(55 days)
No
The device description and performance studies focus on passive temperature sensing and standard electrical and biocompatibility testing, with no mention of AI or ML.
No
The device is intended to monitor skin surface temperature, not to provide therapy or treatment. Its primary function is measurement as an accessory to an infant radiant warmer.
No
Explanation: While the device monitors skin surface temperature, it does not interpret or diagnose any medical condition based on that temperature. It simply provides data to an infant radiant warmer.
No
The device description explicitly details physical components like a probe, wire set, thermistor chip, connector, and adhesive pad, indicating it is a hardware device with a sensor.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to "monitor the neonatal patient's skin surface temperature." This is a direct measurement of a physiological parameter on the patient's body.
- Device Description: The device is a sensor that measures temperature on the skin surface. It does not involve testing samples of biological material (like blood, urine, tissue, etc.) in vitro (outside the body).
- Lack of IVD Characteristics: The description does not mention any reagents, assays, or procedures typically associated with in vitro diagnostic testing.
IVD devices are used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device directly measures a physical property of the patient's body.
N/A
Intended Use / Indications for Use
The HYDRO-TEMP Neonatal Skin Surface Temperature Sensor is a non-sterile device intended for connection to an infant radiant warmer to monitor the neonatal patient's skin surface temperature.
Product codes (comma separated list FDA assigned to the subject device)
FMT
Device Description
The HYDRO-TEMP Neonatal Skin Surface Temperature Sensor consists of a probe used to monitor a neonate's skin surface temperature used as an accessory while the patient is on an infant radiant warmer. The probe is a wire set with a thermistor chip at the distal end that passively modifies the electrical current traveling through the device. A colored connector at the proximal end of the wire set interfaces with the warming bed or a cable that interfaces with the bed. The probe is packaged with an adhesive pad used to affix the sensor to the patient's skin surface. The device is non-sterile and individually packaged in a resealable plastic bag. The probe covers that are packaged with the probe are cleared under K191425. The probes are compatible with the following warming beds: Datex-Ohmeda (Ohmeda, Care Plus, and IWS brands), Draeger (Babytherm, Isolette, Babyleo, Caleo, Resuscitaire, ICS, and Globe-Trotter brands), Atom (Transcapsule, Infa Warmer, INCU 1, and Sunflower brands), and GE (Giraffe and Panda brands).
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Skin surface
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)
The proposed device has been tested and/or evaluated according to the following standards as applicable: ISO 10993-1, IEC 60601-2-21, ISO 80601-2-56, IEC 60601-1, IEC 60601-1-2.
The following biocompatibility tests were performed on the final, finished proposed device in accordance with ISO 10993 and FDA guidance: cytotoxicity, sensitization, and irritation. These results show the proposed device is biologically safe for its intended use.
Accuracy testing was performed to IEC 60601-2-21 demonstrating the tolerance range of temperature readings with the proposed change. Additionally, a time response test in accordance with ISO 80601-2-56 also was performed. The results of this testing demonstrate proposed modification to the thermistor encapsulation does not impact the device's performance of its intended use. Evaluation and testing according to IEC 60601-1 and IEC 60601-1-2 also was performed to ensure the change to the thermistor encapsulation did not affect the electrical safety of the device.
All testing was performed on final, finished product manufactured with the proposed modification. The test results met the requirements of the aforementioned standards and demonstrate that the proposed modification does not impact the safety or efficacy of the device.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Accuracy: +/- 0.2 degrees C
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.
HYDRO-TEMP NICU and Skin Surface Temperature Sensor [K925006]
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.
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: 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".
April 2, 2020
DeRoyal Industries, Inc. Sarah Bennett Senior Regulatory Affairs Specialist 200 DeBusk Lane Powell, Tennessee 37849
Re: K200319
Trade/Device Name: HYDRO-TEMP Neonatal Skin Surface Temperature Sensor, HYDRO-TEMP Neonatal Skin Surface Temperature Sensor with Interface Cable Regulation Number: 21 CFR 880.5130 Regulation Name: Infant Radiant Warmer Regulatory Class: Class II Product Code: FMT Dated: February 5, 2020 Received: February 7, 2020
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
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 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
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Indications for Use
510(k) Number (if known) K200319
Device Name
HYDRO-TEMP Neonatal Skin Surface Temperature Sensor
Indications for Use (Describe)
The HYDRO-TEMP Neonatal Skin Surface Temperature Sensor is a non-sterile device intended for connection to an infant radiant warmer to monitor the neonatal patient's skin surface temperature.
Type of Use (Select one or both, as applicable)
|X 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 contains the logo for DeRoyal. The logo consists of a stylized blue swoosh above the text "DeRoyal" in blue. The swoosh appears to be a curved line that starts thin and becomes thicker as it curves over the text.
DeRoyal Industries, Inc. Traditional 510(k) Submission – HYDRO-TEMP Neonatal Skin Surface Temperature Sensor
510(k) Summary
| Date prepared: | February 5, 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 | |
| F: 865-362-3741 | |
| sabennett@deroyal.com | |
| Contract Manufacturer: | DeRoyal Cientifica de Latinoamerica |
| S.R.L. | |
| Global Park | |
| Box 180-3006, 602 Parkway | |
| La Aurora, Heredia Heredia, Costa | |
| Rica 146 | |
| DeRoyal Industries, Inc. | |
| 185 Richardson Way | |
| Maynardville, TN 37807 | |
| Trade Name: | HYDRO-TEMP Neonatal Skin |
| Surface Temperature Sensor | |
| HYDRO-TEMP Neonatal Skin | |
| Surface Temperature Sensor with | |
| Interface Cable | |
| Common Name: | Skin Surface Temperature Sensor |
| Classification Name: | Warmer, Infant Radiant |
| Device Product Code: | FMT |
| Regulatory Class: | Class II |
| Regulation Number: | 21 CFR 880.5130 |
| Classification Panel: | General Hospital |
| K200319 | February 5, 2020 |
| Page 1 |
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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 text. The "R" in Royal has a registered trademark symbol next to it.
