(37 days)
The IT2CA1 is used in a home use environment to make an accurate prediction of a febrile, or afebrile compliant patients oral temperatures after a measurement time (in the sublingual pocket) of only 4 seconds, and axillary temperatures in approximately 10 seconds in the Rapid mode. In Normal mode, the IT2CA1 provides accurate determination of actual, oral and axillary temperatures of compliant patients. The IT2CA1 is intended for lay or home use only; in a home use environment. It is not intended for use by the clinical professional, such as those utilized in the hospital, clinical, or mobile environment use.
The MicroLife IT2CA1 Digital 4-Sec Predictive Thermometer is the first predictive "Consumer Version" of the clinical thermistor thermometer for use in adults and children. Consumer thermometers currently available do not utilize the predictive technique, and acquire oral and axillary temperature in the standard mode, in which the measurement period is approximately one minute. The IT2CA1 consumer version 4-Sec predictive thermometer, embodies the predictive algorithm of the SureTemp® from Welch Allyn, San Diego, which provides a safe, simple, rapid and accurate method for determining clinical temperature using the traditional body sites and proven technology. The IT2CA1 can be used in either "Rapid" (predictive) mode or "Normal" mode. In Normal mode, the IT2CA1 indicates the actual temperature sensed by the thermistor in the probe. In Normal mode, the measurement ends when temperature rise is <0.1°C/25 sec. In the Rapid mode, the IT2CA1 uses an algorithm to calculate the temperature that the thermistor in the probe would eventually reach (converge to) if it remained in place (in the patient's body). In the Rapid mode, as the probe temperature gets closer to the patient's sublingual (under the tongue), or axillary temperature, the decreasing temperature difference between the probe and the patient causes the rate that the probe warms to decrease. The changes in the probe temperature enable the predictive algorithm to claculate the temperature at which the probe would stop being warmed by the patient (when it reaches the temperature of the patient). The IT2CA1 minimizes the amount of time the probe must be in the patient before the algorithm can calculate the "predicted" final temperature, through the use of the temperature-sensing probe which features the traditional thermistor technology and the predictive algorithm of the SureTemp® from Welch Allyn, San Diego. The minimization of time redues patient immobilization and discomfort is minimized while the convenience for the home user is maximized. The device assembly is made of acrylonitrile butadiene styrene (ABS), Cycolac-T grade or equal. The sensor measures the temperature of the probe tip. It is a negative temperature coefficient ceramic sensing elements, which has leads bonded and then encapsulated in an epoxy-filled polyamide tube. This assembly process renders the sensor hermetically sealed from possible environmental contamination. The resistive warming element within the probe plays a role in enabling the rapid oral temperature determination. Prior to each use, the probe of the IT2CA1 must be covered by a disposable low density polyethylene (LDPE) plastic probe cover that does not significantly reduce the transfer of heat from the patient to the probe body and thermistor. The disposable probe cover prevents microbiological crosscontamination among patients which might occur with a reusable probe cover. The disposable probe covers will be manufactured by Welch Allyn, San Diego.
Here's a breakdown of the acceptance criteria and the study information for the Microlife IT2CA1 thermometer, based on the provided text:
Acceptance Criteria and Device Performance
| Acceptance Criteria | Reported Device Performance (Microlife IT2CA1) |
|---|---|
| Accuracy | ±0.2 °F (±0.1 °C) |
| Technical measuring accuracy in normal (standard) mode and in water bath | ± 0.1°C |
| Temperature Measurement Range | 84°F (28.9°C) - 108°F (42.2°C) |
| Complied Standards | ASTM requirements E1112-86 "Clinical Test Standard", prEN12470-3:1997 |
Note: The provided text compares the Microlife IT2CA1 to the predicate device (Welch Allyn SureTemp®), and these values are presented as specifications for both. The text implies that the Microlife IT2CA1 meets these standards because it is stated to comply with them and shares the same core technology and accuracy claims as the predicate.
Study Information:
The provided document is a 510(k) summary, which is a premarket notification to the FDA. It primarily focuses on demonstrating substantial equivalence to a predicate device rather than presenting a detailed independent clinical study with novel acceptance criteria and extensive performance data generation. The information about the "study" is therefore framed in the context of demonstrating this equivalence.
-
Sample size used for the test set and the data provenance:
- Test Set Sample Size: Not explicitly stated. The document refers to the device embodying "the predictive algorithm of the SureTemp® from Welch Allyn," implying a reliance on the predicate device's established performance. The clinical test standard (ASTM E1112-86) would typically specify required sample sizes for clinical accuracy testing, but the results for the IT2CA1 itself are summarized and not presented in detail as a separate study.
