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.

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.

AI/ML Overview

Here's an analysis of the acceptance criteria and the studies that prove the device meets them, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

Parameter	Acceptance Criteria	Reported Device Performance	Study Type / Details
Heart Rate	Range: 30-300 bpm	30-300 bpm	Safety and performance testing of ECG per IEC 60601-2-27:2011 and IEC 60601-2-47:2012.
	Accuracy: The greater of ±10% or ± 5 bpm	The greater of ±10% or ± 5 bpm	Safety and performance testing of ECG per IEC 60601-2-27:2011 and IEC 60601-2-47:2012.
Respiratory Rate	Range: 8-30 bpm	8-30 bpm	Clinical Study: Comparison to etCO2
	Accuracy: ±3 bpm (Mean Absolute Error - MAE)	Mean absolute error within ±3 bpm	Clinical Study: Comparison to etCO2
Skin Temperature	Range: 73.4°F - 109.4°F (23°C - 43°C)	73.4°F - 109.4°F (23°C - 43°C)	Performance testing (bench testing implied)
	Accuracy: ±0.54°F (±0.3°C)	±0.54°F (±0.3°C)	Performance testing (bench testing implied)
SpO2	Range: 70-100%	70-100%	Clinical Study: Comparison to blood gas analysis
	Accuracy: ARMS ≤ 3%	ARMS = 2.31%	Clinical Study: Comparison to blood gas analysis
Pulse Rate	Range: 30-300 bpm	30-300 bpm	Safety and performance testing of pulse oximeter per ISO 80601-2-61:2017.
	Accuracy: The greater of ±10% or ± 5 bpm	The greater of ±10% or ± 5 bpm	Safety and performance testing of pulse oximeter per ISO 80601-2-61:2017.
Body Position/Fall Detection	Continuous monitoring, visual notification for unchanged position	Continuous monitoring, visual notification	Performance testing (bench testing implied); supported by reference devices.
Activity	Measurement via Accelerometer	Accelerometer-based	Performance testing (bench testing implied); supported by reference devices.
ECG Waveform Display	Compliant to IEC 60601-2-27 and IEC 60601-2-47	Compliant to IEC 60601-2-27 and IEC 60601-2-47	Safety and performance testing of ECG per IEC 60601-2-27:2011 and IEC 60601-2-47:2012.

Note: The document primarily focuses on demonstrating substantial equivalence to predicate and reference devices, with specific performance values provided for SpO2 and Respiratory Rate from clinical studies. The other parameters are stated to meet relevant standards or are equivalent to predicate/reference device performance.

2. Sample Size Used for the Test Set and Data Provenance

SpO2 Accuracy Study:
- Sample Size: n=12 healthy subjects.
- Data Provenance: Not explicitly stated (e.g., country of origin), but implies a controlled clinical setting. The study is described as "Sibel validated the accuracy...".
- Retrospective/Prospective: Implied prospective as it's a validation study conducted by Sibel.
Respiratory Rate Accuracy Study:
- Sample Size: n=40 healthy adult subjects.
- Data Provenance: Not explicitly stated (e.g., country of origin), but implies a controlled clinical setting. The study is described as "Sibel validated the accuracy...".
- Retrospective/Prospective: Implied prospective as it's a validation study conducted by Sibel.
Other Parameters: For other parameters like Heart Rate, ECG waveform display, Activity, etc., "performance testing" and adherence to "consensus standards" are mentioned, but specific sample sizes for these test sets are not provided in this summary. The comparison table also mentions "ambulatory databases" for ECG during motion, but no sample size is given.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of those Experts

SpO2 Accuracy Study: Ground truth was established by "blood gas analysis." This typically involves laboratory analysis, not expert consensus on visual assessment.
Respiratory Rate Accuracy Study: Ground truth was established by "etCO2" (end-tidal CO2). This is a physiological measurement, not an expert consensus.
Other Parameters: No information is provided regarding experts or their qualifications for establishing ground truth for other parameters. Ground truth for these values would likely derive from established measurement techniques compliant with the referenced standards.

