The ANNE View application is intended for the display of physiological data from the ANNE Chest and ANNE Limb devices. The application is also compatible with third-party, FDA-cleared devices for the display of noninvasive blood pressure, SpO2, pulse rate, and body temperature measurements. The ANNE View application notifies healthcare professionals when physiological data fall outside selected parameters. The ANNE View application displays the orientation of patients to aid in the prevention of pressure ulcers for at-risk patients. The system notifies the user when the patient's position has not changed for a preset threshold of time. The ANNE View application communicates to compatible central monitoring platforms, including the Central Hub, for the display and storage of multiple patients' physiological data. The Central Hub has the ability to notify healthcare professionals when physiological data fall outside selected parameters.

The ANNE View and Central Hub are intended for use by trained, qualified healthcare professionals in the clinical or home healthcare environment. The device is not intended for use on critical care patients.

Device Description

The ANNE View application is a bedside patient monitoring device that receives vital signs and physiological data from compatible devices for display and transmission to the Central Hub. The ANNE View application operates on the ANNE Tablet. When connected to the ANNE Chest Sensor, the ANNE View application displays electrocardiography (ECG), skin temperature, heart rate, respiratory rate, and body position data. When connected to the ANNE Limb Sensor, the ANNE View application displays photoplethysmography (PPG), SpO2, pulse rate, and skin temperature data. The ANNE View application is also compatible with optional third-party devices for SpO2, non-invasive blood pressure, and body temperature measurements. The ANNE View application alarms when physiological data are outside of the configured thresholds.

When the ANNE Tablet is connected to Wi-Fi, the vital signs and physiological data are uploaded from the ANNE View application to the Central Hub. The Central Hub allows healthcare professionals to view vitals data from up to 16 beds on one screen and provides storage of up to 48 hours of data from each patient. Alarm conditions are communicated to the Central Hub from the ANNE View application for visual and audio alarms on the Central Hub.

AI/ML Overview

This is a clearance memo for a medical device and does not contain the detailed study information required to answer the prompt. Specifically, it states that "The following consensus standards and bench testing were used to evaluate the safety and effectiveness of ANNE View, Central Hub as compared to the predicate," followed by a list of general standards like electromagnetic compatibility testing, wireless coexistence testing, software verification and validation, usability testing, and cybersecurity evaluation. It also mentions "Verification of the ECG waveform display per IEC 60601-2-27:2011 and IEC 60601-2-47:2012" and "Verification of the alarm system to IEC 60601-1-8:2020," and "Performance evaluation of the HL7 FHIR and IEEE 11073 SDC communication."

However, it does not provide any specific quantitative acceptance criteria or detailed study results that would allow for a table of acceptance criteria vs. reported device performance, nor does it provide information on sample sizes, data provenance, ground truth establishment, expert qualifications, adjudication methods, or MRMC studies.

Therefore, I cannot fulfill the request using only the provided text. The document is a regulatory approval, not a clinical study report.

Summary

{0}------------------------------------------------

Image /page/0/Picture/0 description: The image shows the logo for the U.S. Food & Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services seal on the left and the FDA acronym followed by the full name of the agency on the right. The FDA part of the logo is in blue, with the acronym in a solid blue square and the agency name in a lighter blue. The text reads "FDA U.S. FOOD & DRUG ADMINISTRATION".

January 8, 2025

Sibel Health Inc. Peter Xu Regulatory Affairs Consultant 2017 N Mendell St. Suite 2SE Chicago, Illinois 60614

Re: K242842

Trade/Device Name: ANNE View, Central Hub Regulation Number: 21 CFR 870.2300 Regulation Name: Cardiac Monitor (Including Cardiotachometer And Rate Alarm) Regulatory Class: Class II Product Code: MSX, MWI, KMI, DRG Dated: December 9, 2024 Received: December 9, 2024

Dear Peter Xu:

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"

{1}------------------------------------------------

(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).

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.

All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rue"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-devices/device-advicecomprehensive-regulatory-assistance/unique-device-identification-system-udi-system.

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 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).

{2}------------------------------------------------

Sincerely,

Jennifer W. Shih -S

Jennifer 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

{3}------------------------------------------------

Indications for Use

Submission Number (if known)

K242842

Device Name

ANNE View, Central Hub

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)

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."

