(180 days)
Not Found
No
The document explicitly states "Mentions AI, DNN, or ML: Not Found" and the description focuses on standard biosignal collection and transmission.
No.
The device is described as a monitoring platform that measures vital signs and provides physiological data, intended as an "aid to diagnosis and treatment," rather than providing direct therapy.
Yes
The intended use states that the device provides "continuous physiological information as an aid to diagnosis and treatment." This indicates its role in supporting diagnostic processes.
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 Pediatric device is not an In Vitro Diagnostic (IVD).
Here's why:
- IVDs are used to examine specimens derived from the human body. The ANNE Pediatric device measures vital signs (heart rate, skin temperature, body temperature) directly from the patient's body using skin-mounted sensors. It does not analyze samples like blood, urine, or tissue.
- The intended use describes direct patient monitoring. The description clearly states the device is a "wireless vital signs and physiological data monitoring platform" intended for "measurement of heart rate, skin temperature, and body temperature by qualified healthcare professionals in healthcare settings." This is consistent with a patient monitoring device, not an IVD.
- The device description focuses on biosignal collection from the body. The description mentions collecting "electrocardiography (ECG) and temperature biosignals" from "skin-mounted, bio-integrated sensors." This further reinforces its role in direct patient measurement.
Therefore, the ANNE Pediatric device falls under the category of a patient monitoring device, not an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
ANNE Pediatric is a wireless vital signs and physiological data monitoring platform indicated for the measurement of heart rate, skin temperature, and body temperature by qualified healthcare professionals in healthcare settings. The device is intended for use on neonatal patients of any gestational age up to infants 2 years of age as a general patient monitor to provide continuous physiological information as an aid to diagnosis and treatment. The device is not intended to monitor critically ill patients. The device is not intended to monitor or measure heart rate during motion. The device is not an apnea alarm.
Product codes
DRG, MWI, FLL
Device Description
ANNE Pediatric is a wireless vital signs and physiological data monitoring platform that collects electrocardiography (ECG) and temperature biosignals to measure vital signs such as heart rate (HR), skin temperature, and body temperature. The system features two skin-mounted, bio-integrated sensors that pair with the ANNE View application for the display of real-time vital measurements. Data is transmitted wirelessly from the sensors via Bluetooth to the mobile device.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Chest and Foot
Indicated Patient Age Range
neonatal patients of any gestational age up to infants 2 years of age
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
The functionality and performance of the ANNE Pediatric system was assessed in n=137 neonates at Aga Khan University, a tertiary healthcare facility in Nairobi, Kenya. The study compared the performance of HR measurements with ANNE Pediatric against the Masimo Rad-97 in one open label and three closed-label rounds with n=70 neonates. Median gestational age of neonates included in HR analysis was 38 (range 25 to 42) weeks. The HR analysis cohort was 44.7% female, 52.9% male, and 1.4% intersex. The normalized root mean square deviation (RMSD) in the final closed-label round of testing with n=20 neonates was 1.2%, meeting the accuracy requirement of ±10% or ±5bpm, whichever is greater, defined in IEC 60601-2-27. No adverse events or skin injuries were reported during the study.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
normalized root mean square deviation (RMSD) in the final closed-label round of testing with n=20 neonates was 1.2%, meeting the accuracy requirement of ±10% or ±5bpm, whichever is greater, defined in IEC 60601-2-27.
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
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 logo of the U.S. Food & 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.
November 22, 2022
Sibel Inc. Sarah Coughlin OARA Engineer 6650 W. Touhy Ave. Niles, Illinois 60714
Re: K221530
Trade/Device Name: ANNE Pediatric Regulation Number: 21 CFR 870.29870.2910 Regulation Name: Radiofrequency physiological signal transmitter and receiver Regulatory Class: Class II Product Code: DRG, MWI, FLL Dated: Mav 23, 2022 Received: May 26, 2022
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
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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
510(k) Number (if known)
Device Name ANNE Pediatric
Indications for Use (Describe)
ANNE Pediatric is a wireless vital signs and physiological data monitoring platform indicated for the measurement of heart rate, skin temperature by qualified healthcare professionals in healthcare settings. The device is intended for use on neonatal patients of any gestational age up to infants 2 years of age as a general patient monitor to provide continuous physiological information as an aid to diagnosis and treatment. The device is not intended to monitor critically ill patients. The device is not intended to monitor or measure heart rate during motion. The device is not an apnea alarm.
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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FORM FDA 3881 (6/20)
3
510(K) Summary
-Submitter:
Sibel Inc. 6650 W. Touhy Avenue, Niles, IL 60714 Tel: (224) 251-8859
Official Correspondent: Sarah Coughlin, Senior Regulatory Affairs and Quality Assurance Engineer 6650 W. Touhy Avenue, Niles, IL 60714 Tel: (224) 251-8859
Date Prepared: 10/7/2022
II. Device Information
Name of Device: ANNE Pediatric
510(k) Number: K221530
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
Trade Name: ANNE One Predicate 510(k): K211305 Predicate device manufacturer: Sibel Inc.
