(260 days)
PlusCare 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 use by qualified medical personnel only.
The Skin Temperature Probe and Rectum Temperature Probe are used during patient temperature measurement. These probes consist of a connector on the monitor end and a thermistor on the patient end. These probes are to be used with compatible temperature measurement systems only. Temperature probes measure temperature through a resistor that is sensitive to temperature changes. The probe is connected to the monitor either directly by using the connector or by an extension cable. These probes have a skin or core contact with a patient.
This document is a 510(k) Premarket Notification from the FDA regarding a temperature probe. It is not a document describing the acceptance criteria and study proving an AI/Machine Learning device meets acceptance criteria.
The information provided describes a traditional medical device (a temperature probe) and demonstrates its substantial equivalence to a predicate device. This process primarily relies on comparing design, materials, technological characteristics, and performance specifications, rather than clinical studies involving AI performance metrics like sensitivity, specificity, or reader studies.
Therefore, many of the specific questions you've asked, which are highly relevant to AI/ML device evaluations, are not applicable to the content of this document. For instance:
- No AI/ML device: There is no AI component, so there are no "acceptance criteria" related to AI performance, no "test set" for AI, no "ground truth" to establish for AI, no "MRMC studies," no "standalone algorithm performance," and no "training set."
- Traditional device equivalence: The study instead focuses on demonstrating that the new temperature probe is "exactly the same" as a previously cleared predicate device in terms of its intended use, design, operating principle, materials, measurement range, accuracy, and compliance with relevant safety and biocompatibility standards (e.g., IEC 60601-1, ISO 80601-2-56, ISO 10993 series).
To answer your prompt based solely on the provided text, the response would be:
This document describes the 510(k) clearance for a traditional medical device, the PlusCare Temperature Probe, not an AI/Machine Learning enabled device. Therefore, the information requested regarding acceptance criteria and studies demonstrating performance for an AI/ML device (e.g., sample sizes for test/training sets, expert ground truth, MRMC studies, standalone algorithm performance) is not applicable to this submission.
The "acceptance criteria" for this device relate to its ability to meet established performance standards for clinical thermometers and demonstrate substantial equivalence to a legally marketed predicate device (Unimed Temperature Probe, K121427). The study conducted was a non-clinical test data assessment to ensure compliance with recognized standards for safety, biocompatibility, and performance, demonstrating that the subject device's specifications (e.g., accuracy, measurement range) are identical to those of the predicate device.
Here's what can be extracted from the document relating to its clearance, even though it's not an AI device:
1. A table of acceptance criteria and the reported device performance
For a traditional device like a temperature probe, acceptance criteria are typically specified in recognized standards and internal company specifications. The document highlights the key performance characteristics that were compared and found to be "Same" as the predicate device, implying these represent the performance thresholds met.
| Characteristic | Acceptance Criteria (Predicate Device K121427) | Reported Device Performance (Subject Device K203636) | Meets Acceptance Criteria? |
|---|---|---|---|
| Measurement range | 25-45°C | 25-45°C/77-113°F | Yes (expanded range, but includes predicate's) |
| Thermistor resistance | NTC resistance $2.25 K\Omega @25°C$ | NTC resistance $2.25 K\Omega @25°C$ | Yes |
| Accuracy | $\pm 0.1°C$ | $\pm 0.1°C/\pm 0.18°F$ | Yes |
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Not applicable for "test set" in the context of AI evaluation. This document does not describe patient-based clinical "test sets" for performance evaluation in the way an AI device would.
- The "testing" involved non-clinical lab tests to ensure the device itself met physical, electrical, and biocompatibility standards. The document doesn't specify sample sizes for these internal engineering or bench tests for components, but rather focuses on the device's adherence to established standards.
- Data Provenance: The testing was presumably conducted by the manufacturer (JKH USA, LLC). No country of origin for specific test data is provided, but the submission is to the US FDA. The tests are "non-clinical" which implies laboratory or bench testing, not patient data trials.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
- Not applicable. There is no "ground truth" established by experts in the context of interpreting medical images or data, as this is a measurement device, not an interpretative AI device. The ground truth for temperature measurement is established by calibrated reference thermometers and physical principles.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable. No adjudication method for medical expert interpretations is relevant here. Performance is based on direct measurement and compliance with engineering/biocompatibility standards.
5. 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 relates to AI-assisted human performance, which is not relevant to a simple temperature probe.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable. This describes an algorithm's performance without human interaction. This device is a sensor, not an algorithm.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)
- The "ground truth" for a temperature probe's accuracy is its ability to measure temperature precisely against traceable reference standards (e.g., highly accurate thermometers, known temperature baths).
