The Digital Thermometer is used for the measurement and monitoring of human body temperature. Body temperature can be measured with the Digital Thermometer by oral, axillary (under the arm) and rectal methods. The device is for adult and pediatric use.

Device Description

The Digital Thermometer is a hand-held electronic thermometer comprised of an electronic thermoresistor (thermistor) sensor connected to a printed circuit board (PCB) with liquid crystal display (LCD) user readout. These components are held in a plastic housing with stainless steel metal cap. The housing is a rigid plastic. The Digital Thermometer is supplied with a clear plastic storage case to protect the thermometer.

AI/ML Overview

The provided document is a 510(k) summary for a Digital Thermometer. It does not contain a study that proves the device meets specific acceptance criteria in the manner typically presented for AI/ML or diagnostic devices. Instead, it demonstrates substantial equivalence to a predicate device based on non-clinical tests and adherence to voluntary standards.

Therefore, many of the requested elements (acceptance criteria table with reported performance, sample sizes for test/training sets, ground truth methodology, expert adjudication, MRMC studies, standalone performance, and how ground truth for training was established) are not applicable or cannot be extracted from this document, as it describes a traditional medical device submission, not a study for a new AI/ML or complex diagnostic device with specific performance metrics defined against a ground truth.

However, I can provide information based on what is present in the document regarding the device's characteristics and the basis for its safety and effectiveness claims.

Acceptance Criteria and Device Performance (Based on Substantial Equivalence and Standards)

This submission relies on demonstrating substantial equivalence to a predicate device and compliance with established voluntary standards rather than presenting a performance study against novel acceptance criteria. The "acceptance criteria" here are implicitly met by showing conformity to these standards and equivalence to the predicate.

Acceptance Criteria (Implied by Standards & Equivalence)	Reported Device Performance / Basis of Acceptance
Safety and Effectiveness	Verified through non-clinical tests demonstrating compliance with:
- ASTM E1112-00 (Standard for Clinical Electronic Thermometers)	Not explicitly detailed, but stated as compliant.
- IEC 60601-1 (Medical Electrical Equipment - General requirements for basic safety and essential performance)	Not explicitly detailed, but stated as compliant.
- IEC 60601-1-2 (Medical Electrical Equipment - Electromagnetic compatibility)	Not explicitly detailed, but stated as compliant.
- ISO 10993-1 (Biological evaluation of medical devices)	Materials tested in accordance with ISO 10993 and compared to predicate.
Functional Equivalence (to Predicate Device)
- Intended Use	Identical to predicate device.
- Means of measuring temperature	Similar to predicate device.
- Technology	Similar to predicate device.
- Materials	Tested per ISO 10993 and compared to predicate.
- Environment for Use	Identical to predicate device.
- Patient Population	Identical to predicate device (adult and pediatric).

Study Details (Where Applicable, based on provided document)

Sample size used for the test set and the data provenance:
- Not applicable. This submission relies on "non-clinical tests" and compliance with standards, not a clinical study with a specific test set of patient data. The document does not describe patient data, but rather tests against engineering standards.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable. Ground truth, in the context of diagnostic accuracy, is not mentioned as part of this submission, which focuses on engineering standards and equivalence.
Adjudication method for the test set:
- Not applicable.
If a multi-reader multi-case (MRMC) comparative effectiveness study was done:
- No, an MRMC study was not done. This device is a digital thermometer, a direct measurement tool, not an imaging or diagnostic device requiring human interpretation that could be assisted by AI.
If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- Not applicable. This is a digital thermometer, not an algorithm. Its "performance" is its ability to accurately measure temperature according to established engineering standards.
The type of ground truth used:
- The "ground truth" implicitly refers to the accuracy and performance specifications outlined in the voluntary standards (e.g., ASTM E1112-00 for temperature accuracy), and the safety requirements of IEC 60601-1 and ISO 10993-1. These are engineering and biological safety standards, not a ground truth derived from clinical pathology or expert consensus on patient outcomes.
The sample size for the training set:
- Not applicable. This is not an AI/ML device that requires a training set.
How the ground truth for the training set was established:
- Not applicable.

