(208 days)
Not Found
No
The document describes a standard digital thermometer with predictive capabilities based on established standards (ISO 80601-2-56). There is no mention of AI, ML, or related concepts in the device description, performance studies, or training/test set descriptions. The "predictive" function likely refers to a simple algorithm based on temperature rise rate, not AI/ML.
No
The device is a digital thermometer used for measuring body temperature, not for treating or rehabilitating a disease or condition.
Yes
A digital thermometer, which measures body temperature, is used to aid in the diagnosis of various medical conditions, such as fever or hypothermia. This is a form of diagnostic information.
No
The device description explicitly states it is a "hand-held device" and mentions physical components like an LCD screen and battery operation, indicating it is a hardware device with embedded software, not a software-only medical device.
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 such as blood, urine, or tissue that have been taken from the human body to detect diseases, conditions, or infections.
- Device Function: The AOJ-25 series Digital Thermometer measures human body temperature directly from the body (oral, armpit, rectal). It does not analyze samples taken from the body.
- Intended Use: The intended use is for measuring body temperature, not for analyzing biological samples.
Therefore, this device falls under the category of a general medical device for measuring a physiological parameter, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The AOJ-25 series Digital Thermometer (except AOJ-25B) are designed as reusable battery-operated electronic device, and intended for the measurement of oral, armpit and rectal temperature for people of all ages at home.
The AOJ-25B is intended to measure temperature rectally only for people of all ages at home as well. The device is reusable.
Product codes
FLL
Device Description
The digital thermometer is designed as hand-held device which can measure human body's temperature orally, axillary (under the arm), or rectally. The results can be displayed on LCD.
The digital thermometers have several functions, such as beep indication, °C and °F unit switchable, low battery detection, memories, three-color backlight, auto automatic power off functions.
The device is a predictive digital thermometer. Users only need 10 seconds for quick reading, and will display the temperature value on the screen.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
oral, armpit and rectal
Indicated Patient Age Range
all ages
Intended User / Care Setting
home
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)
Non-Clinical Data:
- Biocompatibility testing: Conducted in accordance with ISO 10993-1. Contact classification: mucosal membrane contacting for less than 24 hours. Tests included Cytotoxicity, Skin Sensitization, and Skin Irritation.
- Electrical safety and electromagnetic compatibility (EMC): Device complies with IEC 60601-1, IEC 60601-1-11, and IEC 60601-1-2.
- Bench Testing: Conducted on the digital thermometer device (all accessories). System complies with ISO 80601-2-56 for performance effectiveness.
- Software Verification and Validation Testing: Documentation provided as recommended by FDA guidance. Software considered "moderate" level of concern.
Clinical data:
- Study Type: Clinical accuracy validated per clause 201.102 of international standard ISO 80601-2-56. This clinical study is a randomization, simple blind homologous control, pairing design of clinical investigation.
- Sample Size: A minimum of 90 subjects.
- Key Results: No single measurement error exceeding the allowable limit, provides a 99% confidence. The acceptance criteria is that clinical accuracy of the subject device is at least the same as that of the reference, and the accuracy is ±0.1℃ as claimed in the manual.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Accuracy: ±0.1 °C (35.5°C-42°C); ±0.2 °C( 42.0°C)
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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 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 features the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.
May 25, 2022
Shenzhen AOJ Medical Technology Co., Ltd. Queena Chen Regulatory Director Room 301&4F, Blk A, Building A, Jingfa IM Park Xiaweiyuan, Gushu Community, Xixiang, Baoan District Shenzhen, Guangdong 518126 China
Re: K213485
Trade/Device Name: Digital Thermometer, Models: AOJ-25B, AOJ-25B, AOJ-25C, AOJ-25D and AOJ-25E Regulation Number: 21 CFR 880.2910 Regulation Name: Clinical Electronic Thermometer Regulatory Class: Class II Product Code: FLL Dated: April 20, 2022 Received: April 25, 2022
Dear Queena 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.
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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 mediation-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.