- For safety and biocompatibility, the ground truth is compliance with recognized international standards (e.g., ISO 10993 for biocompatibility, IEC 60601-1 for electrical safety).
8. The sample size for the training set
- Not applicable. This is not an AI/ML device, so there is no "training set."
9. How the ground truth for the training set was established
- Not applicable. As above.
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August 31, 2021
JKH USA, LLC Bill Quanqin Dai Manager 14271 Jeffrey Rd. #246 Irvine, California 92620
Re: K203636
Trade/Device Name: PlusCare Temperature Probe, Skin Types: PT2252-AS, PTHP-AS, PTMQ-AS, PTSW-AS, PTSM-15AS, PTSL-AS, PTMR-AS; General Purpose Types: PT2252-AG, PTHP-AG, PTMQ-AG, PTSW-AG, PTSM-15AG, PTSL-AG, PTMR-AG Regulation Number: 21 CFR 880,2910 Regulation Name: Clinical Electronic Thermometer Regulatory Class: Class II Product Code: FLL Dated: July 20, 2021 Received: July 28, 2021
Dear Bill Quanqin Dai:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
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Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (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.
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) K203636
Device Name
PlusCare Temperature Probe Skin Types: PT2252-AS, PTHP-AS, PTMQ-AS, PTSW-AS, PTSM-15AS, PTSL-AS, PTMR-AS: Rectum Types: PT2252-AG, PTHP-AG, PTMQ-AG, PTSW-AG, PTSM-15AG, PTSL-AG, PTMR-AG
Indications for Use (Describe)
PlusCare 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 use by qualified medical personnel 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) |
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K203636 - 510(k) Summary
| Submitter: | Name: JKH USA, LLC | ||
|---|---|---|---|
| Mailing Address: 14271 Jeffrey Rd. #246, Irvine, CA 92620 | |||
| Contact Person: | Name: Bill Quanqin Dai | ||
| Phone Number: 909-929-9896 | |||
| Email Address: Bill@jkhUSA.com | |||
| Date Prepared: | 08/31/2021 | ||
| Device Trade Name: | PlusCare Temperature Probe | ||
| Device Common Name: | Clinical electronic thermometer | ||
| Model: | Skin Types: PT2252-AS, PTHP-AS, PTMQ-AS, PTSW-AS, PTSM-15AS, | ||
| PTSL-AS, PTMR-AS; | |||
| Rectum Types:PT2252-AG, PTHP-AG,PTMQ-AG, PTSW-AG, | |||
| PTSM-15AG, PTSL-AG, PTMR-AG | |||
| Regulation Name: | Clinical electronic thermometer | ||
| Regulation Number: | 21 CFR 880.2910 | ||
| Product Code: | FLL | ||
| Device Class: | Class II | ||
| Predicate Device: | |||
| 510(k) Number: | K121427 | ||
| Device Name: | Unimed Temperature Probe | ||
| Manufacturer: | UNIMED MEDICAL SUPPLIES INC |
Description of Devices:
The Skin Temperature Probe and Rectum Temperature Probe are used during patient temperature measurement. These probes consist of a connector on the monitor end and a thermistor on the patient end. These probes are to be used with compatible temperature measurement systems only.
Temperature probes measure temperature through a resistor that is sensitive to temperature changes.
The probe is connected to the monitor either directly by using the connector or by an extension cable. These probes have a skin or core contact with a patient.
| Model | Application site | length |
|---|---|---|
| PT2252-AS | Skin | 3.0m |
| PTHP-AS | Skin | 3.0m |
| PTMQ-AS | Skin | 3.0m |
Table 1. Basic information of devices
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| PTSW-AS | Skin | 3.0m |
|---|---|---|
| PTSM-15AS | Skin | 1.5m |
| PTSL-AS | Skin | 3.0m |
| PTMR-AS | Skin | 3.0m |
| PT2252-AG | Rectum | 3.0m |
| PTHP-AG | Rectum | 3.0m |
| PTMQ-AG | Rectum | 3.0m |
| PTSW-AG | Rectum | 3.0m |
| PTSM-15AG | Rectum | 1.5m |
| PTSL-AG | Rectum | 3.0m |
| PTMR-AG | Rectum | 3.0m |
Operating Principle:
The operating principle is resistance based on the metal conductor increases with temperature decrease, and the linear changes to the characteristics of the temperature measurement. It is to measure differences in resistance and equates that to changes intemperature.
Indications for Use:
PlusCare 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 use by qualified medical personnel only.
Substantial Equivalence Discussion:
The subject and predicate devices are exactly the same. They have the same intended use, the same design principle, the same production process, and the same material composition. See the detailed comparison in the table below.
