(53 days)
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.
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.
The provided document is a 510(k) summary for the ACON™ 30 Second Reliable Digital Thermometer and its associated probe covers. It details the device's characteristics, intended use, and substantial equivalence to a predicate device.
Here's an analysis of the acceptance criteria and study information:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly state "acceptance criteria" in a pass/fail form for the clinical study. However, it does provide "Technical Specifications" which can be considered the performance targets for the device. The clinical study then aimed to demonstrate substantial equivalence to a predicate, implying these specifications were met.
| Feature | Technical Specification (Acceptance Criteria) | Reported Device Performance (Implied from Study Conclusion) |
|---|---|---|
| Measuring Time (Oral) | 30 seconds | Met (comparable to predicate) |
| Measuring Time (Underarm) | 38 seconds | Met (comparable to predicate) |
| Measuring Time (Rectal) | 30 seconds | Met (comparable to predicate) |
| Measurement Range | 89.6 - 109.2°F | Met |
| Measurement Accuracy | $\pm$ 0.2°F | Met (comparable to predicate) |
| Resolution | 0.1°F | Met |
| Other Features (Beep, Memory, etc.) | As specified (e.g., last memory recall) | Met |
The conclusion states that a clinical study demonstrated that the device obtained "comparable body temperature measurement data" to a legally marketed digital thermometer and that it was "safe, accurate and easy-to-use," which implies these technical specifications and other performance aspects were met.
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Test Set: The document states "Controlled human clinical studies were conducted," and "Clinical study results indicate that the non-professional, inexperienced lay persons were able to obtain comparable body temperature measurement data when using the ACON™ 30 Second Reliable Digital Thermometer." However, the specific sample size (number of subjects or measurements) for these clinical studies is not provided.
- Data Provenance: The document does not explicitly state the country of origin for the data. Given the submitter's identification (ACON Laboratories, Inc. in San Diego, California), it is suggested that the studies likely took place within the United States, but this is not explicitly confirmed. The studies appear to be prospective as they were "conducted" for the purpose of demonstrating equivalence for the 510(k) submission.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
The clinical studies involved "non-professional, inexperienced lay persons" using the device. The ground truth appears to be based on comparison to a "legally marketed digital thermometer, BD Flexible Digital Thermometer, Model #524034 (K935267)." Therefore, the study did not use "experts" to establish a ground truth in the traditional sense (e.g., radiologists interpreting images). Instead, the reference standard was another device.
4. Adjudication Method for the Test Set
Since the ground truth was established by comparison to a predicate device, and the study focused on "lay persons" obtaining measurements, a formal adjudication method (like 2+1 or 3+1) involving human experts is not applicable or described in this context. The comparison would likely involve statistical analysis of the measurements taken by the ACON thermometer versus the predicate device.
5. 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
This is not applicable to this device. This is a digital thermometer, not an AI-assisted diagnostic imaging device that involves human readers interpreting results. The study described is a comparison of a new thermometer to a predicate thermometer.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
This is not applicable in the context of an algorithm. The device itself is a standalone thermometer. Its performance was evaluated in terms of its ability to measure temperature. The "standalone" performance is the device's performance, as it directly outputs a temperature reading. The study evaluated its performance with "human-in-the-loop" in the sense that laypersons used it to take measurements.
7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)
The ground truth for the clinical study was based on comparison to a legally marketed predicate device (BD Flexible Digital Thermometer, Model #524034). This means the accuracy and performance of the ACON thermometer were validated against the established performance of another cleared thermometer.
8. The Sample Size for the Training Set
The document does not specify a separate training set. This is typical for a medical device like a thermometer, which does not involve machine learning or AI models that require a distinct "training set" for algorithm development. The device's design and calibration would have been established through engineering and laboratory testing.
9. How the Ground Truth for the Training Set Was Established
As there is no explicit training set described in the context of machine learning, this question is not directly applicable. Any calibration or validation for the device's internal operation would have been established by the manufacturer through controlled laboratory conditions, likely using highly accurate reference thermometers or temperature standards.
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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.: 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
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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 (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
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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
Page 1 of _ 1 ________________________________________________________________________________________________________________________________________________________________
§ 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.