(241 days)
No
The device description explicitly states that the ECG signal is not intended for automated arrhythmia detection or classification and uses the well-known Pan-Tompkins algorithm for heart rate, which is a traditional signal processing method, not AI/ML. There are no mentions of AI, DNN, or ML in the document.
No.
The device is indicated for monitoring and providing physiological information as an aid to diagnosis and treatment, but not for direct therapeutic intervention. It helps prevent pressure ulcers by providing notifications, which is a monitoring function, not a direct treatment.
Yes
Explanation: The "Intended Use / Indications for Use" section states, "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." This explicitly indicates that the device aids in diagnosis.
No
The device description explicitly states the system features "two skin-mounted, bio-integrated sensors" which are hardware components.
Based on the provided information, the ANNE One device is not an In Vitro Diagnostic (IVD).
Here's why:
- IVD Definition: In Vitro Diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- ANNE One's Function: The ANNE One device measures physiological parameters directly from the patient's body (ECG, SpO2, heart rate, respiratory rate, temperature, activity, position, fall detection) using external sensors. It does not analyze samples taken from the body.
- Intended Use: The intended use clearly states it's a "wireless monitoring platform indicated for the measurement of electrocardiography (ECG) waveforms. heart rate, respiratory rate, function of arterial hemoglobin (SpO2), pulse rate, activity, body position, fall detection, skin temperature by qualified healthcare professionals in home and healthcare settings." This describes a patient monitoring device, not an IVD.
Therefore, the ANNE One device 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 monitoring platform indicated for the measurement of electrocardiography (ECG) waveforms. heart rate, respiratory rate, function of arterial hemoglobin (SpO2), pulse rate, activity, body position, fall detection, skin 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, 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 orients to aid in the prevention of pressure ulcers for at-risk patients. The system provides visual notification when the pation 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.
Product codes
DRG, MWI, FLL, DQA, MWJ, KMI
Device Description
ANNE One is a wireless monitoring platform that streams and stores real-time biosignals including electrocardiography (ECG), photoplethysmography (PPG), 3-axis accelerometry, and temperature to measure vital signs such as heart rate, respiratory rate, SpO2, pulse rate, skin temperature, and body temperature. The ECG signal is not intended for automated arrhythmia detection or classification; rather it is intended for manual interpretation, and the automated computation of heart rate through QRS identification using the well-known Pan-Tompkins beat detection algorithm. The displayed waveform is only intended for display as a check for normal ECG rhythm. The waveform is not intended for manual discrimination of any arrhythmias or cardiac conditions. The system features two skin-mounted, bio-integrated sensors that pair with the ANNE View software application for the continuous display, storage, and analysis of vital sign measurements and physiological waveforms. The system is also compatible with optional FDA-cleared third-party devices for SpO2, non-invasive blood pressure, and body temperature measurements.
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
12 years of age or older
Intended User / Care Setting
qualified healthcare professionals in home and 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 (study type, sample size, AUC, MRMC, standalone performance, key results)
SpO2 Accuracy: Sibel validated the accuracy of SpO2 measurements compared to blood gas analysis in n=12 healthy subjects over the range of 70-100% oxygen saturation according to Section 201.12.1 of ISO 80601-2-61 and Pulse Oximeters - Premarket Notification Submissions [510(k)s]: Guidance for Industry and Food and Drug Administration Staff, Issued March 2013. Enrolled subjects had skin tones varying from Fitzpatrick 2-5, with two subjects having darker skin pigmentation (Fitzpatrick 5). The average root mean square error (Agus) was 2.31%, meeting the requirements of the above-mentioned standard.