4. Adjudication Method for the Test Set

Given that the ground truth for SpO2 and Respiratory Rate relied on objective physiological measurements (blood gas analysis and etCO2, respectively), there was likely no "adjudication method" in the sense of reconciling disagreements between multiple graders or clinicians. The measurements themselves serve as the ground truth.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

No MRMC comparative effectiveness study involving human readers and AI assistance is mentioned in the provided text. The device is a "wireless monitoring platform" for physiological measurements. Its primary function is to collect and display vital sign data, not to interpret complex medical images or data that typically require a human reader for adjudication or enhancement by AI.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done

Yes, the performance data provided for SpO2 and Respiratory Rate are standalone algorithm capabilities. The device measures these parameters and the reported accuracy is the algorithm's performance against a reference standard, without human intervention in the measurement or calculation process. The description of "automated computation of heart rate through QRS identification using the well-known Pan-Tompkins beat detection algorithm" also indicates a standalone algorithmic function.

7. The Type of Ground Truth Used

SpO2: Blood gas analysis (objective physiological measurement).
Respiratory Rate: EtCO2 (objective physiological measurement).
Heart Rate: Implied to be derived from ECG signals, with validation against established standards (e.g., IEC 60601-2-27, IEC 60601-2-47), which would use a recognized reference for HR. The Pan-Tompkins algorithm is for beat detection, which is then used to compute HR.
Other Parameters (Skin Temperature, Body Position, Activity, ECG Waveform Display, Pulse Rate): Ground truth is likely established through a combination of physical reference measurements and adherence to recognized consensus standards (e.g., ISO, IEC). Bench testing is mentioned for several parameters.

8. The Sample Size for the Training Set

The document does not explicitly state the sample size for any training set for machine learning models. The device description mentions the use of "the well-known Pan-Tompkins beat detection algorithm" for heart rate, which is a classical signal processing algorithm and may not require a 'training set' in the modern machine learning sense. While algorithms are likely involved in respiratory rate and SpO2 calculations, the summary focuses on validation, not the development or training phase.

9. How the Ground Truth for the Training Set Was Established

As training set information is not provided, the method for establishing its ground truth is also not detailed.

Summary

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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

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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

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Indications for Use

510(k) Number (if known) K223711

Device Name ANNE One

Indications for Use (Describe)

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

-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

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Trade Name: Eclipse Mini 510(k): K212317 Device Manufacturer: Spacelabs

V. Device Description

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.

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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

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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.

