(267 days)
Temperature Probes are intended to be used for monitoring temperature. The temperature probes are reusable or for single patient use and designed for use with Mindray monitor Model PM-8000 and other monitors compatible with YSI 400 series temperature probes.
These devices are used by qualified medical professional only.
The subject devices are used for patient temperature measurement. The probes are reusable or disposable depending on models. 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 increases with temperature decrease, and the linear changes to the characteristics of the temperature measurement. The subject devices are designed to be used in healthcare facilities like hospital and compatible with a monitor of Mindray Model PM-8000 and other monitors compatible with YSI 400 series temperature probes.
The six models have two types of structure designs corresponding to reusable and disposable use which consists of different materials. The NTC of the six models are identical. Reusable models T1306, T2306, T3306, T4306 have a similar structure design with two different sensor shapes for different measure sites and consist of the same materials. Disposable models T5106 and T6106 have a similar structure design with two different sensor shapes for different measure sites and consist of the same materials.
Model: T1306, Description: Skin contact Temperature Probe, adult, reusable
Model: T2306, Description: Body cavity Temperature Probe, Esophageal/Rectal, adult, reusable
Model: T3306, Description: Skin contact Temperature Probe, pediatric, reusable
Model: T4306, Description: Body cavity Temperature Probe, Esophageal/Rectal, pediatric, reusable
Model: T5106, Description: Skin contact Temperature Probe, adult/ pediatric, disposable
Model: T6106, Description: Body cavity Temperature Probe, Esophageal/Rectal, adult/ pediatric, disposable
The provided FDA 510(k) clearance letter describes a medical device, the Reusable and Disposable Temperature Probes, but does not include information about AI/ML performance. Therefore, I will respond to the prompt by extracting the acceptance criteria and study information pertinent to this medical device, which focuses on traditional medical device performance rather than AI/ML.
Here's an analysis of the acceptance criteria and the study that proves the device meets them, based on the provided document:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criterion | Reported Device Performance | Study Supporting Performance |
|---|---|---|
| Accuracy | ±0.1℃ | Bench Testing (ISO 80601-2-56) |
| Measurement Range | 25-45℃ | Bench Testing (ISO 80601-2-56) |
| Electrical Safety | Complies with IEC 60601-1 | Bench Testing (IEC 60601-1) |
| Electromagnetic Compatibility (EMC) | Complies with IEC 60601-1-2 | Bench Testing (IEC 60601-1-2) |
| Biocompatibility | Complies with ISO 10993-1, ISO 10993-5, ISO 10993-10, ISO 10993-23 | Biocompatibility testing |
| Operating Environment | +5 to +40°C, ≤80% humidity (non-condensing), 86kPa~106kPa | Bench Testing (IEC 60601-1 and ISO 80601-2-56) |
| Storage Environment | -20℃ to 55℃, ≤93% humidity, 86kPa~106kPa | Bench Testing (IEC 60601-1 and ISO 80601-2-56) |
| Compatibility with Monitors | Verifies compatibility with Mindray Model PM-8000 and other YSI 400 series compatible monitors | Bench Testing |
Note: The document presents "Accuracy" and "Measurement Range" as inherent characteristics of the device and states that bench testing was conducted to verify that design specifications were met, which implies these values are the acceptance criteria.
2. Sample Size Used for the Test Set and Data Provenance
The document does not explicitly state the sample sizes used for the test sets (e.g., number of units tested, number of temperature measurements, or specific test configurations) for the bench testing or biocompatibility testing.
The document also does not provide information about the provenance of data in terms of country of origin or whether studies were retrospective or prospective. The testing described appears to be laboratory-based verification and validation.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
This information is not applicable and not provided in the document. The device is a clinical electronic thermometer, and its performance is assessed against technical specifications and international standards, not against human expert interpretation of medical images or data. Ground truth for temperature measurement is typically established by reference standards or calibrated equipment.
