(246 days)
The Infrared thermometer Model PC868 can measure body temperature from the forehead of infants and adults without contact to the human body, it can be used by consumers in household environment and by doctors in the clinic.
All objects above absolute zero temperature emits certain percentage of infrared radiation energy based on its temperature. The amount of the radiation energy and the distribution of the wavelength have very closely relationship. When human forehead's temperature in 36-37°C, it emits wavelength 9-13um of infrared radiation. Based on this principle, according to the relationship between surface forehead temperature, we are able to measure the human forehead's actual temperature through measuring surface forehead temperature. Therefore, the subject device is able to measure the temperature of a person by the energy the person emits. The predicate device KI-8280, use the same detection principle to measure the patient's temperature.
These thermometers are a kind of measurement device that utilize infrared radiation to measure forehead and object temperature. The Infrared Thermometers main function as following:
- Forehead and object temperature measure functions
- Have wide range of temperature readings: from 32.0°Cto 42.9°C
- The big LCD display can clear showing the measure result.
- Have memory function
- Low battery indicator
- Have backlight function
- Have ambient temperature detection function
The power supply of Infrared Thermometer is DC 3.0 V, which is offered by two AAA batteries.
This thermometer uses thermopile as the temperature sensor. The enclosure cover is made of ABS plastic material. The thermometer mainly includes the following components: MCU, PCB, LCD, Infrared Sensor, Probe, Batteries, Buzzer, Backlight and Enclosure Cover.
There are only one patient contacting materials: ABS plastic. The material also meet the test requirements of ISO10993-5 (In vitro cytotoxicity) and ISO10993-10 (Irritation and delayedtype hypersensitivity).
The subject device of PC868 also use the focusing design to collect the infrared emitted from nearby area of object surface. This mechanism make the subject device have the ability to detect the object surface temperature.
The compact, small and light-weight design, the Shenzhen Pacom Medical Instruments Co., Ltd. Infrared Thermometer, model PC868, enables to provide safe and reliable result and offers a very good clinical accuracy for human body temperature measurements.
The document describes the regulatory submission for the Infrared Thermometer, Model PC868. This device is a non-contact infrared thermometer intended to measure body temperature from the forehead of infants and adults. The acceptance criteria and the study proving the device meets these criteria are detailed, primarily through a comparison to a predicate device (K-jump Health Co., Ltd.'s Non-contact Infrared Thermometer, model KI-8280, K102947) and adherence to recognized standards.
Here's a breakdown of the requested information based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The primary acceptance criterion for the PC868 thermometer, especially for clinical performance, is compliance with ASTM E 1965-98 (Standard Specification for Infrared Thermometers for Intermittent Determination of Patient Temperature). This standard sets the requirements for accuracy.
| Acceptance Criteria Category | Specific Criterion (Standard/Requirement) | Reported Device Performance (PC868) |
|---|---|---|
| Clinical Performance | ASTM E 1965-98 compliance | Conforms. Clinical performance test protocol and data analysis followed ASTM E 1965-98. |
| Temperature Accuracy | ASTM E 1965-98 for Forehead Mode | ±0.2°C (0.4°F) during 35.5°C-42.0°C (95.9°F-107.6°F) |
| ±0.3°C (0.5°F) for other ranges | ||
| ASTM E 1965-98 for Surface Mode | ±1.0°C (1.8°F) during 15.0°C-60.0°C (59°F-140°F) | |
| ±2.0°C (3.6°F) for other ranges | ||
| Electrical Safety | IEC 60601-1 | Conforms |
| Electromagnetic Compatibility (EMC) | IEC 60601-1-2 | Conforms |
| Home Healthcare Environment | IEC 60601-1-11 | Conforms |
| Biocompatibility | ISO 10993-1, ISO 10993-5 (In vitro cytotoxicity), ISO 10993-10 (Irritation and delayed-type hypersensitivity) | Conforms (only patient contacting material is ABS plastic, which met these test requirements) |
| Software | IEC 62304 | Conforms |
| Risk Management | ISO 14971 | Conforms |
| Measurement Range | Forehead: 32.0°C to 42.9°C (89.6°F-107.9°F) | Met. |
| Surface: 0°C to 100°C (32°F-212°F) | Met. | |
| Measurement Distance | Implied by ASTM E 1965 and clinical test | 3-5cm (predicate was 3-8cm, deemed similar and compliant with standard) |
2. Sample Size Used for the Test Set and Data Provenance
