ACON 30 SECOND RELIABLE DIGITAL THERMOMETER, ACON DIGITAL THERMOMETER PROBE COVERS

K060173 · ACON Laboratories, Inc. · FLL · Mar 17, 2006 · General Hospital

Device Facts

• Record ID: K060173
• Device Name: ACON 30 SECOND RELIABLE DIGITAL THERMOMETER, ACON DIGITAL THERMOMETER PROBE COVERS
• Applicant: ACON Laboratories, Inc.
• Product Code: FLL · General Hospital
• Decision Date: Mar 17, 2006
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.2910
• Device Class: Class 2

Intended Use

The ACON™ 30 Second Reliable Digital Thermometer and the ACON™ Digital Thermometer Probe Covers are intended for the quantitative detection of body temperature, which can be obtained orally, under the arm, and/or rectally. It is intended to be sold over-the-counter for home use by lay persons without any professional training.

Device Story

Electronic thermometer; pen-like housing; metal probe tip; LCD display. Input: thermal energy detected by sensor in probe. Operation: converts thermal input to digital temperature reading; displays result on LCD; provides audible beep upon measurement completion. Used in home or clinical settings by laypeople or clinicians. Output: quantitative body temperature (89.6–109.2°F). Benefits: rapid, accurate temperature monitoring; alternative to mercury thermometers. Includes optional disposable probe covers for hygiene.

Clinical Evidence

Controlled human clinical studies evaluated clinical bias, uncertainty, repeatability, and offset. Study compared ACON thermometer performance against the BD Flexible Digital Thermometer (K935267) using non-professional, inexperienced lay users. Results confirmed lay users obtained comparable temperature data and found the device easy to operate. Bench testing verified accuracy (±0.2°F), measurement range, and mechanical safety.

Technological Characteristics

Electronic clinical thermometer; metal probe sensor; 3-digit LCD. Powered by 1.5V LR41 battery. Dimensions: 5.3" x 1.0" x 0.6"; weight: 0.4 oz. Complies with ASTM E1112, EN 60601-1-2, EN 12470-3, and ISO 10993 biocompatibility standards. Features automatic shut-off (8 min) and last memory recall. Waterproof tip area.

Indications for Use

Indicated for quantitative body temperature measurement in lay persons (all ages) via oral, axillary, or rectal routes. Intended for OTC home use; no contraindications specified.

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

• BD Flexible Digital Thermometer, Model #524034 (K935267)

Reference Devices

• Sanitherm Oral Disposable Thermometer Sheaths (K983406)

Submission Summary (Full Text)

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#### ક. 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 510(k) number is _ K060173

# Submitter's Identification:

ACON Laboratories, Inc. 4108 Sorrento Valley Boulevard San Diego, California 92121

Tel.: [phone] Fax: [phone]

Date Prepared: January 19, 2006

## Contact Person:

Edward Tung, Ph.D. V.P., Regulatory Affairs

## Proprietary Name of the Device:

ACON™ 30 Second Reliable Digital Thermometer/ACON Digital Thermometer Probe Covers

### Common Name:

Thermometer, Electronic Thermometer, Predictive Thermometer

### Classification Name:

Class II §880.2910 Clinical Electronic Thermometer (To be manufactured and marketed for consumer home use)

### Predicate Device:

BD Flexible Digital Thermometer, Model #524034 Becton, Dickinson and Company 510(k) Number: K935267

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# Description:

The ACON™ 30 Second Reliable Digital Thermometer consists of a temperature sensor within a metal probe and a Liquid Crystal Display all situated within a pen-like housing. The device is intended for the quantitative detection of body temperature, which can be obtained orally, under the arm, and / or rectally. It is intended to be sold over-the-counter for home use by laypeople without any professional training. And it could be used in hospitals as a substitute for the traditional mercury thermometer.

This device is intended for repeated use. Although the digital thermometer contains no sterile fittings, the user is recommended to clean the device prior to each use. A storage case or probe cover is provided to keep the metal probe tip covered when the thermometer is not in use. The ACONTM 30 Second Reliable Digital Thermometer can be used in conjunction with or withou a disposable probe cover, when preferred.

