These devices are indicated for use as a barrier accessory to digital thermometers while taking rectal, oral or axillary temperature measurements. These sheaths are non-sterile and intended for single use only. This accessory is contraindicated for use with broken skin.

Device Description

The Medline Digital Thermometer Non-Lubricated Probe Sheath is an accessory to a clinical electronic thermometer, which is intended to measure body temperature. The Medline Digital Thermometer Non-Lubricated Probe Sheath is a flexible plastic sheath that is used to cover the transducer of clinical electronic thermometers while taking body temperature measurements from the oral, axillary, or rectal measurement sites and acts as a barrier to prevent possible contamination of the device during temperature measurement. The sheath is an over-the-counter (OTC), disposable, single use, nonlubricated, and non-sterile device that is compatible with most digital stick thermometers.

AI/ML Overview

The Medline Digital Thermometer Non-Lubricated Probe Sheath is an accessionary to a clinical electronic thermometer. This device aims to prevent contamination of the thermometer during temperature measurement by acting as a barrier. The device is non-sterile and intended for single use only. This accessory is contraindicated for use with broken skin.

Here's the breakdown of the acceptance criteria and study information:

1. Table of Acceptance Criteria and Reported Device Performance:

Test	Testing Standards	Acceptance Criteria	Reported Device Performance
Compatibility	ASTM E1104-98(2016) § 5.4	The probe cover shall not degrade the measurement time or accuracy of the temperature-taking device such that the probe and temperature-taking unit fail to meet the requirements of ASTM E1112 – § 4.2.	Met (conformance to the standard is implied by the conclusion of substantial equivalence)
Leakage	ASTM E1104-98 (2016) § 5.3	There shall be no continuous bubble stream observed from the probe cover within 5 seconds of applying an internal pressure of 8.4 kPa.	Met (conformance to the standard is implied by the conclusion of substantial equivalence)
Biocompatibility - Cytotoxicity	ISO 10993-5	Not explicitly stated, but generally implies non-toxic and compliant with the standard.	Performed and deemed acceptable (implied by the conclusion of substantial equivalence following ISO 10993 guidance).
Biocompatibility - Skin Sensitization	ISO 10993-10: 2010	Not explicitly stated, but generally implies no significant skin sensitization.	Performed and deemed acceptable (implied by the conclusion of substantial equivalence following ISO 10993 guidance).
Biocompatibility - Skin Irritation	ISO 10993-10: 2010	Not explicitly stated, but generally implies no significant skin irritation.	Performed and deemed acceptable (implied by the conclusion of substantial equivalence following ISO 10993 guidance).
Tensile Strength	Not explicitly stated, but implies performance during use.	Not explicitly stated	Performed (listed as "tensile strength" in the performance testing section).

2. Sample Size for the Test Set and Data Provenance:

The provided document does not explicitly state the sample sizes used for the non-clinical performance and biocompatibility testing. It only mentions that testing was conducted to demonstrate safety and effectiveness. The data provenance (e.g., country of origin, retrospective/prospective) is also not specified.

3. Number of Experts Used to Establish Ground Truth and Qualifications:

Not applicable. This device is a physical accessory and does not involve AI or human interpretation for diagnosis, thus no experts were used to establish ground truth in the context of clinical interpretation. Ground truth for its performance is established through adherence to engineering and biological safety standards.

4. Adjudication Method for the Test Set:

Not applicable. As no human interpretation for diagnosis or AI performance evaluation is involved, no adjudication method was used. Performance was assessed directly against pre-defined engineering and biological standards.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:

No. A MRMC comparative effectiveness study was not done as this is a non-AI medical device accessory.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study:

No. This device is a physical accessory and does not involve an algorithm. Performance testing was purely on the physical properties and biological safety of the device.

7. Type of Ground Truth Used:

The ground truth for evaluating the device's performance relies on established engineering standards (ASTM E1104-98 and ASTM E1112 for compatibility and leakage, and general tensile strength properties) and biological safety standards (ISO 10993 series for cytotoxicity, skin sensitization, and skin irritation).

8. Sample Size for the Training Set:

Not applicable. As this is a physical medical device accessory and not an AI algorithm, there is no training set in the typical sense.

9. How the Ground Truth for the Training Set Was Established:

Not applicable, as there is no training set.

Summary

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September 20, 2021

Medline Industries, Inc. Kelsey Closen Regulatory Affairs Specialist Three Lakes Drive Northfield, Illinois 60093

Re: K211931

Trade/Device Name: Medline Digital Thermometer Non-Lubricated Probe Sheath Regulation Number: 21 CFR 880.2910 Regulation Name: Clinical Electronic Thermometer Regulatory Class: Class II Product Code: FLL Dated: June 15, 2021 Received: June 22, 2021

Dear Kelsey Closen:

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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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.

