(133 days)
The Cadi SmartSense Wireless Temperature Monitoring System is intended to measure abdominal surface temperature in adults through neonates. The ThermoSENSOR, a reusable temperature sensor, is applied to the patient by means of single use application tapes.
The ThermoSENSOR provides periodic wireless transmission of temperature data which is utilized by the SmartNODE wireless receiver and the SmartSense PC application program to record, store, and display the temperature information.
Warning: This equipment measures and reports abdominal surface temperature – where direct measurements of body core temperature are required, it is recommended to utilize appropriate core temperature monitoring devices for this purpose.
Prescription Use X (Part 21 CFR 801 Subpart D) AND / OR
Over-The-Counter Use (21 CFR 807 Subpart C)
The Cadi SmartSense Wireless Temperature Monitoring System is intended for wireless automated measurement of abdominal surface temperature in adults through neonates used in any instance where quantifiable measurement of temperature data is desirable.
The system further provides the SmartSense PC Application with a dataentry interface that allows users to manually enter other vital signs parameters.
The SmartSense PC Application additionally provides a Vital Signs Dashboard view for convenient viewing and monitoring of patients' monitored temperature and manually entered vital signs.
The Cadi SmartSense Wireless Temperature Monitoring System consists of the following proprietary components:
- ThermoSENSOR patient applied wireless temperature sensor .
- SmartNODE wireless telemetry receiver receives ThermoSENSOR . data
- SmartSWITCH sensor activator accessory .
- SmartSense PC Application PC application software .
Additional system elements include information technology (IT) equipment used in a local area Ethernet network such as routers and switches.
Here's a breakdown of the acceptance criteria and study information for the Cadi SmartSense Wireless Temperature Monitoring System, based on the provided 510(k) summary:
The device is a Cadi SmartSense Wireless Temperature Monitoring System designed for wireless automated measurement of abdominal surface temperature in adults through neonates.
1. Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Non-Clinical Tests: | Passed |
| Compliance with FDA guidance document on clinical electronic thermometers and referenced standards | |
| Medical device electrical safety standards | Passed |
| Electromagnetic compatibility standards | Passed |
| Environmental operation and storage conditions standards | Passed |
| Resistance to moisture ingress standards | Passed |
| Shock and vibration standards | Passed |
| SmartSense PC/host software and embedded software verification to requirements | Passed |
| SmartSense PC/host software and embedded software validation to meet intended use by software and system level performance testing | Passed |
| Sensor patient contact materials biocompatibility standards | Met applicable standards |
| Clinical Tests: | None submitted / None required (as stated in the document) |
2. Sample Size Used for the Test Set and Data Provenance:
No clinical test set was used, as it was stated that clinical tests were "none / none required." Therefore, information regarding sample size, country of origin, or retrospective/prospective nature of a clinical test set is not applicable. The non-clinical tests involved various engineering and software tests on the device components.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications:
Not applicable, as no clinical test set requiring expert-established ground truth was performed. Ground truth for the non-clinical tests would be established by validated test methodologies and measurement equipment in engineering labs.
4. Adjudication Method for the Test Set:
Not applicable, as no clinical test set requiring adjudication was performed.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done:
No, an MRMC comparative effectiveness study was not done. The document explicitly states "Clinical Tests Submitted: (none / none required)."
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done:
The document focuses on the performance of the integrated system, including the hardware (ThermoSENSOR, SmartNODE, SmartSWITCH) and software (SmartSense PC Application). While the software itself was validated (SmartSense PC/host software and embedded software... validated to meet intended use by software and system level performance testing), the overall evaluation was of the device as a system for temperature monitoring, not just a standalone algorithm's performance independent of the human user or other device components.
7. The Type of Ground Truth Used:
For the non-clinical tests, the "ground truth" was established by compliance with recognized standards and established engineering test methodologies. This would include:
- Reference electrical safety and EMC equipment
- Environmental chambers for temperature, humidity, shock, and vibration testing
- Calibrated measurement devices for software and system performance testing
- Biocompatibility testing against ISO standards.
For clinical validation (which was not performed), the implied "ground truth" would likely have been direct measurements of body core temperature using appropriate core temperature monitoring devices, as the device itself measures abdominal surface temperature with a warning that direct core temperature measurements might be needed for certain situations.
8. The Sample Size for the Training Set:
The document does not mention a "training set" in the context of an AI/ML algorithm or a learning system. The device uses a thermistor-based technology, which is a traditional sensor principle, not a machine learning model that requires a training set. The software mentioned ("SmartSense PC/host software and embedded software") would have undergone typical software development and testing, but not "training" in the AI sense.
9. How the Ground Truth for the Training Set Was Established:
Not applicable, as there was no training set for an AI/ML algorithm.
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K083 N5
MAR 1 1 2009
Page 1 of 3
510(k) Summary of Safety and Effectiveness in accordance with 21 CFR 807.92
- (1) Submitted by: (a) CADI Scientific Pte. Ltd 31 Ubi Road 1, #03-00 Aztech Building Singapore 408694 Tel.: +49-38 41 360 221 Fax: +49-38 41 360 222 E-mail: zenton.goh@cadi.com.sg Contact Person: Mr. GOH Zenton, Ph.D. Position/Title: CEO Date of Preparation: February 23, 2008 (2) Trade Name: Cadi SmartSense Wireless Temperature Monitoring System Common/Classification Name: Thermometer, electronic, clinical FLL; 21 CFR § 880.2910 Product Code(s): Class: Class II (3) Predicate Device(s): Substantial Equivalence to: K Number Model Manufacturer K033534 VitalSense Integrated Mini Mitter Co., Inc. (now Physiological Monitoring Respironics) System K003326 Funai Amy Mama Wireless Funai Radio & Thermometer Monitor (Baby Communications Corp. Minder)
Reason for Submission: New device
(4) Description of Device:
The Cadi SmartSense Wireless Temperature Monitoring System is intended for wireless automated measurement of abdominal surface temperature in adults through neonates used in any instance where quantifiable measurement of temperature data is desirable.
