(85 days)
K# 962497
Not Found
No
The device description details a simple electronic thermometer using a thermistor and ASIC for calculation and display. There is no mention of AI, ML, or any complex algorithms that would suggest their use. The performance studies focus on standard compliance and do not involve training or testing data sets typical of AI/ML applications.
No.
The device is described as an electronic clinical thermometer used to detect body temperature, which is a diagnostic function, not a therapeutic one. It does not treat or cure any condition.
No
A diagnostic device is used to identify a disease, condition, or medical problem. While a thermometer measures body temperature, which can be an indicator of health status (e.g., fever), it does not, by itself, diagnose a specific medical condition. It provides a measurement, which a healthcare professional might then use as part of a diagnostic process.
No
The device description explicitly details hardware components such as a thermistor, ASIC, LCD display, and battery, indicating it is a physical device, not software-only.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections. They are used to diagnose, monitor, or screen for various health issues.
- Device Function: The device described is a digital thermometer that measures body temperature directly from the oral, armpit, and rectal sites. It does not analyze samples taken from the body.
- Intended Use: The intended use is to detect body temperature, which is a physiological measurement, not an analysis of a biological sample.
Therefore, based on the provided information, the OSTI Temp - Teller Digital 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
The device is an electronic clinical thermometer using a thermistor to detect body temperature from the oral, ampit, and rectal in the neonatal, pediatric and adult population used in the clinical and home testing.
Product codes
FLL
Device Description
The OSTI Temp - Teller Digital Thermometer, (Models DT-101, DT-102, DT-103, DT-201, DT-202, and DT-203). is an electronic thermometer using a thermistor as the temperature sensor. The sensor's electric signal is then calculated and displayed by an ASIC (Application Specific IC) Models DT-101 and DT-201 display the temperature within a 100" of a degree. Models DT-101, DT-102 and DT-103 employ a 1.5 times larger LCD display than competitive products for easier reading. Models DT-101, DT-102, DT-201 and DT-202 have a water-resistant function.
The digital thermometer comprises: a thermistor for temperature sensing, a reference resistor for comparing the resistance of the thermistor, a buzzer for sounding effect, an ASIC and a LCD display for calculating and displaying the target temperature digitally which the thermistor is immersed. The system uses a 1.5V DC battery for the power supply and the battery power is displayed in LCD if the battery is exhausted.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
oral, ampit, and rectal
Indicated Patient Age Range
neonatal, pediatric and adult population
Intended User / Care Setting
clinical and home testing
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)
Discussion of Non-Clinical Tests Performed for Determination of Substantial Equivalence are as follows: Compliance to applicable voluntary standards includes ASTM E1112, and Compliance to uppliedblo velancery -1 and IEC 60601-1-2 requirements. Guidance Documents included the FDA "Guidance On The Content of Premarket Notification (510(k)) Submissions for Clinical Electronic Thermometers". Discussion of Clinical Tests Performed: Controlled human clinical studies were not conducted using the OSTI Temp Teller Digital Thermometer and predicate devices.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
K# 962497
Reference Device(s)
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
OCT 27 1999
K 992601
EXHIBIT # 1
510(K) SUMMARY
This summary of 5l0(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR §807.92.
The assigned 5l0(k) number is: ______________
Submitter's Identification: 1.
Oriental System Technology Inc. 2F No. 23, Industry E. Road 9" Science Based Industrial Park Hsinehu, Taiwan, R.O.C.
Contact:
Mr. Herman Lee General Manager
Date Summary Prepared: July 1999
2. Name of the Device:
Temp Teller-Digital Thermometer, Models DT-101, DT-102, DT-103, DT-201, DT-202, and DT-203,
3. Predicate Device Information:
-
- Q-Tips®, Faichney, Private Label Clinical Electronic Thermometers K# 962497
-
- Wallgreens PAP-WD
4. Device Description:
The OSTI Temp - Teller Digital Thermometer, (Models DT-101, DT-102, DT-103, DT-201, DT-202, and DT-203). is an electronic thermometer using a thermistor as the temperature sensor. The sensor's electric signal is then calculated and displayed by an ASIC (Application Specific IC) Models DT-101 and DT-201 display the temperature within a 100" of a degree. Models DT-101, DT-102 and DT-103 employ a 1.5 times larger LCD display than competitive products for easier reading. Models DT-101, DT-102, DT-201 and DT-202 have a water-resistant function.
