(48 days)
Not Verified
No
The description details a calculation based on infrared radiation and room temperature, which is a standard algorithmic approach, not indicative of AI/ML. There are no mentions of AI, ML, or related concepts like training or test sets.
No.
The device's intended use is limited to measurement and monitoring of human body temperature, which is a diagnostic or monitoring function, not a therapeutic one. It does not claim to treat, prevent, or mitigate any disease or condition.
No
The device is intended for "measurement and monitoring of human body temperature," which is a measurement function, not a diagnostic one. It does not identify the nature or cause of a medical condition.
No
The device description explicitly states it uses an infrared sensor (thermopile) and displays the temperature on an LCD, indicating it is a hardware device with embedded software, not a standalone software-only device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Function: The Non-Contact Infrared Thermometer measures human body temperature by detecting infrared radiation from the forehead. This is a direct measurement of a physical property of the body, not a test performed on a sample taken from the body.
- Intended Use: The intended use is "measurement and monitoring of human body temperature," which aligns with a general medical device, not an IVD.
Therefore, this device falls under the category of a general medical device, specifically a thermometer, rather than an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The Non-Contact Infrared Thermometer is intended for measurement and monitoring of human body temperature.
Product codes (comma separated list FDA assigned to the subject device)
FLL
Device Description
The Non-Contact Infrared Thermometer is an electronic thermometer using an infrared sensor (thermopile) to measure forehead temperature. Its operation is based on measuring the natural thermal radiation from the forehead and the adjacent surforms a calculation that factors in room temperature, and then a calculated temperature is displayed on the LCD.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
forehead
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)
The Non-Contact Infrared Thermometer has been manufactured and tested to meet the following safety and effectiveness requirements:
- IEC 60601-1: Medical Electrical Equipment Part 1: General Requirements for Safety, 1988; -Amendment 1, 1991-11, Amendment 2, 1995.
- IEC 60601-1-2: Medical Electrical Equipment Part 1-2: General Requirements for Safety Collateral -Standard: Electromagnetic Compatibility - Requirements and Tests (Edition 2:2001 with Amendment 1:2004); Edition 2.1 (Edition 2:2001 consolidated with Amendment 1:2004).
- IEC 60601-1-4: Medical Electrical Equipment Part 1-4: General Requirements for Safety ---Collateral Standard: Programmable Electrical Medical Systems, Edition 1.1.
- ISO 14971: Medical Devices Application of Risk Management to Medical Devices. .
The performance tests demonstrate that the Non-Contact Infrared Thermometer is as safe, as effective and performs in a substantially equivalent manner to the predicate device.
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
113-0361
510(k) Summary 5.
2 2013 APR
A. Submission date: 01/21/2013
B. Applicant:
- Company name: HuBDIC Co., Ltd
- Address: B-301, Taekwang-industrial Building, 191-1, Anyang 7-dong, Manan-gu, Anyang-si, Gyeonggi-do, Korea, 430-815.
- TEL: +82-31-441-8637
- FAX: +82-31-442-4994
- EMAIL : sales@hubdic.com
B. Contact Person
- Name: Matt Hansen
- Address: 504 Bluegrass Drive, Canonsburg, PA15317, USA
- Tel (US): 516 279 7207
- Tel (Korea): +82 104 255 4562
- E-mail: mbhans80@gmail.com
C. Proprietary and Established Names
- · Common Name: Non-Contact Infrared Thermometer
- Classification Name: Clinical Electronic Thermometer
- Trade Names: 1. Thermofinder
- 2. Thermocare
- Establishment Registration Number: 3008729744
- Product Code and Classification Panel: FLL, 21 CFR 880.2910
- Regulatory Classification: Class II
D. Predicate device: The Infrared Forehead Thermometer, FS-300&301 (K101912)
E. Intended use
The Non-Contact Infrared Thermometer is intended for measurement and monitoring of human body temperature.
