Celsi Monitor

{0}------------------------------------------------ Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services - USA 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. 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. {1}------------------------------------------------ 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 {2}------------------------------------------------ # 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) | <span style="font-size:20px">☑</span> | |---------------------------------------------|---------------------------------------| | Service Contract Use (61 CFR 93) | <span style="font-size:20px">☐</span> | X Prescription Use (Part 21 CFR 801 Subpart D) | | Over-The-Counter Use (21 CFR 801 Subpart C) #### 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. 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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 Human<br>Factors (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 Monitoring<br>System / Cadi Scientific Pte. Ltd | ✓ | {4}------------------------------------------------ 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 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. ### INDICATIONS FOR USE 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 measures abdominal skin temperature through direct contact. ## 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 {5}------------------------------------------------ Image /page/5/Picture/0 description: The image shows the logo for Hadleigh Health Technologies. The logo consists of a stylized "H" formed by a red horizontal bar and a blue vertical bar with a red cross in the middle. To the right of the "H" are the words "HADLEIGH HEALTH" in a larger font, with "TECHNOLOGIES" underneath in a smaller font. | | Subject Device | Predicate Device | Comparison | |-----------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | | Hadleigh<br>Health<br>Technologies Celsi<br>Monitor | CADI Scientific Pte.Ltd.<br>Cadi SmartSense Wireless<br>Temperature Monitoring<br>System<br>K083185 | N/A | | Indications for<br>Use | Celsi Monitor is<br>intended for use in<br>hospitals under a<br>clinician's supervision<br>or at their direction to<br>assist nurses in<br>continuous<br>temperature<br>monitoring of<br>neonates. The device<br>measures abdominal<br>skin temperature<br>through direct contact. | The Cadi SmartSense<br>Wireless Temperature<br>Monitoring System is<br>intended to measure<br>abdominal surface<br>temperature in adults<br>through neonates. The<br>ThermoSENSOR, a reusable<br>temperature sensor, is<br>applied to the patient by<br>means of single use<br>application tapes. The<br>ThermoSENSOR provides<br>periodic wireless<br>transmission of temperature<br>data which is utilized by the<br>SmartNODE wireless receiver<br>and the SmartSense PC<br>application program to<br>record, store, and display the<br>temperature information.<br>Warning: This equipment<br>measures and reports<br>abdominal surface<br>temperature - where direct<br>measurements of body core<br>temperature are required, it<br>is recommended to utilize<br>appropriate<br>core temperature<br>monitoring devices for this<br>purpose. | Similar: Both devices<br>are intended to<br>continuously monitor<br>patient skin<br>temperature, alert<br>users to temperatures<br>outside of the<br>normothermic range,<br>and use thermistors as<br>temperature sensors.<br>Temperature sensors<br>are applied directly to<br>the skin on the<br>abdomen of neonates.<br>Clinical and non-clinical<br>testing have been<br>adequately conducted<br>to demonstrate the<br>differences do not raise<br>new or different<br>questions of safety and<br>effectiveness. | | Product Codes /<br>Regulation<br>Number | FLL / 21 CFR 880.2910 | FLL / 21 CFR 880.2910 | Same | | Regulation<br>Name | Clinical Electronic<br>Thermometer | Clinical Electronic<br>Thermometer | Same | | Monitoring<br>Method | Thermistor-based<br>temperature | Thermistor-based temperature<br>sensor | Same | | | sensor | | | | Temperature<br>Measurement | Resolution: 0.1 °C<br>Range: 25 to 43.9 °C | Unknown | Similar: Temperature<br>measurements were<br>evaluated by<br>performance and clinical<br>testing to demonstrate<br>differences do not raise<br>new or different<br>questions of safety and<br>effectiveness. | | Contact<br>Duration | 12 hours | Unknown | Similar: Safety of contact<br>duration evaluated by<br>biocompatibility and<br>clinical testing to<br>demonstrate differences<br>do not raise new or<br>different questions of<br>safety and effectiveness. | | Patient<br>Population | Neonates | Adults<br>Pediatrics<br>Neonates | Similar: The subject<br>device has a patient<br>population that is a subset<br>of the predicate device.<br>Both devices can be used<br>on neonates. | | Use<br>Environment | Hospital environment | Hospital environment | Same | | User | Healthcare professionals | Healthcare professionals | Same | | Prescription Use | Yes | Yes | Same | | Notifications/Al<br>arms | Audio and visual alarms<br>when temperature is<br><36.0 or >37.9 °C.<br><br>Visual alarms when<br>temperature is <36.5 or<br>>37.5 °C | Unknown | Similar: Temperature<br>measurement and alarms<br>were evaluated by<br>performance and clinical<br>testing to demonstrate<br>differences do not raise<br>new or different<br>questions of safety and<br>effectiveness. | | Power source | Rechargeable lithium-ion<br>battery | Unknown | Similar: Safety and<br>effectiveness of battery<br>evaluated in accordance<br>with IEC 62133. | | Measurement<br>site (skin/body) | Skin (abdomen) | Skin (abdomen) | Same | | Mode (direct or<br>adjusted) | Direct | Direct | Same | | Mode (contact) | Contact | Contact | Same | | or<br>non contact) | | | | | Device Materials | Silicone, stainless steel,<br>acrylonitrile butadiene<br>styrene, and<br>polyurethane | Unknown | Similar: Safety of<br>materials evaluated by<br>biocompatibility testing.<br>Differences do not raise<br>new or different<br>questions of safety and<br>effectiveness. | | Shelf life/ In-use<br>life | 2 years | Unknown | Similar: Device use life<br>evaluated by lifetime<br>analysis testing.<br>Differences do not raise<br>new or different<br>questions of safety and<br>effectiveness. | {6}------------------------------------------------ Image /page/6/Picture/0 description: The image shows the logo for Hadleigh Health Technologies. The logo consists of a stylized "H" formed by a red horizontal bar and a blue vertical bar intersecting to form a cross shape. To the right of the "H" are the words "HADLEIGH HEALTH" in a serif font, with "TECHNOLOGIES" below in a smaller font size. {7}------------------------------------------------ Image /page/7/Picture/0 description: The image shows the logo for Hadleigh Health Technologies. The logo consists of a stylized "H" formed by a red vertical bar and a blue cross. To the right of the "H" are the words "HADLEIGH HEALTH" in a larger font, with the word "TECHNOLOGIES" underneath in a smaller font. ### 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. {8}------------------------------------------------ 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.