(127 days)
Not Found
No
The description focuses on standard infrared temperature measurement and display, with no mention of AI/ML algorithms for data processing or interpretation.
No
A therapeutic device is one that treats or heals a condition. This device is a thermometer, which measures temperature for diagnostic or monitoring purposes, but does not provide therapy.
Yes
The device is described as a "Non-Contact Infrared Thermometer" intended for "non-contact measuring of human body temperature." Measuring body temperature is a diagnostic function because it provides information about a person's health status. The device is used by doctors in a clinic setting.
No
The device description explicitly states it is a "handheld device" and a "hand-held forehead thermometer," indicating it is a physical hardware product that measures infrared energy.
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: This device measures human body temperature by detecting infrared heat emitted from the forehead. It does not analyze any biological samples taken from the body.
- Intended Use: The intended use is for non-contact measurement of human body temperature, which is a physical measurement, not a diagnostic test performed on a sample.
Therefore, while it is a medical device used for health monitoring, it does not fit the definition of an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
The Non-Contact Infrared Thermometer, Models JXB-315, JXB-320, JXB-311, is a non-sterile, reusable, handheld device. It can be used by consumers in household environment and doctor in clinic as reference. It is intended for non-contact measuring of human body temperature of people of all ages (neonate, infant, pediatric, adult) by detecting infrared heat from the center of the forehead.
Product codes (comma separated list FDA assigned to the subject device)
FLL
Device Description
The Non-contact Infrared Thermometer (include models JXB-315, JXB-320, JXB-311) is a hand-held forehead thermometer, and it is intended for the non-contact intermittent measurement and monitoring of forehead temperature of human body which measures the body temperature based on the infrared energy emitted from the forehead. It is indicated for use by people of all ages.
The thermometer is also intended to measure the object temperature. After measurement, the temperature is directly displayed on the LED screen.
These thermometers have the following features:
-
- Body temperature mode
-
- Fahrenheit and Celsius temperature unit setting
- LED display screen with automatic range selection, resolution is 0.1℃ (0.1℃) 3)
-
- Memorize the latest 32 measurement data
- LED display screen 5)
-
- Low battery indication
-
- Measurement distance indication
-
- Over range prompt (HI/LO)
-
- Auto shutdown when the device is idle for 30 seconds
-
- High temperature indication
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Infrared
Anatomical Site
Forehead
Indicated Patient Age Range
people of all ages (neonate, infant, pediatric, adult)
Intended User / Care Setting
consumers in household environment and doctor in clinic as reference.
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 was conducted in according to ISO 80601-2-56:2017+AMD2018. This clinical study is a randomization, simple blind homologous control, pairing design of clinical investigation, consisting of 150 subjects, of which 50 subjects are infants, 50 subjects are children, and the rest 50 subjects are adults (NOTE: Infants---newborn to one year; Children-- greater than one to five years; Adults---greater than five years old.). The clinical validation results demonstrated that the clinical data, represented by clinical bias and clinical repeatability met the acceptance criteria of the clinical validation protocol.
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
Image /page/0/Picture/0 description: The image contains the logos of the Department of Health & Human Services and the Food and Drug Administration (FDA). The Department of Health & Human Services logo is on the left, and the FDA logo is on the right. The FDA logo includes the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.
January 28, 2022
Guangzhou Berrcom Medical Device Co., Ltd. % Yoyo Chen Senior Consultant Shenzhen Joyantech Consulting Co., Ltd. 1713A, 17th Floor, Block A, Zhongguan Times Square, Liuxian Avenue, Xili Town, Nanshan District Shenzhen, Guangdong 518000 China
Re: K213082
Trade/Device Name: Non-contact Infrared Thermometer, Models JXB-315, JXB-319, JXB-311 Regulation Number: 21 CFR 880.2910 Regulation Name: Clinical Electronic Thermometer Regulatory Class: Class II Product Code: FLL Dated: December 14, 2021 Received: December 27, 2021
Dear Yoyo Chen:
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.
1
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.
Gang Peng for Payal Patel 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
2
Indications for Use
510(k) Number (if known) K213082
Device Name
Non-contact Infrared Thermometer, Models JXB-315, JXB-319, JXB-320, JXB-311
Indications for Use (Describe)
The Non-Contact Infrared Thermometer, Models JXB-315, JXB-320, JXB-311, is a non-sterile, reusable, handheld device. It can be used by consumers in household environment and doctor in clinic as reference. It is intended for non-contact measuring of human body temperature of people of all ages (neonate, infant, pediatric, adult) by detecting infrared heat from the center of the forehead.