- Data Provenance: The document does not specify the country of origin for any specific test data for the IT2CA1, nor does it explicitly state whether it was retrospective or prospective. Given that the device "embodies the predictive algorithm of the SureTemp®," it's highly likely that the underlying algorithm's validation data stems from the predicate device's development.
-
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not explicitly stated. This level of detail is typically found in a full clinical study report, not a 510(k) summary focused on substantial equivalence. The "clinical test standard" (ASTM E1112-86) would outline methods for establishing ground truth, which would likely involve controlled temperature measurements by trained personnel, but specific expert qualifications for the IT2CA1's validation are not provided.
-
Adjudication method for the test set: Not explicitly stated.
-
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:
- An MRMC study was not done. This device is a thermometer, not an AI-assisted diagnostic imaging device or a system requiring human interpretation comparison. It provides a direct temperature reading.
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If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- Yes, in essence. The device itself (the thermometer with its predictive algorithm) operates in a standalone manner to provide a temperature reading. The accuracy claims are for the device's output. The "Rapid" (predictive) mode relies entirely on the internal algorithm to calculate the temperature.
-
The type of ground truth used:
- The ground truth for thermometer accuracy is typically established through precisely controlled temperature baths or comparison against highly accurate reference thermometers in a clinical setting. The mention of "technical measuring accuracy in normal (standard) mode and in water bath: ± 0.1°C" suggests that controlled water bath testing was a method for establishing ground truth for the core temperature sensing. For the predictive algorithm, it would involve comparison to actual stabilized body temperatures (clinical ground truth, likely obtained by leaving a standard thermometer in place until stable).
-
The sample size for the training set: Not explicitly stated. The "training set" for the predictive algorithm would have been developed during the creation of the SureTemp® device, and its details are not provided here.
-
How the ground truth for the training set was established:
- The document states that the IT2CA1 "embodies the predictive algorithm of the SureTemp® from Welch Allyn." Therefore, the ground truth for training the algorithm would have been established during the development of the SureTemp® device. This would typically involve:
- Clinical Data Collection: Prospective studies where the probe is placed, initial temperature changes are recorded, and then the probe is left in place for a prolonged period to obtain the actual, stable "converged-to" temperature (the ground truth).
- Controlled Environment Data: Possibly using physical models or simulations with known temperature characteristics to calibrate and refine the algorithm.
The specifics of how Welch Allyn established this ground truth for their SureTemp® algorithm are not detailed in this 510(k) for Microlife.
- The document states that the IT2CA1 "embodies the predictive algorithm of the SureTemp® from Welch Allyn." Therefore, the ground truth for training the algorithm would have been established during the development of the SureTemp® device. This would typically involve:
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- II. 510(k) Summary [As described in CFR §807.92]
| Submitted by: | Micro Idea Instrument Co., LTD.7F, NO.361, TA-NAN RoadShih-lin DistrictTaipei, 11154 China (Taiwan) |
|---|---|
| Contact Person: | Gerhard FrickRegulatory Manager ML Group |
| Date Prepared: | 12/16/98 |
| Proprietary Name: | Microlife IT2CA1 |
| Common Name: | Thermometer, Electronic Thermometer, PredictiveThermometer |
| Classification Name: | Class II §880.2910 Clinical Electronic Thermometer(To be manufactured and marketed for Consumer homeuse) |
| Predicate Device: | SureTemp®Welch Allyn, Inc.510(k) Document Control Number K943695 |
Description of the Device:
The MicroLife IT2CA1 Digital 4-Sec Predictive Thermometer is the first predictive "Consumer Version" of the clinical thermistor thermometer for use in adults and children. Consumer thermometers currently available do not utilize the predictive technique, and acquire oral and axillary temperature in the standard mode, in which the measurement period is approximately one minute. The IT2CA1 consumer version 4-Sec predictive thermometer, embodies the predictive algorithm of the SureTemp® from Welch Allyn, San Diego, which provides a safe, simple, rapid and accurate method for determining clinical temperature using the traditional body sites and proven technology.
