Foley Catheter with Temperature Sensor

K200757 · Deroyal Industries, Inc. · EYC · Oct 15, 2020 · Gastroenterology, Urology

Device Facts

• Record ID: K200757
• Device Name: Foley Catheter with Temperature Sensor
• Applicant: Deroyal Industries, Inc.
• Product Code: EYC · Gastroenterology, Urology
• Decision Date: Oct 15, 2020
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 876.5130
• Device Class: Class 2

Intended Use

The DeRoyal Foley Catheter with Temperature Sensor is to be used for drainary bladder and simultaneous monitoring of core body temperature.

Device Story

Device is a silicone Foley catheter (14-18 French) with an integrated temperature-sensing wire set. A thermistor chip at the distal tip passively modifies electrical current based on temperature; this signal is transmitted via a proximal blue connector to an independent, external temperature monitor. Used in hospital settings by clinicians to drain the bladder while continuously monitoring core body temperature. The device is a modification of a predicate, specifically changing the thermistor chip encapsulation method. The output is displayed on a separate monitor, allowing clinicians to track patient temperature trends and manage clinical care. Benefits include simultaneous bladder drainage and core temperature monitoring in a single device.

Clinical Evidence

Bench testing only. Biocompatibility testing (cytotoxicity, sensitization, irritation, pyrogenicity, acute systemic toxicity) performed per ISO 10993 series. Electrical safety and electromagnetic compatibility tested per IEC 60601-1 and IEC 60601-1-2. Accuracy, time response, and leakage current testing performed per ISO 80601-2-56. All results met acceptance criteria.

Technological Characteristics

Silicone Foley catheter (14-18 French) with 3 lumens and 5cc balloon. Sensing element: ceramic thermistor chip. Materials: copper wire, PVC insulation, PVC-mold brass connector, UV-curing adhesive, polypropylene inflation valve, ABS collar. Connectivity: wired connection to external monitor. Sterilization: sterile. Operation: passive thermistor sensing.

Indications for Use

Indicated for drainage of the urinary bladder and simultaneous monitoring of core body temperature in male and female adults.

Regulatory Classification

Identification

A urological catheter and accessories is a flexible tubular device that is inserted through the urethra and used to pass fluids to or from the urinary tract. This generic type of device includes radiopaque urological catheters, ureteral catheters, urethral catheters, coudé catheters, balloon retention type catheters, straight catheters, upper urinary tract catheters, double lumen female urethrographic catheters, disposable ureteral catheters, male urethrographic catheters, and urological catheter accessories including ureteral catheter stylets, ureteral catheter adapters, ureteral catheter holders, ureteral catheter stylets, ureteral catheterization trays, and the gastro-urological irrigation tray (for urological use).

Predicate Devices

• EXAC-TEMP Foley Catheter and CLINI-TEMP Foley Catheter (K041416)

Submission Summary (Full Text)

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October 15, 2020

DeRoyal Industries, Inc. Sarah Bennett Senior Regulatory Affairs Specialist 200 DeBusk Lane Powell, TN 37849

Re: K200757

> Trade/Device Name: Foley Catheter with Temperature Sensor Regulation Number: 21 CFR§ 876.5130 Regulation Name: Urological Catheter and Accessories Regulatory Class: II Product Code: EYC, EZL Dated: September 11, 2020 Received: September 14, 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 statutes and regulations administered by other Federal agencies.

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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-regulatoryinformation/postmarketing-safety-reporting-combination-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 ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely,

Sharon Andrews Director DHT3B: Division of Reproductive. Gynecology and Urology Devices 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) K200757

Device Name

Foley Catheter with Temperature Sensor

Indications for Use (Describe)

The DeRoyal Foley Catheter with Temperature Sensor is to be used for drainary bladder and simultaneous monitoring of core body 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/1 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.

DeRoyal Industries, Inc. Traditional 510(k) Submission - Foley Catheter with Temperature Sensor March 23, 2020

## 510(k) Summary March 23, 2020 Date prepared: 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: Xeridiem Medical Devices 4700 S Overland Dr Tuscon, AZ 85714 DeRoyal Cientifica de Latinoamerica S.R.L. Global Park Box 180-3006, 602 Parkway La Aurora, Heredia Heredia, Costa Rica 146 Trade Name: Foley Catheter with Temperature Sensor Common Name: Foley Catheter with Temperature Sensor Classification Name: Urological Catheter and accessories Classification: Class II EYC. EZL Device Product Code: Classification Panel: Gastroenterology/Urology Regulation Number: 21 CFR 876.5130 Predicate Devices: EXAC-TEMP Foley Catheter and CLINI-TEMP Foley Catheter [K041416]

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Image /page/4/Picture/1 description: The image shows the logo for DeRoyal. The logo consists of a blue swoosh-like graphic above the text "DeRoyal" in blue font. A registered trademark symbol is located to the right of the word "Royal".

DeRoyal Industries, Inc. Traditional 510(k) Submission - Foley Catheter with Temperature Sensor March 23, 2020

#### Device Description

The Foley Catheter with Temperature Sensor is used for drainage of the urinary bladder and simultaneous monitoring of core body temperature. The device consists of a temperature-sensing wire set secured inside the lumen of a silicone Foley catheter. It is available in 14, 16, and 18 French size catheters. The French size and balloon volume are designated on the device itself.

