(185 days)
Not Found
No
The device is a simple barrier accessory (sheath) for a digital thermometer and the description focuses on material properties and physical performance, with no mention of AI/ML or related concepts.
No
The device is a barrier accessory to a digital thermometer, not a device that treats or prevents disease or modifies bodily functions.
No
The device is described as a "barrier accessory to digital thermometers" and a "single-use disposable device" that "covers the transducer" of a thermometer. Its intended use is to act as a sheath for rectal temperature measurements, not to diagnose a condition itself. The performance studies also focus on its physical properties (strength, accuracy as a sheath, biocompatibility) rather than diagnostic performance metrics like sensitivity or specificity.
No
The device is a physical accessory (sheath) for a digital thermometer, not a software application. The description clearly outlines a tangible, disposable product.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is as a "barrier accessory to digital thermometers while taking rectal temperature measurements." This describes a physical barrier used during a temperature measurement procedure, not a test performed on a sample taken from the body to diagnose a condition.
- Device Description: The description clearly states it's an "accessory to a clinical electronic (digital) thermometer" and "covers the transducer." This reinforces its role as a physical component used with a diagnostic device (the thermometer), not a diagnostic device itself.
- Lack of IVD Characteristics: The description does not mention any analysis of biological samples (blood, urine, tissue, etc.), chemical reactions, or any other processes typically associated with in vitro diagnostics.
In summary, the device is a physical accessory designed to maintain hygiene during a temperature measurement, which is a physiological measurement, not an in vitro diagnostic test.
N/A
Intended Use / Indications for 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.
Product codes
FLL
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).
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
rectal
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
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
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).
Strength: Test Method ASTM E1104:98 (2016). Results: Testing for tensile strength and lubricity (coefficient of friction) of the lubricated sheath met acceptance criteria.
Accuracy: Test Method ASTM E1104:98 (2016). Results: Testing showed that the sheath and lubricant materials met acceptance criteria.
Key Metrics
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.
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). 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
1
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 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)
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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 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
Thermometer Sheath | Predicate | Comparison Analysis | |
|----------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------|-----------|
| 510(k) Number | K183431 | SaniTherm Thermometer
Sheaths, Oral and Rectal,
Digital and Mercury
K983406 | N/A | |
| Indication for 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. | These devices are Indicated for
use as a barrier that is used as
an accessory to oral or rectal,
digital or mercury
thermometers. These sheaths
are non-sterile and are
intended for single patient use
only. | Different | |
| Design: | The Medline Digital Rectal
Thermometer Sheath is an
accessory to a clinical
electronic (digital)
thermometer. The sheath
covers the clinical electronic
thermometer transducer and is
a single-use disposable device.
Medline Digital Rectal
Thermometer Sheaths may not
be suitable for clinical
thermometers which employ
rigid plastic sheaths. The
device is not made of natural
rubber latex. | SaniTherm Disposable
Thermometer Sheaths are
plastic coverings used for
either oral or rectal, mercury
or digital thermometers.
Digital Thermometer Sheaths
may not be suitable for use
with all clinical thermometers.
Example - Clinical
thermometers which employ
rigid plastic sheaths. | Different | |
| Construction | PP Plastic Film with upper
and Lower exterior protective
plastic | PP Plastic Film with upper and
Lower exterior protective
plastic | Same | |
| Use Type | For Single Use | For Single Use | Same | |
| Packaging | Non-Sterile Package | Non-Sterile Package | Same | |
| Outside
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- | ||||
| Tip | 3 ±0.0 | 2 ± 0.0 | Different | |
| Materials in skin | ||||
| contact: | Protective Film: ethylene | |||
| methyl acrylate copolymer | ||||
| film | ||||
| Lubricant: Lubrajel MG | Protective Film: ethylene | |||
| methyl acrylate copolymer | ||||
| film | ||||
| Lubricant: Lubrajel MG | Same | |||
| Biocompatibility | Biocompatibility testing | |||
| according to ISO 10993-5 & | ||||
| 10 | ||||
| Cytotoxicity | ||||
| Sensitization | ||||
| Irritation | Biocompatibility testing | |||
| according to ISO 10993-5 & | ||||
| 10 | ||||
| Cytotoxicity | ||||
| Sensitization | ||||
| Irritation | Same | |||
| Strength | Performance test according to | |||
| ASTM E1104:98 (2016). | Performance test according to | |||
| ASTM E1104:98 (2016). | Same | |||
| Accuracy | Performance test according to | |||
| ASTM E1104:98 §5.4 (2016) | Performance test according to | |||
| 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
| Test | Test Method | Results |
|---|---|---|
| the lubricated sheath met | ||
| acceptance criteria. | ||
| Accuracy | ASTM E1104:98 (2016) | Testing showed that the |
| sheath and lubricant | ||
| materials met acceptance | ||
| 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.