Celsi Monitor is intended for use in hospitals under a clinician's supervision or at their direction to assist nurses in continuous temperature monitoring of neonates. The device abdominal skin temperature through direct contact.

Device Description

Celsi Monitor is a non-invasive continuous temperature monitor. Celsi Monitor achieves its intended purpose by measuring temperature at the surface of a neonate's abdomen by sensing changes in electrical resistance of a thermistor that is in thermal contact with the skin at the measured point. Celsi Monitor is provided with the Celsi Belt. The Celsi Monitor is powered by two rechargeable lithium-ion batteries. Both the Celsi Belt and Celsi Probe are reusable. The device displays measured patient body temperature for up to 12 hours and alarms when the temperature falls outside normothermic levels (<36.5 or >37.5 °C). The device is a skin contacting surface device with duration of contact < 24 hours.

AI/ML Overview

This document is a 510(k) Premarket Notification from the FDA for the "Celsi Monitor" device. It outlines the device's characteristics, intended use, and a comparison to a predicate device, along with summaries of testing performed.

Acceptance Criteria and Device Performance:

The document doesn't explicitly list "acceptance criteria" in a table form with specific performance thresholds for the Celsi Monitor. Instead, it describes general compliance with standards and comparable performance to a predicate device. Its primary acceptance criterion for the 510(k) clearance is demonstrating substantial equivalence to an existing legally marketed device (the predicate device). This substantial equivalence is shown through similar intended uses, technological characteristics, and a demonstration that any differences do not raise new questions of safety or effectiveness.

The "study that proves the device meets the acceptance criteria" refers to the non-clinical and clinical testing performed to support the claim of substantial equivalence.

Here's an attempt to structure the information based on the prompt's request for acceptance criteria and device performance, drawing from the provided text:

Table of Performance and (Implied) Acceptance Criteria:

Performance Metric/Aspect	Implied Acceptance Criteria (Demonstrated Equivalence)	Reported Device Performance (Summary of Testing from Document)
Temperature Measurement Accuracy	Comparable accuracy to the reference (predicate) device (Philips Intellivue MP30)	"Results from both [short and long duration] studies demonstrated comparable temperature measurement accuracy between the subject and predicate devices." (Note: The predicate for this comparison is the Philips Intellivue MP30, K061610, not the Cadi SmartSense, K083185, which is the primary predicate for the 510(k) itself. This indicates the Philips device was used as a reference for accuracy.)
Effects on Subject's Skin	Safe for contact with skin; no adverse effects on skin over duration of use.	Evaluated in short (3 hour) and long (12 hour) clinical studies. Implied satisfactory results as it concluded differences do not raise new safety questions.
Biocompatibility	No cytotoxicity, sensitization, or irritation. Compliance with ISO 10993-5:2009, ISO 10993-10:2010, and ISO 10993-23:2010:2021.	"The subject device was evaluated for cytotoxicity, sensitization, and irritation in compliance to ISO 10993-5:2009, ISO 10993-10:2010, and ISO 10993-23:2010:2021." (Implied successful compliance for substantial equivalence).
Software Verification & Validation	Compliance with IEC 62304.	"The software development and testing were executed with consideration to IEC 62304."
Cybersecurity	Evaluation per AAMI TIR57.	"Cybersecurity was evaluated per AAMI TIR57."
Electromagnetic Compatibility (EMC)	Compliance with IEC 60601-1:2012, IEC 60601-1-2:2014, etc.	"The subject device was tested in compliance with IEC 60601-1:2012, IEC 60601-1-2:2014, IEC 60601-1-6:2013, IEC 60601-1-8:2012, ISO 80601-2-56:2017, and IEC 62133:2012." (Implied successful compliance).
Electrical Safety	Compliance with IEC 60601-1:2012, etc.	"The subject device was tested in compliance with IEC 60601-1:2012, IEC 60601-1-2:2014, IEC 60601-1-6:2013, IEC 60601-1-8:2012, ISO 80601-2-56:2017, and IEC 62133:2012." (Implied successful compliance).
Lifetime Analysis	Meets performance after simulated use cycles.	"Lifetime analysis testing after 100 simulated use cycles ISO 80601-2-56:2017." (Implied satisfactory results as it concluded differences do not raise new safety questions).

