device Sibel Health Inc. | Reference device Sibel Health Inc. | Reference device BioIntelliSense Inc. | Reference Device Leaf Healthcare, Inc. | Reference Device Spacelabs | Variances / Equivalence | |-----------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Trade Name | ANNE One | ANNE One | ANNE Sleep | BioSticker System | Leaf Patient Monitoring System | Eclipse Mini | | | 510(k) Number | K223711 | K211305 | K220095 | K191614 | K141877 | K212317 | | | Class | II | II | II | II | I | II | Equivalent | | Product Code | DRG, MWI, FLL, DQA, MWJ, KMI | DRG, MWI, FLL | MNR | DRG | KMI | MWJ | Similar The DQA product code for the oximeter is supported by the ANNE Sleep reference device. The MWJ product code for ambulatory ECG monitoring without analysis is supported by safety and performance testing to consensus standards as well as the K212317 reference. The KMI product code for bed-patient monitoring is supported by the Leaf Patient Monitoring System reference device. | | Regulati | 870.2910 | 870.2910 | 868.2375 | 870.2910 | 880.2400 | 870.2800 | Equivalent | | on Number and Regulati on Name | Transmitters and Receivers, Physiological Signal, Radiofrequency | Transmitters and Receivers, Physiological Signal, Radiofrequency | Breathing Frequency Monitor | Transmitters and Receivers, Physiological Signal, Radiofrequency | Bed-patient Monitor | Medical magnetic tape recorder | | | Indicatio ns for Use | ANNE One is a wireless monitoring platform indicated for the measurement of electrocardiograph y (ECG) waveforms, heart rate, respiratory rate, functional oxygen saturation of arterial hemoglobin (SpO2), pulse rate, activity, body position, fall detection, skin temperature, and body temperature by qualified healthcare professionals in home and healthcare settings. ANNE One is compatible with third-party, FDA-cleared devices for noninvasive blood | ANNE One is a wireless vital signs and physiological data monitoring platform indicated for the measurement of heart rate, respiratory rate, step count, fall count, skin temperature, and body temperature by qualified healthcare professionals in healthcare settings. The device is intended for use on general care patients who are 18 years of age or older as a general patient monitor to provide continuous physiological information as an aid to diagnosis and treatment. The device is not intended for use on critical care patients. The | ANNE Sleep is a wearable sensor system intended for use in the collection, analysis, display, and storage of physiological parameters to aid in the evaluation of sleep-related breathing disorders of adult patients suspected of sleep apnea. The device is intended for use in the clinical and home setting under the direction and interpretation by a Healthcare Professional (HCP). | The BioSticker System is a remote monitoring system intended for use by healthcare professionals for continuous collection of physiological data in home and healthcare settings while the patient is at rest. This can include heart rate, respiratory rate, and skin temperature. Data are transmitted via wireless connection from the BioSticker for storage and analysis. The device is intended for use on general care patients who are 21 years of age or older as a general patient monitor, to provide physiological | The Leaf Patient Monitoring System monitors the orientation and activity of patients susceptible to pressure ulcers. It allows healthcare providers to implement individualized turn management plans and continuously monitor each patient. The Leaf Patient Monitoring System provides alerts when patient orientation or activity deviates from parameters set by healthcare providers. The device is intended for use in medical, nursing, and long-term care facilities, including independent living, assisted-living and rehabilitation facilities. | The Eclipse MINI Model 98900 is a portable non-invasive continuous ambulatory ECG patch recorder intended to record the patient's electrocardiogram. The recorder is intended to be used by either paediatric or adult patients suspected of cardiac arrhythmias in either a clinical setting or at home. The recorder does no cardiac analysis and is used with Spacelabs Ambulatory ECG Analysis Software. | Similar The subject device utilizes the same sensors and algorithms for the calculation of SpO2 and pulse rate as the reference device, ANNE Sleep. The subject device is compatible with an optional, FDA-cleared third-party device for NIBP monitoring. Ambulatory ECG heart rate monitoring is supported by performance testing to consensus standards as well as the K212317 reference device. Monitoring of body position for turn management in patients susceptible to pressure ulcers with the subject device is supported by the Leaf reference device. The differences do | {8}------------------------------------------------ {9}------------------------------------------------ | pressure, SpO2, pulse rate, and body temperature measurements. The device is indicated for monitoring ECG waveforms and heart rate on ambulatory patients. The device is not intended to monitor or measure respiratory rate, SpO2, pulse rate, or noninvasive blood pressure while the patient undergoes significant motion or is active. | device is not intended to monitor or measure respiratory rate or heart rate on ambulatory