← Product Code [DQA](/submissions/CV/subpart-c%E2%80%94cardiovascular-monitoring-devices/DQA) · K231531 # Pediarity™ (K231531) _Hinlab, Inc. · DQA · Dec 21, 2023 · Cardiovascular · SESE_ **Canonical URL:** https://fda.innolitics.com/submissions/AN/subpart-c%E2%80%94cardiovascular-monitoring-devices/DQA/K231531 ## Device Facts - **Applicant:** Hinlab, Inc. - **Product Code:** [DQA](/submissions/CV/subpart-c%E2%80%94cardiovascular-monitoring-devices/DQA.md) - **Decision Date:** Dec 21, 2023 - **Decision:** SESE - **Submission Type:** Traditional - **Regulation:** 21 CFR 870.2700 - **Device Class:** Class 2 - **Review Panel:** Cardiovascular - **Attributes:** Pediatric ## Indications for Use The Pediarity™ system is intended for use in the home setting for spot checking and/or continuous recording of pulse rate (PR) and functional oxygen saturation of arterial hemoglobin (SpO2) of well-perfused infants and children in non-motion conditions. The Pediarity™ system is not a monitoring device and does not provide physiological alarms during use. Measurements are sent to a web server for remote review by a physician. ## Device Story Pediarity™ is a non-invasive, wearable pulse oximeter for infants and children (up to 12 years). System components: Gabi™ Band (worn on upper arm), Gabi™ Monitor (tablet with pre-installed app), Gabi™ Cloud, and Gabi™ Analytics web interface. The Gabi™ Band uses reflectance-based photoplethysmography (PPG) with a light source and photodetector to measure SpO2 and pulse rate; an integrated accelerometer detects motion. The Gabi™ Monitor App records data and transmits it via Wi-Fi to the Gabi™ Cloud. Healthcare professionals access data via Gabi™ Analytics for remote review. The device is intended for home use; it does not provide real-time physiological alarms. It assists clinicians by providing recorded physiological data for review, aiding in the assessment of well-perfused pediatric patients in non-motion conditions. ## Clinical Evidence Clinical study conducted on 12 healthy adult volunteers (ages 22-30) with varying skin pigmentations. Study used non-randomized, concurrent control design. Hypoxia induced (70-100% SpO2). Comparator: ABL-90 multi-wavelength oximeter. Total of 436 data points collected. Primary endpoint: SpO2 accuracy (Arms). Result: 2.95% Arms, meeting the ≤3.5% requirement for non-motion conditions. Bench testing also performed per ISO 80601-2-61:2017. ## Technological Characteristics Reflectance-based PPG oximetry; light source and photodetector; integrated accelerometer for motion detection. Materials: Biocompatible per ISO 10993-1. Connectivity: Wi-Fi/Bluetooth. Power: Rechargeable Li-ion battery or AC power. Standards: IEC 60601-1, IEC 60601-1-2, ISO 80601-2-61, IEC 62366-1. ## Regulatory 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. ## Predicate Devices - Masimo Rad-G Pulse Oximeter and Accessories ([K201770](/device/K201770.md)) ## Reference Devices - WesperO2 ([K213515](/device/K213515.md)) - Beddr 200 System ([K190399](/device/K190399.md)) - Current Health System ([K231506](/device/K231506.md)) ## Submission Summary (Full Text) > This content was OCRed from public FDA records by [Innolitics](https://innolitics.com). If you use, quote, summarize, crawl, or train on this content, cite Innolitics at https://innolitics.com. > > Innolitics is a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices, including [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/). {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 acronym along with the full name of the agency on the right. The FDA part of the logo is in blue, with the acronym in a bold, sans-serif font and the full name, "U.S. Food & Drug Administration," written below it in a smaller font. December 21, 2023 Gabi SmartCare SA Edouard Carton COO Rue Emile Francqui 6 Mont-Saint-Guibert, Brabant Wallon 1435 Belgium ## Re: K231531 Trade/Device Name: Pediarity™ Regulation Number: 21 CFR 870.2700 Regulation Name: Oximeter Regulatory Class: Class II Product Code: DQA, DRG Dated: May 26, 2023 Received: May 26, 2023 ## Dear Edouard Carton: 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). {1}------------------------------------------------ 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. {2}------------------------------------------------ 