(346 days)
Not Found
No
The device description details a simple circuit that converts sensor resistance to frequency and then calculates temperature. There is no mention of AI/ML algorithms, training data, or complex processing beyond this direct conversion. The "predictive optional thermometers" likely use a standard algorithm for predicting final temperature based on initial readings, not AI/ML.
No
The device is a digital thermometer, which measures body temperature. It is a diagnostic tool, not a therapeutic device designed to treat or cure a disease or condition.
Yes
The device is a digital thermometer, which is explicitly stated to "measure the human body temperature." Measuring body temperature is a diagnostic function, as it provides a reading that can be used by healthcare professionals or individuals to assess health status or detect fever, which is a symptom of various conditions.
No
The device description explicitly states that the device consists of hardware components including a temperature sensor, integrated circuit (IC), LCD display, and buzzer. It also mentions patient contacting materials. This indicates it is a physical device, not software only.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to measure human body temperature. This is a physiological measurement taken directly from the body, not a test performed on a sample taken from the body (like blood, urine, or tissue).
- Device Description: The description details a temperature sensor, IC, LCD display, and buzzer. It measures temperature based on the resistance of the sensor changing with temperature. This is a physical measurement, not a chemical, biological, or immunological test on a sample.
- Lack of IVD Characteristics: The document does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples (blood, urine, etc.)
- Detecting or measuring substances within those samples
- Providing information about a disease state, condition, or physiological state based on sample analysis.
The device is a clinical thermometer, which is a medical device used for direct physiological measurement.
N/A
Intended Use / Indications for Use
The Digital Thermometers DMT series(Except DMT-455) are intended to measure the human body temperature in regular mode orally, rectally or under the arm. And the devices are reusable for clinical or home use on people of all ages, including children under 8 with adult supervision.
The device model DMT-455 is intended to measure temperature orally, and the device is reusable for clinical or home use for children less than 4 years old with adult supervision.
Product codes (comma separated list FDA assigned to the subject device)
FLL
Device Description
The Digital Thermometers DMT series(Except DMT-455) are used to measure the human body temperature in regular mode orally, rectally, or under the arm.The device model DMT-455 is intended to measure temperature orally.
The Digital Thermometers DMT series consists of a temperature sensor, low power consumption integrated circuit (IC), LCD display, and buzzer. The resistance of sensor changes with temperature and the IC converts the resistance to frequency and calculates the temperature according to the relation of resistance and frequency. The calculated temperature is displayed on the LCD.Only model DMT-4726 and DMT-4735 are predictive optional thermometers.The patient contacting materials are Stainless Steel,TPE and Acrylonitrile Butadiene Styrene (ABS).
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
orally, rectally or under the arm
Indicated Patient Age Range
The Digital Thermometers DMT series(Except DMT-455) ... on people of all ages, including children under 8 with adult supervision.
The device model DMT-455 ... for children less than 4 years old with adult supervision.
Intended User / Care Setting
Home use, clinical use
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)
Clinical tests were conducted on the DMT-4726 and DMT-4735. The clinical tests evaluated 450 subjects, and the thermometer was evaluated in three groups 1) infants-newborn to one year; 2) children-greater than one to five years; and 3) adults-greater than five years old.The clinical performance test protocol and data analysis were conducted in accordance with the requirement of ISO 80601-2-56. The test report showed the clinical performance of the subject devices complied with the requirement of ISO 80601-2-56.
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 shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
November 18, 2019
Joytech Healthcare Co., LTD Mr. Ren Yunhua General Manager No. 365 Wuzhou Road, Yuhang Economic Development Zone Hangzhou City Zhejian, 311100 China
Re: K183393
Trade/Device Name: Digital Thermometer DMT series (DMT-101, DMT-411, DMT-301, DMT-102, DMT-202, DMT-412, DMT-423, DMT-433, DMT-455, DMT-108, DMT-418, DMT-106. DMT-206. DMT-416. DMT-427. DMT-437. DMT-4218. DMT-4318. DMT-1019, DMT-2019, DMT-4119, DMT-4220, DMT-4320, DMT-4340, DMT-4343, DMT-4139, DMT-2021, DMT-4121, DMT-209, DMT-1030, DMT-2030, DMT-4130, DMT-1031, DMT-2031, DMT-4131, DMT-4226, DMT-4326, DMT-4726, DMT-1027, DMT-2027, DMT-4127, DMT-1032, DMT-2032, DMT-3032, DMT-4132, DMT-3033, DMT-4233, DMT-4333, DMT-4235, DMT-4335, DMT-4735, DMT-4236, DMT-4336, DMT-3018, DMT-4238, DMT-4338)
Regulation Number: 21 CFR 880.2910 Regulation Name: Clinical Electronic Thermometer Regulatory Class: Class II Product Code: FLL Dated: October 14, 2019 Received: October 17, 2019
Dear Mr. Ren Yunhua:
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.
