(138 days)
No
The document does not mention AI, ML, or any related terms in the device description, intended use, or performance studies. The validation methods described are standard comparisons to reference devices and manual counts, not indicative of AI/ML model training or testing.
No
The device is described as a "wireless vital signs and physiological data monitoring platform" intended for "measurement" and to provide "continuous physiological information as an aid to diagnosis and treatment." It does not mention any therapeutic intervention.
Yes
The "Intended Use / Indications for Use" states that the device is "to provide continuous physiological information as an aid to diagnosis and treatment."
No
The device description explicitly lists multiple hardware components (ANNE Tablet, ANNE Chest Sensor, ANNE Limb Sensor, ANNE Wireless Charger) in addition to the software application.
Based on the provided information, the ANNE One device is not an In Vitro Diagnostic (IVD).
Here's why:
- IVDs are used to examine specimens derived from the human body. The definition of an IVD involves testing samples like blood, urine, tissue, etc., outside of the body to obtain information about a person's health.
- ANNE One directly measures physiological parameters from the patient's body. The device uses skin-mounted sensors to measure heart rate, respiratory rate, temperature, step count, and fall count directly from the individual. It does not analyze samples taken from the body.
- The intended use and device description clearly indicate direct patient monitoring. The language used describes measuring vital signs and physiological data on the patient, not analyzing samples from the patient.
Therefore, ANNE One falls under the category of a patient monitoring device, not an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
ANNE One is a wireless vital signs and physiological data monitoring platform indicated for the measurement of heart rate, respiratory rate, step count, fall temperature, and body temperature by qualified healthcare professionals in healthcare settings. The device is intended for use on general care patients who are 18 years of age or older as a general patient monitor to provide continuous physiological information as an aid to diagnosis and treatment. The device is not intended for use on critical care patients. The device is not intended to monitor or measure respiratory rate on heart rate on ambulatory patients.
Product codes
DRG, MWI, FLL
Device Description
ANNE One is a wireless multi-parameter vital signs monitoring system that consists of the following components, and subsystems:
A. ANNE Tablet (Samsung Galaxy Tablet) - manufactured by Samsung
B. ANNE View Mobile Application (software) manufactured by Sibel Inc.
C. ANNE Chest Sensor manufactured by Sibel Inc.
D. ANNE Limb Sensor manufactured by Sibel Inc.
E. ANNE Wireless Charger manufactured by Sibel Inc.
The ANNE Chest Sensor is a battery-operated, skin-mounted sensor with wireless transceiver capabilities worn on the upper body to measure heart rate, respiratory rate, step count, fall count, and skin temperature.
The ANNE Limb Sensor is an additional battery-operated skin-mounted sensor with wireless transceiver capabilities worn on the finger to measure skin temperature. When placed underneath the axillae, the ANNE Limb Sensor can measure body temperature.
Both the ANNE Chest and ANNE Limb Sensors continuously gather vital signs data from the person being monitored and then transmit the encrypted data to the ANNE Tablet operating the ANNE View Mobile Application-a mobile device software application.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Upper body (for ANNE Chest Sensor), Finger (for ANNE Limb Sensor), Axilla/Armpit (for body temperature measurement using ANNE Limb Sensor).
Indicated Patient Age Range
18 years of age or older
Intended User / Care Setting
Qualified healthcare professionals in healthcare settings.
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
Benchtop Testing and Simulated Use Testing:
- Laboratory accuracy testing according to ISO 80601-2-56:2017 Section 201.101.2 validated the effectiveness of the ANNE Chest and Limb sensor for skin temperature measurements and the Limb Sensor for body temperature measurements when placed under the axillae.
- Heart rate measurements with ANNE One were verified according to IEC 60601-2-27 Sections 201.12.101.15 and 201.12.1.101.17.
- A simulated use study validated heart rate measurements in 35 healthy subjects against an FDA-cleared reference device.
- Respiratory rate measurements with ANNE One were validated in 50 healthy subjects against an FDA-cleared End Tidal Carbon Dioxide (EtCO-) reference device.
- The step and fall count features were demonstrated to conform to their design specifications through comparison to manual counts.
- Simulated use testing validated the measurements of skin temperature, step count, and fall detection by the ANNE One system in n=10 subjects.