DeRoyal Industries, Inc. Traditional 510(k) Submission – HYDRO-TEMP Neonatal Skin Surface Temperature Sensor
Predicate Devices:
HYDRO-TEMP NICU and Skin Surface Temperature Sensor [K925006]
Device Description
The HYDRO-TEMP Neonatal Skin Surface Temperature Sensor consists of a probe used to monitor a neonate's skin surface temperature used as an accessory while the patient is on an infant radiant warmer. The probe is a wire set with a thermistor chip at the distal end that passively modifies the electrical current traveling through the device. A colored connector at the proximal end of the wire set interfaces with the warming bed or a cable that interfaces with the bed. The probe is packaged with an adhesive pad used to affix the sensor to the patient's skin surface.
The device is non-sterile and individually packaged in a resealable plastic bag. The probe covers that are packaged with the probe are cleared under K191425. The probes are compatible with the following warming beds: Datex-Ohmeda (Ohmeda, Care Plus, and IWS brands), Draeger (Babytherm, Isolette, Babyleo, Caleo, Resuscitaire, ICS, and Globe-Trotter brands), Atom (Transcapsule, Infa Warmer, INCU 1, and Sunflower brands), and GE (Giraffe and Panda brands).
Indications for Use
The HYDRO-TEMP Neonatal Skin Surface Temperature Sensor is a non-sterile device intended for connection to an infant radiant warmer to monitor the neonatal patient's skin surface temperature.
Differences to Predicate Device
The encapsulation method of the subject device is different that the predicate device. The predicate device, the current encapsulation method utilizes a molded plastic cap that is filled with epoxy glue, and the thermistor is inserted into this cap. In the subject device, these materials would be replaced with a UV-cured adhesive. The thermistor is dipped into the adhesive and cured under UV light. This is the only component change in the device. The thermistor cap directly contacts the patient's intact skin.
Summary of Technological Characteristics
| Characteristic | HYDRO-TEMP Neonatal
Skin Surface
Temperature Sensor | HYDRO-TEMP NICU
and Skin Surface
Temperature Sensor
Probe (K925006) |
| ---------------- | ----------------------------------------------------------- | ------------------------------------------------------------------------------ |
|---|
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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 text "DeRoyal" in a blue, stylized font. The "R" in "DeRoyal" has a registered trademark symbol next to it.
DeRoyal Industries, Inc. Traditional 510(k) Submission – HYDRO-TEMP Neonatal Skin Surface Temperature Sensor
| Prescription Only | Yes | Yes |
|---|---|---|
| Use Environment | NICU | NICU |
| Design | A wire set packaged with an adhesive pad. The wire set has a thermistor chip at the distal end and a colored connector at the proximal end. | A wire set packaged with an adhesive pad. The wire set has a thermistor chip at the distal end and a colored connector at the proximal end. |
| Materials | Probe Cover – Adhesive pad with polyester film backing and release liner | |
| Wire – Copper with PVC insulation | ||
| Thermistor – Ceramic | ||
| Connector – Plastic-molded metal connector | ||
| Strain Relief – PVC | ||
| Cap – UV-curing Adhesive | Probe Cover – Adhesive pad with polyester film backing and release liner | |
| Wire – Copper with PVC insulation | ||
| Thermistor – Ceramic | ||
| Connector – Plastic-molded metal connector | ||
| Strain Relief – PVC | ||
| Cap – PVC and epoxy glue | ||
| Accuracy | $±0.2°C$ | $±0.2°C$ |
| Sterility | Non-Sterile | Non-Sterile |
| Biocompatibility | ISO 10993-1 compliant | ISO 10993-1 compliant |
| Shelf life | 1 year (intent to extend to 5 years once testing completed) | 3 years |
Summary of Performance Tests
The proposed device has been tested and/or evaluated according to the following standards as applicable: ISO 10993-1, IEC 60601-2-21, ISO 80601-2-56, IEC 60601-1, IEC 60601-1-2.
The following biocompatibility tests were performed on the final, finished proposed device in accordance with ISO 10993 and FDA guidance: cytotoxicity, sensitization, and irritation. These results show the proposed device is biologically safe for its intended use.
Accuracy testing was performed to IEC 60601-2-21 demonstrating the tolerance range of temperature readings with the proposed change. Additionally, a time response test in accordance with ISO 80601-2-56 also was performed. The results of this testing demonstrate proposed modification to the thermistor encapsulation does not impact the device's performance of its intended use. Evaluation and testing according to IEC 60601-1 and IEC 60601-1-2 also was performed to ensure the change to the thermistor encapsulation did not affect the electrical safety of the device.
All testing was performed on final, finished product manufactured with the proposed modification. The test results met the requirements of the aforementioned standards and demonstrate that
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Image /page/6/Picture/0 description: The image shows the logo for DeRoyal. The logo features a stylized blue swoosh above the company name. The company name is also in blue and in a sans-serif font.
DeRoyal Industries, Inc. Traditional 510(k) Submission – HYDRO-TEMP Neonatal Skin Surface Temperature Sensor
the proposed modification does not impact the safet or efficacy of the device.
Conclusion
The results of performance testing demonstrate the HYDRO-TEMP Neonatal Skin Surface Temperature Sensor is substantially equivalent to the predicate device. The difference between the predicate device and subject device is change to the thermistor encapsulation method and all other features are the same.