1
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 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 Geeta Pamidimukkala Acting 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
2
Indications for Use
510(k) Number (if known) K183393
Device Name
Digital Thermometer DMT series(DMT-101.DMT-411.DMT-301.DMT-202.DMT-412.DMT-423.DMT-433.DMT-455.DMT-108.DMT-418.DMT-106.DMT-416.DMT-427.DMT-437.DMT-4218.DMT-4318.DMT-1019,DMT-2019,DMT-4119,DMT-4220,DMT-4320,DMT-4340,DMT-4343,DMT-4139,DMT-4121,DMT-209,DMT-1030,DMT-2030,DMT-4130,DMT-1031,DMT-4131,DMT-4226,DMT-4326,DMT-4726,DMT-1027,DMT-2027,DMT-4127,DMT-1032,DMT-2032,DMT-4132,DMT-3033,DMT-4233,DMT-4233,DMT-4235,DMT-4335,DMT-4735,DMT-4236,DMT-4336,DMT-3018,DMT-4238,DMT-4338)
Indications for Use (Describe)
The Digital Thermometers DMT series(Except DMT-455) are intended to measure the human body temperature in regular mode orally, rectally or under the arm. And the devices are reusable for clinical or home use on people of all ages, including children under 8 with adult supervision.
The device model DMT-455 is intended to measure temperature orally, and the device is reusable for clinical or home use for children less than 4 years old with adult supervision.
Type of Use (Select one or both, as applicable)
□ Prescription Use (Part 21 CFR 801 Subpart D)
区 Over-The-Counter Use (21 CFR 801 Subpart C)
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3
510(k) Summary
The assigned 510(k) number is: K183393
-
- Date Prepared: 2019.11.18
2. Submitter's Identification:
Name: JOYTECH HEALTHCARE CO., LTD.
Add.:No.365, Wuzhou Road, Yuhang Economic Development Zone,
Hangzhou city, 311100 Zhejiang,China
Contact Person: Yunhua Ren
Phone: +86-571-81957767
Fax: +86-571-81957750
Email: RENYH@SEJOY.COM
3. Name of the Device:
Trade Name: Digital Thermometer DMT series
Model:DMT-101、DMT-411、DMT-301、DMT-102、DMT-202、DMT-412、DMT-423、 DMT-433、DMT-455、DMT-108、DMT-418、DMT-106、DMT-206、DMT-416、 DMT-427、DMT-437、DMT-4218、DMT-4318、DMT-1019、DMT-2019、 DMT-4119、DMT-4220、DMT-4320、DMT-4340、DMT-4343、DMT-4139、 DMT-2021、DMT-4121、DMT-209、DMT-1030、DMT-2030、DMT-4130、 DMT-1031、DMT-2031、DMT-4131、DMT-4226、DMT-4326、DMT-4726、 DMT-1027、DMT-2027、DMT-4127、DMT-1032、DMT-2032、DMT-3032、 DMT-4132、DMT-3033、DMT-4233、DMT-4333、DMT-4235、DMT-4335、DMT-4735、DMT-4236、DMT-4336、DMT-3018, DMT-4238、DMT-4338
Common Name: Digital Thermometer
Classification name: Clinical Electronic Thermometer
4. Classification Information:
Product Code: FLL
Device Class: II
Panel: 80
Regulation number:21 C.F.R.880.2910
Regulation Description: Clinical electronic thermometer
4
5. Predicate Device Information:
The Digital Thermometers are substantially equivalent to the following devices: Digital Thermometers, Models: DMT series;
FDA 510(k)number: K 163518;
Manufactured by JOYTECH HEALTHCARE CO., LTD.
