(406 days)
TD-1035 Thermometer is a temperature detector which is intended to measure the body temperature on axillary region. The device is intended for population age of six months and above, which is designed for home use.
TD-1035 Thermometer is a temperature detector which is intended to measure the body temperature on axillary region, and transmit data to personnel device via Bluetooth pairing. The design concept is equivalent to the predicate device, K152680. There are two modifications made to the subject device: (1) indication for use (2) an elastic band was added. The elastic band is designed for more suitable and comfortable wearing. Moreover, the detected sensor contacts user skin directly, which is located on the silicone belt. The parts that contact the user are: (1) elastic band (2) sensor head (3) silicone belt.
The device in question is the TaiDoc TD-1035 Thermometer, intended for measuring body temperature in the axillary region for individuals aged six months and above, designed for home use.
Here's an analysis of the acceptance criteria and the studies performed:
1. Table of Acceptance Criteria and Reported Device Performance
| Test Category | Attachment | Standard | Acceptance Criteria | Reported Device Performance |
|---|---|---|---|---|
| Software | A1.1 | IEC 62304 | Safety and effectiveness of software meet the device's indications for use. | PASS |
| Electrical Safety & Performance | A1.2 | IEC 60601-1 | Basic safety and essential performance of medical electrical equipment and systems. | PASS |
| A1.3 | IEC 60601-1-11 | Basic safety and essential performance of medical electrical equipment and systems for use in the home healthcare environment. | PASS | |
| A1.4 | IEC 60601-1-2 | Maintain Essential Performance and Basic Safety of EMC requirements when exposed to electromagnetic disturbances. | PASS | |
| Risk Management | A2.1 | ISO 14971 | Acceptable level of risk established against risk criteria. | Overall the risks are acceptable. |
| General Performance - Accuracy | A1.5 | ISO 80601-2-56 | Storage Test: Greatest calculated error (δ) should not be > 0.09°F (0.05°C) between 95.00°F to 100.40°F (35.00°C to 38.00°C), and not > 0.18°F (0.10°C) between 68.00°F to 94.98°F (20.00°C to 34.99°C) and 100.42°F to 113.00°F (38.01°C to 45.00°C). | When error δ < 0.09°F (0.05°C) or < 0.18°F (0.10°C) PASS |
| A1.6 | ISO 80601-2-56 | Mechanical Shock Test: Same accuracy criteria as the storage test. | When error δ < 0.09°F (0.05°C) or < 0.18°F (0.10°C) PASS | |
| A1.7 | Display Temperature Range | All measurements meet the manufacturer-claimed display temperature range (68°F (20°C) to 113°F (45°C)) and comply with ISO 80601-2-56:2009 minimum display range (95°F (35.0°C) to 107.6°F (42.0°C)). | PASS (implicitly, as it states "All measurements meet...") | |
| A1.8 | Accuracy Test Report (Laboratory) | A sample size of 80 measurements, with no single measurement error exceeding the allowable limit, provides a confidence of 99% that at least 95% of all measurements will meet the acceptable criteria (same δ criteria as A1.5). | When error δ < 0.09°F (0.05°C) or < 0.18°F (0.10°C) PASS | |
| A1.9 | Operating Environment Test Report | Maximum errors in the operation environment range (41°F to 104°F (5°C to 40°C), 15% to 93% RH) must meet the accuracy requirements (δ < 0.09°F (0.05°C)). | When error δ < 0.09°F (0.05°C) PASS | |
| A1.11 | Accuracy Test Report After Cleaning Procedure | Same accuracy criteria as the storage test, after performing the manufacturer's cleaning procedure. | When error δ < 0.09°F (0.05°C) or < 0.18°F (0.10°C) PASS | |
| Biocompatibility | A1.12 | ISO 10993-1, -5, -10, -12 | Cytotoxicity Test: Cell viability not reduced to < 70% of reagent control extract. Skin Sensitization Test: Grades of 1 or greater in test group generally indicate sensitization (provided control animals have <1). Irritation Test: Calculated irritation score. | Cytotoxicity Test: ≥95% cell viability PASS Skin Sensitization Test: No evidence of causing delayed dermal contact sensitization PASS Irritation Test: PII of the test article was zero PASS |
| A1.13 | ISO 10993-1, -5, -10, -12 | (For Stainless Steel Cap) Same biocompatibility criteria as A1.12. | PASS (Implied by overall biocompatibility results) | |
| A1.14 | ISO 10993-1, -5, -10, -12 | (For Elastic Band) Same biocompatibility criteria as A1.12. | PASS (Implied by overall biocompatibility results) | |
| A1.15 | ISO 10993-1, -5, -10, -12 | (For Silicone Belt) Same biocompatibility criteria as A1.12. | PASS (Implied by overall biocompatibility results) | |
| Clinical Accuracy | A1.16 | ISO 80601-2-56 | Clinical accuracy verified by comparing device output with a reference device. Statistical analysis results for system accuracy of body temperature measurement in non-febrile and febrile groups (infants (6 months and above), children, adults, and elderly) must meet 95% limit of agreement criteria. | The statistics analysis results have demonstrated that the system accuracy of body temperature measurement... were met the criteria of 95% limit of agreement and [remaining text cut off] |
2. Sample Size Used for the Test Set and Data Provenance
- Laboratory Accuracy Test (A1.8): A sample size of 80 measurements was used.
