The disposable rectal temperature probes are intended to be used for continually monitoring temperature for up to 10 minutes from the rectum of adults, the probes may be used for up to 24 hours.

The temperature probes are non-sterile and designed for single patient use with monitors of EDAN model iM50. These devices are indicated for use by qualified medical personnel in hospital environment.

Device Description

Disposable temperature probe is used during patient temperature measurement. The probe consists of a phone plug connector on the adapter cable end and a thermistor on the patient end. The probe measures temperature by a resistor that is sensitive to temperature changes. The probe is connected to the patient monitor by using an interconnect cable.

The probe is used with legacy Edan Instruments, Inc. patient monitors iM50, which was cleared under K113623.

The probe is packed individually into a plastic bag in non-sterile condition. The package label describes product LOT codes, CE-mark, legal entity information and a caution "Rx Only ".

AI/ML Overview

The provided text is a 510(k) Summary for a disposable temperature probe. Based on the content, the acceptance criteria and the study proving the device meets these criteria can be described as follows:

Acceptance Criteria and Device Performance Study for a Disposable Temperature Probe

This medical device is a Disposable Temperature Probe. The acceptance criteria and the performance study were conducted to demonstrate substantial equivalence to a predicate device (Caremed Disposable Temperature Probe K182755).

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria (Set by Standard / Predicate)	Reported Device Performance (Subject Device)
Accuracy Range: 25-45°C	25-45°C
Accuracy: ±0.1°C	±0.1°C
Time Response (Heating transient): < 150s	< 150s
Biocompatibility: Meets ISO 10993-1	Pass (Cytotoxicity, Sensitization, Irritation, Rectal Irritation)
Safety: Meets IEC 60601-1	Pass
EMC (with iM50 monitor): Meets IEC 60601-1-2	Pass
Usability: Meets IEC 60601-1-6	Pass
General Performance: Meets ISO 80601-2-56	Pass
Laboratory Accuracy: Not greater than 0.3 °C for continuous clinical thermometer (unadjusted mode)	Pass

2. Sample Size Used for the Test Set and Data Provenance

The document does not specify a distinct "test set" in terms of subject or patient count for overall device performance. The testing reported appears to be primarily bench testing and standard compliance verification rather than a clinical study with a human subject test set.

Sample Size: Not applicable in the context of a "test set" for human patients for performance, as the study focuses on bench testing and mechanical/electrical characteristics. The "samples" would refer to the probes themselves tested for accuracy, time response, safety, and EMC. The document does not specify the number of probes tested for each criterion.
Data Provenance: The studies were conducted as non-clinical testing. There is no indication of country of origin for this specific testing, nor whether it was retrospective or prospective in a clinical setting. It is assumed to be prospective engineering and laboratory testing.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications

Not applicable. This device is a temperature probe, and its performance (e.g., accuracy, time response) is assessed against objective engineering standards and specifications, not against a "ground truth" established by human experts like radiologists.

4. Adjudication Method for the Test Set

Not applicable. As noted above, the performance is measured against objective standards, not subjective assessments requiring adjudication.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No. An MRMC study is typically performed for AI/image interpretation devices to assess the impact of AI assistance on human reader performance. This device is a temperature probe, not an AI-based diagnostic tool.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

Yes, in essence. The "Performance" section explicitly states "Laboratory accuracy" and "Time response" were tested. While the probe needs to be connected to a monitor (EDAN model iM50), the accuracy and time response are inherent characteristics of the probe itself in combination with the specified monitor, and these tests are conducted in a controlled, standalone manner (i.e., without human interpretation or intervention in the measurement process). The safety, EMC, and usability tests are also "standalone" in the sense of directly evaluating the device's compliance with technical standards.

7. The Type of Ground Truth Used

The ground truth for the performance claims (accuracy, time response) would be established by:

Reference Standards: Highly accurate, calibrated temperature measurement devices used in a laboratory setting.
Industry Standards: Compliance with established international standards such as ISO 80601-2-56 for essential performance and IEC 60601-1/-2 for safety and EMC.