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

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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) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; 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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). 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 (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

For Payal Patel Acting Assistant Director DHT3C: Division of Drug Delivery and General Hospital Devices, and Human Factors OHT3: Office of GastroRenal, ObGyn, General Hospital and Urology Devices Office of Product Evaluation and Ouality Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K211931

Device Name

Medline Digital Thermometer Non-Lubricated Probe Sheath

Indications for Use (Describe)

Type of Use (Select one or both, as applicable)
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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 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 white cross. The cross is composed of four triangular shapes converging at a central point. The logo is set against a blue square background.

edline Industries. Inc Three Lakes Drive Northfield. IL 60093

510(k) SUMMARY K211931

[AS REQUIRED BY 21CFR807.92(c)]

Submitter / 510(k) Sponsor

Medline Industries, Inc. Three Lakes Drive Northfield, IL 60093

Registration Number: 1417592

Contact Person

Contact Person: Kelsey Closen, Regulatory Affairs Specialist Phone: 847-949-2283 Email: KClosen(@medline.com

Summary Preparation Date September 20, 2021

Type of 510(k) Submission

Traditional

Device Name / Classification

Trade Name: Medline Digital Thermometer Non-Lubricated Probe Sheath Common Name: Clinical Electronic Thermometer Regulation Name: Clinical electronic thermometer Product Code: FLL Classification Panel: General Hospital Regulatory Class: II Regulation Number: 21 CFR 880.2910

Predicate Device Medline Digital Rectal Thermometer Sheath, K183431

Device Description

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Image /page/4/Picture/0 description: The image shows the Medline logo. The logo consists of the word "MEDLINE" in a sans-serif font, stacked above a stylized starburst symbol. The logo is set against a blue square background. There is a light gray bar on the right side of the square.

dline Industries. Three Lakes Drive Northfield. IL 60093

temperature measurement. The sheath is an over-the-counter (OTC), disposable, single use, nonlubricated, and non-sterile device that is compatible with most digital stick thermometers.

Indications for Use

Summary of Technological Characteristics

TABLE 1: COMPARISON OF PROPOSED AND PREDICATE DEVICES

Device Characteristic	Proposed Device	Predicate Device	ComparisonAnalysis
Product Name	Medline DigitalThermometer Non-Lubricated Probe Sheath	Medline Digital RectalThermometer Sheath	N/A
510(k) Reference	TBD	K183431	N/A
Product Owner	Medline Industries, Inc.	Medline Industries, Inc.	Same
Indications for Use	These devices are indicatedfor use as a barrier accessoryto digital thermometers whiletaking rectal, oral or axillarytemperature measurements.These sheaths are non-sterileand intended for single useonly. This accessory iscontraindicated for use withbroken skin.	These devices are indicated foruse as a barrier accessory todigital thermometers whiletaking rectal temperaturemeasurements. These sheathsare nonsterile and intended forsingle use only. This accessoryis contraindicated for use withbroken skin.	Different
Design Standard	Conforms to Standard ASTME1104-98	Conforms to Standard ASTME1104-98	Same
Design Features &Configurations	One size, Clear, Flexible,peel- away package, markingfor device insertion	One size, Clear, Flexible, peel-away package, marking fordevice insertion	Same
Prescription vs. OTC	OTC	OTC	Same
Application Site	Oral, axillary, rectal	Rectal	Different

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Image /page/5/Picture/0 description: The image is a logo for Medline. The logo is set against a blue square background. The word "MEDLINE" is written in white, block letters on the left side of the square. To the right of the word is a white symbol that resembles a stylized cross or plus sign, with the vertical line extending downwards beyond the horizontal line.

ledline Industries, Inc. Three Lakes Drive Northfield. IL 60093

Sterile vs. Non-Sterile	Non-Sterile	Non-Sterile	Same
Disposable vs. Non-Disposable	Disposable	Disposable	Same
Single Use vs. Reusable	Single Use	Single Use	Same

Discussion

The application site is different between the proposed device and the predicate. Biocompatibility was conducted per ISO 10993, "Biological Evaluation of the Medical Devices – Part 1: Evaluation of Testing within a Risk Management Process." to address this difference.

Summary of Non-Clinical Testing

Testing was conducted to demonstrate safety and effectiveness of the Medline Digital Thermometer Non-Lubricated Probe Sheath. A summary of testing is presented below with more information provided in the applicable sections.

Biocompatibility Testing

The biological evaluation for the Medline Digital Thermometer Non-Lubricated Probe Sheath was conducted in accordance with FDA guidance document, "Use of International Standard ISO 10993, "Biological Evaluation of Medical Devices Part 1: Evaluation and Testing" and ISO 10993-1 "Biological Evaluation of the Medical Devices – Part 1: Evaluation of Testing within a Risk Management Process."

The following Biocompatibility tests were performed:

ISO 10993-5: Cytotoxicity ●
ISO 10993-10: 2010: Skin Sensitization ●
ISO 10993-10: 2010: Skin Irritation ●

Performance Testing (Bench)

Performance testing on the Medline Digital Thermometer Non-Lubricated Probe Sheath was conducted for compatibility and leakage per the ASTM E1104-98 (2016): Standard Specification for Clinical Thermometer Probe Covers and Sheaths and tensile strength.

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Medline Industries, Inc. Three Lakes Drive Northfield, IL 60093

TABLE 2: Performance Testing

Test	Testing Standards	Acceptance Criteria
Compatibility	ASTM E1104-98(2016) 5.4	Probe cover shall not degrade the measurement time oraccuracy of thetemperature-taking device such that the probe and temperature-taking unit fails tomeet the requirements of ASTM E1112 – § 4.2
Leakage	ASTM E1104-98 (2016) 5.3	There shall be no continuous bubble stream observed from theprobe cover within 5seconds of applying an internal pressure of 8.4 kPa.

Summary of Clinical Testing

Not applicable.

Conclusion

The differences between the predicate and the subject device do not raise and new or different questions of safety or effectiveness. Medline Industries, Inc. concludes that the Medline Digital Thermometer Non-Lubricated Probe Sheath are substantially equivalent to the predicate device Medline Digital Rectal Thermometer Sheath cleared under K183431.

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5-004

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.