(111 days)
Not Found
No
The description focuses on data display, transmission, and threshold-based alarming, with no mention of AI or ML algorithms for analysis or prediction.
No
The device is described as a patient monitoring system that displays and transmits physiological data and issues notifications when data fall outside selected parameters or when a patient's position hasn't changed. Its primary function is to monitor, not to directly treat or cure a disease or condition.
No
The device is a monitoring system that displays physiological data and provides notifications when data fall outside selected parameters. It alerts healthcare professionals to changes but does not diagnose conditions.
No
The device description explicitly states that the ANNE View application operates on the "ANNE Tablet" and receives data from "ANNE Chest Sensor" and "ANNE Limb Sensor," which are hardware components. The submission also includes testing for electromagnetic compatibility, wireless coexistence, and verification of ECG waveform display, all of which relate to hardware performance.
Based on the provided information, the ANNE View application is not an In Vitro Diagnostic (IVD) device.
Here's why:
- IVD Definition: In Vitro Diagnostics are devices intended for use in the examination of specimens derived from the human body (such as blood, urine, or tissue) to provide information for the diagnosis, prevention, monitoring, treatment, or alleviation of disease or injury.
- ANNE View's Function: The ANNE View application displays and transmits physiological data collected from external sensors (ANNE Chest, ANNE Limb, and third-party devices) that are applied to the patient's body. It monitors vital signs and body position.
- No Specimen Analysis: The description does not mention the collection or analysis of any specimens from the human body. The data is collected directly from the patient's body via sensors.
Therefore, the ANNE View application falls under the category of a patient monitoring device, not an In Vitro Diagnostic device.
N/A
Intended Use / 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 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.
Product codes
MSX, MWI, KMI, DRG
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
trained, qualified healthcare professionals in the clinical or home healthcare environment. The device is not intended for use on critical care patients.
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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.
Key results: 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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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).
0
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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)
Device Name
ANNE View, Central Hub
Indications for Use (Describe)
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.
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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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
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
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.
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.
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.
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.
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 Device
Sibel Health Inc. | Primary Predicate
Device
Taiwan Aulisa
Medical Devices
Technologies Inc. | Secondary
Predicate Device
Sibel Health Inc | Variances /
Equivalences |
|----------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Trade Name | ANNE View, Central
Hub | Aulisa Multiple
Patient Digital Vital
Sign Monitoring
System 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 |
| Regulation
Number and
Name | 870.2300
Cardiac monitor
(including
cardiotachometer
and rate alarm) | 870.2300
Cardiac monitor
(including
cardiotachometer
and rate alarm) | 870.2910
Radiofrequency
physiological signal
transmitter and
receiver | Equivalent |
| 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 | The Aulisa Multiple
Patient Digital Vital
Sign Monitoring
System, MP1000, is
intended to provide
remote central
monitoring and
display of information
as recorded by
multiple Aulisa
single-patient
monitoring systems,
on a central remote
screen. The system
can be used in a
hospital type and
clinic environment. | 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, | Equivalent
Both devices are
intended to display
real-time
physiological data for
patient monitoring by
healthcare
professionals. |
| | 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. | | 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. | |
| Environment of
Use | Home and healthcare
settings | Hospitals or hospital
type and clinic
environment | Home and healthcare
settings | Equivalent
The subject device
and K223711
predicate are both
intended for use in
home and healthcare
settings. Regardless
of environment, all |
| | | | | three devices are
intended to be used
solely by healthcare
professionals. |
| Alarms | Visual and auditory
alarms | Visual and auditory
alarms | No alarming | Equivalent |
| Operating
System | ANNE View - Android
14.0
Central Hub Desktop
- Windows 11 | Windows 10 | ANNE View - Android
8.0 or above | Equivalent |
| Communication
Method | The ANNE View
application
communicates with
compatible medical
devices over
Bluetooth. The
Central Hub receives
data from ANNE
View over LAN or
WLAN. | LAN and WLAN | The ANNE View
application
communicates with
compatible medical
devices over
Bluetooth. | Equivalent |
| Monitoring type | The ANNE View
application provides
real time monitoring.
The Central Hub
provides real time
monitoring and data
storage for later
analysis. | Real time monitoring
and data storage. | The ANNE View
application provides
real time monitoring
and data storage for
later analysis. | Equivalent |
| Interoperability | The ANNE View
application is
interoperable with the
ANNE Chest Sensor
and the ANNE Limb
Sensor. The ANNE
View application is
also interoperable
with third party
compatible devices
for non-invasive
blood pressure,
SpO2, pulse rate,
and body
temperature
monitoring.
The ANNE View
application is
interoperable with
central monitoring
platforms including
the Central Hub. | The Aulisa Multiple
Patient Digital Vital
Sign Monitoring
System is
interoperable with
Aulisa single-patient
monitoring systems. | The ANNE View
application is
interoperable with the
ANNE Chest Sensor
and the ANNE Limb
Sensor. The ANNE
View application is
also interoperable
with third party
compatible devices
for non-invasive
blood pressure,
SpO2, pulse rate,
and body
temperature
monitoring. | Equivalent |
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