8. The Sample Size for the Training Set

Not applicable. This device is a physical medical instrument (temperature probe), not an AI/machine learning algorithm that requires a "training set" of data.

9. How the Ground Truth for the Training Set Was Established

Not applicable, for the reasons stated in point 8.

Summary

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July 24, 2020

Shenzhen Changke Connect Electronics Co., Ltd. % Kevin Wang Consultant Chonconn Medical Device Consulting Co., Ltd. No. A415, Block A, NanShan Medical Devices Industrial Park Nanshan District Shenzhen, Guangdong 518067 China

Re: K193625

Trade/Device Name: Disposable Temperature Probe Regulation Number: 21 CFR 880.2910 Regulation Name: Clinical Electronic Thermometer Regulatory Class: Class II Product Code: FLL Dated: June 22, 2020 Received: June 22, 2020

Dear Kevin Wang:

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.

Payal Patel Acting 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) K193625

Device Name Disposable Temperature Probe

The disposable rectal temperature probes are intended to be used for continually monitoring temperature for up to 10 minutes from the rectum of adults, the probes may be used for up to 24 hours.

Prescription Use (Part 21 CFR 801 Subpart D)	Over-The-Counter Use (21 CFR 801 Subpart C)
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510(K) Summary - K193625

Prepared in accordance with the requirements of 21 CFR Part 807.92

Prepared Date: 2020/07/17

Submission sponsor 1.

Name: Shenzhen Changke Connect Electronics Co., Ltd. Address: A2-4th floor of Xiang dali Technology Park, No.87 of HengPing Road, Henggang, Longgang District, Shenzhen, P.R. China Contact person: Yahui Zhou Title: General Manager E-mail: zhouyahui@szcklt.com Tel: +86 136 1301 2560

2. Submission correspondent

Name: Chonconn Medical Device Consulting Co., Ltd.

Address: No. A415, Block A, NanShan Medical devices Industrial Park Nanshan District, Shenzhen,

Guangdong, P.R. China 518067

Contact person: Kevin Wang

E-mail: kevin@chonconn.com

Tel: +86-755 33941160

Trade/Device Name	Disposable Temperature Probe
Model	CK-TP-882121-611D
Common Name	Temperature Probe
Regulatory Class	Class II
Classification	21CFR 880.2910 / Thermometer, electronic, clinical / FLL
Submission type	Traditional 510(K)

3. Subiect Device Information

4. Predicate Device

Manufacturer: Shenzhen Caremed Medical Technology Co., Ltd. Device: Disposable Temperature Probe K#: K182755

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K193625

5. Device Description

The probe is used with legacy Edan Instruments, Inc. patient monitors iM50, which was cleared under K113623.

The probe is packed individually into a plastic bag in non-sterile condition. The package label describes product LOT codes, CE-mark, legal entity information and a caution "Rx Only ".

6. Intended use & Indication for use

The disposable rectal temperature probes are intended to be used for continually monitoring temperature for up to 10 minutes from the rectum of adults, the probes may be used for up to 24 hours.

