(81 days)
Not Found
No
The device is a simple disposable plastic cover for a digital thermometer and the summary explicitly states "Mentions AI, DNN, or ML: Not Found".
No
This device is a probe cover for thermometers, which acts as a barrier and is not directly involved in treating or preventing a disease or condition. Its purpose is to assist in the measurement process, not to provide therapy.
No
The device, ACON™ Digital Thermometer Probe Covers, is an accessory that acts as a barrier for digital thermometers. Its intended use is to facilitate oral or rectal temperature measurements, not to diagnose a condition itself. Testing was performed to ensure its performance as a probe cover (e.g., leakage test), not its diagnostic accuracy.
No
The device description clearly states it is a physical product (plastic coverings) and the performance studies involve physical testing (leakage and validation tests), indicating it is a hardware device, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is as a barrier for digital thermometers during oral or rectal temperature measurements. This is a physical barrier function, not a diagnostic test performed on a sample taken from the body.
- Device Description: The description confirms it's a plastic covering for physical use with a thermometer.
- Lack of Diagnostic Function: There is no mention of analyzing biological samples (blood, urine, tissue, etc.) or providing diagnostic information about a disease or condition.
- Performance Studies: The performance studies focus on the physical integrity and functionality of the probe cover (leakage, validation) and comparison to a predicate device with a similar barrier function. They do not involve evaluating diagnostic accuracy.
IVD devices are specifically designed to perform tests on samples taken from the human body to provide information for the diagnosis, monitoring, or treatment of diseases or conditions. This device does not fit that description.
N/A
Intended Use / Indications for Use
The ACONTM 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.
Product codes
FLL
Device 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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
oral or rectal
Indicated Patient Age Range
Not Found
Intended User / Care Setting
consumer home use
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
Not Found
Summary of Performance Studies
The performance characteristics of the ACONTM 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.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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
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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1
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 Disposable
Thermometer Sheaths
(K983406) | ACON Digital Thermometer
Probe Covers |
|--------------------|---------------------------------------------------------------|------------------------------------------|
| Materials | Ethylene Methyl Acrylate
Copolymer Film | Ethylene Vinyl Alcohol
Copolymer 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.
2
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.
3
. 1.
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.
4
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
5
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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