Reusable Temperature Probe

K182751 · Shenzhen Caremed Medical Technology Co., Ltd. · FLL · Sep 6, 2019 · General Hospital

Device Facts

• Record ID: K182751
• Device Name: Reusable Temperature Probe
• Applicant: Shenzhen Caremed Medical Technology Co., Ltd.
• Product Code: FLL · General Hospital
• Decision Date: Sep 6, 2019
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.2910
• Device Class: Class 2
• Attributes: Pediatric

Intended Use

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 Story

Reusable temperature probes consist of a thermistor (NTC resistance) at the patient end and a phono plug connector at the monitor end; connects directly or via interconnect cable to Nihon Kohden BSM-5135A monitors. Device measures temperature via thermistor resistance changes; provides continuous temperature monitoring. Used in clinical settings by qualified medical personnel. Output displayed on compatible patient monitor to assist clinicians in patient temperature assessment and clinical decision-making.

Clinical Evidence

Bench testing only. Testing included biocompatibility (cytotoxicity, sensitization, irritation, rectal irritation per ISO 10993), electrical safety (IEC 60601-1), EMC (IEC 60601-1-2, ISO 80601-2-56), laboratory accuracy (±0.2°C), time response (<150s), and disinfection validation.

Technological Characteristics

Materials: PVC, TPU, Epoxy, Stainless steel, PA66. Sensing: NTC thermistor (2252 Ohms at 25°C). Form factor: 3m cable with phono plug. Connectivity: Wired connection to Nihon Kohden BSM-5135A monitors. Sterilization: Non-sterile, reusable with disinfection validation. Standards: ISO 80601-2-56, ISO 10993, IEC 60601-1.

Indications for Use

Indicated for adult and pediatric patients requiring temperature monitoring via skin or rectal contact. For use by qualified medical personnel only.

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

• UNIMED TEMPERATURE PROBE (K121427)

Submission Summary (Full Text)

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

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.

| Type of Use (Select one or both, as applicable) | <table style="border:none;"><tr><td><div style="display:inline-block;"> <span style="font-size:1.2em;">☑</span> Prescription Use (Part 21 CFR 801 Subpart D) </div></td><td><div style="display:inline-block;"> ☐ Over-The-Counter Use (21 CFR 801 Subpart C) </div></td></tr></table> | <div style="display:inline-block;"> <span style="font-size:1.2em;">☑</span> Prescription Use (Part 21 CFR 801 Subpart D) </div> | <div style="display:inline-block;"> ☐ Over-The-Counter Use (21 CFR 801 Subpart C) </div> |
|---------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------|
| <div style="display:inline-block;"> <span style="font-size:1.2em;">☑</span> Prescription Use (Part 21 CFR 801 Subpart D) </div> | <div style="display:inline-block;"> ☐ Over-The-Counter Use (21 CFR 801 Subpart C) </div> | | |

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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: [e-mail] Tel: [phone]-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: [phone]

| Trade/Device Name | Reusable Temperature Probe |
|-------------------|------------------------------------------------------------------------------|
| Model | Reusable Temperature Probe: TRAG-2252, TRAS-2252, TRCG-2252 and<br>TRCS-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

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

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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 | Application<br>site | length | Compatible<br>monitors | Measurement<br>range | Accuracy | Time<br>response | Minimum<br>measuring time |
|-----------|---------------------|--------|------------------------|----------------------|----------|------------------|---------------------------|
| TRAG-2252 | Adult Rectum | | | | | | |
| TRAS-2252 | Adult Skin | | Nihon | | | | |
| TRCG-2252 | Pediatric<br>Rectum | 3.0m | Kohden,<br>model: BSM- | 25-45°C | ±0.2°C | < 150S | 5mins |
| TRCS-2252 | Pediatric Skin | | 5135A | | | | |

#### 6. Intended use & Indication for use

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.

| Features | Subject Device | Predicate Device | Comparison |
|---------------------------|---------------------------------------|---------------------------------------|---------------|
| | Reusable Temperature<br>Probe K182751 | Unimed Temperature<br>Probe 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<br>(2252 Ohms in 25°C) | NTC resistance<br>(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 &<br>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) |
| Operational<br>Principles | 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 be<br>used for monitoring<br>temperature. The<br>temperature probes are<br>reusable and designed for<br>use with monitors of Nihon<br>Kohden model BSM-<br>5135A. These devices are<br>indicated for used by<br>qualified medical personnel<br>only. | are intended to be used for<br>monitoring temperature. The<br>temperature probes are<br>designed for use with<br>monitors of Philips,<br>Marquette, Mindray,<br>Spacelabs, Siemens,<br>Artema/S&W and other<br>monitors compatible with<br>YSI 400 series temperature<br>probes.<br>These devices are indicated<br>for used by qualified medical<br>personnel only. | |
|------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------|
| Biocompatibility | Cytotoxicity<br>Sensitization<br>Irritation<br>Rectal Irritation (Rectum<br>probes only) | Cytotoxicity<br>Sensitization<br>Irritation<br>Rectal Irritation (Rectum<br>probes 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.