Medline Digital Rectal Thermometer Sheath

{0}------------------------------------------------ Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo is in blue and includes the letters "FDA" followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in a stacked format. 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). 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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 {2}------------------------------------------------ # 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) ### CONTINUE ON A SEPARATE PAGE IF NEEDED. 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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 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. {4}------------------------------------------------ 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 {5}------------------------------------------------ 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 | {6}------------------------------------------------ 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.