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, # Bradley Q. Quinn -S Bradley Quinn Assistant Director DHT1C: Division of Sleep Disordered Breathing, Respiratory and Anesthesia Devices OHT1: Office of Ophthalmic, Anesthesia, Respiratory, ENT and Dental Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health Enclosure {3}------------------------------------------------ # Indications for Use 510(k) Number (if known) K231531 Device Name Pediarity™ Indications for Use (Describe) The Pediarity™ system is intended for use in the home setting and/or continuous recording of pulse rate (PR) and functional oxygen saturation of arterial hemoglobin (SpO2) of well-perfused infants and children in non-notion conditions. The Pediarity™ system is not a monitoring device and does not provide physiological alarms during use. Measurements are sent to a web server for remote review by a physician. | Type of Use (Select one or both, as applicable) | | |-------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------| | | | #### CONTINUE ON A SEPARATE PAGE IF NEEDED. This section applies only to requirements of the Paperwork Reduction Act of 1995. #### *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.* The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to: > Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov "An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number." {4}------------------------------------------------ | Image: Gabi SMARTCARE logo | Premarket Notification: Traditional 510(k)
Pediarity™ K231531 | Version: 5 | |----------------------------|------------------------------------------------------------------|-----------------------| | | SECTION 5 – 510(K) SUMMARY | Date: 20-
DEC-2023 | # 1. SUBMITTER | Submitter Name: | Gabi SmartCare SA | | |--------------------|----------------------------------------------------------------------|--| | Submitter Address: | Rue Emile Francqui 6, 2nd Floor
1435 Mont-Saint-Guibert - Belgium | | | Phone Number: | +32 472 53 78 41 | | | Contact Person: | Edouard Carton | | | E-Mail: | edouard.carton@gabismartcare.com | | | Date Prepared: | 20-DEC-2023 | | ## 2. DEVICE | Device Trade Name: | Pediarity™ | |-----------------------|-----------------| | Common Name: | Oximeter | | Classification Name: | Oximeter | | Regulation Number: | 21 CFR 870.2700 | | Product Code: | DQA | | Class: | II | | Classification Panel: | Anesthesiology | ## 3. PREDICATE DEVICE | Primary Predicate Device: | Masimo Rad-G Pulse Oximeter and Accessories | |---------------------------|---------------------------------------------| | 510(k) number: | K201770 | # 4. REFERENCE DEVICES | Device Name | WesperO2 | Beddr 200 System | Current Health System | |---------------|----------|------------------|-----------------------| | 510(K) number | K213515 | K190399 | K231506 | {5}------------------------------------------------ | Image: Gobi Smartcare logo | Premarket Notification: Traditional 510(k)
Pediarity™ K231531 | Version: 5 | |----------------------------|------------------------------------------------------------------|------------| | SECTION 5 – 510(K) SUMMARY | Date: 20-
DEC-2023 | | ## 5. DEVICE DESCRIPTION The Pediarity™ system is a non-invasive, innovative, and advanced solution that allows to measure wirelessly several physiological parameters (SpO2, Pulse Rate) of infants and children up to 12 years old in non-motion conditions. The Pediarity™ system is composed of: - a) Gabi™ Band, a non-invasive, wearable, wireless measuring device positioned around the patient's upper arm. - b) Gabi™ Monitor, made of: - Gabi Monitor App: a mobile application dedicated to caregivers, allowing to o start and stop a recording of physiological parameters measured by the Gabi Band, displays measuring information and transfers collected data to the Gabi Cloud via Wi-Fi. - Gabi Monitor Tablet: a tablet provided to the caregiver inside the solution o package, on which the Gabi Monitor App is pre-installed. - c) A Gabi™ Cloud, an online service that stores and manages the collected data and shares them with Gabi Analytics. - d) Gabi™ Analytics, a web interface allowing the Healthcare Professionals (HCP) to access and review remotely the physiological parameters of the patient. The Pediarity™ system is illustrated in Figure 1. Image /page/5/Figure/11 description: The image shows a