F. Device Description
The Non-Contact Infrared Thermometer is an electronic thermometer using an infrared sensor (thermopile) to measure forehead temperature. Its operation is based on measuring the natural thermal radiation from the forehead and the adjacent surforms a calculation that factors in room temperature, and then a calculated temperature is displayed on the LCD.
G. Technological Characteristics:
The Non-Contact Thermometer has the exact same technological characteristics as the predicate device. In fact, the predicate device is the same device with the same intended use, specifications, materials, etc. The only difference between the current device and its predicate is the 'Indication for Use', which will change from Rx to OTC. The specifications of the device are summarized below:
| Measurement method | Infrared measurement, Contactless measurement |
|---|---|
| Measurement range | Object : 15.0°C ~ 60.0°C |
| Body : 34.0°C ~ 42.5°C |
1
| | Only FS-301 Specifications
Humidity :20 ~ 90% RH |
|------------------|--------------------------------------------------------------------------------------------------------------------|
| Accuracy | Object : 15.0°C60.0°C : ±2.0°C35.9°C : ±0.3°C
Body : 34.0°C
36.0°C39.0°C: ±0.2°C42.5°C: ±0.3°C |
39.1°C
| | Only FS-301 Specifications
Humidity : 20% ~ 90% : ±10% |
| Display format | LCD display |
| Display unit | 0.1°C |
| Power idle mode | After 60 seconds |
| Measurement time | Less than 2 second |
| Battery | LR03(AAA) (2EA) at least 5,000 measurements |
| Weight | 120g (without holder and batteries) |
H. Performance (Safety and Effectiveness Information)
The Non-Contact Infrared Thermometer has been manufactured and tested to meet the following safety and effectiveness requirements:
- IEC 60601-1: Medical Electrical Equipment Part 1: General Requirements for Safety, 1988; -Amendment 1, 1991-11, Amendment 2, 1995.
- IEC 60601-1-2: Medical Electrical Equipment Part 1-2: General Requirements for Safety Collateral -Standard: Electromagnetic Compatibility - Requirements and Tests (Edition 2:2001 with Amendment 1:2004); Edition 2.1 (Edition 2:2001 consolidated with Amendment 1:2004).
- IEC 60601-1-4: Medical Electrical Equipment Part 1-4: General Requirements for Safety ---Collateral Standard: Programmable Electrical Medical Systems, Edition 1.1.
- ISO 14971: Medical Devices Application of Risk Management to Medical Devices. .
I. Conclusion:
Technically the device is exactly same as its predicate device (K101912). The 510(k) changes its indication from Prescription (Rx) use to Over-The-Counter (OTC) use.
The performance tests demonstrate that the Non-Contact Infrared Thermometer is as safe, as effective and performs in a substantially equivalent manner to the predicate device.
2
DEPARTMENT OF HEALTH & HUMAN SERVICES
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Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
Hubdic Company, Limited C/O Mr. David Yungvirt Responsible Third Party Official Pharmalink Technical Group, LLC 20 F Street, NW Washington, District of Columbia 20001 April 2, 2013
Re: K130361
Trade/Device Name: Infrared Thermometer Regulation Number: 21 CFR 880.2910 Regulation Name: Clinical Electronic Thermometer Regulatory Class: II Product Code: FLL Dated: March 16, 2013 Received: March 19, 2013
Dear Mr. Yungvirt:
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. Yungvirt
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/CDRH0ffices/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.goy/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours.
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Anthony D. Watson, B.S., M.S., M.B.A. Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Indications for Use
510(k) Number (if known):_____________________________________________________________________________________________________________________________________________________
Device Name: Non-Contact Infrared Thermometer
Indications:
The Non-Contact Infrared Thermometer is intended for measurement and monitoring of human body temperature.
Prescription Use (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use X (21 CFR 807 Subpart C)
" 张
(Please DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
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Concurrence of CDRH. Office of Device Evaluation (ODE) Richard C. Chapman 2013.04.01 14:08:08 -04'00'
(Division Sign-Off) (Division Sign-Off)
Division of Anesthesiology, General Hospital Division Control, Dental Devices
K130361 510(k) Number: