(110 days)
Not Found
No
The device is a disposable probe cover, a passive barrier, and the description contains no mention of AI or ML.
No.
The device is a probe cover for a thermometer, intended to prevent contamination, not to diagnose, treat, or prevent disease.
No
The device is a probe cover for a digital thermometer. While the thermometer itself is diagnostic, the probe cover is a barrier to prevent contamination and is not involved in the diagnostic process of measuring temperature.
No
The device description clearly states it is a "disposable, single use, non-sterile shell-like device used to cover electronic thermometer probes," indicating it is a physical hardware component, not software.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to examine specimens taken from the human body (like blood, urine, or tissue) to provide information about a person's health. This testing is done outside of the body (in vitro).
- Device Function: The Medline Disposable Electronic Thermometer Probe Covers are used as a barrier during temperature measurement. They are applied to a thermometer probe that is then inserted into a body cavity (oral, rectal, or axillary). This is a direct measurement of a physiological parameter within or on the body, not an analysis of a specimen taken from the body.
- Intended Use: The intended use clearly states they are for use as "barriers between any SureTemp and SureTemp Plus digital thermometer probe and users' oral, rectal, or axillary measuring sites to avoid possible contamination and infection during temperature measuring." This is about hygiene and preventing cross-contamination during a direct physiological measurement.
The device is a medical device, but it falls under a different category than In Vitro Diagnostics. It's an accessory for a thermometer, which is a device used for physiological measurement.
N/A
Intended Use / Indications for Use
The Medline Disposable Electronic Thermometer Probe Covers are intended for use as barriers between any SureTemp and SureTemp Plus digital thermometer probe and users' oral, rectal, or axillary measuring sites to avoid possible contamination and infection during temperature measuring. The probe covers are non-sterile and intended for single use only.
Product codes
FLL
Device Description
The proposed device is a disposable, single use, non-sterile shell-like device used to cover electronic thermometer probes of temperature taking devices. The Medline Disposable Electronic Thermometer Probe Cover is compatible with the intended use of all SureTemp and SureTemp Plus reusable digital thermometers probes, which require the use of probe covers for oral, axillary, or rectal temperature measurements.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
oral, rectal, or axillary measuring sites
Indicated Patient Age Range
Not Found
Intended User / Care Setting
health care professional
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)
Non-clinical verification of the Medline Disposable Electronic Thermometer Probe Cover has been conducted to evaluate its performance and functionality. The results of these tests have demonstrated the overall performance of the proposed device and ultimately support a substantial equivalence determination.
Specifically, the evaluation of the proposed device includes:
- Performance Testing (Bench)
- In accordance with ASTM E1104-98 (2016)
- Biocompatibility Testing
- ISO 10993-5: Cytotoxicity MEM Elution;
- ISO 10993-10: Irritation Intracutaneous reactivity; and,
- ISO 10993-10: Delayed-Type Hypersensitivity (Sensitization) Guinea Pig Maximization Test.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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
Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: a symbol on the left and the text "FDA U.S. FOOD & DRUG ADMINISTRATION" on the right. The symbol on the left is a stylized representation of a human figure, while the text on the right is written in a clear, sans-serif font. The FDA logo is a recognizable symbol of the agency's mission to protect and promote public health.
January 17, 2018
Medline Industries, Inc. Dinah Rincones Regulatory Specialist Three Lake Drive Northfield. Illinois 60093
Re: K173113
Trade/Device Name: Medline Disposable Electronic Thermometer Probe Cover Regulation Number: 21 CFR 880.2910 Regulation Name: Clinical Electronic Thermometer Regulatory Class: Class II Product Code: FLL Dated: December 15, 2017 Received: December 18, 2017
Dear Dinah Rincones:
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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
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.
1
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 of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely.
