The Disposable Rectal Temperature Probes are intended to be used for monitoring temperature from the rectum. The temperature probes are non-sterile and designed for single patient use with monitors of Nihon Kohden model BSM-5135A. These devices are indicated for use by qualified medical personnel only.

Skin Temperature Probe:

The Disposable Skin Temperature Probes are intended to be used for monitoring temperature from skin. The temperature probes are non-sterile and designed for single patient use with monitors of Nihon Kohden model BSM-5135A. These devices are indicated for use by qualified medical personnel only.

Device Description

Disposable temperature probes are used during patient temperature measurement. These probes consist of a plug connector on the adapter cable 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 by using an interconnect cable. These probes have a skin or rectal contact with adult patients. Both the skin and rectal probe are single use and provided non-sterile.

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

Here's an analysis of the provided text regarding the acceptance criteria and study proving device performance, formatted to address your specific questions.

Based on the provided document, the device in question is a "Disposable Temperature Probe" (Rectal and Skin types). This is a 510(k) submission, meaning the manufacturer is demonstrating substantial equivalence to a legally marketed predicate device, rather than proving novel safety and effectiveness from scratch. Therefore, the "acceptance criteria" and "study" are primarily focused on showing that the new device performs comparably to the predicate and meets relevant safety and performance standards for its intended use.

1. Table of Acceptance Criteria and Reported Device Performance

Since this is a 510(k) submission for a temperature probe, the "acceptance criteria" are intrinsically tied to the performance standards for clinical electronic thermometers and the performance of the predicate device. The document explicitly states the criteria and the results obtained for the subject device.

Acceptance Criteria (Standard / Predicate Performance)	Reported Device Performance (Subject Device)
Biocompatibility: Conformed with ISO 10993 series standard (no cytotoxicity, negligible irritation, no sensitization). (For skin probes: surface contact > 24 hours, < 30 days. For rectal probes: mucosal contact < 24 hours.)	Shows no cytotoxicity, irritation response was negligible, and no sensitization.
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
Laboratory Accuracy (continuous clinical thermometer, non-adjusted mode): Not greater than ± 0.3°C for continuous clinical thermometer. (Predicate accuracy: ± 0.1°C)	Pass (Implicitly, accuracy is also ± 0.1°C as it claims "Same" as predicate in comparison table, and "Pass" for the general laboratory accuracy criterion).
Time Response (Heating Transient Time): < 150s (Implied from ASTM E1112 and ISO 80601-2-56)	< 150s
Temperature Range: 25-45°C	25-45°C
Thermistor Type: NTC resistance (2252 Ohms in 25°C)	NTC resistance (2252 Ohms in 25°C)

Notes on the Table:

The document doesn't explicitly state "acceptance criteria" as a separate list, but rather "Performance Data" which includes the tests conducted and their "Pass" results, demonstrating compliance with established standards and equivalence to the predicate.
The "Accuracy" value listed under "Features" in the comparison table (±0.1°C) is more stringent than the general laboratory accuracy acceptance criterion (Not greater than 0.3 °C). However, the document states Pass for the laboratory accuracy test, implying it met the more stringent ±0.1°C as well, given the direct comparison to the predicate.

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

The document does not specify the sample size used for the performance tests (e.g., how many probes were tested for accuracy, biocompatibility, etc.).

Data Provenance: Not explicitly stated as "country of origin" for the test data itself (e.g., where the lab tests were conducted). However, the manufacturer is Shenzhen Caremed Medical Technology Co., Ltd. in China, and the correspondent is also in China, suggesting the testing likely occurred there or was overseen by the Chinese entity preparing the submission.
Retrospective or Prospective: The testing described (biocompatibility, electrical safety, EMC, laboratory accuracy, time response) appears to be prospective testing conducted specifically for the purpose of this 510(k) submission, rather than retrospective analysis of existing data.

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

This type of information is not provided in the document. For a temperature probe, "ground truth" for performance would typically be established by calibrated laboratory equipment and standard test methods (e.g., temperature baths, reference thermometers) rather than human experts. Biocompatibility testing follows laboratory protocols and analysis by qualified lab personnel.

4. Adjudication Method for the Test Set

This information is not applicable and therefore not provided. "Adjudication" usually refers to a process where multiple human readers or experts review data and resolve discrepancies to establish a consensus ground truth. This is not how performance data for a temperature probe is typically validated; it relies on objective physical measurements and standardized test procedures.

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

No, an MRMC comparative effectiveness study was not done. Such studies are typically performed for diagnostic imaging AI devices where human interpretation is a critical component, to assess how AI assistance impacts human reader performance. This device is a measurement tool, not an AI diagnostic tool.

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

This question is not applicable in the context of this device. The disposable temperature probe is a physical measuring device, not an AI algorithm. Its performance is inherent in its design and manufacturing, not an algorithm that operates independently. The device's performance characteristics (accuracy, time response) are "standalone" in that they are measured directly from the device's output.

7. The Type of Ground Truth Used

The ground truth for this device's performance was established through:

Standardized laboratory measurements: Using calibrated equipment and following established international standards (e.g.,
- ASTM E1112 for "Standard Specification for Electronic Thermometers for Intermittent Determination of Patient Temperature" (implied for accuracy)
- ISO 80601-2-56 for "Medical electrical equipment - Part 2-56: Particular requirements for basic safety and essential performance of clinical thermometers for body temperature measurement" (referenced for EMC and time response)
- IEC 60601-1 for "Medical electrical equipment - Part 1: General requirements for basic safety and essential performance" (referenced for electrical safety)
Biocompatibility testing: Following ISO 10993 series standards, which involve in-vitro and/or in-vivo tests to assess biological responses.

