(190 days)
Not Found
No
The description of the device modules and performance studies does not mention any AI or ML components or methodologies. The temperature measurement module uses "various algorithms," but this is a general term and doesn't specifically indicate AI/ML.
No.
The device is a thermometer used for measurement and monitoring of body temperature, which is for diagnostic or monitoring purposes, not for treating a condition.
No
Explanation: A diagnostic device identifies a disease or condition. This device measures body temperature, which is a vital sign, but it does not diagnose any specific disease or condition. It is a monitoring device.
No
The device description explicitly lists and describes multiple hardware modules (Buzzer, Display, Battery voltage management, Temperature measurement, Button, Wireless function) that are integral to the device's function.
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, such as blood, urine, or tissue, to detect diseases, conditions, or infections. These tests are performed outside of the body (in vitro).
- Device Function: The Wireless Smart Thermometer measures human body temperature directly from the body (orally, rectally, under the arm). It does not analyze samples taken from the body.
- Intended Use: The intended use is for "intermittent measurement and monitoring of human body temperature," which is a direct physiological measurement, not an in vitro test.
Therefore, based on the provided information, the Wireless Smart Thermometer is a medical device, but it falls under the category of a clinical thermometer rather than an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
Wireless Smart Thermometer is intended to be used at home for the intermittent measurement and monitoring of human body temperature orally, rectally, and under the arm. The devices are reusable for the adult and pediatric patient population (not suitable for neonates).
Product codes (comma separated list FDA assigned to the subject device)
FLL
Device Description
Wireless Smart Thermometer (Model: FDTH3400, FDTH3401, FDTH3402, FDTH3403, FDTH3404, FDTH3405, FDTH3406, FDTH3407, FDTH3408, FDTH3409, FDTH3410, FDTH3411, FDTH-V0-13, FDTH-V0-4) utilizes a modular design method and consists of six main modules:
- Buzzer module: Control the product buzzer to produce audible notifications;
- Display module: Display driver content through notifications, and combine to produce various display interfaces;
- Battery voltage management module: Detect the battery power of the product and output the battery power level;
- Temperature measurement module: After collecting the electrical signal of the external temperature sensor through AD, it is restored to the temperature value through various algorithms
- Button module: This module is used to identify whether the product button is active;
- Wireless function module: Transfer the measurement data to the mobile device.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
orally, rectally, and under the arm
Indicated Patient Age Range
adult and pediatric patient population (not suitable for neonates)
Intended User / Care Setting
used at 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: The biocompatibility evaluation for the FDTH series Upper arm Blood Pressure Monitor and the NIBP CUFF were conducted in accordance with the International Standard ISO 10993-1. The worst case of the whole system is considered tissue contacting for duration of less than 24 hours. And the testing included the following tests:
- Cytotoxicity ●
- Skin Sensitization
- Skin Irritation
Electrical safety and electromagnetic compatibility (EMC): Electrical safety and EMC testing were conducted on the FDTH series Upper arm Blood Pressure Monitor, consisting of all the modules and accessories in the system complies with the IEC 60601-1: 2012 and the IEC 60601-1-2: 2014.
Bench Testing: Bench testing was conducted on the FDTH series Upper arm Blood Pressure Monitor, consisting of all the accessories in the system. The system complies with the IEC 60601-1-11: 2015 and ISO 80601-2-56: 2017.
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:
Clinical testing is conducted per ISO 80601-2-56: 2017.
Based on the same product principle, and the clinical validation data on the FDTH3400 can cover all the models included in this submission.
In this clinical study, 105 patients participated in the subjects were volunteer to take part in the clinical study, all the subjects completed the clinical study without any adverse events. The results showed the accuracy of the subject device is within acceptable scope specified in ISO 80601-2-56.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 880.2910 Clinical electronic thermometer.