David Wolloscheck 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
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Indications for Use
510(k) Number (if known) K213485
Device Name
Digital Thermometer, Models: AOJ-25A, AOJ-25B, AOJ-25C, AOJ-25D and AOJ-25E
Indications for Use (Describe)
The AOJ-25 series Digital Thermometer (except AOJ-25B) are designed as reusable battery-operated electronic device, and intended for the measurement of oral, armpit and rectal temperature for people of all ages at home.
The AOJ-25B is intended to measure temperature rectally only for people of all ages at home as well. The device is reusable.
| Type of Use (Select one or both, as applicable) |
|---|
| ------------------------------------------------- |
| Prescription Use (Part 21 CFR 801 Subpart D) | |
|---|---|
| Over-The-Counter Use (21 CFR 801 Subpart C) | X |
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K213845 - 510(k) Summary
Prepared in accordance with the requirements of 21 CFR Part 807.92
| 1. Submitter:
Contact Person: | Shenzhen AOJ Medical Technology Co., Ltd.
Room 301&4F, Block A, Building A, Jingfa Intelligent Manufacturing Park,
Xiaweiyuan, Gushu Community, Xixiang Street, Bao'an District, 518126,
Shenzhen, China
TEL: 86 755-27786026
Jack Wang |
|---------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Prepare date: | May 24, 2022 |
| 2. Device name
and classification: | Trade Name: Digital Thermometer
Models: AOJ-25A, AOJ-25B, AOJ-25C, AOJ-25D and AOJ-25E
Common Name: Clinical Electronic Thermometer
Classification Number/Name:
21 CFR 880.2910
Clinical Electronic Thermometers
Product code: FLL |
| 3. Reason for
Submission: | Regulatory Class: Class II
New Application. No prior submission for this device before. |
| 3. Class III device
statement | Not applicable, the subject device is a Class II device. |
| 4. Predicate
Device(s):
5. Device
Description: | Joytech Healthcare Co., Ltd, Digital Thermometer, Model DMT-4726, K183393
The digital thermometer is designed as hand-held device which can measure human
body's temperature orally, axillary (under the arm), or rectally. The results can be
displayed on LCD.
The digital thermometers have several functions, such as beep indication, °C and °F
unit switchable, low battery detection, memories, three-color backlight, auto
automatic power off functions.
The device is a predictive digital thermometer. Users only need 10 seconds for
quick reading, and will display the temperature value on the screen. |
| 6. Indications for
Use: | The AOJ-25 series Digital Thermometer (except AOJ-25B) are designed as reusable
battery-operated electronic device, and intended for the measurement of oral, armpit
and rectal temperature for people of all ages at home.
The AOJ-25B is intended to measure temperature rectally only for people of all ages at
home as well. The device is reusable. |
7. Substantial Equivalence Discussion
Comparison to the predicate devices, the subject device has same intended use, similar product design, same performance effectiveness, performance safety as the predicate device.
Please refer to following table to find differences between the subject device and predicate device. All the differences do not affect the basic design principle, usage, effectiveness and safety of the subject device. And no question is raised regarding to effectiveness and safety.
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| ITEM | Proposed Device
AOJ-25A, AOJ-25B, AOJ-25C,
AOJ-25D, AOJ-25E | Predicate Device
DMT-4726/K183393 | Comparison
Result |
|----------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------|
| Manufacturer | Shenzhen AOJ Medical Technology Co.,
Ltd. | Joytech Healthcare Co., Ltd | |
| Intended
Use/Indications for
Use | The AOJ-25 series Digital
Thermometer(except AOJ-25B) are
designed as reusable battery-operated
electronic device, and intended for the
measurement of oral, armpit and rectal
temperature for people of all ages at home.
The AOJ-25B is intended to measure
temperature rectally only for people of all
ages at home as well. The device is reusable | The Digital Thermometers DMT
series(Except DMT-455) are intended
to measure the human body
temperature in regular mode orally,
rectally or under the arm. And the
devices are reusable for clinical or
home use on people of all ages,
including children under 8 with adult
supervision. | Different 1 |
| Operational Specifications | | | |
| Operational principle | A change of thennistor resistance, caused
by changes of temperature. The resistance
is measured by MCU, so changes of
temperature will correspond to changes of
resistance | A change of thermistor resistance,
caused by changes of temperature.
