The Reusable Temperature Probes are intended to be used for monitoring temperature. The temperature probes are reusable and designed for use with monitors of Nihon Kohden model BSM-5135A. These devices are indicated for used by qualified medical personnel only.

Device Description

Reusable temperature probes are used during patient temperature measurement for multi-patient use. These probes consist of a phone plug connector on the monitor end and a thermistor on the patient end. Temperature probes measure temperature by a resistor that is sensitive to temperature changes. These probes are connected to the patient monitor either directly by using a phono plug or by an interconnect cable. These probes have a skin or core contact with a patient.

These temperature probes are typically used with legacy Nihon Kohden monitors BSM-5135A.

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

AI/ML Overview

The provided text describes the performance data for the Reusable Temperature Probe (Models: TRAG-2252, TRAS-2252, TRCG-2252 and TRCS-2252) in support of its substantial equivalence determination.

Here's a breakdown of the requested information based on the text:

1. A table of acceptance criteria and the reported device performance

Criteria	Acceptance Criteria (Standard / Description)	Reported Device Performance
Material Accuracy	25-45°C	25-45°C
Accuracy	±0.2°C	±0.2°C
Laboratory Accuracy	Not greater than 0.3 °C for a continuous clinical thermometer that is not an adjusted mode clinical thermometer (per ISO 80601-2-56)	Pass (within ±0.2°C)
Time Response	Heating transient time < 150s	< 150s
Electrical Safety	Meets requirements of IEC 60601-1	Pass
Electromagnetic Compatibility (EMC)	Meets requirements of IEC 60601-1-2 and ISO 80601-2-56	Pass
Disinfection Validation	Low-level disinfection validation; High-level disinfection validation	Pass
Chemical Disinfection Agent Residue	Non-Cytotoxicity according to ISO 10993-5 (after disinfection)	Pass
Biocompatibility	Complies with ISO 10993-1 (Cytotoxicity, Skin Sensitization, Skin Irritation, Rectal Irritation)	Pass (no cytotoxicity, negligible irritation, no sensitization)

2. Sample size used for the test set and the data provenance

The document does not explicitly state the sample size used for performance testing (e.g., how many probes were tested) nor does it specify the provenance (e.g., country of origin) of the data. It indicates that "All subject devices were conducted performance testing according to ISO 80601-2-56" and references "Laboratory accuracy" and "Time response" results as well as biocompatibility testing. The nature of these tests (e.g. for electrical safety and accuracy) suggests they are conducted in a laboratory setting, not on patient data.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

This section is not applicable as the device is a temperature probe, and the performance testing described is objective measurement against standards and physical characteristics, not expert interpretation of diagnostic images or clinical scenarios requiring ground truth establishment by experts.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

This section is not applicable for the reasons stated above. Adjudication methods are typically relevant for studies involving human interpretation (e.g., radiologists reading images) where disagreement among experts needs resolution.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

This section is not applicable. The device is a Reusable Temperature Probe, which is a physical measurement device, not an AI-assisted diagnostic tool.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

This section is not applicable, as the device is a temperature probe and does not involve an algorithm for diagnostic interpretation. Its performance is inherent in its design and manufacturing.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

For the performance metrics (accuracy, time response, safety, EMC) of the temperature probe, the "ground truth" is established by objective measurement against the specified international standards (e.g., ISO 80601-2-56 for accuracy and time response, IEC 60601-1 for electrical safety, ISO 10993 series for biocompatibility). There is no "expert consensus" or "pathology" involved in determining if a physical temperature measurement falls within a specified range.

8. The sample size for the training set

This section is not applicable. The device is a Reusable Temperature Probe, which is a hardware medical device, not an AI algorithm that requires a training set.

9. How the ground truth for the training set was established

This section is not applicable, as there is no training set for this type of device.

Summary

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September 6, 2019

Shenzhen Caremed Medical Technology Co., Ltd. % Kevin Wang Consultant Chonconn Medical Device Consulting Co., Ltd. No. A415, Block A, Nanshan Medical Devices Industrial Park Nanshan District Shenzhen, 518067 China

Re: K182751

Trade/Device Name: Reusable Temperature Probe (Model: TRAG-2252, TRAS-2252, TRCG-2252 and TRCS-2252) Regulation Number: 21 CFR 880.2910 Regulation Name: Clinical Electronic Thermometer Regulatory Class: Class II Product Code: FLL Dated: August 8, 2019 Received: August 8, 2019

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 (OS) 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 mediation-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.

for Alan Stevens 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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Form Approved: OMB No. 0910-0120

Expiration Date: 06/30/2020

See PRA Statement below.

DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

Indications for Use

510(k) Number (if known)

K182751

Device Name

Reusable Temperature Probe (Model:TRAG-2252, TRAS-2252, TRCG-2252 and TRCS-2252 )

Indications for Use (Describe)

Type of Use (Select one or both, as applicable)	☑ Prescription Use (Part 21 CFR 801 Subpart D) ☐ Over-The-Counter Use (21 CFR 801 Subpart C)	☑ Prescription Use (Part 21 CFR 801 Subpart D)	☐ Over-The-Counter Use (21 CFR 801 Subpart C)
☑ Prescription Use (Part 21 CFR 801 Subpart D)	☐ Over-The-Counter Use (21 CFR 801 Subpart C)

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FORM EDA 3881 (7/17)

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510(K) Summary

Prepared in accordance with the requirements of 21 CFR Part 807.92

Prepared Date: 2019/08/25

1. Submission sponsor

Name: Shenzhen Caremed Medical Technology Co., Ltd. Address: East Side, 3/F, C Building, Kelunte Low-Carbon Industries, Gaofeng Community, Dalang Office, Longhua District, Shenzhen, Guangdong, China Contact person: Alan Xie Title: Quality Manager E-mail: cm003@szcaremed.com Tel: +86-755-36560977-889

Submission correspondent 2.