Respiratory Rate Accuracy: Sibel validated the accuracy of respiratory rate measurements compared to etCO2 in n=40 healthy adult subjects over the output range of 8-30 breaths per minute. The mean absolute error of respiratory rate measurements with ANNE One was within ±3bpm of the reference device, meeting the defined performance criteria.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
SpO2: average root mean square error (Agus) was 2.31%
Respiratory rate: mean absolute error of respiratory rate measurements with ANNE One was within ±3bpm of the reference device
Predicate Device(s)
Reference Device(s)
K220095, K191614, K141877, K212317
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).
0
Image /page/0/Picture/0 description: The image contains the logos of the Department of Health and Human Services and the Food and Drug Administration (FDA). The Department of Health and Human Services logo is on the left, and the FDA logo is on the right. The FDA logo includes the letters "FDA" in a blue square, followed by the words "U.S. Food & Drug Administration" in blue text.
August 10, 2023
Sibel Health Inc. Sarah Coughlin Senior Regulatory Affairs and Quality Assurance Engineer 6650 W Touhv Ave. Niles, Illinois 60714
Re: K223711
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, DQA, MWJ, KMI Dated: July 6, 2023 Received: July 10, 2023
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
1
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
2
Indications for Use
510(k) Number (if known) K223711
Device Name ANNE One
Indications for Use (Describe)
ANNE One is a wireless monitoring platform indicated for the measurement of electrocardiography (ECG) waveforms. heart rate, respiratory rate, function of arterial hemoglobin (SpO2), pulse rate, activity, body position, fall detection, skin 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, 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 orients to aid in the prevention of pressure ulcers for at-risk patients. The system provides visual notification when the pation 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.
Type of Use (Select one or both, as applicable)
| X Prescription Use (Part 21 CFR 801 Subpart D) | ☐ Over-The-Counter Use (21 CFR 801 Subpart C) |
|---|---|
| ------------------------------------------------------------------------------------------------------------------------------- | ---------------------------------------------------------------------------------- |
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3
510(K) Summary
-Submitter:
Sibel Health Inc. 2017 N Mendell St. Suite 2SE Chicago, IL 60614 Tel: (224) 251-8859
Official Correspondent: Sarah Coughlin, Regulatory Affairs Manager 2017 N Mendell St. Suite 2SE Chicago, IL 60614 Tel: (224) 251-8859
Date Prepared: 08/10/2023
II. Device Information
Name of Device: ANNE One 510K Number: K223711 Classification Name: Radiofrequency Physiological Signal Transmitter and Receiver Regulation: 21 CFR §870.2910 Regulatory Class: Class II Product Classification Code: DRG, MWI, FLL, DQA, MWJ, KMI
lll. Predicate Device
Trade Name: ANNE One 510(k): K211305 Device Manufacturer: Sibel Health Inc.
IV. Reference Devices
Trade Name: ANNE Sleep 510(k): K220095 Device Manufacturer: Sibel Health Inc.
Trade Name: BioSticker System 510(k): K191614 Device Manufacturer: BioIntelliSense Inc.
Trade Name: Leaf Patient Monitoring System 510(k): K141877 Device Manufacturer: Leaf Healthcare Incorporated
4
Trade Name: Eclipse Mini 510(k): K212317 Device Manufacturer: Spacelabs
V. Device Description
ANNE One is a wireless monitoring platform that streams and stores real-time biosignals including electrocardiography (ECG), photoplethysmography (PPG), 3-axis accelerometry, and temperature to measure vital signs such as heart rate, respiratory rate, SpO2, pulse rate, skin temperature, and body temperature. The ECG signal is not intended for automated arrhythmia detection or classification; rather it is intended for manual interpretation, and the automated computation of heart rate through QRS identification using the well-known Pan-Tompkins beat detection algorithm. The displayed waveform is only intended for display as a check for normal ECG rhythm. The waveform is not intended for manual discrimination of any arrhythmias or cardiac conditions. The system features two skin-mounted, bio-integrated sensors that pair with the ANNE View software application for the continuous display, storage, and analysis of vital sign measurements and physiological waveforms. The system is also compatible with optional FDA-cleared third-party devices for SpO2, non-invasive blood pressure, and body temperature measurements.