(a)
Identification. A clinical electronic thermometer is a device used to measure the body temperature of a patient by means of a transducer coupled with an electronic signal amplification, conditioning, and display unit. The transducer may be in a detachable probe with or without a disposable cover.(b)
Classification. Class II (performance standards). The device is exempt from the premarket notification procedures in part 807, subpart E of this chapter, subject to the limitations in § 880.9 and the following conditions for exemption:(1) Device is not a clinical thermometer with telethermographic functions;
(2) Device is not a clinical thermometer with continuous temperature measurement functions; and
(3) Appropriate analysis and testing (such as that outlined in the currently FDA-recognized editions, as appropriate, of ISO 80601-2-56, “Medical electrical equipment—Part 2-56: Particular requirements for basic safety and essential performance of clinical thermometers for body temperature measurement,” or ASTM E1965, “Standard Specification for Infrared Thermometers for Intermittent Determination of Patient Temperature,” or ASTM E1112, “Standard Specification for Electronic Thermometer for Intermittent Determination of Patient Temperature,” or ASTM E1104, “Standard Specification for Clinical Thermometer Probe Covers and Sheaths”) must validate specifications and performance of the device.
0
Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services - USA 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.
April 5, 2024
Famidoc Technology Company Limited Amos Zou Management Representative No.212 Yilong Road, Hexi Industrial Zone, Jinxia, Changan Town Dongguan, Guangdong 523853 China
Re: K233192
Trade/Device Name: Wireless Smart Thermometer (Model: FDTH3401, FDTH3402, FDTH3403, FDTH3404, FDTH3405, FDTH3406, FDTH3407, FDTH3408, FDTH3409, FDTH3410, FDTH3411, FDTH-V0-13, FDTH-V0-4) Regulation Number: 21 CFR 880.2910 Regulation Name: Clinical Electronic Thermometer Regulatory Class: Class II Product Code: FLL Dated: March 7, 2024 Received: March 7, 2024
Dear Amos Zou:
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 (the 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 available at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
1
Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
Your device is also subject to, among other requirements, the Quality System (OS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).
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 Part 803) for devices or postmarketing safety reporting (21 CFR Part 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 Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Porsche Bennett
Porsche Bennett for David Wolloscheck, Ph.D. Assistant Director DHT3C: Division of Drug Delivery and
2
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
3
Indications for Use
510(k) Number (if known) K233192
Device Name
Wireless Smart Thermometer (Model: FDTH3400, FDTH3402, FDTH3403, FDTH3404, FDTH3405, FDTH3406, FDTH3407, FDTH3408, FDTH3409, FDTH3410, FDTH3411, FDTH-V0-13, FDTH-V0-4)
Indications for Use (Describe)
Wireless Smart Thermometer is intended to be used at home for the intermittent measurement and monitoring of human body temperature orally, rectally, and under the arm. The devices are reusable for the adult and pediatic patient population (not suitable for neonates).
| 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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4
510(K) SUMMARY -K233192
This summary of 510(K) substantial equivalence information is being submitted in accordance with the requirement 21 CFR 807.92.
