Medline Digital Rectal Thermometer Sheath

K183431 · Medline Industries, Inc. · FLL · Jun 14, 2019 · General Hospital

Device Facts

• Record ID: K183431
• Device Name: Medline Digital Rectal Thermometer Sheath
• Applicant: Medline Industries, Inc.
• Product Code: FLL · General Hospital
• Decision Date: Jun 14, 2019
• 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 temperature measurements. These sheaths are non-sterile and intended for single use only. This accessory is contraindicated for use with broken skin.

Device Story

Medline Digital Rectal Thermometer Sheath; single-use, non-sterile, disposable plastic barrier accessory for clinical electronic (digital) thermometers; covers thermometer transducer during rectal temperature measurement; prevents cross-contamination; used in clinical or home settings; operated by clinicians or patients; provides physical barrier without interfering with temperature reading accuracy; enhances patient safety by reducing infection risk.

Clinical Evidence

Bench testing only. Biocompatibility evaluated per ISO 10993-5 (cytotoxicity) and ISO 10993-10 (sensitization, irritation). Performance testing conducted per ASTM E1104:98 (2016) for tensile strength, lubricity (coefficient of friction), and temperature measurement accuracy. All results met acceptance criteria.

Technological Characteristics

Materials: PP plastic film, ethylene methyl acrylate copolymer film, Lubrajel MG lubricant. Dimensions: 119mm length, 29mm width. Sensing principle: passive barrier for digital thermometer transducer. Non-sterile. Single-use. Biocompatibility per ISO 10993-5/10. Performance per ASTM E1104:98 (2016).

Indications for Use

Indicated for use as a barrier accessory to digital thermometers during rectal 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

• SaniTherm Thermometer Sheaths, Oral and Rectal, Digital and Mercury (K983406)

Submission Summary (Full Text)

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

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.

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 [phone] FAX: [e-mail] 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

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.

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

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.

#### 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 Rectal<br>Thermometer Sheath | Predicate | Comparison Analysis | |
|----------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------|-----------|
| 510(k) Number | K183431 | SaniTherm Thermometer<br>Sheaths, Oral and Rectal,<br>Digital and Mercury<br>K983406 | N/A | |
| Indication for Use | These devices are indicated<br>for use as a barrier accessory<br>to digital thermometers while<br>taking rectal temperature<br>measurements. These sheaths<br>are non-sterile and intended<br>for single use only. This<br>accessory is contraindicated<br>for use with broken skin. | These devices are Indicated for<br>use as a barrier that is used as<br>an accessory to oral or rectal,<br>digital or mercury<br>thermometers. These sheaths<br>are non-sterile and are<br>intended for single patient use<br>only. | Different | |
| Design: | The Medline Digital Rectal<br>Thermometer Sheath is an<br>accessory to a clinical<br>electronic (digital)<br>thermometer. The sheath<br>covers the clinical electronic<br>thermometer transducer and is<br>a single-use disposable device.<br>Medline Digital Rectal<br>Thermometer Sheaths may not<br>be suitable for clinical<br>thermometers which employ<br>rigid plastic sheaths. The<br>device is not made of natural<br>rubber latex. | SaniTherm Disposable<br>Thermometer Sheaths are<br>plastic coverings used for<br>either oral or rectal, mercury<br>or digital thermometers.<br>Digital Thermometer Sheaths<br>may not be suitable for use<br>with all clinical thermometers.<br>Example - Clinical<br>thermometers which employ<br>rigid plastic sheaths. | Different | |
| Construction | PP Plastic Film with upper<br>and Lower exterior protective<br>plastic | PP Plastic Film with upper and<br>Lower exterior protective<br>plastic | Same | |
| Use Type | For Single Use | For Single Use | Same | |
| Packaging | Non-Sterile Package | Non-Sterile Package | Same | |
| Outside<br>Dimension | 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-<br>Tip | 3 ±0.0 | 2 ± 0.0 | Different |
| Materials in skin<br>contact: | | Protective Film: ethylene<br>methyl acrylate copolymer<br>film<br>Lubricant: Lubrajel MG | Protective Film: ethylene<br>methyl acrylate copolymer<br>film<br>Lubricant: Lubrajel MG | Same |
| Biocompatibility | | Biocompatibility testing<br>according to ISO 10993-5 &<br>10<br>Cytotoxicity<br>Sensitization<br>Irritation | Biocompatibility testing<br>according to ISO 10993-5 &<br>10<br>Cytotoxicity<br>Sensitization<br>Irritation | Same |
| Strength | | Performance test according to<br>ASTM E1104:98 (2016). | Performance test according to<br>ASTM E1104:98 (2016). | Same |
| Accuracy | | Performance test according to<br>ASTM E1104:98 §5.4 (2016) | Performance test according to<br>ASTM 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 met<br>acceptance criteria. |
| Accuracy | ASTM E1104:98 (2016) | Testing showed that the<br>sheath and lubricant<br>materials met acceptance<br>criteria. |

#### 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.