(244 days)
Not Found
No
The summary describes a standard digital thermometer that connects to a mobile app for display and historical data. There is no mention of AI, ML, or any complex algorithms beyond basic temperature measurement and data storage.
No
The device is a digital thermometer, which measures temperature but does not provide therapy or treatment.
Yes
The device is a digital thermometer, which measures oral temperature. Measuring a physiological parameter like temperature falls under the definition of a diagnostic device, as it provides information about the state of the human body that can be used to aid in the diagnosis or monitoring of medical conditions.
No
The device description explicitly states it consists of two parts: a thermometer probe (hardware) and a mobile application (software). The probe is a physical, battery-powered unit with a sensor.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body (like blood, urine, tissue) to provide information about a person's health. These tests are performed outside the body.
- Device Function: The Digital Thermometer measures oral temperature directly from the human body. It does not analyze samples taken from the body.
- Intended Use: The intended use is to measure oral temperature, which is a direct physiological measurement, not an in vitro test.
The information provided clearly describes a device that measures a physical parameter (temperature) directly from the patient, which falls under the category of a general medical device, not an IVD.
N/A
Intended Use / Indications for Use
The Digital Thermometer is intended to measure oral temperature of human body. It can be used in home environment or at a doctor's clinic. It is indicated for use by people of all ages.
Product codes (comma separated list FDA assigned to the subject device)
FLL
Device Description
The Digital Thermometer consists two parts. The thermometer probe part is a compact, small, light-weight, and battery-powered unit with thermometer sensor for oral temperature measurements. The thermometer probe must be connected to a compatible mobile phone device through its headphone jack for displaying measured temperatures.
The mobile application could be conducted for operation and display temperature measurement when the Digital Thermometer connects with mobile device. The mobile application can be conducted on iOS operating system and Android operating system of mobile device.
The mobile application could perform the functionality on mobile device screen including measurement activity, historical data activity, trend activity, basic setting and initial setting activity.
Mentions image processing
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Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
oral
Indicated Patient Age Range
people of all ages
Intended User / Care Setting
home environment or at a doctor's clinic
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
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
The performance of the Digital Thermometer is verified and validated to comply with following recognized standards and does not raise any safety and effectiveness issues.
-
- AAMI / ANSI 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
The Digital Thermometer complies with to applicable ANSI/AAMI ES60601-1 requirements including general requirements, protection against electrical hazards, protection against mechanical hazards, protection against excessive temperatures, hazardous situations and fault conditions, and constructions.
- AAMI / ANSI 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
-
- AAMI / ANSI/ IEC 60601-1-2:2014 Medical Electrical Equipment Part 1-2: General Requirements for Basic Safety and Essential Performance - Collateral Standard: Electromagnetic Compatibility - Requirements and Tests
The Digital Thermometer complies with applicable ANSI/AAMI/IEC 60601-1-2 requirements including radiated emission test, electrostatic discharge immunity test, radiated RF electromagnetic field immunity test, and power frequency magnetic field immunity test.
- AAMI / ANSI/ IEC 60601-1-2:2014 Medical Electrical Equipment Part 1-2: General Requirements for Basic Safety and Essential Performance - Collateral Standard: Electromagnetic Compatibility - Requirements and Tests
-
- ASTM E1112-00 (Reapproved 2011), Standard Specification for Electronic Thermometer for Intermittent Determination of Patient Temperature
The Digital Thermometer complies applicable ASTM E1112 requirements including displayed temperature range, maximum permissible laboratory error, ambient conditions for operation and storage, human interface and mechanical test.
- ASTM E1112-00 (Reapproved 2011), Standard Specification for Electronic Thermometer for Intermittent Determination of Patient Temperature
-
- Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices
The Digital Thermometer complicable the guidance requirements including level of concern, software description, software requirements specification, architecture design chart, software design specification, verification and validation documentation.
- Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices
-
- Biocompatibility:
AAMI / ANSI / ISO 10993-1:2009(R)2013 Biological Evaluation of Medical Devices - Part 1: Evaluation and Testing Within a Risk Management Process;
AAMI / ANSI / ISO 10993-5:2009(R)2014 Biological Evaluation of Medical Devices - Part 5: Tests for In Vitro Cytotoxicity and
AAMI / ANSI / ISO 10993-10:2010(R)2014 Biological Evaluation of Medical Devices - Part 10: Tests for Irritation and Skin Sensitization
The Digital Thermometer complies applicable biocompatibility requirements and the device met the endpoints for cytotoxicity, sensitization & irritation-negligible
- Biocompatibility:
The Digital Thermometer is verified and validated by evaluating safety, EMC, device-specific standard ASTM E1112-00, software validation and biocompatibility testing without raising any safety and effectiveness issues.
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/1 description: The image shows the logo for K-Jump. The logo is written in a stylized, sans-serif font, and the color is blue. The "K" and "jump" are connected, and there is a registered trademark symbol to the right of the word "jump".