- Clinical Test (A1.16): The document mentions "non-febrile and febrile group of subjects, infants (6 months and above), children, adults and elderly," but does not specify the exact sample size for the clinical test set.
- Data Provenance: The document does not explicitly state the country of origin for the data or whether the studies were retrospective or prospective. Given that TaiDoc Technology Corporation is based in Taiwan, it is likely the studies were conducted there. The nature of the performance tests (laboratory, mechanical, storage, operating environment) suggests prospective testing. The clinical trial would also typically be prospective.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of those Experts
The document does not provide information on the number of experts or their qualifications for establishing ground truth, particularly for the clinical study. For temperature measurement, ground truth for clinical accuracy studies typically involves highly accurate reference thermometers or direct measurement of core body temperature by qualified medical professionals.
4. Adjudication Method for the Test Set
The document does not describe any adjudication method.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
Not applicable. This is a medical device (thermometer), not an AI-assisted diagnostic tool that involves human "readers" interpreting cases.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
This is a physical thermometer. The performance tests (A1.1 - A1.16) evaluate the device's inherent capabilities, which can be considered "standalone" as they assess the device's readings against established standards or reference measurements. There isn't an "algorithm only" in the sense of software interpreting medical images, but rather the device's internal processing of temperature signals.
7. The Type of Ground Truth Used
- Laboratory Accuracy Tests (A1.5, A1.6, A1.8, A1.9, A1.11): The acceptance criteria refer to "calculated error δ" against a known or reference temperature. This implies comparison against calibrated reference standards/devices in controlled laboratory environments.
- Clinical Test (A1.16): The clinical accuracy is verified "by comparing its output with that of a reference device, which has a specified uncertainty for measuring true temperature." This strongly suggests the use of a highly accurate reference thermometer or method to establish the "true" body temperature for comparison.
8. The Sample Size for the Training Set
The document does not provide information on a "training set" as this is not an AI/machine learning device that typically involves distinct training data. The device's performance is based on its engineering design and calibration, not a learned model from a dataset.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as there is no mention of a training set for an AI/machine learning model.
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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
October 22, 2018
TaiDoc Technology Corporation Sylvia Liu Regulatory Affairs Specialist B1-7F, No.127, Wugong 2nd Rd., Wugu District New Taipei City, 24888 Taiwan
Re: K172733
Trade/Device Name: TD-1035 Thermometer Regulation Number: 21 CFR 880.2910 Regulation Name: Clinical Electronic Thermometer Regulatory Class: Class II Product Code: FLL Dated: September 14, 2018 Received: September 18, 2018
Dear Sylvia Liu:
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.
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
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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/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.htm); good manufacturing practice requirements as set forth in the quality systems (OS) 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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm.
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,
Alan M.
Stevens -S
for 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) K172733
Device Name TD-1035 Thermometer
Indications for Use (Describe)
TD-1035 Thermometer is a temperature detector which is intended to measure the body temperature on axillary region. The device is intended for population age of six months and above, which is designed for home use.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| ------------------------------------------------- | -- |
Prescription Use (Part 21 CFR 801 Subpart D)
|X | Over-The-Counter Use (21 CFR 801 Subpart C)
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Image /page/3/Picture/3 description: The image shows the logo for TaiDoc. The logo consists of the word "TaiDoc" in gray font, followed by three red hearts. Below the hearts is the website address "www.taidoc.com" in white font on a gray background.
