(209 days)
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.
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.
Here's an analysis of the acceptance criteria and the study proving the device meets those criteria, based on the provided document:
1. Table of acceptance criteria and reported device performance:
| Feature | Acceptance Criteria (from ISO 80601-2-61:2017 & FDA Guidance) | Reported Device Performance (Pediarity™) |
|---|---|---|
| SpO2 Accuracy (Arms), non-motion, 70-100% | ≤ 3.5% | 2.95% |
| Pulse Rate Accuracy (non-motion) | 3 bpm (implied by predicate, as it's the same) | 3 bpm |
Note: The document explicitly states the SpO2 accuracy requirement of less than or equal to 3.5%. The pulse rate accuracy of 3 bpm is stated as "Same" as the predicate, implying it meets the same standard.
2. Sample size used for the test set and the data provenance:
- Sample Size (Clinical Study): 12 healthy adult male and female volunteers.
- Data Provenance: The clinical studies were conducted in the United States. They appear to be prospective, as hypoxia was induced to different and stable levels of oxyhemoglobin saturation.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
The document does not explicitly state the number of experts used to establish ground truth or their qualifications. However, for the SpO2 accuracy clinical study, ground truth was established by:
- Blood gas analysis using an ABL-90 multi-wavelength oximeter. This is a highly accurate method for determining oxyhemoglobin saturation and is considered the gold standard for ground truth in SpO2 accuracy studies. The operation and interpretation of this equipment would typically be performed by trained medical professionals (e.g., laboratory technicians, physicians) who are experts in blood gas analysis, but their specific number and qualifications are not provided.
4. Adjudication method for the test set:
Not applicable. The ground truth for SpO2 accuracy was established through direct measurement by a reference device (ABL-90 multi-wavelength oximeter) rather than expert consensus requiring adjudication.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, if so, what was the effect size of how much human readers improve with AI vs without AI assistance:
Not conducted. This type of study (MRMC for AI assistance) is not relevant to this device, which is a standalone oximeter measuring physiological parameters.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
Yes, a standalone clinical study was performed to demonstrate the SpO2 accuracy of the Pediarity™ system. The device itself performs the measurement and calculation of SpO2 and Pulse Rate.
7. The type of ground truth used:
For the SpO2 accuracy clinical study, the ground truth was blood gas analysis performed using an ABL-90 multi-wavelength oximeter.
8. The sample size for the training set:
The document does not specify the sample size for any training set. It describes a clinical study for performance validation (testing) and refers to software verification and validation, but not a specific training set size for an AI/ML algorithm (though it does mention "the signals obtained by the photodetector are then processed," which could imply an algorithm).
9. How the ground truth for the training set was established:
The document does not provide information on a training set or how its ground truth was established.
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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).
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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.
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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
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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) | |
|---|---|
| Prescription Use (Part 21 CFR 801 Subpart D) | Over-The-Counter Use (21 CFR 801 Subpart C) |
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| 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 Floor1435 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 |
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| 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.
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| 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 PredicateDevice | Assessment ofEquivalence |
|---|---|---|---|
| Device name | Pediarity™ | Masimo Rad-G PulseOximeter and Accessories | NA |
| 510(k) Number | NA | K201770 | NA |
| Manufacturer | Gabi SmartCare SA | Masimo Corporation | NA |
| RegulationNumber | 870.2700 | 870.2700 | Same |
| Device Class | Class II | Class II | Same |
| DeviceClassificationName | Oximeter | Oximeter | Same |
| Product Code | DQA | DQA | Same |
| SecondaryProduct Code | DRG | BZQ, DPZ | SimilarPediarity™ includes DRGas its secondary code as ituses radiofrequency totransmit conditionedphysiological signal fromone location to another(Gabi Band to Gabi Monitor). |
| Feature | Proposed Device | Primary Predicate Device | Assessment of Equivalence |