Intended use / Indication for Use: 6.
The Digital Thermometers DMT series(Except DMT-455) are intended to measure the human body temperature in regular mode orally, rectally or under the arm. And the devices are reusable for clinical or home use on people of all ages, including children under 8 with adult supervision.
The device model DMT-455 is intended to measure temperature orally, and the device is reusable for clinical or home use for children less than 4 years old with adult supervision.
7. Device Description:
The Digital Thermometers DMT series(Except DMT-455) are used to measure the human body temperature in regular mode orally, rectally, or under the arm.The device model DMT-455 is intended to measure temperature orally.
The Digital Thermometers DMT series consists of a temperature sensor, low power consumption integrated circuit (IC), LCD display, and buzzer. The resistance of sensor changes with temperature and the IC converts the resistance to frequency and calculates the temperature according to the relation of resistance and frequency. The calculated temperature is displayed on the LCD.Only model DMT-4726 and DMT-4735 are predictive optional thermometers.The patient contacting materials are Stainless Steel,TPE and Acrylonitrile Butadiene Styrene (ABS).
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8.Model List
| Features | A | B | C | D | E | F | G | H | I | J | K |
|---|---|---|---|---|---|---|---|---|---|---|---|
| Models | |||||||||||
| DMT-101 | ○ | ● | ○ | ○ | ○ | ○ | ○ | ○ | ≤60 Seconds | 12.3 x 1.8x 0.9 | Approx. 10 g |
| DMT-411 | ○ | ● | ○ | ● | ○ | ● | ○ | ○ | ≤45 Seconds | 12.3 x 1.8x 0.9 | Approx. 10 g |
| DMT-301 | ○ | ● | ○ | ○ | ○ | ● | ○ | ○ | ≤60 Seconds | 12.3 x 1.8x 0.9 | Approx. 10 g |
| DMT-102 | ○ | ● | ○ | ○ | ○ | ○ | ○ | ○ | ≤60 Seconds | 12.4 x 1.8x 1.1 | Approx. 10 g |
| DMT-202 | ○ | ● | ● | ○ | ○ | ○ | ○ | ○ | ≤60 Seconds | 12.4 x 1.8x 1.1 | Approx. 10 g |
| DMT-412 | ○ | ● | ● | ● | ○ | ● | ○ | ○ | ≤45 Seconds | 12.4 x 1.8x 1.1 | Approx. 10 g |
| DMT-423 | ● | ○ | ● | ○ | ○ | ○ | ○ | ○ | ≤60 Seconds | 12.4 x 2.4x 1.2 | Approx. 12 g |
| DMT-433 | ● | ○ | ● | ● | ○ | ● | ○ | ○ | ≤45 Seconds | 12.4 x 2.4x 1.2 | Approx. 12 g |
| DMT-455 | ○ | ● | ○ | ○ | ○ | ○ | ○ | ○ | ≤60 Seconds | 5.8x 4.1x 4.3 | Approx. 13 g |
| DMT-108 | ○ | ● | ○ | ○ | △ | ○ | ○ | ○ | ≤60 Seconds | 13.9 x 2.3x 1.2 | Approx. 12 g |
| DMT-418 | ○ | ● | ○ | ● | △ | ● | ○ | ○ | ≤45 Seconds | 13.9 x 2.3x 1.2 | Approx. 12 g |