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	Subject deviceSibel Health Inc.	Predicate deviceSibel Health Inc.	Reference deviceSibel Health Inc.	Reference deviceBioIntelliSense Inc.	Reference DeviceLeaf Healthcare, Inc.	Reference DeviceSpacelabs	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	SimilarThe DQA product code for theoximeter is supported by theANNE Sleep reference device.The MWJ product code forambulatory ECG monitoring withoutanalysis is supported by safetyand performance testing toconsensus standards as well asthe K212317 reference. The KMIproduct code for bed-patientmonitoring is supported by theLeaf Patient Monitoring Systemreference device.
Regulati	870.2910	870.2910	868.2375	870.2910	880.2400	870.2800	Equivalent
onNumberandRegulationName	Transmitters andReceivers,PhysiologicalSignal,Radiofrequency	Transmitters andReceivers,PhysiologicalSignal,Radiofrequency	BreathingFrequency Monitor	Transmitters andReceivers,PhysiologicalSignal,Radiofrequency	Bed-patientMonitor	Medical magnetictape recorder
Indications forUse	ANNE One is awireless monitoringplatform indicatedfor themeasurement ofelectrocardiography (ECG)waveforms, heartrate, respiratoryrate, functionaloxygen saturationof arterialhemoglobin(SpO2), pulse rate,activity, bodyposition, falldetection, skintemperature, andbody temperatureby qualifiedhealthcareprofessionals inhome andhealthcaresettings. ANNEOne is compatiblewith third-party,FDA-cleareddevices fornoninvasive blood	ANNE One is awireless vitalsigns andphysiological datamonitoringplatform indicatedfor themeasurement ofheart rate,respiratory rate,step count, fallcount, skintemperature, andbody temperatureby qualifiedhealthcareprofessionals inhealthcaresettings. Thedevice is intendedfor use on generalcare patients whoare 18 years ofage or older as ageneral patientmonitor to providecontinuousphysiologicalinformation as anaid to diagnosisand treatment.The device is notintended for useon critical carepatients. The	ANNE Sleep is awearable sensorsystem intendedfor use in thecollection,analysis, display,and storage ofphysiologicalparameters to aidin the evaluationof sleep-relatedbreathingdisorders of adultpatientssuspected ofsleep apnea. Thedevice is intendedfor use in theclinical and homesetting under thedirection andinterpretation by aHealthcareProfessional(HCP).	The BioStickerSystem is aremote monitoringsystem intendedfor use byhealthcareprofessionals forcontinuouscollection ofphysiological datain home andhealthcaresettings while thepatient is at rest.This can includeheart rate,respiratory rate,and skintemperature. Dataare transmitted viawirelessconnection fromthe BioSticker forstorage andanalysis.The device isintended for useon general carepatients who are21 years of age orolder as a generalpatient monitor, toprovidephysiological	The Leaf PatientMonitoring Systemmonitors theorientation andactivity of patientssusceptible topressure ulcers. Itallows healthcareproviders toimplementindividualized turnmanagementplans andcontinuouslymonitor eachpatient. The LeafPatient MonitoringSystem providesalerts whenpatient orientationor activity deviatesfrom parametersset by healthcareproviders. Thedevice is intendedfor use in medical,nursing, andlong-term carefacilities, includingindependentliving,assisted-living andrehabilitationfacilities.	The Eclipse MINIModel 98900 is aportablenon-invasivecontinuousambulatory ECGpatch recorderintended to recordthe patient'selectrocardiogram.The recorder isintended to beused by eitherpaediatric or adultpatientssuspected ofcardiacarrhythmias ineither a clinicalsetting or at home.The recorder doesno cardiacanalysis and isused withSpacelabsAmbulatory ECGAnalysis Software.	SimilarThe subject deviceutilizes the samesensors andalgorithms for thecalculation of SpO2and pulse rate asthe referencedevice, ANNESleep. The subjectdevice iscompatible with anoptional,FDA-clearedthird-party devicefor NIBPmonitoring.Ambulatory ECGheart ratemonitoring issupported byperformancetesting toconsensusstandards as wellas the K212317reference device.Monitoring of bodyposition for turnmanagement inpatients susceptibleto pressure ulcerswith the subjectdevice is supportedby the Leafreference device.The differences do

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pressure, SpO2,pulse rate, andbody temperaturemeasurements.The device isindicated formonitoring ECGwaveforms andheart rate onambulatorypatients. Thedevice is notintended to monitoror measurerespiratory rate,SpO2, pulse rate,or noninvasiveblood pressurewhile the patientundergoessignificant motionor is active.	device is notintended tomonitor ormeasurerespiratory rate orheart rate onambulatorypatients.	information. Thedata from theBioSticker Systemare intended foruse by healthcareprofessionals asan aid todiagnosis andtreatment.The device is notintended tomeasurephysiologicalparameters whilethe patientundergoessignificant motionor is active. Thedevice is notintended for useon critical carepatients.		not affect safety oreffectiveness.
ANNE Onecontinuouslymonitors theorientation ofpatients to aid inthe prevention ofpressure ulcers forat-risk patients.The systemprovides visualnotification whenthe patient'sposition has not