9. 510(k) Summary
This summary of 510(k) information is being submitted in accordance with the requirements of 21 CFR 807.92.
The Assigned 510(k) number is: K172733
| 1. Submitter Information | |
|---|---|
| Company Name: | TaiDoc Technology Corporation |
| Contact Person: | Sylvia Liu |
| Title: | Regulatory Affairs Specialist |
| Address: | B1-7F., No. 127, Wugong 2nd Rd., Wugu District, New TaipeiCity 24888, TAIWAN |
| Phone: | +886-2-6625-8188 #6134 |
| Fax: | +886-2-6625-0288 |
| E-mail: | Sylvia.liu@taidoc.com.tw |
| Prepared Date: | October 22, 2018 |
| 2. Device Name | |
| Proprietary Name: | TD-1035 Thermometer |
| Common Name: | Electronic Thermometer |
| Product Code: | FLL |
| Review Panel: | General Hospital |
| Device Class: | Class II |
| Regulation Number: | 21 CFR §880.2910 |
| 3. Predicate Device | |
| Proprietary Name: | TD-1035 Thermometer |
| 510(K) no. | K152680 |
4. Device Description
TD-1035 Thermometer is a temperature detector which is intended to measure the body temperature on axillary region, and transmit data to personnel device via Bluetooth pairing. The design concept is equivalent to the predicate device, K152680. There are two modifications made to the subject device: (1) indication for use (2) an elastic band was added. The elastic band is designed for more suitable and comfortable wearing. Moreover, the detected sensor contacts user skin directly, which is located on the silicone belt. The parts that contact the user are: (1) elastic band (2) sensor head (3) silicone belt.
Principle of Operation
As the Bluetooth (BT) signals the CPU to display the temperature measurement. The thermistor is the type of temperature sensor and the CPU is a control center to process the device function.
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Image /page/4/Picture/0 description: The image shows the logo for TaiDoc. The logo consists of the word "TaiDoc" in gray, with three red hearts below it. Below the hearts is the website address "www.taidoc.com" in white text on a gray background.
The operating principle is based on differential temperature sending the signal to CPU which gets the signal than processes it and calculates the results.
5. Indications for Use
TD-1035 Thermometer is a temperature detector which is intended to measure the body temperature on axillary region. The device is intended for population age of six months and above, which is designed for home use.
6. Technological Characteristics
The concept of design is same as predicate product, K152680. There are two modifications were made to the proposed device: (1) indication for use (2) an elastic band was added. The modifications are changing the indication for use for population age of six months and above, which Thermometer is used at home. Also, the elastic band is design for more suitable and comfortable wearing.
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Image /page/5/Picture/0 description: The image shows the logo for TaiDoc. The logo consists of the word "TaiDoc" in gray, with three red hearts underneath. Below the hearts is the website address "www.taidoc.com" in white text on a gray background.
Tel : +886-2-6625-8188 Fax : +886-2-6625-0288
Table of Specification Comparison
| Item | Predicate device | Proposed device | Comparison |
|---|---|---|---|
| 510K Number | K152680 | K172733 | |
| Indication for Use | The TD-1035 Thermometer device is athermometer intended for body temperaturemeasurement at axillary temperaturemeasurement site. The device is intended formeasurement in patients 12 years and older ina home use environment. | TD-1035 Thermometer is a temperaturedetector which is intended to measure thebody temperature on axillary region. Thedevice is intended for population age ofsix months and above, which isdesigned for home use. | Similarity |
| Population | 12 years and older | Six months and above | Difference |
| IntendedEnvironment | Home use | Same as the predicate | Same |
| Item | Predicate device | Proposed device | Comparison |
| 510K Number | K152680 | K172733 | |
| Principles of operation | The Temperature Monitor detects the bodytemperature by thermistor which providessignals to the microcontroller where signals areconverted into a digital temperature value thatdisplayed in LCD screen. The thermistor is as atemperature sensor and the microcontroller isused for signal processing. The basic operatingprinciple is that a change of thermistor causedby changes of temperature provides a signal tothe microcontroller which gets the signal thanprocesses it and calculates the results. | Same as the predicate | Same |
