The Actherm Digital Clinical Thermometer Probe Covers medACCU1010, medACCU1010-1 and medACCU1020 are accessories for digital thermometers, including the models of Actherm Digital Clinical Thermometers. They are indicated for use as barriers between digital thermometers and users' rectum or oral cavities to avoid the possible contamination and infection during temperature measuring. These probe covers are intended for single use when temperature taking.

Device Description

The Digital Clinical Thermometer Probe Covers medACCU1010 and medACCU1010-1 are manufactured in the same shapes and sizes. The only difference between them is medACCU1010-1 coated with lubrication; therefore it is only used for rectal measurements for digital thermometers. The Digital Clinical Thermometer Probe Covers medACCU1020 are manufactured in different shapes and sizes from medACCU1010 and medACCU1010-1. The disposable digital thermometer probe covers medACCU1010 and medACCU1020 are used for either oral or rectal measurements for digital thermometers.

AI/ML Overview

The provided text describes the 510(k) summary for Actherm Digital Clinical Thermometer Probe Covers. However, it does not contain the detailed information necessary to fully answer all the questions regarding acceptance criteria and a specific study proving the device meets those criteria. The document states that the device "meet the ASTM Standard Specification for Clinical Thermometer Probe Covers and Sheaths (ASTM E 1104-98), as well as ISO 10993-1 biocompatibility testing," but does not explicitly provide the acceptance criteria or the specific performance results from a study.

Based on the provided text, here's what can be extracted and what is missing:

Acceptance Criteria and Device Performance

1. A table of acceptance criteria and the reported device performance:

Acceptance Criteria (Inferred from Standards)	Reported Device Performance
ASTM Standard Specification for Clinical Thermometer Probe Covers and Sheaths (ASTM E 1104-98): Specific performance metrics such as barrier integrity, material strength, thermal conductivity impact, etc. (Details not provided in the document).	"Actherm Digital Clinical Thermometer Probe Covers... meet the ASTM Standard Specification for Clinical Thermometer Probe Covers and Sheaths (ASTM E 1104-98)"
ISO 10993-1 Biocompatibility Testing: Biocompatibility requirements to ensure no adverse biological reactions (e.g., cytotoxicity, sensitization, irritation). (Details not provided in the document).	"Actherm Digital Clinical Thermometer Probe Covers... meet the... ISO 10993-1 biocompatibility testing"

Note: The document states that the device "meets" these standards, implying compliance with their respective acceptance criteria. However, the specific quantitative acceptance criteria (e.g., "must have a barrier integrity greater than X") and the actual device performance values (e.g., "device achieved Y for barrier integrity") are not detailed in this 510(k) summary. It only confirms adherence to the standards.

Study Details

The provided document refers to compliance with standards (ASTM E 1104-98 and ISO 10993-1) as "Performance Data," which implies studies were conducted. However, it does not provide details about these studies.
Therefore, the following information is not available in the provided text:

2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective):

This information is not provided in the 510(k) summary. The document only confirms compliance with standards, not the specifics of the testing methodology or data origin.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience):

This type of expert review or ground truth establishment is typically associated with studies involving diagnostic interpretation (e.g., medical imaging). For a device like a thermometer probe cover, the "ground truth" would be established by the physical testing methods defined within the ASTM and ISO standards (e.g., passing a leak test, material characterization). There would not be "experts establishing ground truth" in the diagnostic sense.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:

This is not applicable to the type of device and testing described. Adjudication methods are used for resolving discrepancies in expert interpretations, which is not relevant for physical and biocompatibility testing of a probe cover.

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. MRMC studies and AI assistance relate to diagnostic software or tools, not physical medical devices like thermometer probe covers.

6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:

This is not applicable, as the device is a physical accessory and does not involve an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):

For the performance data cited (ASTM E 1104-98 and ISO 10993-1), the "ground truth" would be the defined specifications and test methods within those standards. For example, for barrier integrity, the ground truth would be that the cover successfully prevents fluid penetration under specified conditions. For biocompatibility, the ground truth would be the absence of cytotoxic effects, irritation, or sensitization as defined by the ISO 10993 series of tests.

8. The sample size for the training set:

Not applicable. There is no concept of a "training set" for a physical device like this, as it does not involve machine learning or AI.

9. How the ground truth for the training set was established:

Not applicable, as there is no training set.

Summary

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Aetherium

K08 3419
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Chapter 15 - 1/2

Chapter 15 510 (K) Summary

JUL 1 6 2009

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.

Submitter's Identification:

Actherm Inc. 6F, No.18, Jhanye 2nd Rd, Hsinchu Science Park, Hsinchu 30078, TAIWAN, R.. O.C.