{4}------------------------------------------------

510(K) Summary

-Submitter:

Sibel Health Inc. 2017 N Mendell St. Suite 2SE Chicago, IL 60614 Tel: (224) 251-8859

Official Correspondent: Peter Xu, Regulatory Affairs Consultant 2017 N Mendell St. Suite 2SE Chicago, IL 60614 Tel: (224) 251-8859

Date Prepared: 12/06/2024

. Device Information

Name of Device: ANNE View, Central Hub

510K Number: K242842

Classification Name: Cardiac monitor (including cardiotachometer and rate alarm)

Requlation: 21 CFR §870.2300

Regulatory Class: Class II

Product Classification Code: MSX, MWI, KMI, DRG

111. Predicate Device

Primary Predicate

Trade Name: Aulisa Multiple Patient Digital Vital Sign Monitoring System MP1000 510(k): K202497 Device Manufacturer: Taiwan Aulisa Medical Devices Technologies Inc.

Secondary Predicate

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

IV. Device Description

{5}------------------------------------------------

devices for SpO2, non-invasive blood pressure, and body temperature measurements. The ANNE View application alarms when physiological data are outside of the configured thresholds.

V. Indications for Use

The ANNE View application is intended for the display of physiological data from the ANNE Chest and ANNE Limb devices. The application is also compatible with third-party. FDA-cleared devices for the display of noninvasive blood pressure, SpO2, pulse rate, and body temperature measurements. The ANNE View application notifies healthcare professionals when physiological data fall outside selected parameters. The ANNE View application displays the orientation of patients to aid in the prevention of pressure ulcers for at-risk patients. The system notifies the user when the pation has not changed for a preset threshold of time. The ANNE View application communicates to compatible central monitoring platforms, including the Central Hub. for the display and storage of multiple patients' physiological data. The Central Hub has the ability to notify healthcare professionals when physiological data fall outside selected parameters.

VI. Performance Data

The following consensus standards and bench testing were used to evaluate the safety and effectiveness of ANNE View, Central Hub as compared to the predicate:

Electromagnetic compatibility testing according to IEC 60601-1-2:2020. .
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.
Verification of the ECG waveform display per IEC 60601-2-27:2011 and IEC . 60601-2-47:2012.
. Usability testing in accordance with the FDA guidance document, Applying Human Factors and Usability Enqineering to Medical Devices and IEC 62366-1:2020.
Cybersecurity evaluation according to the FDA guidance document, Cybersecurity in Medical Devices: Quality System Considerations and Content of Premarket Submissions
Verification of the alarm system to IEC 60601-1-8:2020.
. Performance evaluation of the HL7 FHIR and IEEE 11073 SDC communication.

