(248 days)
Not Found
No
The description focuses on the physical components and the resistance-based working principle of the temperature probes, with no mention of AI or ML.
No
The device is used for monitoring temperature, which is a diagnostic function, not a therapeutic one. It provides data but does not treat or cure a condition.
No
Explanation: The device is used for monitoring temperature, which is a measurement of a physiological parameter, not for diagnosing a disease or condition. While temperature can be an indicator of health issues, this device itself does not provide a diagnosis.
No
The device description explicitly states that the probes consist of a connector and a thermistor, which are hardware components. The working principle is resistance-based, indicating a physical measurement process.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for "monitoring temperature for multi-patient use" or "monitoring temperature for single patient use." This is a physiological measurement taken directly from the patient's body (skin or esophagus).
- Device Description: The device description explains how the probes work by measuring resistance changes based on temperature. This is a direct physical measurement, not an analysis of a sample taken from the body.
- Lack of IVD Characteristics: IVD devices are designed to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening. This device does not interact with or analyze such specimens.
Therefore, the temperature probes described are medical devices used for patient monitoring, but they do not fit the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
Reusable Temperature Probes:
Reusable Temperature Probes are intended to be used for monitoring temperature for multi- patient use. The temperature probes are reusable and designed for use with monitor of GE-Marquette Model DASH3000. These devices are used by qualified medical professionals only.
Disposable Temperature Probes:
Disposable Temperature Probes are intended to be used for monitoring temperature for single patient use. The temperature probes are non-sterile and designed for use with monitors of GE- Marquette Model DASH3000. These devices are used by qualified medical professionals only.
Product codes (comma separated list FDA assigned to the subject device)
FLL
Device Description
The proposed devices are used for patient temperature measurement. The probes are reusable or disposable depending on the model. These probes consist of a connector on the monitor end and a thermistor on the patient end. The working principle is resistance based on the metal conductor increasing with temperature decrease, and the linear changes to the characteristics of the temperature measurement. The proposed devices are designed to be used in a healthcare facility and compatible with a monitor, GE-Marquette Model DASH3000.
The six models have two types of structure designs corresponding to reusable and disposable use which consists of different materials. The Negative Temperature Coefficient (NTC) of the six models are identical. Reusable models ST1304, ST2304, ST3304, ST4304 have a similar structure design with two different sensor shapes for different measure sites and consist of the same materials. Disposable models ST5105A and ST6105A have a similar structure design with two different sensor shapes for different measure sites and consist of the same materials.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Skin, Esophagus
Indicated Patient Age Range
Adult, pediatric
Intended User / Care Setting
Qualified medical professionals / healthcare facility
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)
Non-Clinical Testing:
Biocompatibility testing:
- Cytotoxicity
- Sensitization
- Irritation
- Oral mucosa Irritation (Body cavity Temperature Probe only)
Performance Testing:
- IEC 60601-1-2005+CORR.1:2006+CORR.2:2007+A1:2012, Medical Electrical Equipment- Part 1: General requirements for basic safety and essential performance
- IEC 60601-1-2:2014 Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral standard: Electromagnetic compatibility - Requirements and tests
- ISO 80601-2-56:2017+A1:2018 Medical electrical equipment – Particular requirements for the basic safety and essential performance of clinical thermometers for body temperature measurement.
- ASTM D4169-22 Standard Practice for Performance Testing of Shipping Containers and Systems
All results met the requirements. No clinical testing was performed.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Accuracy: +/- 0.1 degree C
Measurement Range: 25-45 degree C
Measurement Time: 60s
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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
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 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.
August 25, 2023
Shenzhen SINO-K Medical Technology Co., Ltd. % Kevin Wang Consultant Shenzhen Chonconn Medical Consulting Co., Ltd. Room 504, Block C, No. 1029 Nanhai Avenue, Nanshan District Shenzhen, Guangdong 518067 China
Re: K223807
Trade/Device Name: Reusable Temperature Probe, Disposable Temperature Probe Regulation Number: 21 CFR 880.2910 Regulation Name: Clinical Electronic Thermometer Regulatory Class: Class II Product Code: FLL Dated: July 25, 2023 Received: July 26, 2023
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.
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
1
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,
Porsche Bennett
Porsche Bennett For David Wolloscheck, Ph.D. 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) K223807
Device Name
Reusable Temperature Probe, Disposable Temperature Probe
Indications for Use (Describe)
Reusable Temperature Probes:
Reusable Temperature Probes are intended to be used for monitoring temperature for multi- patient use. The temperature probes are reusable and designed for use with monitor of GE-Marquette Model DASH3000. These devices are used by qualified medical professionals only.
