(121 days)
The applicant device of Clinical Electronic Thermometers, Model MT901, Mode MT518 and Mode ECT-1 are the electronic thermometers by using a thermistor as the temperature sensor to measure the body temperature in oral, axillaries (underarm use), and rectal.
The applicant device of Clinical Electronic Thermometers, Model MT901, Model MT518, Model ECT-1 are the electronic thermometers by using a the temperature sensor. tor as the temperature sensor. The signal of sensor is calculated and displayed by an ASIC (Application Specific IC), JA31106, the CMOS digital clinical thermometer IC for measuring body temperature from 32.0℃~42.0℃(90°F ~ 109.0°F)
All variants follow same design, same application with same performance and safety. The only difference is appearance. Therefore, all variants have same specifications parameters, same PCB Design, and same components with exception of shell.
No antimicrobial or antithrombotic ingredient is applied on the applicant device.
No chemical for the enhancement of its clinical performance is applied on or incorporated into applicant device.
No specific drug or biologic is applied with the applicant device.
The provided 510(k) summary for the Clinical Electronic Thermometers (Models MT901, MT518, ECT-1) does not contain the detailed information necessary to complete the requested table and answer all questions regarding acceptance criteria and a definitive study proving the device meets those criteria.
This 510(k) submission is for a Class II device and relies on demonstrating substantial equivalence to a predicate device (Rapid Digital Thermometer, Model RDT-18-XY, K062016). The summary explicitly states: "The applicant device has same classification informations and intended use, same design principle, similar product design and specifications, same performance effectiveness, performance safety as the predicate device."
Therefore, concrete acceptance criteria and a detailed study proving performance against those specific criteria for the new device are generally not provided in such a submission when substantial equivalence is asserted. Instead, the assumption is that if the new device is substantially equivalent to a legally marketed predicate, it shares the predicate's established performance and safety.
However, I can extract the relevant information and infer some details based on typical thermometer requirements and the general nature of 510(k) submissions for substantially equivalent devices.
1. Table of Acceptance Criteria and Reported Device Performance
As the submission relies on substantial equivalence and does not present a new specific performance study against defined acceptance criteria, I will infer typical performance expectations for clinical electronic thermometers and note that the device is stated to meet the "same performance effectiveness" as the predicate.
| Acceptance Criterion (Infered/Typical for Electronic Thermometers) | Reported Device Performance (as per 510(k)) |
|---|---|
| Accuracy (Temperature Measurement Range) | Measures body temperature from 32.0℃~42.0℃ (90°F ~ 109.0°F). Stated to have "same performance effectiveness" as the predicate device. |
| Response Time | Not explicitly stated in the 510(k) summary. Implied to be comparable to the "Rapid Digital Thermometer" predicate. |
| Measurement Sites | Oral, axillary (underarm use), and rectal. |
| Sensor Type | Thermistor. |
| Display Type | Digital (ASIC calculated and displayed). |
| Safety (e.g., Biocompatibility) | No antimicrobial or antithrombotic ingredients applied. No chemical for enhancement. No specific drug or biologic applied. Implied to have "same performance safety" as the predicate. |
| Storage Conditions | "Similar product design and specifications" to predicate. Note: Slight difference in storage condition noted, but deemed "too slight to affect the device effectiveness and safety." |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Test Set: Not specified. It's highly unlikely a new clinical test set was used if the claim is substantial equivalence based on design and specifications rather than a de novo performance study. It's more likely that bench testing was performed to confirm the specifications of the new device match the predicate.
- Data Provenance: Not specified. For substantial equivalence, the "data" primarily refers to the characteristics and specifications of the new device matching the predicate, and possibly engineering/bench testing data. Not a typical clinical study in this context.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of those Experts
- Number of Experts/Qualifications: Not applicable for this type of 510(k) submission. Ground truth, in the sense of clinical expert consensus for diagnosis, is not relevant here as it's a device for direct physiological measurement, not an interpretative AI/diagnostic tool.
4. Adjudication Method for the Test Set
- Adjudication Method: Not applicable. See point 3.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, and if so, what was the effect size of how much human readers improve with AI vs without AI assistance.
- MRMC Study: No. This device is a standalone electronic thermometer, not an AI-assisted diagnostic tool requiring human interpretation.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done.
- Standalone Performance: Yes, in the sense that the device itself is standalone. Bench testing would have been implicit to verify that the thermometer accurately measures temperature within its specified range. However, no specific details of such "standalone" testing are provided in this 510(k) summary beyond asserting it has the "same performance effectiveness" as the predicate.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Type of Ground Truth: For a thermometer, the "ground truth" would be calibrated reference temperature standards used during manufacturing and quality control testing, and implicitly, during any verification testing to confirm the device's accuracy against its specifications.
8. The sample size for the training set
- Sample Size for Training Set: Not applicable. This is not an AI/machine learning device that requires a training set.
9. How the ground truth for the training set was established
- Ground Truth for Training Set Establishment: Not applicable. See point 8.
