(53 days)
No
The device description and performance studies focus on basic temperature sensing and display, with no mention of AI or ML algorithms for data processing or interpretation.
No.
The device is described as a thermometer for quantitative detection of body temperature, not for treatment or therapy.
No
The device measures body temperature, which is a physiological parameter, but it does not make a diagnosis or aid in diagnosing a disease or condition.
No
The device description explicitly states it consists of a temperature sensor within a metal probe and a Liquid Crystal Display, indicating it is a physical hardware device, not software only.
Based on the provided information, this device is not an In Vitro Diagnostic (IVD).
Here's why:
- IVDs analyze samples taken from the body (like blood, urine, tissue). This device directly measures body temperature on or in the body (orally, under the arm, rectally).
- The intended use is for measuring body temperature. This is a physiological measurement, not an analysis of a biological sample.
Therefore, the ACON™ 30 Second Reliable Digital Thermometer is a medical device, but it does not fit the definition of an In Vitro Diagnostic.
N/A
Intended Use / 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.
Product codes (comma separated list FDA assigned to the subject device)
FLL
Device 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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Body
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Laypeople, home use, hospitals
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
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.
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Controlled human clinical studies were conducted using the ACON™ 30 Second Reliable Digital Thermometer and the ACON™ Digital Thermometer Probe Covers. 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. 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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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.
0
. 17 . . .
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.: 858-535-2030 Fax: 858-535-2038
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
1
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:
2
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.
3
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.
4
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 (301) 594-4618. 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 (800) 638-2041 or (301) 443-6597 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
5
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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