(167 days)
The Sterile Disposable Temperature Probe is to be used with Mindray uMEC10 to monitor core temperature or skin temperature. The device is for use by licensed healthcare practitioners only.
The probe is offered in the following two configurations:
-
Body cavity Temperature Probe TGMS-1691 for monitoring of the core temperature in adult and pediatric patients by insertion into the esophageal or rectal cavities.
-
Skin contact Temperature Probe TSMS-1191 for monitoring of skin temperature by application of the probe's adhesive cover to an adult and pediatric patient's skin surface.
Sterile Disposable Temperature Probes are used during patient temperature measurement. These probes consist of a phone plug connector on the adapter cable 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 by using an interconnect cable which is also included in the submission as an accessory. These probes have a skin or core contact with a patient.
These temperature probes are typically used with Mindray uMEC10, which was cleared under K171901.
Products are packed individually into a paper pouch in sterile condition.
The provided document is a 510(k) summary for a medical device (Sterile Disposable Temperature Probe). It does not contain information about a study that proves the device meets specific acceptance criteria in the context of an AI/ML medical device where performance metrics like accuracy, sensitivity, and specificity would be evaluated against a ground truth.
Instead, this document focuses on demonstrating substantial equivalence to an existing predicate device based on design specifications, intended use, and a series of non-clinical tests (biocompatibility, electrical safety, EMC, and compliance with general medical device standards like ISO 80601-2-56 for clinical thermometers).
Therefore, I cannot extract the information required to populate the table and answer the detailed questions about acceptance criteria for AI/ML performance, study design, sample size, expert adjudication, or MRMC studies. This type of information is not relevant to the 510(k) clearance process for this specific traditional medical device (a temperature probe).
The "Performance Data" section (Section 8) lists, for example, "Biocompatibility testing" and "Non-clinical data" showing compliance with various ISO and IEC standards. These are acceptance criteria in the sense of regulatory compliance for a temperature probe, but not performance metrics of an AI model.
Here's an attempt to structure what can be inferred from the document regarding acceptance criteria and performance, but it deviates significantly from the AI/ML context implied by the prompt's questions.
Based on the provided document, which describes a traditional medical device (Sterile Disposable Temperature Probe) and its 510(k) clearance, the concept of "acceptance criteria" and "study that proves the device meets the acceptance criteria" refers to demonstrating substantial equivalence to a predicate device and compliance with relevant medical device standards, rather than the performance evaluation of an AI-powered diagnostic tool.
Therefore, most of the requested information (related to AI/ML performance metrics, ground truth establishment, expert adjudication, and MRMC studies) is not applicable to this document. I will fill in what can be inferred relating to the device's regulatory acceptance.
Acceptance Criteria and Device Performance (Regulatory Compliance)
| Acceptance Criteria Category | Specific Criteria (from document) | Reported Device Performance/Compliance |
|---|---|---|
| Material Safety (Biocompatibility) | Compliance with FDA Guidance for Industry and Staff: Use of International Standard ISO 10993-1, "Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process". Specific tests: Cytotoxicity, Sensitization, Irritation, Rectal Irritation (Body cavity probe only), Oral mucosa Irritation (Body cavity probe only). Device contact: surface/mucosal, < 24 hours. | Testing conducted, results demonstrate compliance with ISO 10993-5 (Cytotoxicity) and ISO 10993-10 (Sensitization, Irritation). |
| Electrical Safety | Compliance with 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. | Testing conducted, results demonstrate compliance. |
| Electromagnetic Compatibility (EMC) | Compliance with 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. | Testing conducted, results demonstrate compliance. |
| Clinical Thermometer Performance | Compliance with 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. This standard covers aspects like rated range, accuracy, operating conditions, and storage conditions. | Testing conducted, results demonstrate compliance. For example, regarding accuracy: "the design meets the design requirement... The subject devices are complied with ISO 80601-2-56 standard." Specifically for rated range and accuracy (from comparison table): - Rated Range: 0-50°C (32°F-122°F) - Accuracy: ± 0.1°C/0.2°F in 25°C/77°F to 45°C/113°F, and ± 0.2°C/0.4°F in 0°C/32°F to 24.9°C/76.8°F and 45.1°C/113.2°F to 50°C/122°F. |
| Stability and Performance | Stability and performance test of the skin temperature probe for 24hrs continues use. | Testing conducted (implied as part of "Non-clinical data" and "meets all design specifications"). |
| Sterilization | Sterilized with Ethylene Oxide. | Stated as "Sterilized with Ethylene Oxide" and accepted as "Same" as predicate. (Implies meeting method effectiveness criteria, though specific data not in this summary). |
Study Details (as inferable from a 510(k) for a traditional device)
-
Sample sizes used for the test set and the data provenance:
- Test Set Sample Size: Not specified in terms of number of devices tested for each standard, but it's implied that sufficient samples were tested to demonstrate compliance with the relevant standards. These are engineering/device performance tests, not clinical studies with patient data.