The digital thermometer comprises: a thermistor for temperature sensing, a reference resistor for comparing the resistance of the thermistor, a buzzer for sounding effect, an ASIC and a LCD display for calculating and displaying the target temperature digitally which the thermistor is immersed.
1
The system uses a 1.5V DC battery for the power supply and the battery power is The system uses a 1.3V DC battery for the power Eappy and displayed in LCD if the battery is exhausted.
Intended Use: ട്.
The device is an electronic clinical thermometer using a thermistor to detect body The device is an electionile official the neonatal, pediatric and adult population used in the clinical and home testing.
Comparison to Predicate Devices: 6.
The OSTI Temp Teller – Digital Thermometer, Models DT-101, DT-102, DT-103, DT-The OOT Temp Tollor - Bigkar bother to the following digital thermometers.
- a. Q-I ips®, Faichney, Private Label Clinical Electronic Thermometers K# 962497
- b. Wallgreens PAP-WD
The OSTI Temp Teller Digital Thermometer is similar in design and intended use to the rrne OOTT Temp Teller Digiter Front range and resolution. All products use the same predicates differing only in ambient - thermistor as well as the use of a metal cap to protect temperature sensing chomblay, ASIC, a buzzer and a 1.55V battery.
Discussion of Non-Clinical Tests Performed for Determination of Substantial 7. Equivalence are as follows:
Compliance to applicable voluntary standards includes ASTM E1112, and Compliance to uppliedblo velancery -1 and IEC 60601-1-2 requirements.
Guidance Documents included the FDA "Guidance On The Content of Premarket Notification (510(k)) Submissions for Clinical Electronic Thermometers".
Discussion of Clinical Tests Performed: 8.
Controlled human clinical studies were not conducted using the OSTI Temp Teller Digital Thermometer and predicate devices.
ರು Conclusions:
The OSTI Temp Teller -- Digital Thermometer, Models DT-101, DT-102, DT-103, DT-201, DT-202, and DT-203, have the same intended use and similar technological characteristics as predicate devices. Moreover, bench testing toonhologiour onaracterission and clinical testing supplied demonstrate that any differences in their technological characteristics do not raise any new questions affierorioso iffectiveness. Thus, the OSTI Temp Teller Digital Thermometer, Models DT-101, DT-102, DT-103, DT-201, DT-201, and DT-203 is substantially equivalent to the predicate devices.
2
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Image /page/2/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized caduceus symbol, which is a staff with two snakes coiled around it, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged in a circular fashion around the symbol. The text is in all caps and is in a sans-serif font. The logo is black and white.
OCT 2 7 1999
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Oriental System Technology, Incorporated C/O Ms. Susan D. Goldstein-Falk Official correspondent for Oriental System Technology, Incorporated MDI Consultants, Incorporated 55 Northern Boulevard, Suite 410 Great Neck, New York 11021
Re : K992601 Trade Name: Temp Teller - Digital Thermometer, Models DT-101, DT-102, DT-103, DT-201, DT-202, and DT-203 Regulatory Class : II Product Code: FLL Dated: July 30, 1999 Received: August 3, 1999
Dear Ms. Susan D. Goldstein-Falk:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, qood manufacturing practice, labeling, and prohibitions against misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Good Manufacturing Practice for Medical Devices: General (GMP) regulation (21 CFR Part 820) and that, through periodic GMP inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP requlation may result in requlatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any
3
Page 2 - Ms. Susan D. Goldstein-Falk
obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
This letter will allow you to begin marketing your device as described in your 510 (k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4692. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".
Sinderely yours,
Alilut
Timothy A. Ulatowski Director Division of Dental, Infection Control and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Exhibit B
Page __ 1 __ of __ 1 __
510(k) Number (if known):
Device Name: Oriental System Technology Inc. Temp Teller Digital Thermometer, Models DT-101, DT-102, DT-103, DT-201, DT-202, DT-203
Indications For Use:
The device is an electronic clinical thermometer using a thermistor to detect body temperature from the oral, ampit, and rectal in the neonatal, pediatric and adult population used in the clinical and home testing.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use (Per 21 CFR 801.109)
Over-The-Counter Use
(Optional Format 1-2-96)
Patricia Cuemke
(Division sign-off)
OR
(Division sign-off) Division of Dental, Infection control, And General Hospital Devices 510(k) number _ A 992601