1. Submitter of 510(K):
| Company Name: | Famidoc Technology Company Limited |
|---|---|
| Address: | No.212 Yilong Road, Hexi Industrial Zone, Jinxia, Changan Town |
| Dongguan Guangdong 523853 CN | |
| Contact person: | Amos Zou |
| TEL: | +86 -769-89272488 |
| E-mail: | qa@famidoc.com |
| Date of Prepared: | April 4, 2024 |
2. Subject Device:
| Device Trade Name: | Wireless Smart Thermometer (Model:
FDTH3400, FDTH3401, FDTH3402,
FDTH3403, FDTH3404,
FDTH3405, FDTH3406, FDTH3407, FDTH3408,
FDTH3409, FDTH3410,
FDTH3411, FDTH-V0-13, FDTH-V0-4) |
|--------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Regulation Name | Clinical electronic thermometer |
| Product Code: | FLL |
| Regulation number | 21 CRF 880.2910 |
| Device Class | II |
3. Predicate Device:
| 510(K) | K173730 |
|---|---|
| Trade Name | Kinsa QuickCare Thermometer |
| Manufacturer | KINSA, Inc. |
| Regulation Name | Clinical electronic thermometer |
| Product Code: | FLL |
| Regulation number | 21 CRF 880.2910 |
| Device Class | II |
4. Description of Subject Device:
Wireless Smart Thermometer (Model: FDTH3400, FDTH3401, FDTH3402,
FDTH3403, FDTH3404, FDTH3405, FDTH3406, FDTH3407, FDTH3408, FDTH3409,
FDTH3410, FDTH3411, FDTH-V0-13, FDTH-V0-4) utilizes a modular design method and consists of six main modules:
- Buzzer module: Control the product buzzer to produce audible notifications;
- Display module: Display driver content through notifications, and combine to produce various display interfaces;
5
- Battery voltage management module: Detect the battery power of the product and output the battery power level;
- Temperature measurement module: After collecting the electrical signal of the external temperature sensor through AD, it is restored to the temperature value through various algorithms
- Button module: This module is used to identify whether the product button is active;
- Wireless function module: Transfer the measurement data to the mobile device.
5. Indications for Use
Wireless Smart Thermometer is intended to be used at home for the intermittent measurement and monitoring of human body temperature orally, rectally, and under the arm. The devices are reusable for the adult and pediatric patient population (not suitable for neonates).
6. Technical Characteristic and Substantial Equivalence
The following table compares the technological characteristics between the subject device to the predicate device.
6
| 7. Comparison of Technological Characteristics with Predicate Device | |
|---|---|
| ---------------------------------------------------------------------- | -- |
| Elements of
Comparison | Subject Devices | | | | | Predicate Device | Comparison
Result |
|--------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------|
| Device Name &
510k Number | Wireless Smart Thermometer (Model: FDTH3400, FDTH3401, FDTH3402, FDTH3403, FDTH3404,
FDTH3405, FDTH3406, FDTH3407, FDTH3408, FDTH3409, FDTH3410,
FDTH3411, FDTH-V0-13, FDTH-V0-4) | | | | | Kinsa QuickCare
Thermometer- K173730 | / |
| Device Model | FDTH3400FDTH3405 | FDTH-V0-13 | FDTH3406FDTH3411 | FDTH-V0-4 | | KSA-110 | / |
| Intended Use and Indications for Use | | | | | | | |
| Intended Use | Wireless Smart
Thermometer is
intended to be used at
home for the intermittent
measurement and
monitoring of human
body temperature orally,
rectally, and under the
arm. The devices are
reusable for the adult
and pediatric patient
population (not suitable
for neonates). | Wireless Smart
Thermometer is
intended to be used at
home for the intermittent
measurement and
monitoring of human
body temperature orally,
rectally, and under the
arm. The devices are
reusable for the adult
and pediatric patient
population (not suitable
for neonates). | Wireless Smart
Thermometer is
intended to be used at
home for the
intermittent
measurement and
monitoring of human
body temperature
orally, rectally, and
under the arm. The
devices are reusable
for the adult and
pediatric patient
population (not suitable
for neonates). | Wireless Smart
Thermometer is
intended to be used at
home for the intermittent
measurement and
monitoring of human
body temperature orally,
rectally, and under the
arm. The devices are
reusable for the adult
and pediatric patient
population (not suitable
for neonates). | | The Kinsa QuickCare
Thermometer is used for
the intermittent
measurement and
monitoring of human body
temperature, orally,
rectally and under the arm.