- Data Provenance: The document states that "Non-clinical testing has been conducted to verify that the Sterile Disposable Temperature Probe meets all design specifications." The testing was likely conducted by the manufacturer or a contracted lab in line with international device standards. There is no mention of country of origin of patient data or whether it was retrospective/prospective, as this is not a study involving patient data collection for performance evaluation.
-
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not Applicable. For a traditional medical device like a temperature probe, "ground truth" typically refers to precise measurement standards and calibrated equipment used in engineering and performance testing (e.g., standard temperature baths for accuracy verification). It does not involve expert readers establishing a medical diagnosis "ground truth" from images or other clinical data.
-
Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not Applicable. This concept is relevant to human interpretation of data, often in AI/ML performance studies. For this device, standard engineering test methods and protocols are followed, where results are measured against defined specifications, not adjudicated by a panel of experts.
-
If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
- Not Applicable. This is a traditional temperature probe, not an AI-assisted diagnostic device. Therefore, no MRMC study would have been performed.
-
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not Applicable. There is no algorithm or AI component in this device. Its performance is inherent to its physical design and sensor.
-
The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- Engineering Standards / Calibrated Reference Measurements. For example, temperature accuracy is verified against a calibrated reference thermometer in a precisely controlled temperature environment. Device safety (e.g., biocompatibility) is determined by specific laboratory assays according to predefined ISO standards.
-
The sample size for the training set:
- Not Applicable. This is not an AI/ML device, so no training set is relevant.
-
How the ground truth for the training set was established:
- Not Applicable. No training set exists for this type of device.
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March 1, 2022
Shenzhen Envisen Industry Co., Ltd % Kevin Wang Consultant Shenzhen Chonconn Medical Consulting Co., Ltd. Room 508, Block C, No. 1029 Nanhai Avenue, Nanshan District Shenzhen, Guangdong 518067 China
Re: K212945
Trade/Device Name: Sterile Disposable Temperature Probe/Model: TGMS-1691 and TSMS-1191 Regulation Number: 21 CFR 880.2910 Regulation Name: Clinical Electronic Thermometer Regulatory Class: Class II Product Code: FLL Dated: January 26, 2022 Received: January 28, 2022
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
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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,
Gang Peng for Payal Patel Assistant Director DHT3C: Division of Drug Delivery and General Hospital Devices, and Human Factors OHT3: Office of GastroRenal, ObGyn, General Hospital and Urology Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K212945
Device Name
Sterile Disposable temperature probe/Model: TGMS-1691 and TSMS-1191
Indications for Use (Describe)
The Sterile Disposable Temperature Probe is to be used with Mindray uMEC10 to monitor core temperature or skin temperature. The device is for use by licensed healthcare practitioners only.
The probe is offered in the following two configurations:
-
Body cavity Temperature Probe TGMS-1691 for monitoring of the core temperature in adult and pediatric patients by insertion into the esophageal or rectal cavities.
