(237 days)
Not Found
No
The device description and performance studies focus on the physical properties and adhesive performance of a temperature probe cover, with no mention of AI or ML technologies.
No
The device is described as an accessory used to affix a temperature sensor and insulate it for accurate readings. It does not directly provide a therapeutic effect or treat a condition, but rather assists in accurate monitoring.
No
This device is an accessory (a cover) for a temperature probe. Its function is to secure and insulate the temperature probe to ensure accurate temperature readings, but it does not itself perform any diagnostic function. The diagnostic function (temperature measurement) is performed by the temperature probe it supports.
No
The device description clearly states it is an adhesive pad made of physical materials (release liner, hydrogel adhesive, metallized polyester backing, and optional foam) used to affix a temperature sensor to the skin. It is a physical accessory, not software.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens taken from the human body (like blood, urine, tissue) to provide information about a person's health. This testing is done outside of the body (in vitro).
- Device Function: The DeRoyal HYDRO-TEMP® Neonatal Skin Temperature Probe Covers are used to adhere a temperature probe to a patient's skin and insulate it. This is a device that interacts directly with the patient's body to facilitate a measurement on the body.
- Lack of Specimen Analysis: The device does not analyze any biological specimens. It is an accessory for a temperature probe, which measures a physical parameter (temperature) directly from the patient's skin.
Therefore, based on the provided information, the device's function and intended use clearly fall outside the scope of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The DeRoyal HYDRO-TEMP® Neonatal Skin Temperature Probe Covers are used to adhere the thermistor of the temperature probe to the patient and insulate the thermistor from ambient room temperature ensuring correct temperature readings.
Product codes (comma separated list FDA assigned to the subject device)
FMT
Device Description
The HYDRO-TEMP® Neonatal Skin Temperature Probe Cover is an accessory to be used with DeRoyal-branded NICU neonatal skin temperature probes used with an infant radiant warmer. They have not been evaluated for use with other manufacturer's products. It is an adhesive pad used to affix a temperature sensor to a neonate's skin to monitor the skin surface temperature. The cover also insulates the temperature sensor from ambient room temperature to ensure temperature readings are accurate.
There are two configurations of the probe cover. Both of these configurations contain a release liner, a patient-contacting hydrogel adhesive, and a metallized polyester backing. One configuration contains an additional foam material that is placed in between the hydrogel adhesive and metallic backing. The device is non-sterile and can be packaged on its own in a foil pouch or in a resealable plastic bag with a temperature probe.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Skin
Indicated Patient Age Range
Neonatal
Intended User / Care Setting
NICU
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)
Mechanical testing was performed to evaluate the adhesive performance of the proposed device compared to the predicate per ASTM D903-98 (Reapproved 2017) - Standard Test Methods for Peel or Stripping Strength of Adhesive Bonds. The results of this testing demonstrate the proposed device has a greater adhesive strength than the predicate. A pull test was performed to evaluate the adhesive performance of the proposed device to the predicate. This was performed to an internal standard. Insulation testing demonstrated that the new material did not result in a temperature difference from the predicate device. Accuracy testing was performed to IEC 60601-2-21 demonstrating the tolerance range of temperature readings when the probe cover was used. The following biocompatibility tests also were performed in accordance with ISO 10993 and FDA guidance: cytotoxicity, sensitization, and irritation. These results show that the proposed device is biologically safe for its intended use.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Average peel force per ASTM D903-98: 4.42N (Proposed Device), 4.28N (Predicate Device)
Average force required to remove cover from surface: 10.1N (Proposed Device), 9.1N (Predicate Device)
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 880.5130 Infant radiant warmer.
(a)
Identification. The infant radiant warmer is a device consisting of an infrared heating element intended to be placed over an infant to maintain the infant's body temperature by means of radiant heat. The device may also contain a temperature monitoring sensor, a heat output control mechanism, and an alarm system (infant temperature, manual mode if present, and failure alarms) to alert operators of a temperature condition over or under the set temperature, manual mode time limits, and device component failure, respectively. The device may be placed over a pediatric hospital bed or it may be built into the bed as a complete unit.(b)
Classification. Class II (Special Controls):(1) The Association for the Advancement of Medical Instrumentation (AAMI) Voluntary Standard for the Infant Radiant Warmer;
(2) A prescription statement in accordance with § 801.109 of this chapter (restricted to use by or upon the order of qualified practitioners as determined by the States); and
(3) Labeling for use only in health care facilities and only by persons with specific training and experience in the use of the device.