| General Functions | |||
| Low temperature display | < 89.60°F (32.00°C): Display: Lo °F (Lo °C) | Same as the predicate | Same |
| High temperature display | >109.40°F (43.00°C):Display: Hi °F (Hi °C) | Same as the predicate | Same |
| Measurement area | Armpit | Same as the predicate | Same |
| Measurement units | °C or °F | Same as the predicate | Same |
| Power source | one 3V CR2032 lithium battery | Same as the predicate | Same |
| Battery life | Approx. 25 days (1 time measurement/day) | Same as the predicate | Same |
| Beeper | None | Same as the predicate | Same |
| Operating condition | 41°F to 104°F (5°C to 40°C);15% to 93% R.H. | Same as the predicate | Same |
| Item | Predicate device | Proposed device | Comparison |
| 510K Number | K152680 | K172733 | |
| Storage condition | -13°F to 158°F (-25°C to 70°C);10% to 95%R.H. | Same as the predicate | Same |
| Data transmission | Bluetooth | Same as the predicate | Same |
| Dimensions (mm) | 40.5 (L) x 27.5 (W) x 11.7 (H) | Same as the predicate | Same |
| Weight (g) | 18 g | Same as the predicate | Same |
| Outer casing | On/off button, LCD display, armband | Same as the predicate | Same |
| Atmosphericpressure range | 700 hPa to 1060 hPa | Same as the predicate | Same |
| Operation altitude | 2000 m | Same as the predicate | Same |
| Expected service life | 3 years | Same as the predicate | Same |
| Type BF appliedpart | Type BF Applied part | Same as the predicate | Same |
| Safety | IEC 60601-1 | Same as the predicate | Same |
| EMC | IEC 60601-1-2 | Same as the predicate | Same |
| Harmonizedstandard | ISO 80601-2-52:2009 | Same as the predicate | Same |
| Water-resistance | IP22 | Same as the predicate | Same |
| Material Description | |||
| Top and BottomCase | ABS | Same as the predicate | Same |
| Battery Cover | ABS | Same as the predicate | Same |
| M-Key | Silicone | Same as the predicate | Same |
| Lens | PC | Same as the predicate | Same |
| Stainless Steel Cap(Patient Contact Part) | SUS304 | Same as the predicate | Same |
| Silicone Belt(Patient Contact Part) | Silicone | Same as the predicate | Same |
| Item | Predicate device | Proposed device | Comparison |
| 510K Number | K152680 | K172733 | |
| Elastic Band(Patient Contact Part) | NA | Nylon & Polyester 190D/Polyester 230g | Difference |
| Biocompatibility Information | |||
| Description | TD-1035 Thermometer detect the temperature by contact to user skin directly, which the contact time shall less than 24hours. A part of silicone belt which is connected with sensor, without cover of the elastic band, located on the back ondevice and contact to user skin directly. | ||
| Standard | ISO 10993-1ISO 10993-5ISO 10993-10ISO 10993-12 | ||
| Patient ContactParts | Stainless Steel Cap, Silicone belt | Stainless Steel Cap, Silicone belt, Elasticband | Similarity |
| Patient Contact Material Information | |||
| Stainless Steel Cap | SUS 304 | Same as the predicate | Same |
| Silicone Belt | Silicone | Same as the predicate | Same |
| Elastic Band | NA | Nylon & Polyester 190D/Polyester 230g | Difference |
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新北市24888五股區五工二路127號6樓 6F., No.127, Wugong 2nd Rd., Wugu Dist., New Taipei City 24888, Taiwan
Tel : +886-2-6625-8188 Fax : +886-2-6625-0288
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Image /page/7/Picture/0 description: The image shows the word "TaiDoc" in gray font. Below the word are three red hearts in a row. The hearts are evenly spaced and appear to be a design element associated with the text above.
泰博科技股份有限公司 新北市24888五股區五工二路127號6樓 6F., No.127, Wugong 2nd Rd., Wugu Dist., TaiDoc Technology Corp. New Taipei City 24888, Taiwan
Tel : +886-2-6625-8188 Fax : +886-2-6625-0288
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Image /page/8/Picture/0 description: The image shows the word "TaiDoc" in gray font. Below the word are three red hearts in a row. The hearts are evenly spaced and appear to be the same size.
Tel : +886-2-6625-8188 Fax : +886-2-6625-0288
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Image /page/9/Picture/0 description: The image shows the logo for TaiDoc. The logo consists of the word "TaiDoc" in gray letters above three red hearts. Below the hearts is the website address "www.taidoc.com" in white letters on a gray background.
