(69 days)
The device is an electronic clinical thermometer using an infrared sensor to detect body temperature from the auditory canal in the neonatal, pediatric and adult population used in the home setting.
The E-Care Technology Corporation Infrared Ear Thermometer, Model LCT-200 is an electronic thermometer using an infrared detector (thermopile detector) to detect body temperature from the auditory canal. Its operation is based on measuring the natural thermal radiation emanating from the tympanic membrane and the adjacent surfaces of the patient.
The E-Care Technology Corporation Infrared Ear Thermometer, Model LCT-200 consists mainly of four parts - an IR detector with a built in ambient temperature sensor, a barrel, an LCD display, and the associated circuit.
The ear canal quides sound to the eardrum. which is thin and flooded with blood at the core temperature. The barrel, usually a cylindrical pipe with a highly reflective inner surface for confining the radiation, is adaptive to the outer canal without contacting the eardrum. When measuring, the radiative fluxes transfer from the tympanum through or reflected by the inner surfaces of the barrel to the IR detector. The ambient sensor is built-in and mounted near the IR sensor element to monitor the ambient temperature.
To measure core temperature, the ear thermometer is inserted into a patient's outer ear canal. A start button is pressed to start the measurement through radiation exchanges. The electrical signal read out from the detector is fed to the circuit for amplification and calculation. The measured temperature then appears on a display. The total operation takes a few seconds.
The provided text describes the E-Care Infrared Ear Thermometer, Model LCT-200, and its substantial equivalence to predicate devices, but lacks detailed acceptance criteria and study results in a format that directly addresses all the requested points. The document focuses on regulatory submission and comparison to existing devices rather than a standalone clinical study report with specific performance metrics.
Based on the available information, here's a breakdown of what can be extracted and what is missing:
Acceptance Criteria and Study Details for E-Care Infrared Ear Thermometer, Model LCT-200
1. Table of Acceptance Criteria and Reported Device Performance:
The document mentions compliance with "applicable voluntary standards includes ASTM E1965 as well as IEC 60601-1 and IEC 60601-1-2 requirements." ASTM E1965-98 is the "Standard Specification for Infrared Thermometers for Intermittent Determination of Patient Temperature." This standard specifies accuracy requirements for clinical thermometers, which would serve as the acceptance criteria. However, the exact performance values measured for the E-Care LCT-200 thermometer against these criteria are not explicitly detailed in the provided text, beyond the general statement that "clinical testing supplied demonstrate that any differences in their technological characteristics do not raise any new questions of safety or effectiveness."
To illustrate, typical ASTM E1965-98 accuracy requirements for clinical infrared thermometers are:
| Temperature Range | Maximum laboratory error (±) |
|---|---|
| 35.0 °C to 42.0 °C | 0.2 °C |
| Below 35.0 °C and above 42.0 °C | 0.3 °C |
Since the document states compliance with ASTM E1965, it is implied that the device met these or similar accuracy criteria for "laboratory error." However, the reported device performance in terms of specific measurement errors or agreement with reference thermometers is not quantified in this summary.
2. Sample Size Used for the Test Set and Data Provenance:
- Sample Size: "The patient population is well represented (neonatal, pediatrics and adults), and the number of patients have been statistically justified." The exact number of patients is not specified.
- Data Provenance: The document does not explicitly state the country of origin for the data. It also does not specify if the study was retrospective or prospective. Given that "Controlled human clinical studies were conducted," it strongly suggests a prospective study.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications:
The document mentions that clinical data compared "IR thermometers to standard oral/rectal thermometers with readings representing a conventional/currently accepted reading, i.e., rectal or oral." This implies that the 'ground truth' was established by readings from these conventional thermometers. No human experts were explicitly mentioned for establishing a ground truth based on their expert opinion for temperature readings, as temperature measurement relies on physical instruments.
4. Adjudication Method for the Test Set:
Not applicable, as temperature measurement relies on instrument readings, not subjective expert assessment requiring adjudication. The comparison was to "standard oral/rectal thermometers."
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done:
No, an MRMC study is typically for evaluating diagnostic imaging systems where human readers interpret medical images. This study concerns the accuracy of a temperature-measuring device.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done:
Yes, the described "Controlled human clinical studies" evaluated the device's performance directly by comparing its readings to conventional thermometers. The device (thermometer) itself is the "algorithm only" in this context, as it automatically processes infrared signals to output a temperature reading. There isn't a human actively "in the loop" making diagnostic decisions based on the device's output that would require a "human-in-the-loop" study in the typical sense.
7. The Type of Ground Truth Used:
The ground truth used was comparative measurements against established clinical standards: "standard oral/rectal thermometers with readings representing a conventional/currently accepted reading, i.e., rectal or oral."
8. The Sample Size for the Training Set:
This information is not provided. Clinical studies for medical devices like thermometers often focus on validation (test set) rather than a "training set" in the machine learning sense. The device's underlying physics-based algorithms are typically designed and calibrated internally by the manufacturer rather than through a distinct, externally validated "training data set."
9. How the Ground Truth for the Training Set Was Established:
This information is not provided. As noted above, the concept of a separate "training set" with ground truth in the machine learning sense is not explicitly discussed for this type of device in the provided document. The device's internal calibration and algorithm development would have been based on engineering principles and potentially internal testing, but specific details are absent.
