MICROLIFE IT2CA1

K990168 · Microlife Systems AG · FLL · Feb 25, 1999 · General Hospital

Device Facts

• Record ID: K990168
• Device Name: MICROLIFE IT2CA1
• Applicant: Microlife Systems AG
• Product Code: FLL · General Hospital
• Decision Date: Feb 25, 1999
• Decision: SESE
• Submission Type: Abbreviated
• Regulation: 21 CFR 880.2910
• Device Class: Class 2
• Attributes: Pediatric

Intended 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.

Device Story

Device is a digital electronic thermometer for home use; utilizes a thermistor-based probe with a resistive warming element. Input: temperature signals from sublingual or axillary sites. Operation: in 'Rapid' mode, a predictive algorithm calculates the final converged temperature based on the rate of probe warming; in 'Normal' mode, it displays the actual sensed temperature. Output: digital temperature reading on an LCD. Operated by the patient or caregiver at home. The device reduces measurement time, minimizing patient discomfort and immobilization. Healthcare providers or users interpret the output to assess febrile status. Benefits include rapid, accurate temperature determination in a non-clinical setting.

Clinical Evidence

No clinical data provided. Substantial equivalence is based on technological comparison, bench testing, and compliance with ASTM E1112-86 and prEN12470-3:1997 standards.

Technological Characteristics

Materials: ABS plastic (Cycolac-T), LDPE probe covers. Sensing: Negative temperature coefficient ceramic thermistor, hermetically sealed in epoxy-filled polyamide tube. Energy: 3 AAA alkaline batteries. Form factor: Handheld, 203mm x 35mm x 23mm. Connectivity: Standalone. Algorithm: Predictive software. Standards: ASTM E1112-86, prEN12470-3:1997.

Indications for Use

Indicated for lay/home users (adults and children) to measure oral and axillary body temperature in either Rapid (predictive) or Normal (actual) modes. Intended for compliant patients; not for clinical/professional use.

Regulatory Classification

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.

Special Controls

(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.

Predicate Devices

• SureTemp® (K943695)

Submission Summary (Full Text)

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K990168

- II. 510(k) Summary [As described in CFR §807.92]

| Submitted by: | Micro Idea Instrument Co., LTD.<br>7F, NO.361, TA-NAN Road<br>Shih-lin District<br>Taipei, 11154 China (Taiwan) |
|----------------------|------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Gerhard Frick<br>Regulatory Manager ML Group |
| Date Prepared: | 12/16/98 |
| Proprietary Name: | Microlife IT2CA1 |
| Common Name: | Thermometer, Electronic Thermometer, Predictive<br>Thermometer |
| Classification Name: | Class II §880.2910 Clinical Electronic Thermometer<br>(To be manufactured and marketed for Consumer home<br>use) |
| Predicate Device: | SureTemp®<br>Welch Allyn, Inc.<br>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 Warmer<br>Circuitry | Thermal Design Warmer<br>Circuitry |
| 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 Key<br>Circuits | 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 ASTM<br>requirements E1112-86<br>"Clinical Test Standard",<br>prEN12470-3:1997 | Complies with ASTM<br>requirements E1112-86 "Clinical<br>Test 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 [phone]. Additionally, for questions on Compilance at (50) advertising of your device, please contact the Office of Compliance at [phone]. 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 [phone] 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. |

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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