IV. Device Description
ANNE Pediatric is a wireless vital signs and physiological data monitoring platform that collects electrocardiography (ECG) and temperature biosignals to measure vital signs such as heart rate (HR), skin temperature, and body temperature. The system features two skin-mounted, bio-integrated sensors that pair with the ANNE View application for the display of real-time vital measurements. Data is transmitted wirelessly from the sensors via Bluetooth to the mobile device.
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V. Indications for Use
ANNE Pediatric is a wireless vital signs and physiological data monitoring platform indicated for the measurement of heart rate, skin temperature, and body temperature by qualified healthcare professionals in healthcare settings. The device is intended for use on neonatal patients of any gestational age up to infants 2 years of age as a general patient monitor to provide continuous physiological information as an aid to diagnosis and treatment. The device is not intended to monitor critically ill patients. The device is not intended to monitor or measure heart rate during motion. The device is not an apnea alarm.
| | Subject device
ANNE Pediatric | Predicate device
Sibel Inc. | Variances/Equivalence |
|-------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------|
| Trade Name | ANNE Pediatric | ANNE One | |
| Class | II | II | Equivalent |
| Product Code | DRG, MWI, FLL | DRG, MWI, FLL | Equivalent |
| Regulation
Number and Name | 870.2910
Transmitters and
Receivers, Physiological
Signal, Radiofrequency | 870.2910
Transmitters and
Receivers, Physiological
Signal, Radiofrequency | Equivalent |
| Indications for Use | ANNE Pediatric is a
wireless vital signs and
physiological data
monitoring platform
indicated for the
measurement of heart
rate, skin temperature,
and body temperature by
qualified healthcare
professionals in
healthcare settings. The
device is intended for
use on neonatal patients
of any gestational age up
to infants 2 years of age
as a general patient
monitor to provide
continuous physiological
information as an aid to
diagnosis and treatment.
The device is not
intended to monitor
critically ill patients. The
device is not intended to
monitor or measure
heart rate during motion.
The device is not an
apnea alarm. | 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. | Substantially
Equivalent |
| Target Population | Neonates and infants up
to 2 years of age | Adults, 18 years of age
and older | Different |
| Use Environment | Healthcare Settings | Healthcare Settings | Equivalent |
| Sensor Placement | Chest and Foot | Chest and Finger | Substantially
Equivalent |
| Data | Data transmitted
wirelessly via Bluetooth
from sensors to mobile
device | Data transmitted
wirelessly via Bluetooth
from sensors to mobile
device | Equivalent |
| Notification | No notification ability | No notification ability | Equivalent |
| Heart Rate | Yes | Yes | Equivalent |
| Skin Temperature | Yes | Yes | Equivalent |
| Body Temperature | Yes | Yes | Equivalent |
| Respiratory Rate | No | Yes | Different |
| Step Count | No | Yes | Different |
| Fall Count | No | Yes | Different |
5
VI. Clinical Data
The functionality and performance of the ANNE Pediatric system was assessed in n=137 neonates at Aga Khan University, a tertiary healthcare facility in Nairobi, Kenya. The study compared the performance of HR measurements with ANNE Pediatric against the Masimo Rad-97 in one open label and three closed-label rounds with n=70 neonates. Median gestational age of neonates included in HR analysis was 38 (range 25 to 42) weeks. The HR analysis cohort was 44.7% female, 52.9% male, and 1.4% intersex. The normalized root mean square deviation (RMSD) in the final closed-label round of testing with n=20 neonates was 1.2%, meeting the accuracy requirement of ±10% or ±5bpm, whichever is greater, defined in IEC 60601-2-27. No adverse events or skin injuries were reported during the study.
VII. Performance Data
The following consensus standards and bench testing were used to evaluate the safety and effectiveness of ANNE Pediatric:
- Electrical safety and electromagnetic compatibility testing according to ANSI/AAMI ES60601-1:2005/(R)2012 and IEC 60601-1-2:2014 standards.
- . 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. ●
- Defibrillation testing according to Section 8.5.5 of ANSI/AAMI ES60601-1:2005/(R)2012 ●
6
- . 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.
- 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.
- o Usability testing in accordance with the FDA guidance document, Applying Human Factors and Usability Engineering to Medical Devices
- Performance testing of body temperature measurements according to ISO 80601-2-56:2017.
- 0 Performance testing of heart rate measurements according to Sections 201.12.1.101.15 and 201.12.1.101.17 of IEC 60601-2-27:2011.
- 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 guidance document, Off-The-Shelf Software Use in Medical Devices
VIII. Conclusion
The results of the substantial equivalence assessment, taken together with the clinical and performance testing data, demonstrate that the ANNE Pediatric system's performance characteristics are substantially equivalent to the predicate device in both technology and intended use.