(17 days)
No
The 510(k) summary describes a standard digital clinical thermometer and does not mention any AI or ML capabilities. The device description and performance study sections are not found, and there are no mentions of AI, DNN, or ML.
No
The device is a digital clinical thermometer that measures human body temperature, which is a diagnostic tool rather than a therapeutic one. It provides information about a patient's condition but does not treat or alleviate illness.
No
Explanation: A diagnostic device is used to identify the nature of a disease or condition. This device is a clinical thermometer, which measures body temperature, a vital sign. While changes in body temperature can be indicators of illness, the thermometer itself does not diagnose a specific disease; it provides a measurement that clinicians may use as part of a diagnostic process.
No
The device is described as a "Digital Clinical thermometer" and mentions measuring temperature, which strongly implies a hardware component for sensing temperature. The lack of a device description and the reference to a predicate device that is also a physical thermometer further support this conclusion.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the device is for "precisely measure human body temperature." This is a direct measurement of a physiological parameter within the body, not an analysis of samples taken from the body (like blood, urine, or tissue).
- Lack of IVD Characteristics: The description does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples.
- Detecting or measuring substances in samples.
- Providing information for diagnosis, monitoring, or screening based on sample analysis.
The device is a clinical thermometer, which is a common medical device used for direct measurement of body temperature.
N/A
Intended Use / Indications for Use
The Digital Clinical thermometer, Model ACT2130, ACT 2230, ACT 2330, ACT 3136, ACT 3030's intended use are medical devices, supplied by internal power and intended to precisely measure human body temperature. It can be used in the measurement of oral, axillary and rectal temperature. This is the same intended use as previously cleared for the Actherm Digital Clinical Thermometers, K010238.
Product codes
FLL
Device Description
Not Found
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
oral, axillary and rectal
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
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)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" around the perimeter. Inside the circle is a stylized image of an eagle with three lines representing its wings and head.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUL 0 7 2003
Mr. Richard Hsieh Vice President Actherm, Incorporated 6″ F, No. 85 Kuan-Min 6 Road Jubei 302 Hsinchu, CHINA (Taiwan) 302
Re: K031905
Trade/Device Name: Digital Clinical Thermometer, Model ACT 2130, ACT 2230, ACT 2330, ACT 3136, ACT 3030 Regulation Number: 21 CFR 880.2910 Regulation Name: Clinical Electronic Thermometer Regulatory Class: II Product Code: FLL Dated: June 6, 2003 Received: June 23, 2003
Dear Mr. Hsieh:
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.
1
Page 2 - Mr. Hsieh
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 (301) 594-4618. 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/dsma/dsmamain.html
Sincerely yours,
Susan Bunce
Susan Runner, DDS, MA Interim Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
......
2
Attachment 2
Indications for Use Statement
| 510(k) Number (if known) | |
|---|---|
| Device Name | Digital Clinical Thermometer, Model ACT2130, ACT 2230, ACT 2330, ACT 3136, ACT 3030 |
| Indications for Use | The Digital Clinical thermometer, Model ACT2130, ACT 2230, ACT 2330, ACT 3136, ACT 3030's intended use are medical devices, supplied by internal power and intended to precisely measure human body temperature. It can be used in the measurement of oral, axillary and rectal temperature. This is the same intended use as previously cleared for the Actherm Digital Clinical Thermometers, K010238. |
PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use
OR
Over-The-Counter Use
(Per 21 CFR 801. 109)
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Patina Cuente
(Division, City or RM
(Division Sign-Off) Division of Anesthesiology, General Hospital, Infection Control, Dental Devices
510(k) Number: K031905