(153 days)
Not Found
No
The description details a standard infrared thermometer operation based on direct infrared radiation measurement and electrical signal processing, with no mention of AI/ML algorithms for interpretation or calculation.
No.
A therapeutic device is used to treat or cure a medical condition. This device is an infrared thermometer, which is used for the measurement of body temperature, a diagnostic purpose, not a therapeutic one.
Yes
The device is described as an "infrared thermometer" intended for "intermittent measurement of body temperature," which involves collecting data to assess a physiological state. While it doesn't diagnose a specific disease, the act of measuring body temperature is a common diagnostic tool used to identify fever, a symptom of illness.
No
The device description explicitly states it is an "electronic thermometer using an infrared sensor (thermopile)" and has a "probe" and "LCD display," indicating it is a physical hardware device, not software only.
No, 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. They are used to examine these samples outside of the body.
- Device Function: The description clearly states that this infrared thermometer measures body temperature by detecting infrared radiation from the auditory canal or central forehead on the body. It does not analyze samples taken from the body.
Therefore, based on the provided information, the Infrared Thermometer, Model MD-H30 is a medical device, but it falls under the category of a non-IVD device.
N/A
Intended Use / Indications for Use
The infrared thermometer is intended for the intermittent measurement of body temperature from the auditory canal or central forehead skin surface on people of all ages. It can be used by consumers in the household environment and by healthcare providers.
Product codes (comma separated list FDA assigned to the subject device)
FLL
Device Description
The Infrared Thermometer, Model MD-H30 is an electronic thermometer using an infrared sensor (thermopile) to detect body temperature from the auditory canal or central forehead. Its operation is based on measuring the natural thermal radiation from the tympanic membrane or central forehead.
To measure body temperature, the probe of the thermometer is inserted into a patient's outer ear canal or put onto the skin of a patient's central forehead. Pressing the activation button (for ear or forehead) to start the measurement of target's infrared radiation. The electrical signal read out from the detector is fed to the circuit for amplification and calculation. The final measured temperature will be appeared on a LCD display.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
auditory canal or central forehead skin surface
Indicated Patient Age Range
all ages
Intended User / Care Setting
consumers in the household environment and by healthcare providers.
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)
Clinical accuracy validation:
The clinical investigation report and data analysis met the requirements of the ASTM E 1965-98. The test report shows the three group's temperature readings difference between digital thermometer and the subject device, MD-H30 are within acceptable range. It can conclude that the Infrared Thermometer, Model MD-H30 is acceptable to measure human body's temperature.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Accuracy: +/- 0.4°F (0.2°C) within 95107.6°F (3542°C), +/- 0.5°F (0.3°C) for other range.
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.
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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo is in blue and includes the letters "FDA" followed by the words "U.S. Food & Drug Administration".
November 13, 2019
Guangzhou Berrcom Medical Device Co., Ltd. % Christy Young Consultant Shenzhen Joyantech Consulting Co., Ltd. NO. 55 Shizhou middle road, Nanshan District Shenzhen. 518000 China
Re: K191570
Trade/Device Name: Infrared Thermometer Model MD-H30 Regulation Number: 21 CFR 880.2910 Regulation Name: Clinical Electronic Thermometer Regulatory Class: Class II Product Code: FLL Dated: May 31, 2019 Received: June 13, 2019
Dear Christy Young:
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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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.
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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 of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
for Geeta Pamidimukkala Acting Assistant Director DHT3C: Division of Drug Delivery and General Hospital Devices. and Human Factors OHT3: Office of Gastrorenal, ObGyn, General Hospital and Urology Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K191570
Device Name Infrared Thermometer Model MD-H30
Indications for Use (Describe)
The infrared thermometer is intended for the intermittent measurement of body temperature from the auditory canal or central forehead skin surface on people of all ages. It can be used by consumers in the household environment and by healthcare providers.
| Type of Use (Select one or both, as applicable) |
|---|
| ------------------------------------------------- |
Prescription Use (Part 21 CFR 801 Subpart D)
|X | Over-The-Counter Use (21 CFR 801 Subpart C)
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Proposed product: Infrared Thermometer Model MD-H30
K191570 510(k) Summary
1. Contact Details
1.1 Applicant information
| Applicant Name | Guangzhou Berrcom Medical Device Co., Ltd. |
|---|---|
| Address | No.38 Huanzhen Xi Road, Dagang Town, Nansha, Guangzhou, |
| Guangdong 511470, China | |
| Phone No. | +86(20)34938449 |
| Fax No. | +86(20)34936960 |
| Contact person | Zhigang Du |
| Date Prepared | November 12 2019 |
1.2 Submission Correspondent
| Shenzhen Joyantech Consulting Co., Ltd | ||
|---|---|---|
| Room 1122, International Mayors Communication Centre, NO. 55 | ||
| Shizhou middle road, Nanshan District, Shenzhen | ||
| 卓远天成 | ||
| Phone No. | +86-755-86069197 | |
| Contact person | Christy Young; Field Fu; | |
| Contact person's e-mail | christy@cefda.com; cefda@foxmail.com | |
| Website | http://www.cefda.com |
Device information 2.
| Trade name | Infrared Thermometer Model MD-H30 |
|---|---|
| Common name | Infrared Thermometer |
| Model | MD-H30 |
| Classification | II |
| Classification name | Clinical Electronic Thermometer |
| Product code | FLL |
| Regulation No. | 880.2910 |
Legally Marketed Predicate Device 3.
| Trade Name | RII Multi-function Infrared Thermometer, Model TH52Z |
|---|---|
| 510(k) Number | K162083 |
| Product Code | FLL |
| Manufacturer | Radiant Innovation Inc |
Device Description 4.
