(55 days)
ThermoFlash LX-26 is an infrared thermometer for body surface and forehead temperature measurement for infants and adults without contact to human body. It can be used by consumers in household environment and doctor in clinic as reference.
Infrared Thermometer ThermoFlash LX-26 is a hand held, reusable, battery operated, maximum device that can measure human body surface and forehead temperature measurement for infants and adults without contact to human body. It can be used by consumers in household environment and doctor in clinic as reference. It is manufactured in accordance with the ASTM 1965-98 Standard Specification for Infrared Thermometers for Intermittent Determination of Patient Temperature. The operation principle is based on infrared sensor technology. IR Sensor can putout different signal when mcasuring different object temperature or in different ambient temperature. An ASIC can turn the signal from IR schsor to digital value and display it by LCD.
The provided text, K080759, is a 510(k) summary for the device "Infrared Thermometer ThermoFlash LX-26". Based on the information provided, it's a submission for an infrared thermometer, which is a fairly mature and well-understood technology. The "acceptance criteria" and "device performance" in such submissions generally refer to compliance with recognized standards rather than a clinical study with detailed statistical outcomes like those for novel AI systems.
Here's the breakdown of the requested information based on the provided document:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria / Standard | Reported Device Performance |
|---|---|
| ASTM E 1965-98 (2003) | The device conforms to applicable standards included ASTM E 1965-98 (2003). (Implicitly, the device meets the performance requirements specified in this standard for infrared thermometers for intermittent determination of patient temperature.) |
| IEC 60601-1 | The device conforms to applicable standards included IEC 60601-1 requirements. (This standard covers general requirements for basic safety and essential performance of medical electrical equipment.) |
| IEC 60601-1-2 | The device conforms to applicable standards included IEC 60601-1-2 requirements. (This standard covers electromagnetic compatibility for medical electrical equipment.) |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document does not provide details about a specific "test set" in the context of a clinical study with a sample size. The conformity to standards implies that the device underwent testing according to those standards, which would involve a test set of the device itself and likely environmental conditions, but not a patient-based "test set" as typically understood in AI/diagnostic device studies. There is no information on data provenance (country of origin, retrospective/prospective).
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
This information is not applicable and not provided in the document. The device is an infrared thermometer, and its performance is evaluated against physical measurement standards, not subjective expert interpretation of images or other data.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not applicable and not provided. Performance is evaluated against technical specifications and standards, not through expert adjudication of results.
5. 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
This information is not applicable and not provided. The device is a standalone temperature measurement tool, not an AI-assisted diagnostic tool that would be used by "human readers" to interpret data.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
The device itself is a standalone device. Its performance is measured directly (algorithm only) against physical standards. However, the term "algorithm only" refers to the device's internal processing of infrared signals to determine temperature. There's no mention of a traditional "standalone study" as would be performed for a complex AI diagnostic algorithm. The compliance with ASTM E 1965-98 essentially serves as the standalone performance evaluation.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The ground truth for an infrared thermometer is typically established by:
- Traceable reference thermometers: These are highly accurate thermometers calibrated against national or international standards, serving as the "true" temperature.
- Standardized black bodies/calibrators: These devices emit a known, stable infrared radiation corresponding to a specific temperature, used to calibrate and verify the accuracy of the infrared thermometer.
- Controlled environmental conditions: Ensuring accurate measurement requires controlling ambient temperature and other environmental factors influencing infrared readings.
The document states conformity to ASTM E 1965-98, which outlines the methods and ground truth definitions for testing infrared thermometers.
8. The sample size for the training set
This information is not applicable and not provided. Infrared thermometers are not typically "trained" in the machine learning sense. Their operation is based on established physical principles of infrared radiation and an internal algorithm for signal conversion.
9. How the ground truth for the training set was established
This information is not applicable and not provided for the reason stated above.