Summary

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AUG 2 3 2012

Summary of Safety and Effectiveness for Digital Thermometer

This summary of 510 (k) safety and effectiveness information is submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92.

1. Submitter's Identification:
  CHINA (Shenyang) Med-land Imp/Exp Corp., Ltd NO. 255 New Jinqiao Road, Room 513 Pudong, Shanghai, P.R. of China, 201206 CHINA

Contact person: Ann D. McGonigle, MPH A.D. McGonigle Consulting Wayland, MA 01778

Contact Telephone Number: (508) 358-9114

Date Prepared: August 20, 2012

1. Name of the Device:
  Digital Thermometer
2.1 Model Nos.:
YT301 / YT302 / YT303
2.2 Regulatory information:
A. Regulation section: 880.2910. Clinical Electronic Thermometer
B. Classification: Class II
C. Product Code: FLL

D. Panel: 80 General Hospital

Predicate Device Information:

MicroLife Digital Thermometer

Device Description:

The Digital Thermometer is a hand-held electronic thermometer comprised of an electronic thermoresistor (thermistor) sensor connected to a printed circuit board (PCB) with liquid crystal display (LCD) user readout. These components are held in a plastic housing with stainless steel metal cap. The housing is a rigid plastic. The Digital Thermometer is supplied with a clear plastic storage case to protect the thermometer.

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Summary of Safety and Effectiveness for Digital Thermometer

1. Intended Use:
  The Digital Thermometer is used for the measurement and monitoring of human body temperature. Body temperature can be measured with the Digital Thermometer by oral, axillary (under the arm) and rectal methods. The device is for adult and pediatric use.
1. Comparison to Predicate Device:
  The Digital Thermometer is substantially equivalent to the predicate device.

Indication: Identical to the predicate device Similar means of measuring temperature to the predicate device. Technology: Materials: Materials have been testing in accordance with ISO 10993 and compare to the results of the predicate device. Environment for Use: Identical to predicate device. Patient Population: Identical to predicate device.

1. Discussion of Non-Clinical Tests Performed for Determination of Substantial Equivalence:
  The Digital Thermometer has demonstrated complicable Voluntary standards of performance and safety, including voluntary standards for Clinical Electronic Thermometers, Medical Electrical Safety, and Biological Evaluation of Medical Devices (ASTM E1112-00, IEC 60601-1, IEC 60601-1-2 and ISQ 10993-1).
1. Conclusions
  The Digital Thermometer has the same intended use and similar technological characteristics as the approved predicate device, MicroLife Digital Thermometer. Verification and validation tests contained in the submission demonstrate that any differences in characteristics do not raise any new questions of safety or effectiveness. If there are any engineering differences, these do not affect the intended use or alter the fundamental scientific technology of the approved predicate device, MicroLife Digital Thermometer.

Therefore, the Digital Thermometer is substantially equivalent to the predicate device, MicroLife Digital Thermometer.

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Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002

China Shenvang Med-Land Imp/Exp Corporation, Limited C/O Ms. Ann D. McGonigle Regulatory Consultant A.D. McGonigle Consulting 19 Sedgemeadow Road Wayland. Massachusetts 01778

Re: K120004

Trade/Device Name: Digital Thermometer Regulation Number: 21 CFR 880.2910 Regulation Name: Clinical Electronic Thermometer Regulatory Class: II Product Code: FLL Dated: July 17, 2012 Received: July 24, 2012

Dear Ms. McGonigle:

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.

AUG 2 3 2012

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Page 2- Ms. McGonigle

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 go to

http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. 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 yours,

for

Anthony D. Watson, B.S., M.S., M.B.A. Director

Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

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Indications for Use

Indications for Use of the Device

K 120004 510 (k) No .:

Device Name: Digital Thermometer

Indications for Use:

Prescription Use (Part 21CFR 801 Subpart D) AND/OR

Over the counter Use X (Part 21CFR 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHÈR PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

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Ried Chapman 8/22/12

(Division Sign-Off) Division of Anesthesiology, General Hospital Infection Control, Dental Devices

510(k) Number: K120004

Page 23 of 185

Regulation Number and Section

§ 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.