The device is for the adult
and pediatric population. | Similar |
| Performance Specification | | | | | | | |
| Power supply
voltage | CR1632 battery | CR1632 battery | CR1632 battery | CR1632 battery | | Battery powered CR2032
(3V) | Similar |
| Display module | LED (No backlight) | LED (No backlight) | LCD (No backlight) | LCD (No backlight) | | LCD (No backlight) | Similar
Note 1 |
| Measuring | Adjusted mode / Direct | Adjusted mode / Direct | Adjusted mode | Adjusted mode | | Adjusted mode | Similar |
| Method | mode | mode | | | | Note 2 | |
| Measuring type | Axillary / Oral / Rectal | Axillary / Oral / Rectal | Axillary / Oral / Rectal | Axillary / Oral / Rectal | Axillary / Oral / Rectal | Same | |
| Measuring range | $32.00°C ~ 42.90°C$ | $32.00°C ~ 42.90°C$ | $32.0°C ~ 42.9°C$ | $32.0°C ~ 42.9°C$ | $32°C-42.8°C$ | Similar | |
| | $(89.60°F109.22°F)$ | $(89.60°F109.22°F)$ | $(89.6°F109.2°F)$ | $(89.6°F109.2°F)$ | $(89.6°F-109.2°F)$ | Note 3 | |
| Measuring
accuracy | $±0.10°C$ :
between
$35.00°C42.00$107.60°F)$
$°C$
$(±0.18°F$ between
$95.00°F
$±0.20°C(or±0.36°F)$ :
outside this ranges | $±0.10°C$ : between
$35.00°C42.00°C$107.60°F)$
$(±0.18°F$ between
$95.00°F
$±0.20°C(or±0.36°F)$ :
outside this ranges | $±0.3°C$ : between
$34.0°C42.0°C$107.6°F)$
$(±0.6°F$ between
$93.2°F
$±0.4°C(or±0.8°F)$ : outside
this ranges | $±0.3°C$ : between
$34.0°C42.0°C$107.6°F)$
$(±0.6°F$ between
$93.2°F
$±0.4°C(or±0.8°F)$ : outside
this ranges | $±0.2°F(0.1°C),89.6°F-109.2°F(32°C-42.8°C)$ | Different
Note 4 | |
| Display resolution | $0.01°C(0.01°F)$ | $0.01°C(0.01°F)$ | $0.1°C(0.1°F)$ | $0.1°C(0.1°F)$ | $0.1°C(0.1°F)$ | Similar
Note 5 | |
| Measurement
time | Adjusted mode: Less than
8s (for water bath)
Direct mode: Less than
50s (for water bath) | Adjusted mode: Less than
8s (for water bath)
Direct mode: Less than
50s (for water bath) | Less than 8s (for water
bath) | Less than 8s (for water
bath) | Adjusted mode: 8 seconds
nominally | Similar
Note 6 | |
| High body
temperature hint | $≥37.60°C(99.68°F)$ | $≥37.60°C(99.68°F)$ | $≥37.6°C(99.7°F)$ | $≥37.6°C(99.7°F)$ | $≥37.8°C(100.4°F)$ | Different
Note 7 | |
| Temperature unit | °C/°F | °C/°F | °C/°F | °C/°F | °C/°F | Same | |
7
8
| Memory group | Last time memory display | Last time memory display | Full temperature history | Similar | ||
|---|---|---|---|---|---|---|
| 8 groups of memories | ||||||
| (FDTH3401) | 8 groups of memories | |||||
| (FDTH3406) | available on mobile device | Note 8 | ||||
| 7 groups of memories | ||||||
| (FDTH3402) | 7 groups of memories | |||||
| (FDTH3407) | ||||||
| 6 groups of memories | ||||||
| (FDTH3403) | 6 groups of memories | |||||
| (FDTH3408) | ||||||
| 5 groups of memories | ||||||
| (FDTH3404) | 5 groups of memories | |||||
| (FDTH3409) | ||||||
| 3 groups of memories | ||||||
| (FDTH3405) | 3 groups of memories | |||||
| (FDTH3410) | ||||||
| Last time memory | Last time memory |
9
| display(FDTH3400) | display(FDTH3411) | |||||
|---|---|---|---|---|---|---|
| Sensor type | Thermistor | Thermistor | Same | |||
| Wireless interface | Bluetooth Low Energy (BLE) | Bluetooth Low Energy (BLE) | Same | |||
| Materials | TPE, ABS, Stainless Steel | TPE, ABS, Stainless Steel | Biocompatible metals and resins | Similar Note 9 | ||