510(k) Summary
1. Submitter
K-jump Health Co., Ltd.
No. 56, Wu Kung 5th Rd. New Taipei Industrial Park New Taipei City 24890, Taiwan
Contact person: JM Lin, Regulatory Affairs Representative +886-2-2299-1378 ext. 237 Phone: Fax: +886-2-2299-1385 Email: jm@kjump.com.tw
Date Prepared: January 25, 2017
2. Name of Device
Trade Name: Digital Thermometer, Model 2180 Common/Usual Name: Digital Thermometer Regulation Number: 21 CFR 880.2910 Classification Name: Clinical electronic thermometer Regulatory Class: II Product Code: FLL
3. Predicate Device
| Device Name | 510(k) Number | Decision Date |
|---|---|---|
| K-jump Health Co., Ltd. | ||
| Basal Digital Thermometer | K141505 | 8/26/2014 |
This predicate has not been subject to a design-related recall.
1
4. Device Description
The Digital Thermometer consists two parts. The thermometer probe part is a compact, small, light-weight, and battery-powered unit with thermometer sensor for oral temperature measurements. The thermometer probe must be connected to a compatible mobile phone device through its headphone jack for displaying measured temperatures.
The mobile application could be conducted for operation and display temperature measurement when the Digital Thermometer connects with mobile device. The mobile application can be conducted on iOS operating system and Android operating system of mobile device.
The mobile application could perform the functionality on mobile device screen including measurement activity, historical data activity, trend activity, basic setting and initial setting activity.
5. Indications for Use
The Digital Thermometer is intended to measure oral temperature of human body. It can be used in home environment or at a doctor's clinic. It is indicated for use by people of all ages.
6. Technological Characteristics
The Digital Thermometer uses a thermistor sensor to detect the thermal energy from human body. The sensor in the thermometer detects temperature change and transfers to the proper electronic signal. The electronic signal could be received and converted to the temperature reading. The measured data will be displayed on the screen of a mobile device. The technological characteristics of Digital Thermometer have no significant difference with predicate device.
7. Comparison of technological characteristics with Predicate Device
2
Image /page/2/Picture/1 description: The image shows the logo for K-Jump. The logo is written in a stylized blue font. There is a registered trademark symbol to the right of the word jump.
The Digital Thermometer is substantially equivalent to the predicate devices, K141505, the Basal Digital Thermometer. The comparison of their technological characteristics is summarized in the table below.
| Characteristics | Digital Thermometer | Basal Digital Thermometer |
|---|---|---|
| 510(k) Number | K170262 | K141505 |
| Intended Use | Similar | Similar |
| Technology | ||
| Measurement method | Thermistor detection | Thermistor detection |
| Feature | Compatible with iOS / Android | |
| Mobile Device via headphone jack | ||
| connection | ||
| Measured data display on the | ||
| screen of mobile device | Compatible with iOS/Android | |
| Mobile Device via | ||
| headphone/NFC connection | ||
| Measured data transfer to | ||
| mobile device | ||
| Function | ||
| Measuring Range | 32.0°C~43.9°C | 32.00°C~43.90°C |
| C/F Switchable | Yes | Yes |
| Performance | ||
| Display | 3 1/2 digits | |
| on the screen of a mobile device | 4 1/2 digits | |
| on the LCD of medical device | ||
| Display Resolution | 0.1°C (°F) | 0.01°C (°F) |
| Measuring accuracy | ±0.1°C (35.5°C to 42.0°C); | |
| ±0.2°C (other range) | ±0.1°C (34.00°C to 42.00°C); | |
| ±0.2°C (other range) | ||
| Low battery detection | Yes | Yes |
| Memory | 1 set memory | 40 set memory |
| Environmental | ||
| Operating condition | 10°C~40°C (50 ~ 104°F) | |
| 15%-95% RH | 5°C~40°C (41.0 ~ 104°F) | |
| 15%-95% RH | ||
| Storage condition | -20°C ~50°C (-4.0 ~ 122°F) | |
| 15%-95% RH | -25°C ~55°C (-13.0 ~ 131°F) | |
| 15%-95% RH |
3
Image /page/3/Picture/1 description: The image shows the logo for K-Jump. The logo is blue and features a stylized "K" with a dot above it, resembling a person jumping. The word "Jump" is written in a cursive font next to the "K", and there is a registered trademark symbol next to the word "Jump".
| Characteristics | Digital Thermometer | Basal Digital Thermometer | |
|---|---|---|---|
| Material | Component materials | Stainless Steel, | |
| Acrylonitrile butadiene styrene | Stainless Steel, | ||
| Acrylonitrile butadiene styrene | |||
| Biocompatibility | No Cytotoxicity | ||
| No Sensitization & | |||
| Irritation-negligible | No Cytotoxicity | ||
| No Sensitization & | |||
| Irritation-negligible | |||
| Power | Internal power | ||
| (one SR41 battery) | Internal power | ||
| (one CR2032 battery) | |||
| Physical | Dimensions | 87.5 x 14.2 x 8.7 mm | 125.5 x 34 x 9.6 mm |
| Weight | 6g (with battery) | 24g (with battery) |
> Discussion of Main Differences:
The Digital Thermometer connects to the mobile device through headphone jack. The measured data will be displayed on the screen of a mobile device. The predicate device could display measured data on the device and transfer measured data to a mobile device.