Type of Use (Select one or both, as applicable)
Registration Under Part 107. FAA Rules & Regulations
Drone Flight Operation Under 107. FAA Rules & Regulations
| | Prescription Use (Part 21 CFR 801 Subpart D)
|X | Over-The-Counter Use (21 CFR 801 Subpart C)
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Image /page/3/Picture/0 description: The image shows the word "Berrcom" in blue font. The first letter "B" is stylized to look like a heart. The rest of the letters are in a simple, sans-serif font. The word is written in lowercase letters.
510(k) Summary
This summary of 510(K) safety and effectiveness information is submitted As Required by requirements of SMDA and 21 CFR §807.92.
1. Administrative Information
| Submission Date | December 14, 2021 |
|---|---|
| Manufacturer | |
| information | Guangzhou Berrcom Medical Device Co., Ltd. |
| Address: | |
| No.38 Huanzhen Xi Road, Dagang Town, Nansha, 511470, | |
| Guangzhou, Guangdong, PEOPLE'S REPUBLIC OF CHINA | |
| Contact person: Zhigang Du | |
| TEL: +86(20)34938449 | |
| E-Mail: dube888@berrcom.com | |
| Submission | |
| Correspondent | Shenzhen Joyantech Consulting Co., Ltd. |
| 1713A, 17th Floor, Block A, Zhongguan Times Square, Liuxian | |
| Avenue, Xili Town, Nanshan District, Shenzhen, Guangdong | |
| Province, China. | |
| Contact person: Ms.Yoyo Chen | |
| E-Mail: yoyo@cefda.com; field@cefda.com | |
| Image: Logo | |
| Establishment | |
| registration number | 3008395508 |
Device Information 2.
| Type of 510(k)
| Submission: | Traditional |
|---|---|
| Device Name: | Non-contact Infrared Thermometer |
| Models: | JXB-315, JXB-319, JXB-320, JXB-311 |
| Classification Name: | Thermometer, Electronic, Clinical |
| Review Panel: | General Hospital |
| Device Class: | 2 |
| Regulation Number: | 880.2910 |
| Product Code: | FLL |
3. Predicate Device
| Manufacturer: | BroadMaster Biotech, Corp. |
|---|---|
| Device Name: | Advocate Non-Contact Infrared Thermometer |
| Model: | EF001A |
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Image /page/4/Picture/0 description: The image shows the logo for Berrcom. The logo is in blue and features a stylized "B" that resembles a heart shape. The text "errcom" is written in a sans-serif font and is connected to the "B".
| 510(K) Number: | K180355 |
|---|---|
| Product Code: | FLL |
| Regulation Number: | 880.2910 |
| Device Class: | 2 |
Device Description 4.
The Non-contact Infrared Thermometer (include models JXB-315, JXB-320, JXB-311) is a hand-held forehead thermometer, and it is intended for the non-contact intermittent measurement and monitoring of forehead temperature of human body which measures the body temperature based on the infrared energy emitted from the forehead. It is indicated for use by people of all ages.
The thermometer is also intended to measure the object temperature. After measurement, the temperature is directly displayed on the LED screen.
These thermometers have the following features:
-
- Body temperature mode
-
- Fahrenheit and Celsius temperature unit setting
- LED display screen with automatic range selection, resolution is 0.1℃ (0.1℃) 3)
-
- Memorize the latest 32 measurement data
- LED display screen 5)
-
- Low battery indication
-
- Measurement distance indication
-
- Over range prompt (HI/LO)
-
- Auto shutdown when the device is idle for 30 seconds
-
- High temperature indication
5. Intended Use
The Non-Contact Infrared Thermometer, Models JXB-315, JXB-319, JXB-320, JXB-311, is a non-sterile, reusable, handheld device. It can be used by consumers in household environment and doctor in clinic as reference. It is intended for non-contact measuring of human body temperature of people of all ages (neonate, infant, pediatric, adult) by detecting infrared heat from the center of the forehead.
| Items | Subject Devices
(K213082) | Predicate Device
(K180355) | Comments |
|------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------|
| Product Code | FLL | FLL | Same |
| Regulation number | 880.2910 | 880.2910 | Same |
| Manufacturer | Guangzhou Berrcom Medical
Device Co., Ltd. | BroadMaster Biotech, Corp. | / |
| Indications for use | The Non-Contact Infrared
Thermometer, Models JXB-315,
JXB-319, JXB-320, JXB-311, is a
non-sterile, reusable, handheld | Advocate Non-Contact
Infrared Thermometer is a
non-sterile, reusable,
handheld device. It can be | Same |
| Items | Subject Devices
(K213082) | Predicate Device
(K180355) | Comments |
| | device. It can be used by consumers
in household environment and doctor
in clinic as reference. It is intended
for non-contact measuring of human
body temperature of people of all
ages (neonate, infant, pediatric,
adult) by detecting infrared heat from
the center of the forehead. | used by consumers in
homecare environment and
doctors in clinic as reference.