Detailed Study Information:

Sample Size Used for the Test Set and Data Provenance:
- Test Set Sample Size: Not explicitly stated in terms of number of neonates or temperature readings. The document mentions "A short duration (3 hour) and long duration (12 hour) clinical evaluation was performed".
- Data Provenance: Not explicitly stated (e.g., country of origin). The studies were "clinical evaluations" and thus would be prospective in nature, designed to test the device's performance directly on subjects.
Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications:
- Not applicable in the context of this device. This is a temperature monitor; ground truth is established by a reference thermometer (Philips Intellivue MP30) or direct physical measurements, not by expert interpretation.
Adjudication Method for the Test Set:
- Not applicable as the ground truth is objective temperature measurement rather than subjective interpretation requiring adjudication.
If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done:
- No, a MRMC study was not described. This type of study is typically for evaluating diagnostic imaging AI where human readers interpret cases. The Celsi Monitor is a measurement device.
If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Yes, the clinical evaluation directly assessed the device's (Celsi Monitor's) temperature measurement performance. While used by nurses, the core "performance" being evaluated (temperature accuracy) is a standalone function of the device itself.
The Type of Ground Truth Used:
- Reference device measurement: The "subject device was compared to the reference device, the Philips Intellivue MP30 (K061610)." The Philips Intellivue MP30 serves as the ground truth for temperature measurements.
The Sample Size for the Training Set:
- Not applicable. This document describes the clearance of a medical device (a thermometer), not an AI/ML algorithm that requires a "training set" in the conventional sense for machine learning. The device's performance is based on its physical design and calibration, not learned from data.
How the Ground Truth for the Training Set was Established:
- Not applicable, as there is no "training set" for this type of device.

Summary

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August 16, 2023

Hadleigh Health Technologies % Allison Komiyama Consultant Rqm+ 2251 San Diego Ave Suite B-257 San Diego, California 92110

Re: K230298

Trade/Device Name: Celsi Monitor Regulation Number: 21 CFR 880.2910 Regulation Name: Clinical Electronic Thermometer Regulatory Class: Class II Product Code: FLL Dated: July 17, 2023 Received: July 18, 2023

Dear Allison Komiyama:

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.

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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 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 (QS) 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 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.

Porsche Bennett

Porsche Bennett For David Wolloscheck, Ph.D. Assistant Director DHT3C: Division of Drug Delivery and General Hospital Devices, and Human Factors OHT3: Office of GastroRenal, ObGyn, General Hospital and Urology 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) K230298

Device Name Celsi Monitor

Indications for Use (Describe)

Celsi Monitor is intended for use in hospitals under a climician's supervision or at their direction to assist nurses in continuous temperature monitoring of neonates. The device abdominal skin temperature through direct contact.

Type of Use (Select one or both, as applicable)

Designation Use (Part 61 CFR 901 Subpart D)	☑
Service Contract Use (61 CFR 93)	☐

X Prescription Use (Part 21 CFR 801 Subpart D)

| | Over-The-Counter Use (21 CFR 801 Subpart C)

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Image /page/3/Picture/0 description: The image shows the logo for Hadleigh Health Technologies. The logo consists of a red symbol that resembles a stylized letter "H" or a medical cross. To the right of the symbol, the words "HADLEIGH HEALTH" are written in a larger, blue font, with the word "TECHNOLOGIES" appearing below in a smaller, blue font.

510(k) Summary K230298

DATE PREPARED

August 16, 2023

MANUFACTURER AND 510(k) OWNER

Hadleigh Health Technologies 200 Gate Five Road, Suite 215 Sausalito, CA 94965 Telephone: Official Contact: Molly McCabe, Managing Director, Projects

REPRESENTATIVE/CONSULTANT

Allison C. Komiyama, PhD, RAC Dulciana Chan, MSE RQM+ Telephone: +1 (412) 816-8253 Email: akomiyama@rqmplus.com dchan@rqmplus.com

DEVICE INFORMATION

Proprietary Name/Trade Name:	Celsi Monitor
Regulation Name:	Clinical Electronic Thermometer
Regulation Number:	21 CFR 880.2910
Regulation Class:	Class II
Product Code:	FLL
Premarket Review:	Drug Delivery and General Hospital Devices, and HumanFactors (DHT3C)
Review Panel:	General Hospital

PREDICATE DEVICE IDENTIFICATION

The Celsi Monitor is substantially equivalent to the following predicate:

510(k) Number	Predicate Device Name / Manufacturer	Primary Predicate
K083185	Cadi SmartSense Wireless Temperature MonitoringSystem / Cadi Scientific Pte. Ltd	✓

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Image /page/4/Picture/0 description: The image shows the logo for Hadleigh Health Technologies. The logo consists of a red symbol that looks like a stylized letter "H" or a cross. To the right of the symbol, the words "HADLEIGH HEALTH" are written in a sans-serif font, with the word "TECHNOLOGIES" written below in a smaller font size. The text is in a light blue color.