The Infrared Thermometer, Model MD-H30 is an electronic thermometer using an infrared sensor (thermopile) to detect body temperature from the auditory canal or central forehead. Its operation is based on measuring the natural thermal radiation from the tympanic membrane or central forehead.
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Proposed product: Infrared Thermometer Model MD-H30
To measure body temperature, the probe of the thermometer is inserted into a patient's outer ear canal or put onto the skin of a patient's central forehead. Pressing the activation button (for ear or forehead) to start the measurement of target's infrared radiation. The electrical signal read out from the detector is fed to the circuit for amplification and calculation. The final measured temperature will be appeared on a LCD display.
Intended Use/Indication for Use 5.
The infrared thermometer is intended for the intermittent measurement of body temperature from the auditory canal or central forehead skin surface on people of all ages. It can be used by consumers in the household environment and by healthcare providers.
| Item | Proposed Device:
Infrared Thermometer | Predicate Device:
RII Multi-function Infrared
Thermometer | Comments | |
|------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------|------|
| Product Code | FLL | FLL | Same | |
| Regulation
number | 21 CFR 880.2910 | 21 CFR 880.2910 | Same | |
| Manufacturer | Guangzhou Berrcom Medical
Device Co., Ltd. | Radiant Innovation Inc. | / | |
| Indications for
Use | The infrared thermometer is
intended for the intermittent
measurement of body
temperature from the auditory
canal or central forehead skin
surface on people of all ages. It
can be used by consumers in
the household environment and
by healthcare providers. | The RII Multi-function Infrared
Thermometer, Model TH52Z is
intended for the intermittent
measurement of human body
temperatures. The device is
intended for the use at home by
people of all ages and it can be
selected Ear mode or Forehead
mode. | Same | |
| | Thermometer
type | Digital thermometer | Digital thermometer | Same |
| | Sensor | Thermopile | Thermopile | Same |
| | Measurement
Method | Infrared radiation detection | Infrared radiation detection | Same |
| | Display Type | LCD | LCD | Same |
| Measuring
range | 32.0-43°C (89.6-109.4°F) | 3442.2°C (93.2108°F) | Similar (note
-
| |
| Accuracy | $\pm$ 0.4°F (0.2°C) within
95107.6°F (3542°C),
$\pm$ 0.5°F (0.3°C) for other range. | $\pm$ 0.4°F (0.2°C) within
95107.6°F (3542°C),
$\pm$ 0.5°F (0.3°C) for other range. | Same | |
6. Substantial Equivalence Comparison
5
Proposed product: Infrared Thermometer Model MD-H30
| Temperature
| unit | °C or °F | °C or °F | Same |
|---|---|---|---|
| Power | |||
| requirements | 2X1.5V AAA battery | 1.5V button battery | Different |
| (note 2) | |||
| Operation | |||
| environment | 10℃~40℃; ≤95% RH | Not available | / |
| Storage | |||
| environment | -20~55°C; ≤95%RH | Not available | / |
| Materials of | |||
| skin-contacting | |||
| components | ABS | ABS | Same |
lssue:
Note 1: The measurement range of subject devices meet the requirements of ISO80601-2-56 and ASTM E1965-98. The difference does not raise different safety and effectiveness issues Note 2: The batteries of proposed device are different from that of predicate device. However, the proposed device has been demonstrated to comply with the requirements of electrical safety identified in the standards. The difference does not raise different safety and effectiveness issues.
7. Non-clinical studies and tests performed
Non-clinical tests were conducted to verify that the targeted device meet all design specifications in order to demonstrate that it is Substantially Equivalent to the predicate device.
The test results demonstrate that the targeted device complies with the following standards:
ASTM E 1965-98 Standard Specification for Infrared Thermometers for Intermittent Determination of Patient Temperature
IEC 60601-1:2012, Medical Electrical Equipment - Part 1: General Requirements for Basic Safety and Essential Performance
IEC 60601-1-2:2014, Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral standard: Electromagnetic compatibility
IEC 60601-1-11:2015 medical electrical equipment - part 1-11: general requirements for basic safety and essential performance - collateral standard: requirements for medical electrical equipment and medical electrical systems used in the home healthcare environment
ISO 80601-2-56: 2009 Medical electrical equipment - part 2-56: particular requirements for basic safety and essential performance of clinical thermometers for body temperature measurement.
Software verification and validation:
Software documentation consistent with moderate level of concern is submitted in this 510(k). System validation testing presented in this 510(k) demonstrates that all software requirement specifications are met and all software hazards have been mitigated to acceptable risk levels.
Biocompatibility test:
The biocompatibility of the device was tested according to:
ISO 10993-5 Biological Evaluation of Medical Devices-Tests For In Vitro Cytotoxicity
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ISO 10993-10 Biological Evaluation of Medical Devices- Tests for Irritation and Skin Sensitization
Reprocessing: Cleaning and Disinfection
The subject device is a non-sterile device. The cleaning validation was performed according to the Instructions for Use.
8. Clinical accuracy validation
The clinical investigation report and data analysis met the requirements of the ASTM E 1965-98. The test report shows the three group's temperature readings difference between digital thermometer and the subject device, MD-H30 are within acceptable range. It can conclude that the Infrared Thermometer, Model MD-H30 is acceptable to measure human body's temperature.
9. Conclusion
Basing on the comparison and analysis above, the proposed device, Infrared Thermometer Model MD-H30 is determined to be Substantially Equivalent (SE) to the predicate device.