The document states, "The clinical performance test protocol and data analysis is followed the requirements the ASTM E 1965-98." However, it does not explicitly state the sample size for the clinical test (test set) or the data provenance (e.g., country of origin, retrospective or prospective). ASTM E 1965-98 specifies the number of subjects and measurements required for clinical accuracy testing (typically a minimum of 20 subjects). While the submission states "conforms to applicable standards," the specific details of the test population are not provided in this excerpt.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
This type of device (infrared thermometer) measures a physical quantity (temperature). The "ground truth" for temperature measurement in a clinical test is typically established using a calibrated reference thermometer, not human experts' subjective interpretations. Therefore, no "experts" (like radiologists) were used to establish ground truth in the way one might for an imaging AI device. The accuracy is assessed by comparing the device's readings against a highly accurate reference.
4. Adjudication Method for the Test Set
Not applicable. As described above, the ground truth is a physical measurement against a reference standard, not a subjective interpretation requiring adjudication.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No MRMC comparative effectiveness study was done for this device. Infrared thermometers are not devices that require human readers to interpret outputs in the same way as medical imaging (e.g., X-rays, MRI). The device provides a direct temperature reading. The study primarily focused on the device's standalone performance and comparison to a predicate device's specifications and relevant industry standards.
6. Standalone Performance
Yes, a standalone performance study was done. The document explicitly states the device's performance metrics, such as accuracy and measurement range, and confirms its adherence to standards like ASTM E 1965-98, IEC 60601-1, and IEC 60601-1-2. The "Performance Summary" table (Section 6.0) confirms that various performance aspects were evaluated and found to conform to recognized consensus standards.
7. Type of Ground Truth Used
The ground truth used for this type of device is direct physical measurement comparison against a calibrated reference standard. For clinical accuracy, this means comparing the thermometer's readings to core body temperature (or a proxy for it, as per ASTM E 1965-98, often oral or rectal temperature measured by highly accurate reference thermometers) in a controlled clinical environment.
8. Sample Size for the Training Set
This document pertains to a medical device's conformity assessment and 510(k) submission, not an AI/ML device where a "training set" would be relevant for model development. The device is a traditional electronic thermometer, not an AI algorithm. Therefore, the concept of a "training set" for an algorithm is not applicable to this device.
9. How the Ground Truth for the Training Set Was Established
As stated above, this question is not applicable because the device is a traditional electronic thermometer and does not involve AI/ML with a training set.
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May 25, 2018
Shenzhen Pacom Medical Instruments Co., Ltd. Liangzhou Zhong Manager 8 Floor, B District, B Building, No. 5 Industry Five Road, Jianbian Community Songgang, Shenzhen, 518105 CHINA
Re: K172889
Trade/Device Name: Infrared Thermometer Regulation Number: 21 CFR 880.2910 Regulation Name: Clinical Electronic Thermometer Regulatory Class: Class II Product Code: FLL Dated: April 16, 2018 Received: April 16, 2018
Dear Liangzhou Zhong:
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. Iisting 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); 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.
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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Tina Kiang
-s
Tina Kiang, Ph.D. Acting Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control, and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known): _K172889
Device Name: Infrared Thermometer, Model: PC868
Indications for Use:
The Infrared thermometer Model PC868 can measure body temperature from the forehead of infants and adults without contact to the human body, it can be used by consumers in household environment and by doctors in the clinic.
Prescription Use (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (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)
Page 1 of 1
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510(k) Summary
This summary of 510(K) information is being submitted in accordance with the requirements of SMDA and 21 CFR §807.92.