DEVICE DESCRIPTION

INDICATIONS FOR USE

COMPARISON OF TECHNOLOGICAL CHARACTERISTICS

Hadleigh Health believes Celsi Monitor is substantially equivalent to the predicate device based on the information summarized here:

The subject device has a similar design and intended use as the device cleared in K083185. Both devices may be used on neonates, are intended to continuously monitor patient temperature, alert users if temperatures are outside of the normothermic range, and uses thermistors as temperature sensors. Both devices have temperature sensors that are applied directly to the skin on the abdomen. The main differences between the subject and predicate device are the temperature probe application and device display. The subject device uses an adjustable belt to maintain contact between the patient and the temperature probe (Celsi Probe). However, the temperature probe of the predicate device is adhered to the patient with a single use application tape. The temperature probe of the subject device connects to a small monitor (Celsi Monitor) with a screen to display results and alerts to the user. The predicate device's temperature probe wirelessly connects to a receiver which can then send temperature data and alerts to be displayed on a PC or tablet. However, these technological characteristics do not raise different questions of safety and effectiveness and have undergone testing to ensure the subject device is substantially equivalent to the predicate device.

In summary, the subject and predicate devices are based on the following same technological elements:

Use of thermistor with direct skin contact on the abdomen .
The following differences exist between the subject and predicate devices:
Use of an adjustable belt to maintain contact between the patient and the temperature . probe
. Use of a small monitor to display measurements

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	Subject Device	Predicate Device	Comparison
	HadleighHealthTechnologies CelsiMonitor	CADI Scientific Pte.Ltd.Cadi SmartSense WirelessTemperature MonitoringSystemK083185	N/A
Indications forUse	Celsi Monitor isintended for use inhospitals under aclinician's supervisionor at their direction toassist nurses incontinuoustemperaturemonitoring ofneonates. The devicemeasures abdominalskin temperaturethrough direct contact.	The Cadi SmartSenseWireless TemperatureMonitoring System isintended to measureabdominal surfacetemperature in adultsthrough neonates. TheThermoSENSOR, a reusabletemperature sensor, isapplied to the patient bymeans of single useapplication tapes. TheThermoSENSOR providesperiodic wirelesstransmission of temperaturedata which is utilized by theSmartNODE wireless receiverand the SmartSense PCapplication program torecord, store, and display thetemperature information.Warning: This equipmentmeasures and reportsabdominal surfacetemperature - where directmeasurements of body coretemperature are required, itis recommended to utilizeappropriatecore temperaturemonitoring devices for thispurpose.	Similar: Both devicesare intended tocontinuously monitorpatient skintemperature, alertusers to temperaturesoutside of thenormothermic range,and use thermistors astemperature sensors.Temperature sensorsare applied directly tothe skin on theabdomen of neonates.Clinical and non-clinicaltesting have beenadequately conductedto demonstrate thedifferences do not raisenew or differentquestions of safety andeffectiveness.
Product Codes /RegulationNumber	FLL / 21 CFR 880.2910	FLL / 21 CFR 880.2910	Same
RegulationName	Clinical ElectronicThermometer	Clinical ElectronicThermometer	Same
MonitoringMethod	Thermistor-basedtemperature	Thermistor-based temperaturesensor	Same
	sensor
TemperatureMeasurement	Resolution: 0.1 °CRange: 25 to 43.9 °C	Unknown	Similar: Temperaturemeasurements wereevaluated byperformance and clinicaltesting to demonstratedifferences do not raisenew or differentquestions of safety andeffectiveness.
ContactDuration	12 hours	Unknown	Similar: Safety of contactduration evaluated bybiocompatibility andclinical testing todemonstrate differencesdo not raise new ordifferent questions ofsafety and effectiveness.
PatientPopulation	Neonates	AdultsPediatricsNeonates	Similar: The subjectdevice has a patientpopulation that is a subsetof the predicate device.Both devices can be usedon neonates.
UseEnvironment	Hospital environment	Hospital environment	Same
User	Healthcare professionals	Healthcare professionals	Same
Prescription Use	Yes	Yes	Same
Notifications/Alarms	Audio and visual alarmswhen temperature is<36.0 or >37.9 °C.Visual alarms whentemperature is <36.5 or>37.5 °C	Unknown	Similar: Temperaturemeasurement and alarmswere evaluated byperformance and clinicaltesting to demonstratedifferences do not raisenew or differentquestions of safety andeffectiveness.
Power source	Rechargeable lithium-ionbattery	Unknown	Similar: Safety andeffectiveness of batteryevaluated in accordancewith IEC 62133.
Measurementsite (skin/body)	Skin (abdomen)	Skin (abdomen)	Same
Mode (direct oradjusted)	Direct	Direct	Same
Mode (contact)	Contact	Contact	Same
ornon contact)
Device Materials	Silicone, stainless steel,acrylonitrile butadienestyrene, andpolyurethane	Unknown	Similar: Safety ofmaterials evaluated bybiocompatibility testing.Differences do not raisenew or differentquestions of safety andeffectiveness.
Shelf life/ In-uselife	2 years	Unknown	Similar: Device use lifeevaluated by lifetimeanalysis testing.Differences do not raisenew or differentquestions of safety andeffectiveness.