| DMT-106 | ○ | ● | ○ | ○ | ○ | ○ | ○ | ○ | ≤60 Seconds | 12.2 x 1.9x 1.1 | Approx. 11 g |
| DMT-206 | ○ | ● | ● | ○ | ○ | ○ | ○ | ○ | ≤60 Seconds | 12.2 x 1.9x 1.1 | Approx. 11 g |
| DMT-416 | ○ | ● | ● | ● | ○ | ● | ○ | ○ | ≤45 Seconds | 12.2 x 1.9x 1.1 | Approx. 11 g |
| DMT-427 | ● | ○ | ● | ○ | ○ | ○ | ○ | ○ | ≤60 Seconds | 12.4 x 1.9x 1.1 | Approx. 11 g |
| DMT-437 | ● | ○ | ● | ● | ○ | ● | ○ | ○ | ≤45 Seconds | 12.4 x 1.9x 1.1 | Approx. 11 g |
| DMT-4218 | ● | ○ | ● | ○ | △ | ○ | ○ | ○ | ≤60 Seconds | 13.9 x 2.2x 1.3 | Approx. 11 g |
| DMT-4318 | ● | ○ | ● | ● | △ | ● | ○ | ○ | ≤45 Seconds | 13.9 x 2.2x 1.3 | Approx. 11 g |
| DMT-3018 | ● | ○ | ● | ○ | △ | ● | ○ | ○ | ≤60 Seconds | 13.9 x 2.2x 1.3 | Approx. 11 g |
| DMT-1019 | ○ | ● | ○ | ○ | △ | ○ | ○ | ○ | ≤60 Seconds | 13.9 x 2.3x 1.3 | Approx. 11 g |
| DMT-2019 | ○ | ● | ● | ○ | △ | ○ | ○ | ○ | ≤60 Seconds | 13.9 x 2.3x 1.3 | Approx. 12 g |
| DMT-4119 | ○ | ● | ● | ● | △ | ● | ○ | ○ | ≤45 Seconds | 13.9 x 2.3x 1.3 | Approx. 12 g |
| DMT-4220 | ● | ○ | ● | ○ | △ | ○ | ○ | ○ | ≤60 Seconds | 13.9 x 2.3x 1.3 | Approx. 13 g |
| DMT-4320 | ● | ○ | ● | ● | △ | ● | ○ | ○ | ≤45 Seconds | 13.9 x 2.3x 1.3 | Approx. 13 g |
| DMT-2021 | ○ | ● | ● | ○ | △ | ○ | ○ | ○ | ≤60 Seconds | 12.2 x 1.9x 1.0 | Approx. 11 g |
| DMT-4121 | ○ | ● | ● | ● | △ | ● | ○ | ○ | ≤45 Seconds | 12.2 x 1.9x 1.0 | Approx. 11 g |
| DMT-209 | ○ | ● | ● | ○ | ○ | ○ | ○ | ○ | ≤60 Seconds | 12.8 x 2.0x 1.2 | Approx. 11 g |
| DMT-1030 | ○ | ● | ○ | ○ | ○ | ○ | ○ | ○ | ≤60 Seconds | 13.2 x 2.3x 1.2 | Approx. 11 g |
| DMT-2030 | ○ | ● | ● | ○ | ○ | ○ | ○ | ○ | ≤60 Seconds | 13.2 x 2.3x 1.2 | Approx. 11 g |
| DMT-4130 | ○ | ● | ● | ● | ○ | ● | ○ | ○ | ≤45 Seconds | 13.2 x 2.3x 1.2 | Approx. 11 g |
| DMT-1031 | ○ | ● | ○ | ○ | ○ | ○ | ○ | ○ | ≤60 Seconds | 13.0 x 1.9x 1.0 | Approx. 12 g |
| DMT-2031 | ○ | ● | ● | ○ | ○ | ○ | ○ | ○ | ≤60 Seconds | 13.0 x 1.9x 1.0 | Approx. 12 g |
| DMT-4131 | ○ | ● | ● | ● | ○ | ● | ○ | ○ | ≤45 Seconds | 13.0 x 1.9x 1.0 | Approx. 12 g |
| DMT-4226 | ● | ○ | ● | ○ | △ | ○ | ○ | ○ | ≤60 Seconds | 13.5 x 3.4x 1.7 | Approx. 22 g |
| DMT-4326 | ● | ○ | ● | ● | △ | ● | ○ | ○ | ≤45 Seconds | 13.5 x 3.4x 1.7 | Approx. 22 g |
| DMT-4726 | ● | ○ | ● | ● | Δ | ● | Δ | Δ | ≤45 Seconds | 13.5 x 3.4x 1.7 | Approx. 22 g |
| DMT-1027 | ○ | ● | ○ | ○ | ○ | ○ | ○ | ○ | ≤60 Seconds | 12.2 x1.8 x 1.1 | Approx. 10 g |
| DMT-2027 | ○ | ● | ● | ○ | ○ | ○ | ○ | ○ | ≤60 Seconds | 12.2 x1.8 x 1.1 | Approx. 10 g |
