(211 days)
No
The device description and performance studies focus on basic temperature sensing technology (thermistor) and standard medical device testing (biocompatibility, safety, EMC, usability, performance, accuracy, time response). There is no mention of AI or ML in the intended use, device description, or performance evaluation sections.
No
The device is described as a disposable rectal temperature probe used for continually monitoring temperature, which is a diagnostic function, not a therapeutic one.
No
This device is a temperature probe used for continually monitoring temperature, which is a measurement function, not a diagnostic one. It provides data (temperature readings) but does not interpret or diagnose conditions based on that data.
No
The device description explicitly details a physical probe with a connector and thermistor, indicating it is a hardware device, not software-only.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body (like blood, urine, tissue) to provide information about a person's health.
- Device Function: This device is a temperature probe that directly measures the temperature of the patient's rectum. It does not perform any tests on samples taken from the body.
- Intended Use: The intended use is for "continually monitoring temperature... from the rectum of adults." This is a direct physiological measurement, not an in vitro test.
- Device Description: The description details a thermistor that measures temperature changes directly.
Therefore, this device falls under the category of a medical device used for direct physiological monitoring, not an In Vitro Diagnostic.
N/A
Intended Use / Indications 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.
Product codes (comma separated list FDA assigned to the subject device)
FLL
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 ".
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
rectum
Indicated Patient Age Range
Adult
Intended User / Care Setting
qualified medical personnel in hospital environment.
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
- 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 Cytotoxicity, Sensitization, Irritation, Rectal Irritation (Rectum probes only).
- Safety Testing: Ensures the temperature probes meet the requirements of IEC 60601-1 Medical electrical equipment - Part 1: General requirements for basic safety and essential performance. Result: Pass.
- EMC Testing: Ensures the temperature probes combined with the iM50 monitor meet the requirements of IEC 60601-1-2. Result: Pass.
- Usability Testing: IEC 60601-1-6 Medical electrical equipment - Part 1-6: General requirements for basic safety and essential performance – Collateral standard: Usability. Result: Pass.
- Performance Testing: ISO 80601-2-56 Medical Electrical Equipment: Particular Requirements for Basic Safety and Essential Performance of Clinical Thermometers for Body Temperature Measurement. Laboratory accuracy - Not greater than 0.3 °C for a continuous clinical thermometer that is not an adjusted mode clinical thermometer. Result: Pass. Time response - Heating transient time
§ 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.
0
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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.
1
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
2
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.
| 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
4
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
Changke Disposable Temperature
Probe | Predicate Device
Caremed Disposable Temperature
Probe K182755 | Comparison |
|--------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------|
| 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 | ±0.1°C | ±0.1°C | Same |
| Measure site | Rectum | Skin & Rectum | Same |
| Population | Adult | Adult | Same |
| Material
contact to
body | Rectum Probe: PVC | Skin Probe: PVC, Foam, Epoxy
adhesive
Rectum Probe: PVC | Same |
| Length | 3.75m | 3.75m | Same |
| Cable
material | PVC | PVC | Same |
| Plug material | PVC | PVC | Same |
| Operational
Principles | Continual | Continual | Same |
| Connector
type | Male, Mono Plug Connector | Male, Mono Plug Connector | Same |
| Features | Subject Device
Changke Disposable Temperature
Probe | Predicate Device
Caremed Disposable Temperature
Probe K182755 | Comparison |
| Time period
of use | Rectum Probe: less than 24h | Skin Probe: less than 30 days
Rectum Probe: less than 24h | Same |
| 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
nonsterile 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. | Rectal Temperature Probe:
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 used by
qualified medical personnel only.
Skin Temperature Probe:
The Disposable Temperature
Probes are intended to be used for
monitoring temperature from skin.
The temperature probes are
nonsterile and designed for single
patient use with monitors of Nihon
Kohden model BSM-5135A. These
devices are indicated for used by
qualified medical personnel only. | Different (1) |
Comparison to the Predicate Device 7.
5
6
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 |