These devices are indicated for use as a barrier accessory to digital thermometers while taking rectal 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 Rectal Thermometer Sheath is an accessory to a clinical electronic (digital) thermometer, a Class II device in the US, intended to measure the body temperature of a patient by means of a transducer coupled with an electronic signal amplification, conditioning and display unit. The sheath covers the transducer and is a single-use disposable device. Digital Thermometer Sheaths may not be suitable for clinical thermometers which employ rigid plastic sheaths.

AI/ML Overview

The provided document is a 510(k) summary for the Medline Digital Rectal Thermometer Sheath. This device is a Class II medical device used as a barrier accessory to digital thermometers for rectal temperature measurements. The document outlines a substantial equivalence argument to a predicate device (SaniTherm Thermometer Sheaths, K983406), rather than a study demonstrating a specific performance metric against clinical acceptance criteria for an AI-powered diagnostic device.

Therefore, many of the requested details regarding acceptance criteria, study design for AI algorithms, sample sizes, ground truth establishment, expert involvement, and MRMC studies are not applicable to this 510(k) submission for a non-AI accessory device.

However, I can extract the information that is relevant to the product's performance and testing for substantial equivalence:

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

Test	Acceptance Criteria (Implied by regulatory standards)	Reported Device Performance
Biocompatibility	Meet appropriate sections of ISO 10993-5 and ISO 10993-10 for cytotoxicity, sensitization, and irritation.	Evaluated for: Cytotoxicity, Sensitization, Irritation. The document states "Biocompatibility testing according to ISO 10993-5 & 10" and later "Biocompatibility in accordance with appropriate sections of ISO 10993-5 and ISO 10993-10 evaluated all materials...". This implies acceptance criteria were met.
Strength	Meet acceptance criteria as defined by ASTM E1104:98 (2016).	"Testing for tensile strength and lubricity (coefficient of friction) of the lubricated sheath met acceptance criteria."
Accuracy	Meet acceptance criteria as defined by ASTM E1104:98 §5.4 (2016).	"Testing showed that the sheath and lubricant materials met acceptance criteria."

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

The document does not specify the sample size for the test sets used in the biocompatibility, strength, or accuracy testing. It also does not provide details on data provenance (e.g., country of origin, retrospective/prospective). These are typically detailed in the full test reports, which are not included in this summary document.

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

This information is not applicable. The device is a thermometer sheath, and its performance testing (biocompatibility, strength, accuracy of temperature transmission) does not involve expert-established ground truth in the way a diagnostic imaging device would. The "ground truth" for these tests would be the established performance standards of the ASTM and ISO documents.

4. Adjudication method for the test set:

Not applicable. The tests performed are objective physical and chemical evaluations against established standards, not subjective assessments requiring adjudication.

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 not an AI-powered diagnostic tool, and therefore, an MRMC study is not relevant.

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

Not applicable. This is not an algorithm or AI device.

7. The type of ground truth used:

For biocompatibility, the "ground truth" is compliance with ISO 10993 standards. For strength and accuracy, the "ground truth" is compliance with ASTM E1104:98 (2016) specifications. These are objective engineering and material science standards, not medical ground truth derived from pathology, outcomes, or expert consensus in a clinical diagnostic sense.

8. The sample size for the training set:

Not applicable. This device does not involve a training set as it is not an AI/machine learning device.

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

Not applicable. This device does not involve a training set.

Summary

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June 14, 2019

Medline Industries, Inc. Dinah Rincones Regulatory Affairs Specialist Three Lakes Drive Northfield, Illinois 60093

Re: K183431

Trade/Device Name: Medline Digital Rectal Thermometer Sheath Regulation Number: 21 CFR 880.2910 Regulation Name: Clinical Electronic Thermometer Regulatory Class: Class II Product Code: FLL Dated: May 14, 2019 Received: May 16, 2019

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. 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 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

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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 Tina Kiang, Ph.D 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 Quality Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known)

Device Name

Medline Digital Rectal Thermometer Sheath

Indications for Use (Describe)

Type of Use (Select one or both, as applicable)Prescription Use (Part 21 CFR 801 Subpart D)

X 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 bold, white letters on a blue background. To the right of the word, there is a white starburst symbol. The starburst is oriented so that one of its points is facing upwards.

5.1.

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

510(k) Device Identification

Medline Digital Rectal Thermometer Sheath 510(k) Summary

K183431

Section 5: 510(k) Summary

DATE OF PREPARATION: June 14, 2019 Medline Industries, Inc. SPONSOR/SUBMITTER: Three Lakes Drive Northfield, IL 60093 Registration Number: 1417592 CONTACT: Dinah Rincones Regulatory Affairs Specialist 847-949-2687 TELEPHONE 224-931-1271 FAX: DRincones@medline.com EMAIL: DEVICE TRADE NAME: Medline Digital Rectal Thermometer Sheath Digital Thermometer Sheaths COMMON NAME: Clinical Electronic Thermometer CLASSIFICATION NAME: 21 CFR 8880.2910 REGULATION NUMBER: PRODUCT CODE: FLL DEVICE CLASS: Class II

PREDICATE DEVICE:

SaniTherm Thermometer Sheaths. Oral and Rectal, Digital and Mercury, K983406

5.2. Device Description

Products offered: Medline Digital Rectal Thermometer Sheaths (Only one model number is being offered).

5.2.1. Device Format

The Medline Digital Rectal Thermometer Sheath is offered over the counter, with 100 sheaths per carton. This accessory to digital rectal thermometers are sold non-sterile.

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Image /page/4/Picture/0 description: The image shows the Medline logo. The logo consists of the word "MEDLINE" in white, bold, sans-serif font, with a stylized white starburst symbol to the right of the text. The background is a solid dark blue color. The logo is simple and clean, with a professional and corporate look.