| DMT-4127 | ○ | ● | ● | ● | ○ | ● | ○ | ○ | ≤45 Seconds | 12.2 x 1.8 x 1.1 | Approx. 10 g |
| DMT-1032 | ○ | ● | ○ | ○ | Δ | ○ | ○ | ○ | ≤60 Seconds | 13.8 x 2.2 x 1.2 | Approx. 12 g |
| DMT-2032 | ○ | ● | ● | ○ | Δ | ○ | ○ | ○ | ≤60 Seconds | 13.8 x 2.2 x 1.2 | Approx. 12 g |
| DMT-3032 | ○ | ● | ● | ○ | ○ | ● | ○ | ○ | ≤60 Seconds | 13.8 x 2.2 x 1.2 | Approx. 12 g |
| DMT-4132 | ○ | ● | ● | ● | Δ | ● | ○ | ○ | ≤45 Seconds | 13.8 x 2.2 x 1.2 | Approx. 12 g |
| DMT-3033 | ● | ○ | ● | ○ | ○ | ● | ○ | ○ | ≤60 Seconds | 13.9 x 2.2x 1.2 | Approx. 12 g |
| DMT-4233 | ● | ○ | ● | ○ | Δ | ○ | ○ | ○ | ≤60 Seconds | 13.9 x 2.2x 1.2 | Approx. 12 g |
| DMT-4333 | ● | ○ | ● | ● | Δ | ● | ○ | ○ | ≤45 Seconds | 13.9 x 2.2 x 1.2 | Approx. 12 g |
| DMT-4235 | ● | ○ | ● | ○ | Δ | ○ | ○ | ○ | ≤60 Seconds | 13.4 x 3.1 x 1.6 | Approx. 23 g |
| DMT-4335 | ● | ○ | ● | ● | Δ | ● | ○ | ○ | ≤45 Seconds | 13.4 x 3.1 x 1.6 | Approx. 23 g |
| DMT-4735 | ● | ○ | ● | ● | Δ | ● | Δ | Δ | ≤45 Seconds | 13.4 x 3.1x 1.6 | Approx. 23 g |
| DMT-4236 | ● | ○ | ● | ○ | ○ | ○ | ○ | ○ | ≤60 Seconds | 13.1 x 2.0x 1.2 | Approx. 10 g |
| DMT-4336 | ● | ○ | ● | ● | ○ | ● | ○ | ○ | ≤45 Seconds | 13.1 x 2.0x 1.2 | Approx. 10 g |
| DMT-4343 | ● | ○ | ● | ● | ○ | ● | ○ | ○ | ≤45 Seconds | 14.2 x 2.3x 1.3 | Approx. 11 g |
| DMT-4238 | ● | ○ | ● | ○ | ○ | ● | ○ | ○ | ≤60 Seconds | 12.5 x 2.1x 1.2 | Approx. 12.8 g |
| DMT-4338 | ● | ○ | ● | ● | ○ | ● | ○ | ○ | ≤45 Seconds | 12.5 x 2.1x 1.2 | Approx. 12.8 g |
| DMT-4139 | ○ | ● | ● | ● | ○ | ● | ○ | ○ | ≤60 Seconds | 13.2 x 2.3x 1.3 | Approx. 14.5 g |
| DMT-4340 | ● | ○ | ● | ● | ○ | ● | ○ | ○ | ≤45 Seconds | 13.2 x 2.3x 1.3 | Approx. 14.5 g |
6
A=Flexible tip
B=Rigid tip
C=Waterproof
D=Instant
E=TEMPERATURE ARROW INDICATING function
F=°C/°F switchable
G=Backlight function
H=Predictive
I=Water Bath Response time
J=Physical dimensions(L x H x W in cm) K=Weight(
including battery in grams )
• = Yes
o = No
△ =Optional
7
9. Comparing to Predicate Device:
| SE Comparisons | Subject device application K183393 | Predicate device K163518
(Model:DMT series) | Comparison
Result |
|-------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------|
| Intended Use
/Indication for use | DMT series(except DMT-455) are
intended to measure the human body
temperature in regular mode orally,
rectally or under the arm. And the
devices are reusable for clinical or
home use on people of all ages.
including children under 8 with adult
supervision.