The resistance is measured by MCU,
so changes of temperature will
correspond to changes of resistance | Same |
| Sensor | Thermistor | Thermistor | Same |
| Components | Sensor, buzz film, housing, stainless steel
cap, LCD display, measurement control
module. | Sensor, buzz film, housing, stainless
steel cap, LCD display, measurement
control module. | Same |
| Signal processing
and display | Internal firmware and local
LCD display | Internal firmware and local
LCD display | Same |
| Predictive mode | YES | Optional | Different 2 |
| Measurement site | orally, rectally or under the arm
(except AOJ-25B, rectal only) | orally, rectally or under the arm | Same |
| Measurement range | 32.0°C- 42.9°C | 32.0°C- 43.9°C | Different 2 |
| Accuracy | 0.1 °C (35.5°C-42°C)
0.2 °C( 42.0°C) | ±0.1 °C (35.5°C-42.0°C)
±0.2 °C( 42.0°C) | |
| Memory data | 10 memories | 10 memories | Same |
| Automatic shutdown | YES | YES | Same |
| Temperature unit and
conversion | Dual temperature units "°C" and "°F"
optional, and the two units can convert by
the conversion key automatically | Dual temperature units "°C" and "°F"
optional, and the two units can
convert by the conversion key
automatically | Same |
| Operating
environment | Temperature: 10°C- 40°C
Humidity: 30%-85% RH, non-condensing
Atmospheric pressure: 70-106 kPa | Temperature: 5°C-40°C
Humidity: 15%-95% RH,
non-condensing
Atmospheric pressure: 70- 106 kPa | Different 3 |
| Storage environment | Ambient Temperature:
- 20 °c to 55°C
Relative Humidity: 10-93% RH,
non-condensing
Atmospheric pressure: 70kPa to 106kPa | Ambient Temperature: - 20 °c to 55°C
Relative Humidity: 0-95% RH,
non-condensing
Atmospheric pressure: 50kPa to
106kPa | |
| Battery type | One 3.0V CR2032 battery | One 3.0V CR2032 battery | Same |
| Applied Standards | | | |
| Electrical safety | IEC 60601-1
IEC 60601-1-11 | IEC 60601-1
IEC 60601-1-11 | Same |
| Table 1 Comparison between predicate DMT-4726 and the subject device AOJ-25 series | |||||
|---|---|---|---|---|---|
| -- | -- | -- | -- | -- | ------------------------------------------------------------------------------------ |
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| EMC | IEC 60601-1-2 | IEC 60601-1-2 | Same |
|---|---|---|---|
| Biocompatibility | ISO 10993-1 | ||
| ISO 10993-5 | |||
| ISO 10993-10 | ISO 10993-1 | ||
| ISO 10993-5 | |||
| ISO 10993-10 | Same | ||
| Physical Specifications | |||
| Weight | AOJ-25A/AOJ-25C/AOJ-25E: | ||
| Approx. 23 grams without battery | |||
| AOJ-25B: Approx. 26 grams including | |||
| battery | Approx. 40 grams including battery | Different 4 | |
| Dimensions | |||
| (Lx Wx H) | AOJ-25A/AOJ-25C/AOJ-25E: | ||
| 142mmx30mmx 14mm | |||
| AOJ-25B: 93mm x 34.5mm x 18mm | 106 mm x 32 mm x 25 mm | ||
| Display screen | LCD | LCD | Same |
| Biological Specifications | |||
| Patient Contacting | |||
| Materials | ABS,TPU,Stainless steel | ABS,TPE,Stainless steel | Different 5 |
| Patient Contacting | Surface-contacting, | ||
| Less than 24 h | Surface-contacting, | ||
| Less than 24 h | Same | ||
| Biocompatibility | |||
| evaluation | Cytotoxicity, skin sensitization and | ||
| irritation | Cytotoxicity, skin sensitization and | ||
| irritation | Same |
Justification for the differences:
-
- Different Indications for Use
As indicated in the comparison table, the application scenario of the predicate device can be used both in hospital and home, while the subject device can be used at home. The absence of application in clinical use reduces the operation risks, no raise of new questions on the safety and effectiveness.
