Medline Disposable Electronic Thermometer Probe Cover

K173113 · Medline Industries, Inc. · FLL · Jan 17, 2018 · General Hospital

Device Facts

• Record ID: K173113
• Device Name: Medline Disposable Electronic Thermometer Probe Cover
• Applicant: Medline Industries, Inc.
• Product Code: FLL · General Hospital
• Decision Date: Jan 17, 2018
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.2910
• Device Class: Class 2

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 possible contamination and infection during temperature measuring. The probe covers are non-sterile and intended for single use only.

Device Story

Disposable, single-use, non-sterile shell-like barrier; designed to fit over SureTemp and SureTemp Plus digital thermometer probes. Used in clinical settings by healthcare professionals during oral, rectal, or axillary temperature measurements. Acts as a physical barrier to prevent microbiological cross-contamination between patients and the reusable thermometer probe. Does not interfere with heat transfer from patient to the thermistor. Benefits include infection control and patient safety.

Clinical Evidence

Bench testing only. Performance testing conducted in accordance with ASTM E1104-98 (2016). Biocompatibility testing performed per ISO 10993-5 (Cytotoxicity) and ISO 10993-10 (Irritation and Delayed-Type Hypersensitivity).

Technological Characteristics

Disposable, single-use, shell-like probe cover. Conforms to ASTM E1104-98 (2016) standards. Non-sterile. Material properties verified via ISO 10993 biocompatibility testing. No electronic components, software, or energy sources.

Indications for Use

Indicated for use as a barrier between SureTemp/SureTemp Plus digital thermometer probes and oral, rectal, or axillary sites to prevent contamination/infection during temperature measurement in patients requiring clinical temperature monitoring.

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

• Welch Allyn SureTemp Plus Thermometer (K030580)

Submission Summary (Full Text)

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

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)

| <span style="font-size:100%;">☒</span> Prescription Use (Part 21 CFR 801 Subpart D) |
|-------------------------------------------------------------------------------------|
| <span style="font-size:100%;">☐</span> 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: [phone] Fax: [phone] Email: [e-mail]

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

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<br>Analysis |
|-----------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Product Name | The Medline Disposable<br>Electronic Thermometer<br>Probe Covers | The Welch Allyn SureTemp<br>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<br>Electronic Thermometer<br>Probe Covers are intended<br>for use as barriers between<br>any SureTemp and<br>SureTemp Plus digital<br>thermometer probe and users'<br>oral, rectal, or axillary<br>measuring sites to avoid the<br>possible contamination and<br>infection during temperature<br>measuring. The probe covers<br>are non-sterile and intended | Electronic Thermometer:<br>The Welch Allyn SureTemp<br>Plus thermometer enables the<br>health care professional to make<br>an accurate prediction of oral,<br>rectal or axillary temperature.<br>Electronic Thermometer Probe<br>Cover:<br>Probe covers are intended to<br>cover the thermometer probe<br>prior to its use. This cover must<br>not be a significant barrier to<br>the transfer of heat from the | Same*<br>*The predicate's<br>thermometer probe<br>covers are<br>accessories to the<br>thermometer itself,<br>and were included in<br>its 510(k) clearance<br>under K030580.<br>Only the probe<br>covers are included<br>in this 510(k), as<br>Medline 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 (and<br>thermistor). In addition, the<br>disposable nature of the probe<br>cover prevents microbiological<br>cross-contamination among<br>patients which might occur with<br>a reusable probe. | intend to market any<br>other component or<br>accessory of the<br>SureTemp Plus<br>thermometer system,<br>nor the thermometer<br>itself. The proposed<br>device's Indications<br>for Use are,<br>therefore, more<br>narrow than the<br>Indications for Use<br>stated in K030580,<br>which applied to<br>both the<br>thermometer and the<br>probe covers, as the<br>proposed device's<br>indications are only<br>applicable to the<br>probe covers. |
|-----------------------------------|------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Regulation Number | 21 CFR 880.2910 | 21 CFR 880.2910 | Same |
| Design Features | Conforms to ASTM Standard<br>E1104 | Conforms to ASTM Standard<br>E1104 | Same |
| Design Configurations | One size | One size | Same |
| Performance Specifications | Conforms to ASTM Standard<br>E1104 | Conforms to ASTM Standard<br>E1104 | Same |
| Prescription vs. OTC | Prescription Only | Prescription Only | Same |
| Sterile vs. Non-Sterile | Non-sterile | Non-sterile | Same |
| Disposable vs. Non-<br>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.