Tel · +886-7-6675
Discussion
The conceptual design of the subject device K172733 is similar with the predicate device K152680, which has the additional component of elastic band.
Considering the user individual circumstances which the predicate device (K152680) could cause the risk of uncomfortable wearing under the long-term effects of temperature monitoring because of the silicone belt has fixed holes size and holes number that are fewer armpit adjustment space. Thus, to modify this issue that the additional elastic band design of the proposal device( K172733) has more space for users to adjust the device wearing, and let the thermo-detector effectively contact the user skin. Additionally, the temperature measurement accuracy of the subject device K172733 have met the criteria of 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.
Also, each parts of the subject device materials passed the biocompatibility test. Furthermore, the clinical trials have demonstrated that the subject device has met the temperature measurement criteria of ISO 80601-2-56. Overall, the performance tests demonstrate the elastic band does not impact device performance.
Conclusions
The concept of design is similar to the predicate device. K152680, which is a detector to measure the body temperature on axillary region, and transmit data to personal device via Bluetooth pairing. There are two modifications were made to the subject device: (1) indication for use (2) an elastic band was added. The elastic band is design for more suitable and comfortable wearing. Moreover, the temperature sensor is still contacting the user skin directly, which is located on the silicone belt.
The material of elastic band has passed the biocompatibility test. Also, the arm girth of elastic band is adjustable for users to apply on the axillary, and more convenient for using on children by guardian. A part of the silicone belt, which is connected with sensor, without cover of the elastic band, located on the back of device and contact to user skin directly. Overall, the performance tests demonstrate that the elastic band does not impact device performance.
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Image /page/10/Picture/0 description: The image shows the logo for TaiDoc, a company that specializes in medical devices. The logo consists of the word "TaiDoc" in gray letters, followed by three red hearts. Below the hearts is the company's website address, "www.taidoc.com", also in gray letters. The background of the logo is white.
新北市24888五股區五工二路127號6樓 6F., No.127, Wugong 2nd Rd., Wugu Dist., New Taipei City 24888, Taiwan
Tel : +886-2-6625-8188 Fax : +886-2-6625-0288
7. Performance Data
| Attachment | Standard | Title | Intended Use | Acceptance Criteria | Results |
|---|---|---|---|---|---|
| A1.1 | IEC62304 | Medical devicesoftware - Softwarelife cycle processes | This validation is to test for product byitself to verify software is safe forpatients using the medical device or not. | The pass/fail criteria is toevaluate the safety andeffectiveness of softwareare met the device'sindication for use. | PASS |
| A1.2 | IEC60601-1 | General requirementsfor basic safety andessential performance | This study is to test for the basic safetyand essential performance of medicalelectrical equipment and medicalelectrical systems which are intended bytheir manufacturer for use. | The pass/fail criteria is toevaluate the basic safetyand essential performanceof medical electricalequipment and medicalelectrical systems. | PASS |
| A1.3 | IEC60601-1-11 | General requirementsfor basic safety andessentialperformance -Collateral Standard:Requirements formedical electricalequipment andmedical electricalsystems used in thehome healthcareenvironment | This study is to evaluate to the basicsafety and essential performance ofmedical electrical equipment and medicalelectrical systems which are intended bytheir manufacturer for use in the homehealthcare environment, regardless ofwhether the medical electrical equipmentor medical electrical system is intendedfor use by a lay operator or by trainedhealthcare personnel. | The pass/fail criteria is toevaluate the basic safetyand essential performanceof medical electricalequipment and medicalelectrical systems for usein the home healthcareenvironment. | PASS |
| A1.4 | IEC60601-1-2 | EMC Test Report | IEC 60601-1-2:2014 applies to the basicsafety and essential performance ofMedical Equipment (ME) equipment andME systems in the presence ofelectromagnetic disturbances and to | The pass/fail criteria islimited to maintain theEssential Performanceand Basic Safety of EMCrequirements. | PASS |
| electromagnetic disturbances emitted byme equipment and me systems. | |||||
| A2.1 | ISO14971 | Risk ManagementReport | The failure of the function resulting inwrong analytical result which may haveserious impairment to the health of apatient may happen. Control measureswere taken to reduce the risk to asminimum as possible. Safety andeffectiveness of use about the system wasthen verified. | The risk criteria wereestablished when settingthe context, the level ofrisk would against thiscriteria in order todetermine whether therisk is acceptable. | Overallthe risksareacceptable |
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Image /page/11/Picture/0 description: The image shows the logo for TaiDoc. The text "TaiDoc" is written in gray, with three red heart shapes underneath the text. The hearts are evenly spaced and aligned horizontally.
