The device is an electronic clinical thermometer using an infrared sensor to detect the human body temperature from the auditory canal in the neonatal, pediatric and adult Populations used in the home setting.

Device Description

The OSTI TempTeller® Infrared Ear Thermometers, model CT-31/31DX/32/32DX, is an electronic thermometer using an infrared sensor to detect human body temperature from the auditory canal. Its operation is based on measuring the natural thermal radiation emanating from the tympanic membrane (eardrum) and the adjacent tissue. OSTI TempTeller® Infrared Ear Thermometers, model CT-31/31DX/32/32DX, consists mainly of five parts: an IR sensor packed together with an ambient temperature sensor, a waveguide, a heat sink made of zinc alloy, a LCD display and the associated circuit. The tympanic membrane (eardrum) is thin and flooded with blood at the core temperature. The wavequide, usually a cylindrical pipe with a highly reflective inner surface for confining the radiation, is adaptive to the outer without contacting the eardrum. When inserting the probe into the ear canal, the radiation fluxes transfer among the tympanum membrane (eardrum), the IR sensor, and the inner surface of the wavequide. The ambient sensor is packed with the IR sensor to monitor the ambient temperature of the IR sensor. To measure core temperature, an ear thermometer is inserted into a patient's outer ear canal. An activation button is pressed to start the measurement through the radiation exchanges. The electrical signal readouts form the IR sensor and the ambient temperature sensor are fed to the circuit for amplification, digitization and calculation. The measured temperature then appears on the LCD. The total operation takes one second. The CT-31/31DX/32/32DX is identical in functionality and performance with the essential change being the external shape of the devices. The modifications to our original 510(k) cleared device, model CT-30/30DX, include dimensional and firmware. The fundamental scientific technology of the modified device remains the same as that of the 510(k) cleared device.

AI/ML Overview

Here's a summary of the acceptance criteria and study information for the Oriental System Technology Inc. TempTeller® Infrared Ear Thermometer, Model CT-31/31DX/32/32DX, based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

The provided 510(k) summary does not detail specific numerical acceptance criteria or explicit reported device performance metrics beyond stating compliance with voluntary standards. Instead, it focuses on demonstrating substantial equivalence to a predicate device.

Acceptance Criteria Category	Specific Criteria (if stated)	Reported Device Performance (if stated)
Voluntary Standards (Electrical Safety & Performance)	Compliance with ASTM E 1965-98, ASTM E 1104, IEC 601-1-1, and IEC 601-1-2 requirements.	The submission states "Compliance to applicable voluntary standards include ASTM E 1965-98 and ASTM E 1104, as well as IEC 601-1-1 and IEC 601-1-2 requirements." This implies that the device met these standards.
Functional Equivalence	Identical functionality to predicate device (Model CT-30/30DX).	"The CT-31/31DX/32/32DX is identical in functionality and performance with the essential change being the external shape of the devices."
Safety and Effectiveness	Maintained original safety and effectiveness after modifications.	"verification and validation tests contained in this submission demonstrate that the modified portions maintained its original safety and effectiveness."
Impact of Modifications	Modifications do not affect intended use or alter fundamental scientific principle.	"Those engineering changes do not: (1) affect the intended use or (2) alter the fundamental scientific of the device."

2. Sample Size Used for the Test Set and Data Provenance

The document does not explicitly state a sample size for a specific clinical test set. The submission references "verification and validation tests" but does not provide details on the number of subjects or the data provenance (e.g., country of origin, retrospective/prospective nature).

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Experts

This information is not provided in the 510(k) summary. The nature of the device (infrared ear thermometer) suggests that ground truth would likely be established through comparative measurements with a reference thermometer, rather than expert interpretation of medical images or data.

4. Adjudication Method for the Test Set

This information is not provided in the 510(k) summary. Given the nature of a thermometer, an adjudication method (like 2+1, 3+1) used for interpreting complex medical data is not typically applicable. Performance is usually assessed against a reference standard.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No, an MRMC comparative effectiveness study was not done. This type of study is typically used for diagnostic imaging devices where human readers interpret medical cases, often with and without AI assistance. Infrared ear thermometers do not involve human interpretation in the same way.

6. If a Standalone Performance Study Was Done

Yes, implicitly. The statement, "Compliance to applicable voluntary standards include ASTM E 1965-98 and ASTM E 1104, as well as IEC 601-1-1 and IEC 601-1-2 requirements," indicates that the device's technical specifications and performance were evaluated against established standards without direct human interaction. These standards include tests for accuracy, stability, and other performance characteristics. The "verification and validation tests" also refer to standalone performance evaluation.

7. The Type of Ground Truth Used

The ground truth for evaluating a thermometer's performance would typically be established by:

Reference Standard Thermometer: Comparing the device's readings against a highly accurate and calibrated reference thermometer.
Known Temperature Environments: Testing the device's accuracy in controlled environments with precisely known temperatures.

The document does not explicitly state the specific type of ground truth employed, but compliance with ASTM E 1965-98 (Standard Specification for Clinical Thermometers, Infrared Ear Type) strongly implies the use of such reference standards and controlled testing.