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															target population issupported by theEclipse Minireference device.Safety andeffectiveness of RRmonitoring in theadolescentsubpopulation isdemonstratedthrough theextrapolation ofadult clinical data.
	changed from apreset threshold oftime.The device isintended for use ongeneral carepatients who are12 years of age orolder as a generalpatient monitor toprovide continuousphysiologicalinformation as anaid to diagnosisand treatment. Thedata from ANNEOne aretransmittedwirelessly fordisplay, storage,and analysis. Thedevice is notintended for use oncritical carepatients.							UseEnvironment	Home andhealthcare settings	Healthcaresettings	Recording in thehome environmentwith the report andinterpretationperformed in theclinical setting.	Home andhealthcaresettings	Medical, nursing,and long-termcare facilities	Clinical and home	Equivalent
TargetPopulation	12 years of ageand older	18 years of ageand older	22 years of ageand older	21 years of age orolder	18 years of ageand older	Pediatric and adult	SimilarThe subjectdevice's targetpopulation includesadolescents aged12 to 17. Safetyand effectiveness inthis population isestablished throughliterature. ECGmonitoring in the	SensorPlacement	Finger and Chest	Finger and Chest	Finger and Chest	Chest	Chest	Chest	Equivalent
HeartRate	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 perminute)	N/A	N/A	Equivalent
Respiratory Rate	Accelerometer-derived8 - 30 bpm(± 3 bpm MAE)	ECG-derived8 - 35 bpm(± 3 bpm RMSE)	N/A	Accelerometer-derived10 - 30 bpm(± 3 bpm MAE)	N/A	N/A	EquivalentThe range andaccuracy of RR issupported by theK211305 predicatedevice and theK191614reference. The useofaccelerometer-derived RR issupported by theK191614 referencedevice.