While connected with mobile device, the usage of Digital Thermometer is identical to the predicate device. Risk analysis, software validation and associated verification have been performed and demonstrated that the display feature of the subject device is acceptable;
8. Performance Summary
The performance of the Digital Thermometer is verified and validated to comply with following recognized standards and does not raise any safety and effectiveness issues.
-
- AAMI / ANSI 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
4
Image /page/4/Picture/1 description: The image shows the logo for K-Jump. The logo is written in a stylized blue font. There is a registered trademark symbol to the right of the word jump.
The Digital Thermometer complies with to applicable ANSI/AAMI ES60601-1 requirements including general requirements, protection against electrical hazards, protection against mechanical hazards, protection against excessive temperatures, hazardous situations and fault conditions, and constructions.
-
- AAMI / ANSI/ IEC 60601-1-2:2014 Medical Electrical Equipment Part 1-2: General Requirements for Basic Safety and Essential Performance - Collateral Standard: Electromagnetic Compatibility - Requirements and Tests
The Digital Thermometer complies with applicable ANSI/AAMI/IEC 60601-1-2 requirements including radiated emission test, electrostatic discharge immunity test, radiated RF electromagnetic field immunity test, and power frequency magnetic field immunity test.
- AAMI / ANSI/ IEC 60601-1-2:2014 Medical Electrical Equipment Part 1-2: General Requirements for Basic Safety and Essential Performance - Collateral Standard: Electromagnetic Compatibility - Requirements and Tests
-
- ASTM E1112-00 (Reapproved 2011), Standard Specification for Electronic Thermometer for Intermittent Determination of Patient Temperature
The Digital Thermometer complies applicable ASTM E1112 requirements including displayed temperature range, maximum permissible laboratory error, ambient conditions for operation and storage, human interface and mechanical test.
- ASTM E1112-00 (Reapproved 2011), Standard Specification for Electronic Thermometer for Intermittent Determination of Patient Temperature
-
- Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices
The Digital Thermometer complicable the guidance requirements including level of concern, software description, software requirements specification, architecture design chart, software design specification, verification and validation documentation.
- Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices
-
- Biocompatibility:
AAMI / ANSI / ISO 10993-1:2009(R)2013 Biological Evaluation of Medical Devices - Part 1: Evaluation and Testing Within a Risk Management Process;
- Biocompatibility:
AAMI / ANSI / ISO 10993-5:2009(R)2014 Biological Evaluation of Medical Devices - Part 5: Tests for In Vitro Cytotoxicity and
5
Image /page/5/Picture/1 description: The image shows the logo for K-Jump. The logo is written in a stylized blue font. To the right of the word "K-Jump" is the registered trademark symbol.
AAMI / ANSI / ISO 10993-10:2010(R)2014 Biological Evaluation of Medical Devices - Part 10: Tests for Irritation and Skin Sensitization
The Digital Thermometer complies applicable biocompatibility requirements and the device met the endpoints for cytotoxicity, sensitization & irritation-negligible
The Digital Thermometer is verified and validated by evaluating safety, EMC, device-specific standard ASTM E1112-00, software validation and biocompatibility testing without raising any safety and effectiveness issues.
9. Conclusions
The Digital Thermometer has the similar intended use, materials, technological characteristics and the same fundamental scientific technology with the predicate device. Moreover, both devices comply with same performance standards. All information described above can demonstrate the subject device is substantial equivalent to the predicate device.
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Image /page/6/Picture/2 description: The image shows the logo for the Department of Health & Human Services - USA. The logo features a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, with a flowing, abstract design connecting them.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
September 28, 2017
K-jump Health Co., Ltd. JM Lin Regulatory Affairs Representative No. 56. Wu Kung 5th Rd., New Taipei Industrial Park New Taipei City, 24890 TAIWAN
Re: K170262
Trade/Device Name: Digital Thermometer, Model 2180 Regulation Number: 21 CFR 880.2910 Regulation Name: Clinical Electronic Thermometer Regulatory Class: Class II Product Code: FLL Dated: August 30, 2017 Received: August 31, 2017
Dear JM Lin:
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.
7
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 devicerelated 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 contact the Division of Industry and Consumer Education (DICE) at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education (DICE) at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely,
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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