| Indications foruse | The Pediarity™ system isintended for use in thehome setting for spotchecking and/orcontinuous recording ofpulse rate (PR) andfunctional oxygensaturation of arterialhemoglobin (SpO2) ofwell-perfused infants andchildren in non-motionconditions.The Pediarity™ system isnot a monitoring deviceand does not providephysiological alarmsduring use.Measurements are sentto a web server forremote review by aphysician. | The Rad-G PulseOximeter and Accessoriesare intended for the non-invasive spot-checking orcontinuous monitoring offunctional oxygensaturation of arterialhemoglobin (SpO2), PulseRate (PR), and PlethRespiration Rate (RRp).The Rad-G PulseOximeter and Accessoriesare indicated for non-invasive spot-checking orcontinuous monitoring offunctional oxygensaturation of arterialhemoglobin (SpO2) andPulse Rate (PR) of adult,pediatric, infant, andneonate patients duringboth no motion and motionconditions, and for patientswho are well or poorlyperfused in hospitals,hospital-type facilities,transport, and homeenvironments. The Rad-GPulse Oximeter andAccessories are indicatedfor the spot-checking orcontinuous monitoring ofRespiration Rate from thephotoplethysmogram(RRp) of adult andpediatric patients during nomotion conditions | DPZ does not apply toPediarity™ as the subjectdevice is not intended to beused as an ear oximeter.BZQ does not apply to thePediarity™ as the subjectdevice is not intended to beused as a breathingfrequency monitor.Therefore, this differencedoes not raise newquestions of safety oreffectiveness.SimilarThe subject deviceintended use includes asubset of the physiologicalparameters, targetpopulation and useenvironment of thepredicate device.Both devices measurephysiological parametersin well-perfused infantsand children in non-motionconditions.This difference does notraise new questions ofsafety 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) | SimilarThe 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 | SimilarBoth 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 | SimilarThe 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 | SimilarBoth 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 PredicateDevice | Assessment ofEquivalence |
| questions of safety or effectiveness. | |||
| Additionally, the Beddr 200System (K190399), anoximeter cleared by theFDA with the sameclassification and sametechnology as the subjectdevice, is used to furthersupport the fact that thetechnology of the subjectdevice does not raise newquestion of safety andeffectiveness. | |||
| SupportedParameters | |||
| Additionally, the CurrentHealth System (K231506),a monitoring devicecleared by the FDA withthe same classification andsimilar supportedparameters as the subjectdevice, is used to furthersupport the fact that themovement parameter usein the subject device doesnot raise new question ofsafety and effectiveness. | |||
| Display range:SpO2 | |||
| Feature | Proposed Device | Primary PredicateDevice | Assessment ofEquivalence |
| Display range:Pulse Rate | 25 – 250 bpm | 25 – 240 bpm | new questions of safety oreffectiveness.SimilarThe subject devicedisplays similar range aspredicate device.Therefore, this differencedoes not raise newquestions of safety oreffectiveness. |
| Display range:Movements | ± 2G | None | SimilarAs mentioned above, themovement is not measuredby the predicate device.However, this is only asecondary feature of thesubject device.Additionally, the CurrentHealth System (K231506),a monitoring devicecleared by the FDA withthe same classification andsimilar supportedparameters as the subjectdevice, is used to furthersupport the fact that themovement parameter usein the subject device doesnot raise new question ofsafety and effectiveness. |
| Performance(Arms), non-motion, 70-100%: SpO2 | 2.95% | 2%(Adults/Pediatrics/Infants)3% (Neonates) | SimilarBoth devices meet thenecessary accuracyrequirements for 70-100%related to its technology asindicated in both the FDAguidance on PulseOximeter – PremarketNotification Submissions[510(k)s] and the ISO80601-2-61.This difference does not raisenew questions of safety oreffectiveness. |
| Performance(Arms), non-motion: PulseRate | 3 bpm | 3 bpm | Same |
| Feature | Proposed Device | Primary PredicateDevice | Assessment ofEquivalence |
| Environment ofuse | Home environment | Hospitals, hospital-typefacilities, transport, andhome environment | SimilarThe subject device useenvironment is a subset ofthe predicate and thereforedoes not raise newquestions of safety andeffectiveness. |
| OperatingTemperature | 5 – 35°C (41 – 95°F) | 0 – 50°C (32 – 122°F) | SimilarThe subject deviceOperating Temperature isa subset of the predicateand therefore does notraise new questions ofsafety and effectiveness. |
| Operational/Storage Humidity | 15 – 90% | 10 – 95%, non-condensing | SimilarThe subject deviceOperational/StorageHumidity is a subset of thepredicate and thereforedoes not raise newquestions of safety andeffectiveness. |
| OperatingAtmosphericPressure | 700 – 1060hPa | 540 – 1060hPa | SimilarThe subject deviceoperating AtmosphericPressure is a subset of thepredicate device.This difference does notraise new questions ofsafety or effectiveness. |
| SupportedPower Source | AC Power or InternalBattery | AC Power or InternalBattery | Same |
| Internal BatteryType | Rechargeable LithiumIon | Rechargeable Lithium Ion | Same |
| AC PowerSource | External AC PowerSupply | External AC Power Supply | Same |