Disposable Temperature Probes:
Disposable Temperature Probes are intended to be used for monitoring temperature for single patient use. The temperature probes are non-sterile and designed for use with monitors of GE- Marquette Model DASH3000. These devices are used by qualified medical professionals only.
| 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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3
510(K) Summary - K223807
Prepared in accordance with the requirements of 21 CFR Part 807.92
Prepared Date: August 25, 2023
1. Submission sponsor
Name: Shenzhen SINO-K Medical Technology Co., Ltd. Room401, Bldg2, Veteran Ind. City, Gongle Community, Xixiang Street, Baoan District, Shenzhen, Guangdong, China Contact person: Lao Chengxin Title: General Manager E-mail: boss(@sino-k.com Tel: +86 137 15333326
Submission correspondent 2.
Name: Shenzhen Chonconn Medical Device Consulting Co., Ltd. Address: Room 504, Block C, No. 1029 Nanhai Avenue, Nanshan District, Shenzhen, Guangdong, P.R. China Contact person: Kevin Wang E-mail: kevin(@chonconn.com Tel: +86-755 33941160
3. Subject Device Information
| Trade/Device Name | Reusable Temperature Probe, Disposable Temperature Probe |
|---|---|
| Regulatory Class | Class II |
| Regulation Number | 21CFR 880.2910 |
| Regulation/Common | |
| Name | Clinical Electronic Thermometer |
| Product Code | FLL |
| Submission type | Traditional 510(K) |
Predicate Device 4.
| Manufacturer Name | Shenzhen Med-link Electronics Tech Co., Ltd. |
|---|---|
| 510(k) Number | K193338 |
| Trade/Device Name | Med-link Reusable Temperature Probes, Med-link Disposable Temperature Probes |
| Regulatory Class | Class II |
| Regulation Number | 21CFR 880.2910 |
| Regulation/Common Name | Clinical Electronic Thermometer |
| Product Code | FLL |
| Submission type | Traditional 510(K) |
4
5. Device Description
The proposed devices are used for patient temperature measurement. The probes are reusable or disposable depending on the model. These probes consist of a connector on the monitor end and a thermistor on the patient end. The working principle is resistance based on the metal conductor increasing with temperature decrease, and the linear changes to the characteristics of the temperature measurement. The proposed devices are designed to be used in a healthcare facility and compatible with a monitor, GE-Marquette Model DASH3000.
The six models have two types of structure designs corresponding to reusable and disposable use which consists of different materials. The Negative Temperature Coefficient (NTC) of the six models are identical. Reusable models ST1304, ST2304, ST3304, ST4304 have a similar structure design with two different sensor shapes for different measure sites and consist of the same materials. Disposable models ST5105A and ST6105A have a similar structure design with two different sensor shapes for different measure sites and consist of the same materials.
| No. | Model | Description |
|---|---|---|
| 1 | ST1304 | Skin contact Temperature Probe, adult, reusable |
| 2 | ST2304 | Body cavity Temperature Probe, Esophageal, adult, reusable |
| 3 | ST3304 | Skin contact Temperature Probe, pediatric, reusable |
| 4 | ST4304 | Body cavity Temperature Probe, Esophageal, pediatric, reusable |
| 5 | ST5105A | Skin contact Temperature Probe, adult, disposable |
| 6 | ST6105A | Body cavity Temperature Probe, Esophageal, adult, disposable |
6. Indication for use
Reusable Temperature Probes:
Reusable Temperature Probes are intended to be used for monitoring temperature for multipatient use. The temperature probes are reusable and designed for use with monitor of GE-Marquette Model DASH3000.
These devices are used by qualified medical professionals only.
Disposable Temperature Probes:
Disposable Temperature Probes are intended to be used for monitoring temperature for single patient use.
The temperature probes are non-sterile and designed for use with monitors of GE-Marquette Model DASH3000.
These devices are used by qualified medical professionals only.