- The ANNE Hydrogel adhesive was also assessed for skin adhesion, pain upon removal, irritation, and comfort. The study demonstrated the functionality and accuracy of the system.
Clinical Study: Not required. Substantial equivalence is supported by Bench and Simulated Use testing.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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).
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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
September 14, 2021
Sibel Inc. % Dave Yungvirt CEO Third Party Review Group, LLC 25 Independence Blvd Warren, New Jersey 07059
Re: K211305
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 Dated: July 23, 2021 Received: July 27, 2021
Dear Dave Yungvirt:
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
1
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 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 (QS) 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 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) K211305
Device Name ANNE One
Indications for Use (Describe)
ANNE One is a wireless vital signs and physiological data monitoring platform indicated for the measurement of heart rate, respiratory rate, step count, fall temperature, and body temperature by qualified healthcare professionals in healthcare settings. The device is intended for use on general care patients who are 18 years of age or older as a general patient monitor to provide continuous physiological information as an aid to diagnosis and treatment. The device is not intended for use on critical care patients. The device is not intended to monitor or measure respiratory rate on heart rate on ambulatory 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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510(K) Summary
Submitter: .
Sibel Inc. 6650 W. Touhy Avenue, Niles, IL 60714 Tel: (224) 251-8859
Official Correspondent: Peter Xu, VP of Quality Assurance and Regulatory Affairs 6650 W. Touhy Avenue, Niles, IL 60714 Tel: (224) 251-8859
Date Prepared: 9/7/2021
ll. Device Information
Name of Device: ANNE One 510K Number: K211305 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
Predicate - Trade Name: Patient Status Engine Predicate 510(k): K172329 Predicate device manufacturer: Isansys Lifecare Ltd
IV. Reference Device
Reference device – Trade Name: Fever Scout Continuous Monitoring thermometer Reference 510(k): K162137 Reference Manufacturer: Vivalnk Inc.
V. Device Description
ANNE One is a wireless multi-parameter vital signs monitoring system that consists of the following components, and subsystems:
A. ANNE Tablet (Samsung Galaxy Tablet) - manufactured by Samsung
- B. ANNE View Mobile Application (software) manufactured by Sibel Inc.
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- C. ANNE Chest Sensor manufactured by Sibel Inc.
- D. ANNE Limb Sensor manufactured by Sibel Inc.
- E. ANNE Wireless Charger manufactured by Sibel Inc.
The ANNE Chest Sensor is a battery-operated, skin-mounted sensor with wireless transceiver capabilities worn on the upper body to measure heart rate, respiratory rate, step count, fall count, and skin temperature.
The ANNE Limb Sensor is an additional battery-operated skin-mounted sensor with wireless transceiver capabilities worn on the finger to measure skin temperature. When placed underneath the axillae, the ANNE Limb Sensor can measure body temperature.
Both the ANNE Chest and ANNE Limb Sensors continuously gather vital signs data from the person being monitored and then transmit the encrypted data to the ANNE Tablet operating the ANNE View Mobile Application-a mobile device software application.
VI. Indications for Use
ANNE One is a wireless vital signs and physiological data monitoring platform indicated for the measurement of heart rate, respiratory rate, step count, fall count, skin temperature, and body temperature by qualified healthcare professionals in healthcare settings. The device is intended for use on general care patients who are 18 years of age or older as a general patient monitor to provide continuous physiological information as an aid to diagnosis and treatment. The device is not intended for use on critical care patients. The device is not intended to monitor or measure respiratory rate or heart rate on ambulatory patients.
