Medline Digital Thermometer Non-Lubricated Probe Sheath

K211931 · Medline Industries, Inc. · FLL · Sep 20, 2021 · General Hospital

Device Facts

• Record ID: K211931
• Device Name: Medline Digital Thermometer Non-Lubricated Probe Sheath
• Applicant: Medline Industries, Inc.
• Product Code: FLL · General Hospital
• Decision Date: Sep 20, 2021
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.2910
• Device Class: Class 2

Intended Use

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 Story

Flexible plastic sheath; acts as barrier accessory for digital stick thermometers; prevents contamination of thermometer transducer during temperature measurement. Used in clinical or home settings; operated by clinicians or patients. Sheath covers thermometer probe; provides physical barrier between device and patient tissue (oral, axillary, rectal). Single-use; disposable; non-lubricated; non-sterile. Benefits patient by reducing cross-contamination risk during temperature monitoring.

Clinical Evidence

No clinical data. Bench testing only. Performance testing included compatibility and leakage testing per ASTM E1104-98(2016). Biocompatibility testing included cytotoxicity (ISO 10993-5), skin sensitization (ISO 10993-10), and skin irritation (ISO 10993-10).

Technological Characteristics

Flexible plastic probe sheath; single-use; non-sterile; non-lubricated. Conforms to ASTM E1104-98. Biocompatibility evaluated per ISO 10993-1, ISO 10993-5, and ISO 10993-10.

Indications for Use

Indicated for use as a barrier accessory to digital thermometers for rectal, oral, or axillary temperature measurements. Contraindicated for use on broken skin.

Regulatory Classification

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.

Special Controls

(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.

Predicate Devices

• Medline Digital Rectal Thermometer Sheath (K183431)

Submission Summary (Full Text)

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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 ([e-mail]) or phone [phone] 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)

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.

| 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 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: [phone] 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

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

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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

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.

#### Summary of Technological Characteristics

# TABLE 1: COMPARISON OF PROPOSED AND PREDICATE DEVICES

| Device Characteristic | Proposed Device | Predicate Device | Comparison<br>Analysis |
|-------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------|
| Product Name | Medline Digital<br>Thermometer Non-<br>Lubricated Probe Sheath | Medline Digital Rectal<br>Thermometer 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 indicated<br>for use as a barrier accessory<br>to digital thermometers while<br>taking rectal, oral or axillary<br>temperature measurements.<br>These sheaths are non-sterile<br>and intended for single use<br>only. This accessory is<br>contraindicated for use with<br>broken skin. | These devices are indicated for<br>use as a barrier accessory to<br>digital thermometers while<br>taking rectal temperature<br>measurements. These sheaths<br>are nonsterile and intended for<br>single use only. This accessory<br>is contraindicated for use with<br>broken skin. | Different |
| Design Standard | Conforms to Standard ASTM<br>E1104-98 | Conforms to Standard ASTM<br>E1104-98 | Same |
| Design Features &<br>Configurations | One size, Clear, Flexible,<br>peel- away package, marking<br>for device insertion | One size, Clear, Flexible, peel-<br>away package, marking for<br>device 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-<br>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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Image /page/6/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, slanted, sans-serif font. A white starburst-like symbol is behind the text, with the text centered on the starburst. There is a gray bar at the top of the blue square.

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 or<br>accuracy of the<br>temperature-taking device such that the probe and temperature-<br>taking unit fails to<br>meet the requirements of ASTM E1112 – § 4.2 |
| Leakage | ASTM E1104-98 (2016) 5.3 | There shall be no continuous bubble stream observed from the<br>probe cover within 5<br>seconds 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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