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	Reusable Temperature Probe
Model	Reusable Temperature Probe: TRAG-2252, TRAS-2252, TRCG-2252 andTRCS-2252
Common Name	Temperature Probe
Regulatory Class	Class II
Classification	21CFR 880.2910 / Thermometer, electronic, clinical / FLL
Submission type	Traditional 510(K)

3. Subject Device Information

4. Predicate Device

510(k) Number: K121427 Applicant: UNIMED MEDICAL SUPPLIES INC. Device name: UNIMED TEMPERATURE PROBE

5. Device Description

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probes have a skin or core contact with a patient.

These temperature probes are typically used with legacy Nihon Kohden monitors BSM-5135A.

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

Model	Applicationsite	length	Compatiblemonitors	Measurementrange	Accuracy	Timeresponse	Minimummeasuring time
TRAG-2252	Adult Rectum
TRAS-2252	Adult Skin		Nihon
TRCG-2252	PediatricRectum	3.0m	Kohden,model: BSM-	25-45°C	±0.2°C	< 150S	5mins
TRCS-2252	Pediatric Skin		5135A

6. Intended use & Indication for use

Features	Subject Device	Predicate Device	Comparison
	Reusable TemperatureProbe K182751	Unimed TemperatureProbe K121427
Classification Name	Temperature Probe	Temperature Probe	Same
Product Code	FLL	FLL	Same
Regulation Number	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
Accuracy range	25-45°C	25-45°C	Same
Accuracy	±0.2°C	±0.1°C	Different (1)
Measure site	Skin & Rectum	Skin & Rectum	Same
Population	Adult & Pediatric	Adult	Different (2)
Material contact to body	PVC, TPU, Epoxy &Stainless steel	PVC, TPU & Stainless steel	Different (3)
Length	3m	1.5m & 3m	Same
Cable material	PVC & TPU	PVC & TPU	Same
Plug material	PA66	ABS	Different (4)
OperationalPrinciples	Continual	Continual	Same
Indication for Use	The Reusable Temperature	Unimed Temperature Probes	Different (5)

7. Comparison to the Predicate Device

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	Probes are intended to beused for monitoringtemperature. Thetemperature probes arereusable and designed foruse with monitors of NihonKohden model BSM-5135A. These devices areindicated for used byqualified medical personnelonly.	are intended to be used formonitoring temperature. Thetemperature probes aredesigned for use withmonitors of Philips,Marquette, Mindray,Spacelabs, Siemens,Artema/S&W and othermonitors compatible withYSI 400 series temperatureprobes.These devices are indicatedfor used by qualified medicalpersonnel only.
Biocompatibility	CytotoxicitySensitizationIrritationRectal Irritation (Rectumprobes only)	CytotoxicitySensitizationIrritationRectal Irritation (Rectumprobes only)	Same

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

Different (1): The accuracy is different from the predicate device. All subject devices were conducted performance testing according to ISO 80601-2-56. The accuracy is within the requirement from the standard. Thus, different accuracy does not raise new questions of safety and effectiveness for the subject device.

Different (2): The only difference between adult probe and pediatric probe is physical size of the cable diameter. All subject devices were conducted performance testing according to ISO 80601-2-56. Thus, different patient population does not raise new questions of safety and effectiveness for the subject device.

Different (3): It's different with the patient contacted material of predicate device. However, it's conformed with ISO 10993 series standard. According to analysis results, all the Patient Contacting Materials shows no cytotoxicity, irritation response was negligible and no sensitization. Thus, different material does not raise new questions of safety and effectiveness for the subject device. Different (4): It's different with the plug material of predicate device. However, it's conformed with ISO 10993 series standard. According to analysis results, all the materials shows no cytotoxicity, irritation response was negligible and no sensitization. Thus, different material of plug does not raise new questions of safety and effectiveness for the subject device.

Different (5): The compatible monitors of proposed devices are different from the predicate device. The proposed devices are intended to use with Nihon Kohden monitors and the predicate devices are intended to use with Philips, Marquette, Mindray, Spacelabs, Siemens, Artema/S&W and other monitors. The core component of temperature probe is Negative Temperature Coefficient (NTC)

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which is identical to the NTC used in predicate device. The NTC determines the accuracy and range of temperature measurement. All subject devices were conducted performance testing according to ISO 80601-2-56. The difference does not raise new questions of safety and effectiveness for the subject device.

8. Performance Data

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

Biocompatibility testing

The biocompatibility evaluation for the Reusable 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
. Skin Sensitization
Skin Irritation .
Rectal Irritation (Rectum probes only) .

The Reusable Temperature Probes are considered surface contacting for a duration of less than 24 hours.

Test	Description	Result
Safety	Ensures the temperature probes meet the requirements of IEC 60601-1 electrical safety	Pass
EMC	Ensures the temperature probes meet the requirements of IEC 60601-1-2 and ISO 80601-2-56 electromagnetic compatibility	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
Disinfection validation	Low-level disinfection validation; High-level disinfection validation	Pass
Chemical Disinfection Agent Residue Validation	According to ISO 10993-5, non- Cytotoxicity.	Pass

Non-clinical data

9. Conclusion

Performance testing and compliance with voluntary standards demonstrate that the proposed devices are 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.