| OPERATING & STORAGE CONDITIONS | ||||||
| Operation condition | Temperature:5 $^{\circ}$ C~40 $^{\circ}$ C | |||||
| (41°F~104°F) | ||||||
| Relative humidity:15%~95%RH, | ||||||
| No condensing | ||||||
| Atmospheric pressure:70 kPa~106 kPa | Temperature:5 $^{\circ}$ C~40 $^{\circ}$ C | |||||
| (41°F~104°F) | ||||||
| Relative humidity:15%~95%RH, | ||||||
| No condensing | ||||||
| Atmospheric pressure:70 kPa~106 kPa | 59°F-95°F(15°C-35°C)15 % to 85% | |||||
| R.H non-condensing | Similar Note 10 | |||||
| Transportation and storage condition | Temperature:-25°C~55°C | |||||
| (-13°F~131°F) | ||||||
| Relative humidity:15%~95%RH, | ||||||
| No condensing | ||||||
| Atmospheric pressure:70 kPa~106 kPa | Temperature:-25°C~55°C | |||||
| (-13°F~131°F) | ||||||
| Relative humidity:15%~95%RH, | ||||||
| No condensing | ||||||
| Atmospheric pressure:70 kPa~106 kPa | -13°Fto +95°F(-25°Cto +35°C)at R.H.up to 90%non-condensingand 95°F to 158°F(35°C to 70°C) at a water vapor pressure up to 50 hPa | Similar Note 11 | ||||
| Shelf life | 5 years | 5 years | Unknown | Different Note 12 | ||
| COMPLIANCE STANDARDS | ||||||
| Electrical Safety | IEC 60601-1 | IEC 60601-1 | Same | |||
| EMC | IEC 60601-1-2 | IEC 60601-1-2 | Same | |||
| Home Use | IEC 60601-1-11 | IEC 60601-1-11 | Same | |||
| Performance | ISO 80601-2-56 | ISO 80601-2-56 | Same | |||
| Biocompatibility | All the patient | |||||
| contracting materials | ||||||
| are evaluated by the | ||||||
| biocompatibility | ||||||
| standard ISO | ||||||
| 10993 -5, -10. | All the patient | |||||
| contracting materials | ||||||
| are evaluated by the | ||||||
| biocompatibility | ||||||
| standard ISO | ||||||
| 10993 -5, -10. | All the patient | |||||
| contracting materials | ||||||
| are evaluated by the | ||||||
| biocompatibility | ||||||
| standard ISO | ||||||
| 10993 -5, -10. | All the patient | |||||
| contracting materials | ||||||
| are evaluated by the | ||||||
| biocompatibility | ||||||
| standard ISO | ||||||
| 10993 -5, -10. | All the patient | |||||
| contracting | ||||||
| materials are | ||||||
| evaluated by the | ||||||
| biocompatibility | ||||||
| standard ISO | ||||||
| 10993 -5, -10. | Same |
10
11
Note 1
The display module of the subject device is different; however, the subject device performance testing demonstrates that the difference does not raise different questions of safety and effectiveness.
Note 2
The measuring method of models FDTH3400 and FDTH-V0-13 of the subject device are different than the predicate device. The subject device models FDTH3400 and FDTH-V0-13 measure in direct mode measurement time is longer than the adjustment mode measurement time; however, device accuracy was tested in accordance with the ISO 80601-2-56 Standard. Therefore, the difference does not raise different questions of safety and effectiveness.
Note 3 and 4
The Measuring Range and Accuracy of the subject device are different; however, the measuring range and accuracy of subject device are both in compliance with IEC 60601-1 and ISO 80601-2-56. Therefore, this difference does not raise different questions of safety and effectiveness.
