Disposable Temperature Probe

K193625 · Shenzhen Changke Connect Electronics Co., Ltd. · FLL · Jul 24, 2020 · General Hospital

Device Facts

• Record ID: K193625
• Device Name: Disposable Temperature Probe
• Applicant: Shenzhen Changke Connect Electronics Co., Ltd.
• Product Code: FLL · General Hospital
• Decision Date: Jul 24, 2020
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.2910
• Device Class: Class 2

Intended 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. 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 Story

Disposable temperature probe; consists of NTC thermistor at patient end and phone plug connector at cable end. Connects to EDAN iM50 patient monitor via interconnect cable. Measures temperature via NTC resistance changes; provides continuous temperature data to monitor. Used in hospital environments by qualified medical personnel. Output displayed on monitor to assist clinical decision-making regarding patient thermal status.

Clinical Evidence

Bench testing only. Testing included biocompatibility (cytotoxicity, sensitization, irritation, rectal irritation per ISO 10993-1), electrical safety (IEC 60601-1), EMC (IEC 60601-1-2), usability (IEC 60601-1-6), and performance (ISO 80601-2-56). Performance results: laboratory accuracy ≤ 0.3°C and heating transient time < 150s.

Technological Characteristics

NTC thermistor (2252 Ohms at 25°C); PVC construction; 3.75m cable length; male mono plug connector. Connectivity: wired to EDAN iM50 monitor. Non-sterile, single-patient use. Standards: ISO 10993-1, IEC 60601-1, IEC 60601-1-2, IEC 60601-1-6, ISO 80601-2-56.

Indications for Use

Indicated for adult patients requiring continuous rectal temperature monitoring for up to 24 hours. For use by qualified medical personnel in hospital environments.

Regulatory Classification

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.

Special Controls

(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.

Predicate Devices

• Disposable Temperature Probe (K182755)

Reference Devices

• Edan Instruments, Inc. patient monitors iM50 (K113623)

Submission Summary (Full Text)

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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 ([e-mail]) or phone [phone] 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.

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.

| <span style="text-decoration: underline;"> <svg height="16" width="16"> <path d="M2 2 L14 14 M2 14 L14 2" stroke="black" stroke-width="2"></path> </svg> </span> Prescription Use (Part 21 CFR 801 Subpart D) | <span> <svg height="16" width="16"> <rect fill="white" height="16" stroke="black" width="16"></rect> </svg> </span> 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: [e-mail] Tel: [phone]

#### 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: [e-mail]

Tel: [phone]

| 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

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 ".

#### 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.

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.

| Features | Subject Device<br>Changke Disposable Temperature<br>Probe | Predicate Device<br>Caremed Disposable Temperature<br>Probe K182755 | Comparison |
|--------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------|
| Classification<br>Name | Temperature Probe | Temperature Probe | Same |
| Product Code | FLL | FLL | Same |
| Regulation<br>Number | 880.2910 | 880.2910 | Same |
| Panel | General Hospital | General Hospital | Same |
| Class | II | II | Same |
| Thermistor | NTC resistance<br>(2252 Ohms in 25°C) | NTC resistance<br>(2252 Ohms in 25°C) | Same |
| Accuracy<br>range | 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 |
| Material<br>contact to<br>body | Rectum Probe: PVC | Skin Probe: PVC, Foam, Epoxy<br>adhesive<br>Rectum Probe: PVC | Same |
| Length | 3.75m | 3.75m | Same |
| Cable<br>material | PVC | PVC | Same |
| Plug material | PVC | PVC | Same |
| Operational<br>Principles | Continual | Continual | Same |
| Connector<br>type | Male, Mono Plug Connector | Male, Mono Plug Connector | Same |
| Features | Subject Device<br>Changke Disposable Temperature<br>Probe | Predicate Device<br>Caremed Disposable Temperature<br>Probe K182755 | Comparison |
| Time period<br>of use | Rectum Probe: less than 24h | Skin Probe: less than 30 days<br>Rectum Probe: less than 24h | Same |
| Indication for<br>Use | The disposable rectal temperature<br>probes are intended to be used for<br>continually monitoring temperature<br>for up to 10 minutes from the<br>rectum of adults, the probes may<br>be used for up to 24 hours.<br>The temperature probes are<br>nonsterile and designed for single<br>patient use with monitors of<br>EDAN model iM50. These devices<br>are indicated for use by qualified<br>medical personnel in hospital<br>environment. | Rectal Temperature Probe:<br>The Disposable Rectal Temperature<br>Probes are intended to be used for<br>monitoring temperature from the<br>rectum. The temperature probes are<br>non-sterile and designed for single<br>patient use with monitors of Nihon<br>Kohden model BSM-5135A. These<br>devices are indicated for used by<br>qualified medical personnel only.<br>Skin Temperature Probe:<br>The Disposable Temperature<br>Probes are intended to be used for<br>monitoring temperature from skin.<br>The temperature probes are<br>nonsterile and designed for single<br>patient use with monitors of Nihon<br>Kohden model BSM-5135A. These<br>devices are indicated for used by<br>qualified 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.