(239 days)
Not Found
No
The device is a disposable probe cover for digital thermometers, which is a simple accessory with no mention of computational or analytical capabilities.
No
The device is described as an accessory for digital thermometers, intended to act as a barrier to prevent contamination and infection during temperature measurement. It does not perform a therapeutic function but rather a preventative and hygeinic one.
No
This device is described as an accessory (probe cover) for digital thermometers, intended to prevent contamination during temperature measurement. It does not perform diagnostic functions itself, but rather supports the function of a diagnostic device (the digital thermometer).
No
The device is described as physical probe covers made of materials, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body (like blood, urine, tissue) to provide information about a person's health.
- Device Function: The Actherm Digital Clinical Thermometer Probe Covers are described as accessories for digital thermometers. Their function is to act as a barrier to prevent contamination during temperature measurement. They do not perform any tests on bodily samples.
- Intended Use: The intended use is clearly stated as "barriers between digital thermometers and users' rectum or oral cavities to avoid the possible contamination and infection during temperature measuring." This is a physical barrier function, not a diagnostic test.
Therefore, the device's purpose and mechanism of action do not align with the definition of an In Vitro Diagnostic device.
N/A
Intended Use / 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.
Product codes (comma separated list FDA assigned to the subject device)
FLL
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
rectum or oral cavities
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
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,
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.
Not Found
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
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 and
Issuing Date: July 8. 2009 |
|---------------|-----------------|------------------|-------------------------------------------------------------------------------------------------------------------------------|
1
Image /page/1/Picture/0 description: The image shows a stylized signature or logo, possibly of a person or company. The text appears to read "Aetherium" in a cursive or calligraphic style. There is a thick, dark line underlining the name, adding emphasis and a sense of grounding to the design.
K083419
2 of 2
Chapter 15 - 2/2
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.
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
2
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.
3
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
4
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
. -
6:5 + 1
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