| AC Power | GabiTM Monitor Tablet:100-240 VAC, 50-60Hz,0.4AGabiTM Band: 100-240VAC, 50-60Hz, 0.2A | 100-240 VAC, 50/60 Hz,0.6A | SimilarDifferent charging currentswill lead to differentcharging times. It wasdemonstrated in non-clinical performancetesting that the speed ofcharging of the subjectdevice is sufficient to meetthe needs of use and itsspecifications. |
| Feature | Proposed Device | Primary Predicate Device | Assessment of Equivalence |
| Network | Wireless (Wi-Fi and Bluetooth) | Wireless (e.g. Wi-Fi, Bluetooth) | difference does not raise new questions of safety or effectiveness. |
| Mode of operation | Spot-check and/or continuous data collection | Continuous & Spot-checking | SimilarThe IFU of the subject device explicitly mentions that it is not a monitoring device, and it does not provide physiological alarms during use, while the predicate device is intended for spot-checking or continuous monitoring and has an alarm function. As mentioned in the FDA guidance on Pulse Oximeters from March 4, 2013, high and low SpO2 and pulse rate alarms should be included for pulse oximeters intended for continuous monitoring only. This difference does not raise any new safety and effective concerns as the subject device is not intended for continuous monitoring and is not intended to be used in the hospital setting as a monitoring device.Additionally, WesperO2 (K213515), an oximeter cleared by the FDA with the same classification and same mode of operation as the subject device, is used to further support the fact that the mode of operation of the subject device does not raise new question of safety and effectiveness. |
Table 1: Comparison of subject device to predicate device
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Image /page/7/Picture/0 description: The image shows the logo for Gabi Smartcare. The logo consists of two parts: a light blue rounded square on the left and the word "Gabi" with "SMARTCARE" underneath on the right. Inside the blue square is a white stylized letter "g" with a circular shape and a tail extending from the bottom. The word "Gabi" is written in a gray sans-serif font, and "SMARTCARE" is in a smaller font size and positioned directly below the "bi" portion of "Gabi."
SECTION 5 – 510(K) SUMMARY
Date: 20DEC-2023
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Image /page/8/Picture/0 description: The image shows the logo for Gabi Smartcare. The logo consists of a light blue rounded square with a white stylized "g" inside it. To the right of the square is the word "Gabi" in gray, with the word "SMARTCARE" in smaller gray letters underneath.
SECTION 5 – 510(K) SUMMARY
Date: 20DEC-2023
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Image /page/9/Picture/0 description: The image contains the logo for Gabi Smartcare. On the left is a light blue square with rounded corners. Inside the square is a white lowercase letter 'g' with a tail that extends below the letter. To the right of the square is the word 'Gabi' in gray, with the word 'SMARTCARE' in smaller gray letters below it.
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Image /page/10/Picture/0 description: The image shows the logo for Gabi Smartcare. The logo features a light blue square with a white lowercase "g" inside. To the right of the square is the word "Gabi" in gray, with the word "SMARTCARE" in smaller gray letters underneath.
SECTION 5 – 510(K) SUMMARY
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Image /page/11/Picture/0 description: The image shows the logo for Gabi Smartcare. The logo consists of two parts: a blue square with rounded corners on the left and the word "Gabi" in gray on the right. Inside the blue square is a white stylized letter "g" with a tail that extends to the bottom right corner. Below the word "Gabi" is the word "SMARTCARE" in smaller gray letters.
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Image /page/12/Picture/0 description: The image shows the logo for Gabi Smartcare. The logo features a light blue rounded square with a white lowercase 'g' inside, stylized with a curved line extending from the bottom. To the right of the square is the word 'Gabi' in gray, with 'SMARTCARE' in smaller gray letters underneath.
SECTION 5 – 510(K) SUMMARY
Equivalence:
The Pediarity™ is comparable to the predicate device with similar technological characteristics and intended use, specifically to measure physiological parameters in well-perfused infants
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| Image: Gobi Smartcare Logo | Premarket Notification: Traditional 510(k)Pediarity™ K231531 | Version: 5 |
|---|---|---|
| SECTION 5 – 510(K) SUMMARY | Date: 20-DEC-2023 |
and children in non-motion conditions. Both devices can be used in a home environment and both devices use rechargeable lithium-lon battery. Pediarity™ thus meets the requirements for 510(k) substantial equivalence.
Differences that are demonstrated to be substantially equivalent:
As indicated in Table 1 above, several differences with respect to technological characteristics were identified between Pediarity™ and the predicate device, namely anatomical sites, alarm type, oximetry technology, measured parameters and mode of operation. Performance testing was conducted to demonstrate substantial equivalence of Pediarity™ to the predicate device in terms of safety and performance. The test results are summarized below.