Contact Person:

Mr. Richard HSIEH

TEL: +886-3-6669596 #888

FAX: +886-3-6669697 E-mail: richard@actherm.com.tw actherm@actherm.com.tw

Date Summary Prepared: July 8, 2009

Manufacturer: Actherm Inc. 6F, No.18, Jhanye 2nd Rd, Hsinchu Science Park, Hsinchu 30078, TAIWAN, R.O.C.

Device Name:

Digital Clinical Thermometer Probe Covers

Trade Name:

Actherm Digital Clinical Thermometer Probe Covers. The Trade models name medACCU1010, medACCU1010-1 and medACCU1020.

Classification Name:

Clinical Electronic Thermometer (per 21 CFR 880.2910)

Predicate Device Information:

BANTA HEALTHCARE GROUP, LTD (Rite Aid Brand) Sanitherm Oral Disposable Thermometer Sheaths 510(k) Number is K983406

ACON LABORATORIES, INC. ACON Digital Thermometer Probe Covers 510(k) Number is K063418

Code: FDA-007	.Version: A	Revision Status:	And and with the count of the first and the first and the first and the first and the first andIssuing Date: July 8. 2009

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Device Description:

Indications for Use:

The Actherm Digital Clinical Thermometer Probe Covers medACCU1010, medACCU1010-1 and medACCU1020 are accessories for digital thermometers, including the models of Actherm Digital Clinical Thermometers. They are indicated for use as barners between digital thermometers and users' rectum or oral cavities to avoid the possible contamination and infection during temperature measuring. These probe covers are intended for single use when temperature taking.

Comparison to Predicate Devices:

The Actherm Digital Clinical Thermometer Probe Covers medACCU1010, medACCU1010-1 and medACCU1020 are substantially equivalent to the following predicate devices: Sanitherm Oral Disposable Thermometer Sheaths (K983406) and ACON Digital Thermometer Probe Covers (K063418).

Performance Data:

Actherm Digital Clinical Thermometer Probe Covers medACCU1010, medACCU1010-1 and medACCU1020 meet the ASTM Standard Specification for Clinical Thermometer Probe Covers and Sheaths (ASTM E 1104-98), as well as ISO 10993-1 biocompatibility testing,

Conclusion:

It is concluded that the Actherm Digital Clinical Thermometer Probe Covers medACCU1010, medACCU1010-1 and medACCU1020 are substantially equivalent to marked products, functions as intended, and with exception to the risks, which have been evaluated within the Hazard Analysis, no additional potential hazards have been found. The assessment of user benefit to health from use as intended is much higher than the probable risks of injury or illness. The study results also demonstrated that the Actherm Digital Clinical Thermometer Probe Covers medACCU1010, medACCU1010-1 and medACCU1020 are safe, effective and easy-to-use.

Code: FDA-007

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of an eagle with its wings spread, symbolizing the department's mission to protect the health of all Americans.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Mr. Richard Hsieh Actherm Incorporated 6F, No. 18 Jhanye 2nd Road Hsinchu Science Park Hsinchu CHINA (TAIWAN) 30078

JUL 1 6 2009

Re: K083419

Trade/Device Name: Actherm Digital Thermometer Probe Covers, Models medACCU1010, medACCU1010-1, and medACCU1020

Regulation Number: 21 CFR 880.2910

Regulation Name: Clinical Electronic Thermometer

Regulatory Class: II

Product Code: FLL

Dated: July 8, 2009 Received: July 14, 2009

Dear Mr. Hsieh:

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 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 – Mr. Hsieh

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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); 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.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/ CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/cdrh/mdr/ for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Susan Payne

Susan Runner, D.D.S., M.A. Acting 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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Indications for Use

510(k) Number (if known): K083419

Device Name: Actherm Digital Thermometer Probe Covers, Models medACCU1010, medACCU1010-1, and medACCU1020

Indications For Use:

Clinical Thermometer Probe Covers medACCU1010, Digital Actherm The medACCU1010-1 and medACCU1020 are accessories for digital thermometers, including the models of Actherm Digital Clinical Thermometers. They are indicated for use as barriers between digital thermometers and users' rectum or oral cavities to avoid the possible contamination and infection during temperature measuring. These probe covers are intended for single use when temperature taking.

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

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Over-The-Counter Use (21 CFR 801 Subpart C)

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

Concurrence of CDRH-Office of Deviee Evaluation (ODE)

(Division Sign-Off)

Division of Anesthesiology, General Hospital Infection Control, Dental Devices

510(k) Number: KD83419

Regulation Number and Section

§ 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.