-
Skin contact Temperature Probe TSMS-1191 for monitoring of skin temperature by application of the probe's adhesive cover to an adult and pediatric patient's skin surface.
| Prescription Use (Part 21 CFR 801 Subpart D) Over-The-Counter Use (21 CFR 801 Subpart C) | |
|---|---|
| -- | -------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------- |
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Type of Use (Select one or both, as applicable)
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510(K) Summary for K212945
Prepared in accordance with the requirements of 21 CFR Part 807.92
Prepared Date: 2022/2/25
Submission sponsor 1.
Name: Shenzhen Envisen Industry Co., Ltd. Address: Block 1, Room 201, 301, 401, 40 Jianlong Street, Baoan Community, Yuanshan Town, Longgang District, Shenzhen, P.R. China Contact person: Ailsa Huang Title: Management Representative E-mail: ailsa.huang@envisen.com Tel: +86 0755 88827227
2. Submission correspondent
Name: Shenzhen Chonconn Medical Device Consulting Co., Ltd. Address: Room 508, 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
| Trade/Device Name | Sterile Disposable Temperature Probe |
|---|---|
| Model | TGMS-1691 and TSMS-1191 |
| Common Name | Temperature Probe |
| Regulatory Class | Class II |
| Regulation Number | 21CFR 880.2910 |
| Regulation Name | Clinical Electronic Thermometer |
| Product Code | FLL |
Subject Device Information 3.
Predicate Device 4.
-
- DeRoyal Industries, Inc., DeRoyal Temperature Monitoring Probe under K200631.
Device Description ട്.
Sterile Disposable Temperature Probes are used during patient temperature measurement. These probes consist of a phone plug connector on the adapter cable 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 by using an interconnect cable which is also included in the submission as an accessory. These probes
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have a skin or core contact with a patient.
These temperature probes are typically used with Mindray uMEC10, which was cleared under K171901.
Products are packed individually into a paper pouch in sterile condition.
6. Indications for use
The Sterile Disposable Temperature Probe is to be used with Mindray uMEC10 to monitor core temperature or skin temperature. The device is for use by licensed healthcare practitioners only.
The probe is offered in the following two configurations:
-
Body cavity Temperature Probe TGMS-1691 for monitoring of the core temperature in adult and pediatric patients by insertion into the esophageal or rectal cavities.
-
Skin contact Temperature Probe TSMS-1191 for monitoring of skin temperature by application of the probe's adhesive cover to an adult and pediatric patient's skin surface.
| Features | Configuration | Subject DeviceSterileDisposableTemperatureProbeK212945 | Predicate DeviceDeRoyalTemperatureMonitoring ProbeK200631 | Comparison |
|---|---|---|---|---|
| ClassificationName | Body cavitySkin contact | TemperatureProbe | TemperatureProbe | Same |
| Product Code | Body cavitySkin contact | FLL | FLL | Same |
| RegulationNumber | Body cavitySkin contact | 880.2910 | 880.2910 | Same |
| Panel | Body cavitySkin contact | GeneralHospital | General Hospital | Same |
| Class | Body cavitySkin contact | II | II | Same |
| Indications forUse | Body cavitySkin contact | TheSterileDisposableTemperatureProbe is to beused withMindrayuMEC10 to | The DeRoyalTemperatureMonitoring Probeis used for routinemonitoring of thepatient's core bodyor skin surface | Different1 |
| monitor core temperature. temperature or skin temperature. The device is for use by licensed healthcare practitioners only. The probe is offered in the following two configurations: - Body cavity Temperature Probe TGMS-1691 for monitoring of the core temperature in adult and pediatric patients by insertion into the esophageal or rectal cavities. - Skin contact Temperature Probe TSMS-1191 for monitoring of skin temperature by application of the probe's adhesive cover to an adult and pediatric patient's skin surface. | The probe is offered in the following three configurations: - General Purpose Temperature Probe for routine monitoring of the core body temperature in adult and pediatric patients by insertion into the nasopharyngeal, esophageal, or rectal cavities. - Adult Skin Temperature Sensor for routine monitoring of skin temperature by application of the probe's adhesive cover to an adult patient's skin surface. - Tympanic Temperature Probe for routine monitoring of the core body temperature in adult and pediatric patients by insertion of the ear piece into the aural canal. The device is single use and for use by licensed | |||