Tina Kiang
S
Tina Kiang, Ph.D. Acting Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control, and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known)
Device Name
Medline Disposable Electronic Thermometer Probe Cover
Indications for Use (Describe)
The Medline Disposable Electronic Thermometer Probe Covers are intended for use as barriers between any SureTemp and SureTemp Plus digital thermometer probe and users' oral, rectal, or axillary measuring sites to avoid possible contamination and infection during temperature measuring. The probe covers are non-sterile and intended for single use only.
Type of Use (Select one or both, as applicable)
| ☒ Prescription Use (Part 21 CFR 801 Subpart D) |
|---|
| ☐ Over-The-Counter Use (21 CFR 801 Subpart C) |
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Image /page/3/Picture/0 description: The image shows the Medline logo. The logo consists of the word "MEDLINE" in white, set against a blue square background. Above the word, there is a white star-like symbol with four points. To the right of the blue square, there is a gray vertical bar.
Medline Industries, Inc. Three Lakes Drive Northfield. IL 60093
K173113
510(k) SUMMARY [AS REQUIRED BY 21CFR807.92(c)]
Submitter / 510(k) Sponsor
Medline Industries, Inc. Three Lakes Drive Northfield, IL 60093 Registration Number: 1417592
Contact Person
Dinah Rincones Regulatory Specialist Phone: 847-949-2687 Fax: 224-931-1271 Email: DRincones@medline.com
Summary Preparation Date September 28, 2017
Type of 510(k) Submission Traditional
Device Name / Classification
Name of Device: Clinical Electronic Thermometer Probe Cover Proprietary Name: Medline Disposable Electronic Thermometer Probe Cover Common Name: Clinical Electronic Thermometer Probe Cover Product Code: FLL Classification Panel: General Hospital Device Class: Class II Regulation #: 21 CFR 880.2910
Predicate Device
The Welch Allyn SureTemp Plus Thermometer (K030580) is identified herein as the predicate device of the Medline Disposable Electronic Thermometer Probe Cover.
Please note that the primary predicate 510(k) to support this submission. K030580. included both the thermometer probe cover, as well as the SureTemp Plus thermometer itself. However, only the thermometer probe cover is included within the scope of this premarket notification; Medline does not
4
Image /page/4/Picture/0 description: The image features the Medline logo, which consists of the word "MEDLINE" in bold, white letters positioned to the left of a stylized white star. The star is composed of four triangular shapes that converge at a central point, creating a dynamic and modern design. The background is a solid, dark blue color, providing a strong contrast that makes the logo stand out. A small gray rectangle is visible in the upper right corner.
edline Industries, Inc hree Lakes Drive
intend to market any other component or accessory of the SureTemp Plus thermometer system, nor the thermometer itself.
Device Description
The proposed device is a disposable, single use, non-sterile shell-like device used to cover electronic thermometer probes of temperature taking devices. The Medline Disposable Electronic Thermometer Probe Cover is compatible with the intended use of all SureTemp and SureTemp Plus reusable digital thermometers probes, which require the use of probe covers for oral, axillary, or rectal temperature measurements.
Indications for Use
The Medline Disposable Electronic Thermometer Probe Covers are intended for use as barriers between any SureTemp and SureTemp Plus digital thermometer probe and users' oral, rectal, or axillary measuring sites to avoid possible contamination and infection during temperature measuring. The probe covers are non-sterile and intended for single use only.
Summary of Technological Characteristics
The Medline Disposable Electronic Thermometer Probe Cover is similar in design, intended use and function to the thermometer probe cover cleared under K030580.
| Device Characteristic | Proposed Device | Predicate Device | Comparison
Analysis |
|-----------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Product Name | The Medline Disposable
Electronic Thermometer
Probe Covers | The Welch Allyn SureTemp
Plus Thermometer | N/A |
| 510(k) Reference | TBD | K030580 | N/A |
| Product Owner | Medline Industries, Inc. | Welch Allyn Inc. | N/A |
| Product Code | FLL | FLL | Same |
| Intended Use | The Medline Disposable
Electronic Thermometer
Probe Covers are intended
for use as barriers between
any SureTemp and
SureTemp Plus digital
thermometer probe and users'
oral, rectal, or axillary
measuring sites to avoid the
possible contamination and
infection during temperature
measuring. The probe covers
are non-sterile and intended | Electronic Thermometer:
The Welch Allyn SureTemp
Plus thermometer enables the
health care professional to make
an accurate prediction of oral,
rectal or axillary temperature.
