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.

AI/ML Overview

This document describes the regulatory approval for a medical device, specifically a "Foley Catheter with Temperature Sensor." It focuses on demonstrating substantial equivalence to a predicate device, rather than proving the device meets strict acceptance criteria through a clinical study in the way an AI/ML device might.

Therefore, many of the typical acceptance criteria and study details requested in your prompt (such as "sample size used for the test set," "number of experts," "adjudication method," "MRMC study," "standalone performance," "type of ground truth," and "training set details") are not applicable to this document. This is because the device is a piece of hardware (a catheter with a temperature sensor), not an AI/ML diagnostic tool.

The document primarily relies on bench testing and biocompatibility testing to prove safety and effectiveness, ensuring the modified device performs similarly to its predicate.

Here's an analysis of the provided text in relation to your questions, highlighting what is present and what is not:

Device Type: Hardware Medical Device (Foley Catheter with integrated temperature sensor).
Purpose: Drainage of the urinary bladder and simultaneous monitoring of core body temperature.
Regulatory Pathway: 510(k) Premarket Notification – seeking substantial equivalence to a legally marketed predicate device.

1. A table of acceptance criteria and the reported device performance

The document does not provide a quantitative table of acceptance criteria with specific numerical targets and reported performance values for accuracy, sensitivity, or specificity in a clinical context. Instead, it refers to compliance with established medical device standards.

Acceptance Criteria (as implied by the document):

Acceptance Criteria Category	Standard/Test References	Stated Performance / Outcome
Biocompatibility	ISO 10993-1, ISO 10993-5, ISO 10993-10, ISO 10993-11	"The following biocompatibility tests were performed... cytotoxicity, skin sensitization, irritation, material-mediated pyrogenicity, and acute systemic toxicity... The test results met the acceptance criteria of the aforementioned standards."
Electrical Safety	IEC 60601-1, IEC 60601-1-2	"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. All testing was performed on final, finished products... The test results met the acceptance criteria of the aforementioned standards."
Accuracy & Time Response	ISO 80601-2-56	"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. All testing was performed on final, finished products... The test results met the acceptance criteria of the aforementioned standards."
Encapsulation Effectiveness	Leakage Current Test (after submersion)	"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... The test results met the acceptance criteria of the aforementioned standards."

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

Sample Size: The document does not specify exact sample sizes for the test set in terms of clinical cases or human subjects. The testing described (biocompatibility, electrical safety, accuracy, time response, leakage current) was performed on "final, finished products manufactured with the proposed modification." This implies a bench test or laboratory setting with a statistically relevant number of manufactured units, rather than a clinical trial with patient data.
Data Provenance: Not applicable in the context of clinical data. The "data" comes from laboratory and bench testing of the manufactured devices. It is implied to be prospective testing of newly manufactured devices.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

N/A. This information is not relevant for a hardware device undergoing bench and biocompatibility testing. Ground truth (e.g., true temperature) would be established by calibrated reference instruments in a laboratory setting, not by human experts interpreting data or images.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

N/A. No adjudication method is mentioned or relevant, as there is no human interpretation or consensus-building involved in the testing described.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

N/A. This is a hardware device, not an AI/ML system. No MRMC comparative effectiveness study was conducted or is applicable.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

N/A. This is a hardware device, not an algorithm. Therefore, "standalone performance" in the context of an algorithm is not applicable. The device's "standalone" performance as a hardware unit is demonstrated through the laboratory testing against standards (e.g., accuracy of the temperature sensor).

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

For temperature accuracy: The ground truth would be established by a primary, highly accurate, and calibrated temperature standard in a laboratory environment, as per ISO 80601-2-56.
For electrical safety/leakage: Ground truth is defined by the limits set in the relevant IEC standards.
For biocompatibility: Ground truth is established by the cellular responses or systemic effects observed in validated biological assays following ISO 10993 standards.

8. The sample size for the training set

N/A. This device does not use machine learning or AI, so there is no "training set."

9. How the ground truth for the training set was established

N/A. As there is no training set, this question is not applicable.

Summary of Device Performance and Equivalence Claim:

The core of the submission is to demonstrate that the small change in the thermistor chip's encapsulation method does not alter the device's safety or effectiveness compared to the predicate. The document concludes:

"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."

This 510(k) summary focuses on engineering validation and compliance with standards rather than clinical study results typically associated with AI/ML device clearances.

Summary

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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 (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

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

Device Description

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-TEMPFoley Catheter andCLINI- TEMPFoley Catheter[K041416]
Indications for Use	The DeRoyal FoleyCatheter withTemperature Sensor is tobe used for drainage ofthe urinary bladder andsimultaneous monitoringof core bodytemperature.	DeRoyal Exac- Tempand Clini- TempFoley Catheter withTemperature Sensorsare to be used fordrainage of theurinary bladder andsimultaneousmonitoring oftemperature.

Summary of Technological Characteristics

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

PatientPopulation	Male and female adults	Male and femaleadults and pediatrics
Use Environment	Hospital	Hospital
Prescription Only	Yes	Yes
French Size	14-18 French	8-18 French
Length	Tip to funnel:17.75 inTip to connector:30.75 in	For 14-18 FrenchcathetersTip to funnel:17.75 inTip 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 ISO80601-2-56	Direct according toISO 80601-2-56
Measuring Site	Urinary bladder	Urinary bladder
Reference Body Site	Core body	Core body
Design	A wire set with athermistor chip at thedistal end and a blueconnector at the proximalend inserted inside asilicone Foleycatheter.	A wire set with athermistor chip at thedistal end and a blueconnector at theproximal end insertedinside a siliconeFoley catheter.
Materials	Wire Set: Copperwire with PVCinsulation,ceramicthermistor, PVC-mold brassconnector, UV-curing adhesive	Wire Set: Copperwire with PVCinsulation,ceramicthermistor, PVC-mold brassconnector, PVCand 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 strainrelief Foley Catheter:Silicone catheter with apolypropyleneinflation valve andABS collar	cap, and PVC strainrelief Foley Catheter:Silicone catheterwith a polypropyleneinflation valve andABS collar
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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.

Regulation Number and Section

§ 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.