| healthcarepractitioners only.The probes aredesigned tointerface withDeRoyal- brandedcables forconnection withYSI 400 or 700series compatiblemonitors,including thefollowing patientmonitors andequivalentmodels: MindrayPassport, PhilipsIntelliVue,Siemens/DraegerInfinity, and GEDatex-Ohmedabrands. | ||||
| ApplicationPopulation | Body cavitySkin contact | adult andpediatric | adult and pediatricadult | SameDifferent 2 |
| PrescriptionOnly | Body cavitySkin contact | Yes | Yes | Same |
| Mode ofoperation | Body cavitySkin contact | Direct mode | Direct mode | Same |
| Measure site | Body cavitySkin contact | Rectum,EsophagusSkin Surface | Rectum,Esophagus,NasopharynxSkin Surface | Different 3Same |
| Sensor | Body cavitySkin contact | Thermistorwhich issensitive totemperaturechange. | Thermistor whichis sensitive totemperaturechange. | Same |
| Reference BodySite | Body cavitySkin contact | Core BodySkin Surface | Core BodySkin Surface | Same |
| Principle ofoperation | Body cavitySkin contact | Thermistorresistance based | Thermistorresistance based | Same |
| on the metalconductor increasewith temperaturedecrease, andthe linearchanges to thecharacteristicsof thetemperaturemeasurement. | on the metalconductor increasewith temperaturedecrease, and thelinear changes tothe characteristicsof the temperaturemeasurement. | |||
| RatedRange | Body cavitySkin contact | 0-50°C(32°F- 122°F) | 25-45°C | Different 4 |
| Accuracy | Body cavitySkin contact | $\pm$ 0.1°C/0.2°F inthe range25°C/77°F to45°C/113°F$\pm$ 0.2°C/0.4°F inthe range0°C/32°F to24.9°C/76.8°Fand45.1°C/113.2°Fto 50°C/122°F | $\pm$ 0.2°C | |
| OperatingConditions | Body cavitySkin contact | 5°C to40°C(41°F to104°F)20% to 85%RH, | 25°C to 45°C\ | Different 5 |
| storageconditions | Body cavitySkin contact | -20 to 55°C (--4°F to 131°F),10% to 93%RH, | -25°C to +55°C\ | Different 6 |
| diameter | Body cavity | 3mm | 3mm,4mm | Same |
| Length | Body cavitySkin contact | 0.75m0.95m | \ | Different 7 |
| Design | Body cavity | Wire set with aphone plugconnector on theadapter cableend and athermistor on | Wire set with athermistor chip atthe distal end and ablue connector atthe proximal end.The wire set is | Same |
| the patient end.The wire set isenclosed in atube that may beinserted into theapplication site. | enclosed in a tubethat may beinserted into theapplication site. | |||
| Skin contact | Wire set with aphone plugconnector on theadapter cableend and athermistor onthe patient end.An adhesiveprobe coverapplies thedevice to thepatients' skin. | Wire set with athermistor chip atthe distal end and ablue connector attheproximal end. Anadhesive probecover applies thedevice to thepatients' skin. | Same | |
| Materials | Body cavity | PVC Connectorand Tube Cable(PVDFMaterial) | Tube: PVCWire: Copper withPVC insulationThermistor:CeramicConnector: PVCmolded brassStrain Relief: PVCCap: UV-curedadhesive | Different 8 |
| Skin contact | Cover: Releaseliner:(PET) andFoam(aluminumfoil/PET) with3M glueWire: Copperwith PVDFinsulationThermistor:CeramicConnector: PVCmolded brassStrain Relief: | Cover: AdhesivefoamWire: Copper withPVC insulationThermistor:CeramicConnector: PVCmolded brassStrain Relief: PVCCap: UV-curedadhesive | ||
| PVCCap:stainlesssteel and epoxyglue | ||||
| Biocompatibility | Body cavity | Cytotoxicitycomplied withISO 10993-5 | Cytotoxicitycomplied with ISO10993-5Sensitizationcomplied with ISO10993-10Irritation compliedwith ISO 10993-10 | Same |
| Skin contact | Sensitizationcomplied withISO 10993-10Irritationcomplied withISO 10993-10 | Same | ||
| Sterilization | Body cavity | Sterilized withEthyleneOxide | Sterilized withEthyleneOxide | Same |
| Skin contact | Sterilized withEthyleneOxide | Sterilized withEthyleneOxide | Same | |
| Disposable | Body cavitySkin contact | Yes | Yes | Same |
Comparison to the Predicate Device 7.
