ANNE Pediatric is a wireless vital signs and physiological data monitoring platform indicated for the measurement of heart rate, skin temperature, and body temperature by qualified healthcare professionals in healthcare settings. The device is intended for use on neonatal patients of any gestational age up to infants 2 years of age as a general patient monitor to provide continuous physiological information as an aid to diagnosis and treatment. The device is not intended to monitor critically ill patients. The device is not intended to monitor or measure heart rate during motion. The device is not an apnea alarm.

Device Description

ANNE Pediatric is a wireless vital signs and physiological data monitoring platform that collects electrocardiography (ECG) and temperature biosignals to measure vital signs such as heart rate (HR), skin temperature, and body temperature. The system features two skin-mounted, bio-integrated sensors that pair with the ANNE View application for the display of real-time vital measurements. Data is transmitted wirelessly from the sensors via Bluetooth to the mobile device.

AI/ML Overview

Here's an analysis of the acceptance criteria and the study proving the device meets them, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria for Heart Rate (HR) measurement are explicitly stated within the text as defined by IEC 60601-2-27. While the general standard is mentioned, the specific performance requirement is a tolerance of ±10% or ±5 bpm, whichever is greater.

Acceptance Criteria (IEC 60601-2-27)	Reported Device Performance (ANNE Pediatric)	Measurement
±10% or ±5 bpm (whichever is greater)	Normalized Root Mean Square Deviation (RMSD) = 1.2%	Heart Rate

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

Sample Size for Test Set (Clinical Data for HR):
- Total neonates assessed: n=137
- Neonates included in the final closed-label round for HR analysis: n=20
- Neonates included in the overall HR analysis (across multiple rounds): n=70
Data Provenance: Clinical data was collected in Nairobi, Kenya at Aga Khan University, a tertiary healthcare facility. The study appears to be prospective as it involved assessing the functionality and performance of the ANNE Pediatric system in "n=137 neonates."

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

The document does not explicitly state the number of experts used or their specific qualifications for establishing ground truth. However, it indicates that the comparison was made against the Masimo Rad-97, which is a widely accepted medical device for physiological monitoring. This implies that the Masimo Rad-97 served as the reference standard, or "ground truth," rather than human expert interpretation of raw data.

4. Adjudication Method for the Test Set

The document mentions "one open label and three closed-label rounds" without detailing specific adjudication methods like 2+1 or 3+1. Given that the ground truth was a reference device (Masimo Rad-97), a traditional adjudication method for human interpretation would not be applicable. The "closed-label" rounds likely refer to blinding the assessors to the ANNE Pediatric output during data collection or analysis against the reference device.

5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was Done

No, an MRMC comparative effectiveness study was not done. The study detailed is a performance assessment of the device against a predicate device for heart rate measurement. There is no mention of human readers or AI assistance.

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

Yes, the described clinical study for heart rate measurement is a standalone performance assessment of the ANNE Pediatric device. It compares the device's output (presumably from its algorithms) directly against a reference medical device (Masimo Rad-97). There is no mention of human-in-the-loop performance in this specific clinical study.

7. The Type of Ground Truth Used

The ground truth used for heart rate measurement was established by a reference medical device, specifically the Masimo Rad-97.

8. The Sample Size for the Training Set

The document does not provide information regarding the sample size used for the training set. The clinical data described is explicitly for performance assessment/testing.

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

Since information regarding the training set and its sample size is not provided, the method for establishing its ground truth is also not available in this document.

Summary

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November 22, 2022

Sibel Inc. Sarah Coughlin OARA Engineer 6650 W. Touhy Ave. Niles, Illinois 60714

Re: K221530

Trade/Device Name: ANNE Pediatric Regulation Number: 21 CFR 870.29870.2910 Regulation Name: Radiofrequency physiological signal transmitter and receiver Regulatory Class: Class II Product Code: DRG, MWI, FLL Dated: Mav 23, 2022 Received: May 26, 2022

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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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

Indications for Use

510(k) Number (if known)

K221530

Device Name ANNE Pediatric

Indications for Use (Describe)

ANNE Pediatric is a wireless vital signs and physiological data monitoring platform indicated for the measurement of heart rate, skin temperature by qualified healthcare professionals in healthcare settings. The device is intended for use on neonatal patients of any gestational age up to infants 2 years of age as a general patient monitor to provide continuous physiological information as an aid to diagnosis and treatment. The device is not intended to monitor critically ill patients. The device is not intended to monitor or measure heart rate during motion. The device is not an apnea alarm.