{6}------------------------------------------------

VII. Conclusion

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

	Subject DeviceSibel Health Inc.	Primary PredicateDeviceTaiwan AulisaMedical DevicesTechnologies Inc.	SecondaryPredicate DeviceSibel Health Inc	Variances /Equivalences
Trade Name	ANNE View, CentralHub	Aulisa MultiplePatient Digital VitalSign MonitoringSystem MP1000	ANNE One
510(k) Number	K242842	K202497	K223711
Class	II	II	II	Equivalent
Product Code	MSX, MWI, KMI	MSX, MWI	DRG, MWI, FLL,DQA, MWJ, KMI	Equivalent
RegulationNumber andName	870.2300Cardiac monitor(includingcardiotachometerand rate alarm)	870.2300Cardiac monitor(includingcardiotachometerand rate alarm)	870.2910Radiofrequencyphysiological signaltransmitter andreceiver	Equivalent
Indications forUse	The ANNE Viewapplication isintended for thedisplay ofphysiological datafrom the ANNE Chestand ANNE Limbdevices. Theapplication is alsocompatible withthird-party,FDA-cleared devicesfor the display ofnoninvasive bloodpressure, SpO2,pulse rate, and bodytemperaturemeasurements. TheANNE Viewapplication notifieshealthcareprofessionals whenphysiological data falloutside selectedparameters. The	The Aulisa MultiplePatient Digital VitalSign MonitoringSystem, MP1000, isintended to provideremote centralmonitoring anddisplay of informationas recorded bymultiple Aulisasingle-patientmonitoring systems,on a central remotescreen. The systemcan be used in ahospital type andclinic environment.	ANNE One is awireless monitoringplatform indicated forthe measurement ofelectrocardiography(ECG) waveforms,heart rate, respiratoryrate, functionaloxygen saturation ofarterial hemoglobin(SpO2 ), pulse rate,activity, bodyposition, falldetection, skintemperature, andbody temperature byqualified healthcareprofessionals inhome and healthcaresettings. ANNE Oneis compatible withthird-party,FDA-cleared devicesfor noninvasive bloodpressure, SpO2,	EquivalentBoth devices areintended to displayreal-timephysiological data forpatient monitoring byhealthcareprofessionals.
	ANNE Viewapplication displaysthe orientation ofpatients to aid in theprevention ofpressure ulcers forat-risk patients. Thesystem notifies theuser when thepatient's position hasnot changed for apreset threshold oftime. The ANNE Viewapplicationcommunicates tocompatible centralmonitoring platforms,including the CentralHub, for the displayand storage ofmultiple patients'physiological data.The Central Hub hasthe ability to notifyhealthcareprofessionals whenphysiological data falloutside selectedparameters.The ANNE View andCentral Hub areintended for use bytrained, qualifiedhealthcareprofessionals in theclinical or homehealthcareenvironment. Thedevice is notintended for use oncritical care patients.		pulse rate, and bodytemperaturemeasurements. Thedevice is indicated formonitoring ECGwaveforms and heartrate on ambulatorypatients. The deviceis not intended tomonitor or measurerespiratory rate,SpO2, pulse rate, ornoninvasive bloodpressure while thepatient undergoessignificant motion oris active. ANNE Onecontinuouslymonitors theorientation of patientsto aid in theprevention ofpressure ulcers forat-risk patients. Thesystem providesvisual notificationwhen the patient'sposition has notchanged from apreset threshold oftime. The device isintended for use ongeneral care patientswho are 12 years ofage or older as ageneral patientmonitor to providecontinuousphysiologicalinformation as an aidto diagnosis andtreatment. The datafrom ANNE One aretransmitted wirelesslyfor display, storage,and analysis. Thedevice is notintended for use oncritical care patients.
Environment ofUse	Home and healthcaresettings	Hospitals or hospitaltype and clinicenvironment	Home and healthcaresettings	EquivalentThe subject deviceand K223711predicate are bothintended for use inhome and healthcaresettings. Regardlessof environment, all
				three devices areintended to be usedsolely by healthcareprofessionals.
Alarms	Visual and auditoryalarms	Visual and auditoryalarms	No alarming	Equivalent
OperatingSystem	ANNE View - Android14.0Central Hub Desktop- Windows 11	Windows 10	ANNE View - Android8.0 or above	Equivalent
CommunicationMethod	The ANNE Viewapplicationcommunicates withcompatible medicaldevices overBluetooth. TheCentral Hub receivesdata from ANNEView over LAN orWLAN.	LAN and WLAN	The ANNE Viewapplicationcommunicates withcompatible medicaldevices overBluetooth.	Equivalent
Monitoring type	The ANNE Viewapplication providesreal time monitoring.The Central Hubprovides real timemonitoring and datastorage for lateranalysis.	Real time monitoringand data storage.	The ANNE Viewapplication providesreal time monitoringand data storage forlater analysis.	Equivalent
Interoperability	The ANNE Viewapplication isinteroperable with theANNE Chest Sensorand the ANNE LimbSensor. The ANNEView application isalso interoperablewith third partycompatible devicesfor non-invasiveblood pressure,SpO2, pulse rate,and bodytemperaturemonitoring.The ANNE Viewapplication isinteroperable withcentral monitoringplatforms includingthe Central Hub.	The Aulisa MultiplePatient Digital VitalSign MonitoringSystem isinteroperable withAulisa single-patientmonitoring systems.	The ANNE Viewapplication isinteroperable with theANNE Chest Sensorand the ANNE LimbSensor. The ANNEView application isalso interoperablewith third partycompatible devicesfor non-invasiveblood pressure,SpO2, pulse rate,and bodytemperaturemonitoring.	Equivalent

{7}------------------------------------------------

{8}------------------------------------------------

Regulation Number and Section

§ 870.2300 Cardiac monitor (including cardiotachometer and rate alarm).

(a)
Identification. A cardiac monitor (including cardiotachometer and rate alarm) is a device used to measure the heart rate from an analog signal produced by an electrocardiograph, vectorcardiograph, or blood pressure monitor. This device may sound an alarm when the heart rate falls outside preset upper and lower limits.(b)
Classification. Class II (performance standards).