The IT2CA1 can be used in either "Rapid" (predictive) mode or "Normal" mode. In Normal mode, the IT2CA1 indicates the actual temperature sensed by the thermistor in the probe. In Normal mode, the measurement ends when temperature rise is <0.1°C/25 sec. In the Rapid mode, the IT2CA1 uses an algorithm to calculate the temperature that the thermistor in the probe would eventually reach (converge to) if it remained in place (in the patient's body). In the Rapid mode, as the probe temperature gets closer to the patient's sublingual (under the tongue), or axillary temperature, the decreasing temperature difference between the probe and the patient causes the rate that the
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probe warms to decrease. The changes in the probe temperature enable the predictive algorithm to claculate the temperature at which the probe would stop being warmed by the patient (when it reaches the temperature of the patient). The IT2CA1 minimizes the amount of time the probe must be in the patient before the algorithm can calculate the "predicted" final temperature, through the use of the temperature-sensing probe which features the traditional thermistor technology and the predictive algorithm of the SureTemp® from Welch Allyn, San Diego. The minimization of time redues patient immobilization and discomfort is minimized while the convenience for the home user is maximized.
The device assembly is made of acrylonitrile butadiene styrene (ABS), Cycolac-T grade or equal. The sensor measures the temperature of the probe tip. It is a negative temperature coefficient ceramic sensing elements, which has leads bonded and then encapsulated in an epoxy-filled polyamide tube. This assembly process renders the sensor hermetically sealed from possible environmental contamination. The resistive warming element within the probe plays a role in enabling the rapid oral temperature determination. Prior to each use, the probe of the IT2CA1 must be covered by a disposable low density polyethylene (LDPE) plastic probe cover that does not significantly reduce the transfer of heat from the patient to the probe body and thermistor. The disposable probe cover prevents microbiological crosscontamination among patients which might occur with a reusable probe cover. The disposable probe covers will be manufactured by Welch Allyn, San Diego. A complete list of features and characteristics for the IT2CA1 have been provided in Table 1.
Intended Use of the Device:
The IT2CA1 thermometer has the same intended use as the predicate device. The device is used in the determination of a febrile, or afebrile patient temperature, in either rapid mode(4sec. Predictive temperature), or standard/monitor mode(actual determination of temperature). The IT2CA1 differs from the predicate device with regards to user environment. The predicate device is utilized in a clinical environment, while the IT2CA1 provides the home user with the ability to determine temerature.
The IT2CA1 is intended for lay or home use only; in a home use environment. It is not intended for use by the clinical professional, such as those utilized in the hospital, clinical, or mobile environment use.
Technological Characteristics:
The IT2CA1 utilizes the same temperature-sensing probe which utilizes the traditional thermistor technology and the predictive algorithm of the SureTemp® predictive clinical electronic thermometer. The following table summarizes the similarities and differences between the IT2CA1 and the predicate device.
Table 1
Specifications & Technological Comparison Between the Microlife IT2CA1 & the Welch Allyn SureTemp®
| MicroLife IT2CA1 | Welch Allyn SureTemp® | |
|---|---|---|
| Type | Instant - Home Use | Instant - Clinical |
| Device Technology | Thermistor in Probe | Thermistor in Probe |
| Probe | Thermal Design WarmerCircuitry | Thermal Design WarmerCircuitry |
| Software | Predictive Algorithm | Predictive Algorithm |
| Accuracy | ±0.2 °F (±0.1 °C) | ±0.2 °F (±0.1 °C) |
| Technical measuring | In normal (standard) mode1 and | In monitor mode2 and in water |
| accuracy | in water bath: ± 0.1°C | bath: ± 0.1°C |
| Temperature | 84°F (28.9°C) | 84°F (28.9°C) |
| Measurement Range | - 108°F (42.2°C) | - 108°F (42.2°C) |
| Measuring Modes | ||
| Oral | Normal or Rapid (Predictive) | Monitor or Normal (Predictive) |
| Axillary | Normal or Rapid (Predictive) | Monitor or Normal (Predictive) |
| Rectal | NA | Monitor or Normal (Predictive) |
| Display | LCD with indicating unit 0.1°C | Custom LCD |
| Acoustic | Indicates readiness for | Indicates readiness for |
| measurement | measurement | |
| Low Battery Indicator | Yes | Yes |
| Number of readings stored | Display of temperature last | Display of temperature last |
| in Memory | measured | measured |
| Unit Dimensions | ||
| Height | 23mm | 57.15 mm |
| Width | 35mm | 76.2 mm |
| Length | 203mm | 177.8 mm |
| Weight | 55g (without batteries) | 318.9 g |
| Operating Environment | +10°C to +40°C | +15°C to +40°C |
| Humidity Range | 15% to 95%, non-condensing | 15% to 95%, non-condensing |
| Storage Environment | -4F° (-20°C) to 120F° (50°C) | -4F° (-20°C) to 120F° (50°C) |
| Storage Humidity Range | 15% to 95%, non-condensing | 15% to 95%, non-condensing |
| Power Source | 3 AAA Alkaline Batteries | 3 AA Alkaline Batteries |
| Battery Life | Approximately 3500 readings | Approximately 5000 readings |
| Internal Diagnostic Tests | Yes | Yes |
| Power Up Test of KeyCircuits | Yes | Yes |
| Power Up Test of Heater | Yes | Yes |
| Fail Safe Circuit | ||
| Mounting Configuration | NA | Various Mounting Applications |
| Case Material | ABS Plastic | ABS Plastic |
| Probe cover material | Polyethylene | Polyethylene |
| Automatic Switch off | 30 seconds after end of | No |
| measurement in rapid mode, 10 | ||
| minutes after end of | ||
| measurement in standard mode | ||
| Standards | Complies with ASTMrequirements E1112-86"Clinical Test Standard",prEN12470-3:1997 | Complies with ASTMrequirements E1112-86 "ClinicalTest Standard" |
| Warranty | Two Years | One Year |
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4-Sec. Predictive Instant Thermometer. ' Rapid Mode:
Normal Mode: Maximum Thermometer (measurement ends when temperature rise is <0.1°C/25 sec).