VI. Indications for Use
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 (SpO-), 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, 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.
5
VII. Performance Data
The following consensus standards and bench testing were used to evaluate the substantial equivalence of ANNE One:
- Electrical safety and electromagnetic compatibility testing according to ANSI/AAMI ● ES60601-1:2005/(R)2012 and IEC 60601-1-2:2014 standards. Electrical safety testing in the home healthcare environment per IEC 60601-1-11:2015.
- Safety and performance testing of pulse oximeter per ISO 80601-2-61:2017. .
- . 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.
- 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.
- Safety and performance testing of ECG per IEC 60601-2-27:2011 and IEC ● 60601-2-47:2012.
- Defibrillation testing according to Section 8.5.5 of ANSI/AAMI ES60601-1:2005/(R)2012 ●
- . 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.
- Usability testing in accordance with the FDA guidance document, Applying Human ● Factors and Usability Engineering to Medical Devices.
- . Performance testing of heart rate, respiratory rate, skin temperature, body temperature, activity, and posture,
- . 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 quidance document. ● Off-The-Shelf Software Use in Medical Devices.
VIII. Clinical Studies
SpO2 Accuracy: Sibel validated the accuracy of SpO2 measurements compared to blood gas analysis in n=12 healthy subjects over the range of 70-100% oxygen saturation according to Section 201.12.1 of ISO 80601-2-61 and Pulse Oximeters - Premarket Notification Submissions [510(k)s]: Guidance for Industry and Food and Drug Administration Staff, Issued March 2013. Enrolled subjects had skin tones varying from Fitzpatrick 2-5, with two subjects having darker skin pigmentation (Fitzpatrick 5). The average root mean square error (Agus) was 2.31%, meeting the requirements of the above-mentioned standard.
Respiratory Rate Accuracy: Sibel validated the accuracy of respiratory rate measurements compared to etCO2 in n=40 healthy adult subjects over the output range of 8-30 breaths per
6
minute. The mean absolute error of respiratory rate measurements with ANNE One was within ±3bpm of the reference device, meeting the defined performance criteria.
IX. Conclusion
The results of the substantial equivalence assessment, taken together with safety and performance testing data, demonstrate that ANNE One's performance characteristics are substantially equivalent to the predicate device in both technology and intended use.
7
| | Subject device
Sibel Health Inc. | Predicate device
Sibel Health Inc. | Reference device
Sibel Health Inc. | Reference device
BioIntelliSense Inc. | Reference Device
Leaf Healthcare, Inc. | Reference Device
Spacelabs | Variances / Equivalence |
|-----------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Trade Name | ANNE One | ANNE One | ANNE Sleep | BioSticker System | Leaf Patient Monitoring System | Eclipse Mini | |
| 510(k) Number | K223711 | K211305 | K220095 | K191614 | K141877 | K212317 | |
| Class | II | II | II | II | I | II | Equivalent |
| Product Code | DRG, MWI, FLL,
DQA, MWJ, KMI | DRG, MWI, FLL | MNR | DRG | KMI | MWJ | Similar
The DQA product code for the
oximeter is supported by the
ANNE Sleep reference device.