4. Adjudication Method for the Test Set
This information is not applicable and not provided in the document. Adjudication methods like 2+1 or 3+1 are typically used in studies involving subjective assessment (e.g., image interpretation by multiple readers), which is not relevant for the objective performance testing of a temperature probe.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No. An MRMC comparative effectiveness study was not conducted as this is a medical device for objective temperature measurement, not an AI-assisted diagnostic tool requiring human-in-the-loop performance evaluation. The document does not mention any AI assistance.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study
No. This device is an electronic temperature probe, not an algorithm or software. Its performance is inherent to its physical and electrical properties, evaluated through bench testing against established standards.
7. Type of Ground Truth Used
The ground truth for the performance evaluations (accuracy, measurement range, electrical safety, etc.) would be established by:
- Reference Standards/Calibrated Equipment: For accuracy and measurement range, the device's readings would be compared against highly accurate and calibrated reference thermometers in controlled temperature environments.
- International Standards: Compliance with electrical safety (IEC 60601-1), EMC (IEC 60601-1-2), and thermometer-specific performance (ISO 80601-2-56) serves as the ground truth for safety and performance.
- Laboratory Analysis: For biocompatibility, laboratory tests (cytotoxicity, sensitization, irritation) are conducted to assess the biological response to the device materials according to ISO 10993 standards.
8. Sample Size for the Training Set
This information is not applicable and not provided. This device is a hardware medical device with no mention of machine learning or algorithms that would require a "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 an AI/ML algorithm involved, no ground truth was established for a training set.
FDA 510(k) Clearance Letter - K243000
Page 1
U.S. Food & Drug Administration
10903 New Hampshire Avenue
Silver Spring, MD 20993
www.fda.gov
Doc ID # 04017.07.05
June 20, 2025
Shenzhen Medke Technology Co., Ltd.
℅ Mrs. Jie Yang
Consultant
Chonconn Medical Device Consulting Co., Ltd.
Room 504, Block C, No. 1029 Nanhai Avenue, Nanshan District
Shenzhen, Guangdong 518067
China
Re: K243000
Trade/Device Name: Reusable Temperature Probe (T1306, T2306, T3306, T4306); Disposable Temperature Probe (T5106, T6106)
Regulation Number: 21 CFR 880.2910
Regulation Name: Clinical Electronic Thermometer
Regulatory Class: Class II
Product Code: FLL
Dated: September 26, 2024
Received: May 23, 2025
Dear Jie Yang:
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 (the 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 available 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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K243000 - Jie Yang Page 2
Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).
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 (reporting of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reporting-combination-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 Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rule"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance/unique-device-identification-system-udi-system.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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-devices/medical-device-safety/medical-device-reporting-mdr-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/medical-devices/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-devices/device-advice-comprehensive-regulatory-
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K243000 - Jie Yang Page 3
assistance/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 P. BENNETT -S
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
Page 4
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
Indications for Use
Form Approved: OMB No. 0910-0120
Expiration Date: 07/31/2026
See PRA Statement below.
Submission Number (if known)
K243000
Device Name
Reusable Temperature Probe(T1306, T2306, T3306, T4306);
Disposable Temperature Probe(T5106, T6106)
Indications for Use (Describe)
Temperature Probes are intended to be used for monitoring temperature. The temperature probes are reusable or for single patient use and designed for use with Mindray monitor Model PM-8000 and other monitors compatible with YSI 400 series temperature probes.
These devices are used by qualified medical professional only.
Type of Use (Select one or both, as applicable)
☒ Prescription Use (Part 21 CFR 801 Subpart D) ☐ Over-The-Counter Use (21 CFR 801 Subpart C)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services
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PRAStaff@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
Page 5
510(K) Summary- K243000
Prepared in accordance with the requirements of 21 CFR Part 807.92
Prepared Date: 2025/06/20
1. Submission sponsor
Name: Shenzhen Medke Technology Co., Ltd.