8. The Sample Size for the Training Set

No training set information is applicable or provided. This device is a measurement tool, not a machine learning or AI algorithm that requires a "training set."

9. How the Ground Truth for the Training Set Was Established

Not applicable, as there is no training set for this type of device.

Summary

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510(K) Summary

This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirement of SMDA 1990 and CFR§807.92.

The assigned 510(k) number is: צע 030299 FEB 2 5 2003

1. Submitter's Identifications:

Oriental System Technology Inc. 2F No.23, Industry E, Road 9th, Science Based Industrial Park Hsinchu, Taiwan, R.O.C

Contact:

Mr. Herman Lee General Manager

Date of Summary Preparation: 30 December 2002

2. Name of the Device:

TempTeller® Infrared Ear Thermometers, Model CT-31/31DX/32/32DX

3. Information of the 510(k) Cleared Device (Predicate Device):

TempTeller® Infrared Ear Thermometers, Model CT-30/30DX 510(k) Number: K#010235

4. Device description:

OSTI TempTeller® Infrared Ear Thermometers, model CT-31/31DX/32/32DX, consists mainly of five parts: an IR sensor packed together with an ambient temperature sensor, a waveguide, a heat sink made of zinc alloy, a LCD display and the associated circuit.

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The tympanic membrane (eardrum) is thin and flooded with blood at the core temperature. The wavequide, usually a cylindrical pipe with a highly reflective inner surface for confining the radiation, is adaptive to the outer without contacting the eardrum. When inserting the probe into the ear canal, the radiation fluxes transfer among the tympanum membrane (eardrum), the IR sensor, and the inner surface of the wavequide. The ambient sensor is packed with the IR sensor to monitor the ambient temperature of the IR sensor.

To measure core temperature, an ear thermometer is inserted into a patient's outer ear canal. An activation button is pressed to start the measurement through the radiation exchanges. The electrical signal readouts form the IR sensor and the ambient temperature sensor are fed to the circuit for amplification, digitization and calculation. The measured temperature then appears on the LCD. The total operation takes one second.

The CT-31/31DX/32/32DX is identical in functionality and performance with the essential change being the external shape of the devices. The modifications to our original 510(k) cleared device, model CT-30/30DX, include dimensional and firmware. The fundamental scientific technology of the modified device remains the same as that of the 510(k) cleared device.

5. Intended Use:

The device is an electronic clinical thermometer using an infrared sensor to detect the body temperature from the auditory canal in the neonatal, pediatric and adult population used in the home setting.

6. Comparison to Predicate Devices:

The OSTI TempTeller® Infrared Ear Thermometers, model CT-31/31DX/32/32DX are substantially equivalent to OSTI TempTeller® Infrared Ear Thermometers, CT-30/30DX. The new models CT-31/31DX/32/32DX have the same intended use as and are similar in design to the 510(k) cleared device.

7. Discussion of Non-Clinical Tests Performed for Determination of Substantial Equivalence are as follows:

Compliance to applicable voluntary standards include ASTM E 1965-98 and ASTM E 1104, as well as IEC 601-1-1 and IEC 601-1-2 requirements.

FDA Guidance documents include the" Deciding When to Submit a 510(k) for a Change to An Exiting Device" and "The New 510(k) Paradigm: Alternate

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Approaches to Demonstrating Substantial Equivalence in Premarket Notifications".

8. Conclusions

The OSTI TempTeller® infrared Ear thermometers, model CT-31/31DX/32/32DX have the same intended use and technological characteristics as the 510(k) cleared device. Moreover, verification and validation tests contained in this submission demonstrate that the modified portions maintained its original safety and effectiveness. Those engineering changes do not: (1) affect the intended use or (2) alter the fundamental scientific of the device.

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

FEB 2 5 2003

Oriental System Technology, Incorporated C/O Ms. Susan D. Goldstein-Falk Official Correspondent Mdi Consultants, Incorporated 55 Northern Boulevard, Suite 200 Great Neck, New York 11021

Re: K030299

Trade/Device Name: Oriental System Technology Incorporated Temp Teller® Infrared Ear Thermometer, Model CT-31/31 DX/32/32DX Regulation Number: 880.2910 Regulation Name: Clinical Electronic Thermometer Regulatory Class: II Product Code: FLL Dated: January 27, 2003 Received: January 29, 2003

Dear Ms. Falk:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food. Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration. listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such additional controls. Existing major regulations affecting vour 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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Page 2 - Ms. Falk

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); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act): 21 CFR 1000-1050.

This letter will allow you to begin marketing your device as described in your Section 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), please contact the Office of Compliance at (301) 594-4618. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely yours,

Susan Kinner

Susan Runner, DDS, MA Interim Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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510(K) Number (If known): K030299

Device Name: Oriental System Technology Inc. TempTeller® Infrared Ear Thermometer, Model CT-31/31DX/32/32DX

Indications for Use

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

	We livinile in BRC
	(Division Sign-Off)
	Division of Anesthesiology, General Hospital,
	Infection Control, Dental Devices
510(k) Number	030299

Prescription Use	Over-The- Counter Use
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(Per 21 CFR 801.109)

ﺎ i ne- Counter U (Optional Format 1-2-96)

Regulation Number and Section

§ 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.