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SkinTemperature	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 to37°C ± 0.2°C)98°F to 102°F ±0.2°F (37°C to39°C ± 0.1°C)102°F to 106°F ±0.3°F (39°C to41°C ± 0.2°C)> 106°F ± 0.5°F(> 41°C ± 0.3°C)	N/A	N/A	Equivalent
BodyTemperature	± 0.05°C ( ± 0.1°F ) during35.00°C ~38.00°C(95.00°F~100.40°F) ±0.1°C (± 0.2°F )duringT<35.00°C(95.00°F) orT>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	DifferentThe subjectdevice may beused with athird-party,FDA-clearedthermometer forspot-check bodytemperature.
SpO2	ARMS ≤ 3% (range70-100%)	N/A	ARMS ≤ 3% (range70-100%)	N/A	N/A	N/A	Equivalent
PulseRate	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 PositionFall Detection	Fall Count	Body Position	Body Position	Body Position	N/A	Equivalent
Non-InvasiveBloodPressure (NIBP)	0 - 300 mmHg(± 3 mmHg)	N/A	N/A	N/A	N/A	N/A	DifferentThe subject devicemay be used withan FDA cleared BPmonitor.
ECGWaveformDisplay	Compliant to IEC60601-2-27Compliant to IEC60601-2-47	Continuous ECGwaveformcollection	Continuous ECGwaveformcollection	N/A	N/A	Compliant to IEC60601-2-47	DifferentWhile the K211305predicate devicecollects ECGsignals, thewaveform is notdisplayed on theapplication. Safetyand effectivenessfor the ECGwaveform displayare establishedthrough recognizedconsensusstandards includingIEC 60601-2-27and IEC60601-2-47 as wellas the K212317reference.
ECGSamplingFrequenсу	ECG SamplingFrequency: 512 HzStreamingFrequency: 256 Hz	ECG SamplingFrequency: 512HzStreamingFrequency: 256Hz	ECG SamplingFrequency: 512HzStreamingFrequency: 256Hz	N/A	N/A	Not publiclyavailable	Equivalent
ECGResolution	18 bit	18 bit	18 bit	N/A	N/A	Not publiclyavailable	Equivalent
Data	Data is transmittedwirelessly viaBluetooth from thesensors to amobile device.Data may bedownloaded forlater storage andanalysis.	Data istransmittedwirelessly viaBluetooth from thesensors to amobile device.	Patient data iswirelesslytransferred viaBluetooth from thesensors to amobile phone.Data is thenwirelesslytransferred fromthe phone to thecloud whenconnected to theinternet.	Data istransmittedwirelessly viaBluetooth from thesensor to a mobiledevice for storageand analysis.	Data istransmittedwirelessly via LeafAntennas to amonitoring stationequipped with aUSB RFTransceiver andthe Leaf TurnManagementSoftware.	Data istransmitted fromthe sensor to acomputer with astandard USBcable	SimilarThe subject deviceallows datadownload to themobile device. Thisfunctionality wasverified throughtesting.
Notification	Provides visualnotification onpatient orientation.	No notificationability	No notificationability	No notificationability	Provides alerts onpatient orientation.	N/A	SimilarThe subject deviceprovides a visualnotification onpatient orientation.
Motion	Respiratory rate,SpO2, and pulseratemeasurementsshould not betaken duringmotion.Heart rate andECG may be takenduring motion.	Heart rate andrespiratory ratenot indicated foruse during motion.	Not indicated foruse during motion	Not indicated foruse during motion	N/A	ECG duringmotion.	SimilarBoth the subjectand predicatedevices are notindicated forrespiratory ratemeasurementsduring motion. Thesubject and ANNESleep reference arenot indicated forSpO2 or pulse ratemeasurementsduring motion. TheANNE One deviceis indicated forheart ratemeasurementsduring motion. Thisdifference issupported bytesting on standardambulatory
Measurementmodality	ContinuousMeasurements:Respiratory rate,ECG, heart rate,SpO2, pulse rate,skin temperature,body positionSpot CheckMeasurementswith third partydevices:Blood pressure,body temperature	ContinuousMeasurements:Respiratory rate,heart rate, skintemperature, bodytemperature, bodyposition, stepcount	Continuousmeasurements:SpO2, pulse rate,heart rate,peripheral arterialtonometry, snore,chest movement,body position	Continuousmeasurements:Heart rate,respiratory rate,skin temperature	Continuousmeasurements:Body Position	Continuousmeasurements:ECG	databases asdescribed in IEC60601-2-47.SimilarANNE One and thepredicate K211305display continuousheart rate,respiratory rate,skin temperature,and body position.The ANNE Onesubject device alsostreams continuousECG for display onthe ANNE Viewapplication. Thisdifference isdemonstrated tonot influence safetyor effectivenessthrough testingaccording toconsensusstandards. Thesubject device andANNE Sleepreference includecontinuous SpO2and pulse ratemeasurement fromPPG. The ANNEOne subject devicedoes not includecontinuous bodytemperaturemeasurements, butinstead allowsusers to take spotcheckmeasurements witha standard,FDA-cleared
							third-partythermometer. TheANNE One subjectdevice is alsocompatible with anoptionalFDA-cleared thirdpart blood pressuremonitor for spotcheck NIBPmeasurements.
Monitoring Type	Real timemonitoringData storage forlater analysis	Real timemonitoring	Data storage forlater analysis	Real timemonitoring	Real timemonitoringData storage forlater analysis	Data storage forlater analysis	EquivalentThe subject andpredicate devicescontinuouslystreamphysiological datafor display on theANNE Tablet viaBluetooth. Data isalso stored on thesensors in thesubject device andcan be offloaded tothe ANNE Tablet atthe end of themonitoring session,similar to the ANNESleep referencedevice. The abilityof the device tostream data is notimpacted by thestorage feature.Both real timestreaming andstorage for lateranalysis wereverified in softwaresystem testing.
Alarms	No alarmingcapabilities	No alarmingcapabilities	No alarmingcapabilities	No alarmingcapabilities	No alarmingcapabilities	No alarmingcapabilities	EquivalentANNE One is
	Visual alerts forturn management.				Visual alerts forturn management.		equivalent to theLeaf Healthcarereference device.
ApneaClaims	Not an apneamonitor	Not an apneamonitor	Not an apneamonitor	Not an apneamonitor	Not an apneamonitor	Not an apneamonitor	Equivalent

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Regulation Number and Section

§ 870.2910 Radiofrequency physiological signal transmitter and receiver.

(a)
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.(b)
Classification. Class II (performance standards).