Address: 4/F, Bldg. A1, Anle Ind. Zone, Hangcheng RD., Baoan District,518126, Shenzhen, China
Contact person: Li Wei Tao
Title: CEO
E-mail: tate@medke.com
Tel: 0755-23463462
2. Submission correspondent
Name: Chonconn Medical Device Consulting Co., Ltd.
Address: Room 504, Block C, No. 1029 Nanhai Avenue, Nanshan District, Shenzhen, Guangdong, P.R. China
Contact person: Yang Jie
E-mail: yangjie@chonconn.com
Tel: +86-755 33941160
3. Subject Device Information
| Trade/Device Name | Reusable Temperature Probe (T1306, T2306, T3306, T4306); Disposable Temperature Probe (T5106, T6106) |
|---|---|
| Common Name | Temperature Probe |
| Regulatory Class | Class II |
| Regulation & Name | 21CFR 880.2910 / Thermometer, electronic, clinical |
| Product Code | FLL |
| Submission type | Traditional 510(K) |
4. Predicate Device
| Predicate Device name and model | K number | Manufacturer | |
|---|---|---|---|
| Primary Predicate device | Unimed Temperature Probe (Unimed Skin Temperature Probe, Unimed General Purpose Temperature Probe) | K121427 | Unimed Medical Supplies Inc. |
| Reference device | ESOPHAGEAL RECTAL TEMPERATURE PROBE ER400-9, ER400-12 | K863646 | RESPIRATORY SUPPORT PRODUCTS, INC. (owned by ICU Medical, Inc. now) |
Page 6
5. Device Description
The subject devices are used for patient temperature measurement. The probes are reusable or disposable depending on models. 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 increases with temperature decrease, and the linear changes to the characteristics of the temperature measurement. The subject devices are designed to be used in healthcare facilities like hospital and compatible with a monitor of Mindray Model PM-8000 and other monitors compatible with YSI 400 series temperature probes.
The six models have two types of structure designs corresponding to reusable and disposable use which consists of different materials. The NTC of the six models are identical. Reusable models T1306, T2306, T3306, T4306 have a similar structure design with two different sensor shapes for different measure sites and consist of the same materials. Disposable models T5106 and T6106 have a similar structure design with two different sensor shapes for different measure sites and consist of the same materials.
| Model | Description |
|---|---|
| T1306 | Skin contact Temperature Probe, adult, reusable |
| T2306 | Body cavity Temperature Probe, Esophageal/Rectal, adult, reusable |
| T3306 | Skin contact Temperature Probe, pediatric, reusable |
| T4306 | Body cavity Temperature Probe, Esophageal/Rectal, pediatric, reusable |
| T5106 | Skin contact Temperature Probe, adult/ pediatric, disposable |
| T6106 | Body cavity Temperature Probe, Esophageal/Rectal, adult/ pediatric, disposable |
6. Intended use & Indication for use
Temperature Probes are intended to be used for monitoring temperature. The temperature probes are reusable or for single patient use and designed for use with Mindray monitor Model PM-8000 and other monitors compatible with YSI 400 series temperature probes.
These devices are used by qualified medical professional only.
7. Comparison to the Predicate Device
The following tabulation indicates the detailed differences between the subject devices and the predicate device.
