(260 days)
Not Found
No
The device description and performance studies focus on standard temperature measurement technology (thermistors) and do not mention any AI or ML components or algorithms. The "Mentions AI, DNN, or ML" section is explicitly marked as "Not Found".
No
The device is described as a temperature probe intended for monitoring temperature, not for providing therapeutic treatment.
No
Explanation: The device is used for monitoring temperature, which is a physiological parameter, not for diagnosing a disease or condition. While temperature can be a diagnostic indicator, the device itself only measures and does not interpret or diagnose.
No
The device description explicitly states that the probes consist of a connector and a thermistor, which are hardware components. The device also involves physical contact with the patient (skin or core).
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections. These tests are performed outside of the body.
- Device Function: The PlusCare Temperature Probes are used for monitoring temperature by having direct contact with the patient's skin or rectum. This is a measurement taken on or within the body, not on a sample taken from the body.
- Intended Use: The intended use clearly states "monitoring temperature," which is a physiological measurement, not a diagnostic test performed on a sample.
Therefore, the function and intended use of the PlusCare Temperature Probes fall outside the scope of In Vitro Diagnostics. They are considered a medical device used for physiological monitoring.
N/A
Intended Use / 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.
Product codes (comma separated list FDA assigned to the subject device)
FLL
Device Description
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Skin, Rectum
Indicated Patient Age Range
Adult
Intended User / Care Setting
qualified medical personnel
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 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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
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 contains the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA acronym with the full name of the agency on the right. The FDA part of the logo is in blue, with the acronym in a square and the full name written out to the right of the square.
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.
1
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely.
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
2
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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3
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
4
| 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 | |
| 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. | 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. | Same | |||
| Contact | ||||
| duration | ||||
| period of use | Skin-Type Probe: less than 30 days | |||
| Rectum-Type Probe: less than 24h | Skin-Type Probe: less than 30 days | |||
| Rectum-Type Probe: less than 24h | Same | |||
| Prescription/ | ||||
| OTC use | Prescription | Prescription | Same | |
| Energy source | Powered by compatible | |||
| devices | Powered by compatible | |||
| devices | Same | |||
| Operating | ||||
| Principle | Thermistor resistance based on | |||
| the metal conductor increase | ||||
| with temperature decrease, and | ||||
| the linear changes to the | ||||
| characteristics of the | ||||
| temperature measurement. | Thermistor resistance based on | |||
| the metal conductor increase | ||||
| with temperature decrease, and | ||||
| the linear changes to the | ||||
| characteristics of the | ||||
| temperature measurement. | Same | |||
| Technology | Temperature sensitive resistor | Temperature sensitive resistor | Same | |
| Application | ||||
| site | 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 | |||
| Measurement | ||||
| range | 25-45°C/77-113°F | 25-45°C | Same | |
| Thermistor | ||||
| resistance | 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 and | |||
| temperature sensing probe | plug, cable and | |||
| temperature sensing probe | Same | |||
| Usage | Reusable | Reusable | Same | |
| Operation | ||||
| Environment | 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 | |||
| Storage | ||||
| environment | Temperature: | |||
| -25°C | ||||
| Relative humidity | ||||
| range: ≤85% | Temperature: | |||
| -25°C | ||||
| Relative humidity | ||||
| range: ≤85% | Same | |||
| Biocompatibility | All the patient- | |||
| contacting materials are | ||||
| evaluated by the | ||||
| biocompatibility | ||||
| standard ISO10993-5, | ||||
| ISO 10993-10. | All the patient- | |||
| contacting materials are | ||||
| evaluated by the | ||||
| biocompatibility | ||||
| standard 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 |
5
6
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.