8. The Sample Size for the Training Set

This information is not applicable and therefore not provided. This device is a physical medical instrument, not a machine learning model. Therefore, there is no "training set."

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

This information is not applicable as there is no "training set" for this device.

Summary

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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 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.

December 21, 2018

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, Guangdong, 518067 China

Re: K182755

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: December 3, 2018 Received: December 3, 2018

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/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.htm); 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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm.

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/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

Sapana Patel -S

For Tina Kiang, Ph.D. Acting Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control, and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

Indications for Use

510(k) Number (if known) K182755

Device Name Disposable Temperature Probe

Indications for Use (Describe)

Rectal Temperature Probe:

Skin Temperature Probe:

Type of Use (Select one or both, as applicable)

X Prescription Use (Part 21 CFR 801 Subpart D)

| Over-The-Counter Use (21 CFR 801 Subpart C)

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510(K) Summary

Prepared in accordance with the requirements of 21 CFR Part 807.92

Prepared Date: 2018/09/25

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	Disposable Temperature Probe
Model	Disposable Temperature Probe: TDAC75-MQ and TDAS75-MQ.
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

Draeger Medical GmbH, General Purpose Temperature Probe, Skin Temperature Probe under K121999.

Device Description ട.

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

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LOT codes, CE-mark, legal entity information and a caution "Rx Only ".

Indication for use 6.

Rectal Temperature Probe:

Skin Temperature Probe:

Features	Subject Device	Predicate Device	Comparison
	Caremed Disposable TemperatureProbe	Draeger Temperature ProbeK121999
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	Skin & Rectum	Skin & Rectum	Same
Population	Adult	Adult	Same
Materialcontact tobody	Skin Probe: PVC, Foam, EpoxyadhesiveRectum Probe: PVC	Skin Probe: Stainless steel, TPERectum Probe: TPO, TPE	Different (1)
Length	3.75m	1.6m & 3m	Different (2)
Cablematerial	PVC	TPE	Different (3)
Plug material	PVC	TPS	Same
OperationalPrinciples	Continual	Continual	Same

7. Comparison to the Predicate Device

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Components	Temperature ProbeInterconnect Cable	Temperature Probe	Different (4)
Indication forUse	Rectal Temperature Probe:The Disposable RectalTemperature Probes are intendedto be used for monitoringtemperature from the rectum.The temperature probes are non-sterile and designed for singlepatient use with monitors ofNihon Kohden model BSM-5135A. These devices areindicated for use by qualifiedmedical personnel only.Skin Temperature Probe:The Disposable Skin TemperatureProbes are intended to be used formonitoring temperature from skin.The temperature probes are non-sterile and designed for singlepatient use with monitors of NihonKohden model BSM-5135A.These devices are indicated for useby qualified medicalpersonnel only.	General Purpose TemperatureProbes:Draeger disposable general-purposetemperature probes are intended forpatient core body temperaturemeasurement in combination withDraeger and Siemens patientmonitoring systems. The probes areinserted into the oesophagus or therectum.Skin Temperature Probes:Draeger disposable skintemperature probes are intended forpatient skin temperaturemeasurement in combination withDraeger and Siemens patientmonitoring systems. The probes areaffixed on the patient's skin with anadhesive cover.	Different (5)

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

Different (1): 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 will not raise any safety or biocompatibility issues.

Different (2): The cable length of proposed device is different with predicate device. All subject devices were conducted performance testing according to ISO 80601-2-56. Thus, different cable length will not raise any safety or performance issues.

Different (3): It's different with the cable material of predicate device. However, it's conformed with ISO 10993 series standard. According to analysis results, all the cable shows no cytotoxicity, irritation response was negligible and no sensitization. Thus, different material will not raise any safety or biocompatibility issues.

Different (4): The subject device contains an interconnect cable which is designed to connect the monitor and the temperature probe. All components were conducted safety, EMC and performance testing. Thus, this different will not raise any question of safety and effectiveness.

Different (5): The compatible monitors of proposed devices are different from the predicate device. The

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proposed devices are intended to use with Nihon Kohden monitors and the predicate devices are intended to use with Draeger and Siemens monitors. 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.

Performance Data 8.

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

Biocompatibility testing

The biocompatibility evaluation for the Caremed 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) .

The skin temperature probes are considered surface contacting for a duration of exceed 24 hours but not 30 days.

The rectal temperature probes are considered mucosal contacting for a duration of not exceed 24 hours.

Non-clinical data

The following standard and test requirements have been applied to Caremed Temperature probes with adaptor cable and compatible patient monitor Nihon Kohden Model BSM-5135A.

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

The thermometer testing followed ASTM E1112 and ASTM 80601-2-56

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.

Sapana Patel -S

Indications for Use

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510(K) Summary

Prepared in accordance with the requirements of 21 CFR Part 807.92

Prepared Date: 2018/09/25

1. Submission sponsor

Submission correspondent 2.

3. Subject Device Information

4. Predicate Device

Device Description ട.

Indication for use 6.

Rectal Temperature Probe:

Skin Temperature Probe:

7. Comparison to the Predicate Device

Performance Data 8.

Biocompatibility testing

Non-clinical data

9. Conclusion

§ 880.2910 Clinical electronic thermometer.

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