| | Subject device
Sibel Inc. | Predicate device
Isansys Lifecare Ltd | Variances / Equivalence |
|---------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Trade Name | ANNE One | Patient Status Engine | |
| 510(k) Number | K211305 | K172329 | N/A |
| Class | II | II | Equivalent |
| Product Code | DRG, MWI, FLL | DRG | Equivalent |
| Regulation
Number and
Regulation Name | 870.2910
Transmitters and
Receivers, Physiological
Signal, Radiofrequency | 870.2910
Transmitters and Receivers,
Physiological Signal,
Radiofrequency | Equivalent |
| | Subject device
Sibel Inc. | Predicate device
Isansys Lifecare Ltd | Variances / Equivalence |
| Indications for
Use | ANNE One is a wireless
vital signs and
physiological data
monitoring platform
indicated for the
measurement of heart
rate, respiratory rate,
step count, fall count,
skin temperature, and
body temperature by
qualified healthcare
professionals in
healthcare settings. The
device is intended for
use on general care
patients who are 18
years of age or older as
a general patient monitor
to provide continuous
physiological information
as an aid to diagnosis
and treatment. The
device is not intended for
use on critical care
patients. The device is
not intended to monitor
or measure respiratory
rate or heart rate on
ambulatory patients. | The device is a wireless
remote monitoring system
intended for use by
healthcare professionals for
continuous collection of
physiological data in home
and healthcare settings.
This includes heart rate,
heart rate variability (R-R
interval), ECG derived
respiration rate data (EDR),
skin temperature, activity,
posture and optional SpO2
and noninvasive Blood
Pressure (BP). Data is
transmitted wirelessly from
the sensors to the Patient
Gateways and from the
Patient Gateways to a
central Server where it is
stored for analysis. The
Patient Status Engine can
include the ability to notify
healthcare professionals
when physiological data fall
outside selected
parameters. | Similar
ANNE One does not include
optional SpO2 and
non-invasive BP
measurements. ANNE One
does not measure heart rate
variability. ANNE One does not
include the ability to notify
healthcare professionals when
physiological data fall outside
selected parameters. ANNE
One does not store data for
future analysis. ANNE One is
not intended to monitor or
measure respiratory rate or
heart rate on ambulatory
patients. The differences do
not affect safety or
effectiveness. |
| Intended Use | ANNE One is intended
for use on general care
patients who are 18
years of age or older as
a general patient monitor,
to provide continuous
physiological information. | The device is intended for
use on general care patients
who are 18 years of age or
older as a general patient
monitor, to provide
physiological information. | Equivalent |
| Use Environment | Healthcare Settings | Home and Healthcare
Settings | Different
ANNE One does not offer
Home use. The differences do
not affect safety or
effectiveness. |
| Heart Rate | Yes | Yes | Equivalent |
| | Subject device
Sibel Inc. | Predicate device
Isansys Lifecare Ltd | Variances / Equivalence |
| R-R Interval | No | Yes | Different
ANNE One is not indicated for
the display of R-R interval.
However, it does calculate the
R-R interval to determine HR.
This difference does not affect
safety or effectiveness. |
| Respiration Rate | Yes | Yes | Equivalent
Both the ANNE One and
Patient Status Engine derive
respiratory rate from ECG
alone (EDR). |
| Skin Temperature | Yes | Yes | Equivalent |
| Body
Temperature | Yes on axilla/armpit | Yes* | Equivalent
The differences do not affect
safety or effectiveness. |
| SpO2 | No | Yes - optional with a FDA
cleared SpO2 oximeter | Different
Without the optional SpO2
oximeter, the devices are
equivalent. The difference
does not affect safety or
effectiveness. |
| Activity | Yes | Yes | Equivalent
The ANNE One specifically
measures activity as step
count. The differences do not
affect safety or effectiveness. |
| Posture | Yes | Yes | Equivalent
The ANNE One specifically
measures posture only as it
relates to fall count. The
differences do not affect safety
or effectiveness |
| Non-Invasive
Blood Pressure
(NIBP) | No | Yes - optional with a FDA
cleared NIBP device | Different
Without the optional NIBP
device, the devices are
equivalent. The difference
does not affect safety or
effectiveness. |
| | Subject device
Sibel Inc. | Predicate device
Isansys Lifecare Ltd | Variances / Equivalence |
| Data | Data transmitted
wirelessly via Bluetooth
from sensors to mobile
device | Data is transmitted
wirelessly via Bluetooth from
the sensors to the Patient
Gateways and from the
Patient Gateways to a
central Server where it is
stored for analysis. | Equivalent
ANNE One does not offer data
transmission to a central
Server or data download. The
differences do not affect safety
or effectiveness. |
| Notification | No notification ability | The Patient Status Engine
can include the ability to
notify healthcare
professionals when
physiological data fall
outside selected
parameters. | Different
ANNE One does not offer a
notification but provides a
real-time display. This
difference does not affect
safety of the device.