It is intended for measuring
human body temperature of
all ranges of people by
detecting infrared heat from
the forehead. | |
| Prescription/OTC | OTC use | OTC use | Same |
| Intended user | Lay user and professional | Lay user and professional | Same |
| Intended patient
population | Neonate, infant, pediatric, adult | Neonate, infant, pediatric,
adult | Same |
| Sensor | Thermopile | Thermopile | Same |
| Operational
principle | Infrared radiation detection | Infrared radiation detection | Same |
| Contact type | Non-contact use | Non-contact use | Same |
| Display type | LED display | LCD display | SE
(Note 1) |
| Measurement site | Forehead | Forehead | Same |
| Measurement
Range | $32.0°C ~ 43.0°C(89.6°F ~ 109.4°F)$ | $32.0°C43°C(89.6°F109.4°F)$ | Same |
| Measurement
accuracy | $32.0°C~ 34.9°C(89.6°F94.8°F) :±0.3°C(±0.6°F)$ | $34.0°C34.8°C(93.2°F94.8°F) :±0.3°C(±0.5°F)$ | SE 42.0°C(95°F
(Note 2) |
| | $35.0°C107.6°F):±0.2°C(±0.4°F);$ | $35.0°C42.0°C(95°F107.6°F):±0.2°C(±0.4°F);$ | | 43.0°C(107.8°F
| | $42.1°C109.4°F ):±0.3°C(±0.6°F)$ | $42.1°C43.0°C(107.8°F109.4°F ):±0.3°C(±0.5°F)$ | |40°C
| Measurement
distance | ≤3cm (1.2in) | 5-10 cm (2-3.94in) | SE
(Note 3) |
| Display resolution | 0.1°C (0.1°F) | 0.1°C (0.1°F) | Same |
| Power supply | DC 3V (2pcs AAA batteries) | DC 3V (2pcs AAA batteries) | Same |
| Measurement time | 1 second | 1 second | Same |
| Memory capacity | 32sets | 12 sets | SE
(Note 4) |
| Low battery | Yes | Yes | Same |
| Items | Subject Devices
(K213082) | Predicate Device
(K180355) | Comments |
| indication | | | |
| Degree of protection | IP22 | IP20 | SE
(Note 5) |
| Auto-off time | 30s | 60s | SE
(Note 6) |
| Operation Condition | Temperature: 10°C
Relative Humidity: ≤85%,
Atmospheric Pressure:
70kPa106kPa | Temperature: 10°C40°C
Relative Humidity: ≤80%
Atmospheric Pressure:
70kPa106kPa | SE55°C
(Note 7) |
| Storage and
transportation
condition | Temperature: -20°C
Relative Humidity: ≤95%RH,
noncondensing
Atmospheric Pressure:
70kpa106kpa | Temperature: -20°C55°C
Relative Humidity: ≤95%RH,
Atmospheric Pressure:
70kpa~106kpa | Same |
| Materials of skin-
contacting
components | ABS, PC | Enclosure of red &black ABS,
LCD Lens of PMMA and
Probe of Metals | SE
(Note 8) |
| Biocompatibility | Comply with
ISO10993-5:2009 &
ISO10993-10:2010 | Comply with
ISO10993-5:2009 &
ISO10993-10:2010 | Same |
| Electrical safety | IEC 60601-1 | IEC 60601-1 | Same |
| EMC | IEC60601-1-2 | IEC60601-1-2 | Same |
| Performance | ASTM E1965-98
ISO80601-2-56 | ASTM E1965-98
ISO80601-2-56 | Same |
6. Comparison with predicate device
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Image /page/5/Picture/0 description: The image shows the word "Derrcom" in a stylized, sans-serif font. The word is rendered in a blue color. The "D" in "Derrcom" is stylized with a heart shape.
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Image /page/6/Picture/0 description: The image shows the word "Berrcom" in blue font. The "B" is stylized with a heart shape on the left side. The rest of the letters are in lowercase and connected in a cursive style. The overall design is simple and clean.
Note 1: Display type
The subject device meets the basic safety requirement of IEC 60601-1:2005+AMD 1: 2012, and IEC 60601-1-11. The difference does not raise any issues on the device safety and effectiveness.