| Item | Subject Device | Primary Predicate Device | Comparison |
|---|---|---|---|
| Trade name | Reusable Temperature Probe (T1306, T2306, T3306, T4306); Disposable Temperature Probe (T5106, T6106) | Unimed Temperature Probe | / |
| 510(k) submitter | Shenzhen Medke Technology Co., Ltd. | Unimed Medical Supplies Inc. | / |
| 510(k) Number | K243000 | K121427 | / |
Page 7
| Models | Skin Temperature Probe: Reusable: T1306, T3306 Disposable: T5106 Body cavity Temperature Probe: | Unimed Skin Temperature Probe, Unimed General Purpose Temperature Probe | / |
|---|
| Item | Subject Device | Primary Predicate Device | Comparison |
|---|---|---|---|
| Reusable: T2306, T4306 Disposable: T6106 | |||
| Classification Regulation | 880.2910 | 880.2910 | Same |
| Class | II | II | Same |
| Product Code | FLL | FLL | Same |
| Common Name | Temperature Probe | Temperature Probe | Same |
| Type of use | Prescription | Prescription | Same |
| Indication for Use | Temperature Probes are intended to be used for monitoring temperature. The temperature probes are reusable or for single patient use and designed for use with Mindray monitor Model PM-8000 and other monitors compatible with YSI 400 series temperature probes. These devices are used by qualified medical professional only. | Unimed Temperature Probes are intended to be used for monitoring temperature. The temperature probes are reusable and designed for use with monitors of Philips, Marquette, Mindray, Spacelabs, Siemens, Artema/S&W and other monitors compatible with YSI 400 series temperature probes. These devices are indicated for used by qualified medical personnel only. | Similar, note 1 |
| 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 |
Page 8
| Models | Skin Temperature Probe: Reusable: T1306, T3306 Disposable: T5106 Body cavity Temperature Probe: | Unimed Skin Temperature Probe, Unimed General Purpose Temperature Probe | / |
|---|
| Item | Subject Device | Primary Predicate Device | Comparison |
|---|---|---|---|
| Reusable: T2306, T4306 Disposable: T6106 | |||
| Classification Regulation | 880.2910 | 880.2910 | Same |
| Class | II | II | Same |
| Product Code | FLL | FLL | Same |
| Common Name | Temperature Probe | Temperature Probe | Same |
| Type of use | Prescription | Prescription | Same |
| Indication for Use | Temperature Probes are intended to be used for monitoring temperature. The temperature probes are reusable or for single patient use and designed for use with Mindray monitor Model PM-8000 and other monitors compatible with YSI 400 series temperature probes. These devices are used by qualified medical professional only. | Unimed Temperature Probes are intended to be used for monitoring temperature. The temperature probes are reusable and designed for use with monitors of Philips, Marquette, Mindray, Spacelabs, Siemens, Artema/S&W and other monitors compatible with YSI 400 series temperature probes. These devices are indicated for used by qualified medical personnel only. | Similar, note 1 |
| 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, Esophageal and Rectal | Skin, Esophageal and Rectal | Same |
| Operation mode | Direct mode | Direct mode | Same |
| Usage | Reusable, Disposable | Reusable | Similar Note 1 |
| Item | Subject Device | Primary Predicate Device | Comparison |
|---|---|---|---|
| Measurement Range | 25-45℃ | 25-45℃ | Same |
| Accuracy | ±0.1℃ | ±0.1℃ | Same |
| Component | plug, cable and temperature sensing probe | plug, cable and temperature sensing probe | Same |
| Thermistor resistance | 2.25KΩ@25℃ | 2.252KΩ@25℃ | Same |
| Material | Materials of reusable probe: PVC, Copper nickel plated, Expoxy AB glue Materials of disposable probe: PVC, Foam, Aluminum foil | Not-provided | Similar Note 2 |
| Compatible Monitors | Mindray Model PM8000, and other monitors compatible with YSI 400 series temperature probes. | Philips, Marquette, Mindray, Spacelabs, Siemens, Artema/S&W and other monitors compatible with YSI 400 series temperature probes. | Similar, Note 1 |
| Operating Environment | Temperature: +5 to+40°C Humidity: ≤80％(non-condensing) Atmospheric pressure： 86kPa～106kPa | Not-provided | Similar Note 3 |
| Storage Environment | Temperature range: -20℃ to 55℃(-4 to 131℉) Humidity (Operating): ≤93% Hyperbaric Pressure: 86kPa～106kPa | Not-provided | Similar Note 3 |