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 Inc. 6650 W. Touhy Avenue, Niles, IL 60714 Tel: (224) 251-8859

Official Correspondent: Sarah Coughlin, Senior Regulatory Affairs and Quality Assurance Engineer 6650 W. Touhy Avenue, Niles, IL 60714 Tel: (224) 251-8859

Date Prepared: 10/7/2022

II. Device Information

Name of Device: ANNE Pediatric

510(k) Number: K221530

Common or Usual Name: Wireless Remote Monitoring System

Classification Name: Radiofrequency Physiological Signal Transmitter and Receiver

Review Panel: Cardiovascular

Regulation: 21 CFR §870.2910

Regulatory Class: Class II

Product Classification Code: DRG, MWI, FLL

. Predicate Device

Trade Name: ANNE One Predicate 510(k): K211305 Predicate device manufacturer: Sibel Inc.

IV. Device Description

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V. Indications for Use

	Subject deviceANNE Pediatric	Predicate deviceSibel Inc.	Variances/Equivalence
Trade Name	ANNE Pediatric	ANNE One
Class	II	II	Equivalent
Product Code	DRG, MWI, FLL	DRG, MWI, FLL	Equivalent
RegulationNumber and Name	870.2910Transmitters andReceivers, PhysiologicalSignal, Radiofrequency	870.2910Transmitters andReceivers, PhysiologicalSignal, Radiofrequency	Equivalent
Indications for Use	ANNE Pediatric is awireless vital signs andphysiological datamonitoring platformindicated for themeasurement of heartrate, skin temperature,and body temperature byqualified healthcareprofessionals inhealthcare settings. Thedevice is intended foruse on neonatal patientsof any gestational age upto infants 2 years of ageas a general patientmonitor to providecontinuous physiologicalinformation as an aid todiagnosis and treatment.The device is notintended to monitorcritically ill patients. Thedevice is not intended tomonitor or measureheart rate during motion.The device is not anapnea alarm.	ANNE One is a wirelessvital signs andphysiological datamonitoring platformindicated for themeasurement of heartrate, respiratory rate,step count, fall count,skin temperature, andbody temperature byqualified healthcareprofessionals inhealthcare settings. Thedevice is intended foruse on general carepatients who are 18years of age or older asa general patient monitorto provide continuousphysiological informationas an aid to diagnosisand treatment. Thedevice is not intended foruse on critical carepatients. The device isnot intended to monitoror measure respiratoryrate or heart rate onambulatory patients.	SubstantiallyEquivalent
Target Population	Neonates and infants upto 2 years of age	Adults, 18 years of ageand older	Different
Use Environment	Healthcare Settings	Healthcare Settings	Equivalent
Sensor Placement	Chest and Foot	Chest and Finger	SubstantiallyEquivalent
Data	Data transmittedwirelessly via Bluetoothfrom sensors to mobiledevice	Data transmittedwirelessly via Bluetoothfrom sensors to mobiledevice	Equivalent
Notification	No notification ability	No notification ability	Equivalent
Heart Rate	Yes	Yes	Equivalent
Skin Temperature	Yes	Yes	Equivalent
Body Temperature	Yes	Yes	Equivalent
Respiratory Rate	No	Yes	Different
Step Count	No	Yes	Different
Fall Count	No	Yes	Different

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VI. Clinical Data

The functionality and performance of the ANNE Pediatric system was assessed in n=137 neonates at Aga Khan University, a tertiary healthcare facility in Nairobi, Kenya. The study compared the performance of HR measurements with ANNE Pediatric against the Masimo Rad-97 in one open label and three closed-label rounds with n=70 neonates. Median gestational age of neonates included in HR analysis was 38 (range 25 to 42) weeks. The HR analysis cohort was 44.7% female, 52.9% male, and 1.4% intersex. The normalized root mean square deviation (RMSD) in the final closed-label round of testing with n=20 neonates was 1.2%, meeting the accuracy requirement of ±10% or ±5bpm, whichever is greater, defined in IEC 60601-2-27. No adverse events or skin injuries were reported during the study.

VII. Performance Data

The following consensus standards and bench testing were used to evaluate the safety and effectiveness of ANNE Pediatric:

Electrical safety and electromagnetic compatibility testing according to ANSI/AAMI ES60601-1:2005/(R)2012 and IEC 60601-1-2:2014 standards.
. 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. ●
Defibrillation testing according to Section 8.5.5 of ANSI/AAMI ES60601-1:2005/(R)2012 ●

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. 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.
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.
o Usability testing in accordance with the FDA guidance document, Applying Human Factors and Usability Engineering to Medical Devices
Performance testing of body temperature measurements according to ISO 80601-2-56:2017.
0 Performance testing of heart rate measurements according to Sections 201.12.1.101.15 and 201.12.1.101.17 of IEC 60601-2-27:2011.
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 guidance document, Off-The-Shelf Software Use in Medical Devices

VIII. Conclusion

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

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).