泰博科技股份有限公司 新北市24888五股區五工二路127號6樓 6F., No.127, Wugong 2nd Rd., Wugu Dist., TaiDoc Technology Corp. New Taipei City 24888, Taiwan
Tel : +886-2-6625-8188 Fax : +886-2-6625-0288
General Performance Test:
| Attachment | Standard | Title | Intended Use | Acceptance Criteria | Results |
|---|---|---|---|---|---|
| A1.5 | ISO80601-2-56 | Storage TestReport | This report is intended toevaluate the accuracy ofThermometer after having beenstored or transported withinmanufacturer's claimed range. | The pass/fail criteria is to simulate the worstcase of the transportation and the storageconditions of the device when exposing at --13°F and at 158°F environment.The greatest calculated error δ should notbe greater than 0.09°F (0.05°C) betweenthe measuring range from 95.00°F to100.40°F (35.00°C to 38.00°C). The greatest calculated error δ should notbe greater than 0.18°F (0.10°C) betweenthe measuring range from 68.00°F to 94.98°F (20.00°C to 34.99°C) and the measuringrange from 100.42°F to 113.00°F (38.01°C to 45.00°C). | When errorδ<0.09°F(0.05°C) or<0.18°F(0.10°C)PASS |
| A1.6 | ISO80601-2-56 | MechanicalShock TestReport | Verify the performance ofThermometer is complied withISO 80601-2-56:2009 after | The greatest calculated error δ should notbe greater than 0.09°F (0.05°C) betweenthe measuring range from 95.00°F to | When errorδ<0.09°F(0.05°C) or |
| mechanical shock. | 100.40°F (35.00°C to 38.00°C).➤ The greatest calculated error δ should notbe greater than 0.18°F (0.10°C) betweenthe measuring range from 68.00°F to 94.98°F (20.00°C to 34.99°C) and the measuringrange from 100.42°F to 113.00°F (38.01°C to 45.00°C). | <0.18°F(0.10°C)PASS | |||
| A1.7 | DisplayTemperatureRange | Verify the measuring displayrange of Thermometer iscomplied with the manufacture-claimed display temperaturerange and the FDArecommended standard, ISO80601-2-56:2009, which has therequirement of covering theminimum display range from 95°F (35.0°C) to 107.6°F (42.0°C). | All measurements meet the manufacture-claimed display temperature range which iscover the measuring range from 68°F (20°C) to113°F (45°C) and it is in accordance with therequirement of ISO 80601-2-56:2009 that theminimum display range shall cover from 95°F(35.0°C) to 107.6°F (42.0°C). | TemperatureRangeDisplay | |
| A1.8 | AccuracyTest Report | Assess the laboratory accuracyof Thermometer under referenceconditions. | A sample-size of 80 measurements, with nosingle measurement error exceeding theallowable limit, provides a confidence of 99%that at least 95% of all measurement will meetthe acceptable criteria. | When errorδ<0.09°F(0.05°C) or<0.18°F(0.10°C)PASS | |
| A1.9 | OperatingEnvironmentTest Report | Verify the operatingenvironment of Thermometerthat met the accuracyrequirements when operated inan environment of 41°F to 104 | To evaluate the maximum errors in theoperation environment range of 41°F to 104°F(5°C to 40°C) and a relative humidity of 15% to93% noncondensing, the environment chamberswere used to create the prospective condition. | When errorδ<0.09°F(0.05°C)PASS | |
| www.taidoc.com | |||||
| A1.11 | AccuracyTest ReportAfterCleaningProcedure | °F (5°C to 40°C) and a relativehumidity of 15% to 93%noncondensing. The operatingenvironment of 41°F to 104°F(5°C to 40°C) and a relativehumidity of 15% to 93%noncondensing are compliedwith the requirement of ISO80601-2-56:2009 internationalstandard that an ambienttemperature operating rangeshould at least be from 15°C to35°C and a relative humidityrange of 15% to 85%noncondensing.This test is intended to evaluatethe accuracy of TD-1035Thermometer after performingcleaning procedure by themanufacturer instruction. | Two temperatures of chamber were set asdescribed in the standard. | The greatest calculated error δ should notbe greater than 0.09°F (0.05°C) betweenthe measuring range from 95.00°F to100.40°F (35.00°C to 38.00°C). The greatest calculated error δ should notbe greater than 0.18°F (0.10°C) betweenthe measuring range from 68.00°F to 94.98°F (20.00°C to 34.99°C) and the measuringrange from 100.42°F to 113.00°F (38.01°C to 45.00°C). | When errorδ<0.09°F(0.05°C) or<0.18°F(0.10°C)PASS |