{0}------------------------------------------------
510(K) SUMMARY
MAY 12 2008
This summary of 510(K) safety and effectiveness information is being submitted in accordance with the requirements of SMDA and 21 CFR § 807.92
1.0 Submitter's Information
| Name: | JXB Co, LTD Guangzhou (China) |
|---|---|
| Address: | Nº 38 Huanzhen Xi Road, Dagang Town,Panuy, Guangzhou, China |
| Phone: | +86-20-34936960 |
| Fax: | +86-20-34936960 |
| Contact: | Tray Cui |
| Email: | Trayhtb@hotmail.com |
2.0 Device Information
| Name: | Infrared Thermometer |
|---|---|
| Trade Name: | ThermoFlash LX-26 |
| Model: | ThermoFlash LX-26 |
Classification 3.0
| Product Code: | FLL---clinical electronic thermometer |
|---|---|
| Regulation: | 880.2910 |
| Number: | |
| Classification: | II |
| Panel: | 80 |
Predicate Device Information 4.0
| Sponsor: | Famidoc Technology Co., Ltd |
|---|---|
| Device: | Infrared Thermometer, Model: FDIR-V1 |
| 510(K) Number: | K052849 |
5.0 Device description
Infrared Thermometer ThermoFlash LX-26 is a hand held, reusable, battery operated, maximum device that can measure human body surface and forehead
{1}------------------------------------------------
temperature measurement for infants and adults without contact to human body. It can be used by consumers in household environment and doctor in clinic as reference. It is manufactured in accordance with the ASTM 1965-98 Standard Specification for Infrared Thermometers for Intermittent Determination of Patient Temperature.
The operation principle is based on infrared sensor technology. IR Sensor can putout different signal when mcasuring different object temperature or in different ambient temperature. An ASIC can turn the signal from IR schsor to digital value and display it by LCD.
6.0 Intended Use
ThermoFlash LX-26 is an infrared thermometer for body surface and forehead temperature measurement for infants and adults without contact to human body. It can be used by consumers in household environment and doctor in clinic as reference.
7.0 Performance Summary
The device conforms to applicable standards included ASTM E 1965-98(2003). IEC 60601-1 and IEC 60601-1-2 requirements.
Comparison to predicate device and conclusion 8.0
Our Infrared Thermometer ThermoFlash LX-26 is substantially equivalent to Infrared Thermometer, Model: FDIR-V1 whose 510(K) number is K052849.
The two devices are very similar in design principle, intended use, functions, material and the applicable standards. Only their outlook and some parameter such as measurement rang are different. However, the tests in this submission provide demonstration these small differences do not raise any new question of safety or effectiveness.
{2}------------------------------------------------
The infrared thermometer ThermoFlash LX-26 is substantially equivalent to the predicate device.
.
- 9.0 Draft date: June 21, 2007
.
:
.
:
:
{3}------------------------------------------------
Image /page/3/Picture/1 description: The image shows the seal of the Department of Health & Human Services, USA. The seal features a stylized eagle with its wings spread, symbolizing protection and service. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES, USA" is arranged in a circular pattern around the eagle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAY 12 2008
JXB Company, Limited Guangzhou C/O Mr. Casey Conry Responsible Third Party Official Underwriters Laboratories, Incorporated 1285 Walt Whitman Road Melville, New York 11747
Re: K080759
Trade/Device Name: ThermoFlash LX-26 Regulation Number: 21 CFR 880.2910 Regulation Name: Clinical Electronic Thermometer Regulatory Class: II Product Code: FLL Dated: April 25, 2008 Received: April 28, 2008
Dear Mr. Conry:
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.
{4}------------------------------------------------
Page 2 - Mr. Conry
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) 276-0115. 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,
Chiu Lin, 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
{5}------------------------------------------------
Image /page/5/Picture/0 description: The image shows the Underwriters Laboratories Inc. logo. The logo consists of the letters "UL" inside of a circle on the left. To the right of the circle are the words "Underwriters Laboratories Inc." in bold black font. The logo is a registered trademark.
Statement of Indications for Use
510(k) Number (if known):
Device Name: ThermoFlash LX-26
Indications For Use:
ThermoFlash LX-26 is an infrared thermometer for body surface and forellead temperature measurement for infants and adults without contact to human body.
Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use AND/OR (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)
Cim 200
Page 15 of
(Division Sign-Off) Division of Anesthesiology, General Hospital Infection Control, Dental Devices
510(k) Number:
- I ર -
§ 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.