The ANNE Limb Sensor is a pulse oximeter intended for continuous monitoring of functional oxygen saturation of arterial hemoglobin (SpO2), pulse rate, and skin temperature. The ANNE Limb Sensor is not intended to monitor or measure SpO2 or pulse rate while the patient undergoes significant motion or is active. The ANNE Limb Sensor communicates with compatible software applications for the display, storage, and analysis of data. The device is indicated for use 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 Description

The ANNE Limb sensor is a wearable, bio-integrated sensor that collects real-time biosignals including photoplethysmography (PPG) and temperature. The ANNE Limb sensor has on-device processing of raw data for the calculation of SpO2 and pulse rate. The sensor communicates via Bluetooth to the Sibel SDK, which may be integrated within software applications for the display and storage of data.

AI/ML Overview

The provided text describes the acceptance criteria and study proving the ANNE Limb device meets these criteria, specifically for SpO2 accuracy.

1. Table of acceptance criteria and reported device performance

Parameter	Acceptance Criteria (Standard)	Reported Device Performance (ANNE Limb)
SpO2 Accuracy	ARMS ≤ 3% (range 70-100%)	2.31% (range 70-100%)
Pulse Rate	30-300 bpm (±3 bpm RMSE)	Not explicitly reported, but "Equivalent" to predicate
Skin Temperature	73.4°F - 109.4°F (±0.54°F) / 23°C - 43°C (±0.3°C)	Not explicitly reported, but "Equivalent" to predicate

2. Sample size used for the test set and the data provenance

Sample Size: n=12 healthy subjects.
Data Provenance: The text does not explicitly state the country of origin but implies a clinical study, which is typically prospective. It mentions "Enrolled subjects had skin tones varying from Fitzpatrick 2-5, with two subjects having darker skin pigmentation (Fitzpatrick 5)", indicating a controlled and prospective enrollment.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Not applicable for this study. The ground truth for SpO2 accuracy was established through blood gas analysis, a direct physiological measurement, not expert consensus reading of images or other data.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set

Not applicable. Ground truth was established by blood gas analysis.

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. This study focused on the ANNE Limb device's standalone performance for physiological measurements (SpO2, pulse rate, skin temperature) rather than AI assistance to human readers for interpretation.

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

Yes, the study described in section "VII. Clinical Studies" on page 4 evaluates the "SpO2 Accuracy" of the ANNE Limb device as a standalone measurement, comparing it to blood gas analysis.

7. The type of ground truth used

The ground truth for SpO2 accuracy was established by blood gas analysis.

8. The sample size for the training set

The document does not specify a training set for the current device's SpO2 accuracy evaluation. The clinical study described appears to be a validation study for the device's performance, not a training phase for a learning algorithm.

9. How the ground truth for the training set was established

Not applicable, as a training set for a learning algorithm is not mentioned in the context of this specific SpO2 accuracy study. The device's SpO2 and pulse rate calculations involve on-device processing of raw PPG data, suggesting a more traditional signal processing and algorithmic approach as opposed to a deep learning model requiring a large labeled training dataset. The device leverages the "same sensor and algorithms for the calculation of SpO2, pulse rate, and skin temperature as the Limb Sensor of the predicate device, ANNE One," implying that any model training would have occurred during the development of the predicate device and is not detailed here.

Summary

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May 28, 2024

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

Re: K240305

Trade/Device Name: ANNE Limb Regulation Number: 21 CFR 870.2700 Regulation Name: Oximeter Regulatory Class: Class II Product Code: DQA, FLL Dated: Mav 7, 2024 Received: May 7, 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 (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

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Indications for Use

Submission Number (if known)

K240305

Device Name

ANNE Limb

Indications for Use (Describe)

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: (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: 04/26/2024

. Device Information

Name of Device: ANNE Limb 510K Number: K240305 Classification Name: Oximeter Regulation: 21 CFR §870.2700 Regulatory Class: Class II

Product Classification Code: DQA, FLL

III. Predicate Device

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

IV. Device Description

V. Indications for Use

The ANNE Limb Sensor is a pulse oximeter intended for continuous monitoring of functional oxygen saturation of arterial hemoglobin (SpO2), pulse rate, and skin temperature. The ANNE

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Limb Sensor is not intended to monitor or measure SpO2 or pulse rate while the patient undergoes significant motion or is active. The ANNE Limb Sensor communicates with compatible software applications for the display, storage, and analysis of data. The device is indicated for use 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 safety and performance of ANNE Limb:

. Electrical safety and electromagnetic compatibility testing according to ANSI/AAMI ES60601-1:2005/(R)2012 and IEC 60601-1-2 Edition 4.0 2014 standards. Electrical safety testing in the home healthcare environment per IEC 60601-1-11:2015.
. Biocompatibility testing according to 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 quidance 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.
. Shelf life testing of the adhesive to demonstrate safety and 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 Enqineering to Medical Devices.
. Performance testing of pulse rate and skin temperature.
. Cybersecurity evaluation according to the FDA quidance document. Cybersecurity in Medical Devices: Quality System Considerations and Content of Premarket Submissions

VII. 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 (ARMS) was 2.31%, meeting the requirements of the above-mentioned standard.

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VIII. Conclusion

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

Subject deviceSibel Health Inc.	Predicate deviceSibel Health Inc.	Variances / Equivalence
Trade Name	ANNE Limb	ANNE One
510(k) Number		K223711
Class	II	II	Equivalent
Product Code	DQA, FLL	DRG, DQA, FLL, KMI, MWI,MWJ	SimilarThe MWJ, MWI, KMI, andDRG product codes representfunctionalities supported by theANNE One predicate devicethat are not part of theintended use of the subjectdevice.Both devices share the DQAand FLL product codes.
RegulationNumber andRegulationName	870.2700Oximeter	870.2910Transmitters and Receivers,Physiological Signal,Radiofrequency	DifferentThe primary product codes aredifferent. The predicate devicealso has the DQA product codefor oximetry.
Indications forUse	The ANNE Limb Sensor is apulse oximeter intended forcontinuous monitoring offunctional oxygen saturation ofarterial hemoglobin (SpO2),pulse rate, and skintemperature. The ANNE LimbSensor is not intended tomonitor or measure SpO2 orpulse rate while the patientundergoes significant motion oris active. The ANNE LimbSensor communicates withcompatible softwareapplications for the display,storage, and analysis of data.The device is indicated for useas an aid to diagnosis andtreatment by healthcareprofessionals in general carepatients who are 12 years ofage or older in clinical and	ANNE One is a wirelessmonitoring platform indicatedfor the measurement ofelectrocardiography (ECG)waveforms, heart rate,respiratory rate, functionaloxygen saturation of arterialhemoglobin (SpO2), pulse rate,activity, body position, falldetection, skin temperature,and body temperature byqualified healthcareprofessionals in home andhealthcare settings. ANNE Oneis compatible with third-party,FDA-cleared devices fornoninvasive blood pressure,SpO2, pulse rate, and bodytemperature measurements.The device is indicated formonitoring ECG waveformsand heart rate on ambulatory	SimilarThe subject device utilizes thesame sensor and algorithmsfor the calculation of SpO2,pulse rate, and skintemperature as the LimbSensor of the predicate device,ANNE One. The ANNE Onepredicate had additionaloutputs including ECG, heartrate, respiratory rate, and bodyposition. This difference doesnot affect the substantialequivalence of the outputparameters indicated for use inthe subject device.
	home environments. Thedevice is not intended for useon critical care patients.	patients. The device is notintended to monitor or measurerespiratory rate, SpO2, pulserate, or noninvasive bloodpressure while the patientundergoes significant motion oris active.ANNE One continuouslymonitors the orientation ofpatients to aid in the preventionof pressure ulcers for at-riskpatients. The system providesvisual notification when thepatient's position has notchanged from a presetthreshold of time.The device is intended for useon general care patients whoare 12 years of age or older asa general patient monitor toprovide continuousphysiological information as anaid to diagnosis and treatment.The data from ANNE One aretransmitted wirelessly fordisplay, storage, and analysis.The device is not intended foruse on critical care patients.
TargetPopulation	12 years of age and older	12 years of age and older	Equivalent
UseEnvironment	Home and healthcare settings	Home and healthcare settings	Equivalent
Reprocessing	Reusable on multiple patients.	Reusable on a single patient.	SimilarThe subject device is reusableon multiple patients. Validationof the cleaning process andmechanical testingdemonstrate that thisdifference does not impactsubstantial equivalence.
SensorPlacement	Finger	Finger and Chest	SimilarPlacement of the ANNE Limbsensor on the finger is thesame between the subject andpredicate devices. Thepredicate device includes anadditional sensor, the ANNEChest Sensor, that is worn onthe chest. The ANNE Chestsensor is not part of the scope
			of the subject device.
Heart Rate	Not Applicable	30-270 bpm(the greater of ± 10% or ± 5 bpm)	Not Applicable
RespiratoryRate	Not Applicable	Accelerometer-derived8 - 30 bpm(± 3 bpm RMSE)	Not Applicable
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)	Equivalent
SpO2	$A_{RMS}$ ≤ 3% (range 70-100%)	$A_{RMS}$ ≤ 3% (range 70-100%)	Equivalent
Pulse Rate	30-300 bpm (±3 bpm RMSE)	30-300 bpm (±3 bpm RMSE)	Equivalent
Activity	Not Applicable	Accelerometer	Not Applicable
Posture	Not Applicable	Body PositionFall Detection	Not Applicable
Non-InvasiveBlood Pressure(NIBP)	Not Applicable	0 - 300 mmHg(± 3 mmHg)	Not Applicable
Data	Data is transmitted wirelesslyvia Bluetooth from the sensorto the Sibel SDK, which maybe integrated within softwareapplications for the display andstorage of data.	Data is transmitted wirelesslyvia Bluetooth from the sensorsto a mobile device. Data maybe downloaded for laterstorage and analysis.	SimilarThe subject device allowscommunication with compatiblesoftware applications for thedisplay, storage, and analysisof data.
Notification	No notification ability.	Provides visual notification onpatient orientation.	SimilarThe subject device provides avisual notification on patientorientation.

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Regulation Number and Section

§ 870.2700 Oximeter.

(a)
Identification. An oximeter is a device used to transmit radiation at a known wavelength(s) through blood and to measure the blood oxygen saturation based on the amount of reflected or scattered radiation. It may be used alone or in conjunction with a fiberoptic oximeter catheter.(b)
Classification. Class II (performance standards).