Features	Subject DeviceChangke Disposable TemperatureProbe	Predicate DeviceCaremed Disposable TemperatureProbe K182755	Comparison
ClassificationName	Temperature Probe	Temperature Probe	Same
Product Code	FLL	FLL	Same
RegulationNumber	880.2910	880.2910	Same
Panel	General Hospital	General Hospital	Same
Class	II	II	Same
Thermistor	NTC resistance(2252 Ohms in 25°C)	NTC resistance(2252 Ohms in 25°C)	Same
Accuracyrange	25-45°C	25-45°C	Same
Accuracy	±0.1°C	±0.1°C	Same
Measure site	Rectum	Skin & Rectum	Same
Population	Adult	Adult	Same
Materialcontact tobody	Rectum Probe: PVC	Skin Probe: PVC, Foam, EpoxyadhesiveRectum Probe: PVC	Same
Length	3.75m	3.75m	Same
Cablematerial	PVC	PVC	Same
Plug material	PVC	PVC	Same
OperationalPrinciples	Continual	Continual	Same
Connectortype	Male, Mono Plug Connector	Male, Mono Plug Connector	Same
Features	Subject DeviceChangke Disposable TemperatureProbe	Predicate DeviceCaremed Disposable TemperatureProbe K182755	Comparison
Time periodof use	Rectum Probe: less than 24h	Skin Probe: less than 30 daysRectum Probe: less than 24h	Same
Indication forUse	The disposable rectal temperatureprobes are intended to be used forcontinually monitoring temperaturefor up to 10 minutes from therectum of adults, the probes maybe used for up to 24 hours.The temperature probes arenonsterile and designed for singlepatient use with monitors ofEDAN model iM50. These devicesare indicated for use by qualifiedmedical personnel in hospitalenvironment.	Rectal Temperature Probe:The Disposable Rectal TemperatureProbes are intended to be used formonitoring temperature from therectum. The temperature probes arenon-sterile and designed for singlepatient use with monitors of NihonKohden model BSM-5135A. Thesedevices are indicated for used byqualified medical personnel only.Skin Temperature Probe:The Disposable TemperatureProbes are intended to be used formonitoring temperature from skin.The temperature probes arenonsterile and designed for singlepatient use with monitors of NihonKohden model BSM-5135A. Thesedevices are indicated for used byqualified medical personnel only.	Different (1)

Comparison to the Predicate Device 7.

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K193625

Justifications for differences between proposed Temperature Probe and the predicate device are shown as below:

Different (1): The proposed device only includes the rectal probes which is in the scope of the predicate and the IEC80601-2-56 demonstrated compatibility. In addition, the compatible monitors of proposed devices are different from the predicate device. The proposed devices are intended to use with EDAN monitor and the predicate devices are intended to use with Nihon Kohden monitor. The core component of temperature probe is Negative Temperature Coefficient (NTC) which is identical to the NTC used in predicate device. The NTC determines the accuracy and range of temperature measurement. Therefore, the indication for use of proposed devices is essentially the same as predicate device.

8. Non-Clinical Testing

The following performance data were provided in support of the substantial equivalence determination.

Biocompatibility testing

The biocompatibility evaluation for the proposed Temperature Probes was conducted in accordance with the FDA Guidance for Industry and Food and Drug Administration Staff: Use of International Standard ISO 10993-1, "Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process". The battery of testing included the following tests:

. Cytotoxicity
Sensitization
Irritation ●
. Rectal Irritation (Rectum probes only)

Test	Description	Result
Safety	Ensures the temperature probes meet the requirements of IEC 60601-1 Medical electrical equipment - Part 1: General requirements for basic safety and essential performance	Pass
EMC	Ensures the temperature probes combined with the iM50 monitor meet the requirements of IEC 60601-1-2	Pass
Usability	IEC 60601-1-6 Medical electrical equipment - Part 1-6: General requirements for basic safety and essential performance – Collateral standard: Usability	Pass
Performance	ISO 80601-2-56 Medical Electrical Equipment: Particular Requirements for Basic Safety and Essential Performance of Clinical Thermometers for Body Temperature Measurement	pass
	Laboratory accuracy - Not greater than 0.3 °C for a continuous clinical thermometer that is not an adjusted mode clinical thermometer	Pass
	Time response - Heating transient time < 150s	Pass

The following standard and test requirements have been applied to Temperature probes with adaptor cable and compatible patient monitor EDAN Model iM50.

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9. Conclusion

Performance testing and compliance with voluntary standards demonstrate that the proposed subject device is substantially equivalent to the predicate device.

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.