9. PERFORMANCE DATA
| BiocompatibilityTesting: | The Gabi™ band, which is the only part intended to make direct contactwith the patient, was the subject of a range of biocompatibility tests inaccordance with ISO 10993-1 including:Cytotoxicity, 10993-5:2009 Sensitization, 10993-10:2021 Irritation, 10993-23:2021 Test results demonstrate that the patient contacting materials meet thebiological safety requirements for its categorization. No toxicologicalhazards are associated with the use of the materials of Pediarity™ andno appreciable toxicological risk are likely to arise from its intended use. |
|---|---|
| Electrical Safetyand EMC testing: | Pediarity™ complies with the IEC 60601-1:2005/AMD2:2021, IEC 60601–1-6:2010, ISO 80601-2-61:2017 standards for safety and the IEC 60601-1-2:2014/Amd1:2021 standard for EMC. Electrical safety testing andElectromagnetic Compatibility testing results show that Pediarity™ meetsits specifications. |
| SoftwareVerification andValidationTesting: | Software verification and validation testing were conducted, and thedocumentation is provided as recommended by FDA's Guidance,Guidance for the Content of Premarket Submissions for SoftwareContained in Medical Devices, dated May 11, 2005 and in compliancewith ISO 62304:2006/Amd1:2015. The software for this device isconsidered as a "moderate" level of concern, as defined by the FDAguidance, Guidance for Industry and FDA Staff – Pulse Oximeters –Premarket Notification Submissions [510(k)s], dated March 4, 2013,which identifies that a failure or latent flaw in the software could directlyresult in minor to moderate injury to the patient. |
| Usability Testing: | Pediarity™ was assessed with regards to usability and complies with IEC62366-1:2015 + AMD1:2020 – Medical devices - Application of usabilityengineering to medical devices. The Usability Testing was conducted andthe documentation is provided as recommended by FDA's Guidance onApplying Human Factors and Usability Engineering to Medical Devices,dated February 3, 2016 |
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| Image: GabiSMARTCARE | Premarket Notification: Traditional 510(k)Pediarity™ K231531 | Version: 5 |
|---|---|---|
| SECTION 5 – 510(K) SUMMARY | Date: 20-DEC-2023 |
Pediarity™ was subjected to bench testing, including pulse rate validation Non-clinical tests to validate the pulse rate feature and to confirm its accuracy in Performance Testing: accordance with ISO 80601-2-61:2017 and the FDA Pulse Oximeters -Premarket Notification Submissions: Guidance for Industry and FDA Staff, issued on March 4, 2013 and the performance and safety of PediarityTM. Bench testing also included SpO2 validation tests, to validate the SpO2 feature and to confirm its accuracy over the complete range. Non-clinical Performance Testing results demonstrate that Pediarity 100 is safe and effective for the patients considering its intended use.
- Clinical Testing: One clinical study was performed with Pediarity™ to demonstrate substantial equivalence of SpO2 accuracy with Clause 201.12.1.101.1 of ISO 80601-2-61:2017 as recommended in the FDA guidance on Pulse Oximeters - Premarket Notification Submissions. Both clinical studies were conducted in the United States.
The clinical test, non-randomized with concurrent ("active") control, performed for measuring SpO2 was completed on a total of 12 healthy adult male and female volunteers of age 22-30 with different skin pigmentations. All of the subjects enrolled in the study had normal hemoglobin levels (Hemoglobin ≥ 10 gm*dl"). Two devices were used in the study. Hypoxia was induced to different and stable levels of oxyhemoglobin saturation (between 70% to 100%). Blood gas analysis to determine oxyhemoglobin saturation was performed using an ABL-90 multi wavelength oximeter. The obtained SpO2 accuracy result is 2.95% with a total combined data points of 436 between the two tested devices (at least 200 data points per device). Therefore, the subject device meets the accuracy requirement of less than or equal to 3.5% under no motion condition. The accuracy specification is reported as accuracy root mean square (Arms).
Results of the clinical study support the indications for use of Pediarity™, its conformance with ISO 80601-2-61:2011 and substantial equivalence to the predicate device.
10. CONCLUSION
The subject device, Pediarity™, and the predicate device, Masimo Rad-G Pulse Oximeter and Accessories, have an equivalent intended use and the differences in technological features do not raise questions of safety and effectiveness. The information discussed above and provided in the 510(k) submission demonstrate that the Pediarity™ is substantially equivalent to the predicate device.
§ 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).