(116 days)
Not Found
No
The summary mentions "on-device processing of raw data for the calculation of SpO2 and pulse rate" but does not mention AI, ML, or any related terms, nor does it describe training or test sets typically associated with ML development.
No.
The device is intended as an aid to diagnosis and treatment, and is a monitoring device, not a therapeutic one. It monitors SpO2, pulse rate, and skin temperature.
Yes
The "Intended Use / Indications for Use" section states: "The device is indicated for use as an aid to diagnosis and treatment by healthcare professionals..."
No
The device description explicitly states "The ANNE Limb sensor is a wearable, bio-integrated sensor that collects real-time biosignals including photoplethysmography (PPG) and temperature." This indicates a physical hardware component is part of the device.
Based on the provided information, the ANNE Limb Sensor is not an In Vitro Diagnostic (IVD) device.
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections. These tests are performed outside of the living body (in vitro).
- ANNE Limb Sensor Function: The ANNE Limb Sensor is a pulse oximeter that measures physiological parameters (SpO2, pulse rate, skin temperature) directly from the patient's body using non-invasive methods (photoplethysmography). It does not analyze samples taken from the body.
Therefore, the ANNE Limb Sensor falls under the category of a non-invasive physiological monitoring device, not an IVD.
N/A
Intended Use / Indications for Use
The ANNE Limb Sensor is a pulse oximeter intended for continuous monitoring of functional oxygen saturation of arterial hemoglobin (SpO2), pulse rate, and skin temperature. The ANNE Limb Sensor is not intended to monitor or measure SpO2 or pulse rate while the patient undergoes significant motion or is active. The ANNE Limb Sensor communicates with compatible software applications for the display, storage, and analysis of data. The device is indicated for use as an aid to diagnosis and treatment by healthcare professionals in general care patients who are 12 years of age or older in clinical and home environments. The device is not intended for use on critical care patients.
Product codes (comma separated list FDA assigned to the subject device)
DQA, FLL
Device Description
The ANNE Limb sensor is a wearable, bio-integrated sensor that collects real-time biosignals including photoplethysmography (PPG) and temperature. The ANNE Limb sensor has on-device processing of raw data for the calculation of SpO2 and pulse rate. The sensor communicates via Bluetooth to the Sibel SDK, which may be integrated within software applications for the display and storage of data.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Finger
Indicated Patient Age Range
12 years of age or older
Intended User / Care Setting
healthcare professionals in general care patients who are 12 years of age or older in clinical and home environments.
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 (ARMS) was 2.31%, meeting the requirements of the above-mentioned standard.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
ARMS = 2.31% for SpO2 (range 70-100%)
Skin Temperature: 73.4°F - 109.4°F (plus/minus 0.54°F), 23°C - 43°C (plus/minus 0.3°C)
Pulse Rate: 30-300 bpm (plus/minus 3 bpm RMSE)
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
§ 870.2700 Oximeter.
(a)
Identification. An oximeter is a device used to transmit radiation at a known wavelength(s) through blood and to measure the blood oxygen saturation based on the amount of reflected or scattered radiation. It may be used alone or in conjunction with a fiberoptic oximeter catheter.(b)
Classification. Class II (performance standards).
0
Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo is in blue and includes the letters "FDA" followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in a stacked format.
May 28, 2024
Sibel Health Inc. Sarah Coughlin Regulatory Affairs Manager 2017 N Mendell St. Suite 2SE Chicago, Illinois 60614
Re: K240305
Trade/Device Name: ANNE Limb Regulation Number: 21 CFR 870.2700 Regulation Name: Oximeter Regulatory Class: Class II Product Code: DQA, FLL Dated: Mav 7, 2024 Received: May 7, 2024
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 (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" (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).
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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.
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 medical devices and radiation-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
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Indications for Use
Submission Number (if known)
K240305
Device Name
ANNE Limb
Indications for Use (Describe)
The ANNE Limb Sensor is a pulse oximeter intended for continuous monitoring of functional oxygen saturation of arterial hemoglobin (SpO2), pulse rate, and skin temperature. The ANNE Limb Sensor is not intended to monitor or measure SpO2 or pulse rate while the patient undergoes significant motion or is active. The ANNE Limb Sensor communicates with compatible software applications for the display, storage, and analysis of data. The device is indicated for use as an aid to diagnosis and treatment by healthcare professionals in general care patients who are 12 years of age or older in clinical and home environments. 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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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: 04/26/2024
. Device Information
Name of Device: ANNE Limb 510K Number: K240305 Classification Name: Oximeter Regulation: 21 CFR §870.2700 Regulatory Class: Class II
Product Classification Code: DQA, FLL
III. Predicate Device
Trade Name: ANNE One 510(k): K223711 Device Manufacturer: Sibel Health Inc.
IV. Device Description
The ANNE Limb sensor is a wearable, bio-integrated sensor that collects real-time biosignals including photoplethysmography (PPG) and temperature. The ANNE Limb sensor has on-device processing of raw data for the calculation of SpO2 and pulse rate. The sensor communicates via Bluetooth to the Sibel SDK, which may be integrated within software applications for the display and storage of data.