The MWJ product code for
ambulatory ECG monitoring without
analysis is supported by safety
and performance testing to
consensus standards as well as
the K212317 reference. The KMI
product code for bed-patient
monitoring is supported by the
Leaf Patient Monitoring System
reference device. |
| Regulati | 870.2910 | 870.2910 | 868.2375 | 870.2910 | 880.2400 | 870.2800 | Equivalent |
| on
Number
and
Regulati
on
Name | Transmitters and
Receivers,
Physiological
Signal,
Radiofrequency | Transmitters and
Receivers,
Physiological
Signal,
Radiofrequency | Breathing
Frequency Monitor | Transmitters and
Receivers,
Physiological
Signal,
Radiofrequency | Bed-patient
Monitor | Medical magnetic
tape recorder | |
| Indicatio
ns for
Use | ANNE One is a
wireless monitoring
platform indicated
for the
measurement of
electrocardiograph
y (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 | 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 | ANNE Sleep is a
wearable sensor
system intended
for use in the
collection,
analysis, display,
and storage of
physiological
parameters to aid
in the evaluation
of sleep-related
breathing
disorders of adult
patients
suspected of
sleep apnea. The
device is intended
for use in the
clinical and home
setting under the
direction and
interpretation by a
Healthcare
Professional
(HCP). | The BioSticker
System is a
remote monitoring
system intended
for use by
healthcare
professionals for
continuous
collection of
physiological data
in home and
healthcare
settings while the
patient is at rest.
This can include
heart rate,
respiratory rate,
and skin
temperature. Data
are transmitted via
wireless
connection from
the BioSticker for
storage and
analysis.
The device is
intended for use
on general care
patients who are
21 years of age or
older as a general
patient monitor, to
provide
physiological | The Leaf Patient
Monitoring System
monitors the
orientation and
activity of patients
susceptible to
pressure ulcers. It
allows healthcare
providers to
implement
individualized turn
management
plans and
continuously
monitor each
patient. The Leaf
Patient Monitoring
System provides
alerts when
patient orientation
or activity deviates
from parameters
set by healthcare
providers. The
device is intended
for use in medical,
nursing, and
long-term care
facilities, including
independent
living,
assisted-living and
rehabilitation
facilities. | The Eclipse MINI
Model 98900 is a
portable
non-invasive
continuous
ambulatory ECG
patch recorder
intended to record
the patient's
electrocardiogram.
The recorder is
intended to be
used by either
paediatric or adult
patients
suspected of
cardiac
arrhythmias in
either a clinical
setting or at home.
The recorder does
no cardiac
analysis and is
used with
Spacelabs
Ambulatory ECG
Analysis Software. | Similar
The subject device
utilizes the same
sensors and
algorithms for the
calculation of SpO2
and pulse rate as
the reference
device, ANNE
Sleep. The subject
device is
compatible with an
optional,
FDA-cleared
third-party device
for NIBP
monitoring.
Ambulatory ECG
heart rate
monitoring is
supported by
performance
testing to
consensus
standards as well
as the K212317
reference device.
Monitoring of body
position for turn
management in
patients susceptible
to pressure ulcers
with the subject
device is supported
by the Leaf
reference device.
The differences do |
8
9
| pressure, SpO2,
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. | device is not
intended to
monitor or
measure
respiratory rate or
heart rate on
ambulatory
patients. | information. The
data from the
BioSticker System
are intended for
use by healthcare
professionals as
an aid to
diagnosis and
treatment.
The device is not
intended to
measure
physiological
parameters while
the patient
undergoes
significant motion
or is active. The
device is not
intended for use
on critical care
patients. | | not affect safety or
effectiveness. |
|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--|----------------------------------------|
| 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 | | | | |
10
| | | | | | | | | | | | | | | | target population is
supported by the
Eclipse Mini
reference device.