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AUG 0 6 2002
Ko21753
EXHIBIT # 1
510(K) SUMMARY
This summary of 510(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:
1. Submitter's Identification:
E-Care Technology Corporation 8F-11, No.35, Hsin-Tai Road Chubei City, Hsinchu, Taiwan 302
Date Summary Prepared:
Contact: Kun-Yuan Ko
2. Name of the Device:
E-Care Infrared Ear Thermometer, Model LCT-200
3. Predicate Device Information:
Braun/ThermoScan Instant Thermometer, IRT3020, IRT3520, Braun Ltd. K#983295, ThermoScan Inc.
Omron Gentle Temp MC-505. Omron Health Care K#922344. Omron Health Care.
4. Device Description:
The E-Care Technology Corporation Infrared Ear Thermometer, Model LCT-200 is an electronic thermometer using an infrared detector (thermopile detector) to detect body temperature from the auditory canal. Its operation is based on measuring the natural thermal radiation emanating from the tympanic membrane and the adjacent surfaces of the patient.
The E-Care Technology Corporation Infrared Ear Thermometer, Model LCT-200 consists mainly of four parts - an IR detector with a built in ambient temperature sensor, a barrel, an LCD display, and the associated circuit.
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The ear canal quides sound to the eardrum. which is thin and flooded with blood at the core temperature. The barrel, usually a cylindrical pipe with a highly reflective inner surface for confining the radiation, is adaptive to the outer canal without contacting the eardrum. When measuring, the radiative fluxes transfer from the tympanum through or reflected by the inner surfaces of the barrel to the IR detector. The ambient sensor is built-in and mounted near the IR sensor element to monitor the ambient temperature.
To measure core temperature, the ear thermometer is inserted into a patient's outer ear canal. A start button is pressed to start the measurement through radiation exchanges. The electrical signal read out from the detector is fed to the circuit for amplification and calculation. The measured temperature then appears on a display. The total operation takes a few seconds.
ട. Intended Use:
The device is an electronic clinical thermometer using an infrared sensor to detect body temperature from the auditory canal in the neonatal, pediatric and adult population used in the home setting.
6. Comparison to Predicate Devices:
The E-Care Infrared Ear Thermometer, Model LCT-200 is substantially equivalent to the following infrared ear thermometers.
Braun ThermoScan Instant Thermometer, IRT 3020, IRT3520, Braun Ltd., and,
Omron Gentle Temp MC-505, Omron Health Care.
The E-Care Infrared Ear Thermometer, Model LCT-200 uses the well know infrared radiation theory as the predicates and has the similar intended use to the predicates differing only in the infrared sensor used and/or method used to determine the reference ambient temperature.
7. Discussion of Non-Clinical Tests Performed for Determination of Substantial Equivalence are as follows:
Compliance to applicable voluntary standards includes ASTM E1965 as well as IEC 60601-1 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".
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8. Discussion of Clinical Tests Performed:
Controlled human clinical studies were conducted using the E-Care Infrared Ear Thermometer, Model LCT-200 and predicate devices. Clinical data is presented comparing the IR thermometers to standard oral/rectal thermometers with readings representing a conventional/currently accepted reading, i.e., rectal or oral. The patient population is well represented (neonatal, pediatrics and adults), and the number of patients have been statistically justified.
9. Conclusions:
The E-Care Infrared Ear Thermometer, Model LCT-200 has the same intended use and similar characteristics as the Braun/ThermoScan Instant Thermometer and Omron Gentle Temp MC-505 devices. Moreover, bench testing contained in this submission and clinical testing supplied demonstrate that any differences in their technological characteristics do not raise any new questions of safety or effectiveness. Thus, the E-Care Infrared Ear Thermometer, Model LCT-200 is substantially equivalent to the predicate devices.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
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AUG 0 6 2002
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
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E-Care Technology Corporation C/O Ms. Susan D. Goldstein-Falk MDI Consultants, Incorporated 55 Northern Boulevard Great Neck, New York 11021
Re: K021753
Trade/Device Name: E-Care Infared Ear Thermometer, Model LCT-200 Regulation Number: 880.2910 Regulation Name: Clinical Electronic Thermometer Regulatory Class: II Product Code: FLL Dated: May 24, 2002 Received: May 29, 2002
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 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.
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Page 2 - Ms. Falk
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 and additionally 21 CFR Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4618. 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" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained 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.qov/cdrh/dsma/dsmamain.html
Sincerely yours,
Timothy J. Ulatowski
Timothy 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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Exhibit B
Page 1 of 1
510(k) Number (if known): _ KO2 / ワ5 3
Device Name: E-Care Infrared Ear Thermometer, Model LCT-200.
Indications For Use:
The device is an electronic clinical thermometer using an infrared sensor to detect body temperature from the auditory canal in the neonatal, pediatric and adult population used in the home setting.
(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)
OR
Over-The-Counter Use \$\frac{v}{}$
(Optional Format 1-2-96)
Alture Cucerik
esthesiology, General Hospital,
510(k) Number: 4021753
§ 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.