patients. | information. The data from the BioSticker System are intended for use by healthcare professionals as an aid to diagnosis and treatment. The device is not intended to measure physiological parameters while the patient undergoes significant motion or is active. The device is not intended for use on critical care patients. | | not affect safety or effectiveness. | |-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--|----------------------------------------| | ANNE One continuously monitors the orientation of patients to aid in the prevention of pressure ulcers for at-risk patients. The system provides visual notification when the patient's position has not | | | | | {10}------------------------------------------------ | | | | | | | | | | | | | | | | target population is supported by the Eclipse Mini reference device. Safety and effectiveness of RR monitoring in the adolescent subpopulation is demonstrated through the extrapolation of adult clinical data. | |----------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------|----------------------------------------------------|-------------------------------------------------------|------------------------------|---------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------|---------------------------------|------------------------|------------------------------------------------------------------------------------------------------------------------|------------------------------------|-------------------------------------------------------|-------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | | changed from a preset threshold of time. The device is intended for use on general care patients who are 12 years of age or older as a general patient monitor to provide continuous physiological information as an aid to diagnosis and treatment. The data from ANNE One are transmitted wirelessly for display, storage, and analysis. The device is not intended for use on critical care patients. | | | | | | | Use Environment | Home and healthcare settings | Healthcare settings | Recording in the home environment with the report and interpretation performed in the clinical setting. | Home and healthcare settings | Medical, nursing, and long-term care facilities | Clinical and home | Equivalent | | Target Population | 12 years of age and older | 18 years of age and older | 22 years of age and older | 21 years of age or older | 18 years of age and older | Pediatric and adult | Similar The subject device's target population includes adolescents aged 12 to 17. Safety and effectiveness in this population is established through literature. ECG monitoring in the | Sensor Placement | Finger and Chest | Finger and Chest | Finger and Chest | Chest | Chest | Chest | Equivalent | | Heart Rate | 30-300 bpm (the greater of ± 10% or ± 5 bpm) | 30 - 270 bpm (the greater of ± 10% or ± 5bpm) | 30-300 bpm (the greater of ± 10% or ± 5 bpm) | 40-125 bpm (<± 5 beats per minute) | N/A | N/A | Equivalent | | | | | | | | | | Respiratory Rate | Accelerometer-derived 8 - 30 bpm (± 3 bpm MAE) | ECG-derived 8 - 35 bpm (± 3 bpm RMSE) | N/A | Accelerometer-derived 10 - 30 bpm (± 3 bpm MAE) | N/A | N/A | Equivalent The range and accuracy of RR is supported by the K211305 predicate device and the K191614 reference. The use of accelerometer-derived RR is supported by the K191614 reference device. | | | | | | | | | {11}------------------------------------------------ {12}------------------------------------------------ | Skin Temperature | 73.4°F - 109.4°F (±0.54°F) 23°C - 43°C (±0.3°C) | 73.4°F - 109.4°F (±0.54°F) 23°C - 43°C (±0.3°C) | N/A | 86°F - 107.6°F (30°C - 42°C) < 96.4°F ± 0.5°F (< 35.8°C ± 0.3°C) 96.4°F to 98°F ± 0.3°F (35.8°C to 37°C ± 0.2°C) 98°F to 102°F ± 0.2°F (37°C to 39°C ± 0.1°C) 102°F to 106°F ± 0.3°F (39°C to 41°C ± 0.2°C) > 106°F ± 0.5°F (> 41°C ± 0.3°C) | N/A | N/A | Equivalent | |--------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Body Temperature | ± 0.05°C ( ± 0.1°F ) during 35.00°C ~38.00°C (95.00°F ~100.40°F) ± 0.1°C (± 0.2°F ) during T<35.00°C (95.00°F) or T>38.00°C (100.40°F) | 93.2°F - 109.4°F (±0.54°F) 34°C - 43°C (±0.3°C) | N/A | N/A | N/A | N/A | Different The subject device may be used with a third-party, FDA-cleared thermometer for spot-check body temperature. | | SpO2 | ARMS ≤ 3% (range 70-100%) | N/A | ARMS ≤ 3% (range 70-100%) | N/A | N/A | N/A | Equivalent | | Pulse Rate | 30-300 bpm (the greater of ± 10% or ± 5 bpm) | N/A | 30-300 bpm (the greater of ± 10% or ± 5 bpm) | N/A | N/A | N/A | Equivalent | | Activity | Accelerometer | Accelerometer | Accelerometer | Accelerometer | Accelerometer | N/A | Equivalent | | Posture | Body Position Fall Detection | Fall Count | Body Position | Body Position | Body Position | N/A | Equivalent | | Non-Inv asive Blood Pressur e (NIBP) | 0 - 300 mmHg (± 3 mmHg) | N/A | N/A | N/A | N/A | N/A | Different The subject device may be used with an FDA cleared BP monitor. | | ECG Wavefor m Displ…

ANNE One

Device Facts

Intended Use

Device Story

Clinical Evidence

Technological Characteristics

Indications for Use

Regulatory Classification

Identification

Predicate Devices

Reference Devices

Related Devices

Submission Summary (Full Text)

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Device Story

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