- Different Indications for Use
-
- Different measurement range
The subject device measurement range has been evaluated per the internal standards ISO 80601-2-56, the results tell the accuracy can be matched as claimed, no extra risk will be introduced due to the minor difference.
- Different measurement range
-
- Different Operation, storage, and transportation Environments
Minor difference to operation and storage and transportation environments for the subject device, but the system has been proved to be safe and effective since the safety testing was conducted under the suggested environment; Moreover, environment testing data shows the device can work as declared under the suggested conditions. So those changes will not cause any safety and effectiveness problem.
- Different Operation, storage, and transportation Environments
-
- Different Physical Specifications
The subject and the predicate are of different size but proximity. Moreover, such engineering design has been verified during the international standards, so such minor different ill not raise any safety and effectiveness questions.
- Different Physical Specifications
-
- Different Patient Contacting Materials
Minor different material used for the housing, but both comply with the same standards, and evaluated to be safe after the biocompatibility testing as defined in Annex I of ISO 10993-1. Therefore, this material difference will not cause any safety and effectiveness problem.
- Different Patient Contacting Materials
As seen in the comparison tables, the subject and predicate devices have almost the same design features and performance specifications. The differences between the subject and predicate devices do not raise different
6
questions of safety oreffectiveness. Moreover, as demonstrated in the bench testing, the different technological characteristics do not affect the safety and effectiveness of the subject device.
8. Performance Testing:
Performance data includes "Non-Clinical Data", brief description of which are shown as below.
Non-Clinical Data:
The following performance data were provided in support of the substantial equivalence determination.
Biocompatibility testing
The biocompatibility evaluation for the digital thermometer were conducted in accordance with the International Standard ISO 10993-1 "Biological Evaluation of Medical Devices - Part 1: Evaluation and Testing Within a Risk Management Process," as recognized by FDA. The contact classification is considered mucosalmembrane contacting for a duration of less than 24 hours. The battery of testing included the following tests:
- Cytotoxicity
- Skin Sensitization
- Skin Irritation
Electrical safety and electromagnetic compatibility (EMC)
Electrical safety andEMC testing were conducted on the digital thermometer device. The device complies with the IEC 60601-1 Medical electrical equipment Part 1: General requirements for basic safety and essential performance for safety, IEC 60601-1-11 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, and the IEC 60601-1-2 Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral Standard: Electromagnetic disturbances - Requirements and tests standard for EMC.
Bench Testing
Bench testing was conducted on the digital thermometer device, consisting of all the accessories in the system. The system complies with the 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 for performance effectiveness.
Software Verification and Validation Testing
Software verification and validation testing were conducted and documentation was provided as recommended by FDA's Guidance for Industry and FDA Staff, "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices." The software for this device was considered as a "moderate" level of concern.
Clinical data:
The CLINICAL ACCURACY in each adjusted mode was validated per the requirements defined in clause 201.102 of international standard ISO 80601-2-56. This clinical study is a randomization, simple blind homologous control, pairing design of clinical investigation, consists of a minimum of 90 subjects as required, and divided into four age groups as defined in Table 201.102 of the standard shown as below.
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| Age group | Age[11] |
|---|---|
| A1 | 0 up to 3 months |
| A2 | 3 months up to 1 year |
| B | older than 1 year and younger than 5 years |
| C | older than 5 years |
Table 201.102 - Subject age groups
No single measurement error exceeding the allowable limit, provides a 99% confidence. A reference device is introduced as required by the standard, and the acceptance criteria is that clinical accuracy of the subject device is at least the same as that of the reference, and the accuracy is ±0.1℃ as claimed in the manual.
Summary
Based on the non-clinical performance data as documented in the device development, the subject devices were found to have a similar safety and effectiveness profile as the predicate device.
9. Conclusion:
The differences between the predicate and the subject device do not raise any new or different questions of safety and effectiveness. Verification and validation testing was conducted on the subject device and all testing passed pre-specified criteria. This premarket notification submission demonstrates that the AOJ-25 series Digital Thermometer is substantially equivalent to the predicate device.