diagram of the Gabi system, which includes the Gabi Band, Gabi Monitor, Gabi Cloud, and Gabi Analytics. The Gabi Band is a wearable device that tracks the user's vital signs. The Gabi Monitor is a mobile app that displays the user's vital signs and allows them to record their symptoms. The Gabi Cloud is a secure cloud storage system that stores the user's data. The Gabi Analytics is a web-based platform that allows healthcare providers to view and analyze the user's data. Figure 1: Pediarity System components #### 6. INDICATIONS FOR USE The Pediarity™ system is intended for use in the home setting for spot checking and/or continuous recording of pulse rate (PR) and functional oxygen saturation of arterial hemoglobin (SpO2) of well-perfused infants and children in non-motion conditions. The Pediarity™ system is not a monitoring device and does not provide physiological alarms during use. Measurements are sent to a web server for remote review by a physician. {6}------------------------------------------------ | Image: Gobi Smartcare Logo | Premarket Notification: Traditional 510(k)
Pediarity™ K231531 | Version: 5 | |----------------------------|------------------------------------------------------------------|-----------------------| | | SECTION 5 – 510(K) SUMMARY | Date: 20-
DEC-2023 | ## 7. TECHNOLOGICAL CHARACTERISTICS Pediarity™ uses the principle of pulse oximetry, which is based upon the fundamental principle that hemoglobin bound to oxygen (oxyhemoglobin unbound to oxygen (deoxyhemoglobin) absorb light differently. This variation in absorption can then be used to determine the SpO₂. PPG technology is also used to obtain the pulse rate (PR) based on the variation in blood volume in the body. The sensor uses the non-invasive photoplethysmography (PPG) technology to continuously measure Pulse Rate (PR) and Oxygen Saturation (SpO2). The technology contains a light source and a photodetector. Gabi™ Band is applied to the patient's upper arm where the light source emits light to the tissue and the photodetector measures the intensity of reflected light from the tissue. Consequently, this light quantity is less than the one sent by the light source, as some has been absorbed by the tissues and blood. The measurement of motion is enabled by an accelerometer. The signals obtained by the photodetector are then processed and passed to the Gabi™ Monitor App where the values of SpO2, PR and movement are then displayed. #### 8. COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH PREDICATE DEVICE The comparison chart below provides evidence to facilitate the substantial equivalence determination between the Pediarity™ and the predicate device. Masimo Rad-G Pulse Oximeter and Accessories (K201770) with respect to intended use, technological characteristics and principles of operation. | Feature | Proposed Device | Primary Predicate
Device | Assessment of
Equivalence | |----------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Device name | Pediarity™ | Masimo Rad-G Pulse
Oximeter and Accessories | NA | | 510(k) Number | NA | K201770 | NA | | Manufacturer | Gabi SmartCare SA | Masimo Corporation | NA | | Regulation
Number | 870.2700 | 870.2700 | Same | | Device Class | Class II | Class II | Same | | Device
Classification
Name | Oximeter | Oximeter | Same | | Product Code | DQA | DQA | Same | | Secondary
Product Code | DRG | BZQ, DPZ | Similar
Pediarity™ includes DRG
as its secondary code as it
uses radiofrequency to
transmit conditioned
physiological signal from
one location to another
(Gabi Band to Gabi Monitor). | | Feature | Proposed Device | Primary Predicate Device | Assessment of Equivalence | | Indications for
use | The Pediarity™ system is
intended for use in the
home setting for spot
checking and/or
continuous recording of
pulse rate (PR) and
functional oxygen
saturation of arterial
hemoglobin (SpO2) of
well-perfused infants and
children in non-motion
conditions.
The Pediarity™ system is
not a monitoring device
and does not provide
physiological alarms
during use.
Measurements are sent
to a web server for
remote review by a
physician. | The Rad-G Pulse
Oximeter and Accessories
are intended for the non-
invasive spot-checking or
continuous monitoring of
functional oxygen
saturation of arterial
hemoglobin (SpO2), Pulse
Rate (PR), and Pleth
Respiration Rate (RRp).