The wire set contains a thermistor chip, which is located near the distal tip of the catheter. The thermistor passively modifies the electrical current traveling through the wire set. A blue connector is located at the proximal end of the device. This connector interfaces with a cable that is connected to an independent temperature monitor used to display temperature readings.

The catheters are individually packaged and sold sterile.

The subject device is identical to the predicate device with the exception of the encapsulation method of the thermistor chip.

## Indications for Use

The DeRoyal Foley Catheter with Temperature Sensor is to be used for drainage of the urinary bladder and simultaneous monitoring of core body temperature.

| Characteristic | Foley Catheter w/<br>Temperature Sensor<br>(Proposed Device) | EXAC-TEMP<br>Foley Catheter and<br>CLINI- TEMP<br>Foley Catheter<br>[K041416] |
|---------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Indications for Use | The DeRoyal Foley<br>Catheter with<br>Temperature Sensor is to<br>be used for drainage of<br>the urinary bladder and<br>simultaneous monitoring<br>of core body<br>temperature. | DeRoyal Exac- Temp<br>and Clini- Temp<br>Foley Catheter with<br>Temperature Sensors<br>are to be used for<br>drainage of the<br>urinary bladder and<br>simultaneous<br>monitoring of<br>temperature. |

#### Summary of Technological Characteristics

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Image /page/5/Picture/1 description: The image features the logo for "DeRoyal", a company specializing in medical products. The logo consists of a stylized, curved blue swoosh above the company name. The text "DeRoyal" is written in a blue, serif font, with a registered trademark symbol next to the word "Royal".

## DeRoyal Industries, Inc. Traditional 510(k) Submission – Foley Catheter with Temperature Sensor March 23, 2020

| Patient<br>Population | Male and female adults | Male and female<br>adults and pediatrics |
|-----------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------|
| Use Environment | Hospital | Hospital |
| Prescription Only | Yes | Yes |
| French Size | 14-18 French | 8-18 French |
| Length | Tip to funnel:<br>17.75 in<br><br>Tip to connector:<br>30.75 in | For 14-18 French<br>catheters<br>Tip to funnel:<br>17.75 in<br><br>Tip to connector:<br>30.75 in |
| Number of Lumens | 3 | 3 |
| Balloon Size | 5 cc | 3 or 5 cc |
| Single Use | Yes | Yes |
| Mode of Operation | Direct according to ISO<br>80601-2-<br>56 | Direct according to<br>ISO 80601-2-<br>56 |
| Measuring Site | Urinary bladder | Urinary bladder |
| Reference Body Site | Core body | Core body |
| Design | A wire set with a<br>thermistor chip at the<br>distal end and a blue<br>connector at the proximal<br>end inserted inside a<br>silicone Foley<br>catheter. | A wire set with a<br>thermistor chip at the<br>distal end and a blue<br>connector at the<br>proximal end inserted<br>inside a silicone<br>Foley catheter. |
| Materials | Wire Set: Copper<br>wire with PVC<br>insulation,<br>ceramic<br>thermistor, PVC-<br>mold brass<br>connector, UV-<br>curing adhesive | Wire Set: Copper<br>wire with PVC<br>insulation,<br>ceramic<br>thermistor, PVC-<br>mold brass<br>connector, PVC<br>and epoxy glue |

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Image /page/6/Picture/1 description: The image shows the logo for DeRoyal. The logo consists of a blue swoosh-like graphic on the left, followed by the company name "DeRoyal" in blue lettering. The "R" in Royal has a registered trademark symbol next to it.

DeRoyal Industries, Inc. Traditional 510(k) Submission - Foley Catheter with Temperature Sensor March 23, 2020

| cap, and PVC strain<br>relief Foley Catheter:<br>Silicone catheter with a<br>polypropylene<br>inflation valve and<br>ABS collar | cap, and PVC strain<br>relief Foley Catheter:<br>Silicone catheter<br>with a polypropylene<br>inflation valve and<br>ABS collar |
|---------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------|
|---------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------|

The subject and predicate device have the same indications for use statement but different technological characteristics as described in the table above. The different technological characteristics doe not raise different questions of safety and effectiveness.

## Summary of Performance Tests

The following biocompatibility tests were performed on final, finished products manufactured with the proposed change: cytotoxicity, skin sensitization, irritation, material-mediated pyrogenicity, and acute systemic toxicity per I SO 10993-1, ISO 10993-5, ISO 10993-10, ISO 10993-11. Implantation testing according to ISO 10993-6 was performed on a predicate device and was not repeated because the testing was performed according to the current recognized version of the standard and the proposed change is to a non-patient contacting device component.

Testing according to IEC 60601-1 and IEC 60601-1-2 was performed to ensure the change in the encapsulation did not affect the electrical safety of the device. Accuracy and time response testing according to ISO 80601-2-56 was performed to ensure the proposed device completed its essential performance safely and effectively. A leakage current test also was performed after submerging the device in solution to ensure the encapsulation method is effective. All testing was performed on final, finished products manufactured with the proposed modification.

The test results met the acceptance criteria of the aforementioned standards.

# Conclusion

The results of performance testing demonstrate the Foley Catheter with Temperature Sensor is as safe and effective as the predicate. The proposed device is substantially equivalent to the predicate.