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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: a symbol on the left and the FDA name on the right. The symbol on the left is a stylized image of a human figure, while the FDA name on the right is written in blue letters. The words "U.S. FOOD & DRUG ADMINISTRATION" are written in a clear, sans-serif font.
January 21, 2020
DeRoyal Industries, Inc. Sarah Bennett Senior Regulatory Affairs Specialist 200 DeBusk Lane Powell, Tennessee 37849
Re: K191425
Trade/Device Name: Hydro-Temp® Neonatal Skin Temperature Probe Cover Regulation Number: 21 CFR 880.5130 Regulation Name: Infant Radiant Warmer Regulatory Class: Class II Product Code: FMT Dated: December 20, 2019 Received: December 23, 2019
Dear Sarah Bennett:
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
1
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 (OS) 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 medical devices and radiation-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 Geeta Pamidimukkala 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 Quality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K191425
Device Name
HYDRO-TEMP® Neonatal Skin Temperature Probe Cover
Indications for Use (Describe)
The DeRoyal HYDRO-TEMP® Neonatal Skin Temperature Probe Covers are used to adhere the thermistor of the temperature probe to the patient and insulate the thermistor from ambient room temperature ensuring correct temperature readings.
Type of Use (Select one or both, as applicable)
| X Prescription Use (Part 21 CER 801 Subpart D) | ☐ Over-The-Counter Use (21 CER 801 Subpart C) |
|---|---|
| -------------------------------------------------------------------------------------------- | ------------------------------------------------------------------------------------------- |
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Image /page/3/Picture/0 description: The image shows the logo for DeRoyal. The logo consists of a blue swoosh-like graphic on the left, followed by the text "DeRoyal" in blue. The "R" in "Royal" has a registered trademark symbol next to it.
Corporate 200 DeBusk Lane Powell, TN 37849 USA 865.938.7828 800.251.9864 www.deroyal.com
DeRoyal Industries, Inc. Traditional 510(k) – HYDRO-TEMP® Neonatal Skin Temperature Probe Cover (K191425) January 16, 2020
510(k) Summary
| Date prepared: | January 16, 2020 |
|---|---|
| 510(k) Owner: | DeRoyal Industries, Inc. |
| 200 DeBusk Lane | |
| Powell, TN 37849 | |
| Owner/Operator #1044833 | |
| 510(k) Contact: | Sarah Bennett |
| Senior Regulatory Affairs Specialist | |
| P: 865-362-6112 | |
| sabennett@deroyal.com | |
| Contract Manufacturer: | DeRoyal Industries, Inc. |
| 185 Richardson Way | |
| Maynardville, TN 37849 | |
| FDA Establishment # 1034876 | |
| Trade Name: | HYDRO-TEMP® Neonatal Skin |
| Temperature Probe Cover | |
| Common Name: | Skin Temperature Probe Cover |
| Classification Name: | Warmer, Infant Radiant |
| Device Product Code: | FMT |
| Regulatory Class: | Class II |
| Regulation Name: | 21 CFR 880.5130 |
| Classification Panel: | General Hospital |
| Predicate Devices: | HYDRO-TEMP® NICU and Skin |
| Surface Temperature Sensor |
Device Description
The HYDRO-TEMP® Neonatal Skin Temperature Probe Cover is an accessory to be used with DeRoyal-branded NICU neonatal skin temperature probes used with an infant radiant warmer. They have not been evaluated for use with other manufacturer's
January 16, 2020
4
Image /page/4/Picture/0 description: The image shows the logo for DeRoyal. The logo consists of a blue swoosh-like graphic on the left, followed by the word "DeRoyal" in blue, sans-serif font. The "R" in Royal has a registered trademark symbol next to it.
Corporate 200 DeBusk Lane Powell, TN 37849 USA 865.938.7828 800.251.9864 www.deroyal.com products. It is an adhesive pad used to affix a temperature sensor to a neonate's skin to monitor the skin surface temperature. The cover also insulates the temperature sensor from ambient room temperature to ensure temperature readings are accurate.