5
| Item | Subject Device,
K223807 | Predicate Device,
K193338 | Comparison |
|--------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------|
| Trade name | Reusable Temperature
Probe, Disposable
Temperature Probe | Med-link Reusable
Temperature Probes,
Med-link Disposable
Temperature Probes | / |
| 510(k) submitter | Shenzhen SINO-K
Medical Technology
Co., Ltd. | Shenzhen Med-link
Electronics Tech Co.,
Ltd. | / |
| 510(k) Number | K223807 | K193338 | / |
| Models | Reusable
adult/pediatric
models: ST1304,
ST2304, ST3304,
ST4304
Disposable
adult/pediatric
models:
ST5105A, ST6105A | Reusable pediatric
models:
W0003D,W0001C,W000
1D,
W00008C,W00008D
Disposable
adult/pediatric models:
W0001E, W0001F,
W0099F, W0003E,
W0003F | SE
Note 1 |
| Type of use | Prescription/Rx | Prescription/Rx | Same |
| Indication for
Use | Reusable Temperature
Probes:
Reusable Temperature
Probes are intended to
be used for monitoring
temperature for multi-
patient use. The
temperature probes are
reusable and designed
for use with monitor of
GE-Marquette Model
DASH3000.
These devices are used
by qualified | Med-link Reusable
Temperature Probes:
Med-link Temperature
Probes are intended to be
used for monitoring
temperature for multi-
patient use. The
temperature probes are
reusable and designed for
use with monitors of
Philips Model
IntelliVueMP50,
Mindray Model PM-9000
and Drager Model | SE
Note 1 |
| Item | Subject Device,
K223807 | Predicate Device,
K193338 | Comparison |
| | professional only.
Disposable
Temperature Probes:
Disposable
Temperature Probes
are intended to be used
for monitoring
temperature for single
patient use. The
temperature probes are
non-sterile and
designed for use with
monitors of GE-
Marquette Model
DASH3000.
These devices are used
by qualified medical
professional only. | These devices are used
by qualified medical
professional only.
Med-link Disposable
Temperature Probes:
Med-link Disposable
Temperature Probes are
intended to be used for
monitoring temperature
for single patient use.
The temperature probes
are
non-sterile and designed
for use with monitors of
GE Model B20 and
Philips Model
IntelliVueMP50.
These devices are used
by qualified medical
professional only. | |
| Operating
Principle | Resistance of
thermistor based on
the metal conductor
increases with
temperature decrease,
and the linear changes
to the characteristics
of the temperature
measurement. | Resistance of thermistor
based on the metal
conductor increases with
temperature decrease,
and the linear changes to
the characteristics of the
temperature
measurement. | Same |
| Measure site | Skin, Esophagus | Skin, Esophageal and
Rectal | SE
Note 2 |
| Usage | Reusable, Disposable | Reusable, Disposable | Same |
| Measurement
Range | 25-45°C | 25-45°C | Same |
| Measurement
Time | 60s | 180s | SE Note 3 |
| Accuracy | ±0.1°C | ±0.1°C | Same |
| Components | plug, cable and
temperature sensing | plug, cable and
temperature sensing | Same |
| Item | Subject Device,
K223807 | Predicate Device,
K193338 | Comparison |
| | probe | probe | |
| Thermistor
resistance | 2.25KΩ@25°C | 2.25KΩ@25°C | Same |
| Device
Dimension | Reusable models:3m
Disposable models:
0.8m | Unknown | SE
Note 4 |
| Material | Materials of reusable
probe:
Cable: PVC
Probe end: Steel,
Epoxy, PA66
Materials of
disposable probe:
Cable: PVC
Probe end: Epoxy,
Medical pressure-
sensitive adhesive | Materials of reusable
probe:
Cable: TPU
Probe end: Epoxy,
S304 Stainless Steel;
Materials of disposable
probe:
Cable: PVC
Probe end: Epoxy, PVC | SE
Note 5 |
| Compatible
Monitors | GE-Marquette Model
DASH3000 | Reusable temperature
probes are compatible
with Philips Model
IntelliVue MP50,
Mindray Model PM-
9000, Drager Model
Infinity Gamma XL, and
disposable temperature
probes are compatible
with GE Model B20 and
Philips Model IntelliVue
MP50. | SE
Note 1 |
| Operating
Environment | Temperature: +5
to+40°C
Humidity: ≤80%
(non-condensing)
Atmospheric pressure
: 86kPa ~
106kPa | Temperature:
+5°C~+40°C;
Atmospheric Pressure: 86
kPa to 106 kPa
Relative humidity
range:0 % to 80 %,
non-condensing (% RH) | Same |
| Storage
Environment | Temperature: -10°C to
+40°C | Temperature: -10°C to
+40°C | Same |
| Electrical Safety | Comply with IEC 60601-1 | Comply with IEC 60601-1 | Same |
| Performance | ISO 80601-2-56 | ISO 80601-2-56 | Same |
| Biocompatibility | All the patient-contacting materials are evaluated by the biocompatibility standard ISO10993-1 | All the patient-contacting materials are evaluated by the biocompatibility standard ISO10993-5, ISO 10993-10. | Same |
| Sterilization | Non-sterile | Non-sterile | Same |
| Operational Type | Continual | Continual | Same |
| Shelf life | 2 years | Unknown | SE
Note 6 |
7. Comparison to the Predicate Device
6
7
8
Note 1
The subject device is compatible with a different monitor than the predicate device. In addition, the intended patient population of both the subject device and the predicate device include adult and pediatric patient populations with the only difference being that The core component of the temperature probes in the subject devices is Negative Temperature Coefficient (NTC) which is identical to the NTC used in the predicate devices. The NTC determines the accuracy and range of temperature measurement. The subject device performance was tested in accordance with ISO 80601-2-56 for all models, using the compatible monitor. All results met the requirements. Therefore, the differences do not raise new questions of safety and effectiveness.