The assigned 510(k) number is: K172889
1.0 Information of Submitter and Correspondent
Submitter's information:
Shenzhen Pacom Medical Instruments Co., Ltd. Address: On the 8tt floor of B District, B Building, No.5, Industry five road, Jianbian Community, Songgang, Shenzhen 518105, China. Phone:+86-755-32920339 Fax: +86-755-32920339 Contact Person: Mr.Zhong E-mail: reanny@reanny.com
Submission contact information:
Shenzhen Reanny Medical Devices Management Consulting Co., Ltd
Address: Room 2012#, Gebu commercial building, Hongxing community, Songgang street, Baoan district, Shenzhen 518000, China
Contact Person: Reanny Wang; E-mail: reanny@reanny.com
2.0 Device Information
| Type of 510(k) submission: | Traditional |
|---|---|
| Trade Name: | Infrared Thermometer, Model: PC868 |
| Model: | PC868 |
| Classification name: | thermometer, electronic, clinical General |
| Review Panel: | Hospital |
| Product Code: | FLL |
| Device Class: | II |
| Regulation Number: | 880.2910 |
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3.1 Predicate Device Information
| Sponsor: | K-jump Health Co., Ltd. |
|---|---|
| Device: | Non-contact Infrared Thermometer, model KI-8280 |
| 510(K) Number: | K102947 |
4.0 Device Description
All objects above absolute zero temperature emits certain percentage of infrared radiation energy based on its temperature. The amount of the radiation energy and the distribution of the wavelength have very closely relationship. When human forehead's temperature in 36-37°C, it emits wavelength 9-13um of infrared radiation. Based on this principle, according to the relationship between surface forehead temperature, we are able to measure the human forehead's actual temperature through measuring surface forehead temperature. Therefore, the subject device is able to measure the temperature of a person by the energy the person emits. The predicate device KI-8280, use the same detection principle to measure the patient's temperature.
These thermometers are a kind of measurement device that utilize infrared radiation to measure forehead and object temperature. The Infrared Thermometers main function as following:
- Forehead and object temperature measure functions
- Have wide range of temperature readings: from 32.0°Cto 42.9°C
- The big LCD display can clear showing the measure result.
- Have memory function
- Low battery indicator
- Have backlight function ロ
- Have ambient temperature detection function
The power supply of Infrared Thermometer is DC 3.0 V, which is offered by two AAA batteries.
This thermometer uses thermopile as the temperature sensor. The enclosure cover is made of ABS plastic material. The thermometer mainly includes the following components: MCU, PCB, LCD, Infrared Sensor, Probe, Batteries, Buzzer, Backlight and Enclosure Cover.
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There are only one patient contacting materials: ABS plastic. The material also meet the test requirements of ISO10993-5 (In vitro cytotoxicity) and ISO10993-10 (Irritation and delayedtype hypersensitivity).
The subject device of PC868 also use the focusing design to collect the infrared emitted from nearby area of object surface. This mechanism make the subject device have the ability to detect the object surface temperature.
The compact, small and light-weight design, the Shenzhen Pacom Medical Instruments Co., Ltd. Infrared Thermometer, model PC868, enables to provide safe and reliable result and offers a very good clinical accuracy for human body temperature measurements.
Power requirements:
d.c.3V,twoAAbatteries,meetstherequirementsofUL544
Sterilization information: Theinfraredthermometerisnotsoldsterile
Temperaturerange: Forforeheadmode: 32.0℃to42.9℃; For surface mode: 0℃ to 100℃
Ambient temperature environment: Temperature: 10°C-40°C; Relative humidity: 15%-85%RH; Atmospheric pressure: 70-106KPa
Storageenvironment: Temperature:0°C-50°C;Relativehumidity:15%-85%RH; Atmospheric pressure:70-106KPa
Accuracyandrepeatability: For forehead mode: ±0.2℃(0.4℃)during35.5℃-42.0℃;(95.9℃-107.6℃) ±0.3℃(0.5℃(0.5℃)otherranges; For surface mode: ±1.0℃(1.80F)during15.0℃-60.0℃(59°F-140°F);
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Sponsor: Shenzhen Pacom Medical Instruments Co., Ltd.