Performance data
demonstrates that this change
does not affect effectiveness. |
Table 5-1: Substantial Equivalence for Indication for Use
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*The labeling for the Patient Status Engine states that the LifeTemp Sensor can be used for body temperature measurement if placed under the axilla, but this feature is not included in the device's indications for use.
Validation methods and laboratory accuracy data for body temperature measurements from the Fever Scout reference device were further utilized to demonstrate substantial equivalence to ANNE One.
VII. Performance Data
Verification and Validation tests established the safety and effectiveness of ANNE One. The following performance data have been provided in support of the substantial equivalence determination:
Sterilization & Shelf-life Testing
ANNE One is non-sterile, and therefore sterilization data is not provided. The shelf-life study under accelerated aging data has been provided to support the labeled shelf-life claim for ANNE One. Additional peel force testing established the safety of the ANNE adhesive compared to standard FDA-cleared medical adhesives.
Biocompatibility Testing
Biocompatibility testing was performed for all patient-contacting materials used in ANNE One, and the results indicated that all patient-contacting materials in the ANNE One system are biologically compatible and satisfy the requirements defined in ISO 10993 Part 1, entitled 'Use of International Standard ISO-10993-1, Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process.
Electromagnetic Compatibility and Electrical Safety
Electrical safety and electromagnetic compatibility testing were conducted on ANNE One. The device complies with the ANSI/AAMI ES60601-1:2005/(R)2012 and IEC 60601-1-2:2014
8
standards. The device also complies with the FCC CFR 47 Part 15 Subpart C standards for wireless communication. The device was tested and demonstrated to be safe in case of defibrillation according to Section 8.5.5 of ANSI/AAMI ES60601-1:2005/(R)2012.
Software Verification and Validation Testing
Software verification and validation testing demonstrated the safety and effectiveness of ANNE One. Based on the FDA's Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices, the software level of concern for ANNE One is determined to be Moderate.
Benchtop Testing and Simulated Use Testing
Bench testing was performed to verify device specifications and to ensure mechanical and electrical requirements were met. Laboratory accuracy testing according to ISO 80601-2-56:2017 Section 201.101.2 validated the effectiveness of the ANNE Chest and Limb sensor for skin temperature measurements and the Limb Sensor for body temperature measurements when placed under the axillae. Heart rate measurements with ANNE One were verified according to IEC 60601-2-27 Sections 201.12.101.15 and 201.12.1.101.17. A simulated use study validated heart rate measurements in 35 healthy subjects against an FDA-cleared reference device. Respiratory rate measurements with ANNE One were validated in 50 healthy subjects against an FDA-cleared End Tidal Carbon Dioxide (EtCO-) reference device. The step and fall count features were demonstrated to conform to their design specifications through comparison to manual counts.
Simulated use testing validated the measurements of skin temperature, step count, and fall detection by the ANNE One system in n=10 subjects. The ANNE Hydrogel adhesive was also assessed for skin adhesion, pain upon removal, irritation, and comfort. The study demonstrated the functionality and accuracy of the system.
Animal Studv
Animal testing was not required to demonstrate the safety and effectiveness of ANNE One.
Clinical Study
Clinical testing was not required to demonstrate the safety and effectiveness of ANNE One. Instead, substantial equivalence is supported by Bench and Simulated Use testing.
Usability Testing
Studies related to human factors engineering and ease of use of the ANNE One were conducted in accordance with the principles of IEC 62366, Medical devices - Applications of usability engineering to medical devices and the document entitled Applying Human Factors and Usability Engineering to Medical Devices.
VII. Conclusion
The results of the substantial equivalence assessment, taken together with the performance testing data, demonstrate that ANNE One's performance characteristics are substantially equivalent to the predicate device in both design and intended use.
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It has been shown through the documents provided in this 510(k) submission that the minor differences between ANNE One and the predicate device of Patient Status Engine, as well as the reference device of the Fever Scout Continuous Monitoring thermometer, do not raise any new questions regarding its safety and performance. Any differences between the subject device and the predicate/reference devices have no significant effect on safety or effectiveness as established through performance testing.