Note 5
The display resolution of the subject device and predicate device are different as the subject device models FDTH3400 and FDTH-V0-13 have a higher display accuracy, However, this difference does not raise any different questions of safety and effectiveness.
Note 6
The measurement time of subject device and predicate device is different as the subject device models, FDTH3400 and FDTH-V0-13 measure in direct mode and therefore the measurement time is longer. Performance testing was adequately conducted in accordance with IEC 60601-1 and ISO 80601-2-56 and demonstrate that the different questions of safety and effectiveness.
Note 7
The high body temperature alert is different between the subject and predicate device. However, performance testing demonstrates that the difference does not raise new questions of safety and effectiveness.
Note 8
The Memory group of the subject device and predicate device are different. The memory measurement storage is indicated in the user manual and outer carton, The difference does not raise different questions of safety and effectiveness.
Note 9
The materials between the subject and predicate device are different; however, biocompatibility testing demonstrates the difference does not raise different questions of safety and effectiveness.
Note 10 and Note 11
The Temperature, Relative Humidity and Atmospheric pressure of Operation as well as the storage environment of subject devices is different between the subject and predicate device;
12
however, they are both in compliance with IEC 60601-1-11 and therefore, the differences do not raise different questions of safety and effectiveness.
Note 12
The subject device performance was tested over the shelf life to applicable standards as identified below. Therefore, the difference does not raise different questions of safety and effectiveness.Performance Testing: Performance data includes "Non-Clinical Data" and "Clinical Data", brief description of which are shown as below.
7.1 Non-Clinical Data:
The following performance data were provided in support of the substantial equivalence determination.
7.2 Biocompatibility testing
The biocompatibility evaluation for the FDTH series Upper arm Blood Pressure Monitor and the NIBP CUFF 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 worst case of the whole system is considered tissue contacting for duration of less than 24 hours. And the testing included the following tests:
- Cytotoxicity ●
- Skin Sensitization
- Skin Irritation
7.3 Electrical safety and electromagnetic compatibility (EMC)
Electrical safety and EMC testing were conducted on the FDTH series Upper arm Blood Pressure Monitor, consisting of all the modules and accessories in the system complies with the IEC 60601-1: 2012 Medical electrical equipment Part 1: General requirements for basic safety and essential performance for safety and the IEC 60601-1-2: 2014 Medical electrical equipment –Part 1-2: General requirements for basic safety and essential performance – Collateral Standard: Electromagnetic disturbances - Requirements and tests standard for EMC.
7.4 Bench Testing
Bench testing was conducted on the FDTH series Upper arm Blood Pressure Monitor, consisting of all the accessories in the system. The system complies with the IEC 60601-1-11: 2015 MEDICAL ELECTRICAL EQUIPMENT –Part 1-11: General requirements for basic safety and essential performance -Collateral Standard: Requirements for medical electrical equipment and medical electrical systems used in the home healthcare environment, ISO 80601-2-56: 2017 Medical electrical equipment -- Part 2-56: Particular requirements for basic safety and essential performance of clinical thermometers for body temperature measurement.
7.5 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.
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7.6 Clinical data:
Clinical testing is conducted per ISO 80601-2-56: 2017 Medical electrical equipment — Part 2-56:Particular requirements for basic safety and essential performance of clinical thermometers for body temperature measurement.
Based on the same product principle, and the clinical validation data on the FDTH3400 can cover all the models included in this submission.
In this clinical study, 105 patients participated in the subjects were volunteer to take part in the clinical study, all the subjects completed the clinical study without any adverse events. The results showed the accuracy of the subject device is within acceptable scope specified in ISO 80601-2-56.
8. Conclusions:
The subject device has the same intended use and similar technological characteristics as the predicate device, Kinsa QuickCare Thermometer cleared under K173730. Clinical testing demonstrate that any differences in their technological characteristics do not raise any new questions of safety or effectiveness. The subject device is substantially equivalent to the predicate device.