Infrared Thermometer, model: PC868 Subject Device:
±2.0°C(3.6°F)otherranges;
Othercapabilities:
- a) LCDdisplaywithcolorchangingbacklight
- b) ReadstemperatureinFahrenheitorcentigrade
- Automatic power saving in 15 seconds c)
- d) Automaticallysaveslast99readings
- e) BatteryLifespangreaterthan1000reads,replaceablebatteries
5.0 Intended Use
The Infrared thermometer Model PC868 can measure body temperature from the forehead ofinfantsand adultswithoutcontacttothehumanbody.itcanbeusedbyconsumersin householdenvironmentandbydoctorsin theclinic.
6.0 Performance Summary
The devices conform to applicable standards as follow table:
| Item | Description | FDA recognizedconsensusstandards | Justification |
|---|---|---|---|
| Safety | IEC 60601-1 | Yes | Conform |
| EMC | IEC 60601-1-2 | Yes | Conform |
| Home healthcareenvironment | IEC 60601-1-11 | Yes | Conform |
| Performance | ASTM E 1965-98ISO 80601-2-56 | Yes | Conform |
| Biocompatibilityevaluation | ISO 10993-1 | Yes | Conform |
| Biocompatibility test | ISO 10993-5ISO 10993-10 | Yes | Conform |
| Software | IEC 62304 | Yes | Conform |
| Risk management | ISO 14971 | Yes | Conform |
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Subject Device: Infrared Thermometer, model: PC868
7.0 Comparison to predicate device and conclusion
The subject device is substantially equivalent to predicate devices, K102947, KI-8280. The substantial equivalence chart is provided as follows:
| Elements ofComparison | Predicate Device | Subject Device | Judgment |
|---|---|---|---|
| Models | KI-8280 | PC868 | -- |
| Company | K-jump Health Co., Ltd. | Shenzhen Pacom MedicalInstruments Co., Ltd. | -- |
| Device Name | Non-Contact InfraredThermometer | Infrared Thermometer | -- |
| 510(k) Number | K102947 | Pending | -- |
| Intended use | The non-contact infraredthermometer, Model KI-8280, can measure bodytemperature for infants andadults without contact tohuman body, it can be usedby consumers in householdenvironment and doctor inclinic as reference. | The thermometers are intendedto measure forehead temperaturewithout contact at home orhospital, including anyone, suchas infants, children and adults. | Similar |
| Sensor | Infrared Sensor | Infrared Sensor | Same |
| Measurementmethod | Infrared radiation detection | Infrared radiation detection | Same |
| Measurementmode | Forehead and surfacemeasure mode | Forehead and surface measuremode | Same |
| Measurementrange | Forehead mode:32.2°C-43.3°C (90.0°F-109.9°F);Surface mode:0.0°C-100°C (32°F -212°F); | For forehead mode:32.0°C to 42.9°C (89.6°F-107.9°F);For surface mode:0°C to 100°C (32°F-212°F) | SimilarNote 1 |
| Measuringaccuracy | Forehead mode:±0.2°C(0.4°F);Surface mode:±1°C(1.8°F) | For forehead mode:± 0.2 °C (0.4°F) during 35.5 °C -42.0°C; (95.9°F-107.6°F)±0.3°C (0.5°F) other ranges;For surface mode:± 1.0°C (1.8°F) during 15.0 °C -60.0°C (59°F-140°F);±2.0°C(3.6°F) other ranges; | SimilarNote 2 |
| Elements ofComparison | Predicate Device | Subject Device | Judgment |
| Models | KI-8280 | PC868 | -- |
| Displayresolution | 0.1°C/0.1°F | 0.1°C/0.1°F | Same |
| Response Time | 1 second | 1 second | Same |
| Signal outputand display | LCD, Buzzer | LCD, Buzzer | Same |
| C/F switchable | Yes | Yes | Same |
| Measurementdistance | 3-8cm | 3-5cm | SimilarNote 3 |
| Memory | 10 sets | 99sets | SimilarNote 4 |
| Power supply | Two 1.5V AAA batteries | Two 1.5V AAA batteries | Same |
| Low batteryindication | Yes | Yes | Same |
| Waterproof | No | IP22 | SimilarNote 5 |
| Hightemperaturehint | Higher than 38°C(100.4°F) | Higher than 38°C(100.4°F) | Same |
| Operationenvironment | Temperature:10.0°C | Temperature:10.0°C | SimilarNote 6 |