Safety and
effectiveness of RR
monitoring in the
adolescent
subpopulation is
demonstrated
through the
extrapolation of
adult clinical data. |
|----------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------|----------------------------------------------------|-------------------------------------------------------|------------------------------|---------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------|---------------------------------|------------------------|------------------------------------------------------------------------------------------------------------------------|------------------------------------|-------------------------------------------------------|-------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | 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. | | | | | | | Use
Environment | Home and
healthcare settings | Healthcare
settings | Recording in the
home environment
with the report and
interpretation
performed in the
clinical setting. | Home and
healthcare
settings | Medical, nursing,
and long-term
care facilities | Clinical and home | Equivalent |
| Target
Population | 12 years of age
and older | 18 years of age
and older | 22 years of age
and older | 21 years of age or
older | 18 years of age
and older | Pediatric and adult | Similar
The subject
device's target
population includes
adolescents aged
12 to 17. Safety
and effectiveness in
this population is
established through
literature. ECG
monitoring in the | Sensor
Placement | Finger and Chest | Finger and Chest | Finger and Chest | Chest | Chest | Chest | Equivalent |
| Heart
Rate | 30-300 bpm
(the greater of ±
10% or ± 5 bpm) | 30 - 270 bpm
(the greater of ±
10% or ± 5bpm) | 30-300 bpm
(the greater of ±
10% or ± 5 bpm) | 40-125 bpm
( 106°F ± 0.5°F
(> 41°C ± 0.3°C) | N/A | N/A | Equivalent |
|--------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Body
Temperature | ± 0.05°C ( ± 0.1°F ) during
35.00°C ~38.00°C
(95.00°F
~100.40°F) ±
0.1°C (± 0.2°F )
during
T38.00°C
(100.40°F) | 93.2°F - 109.4°F
(±0.54°F)
34°C - 43°C
(±0.3°C) | N/A | N/A | N/A | N/A | Different
The subject
device may be
used with a
third-party,
FDA-cleared
thermometer for
spot-check body
temperature. |
| SpO2 | ARMS ≤ 3% (range
70-100%) | N/A | ARMS ≤ 3% (range
70-100%) | N/A | N/A | N/A | Equivalent |
| Pulse
Rate | 30-300 bpm
(the greater of ±
10% or ± 5 bpm) | N/A | 30-300 bpm
(the greater of ±
10% or ± 5 bpm) | N/A | N/A | N/A | Equivalent |
| Activity | Accelerometer | Accelerometer | Accelerometer | Accelerometer | Accelerometer | N/A | Equivalent |
| Posture | Body Position
Fall Detection | Fall Count | Body Position | Body Position | Body Position | N/A | Equivalent |
| Non-Inv
asive
Blood
Pressur
e (NIBP) | 0 - 300 mmHg
(± 3 mmHg) | N/A | N/A | N/A | N/A | N/A | Different
The subject device
may be used with
an FDA cleared BP
monitor. |
| ECG
Wavefor
m
Display | Compliant to IEC
60601-2-27
Compliant to IEC
60601-2-47 | Continuous ECG
waveform
collection | Continuous ECG
waveform
collection | N/A | N/A | Compliant to IEC
60601-2-47 | Different
While the K211305
predicate device
collects ECG
signals, the
waveform is not
displayed on the
application. Safety
and effectiveness
for the ECG
waveform display
are established
through recognized
consensus
standards including
IEC 60601-2-27
and IEC
60601-2-47 as well
as the K212317
reference. |
| ECG
Samplin
g
Frequen
су | ECG Sampling
Frequency: 512 Hz
Streaming
Frequency: 256 Hz | ECG Sampling
Frequency: 512
Hz
Streaming
Frequency: 256
Hz | ECG Sampling
Frequency: 512
Hz
Streaming
Frequency: 256
Hz | N/A | N/A | Not publicly
available | Equivalent |
| ECG
Resoluti
on | 18 bit | 18 bit | 18 bit | N/A | N/A | Not publicly
available | Equivalent |
| Data | Data is transmitted
wirelessly via
Bluetooth from the
sensors to a
mobile device.
Data may be
downloaded for
later storage and
analysis. | Data is
transmitted
wirelessly via
Bluetooth from the
sensors to a
mobile device. | Patient data is
wirelessly
transferred via
Bluetooth from the
sensors to a
mobile phone.
