(208 days)
Duteck (micHealth) Digital Clinical Thermometer, DT2306 series (product code FLL) is used to measure human body temperature with the following features:
The device display body temperature in digital format at LCD
The device make intended contact with patient in 2 ways
(1) Surface contact: armpit.
(2) Invasive contact: oral.
The device is used and installed by patients, Nurses, doctors and people with the exception of handicapped people and children.
The device is used in ENVIRONMENT of room temperature and normal environment condition.
Duteck (micHealth) Digital Clinical Thermometer, DT2306 series is hand-held, reusable, battery operated device that can measure human body temperature via the human oral and armpit.
The provided document does not contain a study or data to establish acceptance criteria for the Duteck (micHealth) Digital Clinical Thermometer, DT2306 series. Instead, it presents a 510(k) summary claiming substantial equivalence to a predicate device (Duteck Digital Clinical Thermometer K992327).
The document focuses on comparing the technical characteristics and intended use of the new device with its predicate device. It states that the new device "had been tested to the appropriate electrical tested standard and biocompatibility standards and have been found safe for intended use." However, it does not provide any specifics about these tests, the acceptance criteria used, or the results obtained.
Therefore, I cannot fulfill your request for the tables and study details based on the provided text.
Here is an analysis of what can be extracted or inferred from the document regarding the acceptance criteria and performance, and why the other points cannot be addressed:
1. Table of Acceptance Criteria and Reported Device Performance
Not available in the document. The document only provides technical specifications for both the new device and the predicate device. It does not list specific performance metrics with associated acceptance criteria and the actual performance achieved against those criteria in a study.
| Element of Comparison | Acceptance Criteria (Not Explicitly Stated as AC) | Reported Device Performance (DT2306) |
|---|---|---|
| Displayed Temperature Range | (Implied: 32.00°C~42.00°C) | 32.00°C |
| Operation Environment | (Implied: 16.00°C~40.00°C) | 16.00°C |
| Display Resolution | (Implied: ±0.01°C/°F) | ±0.01°C/°F |
| Response Time | (Implied: ~4 seconds, based on comparison) | 4 second |
Note: The "Acceptance Criteria" column above is based on the reported characteristics of the new device and the comparison to the predicate, as explicit acceptance criteria are not provided. The document states that the device "had been tested to the appropriate electrical tested standard and biocompatibility standards and have been found safe for intended use," but does not detail the results of these tests or the specific pass/fail criteria.
Study Details (Not Available in the Document)
The document is a 510(k) summary, which typically focuses on demonstrating substantial equivalence rather than presenting detailed study results for establishing performance against novel acceptance criteria. It refers to "performance and safety. testing" but provides no specifics.
Therefore, the following information cannot be provided from the given text:
- Sample size used for the test set and the data provenance: Not mentioned.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not mentioned.
- Adjudication method for the test set: Not mentioned.
- 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 device is a digital clinical thermometer, not an AI-powered diagnostic tool engaging with human readers.
- If a standalone (i.e. algorithm only, without human-in-the-loop performance) was done: Not applicable. This is a non-AI device. While its performance is standalone, no separate analysis is provided given the information.
- The type of ground truth used: Not mentioned. For a thermometer, the "ground truth" would likely involve comparison to a highly accurate reference thermometer, but this is not detailed.
- The sample size for the training set: Not applicable. This is not an AI/machine learning device that requires a training set in the typical sense.
- How the ground truth for the training set was established: Not applicable.
{0}------------------------------------------------
K132140 EEB - 4 2014
Duteck: micHealth Digital Clinical Thermometer 510(K) Submission
510(K) Summary 807.92(C)
Company Name: Duteck Industrial Co., Ltd
Company Address: 3F-2, No 26, Ln513 Rui-Kuang Rd
Taipei 114, Taiwan ROC
Telephone number: 886-2-8797-5035.
Fax number
Contact person: Joseph Chan
Summary preparation: June 11, 2013
Device name:
807.92(a)(2)
Trade name: Duteck(micHealth) Digital Clinical Thermometer, DT2306
Regulation Name: Digital Clinical Thermometer
Product Code: FLL
Registration Number: 9616844
Regulation Number: 21 CFR 880.2910
Regulatory Class: II
Predicate device:
807 92(a)(3)
Duteck Digital Clinical Thermometer (K992327)
- Device description:
807.92(a)(4)
Duteck (micHealth) Digital Clinical Thermometer, DT2306 series is hand-held, reusable, battery operated device that can measure human body temperature via the human oral and armpit.