Table 2. Comparison of Technological Characteristics
| Description | Subject Device (K203636) | Predicate Device (K121427) | Comparison | |
|---|---|---|---|---|
| Trade name | PlusCare Temperature Probe | Unimed Temperature Probe | N/A | |
| Population | Adult | Adult | Same | |
| Indicationsfor Use | PlusCare Temperature Probesare intended to be used formonitoring temperature. Thetemperature probes arereusable and designed for usewith monitors of Philips,Marquette, Mindray,Spacelabs, Siemens,Artema/S&W and othermonitors compatible with YSI400 series temperature probes.These devices are indicated foruse by qualified medicalpersonnel only. | Unimed Temperature Probesare intended to be used formonitoring temperature. Thetemperature probes arereusable and designed for usewith monitors of Philips,Marquette, Mindray,Spacelabs, Siemens,Artema/S&W and othermonitors compatible with YSI400 series temperature probes.These devices are indicated forused by qualified medicalpersonnel only. | Same | |
| Contactdurationperiod of use | Skin-Type Probe: less than 30 daysRectum-Type Probe: less than 24h | Skin-Type Probe: less than 30 daysRectum-Type Probe: less than 24h | Same | |
| Prescription/OTC use | Prescription | Prescription | Same | |
| Energy source | Powered by compatibledevices | Powered by compatibledevices | Same | |
| OperatingPrinciple | Thermistor resistance based onthe metal conductor increasewith temperature decrease, andthe linear changes to thecharacteristics of thetemperature measurement. | Thermistor resistance based onthe metal conductor increasewith temperature decrease, andthe linear changes to thecharacteristics of thetemperature measurement. | Same | |
| Technology | Temperature sensitive resistor | Temperature sensitive resistor | Same | |
| Applicationsite | Skin, rectum | Skin, rectum | Same | |
| Material | ABS, copper, PA6, PVC,Gilded copper needle, TPU,NTC thermistor, Epoxy resin,Stainless steel plate | ABS, copper, PA6, PVC,Gilded copper needle, TPU,NTC thermistor, Epoxy resin,Stainless steel plate | Same | |
| Measurementrange | 25-45°C/77-113°F | 25-45°C | Same | |
| Thermistorresistance | NTC resistance$2.25 K\Omega @25°C$ | NTC resistance$2.25 K\Omega @25°C$ | Same | |
| Accuracy | $\pm 0.1°C/\pm 0.18°F$ | $\pm 0.1°C$ | Same | |
| Component | plug, cable andtemperature sensing probe | plug, cable andtemperature sensing probe | Same | |
| Usage | Reusable | Reusable | Same | |
| OperationEnvironment | Temperature:0°C~40°C (32°F ~104°F);Relative humidity range: 15%to 85% | Temperature:0°C~40°C (32°F ~104°F);Relative humidity range: 15%to 85% | Same | |
| Storageenvironment | Temperature:-25°C | Temperature:-25°C | Same | |
| Biocompatibility | All the patient-contacting materials areevaluated by thebiocompatibilitystandard ISO10993-5,ISO 10993-10. | All the patient-contacting materials areevaluated by thebiocompatibilitystandard ISO10993-5,ISO 10993-10. | Same | |
| Sterile | Non-sterile | Non-sterile | ||
| Standards met | IEC 60601-1 | IEC 60601-1 | Same | |
| ISO 80601-2-56 | ISO 80601-2-56 | |||
| ISO 10993-1 | ISO 10993-1 | |||
| ISO 10993-5 | ISO 10993-5 | |||
| ISO 10993-10 | ISO 10993-10 |
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Non-Clinical Test Data:
The subject device meets the following recognized standards:
- IEC 60601-1 Medical Electrical Equipment-Part 1: General Requirements for Safety
- 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
- ISO 10993-1 Biological evaluation of medical devices-Part 1: Evaluation and testing within a risk management process
- ISO 10993-5, Biological evaluation of medical devices-Part 5: Tests for In Vitrocytotoxicity
- ISO 10993-10, Biological evaluation of medical devices-Part 10: Tests for irritation and delayed-type hypersensitivity
The subject device is classified as a skin contacting device with a contact duration of less than 30 days. Biocompatibility tests have been conducted on the subject device, including cytotoxicity, sensitization, and skin irritation. The test results show that the subject device met the requirements of the standards.
Substantial Equivalence:
The subject and predicate devices are exactly the same. Therefore, the PlusCare Temperature Probe is substantially equivalent to the Unimed Temperature Probe cleared under K121427 with respect to the intended use, target populations, treatment method, and technological characteristics.
§ 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.