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Different
The subject device has the same Intended use as the predicate device. However, there is some differences in the indications for use.
Predicate K200631 General purpose probe has one more application site nasopharyngeal compared with the subject body cavity probe. The esophageal and rectal cavities measurement sites of the subject body cavity temperature probe and predicate device general purpose temperature probe are the same. The measurement site of the subject body cavity temperature probe is a subset of the predicate device. The difference does not raise any new safety and effective questions.
Predicate K200631 skin probe is only appliable to adult while the subject skin probe is applicable to adult and pediatric. However, the skin contact probe design meets design requirements and is complied with ISO 80601-2-56 standard. The difference does not raise any new safety and effective questions.
The compatible monitors of proposed devices are different from the predicate device. The validate testing was conducted in accordance with the ISO 80601-2-56 standard. The difference does not raise any new safety and effective questions.
Different 2
Predicate K200631 skin probe is only appliable to adult while the subject skin probe is applicable to adult and pediatric. However, the skin contact probe design meets design
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requirements and is complied with ISO 80601-2-56 standard. The difference does not raise any new safety and effective questions.
Different 3
K200631 General purpose probe has one more application site nasopharyngeal compared with the subject body cavity probe. The application site of the subject device is the subset of the predicate device and complies with ISO 80601-2-56 standard, the difference does not raise any new safety and effective questions.
Different 4
Although the measurement range and accuracy of the subject devices are different form the predicate device, the design meets the design requirement. The subject devices are complied with ISO 80601-2-56 standard. Therefore, the difference does not raise any new safety and effective questions.
Different 5
The operating conditions of the subject devices are different from the predicate device. According to ISO 80601-2-56, a clinical thermometer shall operate in normal use over the ranges of an ambient temperature operating range from 15℃ to 40℃. The ambient temperature of the subject device covers this range, it has also been tested according to ISO 80601-2-56, which has proved that the subject device functions well under specified ambient temperature environment.
Different 6
The storage temperature is the same while the humidity range information of the predicate is not available. However, the validation test was conducted according to ISO 80601-2-56 standard, which has proved that the subject device functions well under specified humidity environment.
Different 7
The information of the predicate is not available. However, the validation test was conducted according to ISO 80601-2-56 standard and the difference does not raise any new safety and effective questions.
Different 8
There are some differences in the materials used in the subject devices and the predicate devices. A biocompatibility testing was performed on the subject products. Electrical Safety and EMC testing also were performed on the subject devices. The results of the testing demonstrate the subject devices comply with ISO 10993-5 and ISO 10993-10 standard and the difference does not raise any new safety and effective questions.
Performance Data 8.
The following performance data were provided in support of the substantial equivalence determination.
Biocompatibility testing
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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 (Body cavity Temperature Probe only)
- Oral mucosa Irritation (Body cavity Temperature Probe only)
The Sterile Disposable temperature probe is considered surface/mucosal contacting for a duration of not exceed 24 hours.
Non-clinical data
Non-clinical testing has been conducted to verify that the Sterile Disposable Temperature Probe meets 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.
- Stability and performance test of the skin temperature probe for 24hrs continues use.
9. Conclusion
Based on the performance testing, comparison and analysis, the proposed subject devices are 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.