DMT-455 is intended to measure
temperature orally, and the device is
reusable for clinical or home use for
children less than 4 years old with
adult supervision. | DMT series(except DMT-455) are
intended to measure the human body
temperature in regular mode orally,
rectally or under the arm. And the
devices are reusable for clinical or
home use on people of all ages.
including children under 8 with adult
supervision.
DMT-455 is intended to measure
temperature orally, and the device is
reusable for clinical or home use for
children less than 4 years old with
adult supervision. | Identical |
| Measurement Site | DMT series (except DMT-455):
orally, rectally or under the arm
DMT-455:orally | DMT series (except DMT-455):
orally, rectally or under the arm
DMT-455:orally | Identical |
| Range | DMT series
(except DMT-30XX, DMT-47XX):
$32.0°C43.9°C (90.0°F111.9°F)$
DMT-301,DMT-3032,DMT-3033,
DMT-3018:
$32.00°C43.99°C(90.00°F111.99°F)$
DMT-4735,DMT-4726: $32.0°C43.9°C (89.6°F111.0°F)$ | DMT series
(except DMT-30XX,DMT-47XX):
$32.0°C42.9°C (90°F109.9°F)$
DMT-301,DMT-3032,DMT-3033:
$32.00°C42.99°C (90.00°F109.99°F)$
DMT-4735,DMT-4726: $32.0°C42.9°C (89.6°F109.2°F)$ | Similar |
| Accuracy | $±0.1°C$ between $35.5°C$ to
$42.0°C (±0.2°F,95.9°F-107.6°F)$ ,
$±0.2°C$ under $35.5°C$ or over
$42.0°C (±0.4°F$ under $95.9°F$ or over
$107.6°F$ )
DMT-301, DMT-3032, DMT-3033, DMT-
3018: $±0.10 °C$ between $35.5°C$ to $42°C$ | $±0.1°C$ between $35.5°C$ to
$42.0°C (±0.2°F,95.9°F-107.6°F)$ ,
$±0.2°C$ under $35.5°C$ or over
$42.0°C (±0.4°F$ under $95.9°F$ or over
$107.6°F$ ) | Identical |
8
| | | DMT series(except DMT-301,
DMT-3032,DMT-3033,DMT-3018):
0.1°C/0.1 °F
DMT-301,DMT-3032,DMT-3033,
DMT-3018:0.01℃/0.01°F | DMT series(except DMT-301,
DMT-3032,DMT-3033):
0.1°C/0.1 °F
DMT-301,DMT-3032,DMT-3033:
0.01 ℃/0.01°F | Identical | |
|--------------------------------------------|--------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------|-----------|
| Display resolution | | | | | |
| components | | Sensor, buzz film, housing, stainless
steel cap, LCD display, measurement
control module. | Sensor, buzz film, housing, stainless
steel cap, LCD display,
measurement control module. | Identical | |
| Principle of operation | | A change of thermistor resistance,
caused by changes of temperature.
The resistance is measured by
microcontroller unit (MCU), so
changes of temperature will
correspond to changes of resistance. | A change of thermistor resistance,
caused by changes of temperature.