Note 2
The subject device measurement sites are a subset of the predic sites. The subject device performance and biocompatibility was tested in accordance to ISO 80601-2-56 and ISO10993-1, respectively. Therefore, the difference does not raise new questions of safety and effectiveness.
Note 3
The meas ne of the subject device is 60 seconds; he time of the predicate device is 180 seconds. The subject device's measurement time is le than that of the predicate and the device performance of all models have been tested to ISO80601-2-56. Therefore, the differences do not raise new or different questions of safet and effectiveness.
Note 4
ns of the predicate device are unknown. The ide flexibility for clinical use. The length e of the subject devices. The performance o
9
been verified with ISO 80601-2-56; the difference does not raise new questions of safety and effectiveness.
Note 5
Although patient-contacting materials are different between the subject devices and predicate devices, all of the subject device models were tested in accordance to and complied with ISO 10993-5 and ISO 10993-10. Therefore, the differences do not raise new questions of safety and effectiveness.
Note 6
The shelf life of the subject device is 2 years; however, the shelf life of the predicate device is unknown. The performance of the subject device has been verified for the claimed shelf life. Therefore, the difference does not raise new questions of safety and effectiveness.
8. Non- Clinical Testing
The following testing was conducted to demonstrate substantial equivalence.
Biocompatibility testing
The biocompatibility evaluation for the subject devices were 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 biocompatibility testing included the following tests:
- Cytotoxicity
- o ISO10993-5 Third edition 2009-06-01 Biological evaluation of medical devices - Part 5: Tests for in vitro cytotoxicity
- . Sensitization
- ISO10993-10 Third Edition 2010-08-01 Biological evaluation of medical 0 devices - Part 10: Tests for irritation and skin sensitization
- Irritation .
- ISO10993-10 Third Edition 2010-08-01 Biological evaluation of medical O devices - Part 10: Tests for irritation and skin sensitization
- Oral mucosa Irritation (Body cavity Temperature Probe only)
Performance Testing
Non-clinical testing has been conducted to verify that the subject devices meet all design specifications which support the conclusion that it's Substantially Equivalent (SE) to the predicate devices. The testing results demonstrate that the targeted device complies with the following standards:
- IEC 60601-1-2005+CORR.1:2006+CORR.2:2007+A1:2012, Medical Electrical
10
Equipment- Part 1: General requirements for basic safety and essential performance
- . IEC 60601-1-2:2014 Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral standard: Electromagnetic compatibility - Requirements and tests
- ISO 80601-2-56:2017+A1:2018 Medical electrical equipment – Particular requirements for the basic safety and essential performance of clinical thermometers for body temperature measurement.
- ASTM D4169-22 Standard Practice for Performance Testing of Shipping Containers and Systems
9. Clinical Testing
No clinical testing was performed as this device does not require clinical studies to demonstrate substantial equivalence with the predicate device.
10. Conclusion
It can be concluded that the differences between the subject devices, Reusable Temperature Probe, Disposable Temperature Probe and predicate devices do not raise new or different questions of safety or effectiveness. The subject device is substantially equivalent to the predicate device. Med-link Reusable Temperature Probes, Med- link Disposable Temperature Probes, cleared under K193338.