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