V. Indications for Use
The ANNE Limb Sensor is a pulse oximeter intended for continuous monitoring of functional oxygen saturation of arterial hemoglobin (SpO2), pulse rate, and skin temperature. The ANNE
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Limb Sensor is not intended to monitor or measure SpO2 or pulse rate while the patient undergoes significant motion or is active. The ANNE Limb Sensor communicates with compatible software applications for the display, storage, and analysis of data. The device is indicated for use as an aid to diagnosis and treatment by healthcare professionals in general care patients who are 12 years of age or older in clinical and home environments. 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 performance of ANNE Limb:
- . Electrical safety and electromagnetic compatibility testing according to ANSI/AAMI ES60601-1:2005/(R)2012 and IEC 60601-1-2 Edition 4.0 2014 standards. Electrical safety testing in the home healthcare environment per IEC 60601-1-11:2015.
- . Biocompatibility testing according to 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 quidance 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.
- . Shelf life testing of the adhesive to demonstrate safety and 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 Enqineering to Medical Devices.
- . Performance testing of pulse rate and skin temperature.
- . Cybersecurity evaluation according to the FDA quidance document. Cybersecurity in Medical Devices: Quality System Considerations and Content of Premarket Submissions
VII. 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 (ARMS) was 2.31%, meeting the requirements of the above-mentioned standard.
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VIII. Conclusion
The results of the substantial equivalence assessment, taken together with safety and performance testing data, demonstrate that ANNE Limb's performance characteristics are substantially equivalent to the predicate device in both technology and intended use.
| Subject device
Sibel Health Inc. | Predicate device
Sibel Health Inc. | Variances / Equivalence | |
|------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Trade Name | ANNE Limb | ANNE One | |
| 510(k) Number | | K223711 | |
| Class | II | II | Equivalent |
| Product Code | DQA, FLL | DRG, DQA, FLL, KMI, MWI,
MWJ | Similar
The MWJ, MWI, KMI, and
DRG product codes represent
functionalities supported by the
ANNE One predicate device
that are not part of the
intended use of the subject
device.
Both devices share the DQA
and FLL product codes. |
| Regulation
Number and
Regulation
Name | 870.2700
Oximeter | 870.2910
Transmitters and Receivers,
Physiological Signal,
Radiofrequency | Different
The primary product codes are
different. The predicate device
also has the DQA product code
for oximetry. |
| Indications for
Use | The ANNE Limb Sensor is a
pulse oximeter intended for
continuous monitoring of
functional oxygen saturation of
arterial hemoglobin (SpO2),
pulse rate, and skin
temperature. The ANNE Limb
Sensor is not intended to
monitor or measure SpO2 or
pulse rate while the patient
undergoes significant motion or
is active. The ANNE Limb
Sensor communicates with
compatible software
applications for the display,
storage, and analysis of data.
The device is indicated for use
as an aid to diagnosis and
treatment by healthcare
professionals in general care
patients who are 12 years of
age or older in clinical and | 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, pulse rate, and body
temperature measurements.
The device is indicated for
monitoring ECG waveforms
and heart rate on ambulatory | Similar
The subject device utilizes the
same sensor and algorithms
for the calculation of SpO2,
pulse rate, and skin
temperature as the Limb
Sensor of the predicate device,
ANNE One. The ANNE One
predicate had additional
outputs including ECG, heart
rate, respiratory rate, and body
position. This difference does
not affect the substantial
equivalence of the output
parameters indicated for use in
the subject device. |
| | home environments. The
device is not intended for use
on critical care patients. | 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. | |
| Target
Population | 12 years of age and older | 12 years of age and older | Equivalent |
| Use
Environment | Home and healthcare settings | Home and healthcare settings | Equivalent |
| Reprocessing | Reusable on multiple patients. | Reusable on a single patient. | Similar
The subject device is reusable
on multiple patients. Validation
of the cleaning process and
mechanical testing
demonstrate that this
difference does not impact
substantial equivalence. |
| Sensor
Placement | Finger | Finger and Chest | Similar
Placement of the ANNE Limb
sensor on the finger is the
same between the subject and
predicate devices. The
predicate device includes an
additional sensor, the ANNE
Chest Sensor, that is worn on
the chest. The ANNE Chest
sensor is not part of the scope |
| | | | of the subject device. |
| Heart Rate | Not Applicable | 30-270 bpm
(the greater of ± 10% or ± 5 bpm) | Not Applicable |
| Respiratory
Rate | Not Applicable | Accelerometer-derived
8 - 30 bpm
(± 3 bpm RMSE) | Not Applicable |
| Skin
Temperature | 73.4°F - 109.4°F (±0.54°F)
23°C - 43°C (±0.3°C) | 73.4°F - 109.4°F (±0.54°F)
23°C - 43°C (±0.3°C) | Equivalent |
| SpO2 | $A_{RMS}$ ≤ 3% (range 70-100%) | $A_{RMS}$ ≤ 3% (range 70-100%) | Equivalent |
| Pulse Rate | 30-300 bpm (±3 bpm RMSE) | 30-300 bpm (±3 bpm RMSE) | Equivalent |
| Activity | Not Applicable | Accelerometer | Not Applicable |
| Posture | Not Applicable | Body Position
Fall Detection | Not Applicable |
| Non-Invasive
Blood Pressure
(NIBP) | Not Applicable | 0 - 300 mmHg
(± 3 mmHg) | Not Applicable |
| Data | Data is transmitted wirelessly
via Bluetooth from the sensor
to the Sibel SDK, which may
be integrated within software
applications for the display and
storage of data. | Data is transmitted wirelessly
via Bluetooth from the sensors
to a mobile device. Data may
be downloaded for later
storage and analysis. | Similar
The subject device allows
communication with compatible
software applications for the
display, storage, and analysis
of data. |
| Notification | No notification ability. | Provides visual notification on
patient orientation. | Similar
The subject device provides a
visual notification on patient
orientation. |
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