Device intended to use:
807.92(a)(5)
Duteck (micHealth) Digital Clinical Thermometer, DT2306 series is electronic thermometer using a thermopile detector to detect body temperature from the oral or armpit. It intended
{1}------------------------------------------------
Duteck: micHealth Digital Clinical Thermometer 510(K) Submission
for the intermittent measurement of human body temperature in people of all ages.
| ELEMENTOFCOMPARISON | Duteck DigitalThermometer | Clinical Duteck (micHealth) Digital ClinicalThermometer, DT2306 series |
|---|---|---|
| 510(K) Number | K992327 | New |
| DisplayedTemperatureRange | 32°C | 32.00°C |
| OperationEnvironment | 16°C | 16.00°C |
| PowerRequirement | LR41 1.5V batteries x1 | CR 1620 3V x1 |
| DisplayResolution | ±0.1°C/°F | ±0.01°C/°F |
| Display | TN LCD | TN LCD |
| Response Time | 15 second | 4 second |
Comparison of technical characteristics: 807.92(a)(6)
Safety and effectiveness
807.92(b)
The Duteck (micHealth) Digital Clinical Thermometer, DT2306, had been tested to the appropriate electrical tested standard and biocompatibility standards have been found safe for intended use. (As Appendix III)
Conclusion:
807.92(b)(3)
The Duteck (micHealth) Digital Clinical Thermometer is as same as the predicate device in intended use and technological characteristics. After analyzing performance and safety. testing, it is the conclusions of Duteck (micHealth) Digital Clinical Thermometer is as safe and effective as the predicate devices and introduce no new questions concerning safety and effectiveness.
Sincerely Yours,
oseph Chen
7
{2}------------------------------------------------
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized caduceus symbol, which features a staff with a snake winding around it, and three horizontal bars above it. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged in a circular fashion around the symbol.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
February 4, 2014
Duteck Industrial Company, Limited C/O Joseph Chen, President 3F-2, Number 26, Lane 513 Rui-Kuang Road Taipei 114 Taiwan R.O.C.
Re: K132140
Trade/Device Name: Duteck (micHealth) Digital Clinical Thermometer, DT2306 series Regulation Number: 21 CFR 880.2910 Regulation Name: Clinical Electronic Thermometer Regulatory Class: Class II Product Code: FLL Dated: January 7, 2014 Received: January 15, 2014
Dear Mr. Chen:
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. 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.
{3}------------------------------------------------
Page 2 - Mr. Chen
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.
Sincerely vours.
Image /page/3/Picture/8 description: The image shows the name Kwame Ulmer in a stylized font. The letters are bold and black, and they are arranged in two rows. The first row contains the name Kwame, and the second row contains the name Ulmer. The letters are partially obscured by a geometric design that is made up of lines and shapes. The design is black and white, and it is placed behind the letters.
for
Erin I. Keith, M.S. Acting Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
{4}------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
510(k) Number (if known) K132140
Device Name
micHealth Digital Clinical Thermometer, DT2306 series
Indications for Use (Describe)
Duteck (micHealth) Digital Clinical Thermometer, DT2306 series (product code FLL) is used to measure human body temperature with the following features:
The device display body temperature in digital format at LCD The device make intended contact with patient in 2 ways
(1) Surface contact: armpit.
(2) Invasive contact: oral.
The device is used and installed by patients, Nurses, doctors and people with the exception of handicapped people and children.
The device is used in ENVIRONMENT of room temperature and normal environment condition.
Type of Use (Select one or both, as applicable)
] Prescription Use (Part 21 CFR 801 Subpart D)
X Over-The-Counter Use (21 CFR 801 Subpart C)
PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.
FOR FDA USE ONLY
Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)
Image /page/4/Picture/18 description: The image shows the name "Sajjad H. Syed -S" in large, bold font on the left side. To the right of the name is a digital signature with the same name, along with information such as "o=U.S. Government, ou=HHS, ou=FDA," and a date and time stamp of "2014.01.30 14:55:10 -05'00'." There are also some numbers included in the digital signature, such as "19200300.100.1.1=2000601742".
Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement on last page.
{5}------------------------------------------------
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
§ 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.