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Page 2 of 3
The system further provides the SmartSense PC Application with a dataentry interface that allows users to manually enter other vital signs parameters.
The SmartSense PC Application additionally provides a Vital Signs Dashboard view for convenient viewing and monitoring of patients' monitored temperature and manually entered vital signs.
The Cadi SmartSense Wireless Temperature Monitoring System consists of the following proprietary components:
- ThermoSENSOR patient applied wireless temperature sensor .
- SmartNODE wireless telemetry receiver receives ThermoSENSOR . data
- SmartSWITCH sensor activator accessory .
- SmartSense PC Application PC application software .
Additional system elements include information technology (IT) equipment used in a local area Ethernet network such as routers and switches.
(5) Intended use:
Abominal surface temperature monitoring provides a convenient means to track patient temperature and trends without limiting patient mobility. The system is intended to be deployed within a health care facility to allow the monitoring of temperature wherever the patient applied sensor is within range of a receiver or receivers.
Indications for Use:
The Cadi SmartSense Wireless Temperature Monitoring System is intended to measure abdominal surface temperature in adults through neonates. The ThermoSENSOR, a reusable temperature sensor, is applied to the patient by means of single use application tapes.
ThermoSENSOR provides periodic wireless transmission of The temperature data which is utilized by the SmartNODE wireless receiver and the SmartSense PC application program to record, store, and display the temperature information.
WARNING This equipment measures and reports abdominal surface temperature - where direct measurements of body core temperature are required, it is recommended to utilize appropriate core temperature monitoring devices for this purpose.
Prescription device.
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(6) Technological Characteristics:
The CADI SmartSense Wireless Temperature Monitoring System employ the same technological characteristics as the predicate device to measure temperature - a thermistor temperature sensor changes electrical characteristics in response to temperature. The resultant electrical signal is digitized and transmitted to the host to determine the measured Temperature information is displayed on a PC monitor temperature. display.
The SmartSense system utilizes a four-layer architecture in which the temperature measurement and wireless transmit functions are managed by the ThermoSENSOR. Wireless receiver, SmartSWITCH accessory, and SmartSense PC application functions are managed by separate control programs.
(b) (1) Non-Clinical Tests Submitted:
The SmartSense System was evaluated to the requirements of the FDA guidance document on clinical electronic thermometers and referenced standards.
The system elements were tested in accordance with applicable standards for medical device electrical safety, electromagnetic compatibility, environmental operation and storage conditions, resistance to moisture ingress, and shock and vibration. The device passed all of the tests.
SmartSense PC/host software and embedded software in the subsystems was verified to requirements and validated to meet intended use by software and system level performance testing.
Sensor patient contact materials meet applicable standards for biocompatibility.
(2) Clinical Tests Submitted:
(none / none required).
(3) Conclusions from Tests:
As described above, the Cadi SmartSense Wireless. Temperature Monitoring System including accessory ThermoSENSOR's function and perform in a manner equivalent to the predicate device(s) as validated by parameter and bench testing. Device safety is substantiated by compliance testing to applicable standards and by biocompatibility of patient contact materials.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol that resembles an eagle or bird in flight.
MAR 1 1 2009
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
CADI Scientific Pte. Limited C/o Mr. Stephen H. Gorski Imagenix, Incorporated S65 W35739 Piper Road Eagle, Wisconsin 53119
Re: K083185
Trade/Device Name: CADI Scientific Pte.Ltd. Cadi SmartSense Wireless Temperature Monitoring System
Regulation Number: 21 CFR 880.2910 Regulation Name: Clinical Electronic Thermometer Regulatory Class: II Product Code: FLL Dated: February 23, 2009 Received: February 25, 2009
Dear Mr. Gorski:
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. 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.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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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Page 2 - Mr. Gorski
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); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely vours.
Sayette Y. Michael ms.
Ginette Y. Michaud, M.D. Acting Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known):
Device Name:
CADI Scientific Pte. Ltd. Cadi SmartSense Wireless Temperature Monitoring System
Indications for use:
The Cadi SmartSense Wireless Temperature Monitoring System is intended to measure abdominal surface temperature in adults through neonates. The ThermoSENSOR, a reusable temperature sensor, is applied to the patient by means of single use application tapes.
The ThermoSENSOR provides periodic wireless transmission of temperature data which is utilized by the SmartNODE wireless receiver and the SmartSense PC application program to record, store, and display the temperature information.
Warning: This equipment measures and reports abdominal surface temperature – where direct measurements of body core temperature are required, it is recommended to utilize appropriate core temperature monitoring devices for this purpose.
Prescription Use X (Part 21 CFR 801 Subpart D) AND / OR
Over-The-Counter Use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Hall
(Division Sign-Off) Division of Anesthesiology, General Hospital Infection Control, Dental Devices
Page 1 of __
510(k) Number: K083185
§ 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.