| Attachment | Standard | Title | Intended Use | Acceptance Criteria | Results |
| A1.12 | BiocompatibilityTest Report forThermometer | When assessingmedical device, thesponsor should | Cytotoxicity Test:If cell viability is reduced to < 70%of the reagent control extract, a | Cytotoxicity Test:≥95% cell viabilityPASS | |
| A1.13 | ISO 10993-1ISO 10993-5ISO 10993-10ISO 10993-12 | BiocompatibilityTest Report forStainless SteelCap | specifically state if themedical device doesnot result in any risk ofdirect or indirect tissue- | cytotoxic potential exists.Skin Sensitization Test:Grades of 1 or greater observed inthe test group generally indicated | PASSSkin Sensitization Test:The test article extractsand the test article |
| A1.14 | BiocompatibilityTest Report forElastic Band | contacting components.Thus, performing thebiocompatibility test to | sensitization, provided that grades ofless than 1 were observed on thecontrol animals. | showed no evidence ofcausing delayed dermalcontact sensitization.PASS | |
| A1.15 | BiocompatibilityTest Report forSilicone belt | indicate the safety ofdevice, which includeswith Cytotoxicity Test,Skin Sensitization Test,and Irritation Test. | Irritation Test:For each rabbit, the irritation scorefor test area was calculated by addingtogether the scores of erythema andedema at each time point and dividethe sum by the total number ofobservation. | Irritation Test:The Primary irritationindex (PII) of the testarticle was zero.PASS | |
| A1.16 | ISO 80601-2-56 | Clinical TestReport | This study is intendedto evaluate if the safetyand effectiveness ofdevice consistentlymeet the requirementsof the intended use. | Clinical Accuracy of a thermometeris verified by comparing its outputwith that of a reference device, whichhas a specified uncertainty formeasuring true temperature. | The statistics analysisresults havedemonstrated that thesystem accuracy ofbody temperaturemeasurement in non-febrile and febrilegroup of subjects,infants (6months andabove), children, adultsand elderly were metthe criteria of 95% limitof agreement and |
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新北市24888五股區五工二路127號6樓 6F., No.127, Wugong 2nd Rd., Wugu Dist., New Taipei City 24888, Taiwan
Tel : +886-2-6625-8188 Fax : +886-2-6625-0288
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Image /page/13/Picture/0 description: The image shows the word "TaiDoc" in gray font. Below the word are three red hearts in a row. The hearts are evenly spaced and appear to be a part of the logo.
新北市24888五股區五工二路127號6樓 6F., No.127, Wugong 2nd Rd., Wugu Dist., New Taipei City 24888, Taiwan
Tel : +886-2-6625-8188 Fax : +886-2-6625-0288
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Image /page/14/Picture/0 description: The image shows the logo for TaiDoc. The logo consists of the word "TaiDoc" in gray, with three red hearts below it. Below the hearts is the website address "www.taidoc.com" in white text on a gray background.
新北市24888五股區五工二路127號6樓 6F., No.127, Wugong 2nd Rd., Wugu Dist., New Taipei City 24888, Taiwan
Tel : +886-2-6625-8188 Fax : +886-2-6625-0288
Biocompatibility & Clinical Test Report
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Image /page/15/Picture/0 description: The image shows the logo and contact information for TaiDoc Technology Corp. The logo includes the company name and three red hearts. The contact information includes the address, phone number, fax number, and website. The address is 6F., No.127, Wugong 2nd Rd., Wugu Dist., New Taipei City 24888, Taiwan. The phone number is +886-2-6625-8188 and the fax number is +886-2-6625-0288.
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8. Conclusions
The TD-1035 Thermometer has same test principle, similar product design and specifications with the predicate device. Based on the information provided in this submission, the TD-1035 Thermometer is substantially equivalent to the predicate device (K152680).
§ 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.