Hydro-Temp Neonatal Skin Temperature Probe Cover

K191425 · Deroyal Industries, Inc. · FMT · Jan 21, 2020 · General Hospital

Device Facts

• Record ID: K191425
• Device Name: Hydro-Temp Neonatal Skin Temperature Probe Cover
• Applicant: Deroyal Industries, Inc.
• Product Code: FMT · General Hospital
• Decision Date: Jan 21, 2020
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.5130
• Device Class: Class 2
• Attributes: Pediatric

Intended 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.

Device Story

Device is an adhesive probe cover used in NICU settings; functions as an accessory to DeRoyal-branded neonatal skin temperature probes. Consists of a release liner, patient-contacting hydrogel adhesive, and metallized polyester backing; one configuration includes polyethylene foam. Operates by affixing thermistor to neonate's skin and insulating sensor from ambient room temperature. Clinicians apply the cover to ensure accurate temperature readings during infant radiant warmer use. Benefits include secure sensor placement and improved thermal isolation for precise monitoring.

Clinical Evidence

Bench testing only. Mechanical testing per ASTM D903-98 demonstrated greater adhesive strength (4.42N vs 4.28N) and pull force (10.1N vs 9.1N) compared to predicate. Insulation testing confirmed no significant temperature difference. Accuracy testing performed per IEC 60601-2-21. Biocompatibility testing (cytotoxicity, sensitization, irritation) performed per ISO 10993.

Technological Characteristics

Materials: Polyester film release liner, hydrogel adhesive, metallized polyester backing, optional polyethylene foam. Non-sterile. Biocompatibility: ISO 10993-1 compliant. Adhesive performance: ASTM D903-98. Accuracy testing: IEC 60601-2-21.

Indications for Use

Indicated for neonates in the NICU to secure temperature probe thermistors to skin and provide thermal insulation for accurate temperature monitoring.

Regulatory Classification

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.

Special Controls

*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.

Predicate Devices

• HYDRO-TEMP® NICU and Skin Surface Temperature Sensor (K925006)

Submission Summary (Full Text)

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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

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

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# 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)

| <span style="font-family:Wingdings;">X</span> Prescription Use (Part 21 CER 801 Subpart D) | <span style="font-family:Wingdings;">☐</span> 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.<br>200 DeBusk Lane<br>Powell, TN 37849<br>Owner/Operator #1044833 |
| 510(k) Contact: | Sarah Bennett<br>Senior Regulatory Affairs Specialist<br>P: 865-362-6112<br>[e-mail] |
| Contract Manufacturer: | DeRoyal Industries, Inc.<br>185 Richardson Way<br>Maynardville, TN 37849<br>FDA Establishment # 1034876 |
| Trade Name: | HYDRO-TEMP® Neonatal Skin<br>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<br>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

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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®<br>Neonatal Skin<br>Temperature Probe<br>Cover | HYDRO-TEMP®<br>NICU and Skin Surface<br>Temperature Sensor<br>Probe (K925006) |
|-------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Prescription Only | Yes | Yes |
| Use Environment | NICU | NICU |
| Design | A pad consisting of a<br>release liner, non-<br>sensitizing hydrogel<br>adhesive that contacts the<br>patient's skin, and<br>metalized film backing.<br>One configuration also<br>contains a polyethylene<br>foam that is placed in<br>between the gel and film. | The device is a<br>disposable skin surface<br>temperature probe. The<br>device consists of wire<br>sets and a pad. The pad<br>holds the sensing device<br>against the skin. It is<br>adhesive lined or<br>hydrogel lined foam. The<br>pad is composed of<br>materials which will<br>insulate the sensing<br>elemnt from the ambient<br>temperature and adhere<br>the element to the skin. |
| Materials | Release liner: Polyester<br>film | Release liner: Polyester<br>film |

#### Summary of Technological Characteristics

January 16, 2020

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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:<br>Hydrogel<br>Foam: Polyethylene foam<br>Backing: Metallic polyester film | Patient adhesive:<br>Hydrogel<br>Foam: Polyethylene foam<br>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.