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510(k) Summary
JAN 17 2008
This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR 9807.92.
The Assigned 510(k) Number is:
- Applicant Device Information
Trade/Proprietary Name: Clinical Electronic Thermometers, Model MT901, Model MT518, Model ECT-1
Common Name: Clinical electronic thermometer.
Classification Name: Thermometer, electronic, clinical
Device Class: II
Product Code: FLL
Regulation Number: 880.2910
Intended Use:
The applicant device of Clinical Electronic Thermometers, Model MT901, Mode MT518, Mode ECT-1 are the electronic thermometers by using a thermistor as the temperature sensor to measure the body temperature in oral, axillaries (underarm use), and rectal.
2. Submitter Information
Establishment Registration Name:
Ningbo HuaHui Medical Instruments Co., LTD No. 10 Jiangshantou Cun, Jiangshan Town, Ningbo City, China 315191
Contact Person of the Submission:
Ms. Diana. Hong, Mr. Eric. Chen Shanghai Mid-link Consulting Co., Ltd. Suite 8D, Zhongxin Zhongshan Building, No. 19, Lane 999, Zhongshan 2nd Road (S) Shanghai, 200030 China
Phone: +86-21-64264467 Ext. 278 Fax: +86-21-64264468 Ext. 809 Cellphone: +86 1391 6364 846 Email: Diana.hong@mid-link.net Please CC: Eric.chen@mid-link.net
Shanghai Midlink Business Consulting Co. Ltd
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3. Predicate Device
Rapid Digital Thermometer, Model RDT-1 8-XY (X=0-9, Y=1-9)
K-number: K062016
Product Code: FLL
Intended Use:
The Rapid Digital Thermometer is an electronic thermometer used to measure body temperature in oral, axillaries (underarm use), and rectal.
Manufactured by:
Choice Smart Health Care Company Limited. RM 1901, CC WU BUILDINQ 302 HENNESSY ROAD, WANCHAI Hong Kong
4. Device Description
The applicant device of Clinical Electronic Thermometers, Model MT901, Model MT518, Model ECT-1 are the electronic thermometers by using a the temperature sensor. tor as the temperature sensor. The signal of sensor is calculated and displayed by an ASIC (Application Specific IC), JA31106, the CMOS digital clinical thermometer IC for measuring body temperature from 32.0℃~42.0℃(90°F ~ 109.0°F)
All variants follow same design, same application with same performance and safety. The only difference is appearance. Therefore, all variants have same specifications parameters, same PCB Design, and same components with exception of shell.
No antimicrobial or antithrombotic ingredient is applied on the applicant device.
No chemical for the enhancement of its clinical performance is applied on or incorporated into applicant device.
No specific drug or biologic is applied with the applicant device.
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Substantially Equivalence 5.
Comparison Analysis:
The applicant device has same classification informations and intended use, same design principle, similar product design and specifications, same performance effectiveness, performance safety as the predicate device. The only differences are device weight and storage condition which are too slight to affect the device effectiveness and safety. No new design is applied. No new material is applied. No new question is raised.
Conclusion:
The applicant device is Substantially Equivalent (SE) to the predicate device which is US legally market device. Therefore, the applicant device is determined as safe and effectiveness.
Shanghai Midlink Business Consulting Co. Ltd
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Image /page/3/Picture/2 description: The image shows the seal of the U.S. Department of Health and Human Services. The seal features an abstract design resembling an eagle or bird in flight, composed of three curved lines. The text "DEPARTMENT OF HEALTH AND HUMAN SERVICES - USA" is arranged in a circular pattern around the design.
JAN 17 2008
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Ningbo HuaHui Medical Instruments Company, Limited C/O Ms. Diana Hong General Manager Shanghai Midlink Business Consulting Company, Limited Suite 8D Zhongxin Zhongshan Building No. 19, Lanc 999, Zhongshan 2nd Road (S) Shanghai, 200030 CHINA
Re: K072635
Trade/Device Name: Clinical Electronic Thermometers, Model MT901, Model MT518, Model ECT-1 Regulation Number: 21 CFR 880.2910 Regulation Name: Clinical Electronic Thermometers Regulatory Class: II Product Code: FLL Dated: January 2, 2008 Received: January 10, 2008
Dear Ms. Hong:
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.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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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Page 2 - Ms. Hong
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); 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.
This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html,
Sincerely yours,
Chris Lino, Ph.D.
Chiu Lin, Ph.D. Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number:
Clinical Electronic Thermometers, Model MT901, Model MT518, Device Name: __ Model ECT-1
Indications for Use:
The applicant device of Clinical Electronic Thermometers, Model MT901, Mode MT518 and Mode ECT-1 are the electronic thermometers by using a thermistor as the temperature sensor to measure the body temperature in oral, axillaries (underarm use), and rectal.
Prescription Use (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
(Division Sign-Off)
Division of Anesthesiology, General Hospital Infection Control, Dental Devices
Page 1 of 1
510(k) Number: K072635
Shanghai Midlink Business Consulting Co., Ltd.
§ 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.