2 Normal Mode: 4-Sec. Predictive Instant Thermometer.
Monitor Mode: Continuous actual temperature readings sensed by the thermistor in the probe.
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Microlife IT2CA1 Premarket Notification
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Image /page/4/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract image of an eagle with three heads.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
FEB 2 5 1999
Microlide Systems AG C/O Mr. Gerhard Frick Regulatory Manager ML Group Micro Idea Instrument Co. Ltd. 7F, NO.361, TA-NAN Road Shih-lin District Taipei, 11154 China (TAIWAN)
K990168 Re : Microlife IT2CA1 Trade Name: Regulatory Class: II Product Code: FLL December 16, 1998 Dated: January 19, 1999 Received:
Dear Mr. Frick
We have reviewed your Section 510(k) notification of intent to we have reviewed your becomed above and we have determined the market the device refly equivalent (for the indications for device is substancially equices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Commerce prior comments, or to devices that have been reclassified in accordance with the provisions of the Federal You may, therefore, Food, Drug, and Cosmetic Act (Act). market the device, subject to the general controls provisions The general controls provisions of the Act 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 (Premarket Approval), it may be subject to such additional controls. Existing major be subject to back adding your device can be found in the Code of Federal Requlations, Title 21, Parts 800 to 895. ਬ rederal negalation determination assumes compliance with the Good Manufacturing Practice for Medical Devices: General che Good Handraosang Barant 820) and that, through periodic (MP inspections, the Food and Drug Administration (FDA) will orn InBpederens) Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in Please note: this response to your the Federal Register. premarket notification submission does not affect any 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.
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Page 2 - Mr. Frick
This letter will allow you to begin marketing your device as Inis lecter will arrow for market notification. The FDA described in your 510(x) promatence of your device to a legally marketed predicate device results in a classification for your marketed predicate device bur device to proceed to the market.
If you desire specific advice for your device on our labeling If you desire specific advice for fishionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4692. Additionally, for questions on Compilance at (50) advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to the regulacion encreted, "Mibidian" = " Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance obtained from the Division. 01 638-2041 or (301) 443-6597 or at its internet address "http://www.fday.gov/cdrh/dsmamain.html".
Sincerely yours,
Timothy A. Ulatowski
Director Division of Dental, Infection Control, and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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VII. Indications for Use Statement
| 510(k) Number: | Unknown |
|---|---|
| Device Name: | Microlife IT2CA1 Electronic Intermittent Thermometer |
| Indications for use: | The IT2CA1 is used in a home use environment to make an accurate prediction of a febrile, or afebrile compliant patients oral temperatures after a measurement time (in the sublingual pocket) of only 4 seconds, and axillary temperatures in approximately 10 seconds in the Rapid mode. In Normal mode, the IT2CA1 provides accurate determination of actual, oral and axillary temperatures of compliant patients. The IT2CA1 is intended for lay or home use only; in a home use environment. It is not intended for use by the clinical professional, such as those utilized in the hospital, clinical, or mobile environment use. |
(Please Do Not Write Below This Line - Continue On Another Page If Needed)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use
Over-The-Counter Use Or
(Per 21 CFR §801.109)
Patricia Vincent
(Division Sign-Off) Division of Dental, Infection Control, and General Hospital Device 510(k) Number
§ 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.