(81 days)
The ACON™ Digital Thermometer Probe Covers are intended for use as a barrier that is used as an accessory to oral or rectal measurements for digital thermometers, including the ACON 30 Second Reliable Digital Thermometer. These probe covers are non-sterile and intended for single use only.
The disposable digital thermometer probe covers are plastic coverings used for either oral or rectal measurements for digital thermometers. The product is non-sterile and contains latex.
The provided text is a 510(k) summary for ACONTM Digital Thermometer Probe Covers. It outlines the device's description, intended use, and comparison to a predicate device. The information primarily focuses on substantial equivalence for regulatory approval rather than a detailed performance study with acceptance criteria and results in the format requested.
Here's an analysis based on the provided text, addressing your questions to the best extent possible given the information:
1. Table of acceptance criteria and the reported device performance
The document does not explicitly state quantitative acceptance criteria for the probe covers. Instead, it relies on demonstrating substantial equivalence to a predicate device and qualitative performance verification through "probe cover leakage test and probe cover validation test."
| Performance Characteristic | Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|---|
| Leakage | Not explicitly stated, but implied to be "robust" and "satisfactory" to prevent cross-contamination. | Satisfactory performance based on "probe cover leakage test." |
| Validation | Not explicitly stated, but implied to be "robust" and "satisfactory" for the intended use. | Satisfactory performance based on "probe cover validation test." |
| Biocompatibility | Compliance with ISO 10993-5 and ISO 10993-10. | Compliance to applicable voluntary standards including ISO 10993-5 and ISO 10993-10 biocompatibility testing. |
| Compliance to Standards | Compliance with ASTM E1104. | Compliance to applicable voluntary standards including ASTM E1104. |
2. Sample size used for the test set and the data provenance
The document does not specify the sample size used for the "probe cover leakage test" or the "probe cover validation test."
The data provenance is not explicitly stated beyond being "laboratory testing results." It is implied to be prospective testing conducted by the manufacturer (ACON Laboratories, Inc.) given it's part of a 510(k) submission for a new device.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This information is not applicable to this type of device and study. The testing for a digital thermometer probe cover typically involves objective physical and material tests (e.g., leakage, material compatibility, strength) rather than expert interpretation of data or images.
4. Adjudication method for the test set
This information is not applicable for the reasons stated above.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done
No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. This type of study is more relevant for diagnostic devices where human readers interpret results, and the AI's impact on their performance is being evaluated.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This concept is not applicable as the device is a physical probe cover, not an algorithm or AI system.
7. The type of ground truth used
The concept of "ground truth" in the context of expert consensus, pathology, or outcomes data is not applicable to this device. The "truth" for a probe cover is its ability to physically perform its barrier function and protect against contamination, which is assessed through direct physical testing (leakage, structural integrity, material properties).
8. The sample size for the training set
This information is not applicable as the device is not an AI or machine learning model that requires a training set.
9. How the ground truth for the training set was established
This information is not applicable for the same reason as point 8.
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5. 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
Submitter's Identification:
ACON Laboratories, Inc. 4108 Sorrento Valley Boulevard San Diego, California 92121
Tel.: 858-875-8028 Fax: 858-875-8099
Date Prepared: November 10, 2006
Contact Person:
Jinn-nan Lin, Ph.D. V.P., Regulatory Affairs
Proprietary Name of the Device:
ACONTM Digital Thermometer Probe Covers
Common Name:
Digital Thermometer Probe Covers
Classification Name:
Class II §880.2910 Clinical Electronic Thermometer (To be manufactured and marketed for consumer home use)
Predicate Device:
Sanitherm Oral Disposable Thermometer Sheaths Banta Healthcare Group, LTD (Rite Aid Brand) 510(k) Number: K983406
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Description:
The disposable digital thermometer probe covers are plastic coverings used for either oral or rectal measurements for digital thermometers. The product is non-sterile and contains latex.
Intended Use:
The ACON101 Digital Thermometer Probe Covers are intended for use as a barrier that is used as an accessory to oral or rectal measurements for digital thermometers, including the ACON 30 Second Reliable Digital Thermometer. These probe covers are non-sterile and intended for single use only.
Comparison to Predicate Devices:
The ACON™ Digital Thermometer Probe Covers are similar to the FDA-cleared Sanitherm Oral Disposable Thermometer Sheaths for Banta Healthcare Group, LTD (K983406) (Rite Aid Brand).
A Substantial Equivalence Comparison Table for the ACON Digital Thermometer Probe Covers and the Predicate Probe Covers is presented below:
| Sanitherm Oral DisposableThermometer Sheaths(K983406) | ACON Digital ThermometerProbe Covers | |
|---|---|---|
| Materials | Ethylene Methyl AcrylateCopolymer Film | Ethylene Vinyl AlcoholCopolymer Film |
| Latex Content | Latex-Free | Non Latex-Free |
| Sterility | Non-Sterile | Non-Sterile |
| Indication for Use | Oral or Rectal | Oral or Rectal |
| Usage | Single Use Only | Single Use Only |
Discussion of Non-Clinical Tests Performed for Determination of Substantial Equivalence are as follows:
Compliance to applicable voluntary standards includes ASTM E1104 as well as ISO 10993-5 and ISO 10993-10 biocompatibility testing.
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Conclusion:
The performance characteristics of the ACON™ Digital Thermometer Probe Covers were verified by probe cover leakage test and probe cover validation test. Testing results indicate that the ACONTM Digital Thermometer Probe Covers are robust and can perform satisfactorily when used according to the "Indication for Use" statement specified in the package insert.
The laboratory testing results demonstrated a substantial equivalency in performance between the ACON™ Digital Thermometer Probe Covers and a legally marketed predicate device, Sanitherm Oral Disposable Thermometer Sheaths for Banta Healthcare Group, LTD (K983406) (Rite Aid Brand), with the same intended use and product features. The study results also demonstrated that the ACON™ Digital Thermometer Probe Covers are safe, effective and casyto-use.
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Image /page/3/Picture/1 description: The image shows the seal of the Department of Health and Human Services (HHS). The seal features a stylized eagle with three stripes forming its body and wings. 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
Dr. Jinn-Nan Lin Vice President for Regulatory Affairs ACON Laboratories, Incorporated 4108 Sorrento Valley Boulevard San Diego, California 92121
FEB - 2 2007
Re: K063418
Trade/Device Name: ACONTM Digital Thermometer Probe Covers Regulation Number: 880.2910 Regulation Name: Clinical Electronic Thermometer Regulatory Class: II Product Code: FLL Dated: January 11, 2007 Received: January 12, 2007
Dear Dr. Lin:
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. Lin
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 (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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/industry/support/index.html.
Sincerely yours,
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
510(k) Number (if known):
ACONTM Digital Thermometer Probe Covers Device Name:
Indications for Use:
The ACON™ Digital Thermometer Probe Covers are intended for use as a barrier that is used as an accessory to oral or rectal measurements for digital thermometers, including the ACON 30 Second Reliable Digital Thermometer. These probe covers are non-sterile and intended for single use only.
Prescription Use (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use X (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)
Anton V. Watson
(Division Sign-Off) (Division Sign-Off)
Division of Anesthesiology, General Hospital, Division of Ancol. Dental Devices
kd63418 510(k) Number:
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§ 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.