| Electrical Safety | Comply with IEC 60601-1 | Comply with IEC 60601-1 | Same |
| Performance | ISO 80601-2-56 | EN 12470-4 | Similar, Note 4 |
Page 9
| Measure site | Skin, Esophageal and Rectal | Skin, Esophageal and Rectal | Same |
|---|---|---|---|
| Operation mode | Direct mode | Direct mode | Same |
| Usage | Reusable, Disposable | Reusable | Similar Note 1 |
| Item | Subject Device | Primary Predicate Device | Comparison |
|---|---|---|---|
| Measurement Range | 25-45℃ | 25-45℃ | Same |
| Accuracy | ±0.1℃ | ±0.1℃ | Same |
| Component | plug, cable and temperature sensing probe | plug, cable and temperature sensing probe | Same |
| Thermistor resistance | 2.25KΩ@25℃ | 2.252KΩ@25℃ | Same |
| Material | Materials of reusable probe: PVC, Copper nickel plated, Expoxy AB glue Materials of disposable probe: PVC, Foam, Aluminum foil | Not-provided | Similar Note 2 |
| Compatible Monitors | Mindray Model PM-8000, and other monitors compatible with YSI 400 series temperature probes. | Philips, Marquette, Mindray, Spacelabs, Siemens, Artema/S&W and other monitors compatible with YSI 400 series temperature probes. | Similar, Note 1 |
| Operating Environment | Temperature: +5 to+40°C Humidity: ≤80％(non-condensing) Atmospheric pressure： 86kPa～106kPa | Not-provided | Similar Note 3 |
| Storage Environment | Temperature range: -20℃ to 55℃(-4 to 131℉) Humidity (Operating): ≤93% Hyperbaric Pressure: 86kPa～106kPa | Not-provided | Similar Note 3 |
| Electrical Safety | Comply with IEC 60601-1 | Comply with IEC 60601-1 | Same |
| Performance | ISO 80601-2-56 | EN 12470-4 | Similar, Note 4 |
| Biocompatibility | All the patient-contacting materials are evaluated by the biocompatibility standard ISO10993-5, ISO 10993-10, ISO 10993-23 | All the patient-contacting materials are evaluated by the biocompatibility standard ISO10993-5, ISO 10993-10. | Similar, Note 4 |
Page 10
| Item | Subject Device | Primary Predicate Device | Comparison |
|---|---|---|---|
| Sterilization | Non-sterile | Non-sterile | Same |
| Operational Type | Continual | Continual | Same |
Justification of differences:
Note 1
The subject device claims different compatible patient monitor compared with predicate device. However, they all compatible with monitors compatible with YSI 400 series temperature probes. The compatibility has been verified by bench testing. Besides, the subject device includes both reusable and disposable models while the predicate only include reusable models. The reusable models are considered higher risk models and can be used to cover both reusable and disposable models of the subject devices. Therefore, the difference does not raise any new or different safety and effectiveness questions.
Note 2
The materials information of the predicate is not available. However, the biocompatibility of the subject device has been evaluated per ISO 10993-1. The difference does not raise any new or different safety and effectiveness questions.
Note 3
Operating and Storage condition difference: The subject device has been tested and the test results met the requirements of IEC 60601-1 and ISO 80601-2-56. The difference does not raise any new or different safety and effectiveness questions.
Note 4
The subject device complies with the newest FDA recognized standard compared with the predicate device. The difference does not raise any new or different safety and effectiveness questions.
8. Non-clinical Data
The following performance data were provided in support of the substantial equivalence determination.
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
- Sensitization
Page 11
- Irritation
- Oral mucosa/ Rectal Irritation (Body cavity Temperature Probe only)
Bench testing
Bench 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 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.
9. Clinical study
No clinical study is needed for the subject device.
10. Conclusion
Substantial equivalence comparisons, performance testing and compliance with voluntary standards demonstrate that the differences between the subject and predicate device do not raise new questions of safety and effectiveness. The subject device is substantially equivalent to the predicate device.
§ 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.