(205 days)
Not Found
No
The device description and performance studies focus on the physical components and electrical safety of a temperature-sensing catheter, with no mention of AI or ML algorithms for data processing or interpretation.
No.
The device is primarily used for drainage and monitoring, not for treating a disease or condition. While it has a monitoring function, its main purpose is to drain the bladder.
No
The device monitors core body temperature, which is a physiological parameter, but it does not diagnose a disease or condition based on that monitoring. Its primary function is drainage and simultaneous temperature tracking.
No
The device description clearly outlines physical components including a catheter, temperature-sensing wire set, thermistor chip, and a connector, indicating it is a hardware device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for "drainary bladder and simultaneous monitoring of core body temperature." This is a direct physiological measurement and intervention within the body.
- Device Description: The device is a Foley catheter with a temperature sensor. It is inserted into the urinary bladder.
- Mechanism: The temperature sensor passively modifies electrical current based on the temperature within the bladder, which is used as a proxy for core body temperature. This is a physical measurement, not an analysis of a biological sample in vitro (outside the body).
IVD devices are designed to examine specimens derived from the human body (like blood, urine, tissue) in vitro to provide information for diagnosis, monitoring, or screening. This device is used in vivo (within the body) for drainage and direct temperature measurement.
N/A
Intended Use / Indications for Use
The DeRoyal Foley Catheter with Temperature Sensor is to be used for drainary bladder and simultaneous monitoring of core body temperature.
Product codes
EYC, EZL
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Urinary bladder (Measuring Site)
Core body (Reference Body Site)
Indicated Patient Age Range
Male and female adults
Intended User / Care Setting
Hospital
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
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 ISO 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.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 876.5130 Urological catheter and accessories.
(a)
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).(b)
Classification. (1) Class II (performance standards).(2) Class I for the ureteral stylet (guidewire), stylet for gastrourological catheter, ureteral catheter adapter, ureteral catheter connector, and ureteral catheter holder. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 876.9.
0
Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which consists of the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.
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.
1
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 (DICE@fda.hhs.gov) or phone (1-800-638-2041 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
2
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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3
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/
Temperature Sensor
(Proposed Device) | EXAC-TEMP
Foley Catheter and
CLINI- TEMP
Foley Catheter
[K041416] |
|---------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 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. | DeRoyal Exac- Temp
and Clini- Temp
Foley Catheter with
Temperature Sensors
are to be used for
drainage of the
urinary bladder and
simultaneous
monitoring of
temperature. |
Summary of Technological Characteristics
5
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
Population | Male and female adults | Male and female
adults and pediatrics |
|-----------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------|
| Use Environment | Hospital | Hospital |
| Prescription Only | Yes | Yes |
| French Size | 14-18 French | 8-18 French |
| Length | Tip to funnel:
17.75 in
Tip to connector:
30.75 in | For 14-18 French
catheters
Tip to funnel:
17.75 in
Tip to connector:
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
80601-2-
56 | Direct according to
ISO 80601-2-
56 |
| Measuring Site | Urinary bladder | Urinary bladder |
| Reference Body Site | Core body | Core body |
| Design | A wire set with a
thermistor chip at the
distal end and a blue
connector at the proximal
end inserted inside a
silicone Foley
catheter. | A wire set with a
thermistor chip at the
distal end and a blue
connector at the
proximal end inserted
inside a silicone
Foley catheter. |
| Materials | Wire Set: Copper
wire with PVC
insulation,
ceramic
thermistor, PVC-
mold brass
connector, UV-
curing adhesive | Wire Set: Copper
wire with PVC
insulation,
ceramic
thermistor, PVC-
mold brass
connector, PVC
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
relief Foley Catheter:
Silicone catheter with a
polypropylene
inflation valve and
ABS collar | cap, and PVC strain
relief Foley Catheter:
Silicone catheter
with a polypropylene
inflation valve and
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.