## Intended Use:

The ACON™ 30 Second Reliable Digital Thermometer and the ACON™ Digital Thermometer Probe Covers are intended for the quantitative detection of body temperature, which one be obtained orally, under the arm, and / or rectally. It is intended to be sold over-the-counter for home use by laypeople without any professional training. And it could be used in hosputals a a substitute for the traditional mercury thermometer.

| Feature | Technical Specification |
|-------------------------------------|-------------------------------------------------------------------|
| Measuring Time | 30 seconds (Oral), 38 seconds (Underarm), 30 seconds (Rectal) |
| Beep | When thermometer is turned on and after completion of measurement |
| Measurement Range | 89.6 - 109.2°F |
| Measurement Accuracy | $\pm$ 0.2°F |
| Resolution | 0.1°F |
| Memory | Last memory recall |
| Automatic Shut Off | After about 8 minutes |
| Display | 3 digit LCD display |
| Operating Temperature | 50 - 109.2°F |
| Storage Temperature | 14 - 140°F |
| Operating/Storage Relative Humidity | 10 - 95% |
| Waterproof | At tip area |
| Battery and Battery Life | 1.5V LR41 battery; about 1,000 uses or 2 years battery life |
| Thermometer Dimensions | 5.3" x 1.0" x 0.6" |
| Thermometer Weight | 0.4 oz |

# Technological Characteristics:

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# Comparison to Predicate Devices:

The ACON™ 30 Second Reliable Digital Thermometer is substantially equivalent to the BD Flexible Digital Thermometer, Model #524034, K935267.

The ACON™ Digital Thermometer Probe Covers are similar to FDA-cleared Sanitherm Oral Disposable Thermometer Sheaths for Banta Healthcare Group, LTD (K983406) (Rite Aid Brand).

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

Compliance to applicable voluntary standards includes ASTM E1112, as well as EN 60601-1-2 and EN 12470-3 requirements and as well as ISO 10993 biocompatibility testing.

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 conducted using the ACON™ 30 Second Reliable Digital Thermometer and the ACON™ Digital Thermometer Probe Covers. Clinical were presented evaluating clinical bias, clinical uncertainty, clinical repeatability and clinical offset per ACON clinical test protocol for Digital Thermometer. Clinical study results indicate that the non-professional, inexperienced lay persons were able to obtain comparable body temperature measurement data when using the ACONTM 30 Second Reliable Digital Thermoment and a legally marketed digital thermometer, BD Flexible Digital Thermometer, Model #524034 (K935267). In addition, the lay persons also satisfied to the ease of the operation following the Instructions for Use in the Instruction Manual.

## Conclusion:

The performance characteristics of the ACON™ 30 Second Reliable Digital Thermometer were verified by temperature range test, accuracy test, resolution test, cleaning test, battery condition test, operation environment test, storage environment test, indicating unit test, function safient, mechanical safety test and Rite Aid disposable probe cover validation test. Testing results, indicate that the ACON™ Digital Thermometer is robust and can perform satisfactorily when used according to the "Indication for Use" statement specified in the Instruction Manuals.

The laboratory testing results and lay person studies demonstrated a substantial equivalency on performance between the ACON™ 30 Second Reliable Digital Thermometer and a FDA-cleared Digital Thermometer, BD Flexible Digital Thermometer, Model #524034 (K935267), with the same intended use and product features. The lay person study results also demonstrated that the ACON™ 30 Second Reliable Digital Thermometer and ACON™ Digital Thermoment that he Covers are safe, accurate and easy-to-use.

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Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized eagle with three lines forming its body and head. The eagle is facing to the right. The text "DEPARTMENT OF HEALTH AND HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAR 17 2006

Dr. Edward Tung, Ph.D. Regulatory Affairs Acon Laboratories, Incorporated 4108 Sorrento Valley Boulevard San Diego, California 92121

Re: K060173

Trade/Device Name: ACON™ 30 Second Reliable Digital Thermometer ACONTM 30 Digital Thermometer Probe Covers Regulation Number: 21 CFR 880.2910 Regulation Name: Clinical Electronic Thermometer Regulatory Class: II Product Code: FLL Dated: February 24, 2006 Received: March 1, 2006

Dear Dr. Tung:

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.

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#### Page 2 - Dr. Edward Tung

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 [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CF/R 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 [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely vours,

Chiu Lin, Ph.D.

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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#### 4. INDICATIONS FOR USE

K660173 510(k) Number (if known):

ACONTM 30 Second Reliable Digital Thermometer Device Name: ACONTM Digital Thermometer Probe Covers

### Indications for Use:

The ACON™ 30 Second Reliable Digital Thermometer and the ACON™ Digital Thermometer Probe Covers are intended for the quantitative detection of body temperature, which can be obtained orally, under the arm, and/or rectally. It is intended to be sold over-the-counter for home use by lay persons without any professional training.

Prescription Use (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use _ (21 CFR 807 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Anthony V. Grant

and only General Husain 1. . Jental Dovices

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