Note 2: Measurement Accuracy
The measurement accuracy of subject devices in the range of 34°C to 43°C is same with predicate device, and the measurement accuracy of subject device still compiles with the requirement of ASTM E1965-98 and ISO 80601-2-56 standard. This difference does not raise any issues on the device safety and effectiveness.
Note 3: Measurement distance
The performance of subject device within the specified measurement distance compiles with the requirement of ASTM E1965-98 and ISO 80601-2-56 standard. This difference does not raise any issues on the device safety and effectiveness.
Note 4: Memory capacity
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Image /page/7/Picture/0 description: The image shows the word "Berrcom" in blue font. The first letter "B" is stylized with a heart shape on the left side. The rest of the letters are in lowercase and connected to each other. The image appears to be a logo or brand name.
urpose of function of measurement data memories is intended to store and view the previous readings. This function has been verified during software verification, and the performance testing shows that the subject device complies with performance standard ISO 80601-2-56 and ASTM E1965-98. The difference does not raise any issues on the device safety and effectiveness.
Note 5: Degree of protection
The subject device complies with the requirement of IEC60601-1, ASTM E1965-98 and ISO 80601-2-56 standard. The difference does not raise any issues on the device safety and effectiveness.
Note 6: Auto-off time
Although the time of auto-off time is shorter than predicate device, but both of subject devices and predicate device are meet the basic safety requirement of IEC 60601-1, and IEC 60601-111. The difference does not raise any issues on the device safety and effectiveness.
Note 7: Operation Condition
The operation condition of the subject device is tested and validated to meet the requirement of ASTM E1965-98 and ISO80601-2-56. The difference does not raise any issues on the device safety and effectiveness.
Note 8: Materials of skin-contacting components
The biocompatibility tests have conducted on the finished device to demonstrate that the subject device did not have any potential toxicity, skin sensitization and skin irritation during normal use. The difference does not raise any issues on the device safety and effectiveness.
7. Non-Clinical Test Summary
7.1. Electromagnetic Compatibility and Electrical Safety Test
The subject device meets the following standards:
-
- ANSI AAMI ES60601-1:2005/(R)2012 and A1:2012, C1:2009/(R)2012 and A2:2010/(R)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 disturbances - Requirements and tests
-
- 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
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Image /page/8/Picture/0 description: The image shows the word "Berrcom" in a stylized, sans-serif font. The word is rendered in a dark blue color. The "B" in "Berrcom" is designed with a rounded shape that resembles a heart or a stylized leaf, adding a unique visual element to the logo. The rest of the letters are more conventional, but still maintain a rounded and modern appearance.
patibility Test
The subject device has passed biocompatibility tests in according to following standards.
-
- ISO 10993-5:2009 Biological evaluation of medical devices - Part 5: Tests for in vitro cytotoxicity
-
- ISO 10993-10:2010 Biological evaluation of medical devices - Part 10: Tests for irritation and skin sensitization
7.3. Performance Test-Bench
The subject device has passed performance tests in according to following standards.
- ISO 80601-2-56:2017+AMD2018 Medical electrical equipment Part 2-56: Particular 1) requirements for basic safety and essential performance of clinical thermometers for body temperature measurement
-
- ASTM E1965-98 (Reapproved 2016) Standard Specification for Infrared Thermometers for Intermittent Determination of Patient Temperature
7.4. Software Verification and Validation
Software documentation consistent with moderate level of concern was submitted in this 510(k). System validation testing presented in this 510(k) demonstrated that all software requirement specifications are met, and all software hazards have been mitigated to acceptable risk levels.
8. Clinical Accuracy Validation
Clinical accuracy validation was conducted in according to ISO 80601-2-56:2017+AMD2018. This clinical study is a randomization, simple blind homologous control, pairing design of clinical investigation, consisting of 150 subjects, of which 50 subjects are infants, 50 subjects are children, and the rest 50 subjects are adults (NOTE: Infants---newborn to one year; Children-- greater than one to five years; Adults---greater than five years old.). The clinical validation results demonstrated that the clinical data, represented by clinical bias and clinical repeatability met the acceptance criteria of the clinical validation protocol.
9. Conclusion
The subject devices Non-contact Infrared Thermometer (Models: JXB-315, JXB-319, JXB-320, JXB-311) is substantially equivalent to the predicate device (K180355). This conclusion is based upon comparison on intended use, technological characteristics and applicable safety standards. Any difference in the technological characteristics does not raise any new issues or concerns of safety or effectiveness.