Electronic Thermometer Probe
Cover:
Probe covers are intended to
cover the thermometer probe
prior to its use. This cover must
not be a significant barrier to
the transfer of heat from the | Same*
*The predicate's
thermometer probe
covers are
accessories to the
thermometer itself,
and were included in
its 510(k) clearance
under K030580.
Only the probe
covers are included
in this 510(k), as
Medline does not |
TABLE 1: COMPARISON OF PROPOSED AND PREDICATE DEVICES
5
Image /page/5/Picture/0 description: The image features the logo of Medline, a healthcare company. The logo consists of the word "MEDLINE" in a bold, sans-serif font, positioned to the left of a stylized starburst or cross-like symbol. The background is a solid dark blue color, providing a strong contrast to the white text and symbol.
Medline Industries, Inc. Three Lakes Drive Northfield, IL 60093
| | for single use only. | patient to the probe body (and
thermistor). In addition, the
disposable nature of the probe
cover prevents microbiological
cross-contamination among
patients which might occur with
a reusable probe. | intend to market any
other component or
accessory of the
SureTemp Plus
thermometer system,
nor the thermometer
itself. The proposed
device's Indications
for Use are,
therefore, more
narrow than the
Indications for Use
stated in K030580,
which applied to
both the
thermometer and the
probe covers, as the
proposed device's
indications are only
applicable to the
probe covers. |
|-----------------------------------|------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Regulation Number | 21 CFR 880.2910 | 21 CFR 880.2910 | Same |
| Design Features | Conforms to ASTM Standard
E1104 | Conforms to ASTM Standard
E1104 | Same |
| Design Configurations | One size | One size | Same |
| Performance Specifications | Conforms to ASTM Standard
E1104 | Conforms to ASTM Standard
E1104 | Same |
| Prescription vs. OTC | Prescription Only | Prescription Only | Same |
| Sterile vs. Non-Sterile | Non-sterile | Non-sterile | Same |
| Disposable vs. Non-
Disposable | Disposable | Disposable | Same |
| Single Use vs. Reusable | Single Use Only | Single Use Only | Same |
Summary of Non-Clinical Testing
Non-clinical verification of the Medline Disposable Electronic Thermometer Probe Cover has been conducted to evaluate its performance and functionality. The results of these tests have demonstrated the overall performance of the proposed device and ultimately support a substantial equivalence determination.
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Image /page/6/Picture/0 description: The image features the logo of Medline, a healthcare company. The logo is set against a blue square background. The word "MEDLINE" is written in bold, white letters, stacked on top of a white, stylized starburst symbol. A gray bar is visible on the right side of the image.
ledline Industries. Three Lakes Drive Northfield II 60093
Specifically, the evaluation of the proposed device includes:
- . Performance Testing (Bench)
- o In accordance with ASTM E1104-98 (2016)
- . Biocompatibility Testing
- ISO 10993-5: Cytotoxicity MEM Elution; o
- ISO 10993-10: Irritation Intracutaneous reactivity; and, o
- o ISO 10993-10: Delayed-Type Hypersensitivity (Sensitization) Guinea Pig Maximization Test.
Conclusion
In accordance with 21 CFR Part 807, and based on a comparison of 'Indications for Use,' technological characteristics and performance data, Medline Industries, Inc. concludes that the proposed Medline Thermometer Probe Cover is substantially equivalent to the predicate device cleared under K030580.