| Storageenvironment | Temperature:-25.0°C | Temperature: 0°C-50°C(32.0°F~122.0°F);Relative humidity: 15%-85%RH; | SimilarNote 6 |
| Dimension | 138×90×45mm | 149×95×45mm | Similar |
| Weight | 125g (including batteries) | 140g (including batteries) | Similar |
| Performance | Compliance with ASTM E1965-98 | Compliance with ASTM E1965- 98 | Same |
| Biocompatibility | All the patient contactingmaterials are compliancewith ISO 10993-1/-5/-10 | All the patient contactingmaterials are compliancewith ISO 10993-1/-5/-10 | Same |
| Electrical Safety | Compliance with IEC60601-1 | Compliance with IEC 60601-1 | Same |
| EMC | Compliance with IEC | Compliance with IEC 60601-1-2 | Same |
| Elements ofComparison | Predicate Device | Subject Device | Judgment |
| Models | KI-8280 | PC868 | -- |
| 60601-1-2 |
Chapter 9, Page 5 of 8
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Shenzhen Pacom Medical Instruments Co., Ltd. Sponsor:
Infrared Thermometer, model: PC868 Subject Device:
Chapter 9, Page 6 of 8
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Shenzhen Pacom Medical Instruments Co., Ltd. Sponsor:
Subject Device: Infrared Thermometer, model: PC868
Note 1 and note2 :
Although the measurement range and measuring accuracy of subject devices are different from predicate device, they both comply with the ASTM E 1965 standard, so the difference will not raise different safety or effectiveness issue.
Note2 :
Although the measurement distance of subject devices is different than predicate device, they both comply with the ASTM E 1965 standard and clinical test, so the difference will notraise different safety or effectiveness questions.
Note 3:
Although the measurement distance of subject devices is different than predicate device, they both comply with the ASTM E 1965 standard and clinical test, so the difference will not raise different safety or effectiveness questions.
Note 4:
The memory of subject devices is less than predicate device, but they both comply with the ASTME 1965 standard, so the difference will not raise different safety or effectiveness questions.
Note 5:
The Waterproof of subject devices is IP22 and this have pass the IEC60601-1 test, will notraise different safety or effectiveness questions.
Note 6:
The Storage environment of subject devices is less than predicate device, but they both comply with the ASTM E 1965 and IEC 60601-1 standard, so the difference will not raise different safety or effectiveness questions.
Final Conclusion:
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The subject devices have all features of the predicate device. The few differences do not affect the substantial equivalence of the subject devices.
Thus, the subject devices are substantially equivalent to the predicate device.
8.0 Discussion of Clinical Tests Performed
The clinical performance test protocol and data analysis is followed the requirements the ASTM E 1965-98. It can conclude that the Thermometer, PC868 is acceptable to measure patient's temperature.
9.0 Conclusions
Infrared Thermometer, Model PC868 has the same intended use and similar characteristics as the predicate device. Moreover, the subject device demonstrates product safety by successful completion of testing to the IEC 60601-1 standard and electromagnetic standard IEC 60601-1-2. The performance test demonstrates the PC868 meets the ASTM E 1965-98 and concludes that any differences in their characteristics does not raise different questions of safety and effectiveness.
Form the above information we conclude the subject device. PC868 is substantially equivalent to the predicate devices.
10.0 Summary prepared date
May 10, 2018
§ 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.