The Rad-G Pulse
Oximeter and Accessories
are indicated for non-
invasive spot-checking or
continuous monitoring of
functional oxygen
saturation of arterial
hemoglobin (SpO2) and
Pulse Rate (PR) of adult,
pediatric, infant, and
neonate patients during
both no motion and motion
conditions, and for patients
who are well or poorly
perfused in hospitals,
hospital-type facilities,
transport, and home
environments. The Rad-G
Pulse Oximeter and
Accessories are indicated
for the spot-checking or
continuous monitoring of
Respiration Rate from the
photoplethysmogram
(RRp) of adult and
pediatric patients during no
motion conditions | DPZ does not apply to
Pediarity™ as the subject
device is not intended to be
used as an ear oximeter.

BZQ does not apply to the
Pediarity™ as the subject
device is not intended to be
used as a breathing
frequency monitor.

Therefore, this difference
does not raise new
questions of safety or
effectiveness.

Similar

The subject device
intended use includes a
subset of the physiological
parameters, target
population and use
environment of the
predicate device.

Both devices measure
physiological parameters
in well-perfused infants
and children in non-motion
conditions.

This difference does not
raise new questions of
safety or effectiveness. | | Feature | Proposed Device | Primary Predicate Device | Assessment of Equivalence | | Intended patient population | Infants and children up to and including 12 years of age | Adults and pediatrics (all parameters),
Adults, pediatrics, infants and neonates (SpO2, PR) | Similar
The subject device target population is a subset of the predicate device.
This difference does not raise new questions of safety or effectiveness. | | Anatomical sites | Upper arm | Finger or foot | Similar
Both devices are worn to provide device access to peripheral arteries.
Differences in wearing location on the body does not raise new questions of safety or efficacy in this case. | | Display Type | GabiTM Monitor Tablet:
Touchscreen | Touchscreen | Same | | Alarm Type | No physiological alarm | Visual, Audible | Similar
The subject device is not intended for continuous vital sign monitoring and is intended to be used outside hospital-type facilities.
This difference does not raise new questions of safety or effectiveness. | | Technology | Reflectance based oximetry | Transmittance based oximetry | Similar
Both technologies rely on the principle that hemoglobin at different oxygenation states absorbs light differently based upon the wavelength of light. Both methods (reflectance and transmittance) are well understood and accepted methodologies to accurately measure SpO2 and Pulse Rate.
The technology difference | | Feature | Proposed Device | Primary Predicate
Device | Assessment of
Equivalence | | | | | questions of safety or effectiveness. | | | | | Additionally, the Beddr 200
System (K190399), an
oximeter cleared by the
FDA with the same
classification and same
technology as the subject
device, is used to further
support the fact that the
technology of the subject
device does not raise new
question of safety and
effectiveness. | | | | | Supported
Parameters | | | | | Additionally, the Current
Health System (K231506),
a monitoring device
cleared by the FDA with
the same classification and
similar supported
parameters as the subject
device, is used to further
support the fact that the
movement parameter use
in the subject device does
not raise new question of
safety and effectiveness. | | | | | Display range:
SpO2 | | Feature | Proposed Device | Primary Predicate
Device | Assessment of
Equivalence | | Display range:
Pulse Rate | 25 – 250 bpm | 25 – 240 bpm | new questions of safety or
effectiveness.
Similar
The subject device
displays similar range as
predicate device.
Therefore, this difference
does not raise new
questions of safety or
effectiveness. | | Display range:
Movements | ± 2G | None… --- **Source:** [https://fda.innolitics.com/submissions/AN/subpart-c%E2%80%94cardiovascular-monitoring-devices/DQA/K231531](https://fda.innolitics.com/submissions/AN/subpart-c%E2%80%94cardiovascular-monitoring-devices/DQA/K231531) **Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices. If you're preparing [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/), [get in touch](https://innolitics.com/contact). **Cite:** Innolitics at https://innolitics.com