There are two configurations of the probe cover. Both of these configurations contain a release liner, a patient-contacting hydrogel adhesive, and a metallized polyester backing. One configuration contains an additional foam material that is placed in between the hydrogel adhesive and metallic backing. The device is non-sterile and can be packaged on its own in a foil pouch or in a resealable plastic bag with a temperature probe.
Indications for Use:
The DeRoyal HYDRO-TEMP® Neonatal Skin Temperature Probe Covers are used to adhere the thermistor of the temperature probe to the patient and insulate the thermistor from ambient room temperature ensuring correct temperature readings.
Differences to Predicate Device:
The subject device has greater adhesive bond to the predicate device. This was demonstrated through peel strength testing between both devices. The Indications for Use statement for the subject device is specifically for the probe cover whereas the predicate device included the temperature sensor probe and the probe cover for monitoring temperature. The differences in thickness do not impact the safety or effectiveness.
| Characteristic | HYDRO-TEMP®
Neonatal Skin
Temperature Probe
Cover | HYDRO-TEMP®
NICU and Skin Surface
Temperature Sensor
Probe (K925006) |
|-------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Prescription Only | Yes | Yes |
| Use Environment | NICU | NICU |
| Design | A pad consisting of a
release liner, non-
sensitizing hydrogel
adhesive that contacts the
patient's skin, and
metalized film backing.
One configuration also
contains a polyethylene
foam that is placed in
between the gel and film. | The device is a
disposable skin surface
temperature probe. The
device consists of wire
sets and a pad. The pad
holds the sensing device
against the skin. It is
adhesive lined or
hydrogel lined foam. The
pad is composed of
materials which will
insulate the sensing
elemnt from the ambient
temperature and adhere
the element to the skin. |
| Materials | Release liner: Polyester
film | Release liner: Polyester
film |
Summary of Technological Characteristics
January 16, 2020
5
Image /page/5/Picture/0 description: The image shows the logo for DeRoyal. The logo consists of a blue swoosh-like graphic on the left, followed by the word "DeRoyal" in blue, with the "®" symbol in the upper right corner of the word. The logo is simple and modern, and the blue color gives it a sense of trustworthiness and reliability.
Corporate 200 DeBusk Lane Powell, TN 37849 USA 865.938.7828 800.251.9864 www.deroyal.com
| | Patient adhesive:
Hydrogel
Foam: Polyethylene foam
Backing: Metallic polyester film | Patient adhesive:
Hydrogel
Foam: Polyethylene foam
Backing: Metallic polyester film |
|-----------------------------------------------------|----------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------|
| Adhesive | Hydrogel | Hydrogel |
| Sterility | Non-Sterile | Non-Sterile |
| Biocompatibility | ISO 10993-1 compliant | ISO 10993-1 compliant |
| Average peel force per ASTM D903-98 | 4.42N | 4.28N |
| Average force required to remove cover from surface | 10.1N | 9.1N |
Summary of Performance Tests
Mechanical testing was performed to evaluate the adhesive performance of the proposed device compared to the predicate per ASTM D903-98 (Reapproved 2017) - Standard Test Methods for Peel or Stripping Strength of Adhesive Bonds. The results of this testing demonstrate the proposed device has a greater adhesive strength than the predicate. A pull test was performed to evaluate the adhesive performance of the proposed device to the predicate. This was performed to an internal standard. Insulation testing demonstrated that the new material did not result in a temperature difference from the predicate device. Accuracy testing was performed to IEC 60601-2-21 demonstrating the tolerance range of temperature readings when the probe cover was used. The following biocompatibility tests also were performed in accordance with ISO 10993 and FDA guidance: cytotoxicity, sensitization, and irritation. These results show that the proposed device is biologically safe for its intended use.
Conclusion
The HYDRO-TEMP® Neonatal Skin Temperature Probe Cover is substantially equivalent to the predicate device, HYDRO-TEMP® NICU and Skin Surface Temperature Sensor (K925006). The tests performed demonstrate the device is substantially eqivalent to the predicate device. The proposed device is similar to the predicate but with a modified hydrogel material to improve the adhesive strength, which is supported by performance testing.