(90 days)
No
The device is a simple plastic sheath and the description contains no mention of AI or ML.
No
The device is described as an accessory to a digital thermometer, providing a barrier to contamination but not directly measuring, treating, or diagnosing a medical condition itself.
No
The device is a probe sheath for a thermometer, acting as a barrier to prevent contamination, not to diagnose a condition.
No
The device is a physical probe sheath, a hardware accessory, not a software-only medical device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is clearly stated as a "barrier accessory to digital thermometers while taking rectal, oral or axillary temperature measurements." This describes a physical barrier for hygiene and contamination prevention during a temperature measurement, which is a physiological measurement, not an in vitro diagnostic test.
- Device Description: The description reinforces its function as a "flexible plastic sheath that is used to cover the transducer of clinical electronic thermometers" and acts as a "barrier to prevent possible contamination." This aligns with a physical accessory for a medical device, not a device that performs a test on a sample taken from the body.
- No mention of biological samples or analysis: IVD devices are designed to perform tests on biological samples (like blood, urine, tissue, etc.) to provide information about a person's health. This device does not interact with or analyze any biological samples.
- Performance Studies: The performance studies focus on physical properties like compatibility, leakage, and tensile strength, which are relevant to a physical barrier accessory, not an IVD test.
In summary, the device's purpose is to provide a hygienic barrier for a thermometer, which is used for a physiological measurement. It does not perform any diagnostic testing on biological samples, which is the defining characteristic of an IVD.
N/A
Intended Use / 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.
Product codes
FLL
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 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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
rectal, oral or axillary temperature measurements
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.
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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
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
1
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 (DICE@fda.hhs.gov) or phone (1-800-638-2041 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: 847-949-2283 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
Analysis |
|-------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------|
| Product Name | Medline Digital
Thermometer Non-
Lubricated Probe Sheath | Medline Digital Rectal
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
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. | These devices are indicated for
use as a barrier accessory to
digital thermometers while
taking rectal temperature
measurements. These sheaths
are nonsterile and intended for
single use only. This accessory
is contraindicated for use with
broken skin. | Different |
| Design Standard | Conforms to Standard ASTM
E1104-98 | Conforms to Standard ASTM
E1104-98 | Same |
| Design Features &
Configurations | One size, Clear, Flexible,
peel- away package, marking
for device insertion | One size, Clear, Flexible, peel-
away package, marking for
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- | |||
| 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 |
| accuracy of the | ||
| temperature-taking device such that the probe and temperature- | ||
| taking unit fails to | ||
| 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 |
| probe cover within 5 | ||
| 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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