The resistance is measured by
microcontroller unit (MCU), so
changes of temperature will
correspond to changes of resistance | Identical | |
| Operating range | | Temperature: 41°F~104°F (5°C
~40°C) Relative humidity:
15%95%RH104°F (5°C
Atmospheric Pressure : 700hPa ~
1060hPa | Temperature: 41°F
~40°C) Relative humidity:
15%95%RH131°F (-20℃~55℃)
Atmospheric Pressure : 700hPa ~
1060hPa | Identical | |
| Patient contact
material | | ABS,TPE,Stainless Steel | ABS,TPE,Stainless Steel | Identical | |
| Colour coding | ABS | 9003 | ABS | 9003 | Identical |
| | TPE | P351C,P288C,P374C,P2
84C,P2715C,P109C,P42
8C,P427C | TPE | P351C,P288C,P374C,P
284C,P2715C,P109C,P
428C,P427C | |
| Storage and
transportation
condition | Temperature: | -4°F
Relative humidity: 15%95%RH131°F (-20℃~55℃)
Atmospheric Pressure : 700hPa ~ | Temperature: | -4°F
Relative humidity: 15%~95%RH
Atmospheric Pressure : 700hPa ~ | Identical |
9
| 1060hPa | 1060hPa | ||
|---|---|---|---|
| Battery type | One 1.5 V DC. button battery (size | ||
| LR41or SR41, UCC 392) | |||
| DMT-4726,DMT-4735: | |||
| One 3.0V CR2032 battery | One 1.5 V DC. button battery (size | ||
| LR41or SR41, UCC 392) | |||
| DMT-4726,DMT-4735: | |||
| One 3.0V CR2032 battery | Identical | ||
| Biocompatibility | Comply with ISO 10993-5 and ISO | ||
| 10993-10 | Comply with ISO 10993-5 and ISO | ||
| 10993-10 | Identical | ||
| Electrical Safety | Complied with IEC 60601-1 | Complied with IEC 60601-1 | Identical |
| EMC | Complied with IEC 60601-1-2 | Complied with IEC 60601-1-2 | Identical |
The differences between two devices are:
- Changed thermometer chip to extend temperature measuring range from 32.0
42.9℃ to 32.043.9 ℃ ,as new version of standard ISO 80601-2-56:2017 required, no other functions changed.
2.New model DMT-3018: it is a new model that have same appearance and same electrical scheme with predicate device model DMT-4318 but have only different temperature range and PCB with the predictive device.
10. Performance data
The following performance data were provided in support of the substantial equivalence determination:
Performance testing was conducted to validate and verify that Digital Thermometers, DMT series met all requirements of related international standards, including electrical safety, EMC, biocompatibility, software validation and product specifications. Results of these tests demonstrate compliance to the requirements of the below consensus standards.
Electrical Safety and performance requirements:
- . AAMI / ANSI ES60601-1:2005/(R)2012 And A1:2012,C1:2009/(R)2012 And A2:2010/(R)2012 Medical Electrical Equipment
- ISO80601-2-56:2017 Medical electrical equipment Part 2-56 Particular requirements for basic safety and essential performance of clinical thermometers for body temperature measurement
- · ASTM E1112:00(Reapproved 2011) Standard specification for Electronic Thermometer for Intermittent Determination of Patient Temperature
10
Home-used medical equipment requirements and environmental test:
-
IEC 60601-1-11:2015 General requirements for basic safety and essential performance -- Collateral standard: Requirements for medical electrical equipment and medical electrical systems used in the home healthcare environment
Electromagnetic compatibility requirements: -
IEC 60601-1-2:2014 Medical electrical equipment Part 1-2: General requirements for basic safety and essential performance - Collateral Standard: Electromagnetic disturbances - Requirements and tests
Biocompatibility Evaluation for patient contacting components: -
· ISO 10993-5:2009 Biological evaluation of medical devices -- Part 5: Tests for in vitro cytotoxicity
-
· ISO10993-10:2010 Biological evaluation of medical devices -- Part 10: Tests for irritation and skin sensitization
Guidance Document:
· Guidance on the content of Premarket Notifications [510(k)] Submissions for clinical electronic thermometers
The software/firmware verification and validation was provided in accordance with the "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices," dated May 11, 2005.
11. Discussion of Clinical Tests Performed:
Clinical tests were conducted on the DMT-4726 and DMT-4735. The clinical tests evaluated 450 of subjects. and the thermometer was evaluated in three groups 1) infants-newborn to one year; 2) children-greater than one to five years; and 3) adults-greater than five years old.The clinical performance test protocol and data analysis were conducted in accordance with the requirement of ISO 80601-2-56. The test report showed the clinical performance of the subject devices complied with the requirement of ISO 80601-2-56.
12. Conclusions:
Based on the information provided in this submission,the subject digital thermometers DMT series are substantially equivalent to the predicate thermometers, model: DMT series.