Data is then
wirelessly
transferred from
the phone to the
cloud when
connected to the
internet. | Data is
transmitted
wirelessly via
Bluetooth from the
sensor to a mobile
device for storage
and analysis. | Data is
transmitted
wirelessly via Leaf
Antennas to a
monitoring station
equipped with a
USB RF
Transceiver and
the Leaf Turn
Management
Software. | Data is
transmitted from
the sensor to a
computer with a
standard USB
cable | Similar
The subject device
allows data
download to the
mobile device. This
functionality was
verified through
testing. |
| Notificati
on | Provides visual
notification on
patient orientation. | No notification
ability | No notification
ability | No notification
ability | Provides alerts on
patient orientation. | N/A | Similar
The subject device
provides a visual
notification on
patient orientation. |
| Motion | Respiratory rate,
SpO2, and pulse
rate
measurements
should not be
taken during
motion.
Heart rate and
ECG may be taken
during motion. | Heart rate and
respiratory rate
not indicated for
use during motion. | Not indicated for
use during motion | Not indicated for
use during motion | N/A | ECG during
motion. | Similar
Both the subject
and predicate
devices are not
indicated for
respiratory rate
measurements
during motion. The
subject and ANNE
Sleep reference are
not indicated for
SpO2 or pulse rate
measurements
during motion. The
ANNE One device
is indicated for
heart rate
measurements
during motion. This
difference is
supported by
testing on standard
ambulatory |
| Measure
ment
modality | Continuous
Measurements:
Respiratory rate,
ECG, heart rate,
SpO2, pulse rate,
skin temperature,
body position
Spot Check
Measurements
with third party
devices:
Blood pressure,
body temperature | Continuous
Measurements:
Respiratory rate,
heart rate, skin
temperature, body
temperature, body
position, step
count | Continuous
measurements:
SpO2, pulse rate,
heart rate,
peripheral arterial
tonometry, snore,
chest movement,
body position | Continuous
measurements:
Heart rate,
respiratory rate,
skin temperature | Continuous
measurements:
Body Position | Continuous
measurements:
ECG | databases as
described in IEC
60601-2-47.
Similar
ANNE One and the
predicate K211305
display continuous
heart rate,
respiratory rate,
skin temperature,
and body position.
The ANNE One
subject device also
streams continuous
ECG for display on
the ANNE View
application. This
difference is
demonstrated to
not influence safety
or effectiveness
through testing
according to
consensus
standards. The
subject device and
ANNE Sleep
reference include
continuous SpO2
and pulse rate
measurement from
PPG. The ANNE
One subject device
does not include
continuous body
temperature
measurements, but
instead allows
users to take spot
check
measurements with
a standard,
FDA-cleared |
| | | | | | | | third-party
thermometer. The
ANNE One subject
device is also
compatible with an
optional
FDA-cleared third
part blood pressure
monitor for spot
check NIBP
measurements. |
| Monitori
ng Type | Real time
monitoring
Data storage for
later analysis | Real time
monitoring | Data storage for
later analysis | Real time
monitoring | Real time
monitoring
Data storage for
later analysis | Data storage for
later analysis | Equivalent
The subject and
predicate devices
continuously
stream
physiological data
for display on the
ANNE Tablet via
Bluetooth. Data is
also stored on the
sensors in the
subject device and
can be offloaded to
the ANNE Tablet at
the end of the
monitoring session,
similar to the ANNE
Sleep reference
device. The ability
of the device to
stream data is not
impacted by the
storage feature.
Both real time
streaming and
storage for later
analysis were
verified in software
system testing. |
| Alarms | No alarming
capabilities | No alarming
capabilities | No alarming
capabilities | No alarming
capabilities | No alarming
capabilities | No alarming
capabilities | Equivalent
ANNE One is |
| | Visual alerts for
turn management. | | | | Visual alerts for
turn management. | | equivalent to the
Leaf Healthcare
reference device. |
| Apnea
Claims | Not an apnea
monitor | Not an apnea
monitor | Not an apnea
monitor | Not an apnea
monitor | Not an apnea
monitor | Not an apnea
monitor | Equivalent |
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