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

5.3. Indications for Use Statement

Subject Device vs. Predicate Device (Substantial Equivalence) 5.4.

The Medline Digital Rectal Thermometer Sheaths are substantially equivalent to the predicate SaniTherm Thermometer Sheaths, Oral and Rectal, Digital and Mercury, K983406. The comparison of the characteristics are summarized below.

Feature	Medline Digital RectalThermometer Sheath	Predicate	Comparison Analysis
510(k) Number	K183431	SaniTherm ThermometerSheaths, Oral and Rectal,Digital and MercuryK983406	N/A
Indication for Use	These devices are indicatedfor use as a barrier accessoryto digital thermometers whiletaking rectal temperaturemeasurements. These sheathsare non-sterile and intendedfor single use only. Thisaccessory is contraindicatedfor use with broken skin.	These devices are Indicated foruse as a barrier that is used asan accessory to oral or rectal,digital or mercurythermometers. These sheathsare non-sterile and areintended for single patient useonly.	Different
Design:	The Medline Digital RectalThermometer Sheath is anaccessory to a clinicalelectronic (digital)thermometer. The sheathcovers the clinical electronicthermometer transducer and isa single-use disposable device.Medline Digital RectalThermometer Sheaths may notbe suitable for clinicalthermometers which employrigid plastic sheaths. Thedevice is not made of naturalrubber latex.	SaniTherm DisposableThermometer Sheaths areplastic coverings used foreither oral or rectal, mercuryor digital thermometers.Digital Thermometer Sheathsmay not be suitable for usewith all clinical thermometers.Example - Clinicalthermometers which employrigid plastic sheaths.	Different
Construction	PP Plastic Film with upperand Lower exterior protectiveplastic	PP Plastic Film with upper andLower exterior protectiveplastic	Same
Use Type	For Single Use	For Single Use	Same
Packaging	Non-Sterile Package	Non-Sterile Package	Same
OutsideDimension	Length	$119 \text{ mm } \pm 0.0$	$122.3 \pm 0.6$	Different
	Width	$29 \text{ mm } \pm 0.0$	$28.3 \pm 0.6$	Different

Comparison of Technological Characteristics with the Predicate Device

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Image /page/5/Picture/0 description: The image shows the Medline logo. The logo consists of the word "MEDLINE" in white, bold, sans-serif font, positioned to the left of a white, four-pointed star-like symbol. The background is a solid dark blue color. The logo is simple and modern, with a clean design.

Medline Industries, Inc Three Lakes Drive Northfield, IL 60093

Medline Digital Rectal Thermometer Sheath 510(k) Summary

K183431

	Radius
	Base-Tip	3 ±0.0	2 ± 0.0	Different
Materials in skincontact:		Protective Film: ethylenemethyl acrylate copolymerfilmLubricant: Lubrajel MG	Protective Film: ethylenemethyl acrylate copolymerfilmLubricant: Lubrajel MG	Same
Biocompatibility		Biocompatibility testingaccording to ISO 10993-5 &10CytotoxicitySensitizationIrritation	Biocompatibility testingaccording to ISO 10993-5 &10CytotoxicitySensitizationIrritation	Same
Strength		Performance test according toASTM E1104:98 (2016).	Performance test according toASTM E1104:98 (2016).	Same
Accuracy		Performance test according toASTM E1104:98 §5.4 (2016)	Performance test according toASTM E1104:98 §5.4 (2016)	Same

Discussion of differences: Both the subject device and predicate device have similar intended use, same materials and structures. The difference in the dimensions do not raise new or different questions of safety or effectiveness. In addition, the difference in the indications for the subject device to be used for rectal temperature readings only does not raise new or different questions because the predicate device is also used for rectal temperature readings and oral temperature readings.

5.5. Performance Summary

5.5.1.1. Biocompatibility

Biocompatibility in accordance with appropriate sections of ISO 10993-5 and ISO 10993-10 evaluated all materials used in the Medline Digital Rectal Thermometer Sheaths for:

Cytotoxicity ●
Sensitization ●
Irritation

5.5.2. Performance Study

Material strength and temperature compatibility of the Medline Digital Rectal Thermometer Sheaths were tested per ASTM E1104:98 (2016) and compared with the predicate device. Sheath material strength and accuracy met acceptance criteria. The medical grade lubricant used for the thermometer sheaths met the acceptance criteria for lubricity (coefficient of friction).

Test	Test Method	Results
Strength	ASTM E1104:98 (2016)	Testing for tensile strength and lubricity (coefficient of friction) of

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Image /page/6/Picture/0 description: The image features the logo of Medline, a healthcare company. The logo consists of the word "MEDLINE" in bold, white letters, positioned horizontally. Behind the text is a white, four-pointed star-like shape, with each point extending outward from the center. The background of the logo is a solid, dark blue color, providing a strong contrast to the white elements.

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

Medline Digital Rectal Thermometer Sheath 510(k) Summary

K183431

Test	Test Method	Results
		the lubricated sheath metacceptance criteria.
Accuracy	ASTM E1104:98 (2016)	Testing showed that thesheath and lubricantmaterials met acceptancecriteria.

5.6. Conclusion

The Medline Digital Rectal Thermometer Sheath has similar intended use, materials and characteristics as the predicate device. Performance testing demonstrated that the subject device is shown to be substantially equivalent to the predicate device, SaniTherm Thermometer Sheaths, Oral and Rectal, Digital and Mercury, K983406.

There are no new or different questions of safety and effectiveness of the Medline Digital Rectal Thermometer Sheath when compared to the predicate device.

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.