(195 days)
No
The description focuses on direct temperature measurement via a thermistor and basic alarming based on fixed thresholds. There is no mention of AI/ML terms, image processing, or data analysis beyond simple comparison to a predicate device.
No
The device is a monitor that measures and alarms for temperature deviations, but it does not actively treat or provide therapy to the patient.
No
The device is a continuous temperature monitor, which provides measurements and alarms. While monitoring can inform diagnosis, the device itself does not perform a diagnostic function (i.e., it does not identify diseases or conditions).
No
The device description explicitly mentions hardware components such as a thermistor, Celsi Belt, Celsi Probe, and rechargeable lithium-ion batteries, indicating it is not a software-only device.
Based on the provided information, the Celsi Monitor is not an In Vitro Diagnostic (IVD) device.
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening.
- Celsi Monitor's Function: The Celsi Monitor directly measures the temperature of a neonate's skin through physical contact. It does not analyze any biological specimens.
Therefore, the Celsi Monitor falls under the category of a non-invasive physiological monitoring device, not an IVD.
N/A
Intended Use / 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.
Product codes
FLL
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 (37.5 °C). The device is a skin contacting surface device with duration of contact
§ 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.
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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 Human |
| 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 | |
| System / 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
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 (37.5 °C). The device is a skin contacting surface device with duration of contact 37.9 °C.
Visual alarms when
temperature is 37.5 °C | Unknown | Similar: Temperature
measurement and alarms
were evaluated by
performance and clinical
testing to demonstrate
differences do not raise
new or different
questions of safety and
effectiveness. |
| Power source | Rechargeable lithium-ion
battery | Unknown | Similar: Safety and
effectiveness of battery
evaluated in accordance
with IEC 62133. |
| Measurement
site (skin/body) | Skin (abdomen) | Skin (abdomen) | Same |
| Mode (direct or
adjusted) | Direct | Direct | Same |
| Mode (contact) | Contact | Contact | Same |
| or
non contact) | | | |
| Device Materials | Silicone, stainless steel,
acrylonitrile butadiene
styrene, and
polyurethane | Unknown | Similar: Safety of
materials evaluated by
biocompatibility testing.
Differences do not raise
new or different
questions of safety and
effectiveness. |
| Shelf life/ In-use
life | 2 years | Unknown | Similar: Device use life
evaluated by lifetime
analysis testing.
Differences do not raise
new or different
questions of safety and
effectiveness. |
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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.
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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.
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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.