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.

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.

AI/ML Overview

The provided text describes a 510(k) premarket notification for the Medline Disposable Electronic Thermometer Probe Cover (K173113) and compares it to a predicate device, the Welch Allyn SureTemp Plus Thermometer (K030580). This document focuses on demonstrating substantial equivalence, not conducting a study to prove a device meets acceptance criteria as would be typical for a novel AI device.

Therefore, many of the requested elements are not applicable to this type of regulatory submission for a simple medical accessory. However, I can extract the information that is present regarding the non-clinical testing performed.

Here's the breakdown of the information that can be extracted from the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria (Standard)	Reported Device Performance (Compliance)
ASTM E1104-98 (2016) for Performance Testing	Conforms to ASTM Standard E1104
ISO 10993-5: Cytotoxicity MEM Elution	Biocompatibility met
ISO 10993-10: Irritation Intracutaneous reactivity	Biocompatibility met
ISO 10993-10: Delayed-Type Hypersensitivity (Sensitization) Guinea Pig Maximization Test	Biocompatibility met

2. Sample size used for the test set and the data provenance

Test Set Sample Size: Not specified for any of the tests.
Data Provenance: The tests are "Non-clinical verification" and "Performance Testing (Bench)", implying laboratory data. The country of origin is not specified, but the applicant (Medline Industries, Inc.) is based in Northfield, Illinois, USA. The data is prospective in the sense that these tests were conducted for this specific submission to demonstrate equivalence.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Not applicable. These are standard engineering and biocompatibility tests conducted according to established procedures, not requiring expert consensus for ground truth on a 'test set' in the context of an AI device.

4. Adjudication method for the test set

Not applicable. As above, these are standard engineering and biocompatibility tests.

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

Not applicable. This device is a thermometer probe cover, not an AI device.

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

Not applicable. This device is a thermometer probe cover, not an AI device.

7. The type of ground truth used

For Performance Testing (ASTM E1104-98): The ground truth would be defined by the specified technical parameters and tolerances within the ASTM standard. This standard typically covers accuracy and response time of clinical electronic thermometers, and the probe cover's performance is evaluated against how it affects these parameters.
For Biocompatibility Testing (ISO 10993 series): The ground truth is established by the specified biological responses (e.g., absence of cytotoxicity, irritation, or sensitization) as defined by the ISO standards and their acceptance criteria.

8. The sample size for the training set

Not applicable. This device is a thermometer probe cover, not an AI device that requires a training set.

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

Not applicable. This device is a thermometer probe cover, not an AI device that requires a training set and ground truth establishment in that context.

Summary of the Study:

The "study" described here is a series of non-clinical (bench and biocompatibility) tests conducted to demonstrate that the Medline Disposable Electronic Thermometer Probe Cover meets recognized standards and performs similarly to its predicate device's component. The primary standard referenced is ASTM E1104-98 (2016) for performance, and ISO 10993 series for biocompatibility. The results "demonstrated the overall performance of the proposed device and ultimately support a substantial equivalence determination." The tests confirm that the probe covers do not significantly impede the thermometer's performance according to the ASTM standard and are biologically safe according to ISO standards.

Summary

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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.

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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

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Indications for Use

510(k) Number (if known)

K173113

Device Name

Medline Disposable Electronic Thermometer Probe Cover

Indications for Use (Describe)

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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4-001

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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

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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

Indications for Use

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	ComparisonAnalysis
Product Name	The Medline DisposableElectronic ThermometerProbe Covers	The Welch Allyn SureTempPlus 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 DisposableElectronic ThermometerProbe Covers are intendedfor use as barriers betweenany SureTemp andSureTemp Plus digitalthermometer probe and users'oral, rectal, or axillarymeasuring sites to avoid thepossible contamination andinfection during temperaturemeasuring. The probe coversare non-sterile and intended	Electronic Thermometer:The Welch Allyn SureTempPlus thermometer enables thehealth care professional to makean accurate prediction of oral,rectal or axillary temperature.Electronic Thermometer ProbeCover:Probe covers are intended tocover the thermometer probeprior to its use. This cover mustnot be a significant barrier tothe transfer of heat from the	Same**The predicate'sthermometer probecovers areaccessories to thethermometer itself,and were included inits 510(k) clearanceunder K030580.Only the probecovers are includedin this 510(k), asMedline does not

TABLE 1: COMPARISON OF PROPOSED AND PREDICATE DEVICES

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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 (andthermistor). In addition, thedisposable nature of the probecover prevents microbiologicalcross-contamination amongpatients which might occur witha reusable probe.	intend to market anyother component oraccessory of theSureTemp Plusthermometer system,nor the thermometeritself. The proposeddevice's Indicationsfor Use are,therefore, morenarrow than theIndications for Usestated in K030580,which applied toboth thethermometer and theprobe covers, as theproposed device'sindications are onlyapplicable to theprobe covers.
Regulation Number	21 CFR 880.2910	21 CFR 880.2910	Same
Design Features	Conforms to ASTM StandardE1104	Conforms to ASTM StandardE1104	Same
Design Configurations	One size	One size	Same
Performance Specifications	Conforms to ASTM StandardE1104	Conforms to ASTM StandardE1104	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.

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.