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SUMMARY OF NON-CLINICAL TESTING

Biocompatibility:

The subject device was evaluated for cytotoxicity, sensitization, and irritation in compliance to ISO 10993-5:2009, ISO 10993-10:2010, and ISO 10993-23:2010:2021.

Software Verification and Cybersecurity:

The software development and testing were executed with consideration to IEC 62304. Cybersecurity was evaluated per AAMI TIR57.

Electromagnetic Compatibility and Electrical Safety:

The subject device was tested in compliance with IEC 60601-1:2012, IEC 60601-1-2:2014, IEC 60601-1-6:2013, IEC 60601-1-8:2012, ISO 80601-2-56:2017, and IEC 62133:2012.

Performance testing:

Lifetime analysis testing after 100 simulated use cycles ISO 80601-2-56:2017

SUMMARY OF CLINICAL TESTING

A short duration (3 hour) and long duration (12 hour) clinical evaluation was performed using the subject device to evaluate its temperature measurement accuracy and effects on the subject's skin. The subject device was compared to the reference device, the Philips Intellivue MP30 (K061610). Results from both studies demonstrated comparable temperature measurement accuracy between the subject and predicate devices.

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Image /page/8/Picture/0 description: The image shows the logo for Hadleigh Health Technologies. The logo consists of a stylized letter "H" formed by a combination of red and blue lines, with the word "HADLEIGH HEALTH" in blue, sans-serif font to the right of the "H". Below that, the word "TECHNOLOGIES" is written in a smaller, blue, sans-serif font.

CONCLUSION

Based on the performance testing, biocompatibility, software verification and validation, electromagnetic compatibility and electrical safety, and clinical testing, it can be concluded that the differences between the subject and predicate device do not raise new or different questions of safety and effectiveness. Therefore, the subject device, Celsi Monitor is substantially equivalent to the predicate device, Cadi SmartSense Wireless Temperature Monitoring System cleared under K083185.

Regulation Number and Section

§ 880.2910 Clinical electronic thermometer.

(a)
Identification. A clinical electronic thermometer is a device used to measure the body temperature of a patient by means of a transducer coupled with an electronic signal amplification, conditioning, and display unit. The transducer may be in a detachable probe with or without a disposable cover.(b)
Classification. Class II (performance standards). The device is exempt from the premarket notification procedures in part 807, subpart E of this chapter, subject to the limitations in § 880.9 and the following conditions for exemption:(1) Device is not a clinical thermometer with telethermographic functions;
(2) Device is not a clinical thermometer with continuous temperature measurement functions; and
(3) Appropriate analysis and testing (such as that outlined in the currently FDA-recognized editions, as appropriate, of ISO 80601-2-56, “Medical electrical equipment—Part 2-56: Particular requirements for basic safety and essential performance of clinical thermometers for body temperature measurement,” or ASTM E1965, “Standard Specification for Infrared Thermometers for Intermittent Determination of Patient Temperature,” or ASTM E1112, “Standard Specification for Electronic Thermometer for Intermittent Determination of Patient Temperature,” or ASTM E1104, “Standard Specification for Clinical Thermometer Probe Covers and Sheaths”) must validate specifications and performance of the device.