(134 days)
The Poiesis Medical Duette™ 100% Silicone Dual-Balloon, Temperature Sensing Catheter is intended for use in the drainage/collection of urine from the urinary bladder and simultaneous monitoring of the body core temperature during surgical or post-surgical intervals.
The Poiesis Medical Duette™ 100% Silicone Dual-Balloon, Temperature Sensing Catheter is intended for use in the drainage/collection of urine from the urinary bladder and simultaneous monitoring of the body core temperature during surgical or post-surgical intervals. The device is a Foley Catheter that is used for simultaneous monitoring of the body core temperature during surgical intervals. It is composed of 100% silicone.
The Duette™ 100% Silicone Dual-Balloon, Temperature Sensing Catheter comes in two sizes (16Fr and 18Fr). The catheters consist of a shaft with eyelets near the tip, two (2) balloons, drainage funnel and two (2) inflation arms with cap and valve. The eyelets allow for drainage of urine from the tip of the catheter through the drainage lumen. When inflated the balloons retains the catheter within the bladder. There are four (4) lumens in each catheter: one (1) for urine drainage, two (2) for individual balloon inflation/deflation and one (1) for the temperature sensing capability. The device is EtO sterilized and is a single-use device.
The provided text describes a 510(k) premarket notification for a medical device, the Duette™ 100% Silicone Dual-Balloon, Temperature-Sensing Catheter. This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than conducting new clinical studies to prove performance against specific acceptance criteria in the way an AI/ML device study would.
Therefore, the document does not contain the acceptance criteria or a study design in the context of an AI/ML device. Instead, it presents a summary of non-clinical testing performed to demonstrate that the device meets the safety and performance requirements expected of such a device and is substantially equivalent to existing devices.
Here's an attempt to answer the questions based on the non-clinical information provided, acknowledging the different context:
1. A table of acceptance criteria and the reported device performance
The document refers to the FDA consensus standard ASTM F623-99 (2013), "Standard Performance Specification for Foley Catheter," as the basis for nonclinical functional performance testing. While the standard serves as the acceptance criteria, the specific numerical targets and the detailed reported performance are not explicitly provided in the summary.
| Acceptance Criteria (Based on ASTM F623-99) | Reported Device Performance |
|---|---|
| Functional Performance (e.g., balloon inflation/deflation, drainage, strength, biocompatibility, etc.) | Met the requirements of ASTM F623-99 (2013) for functional performance. Specific numerical results are not detailed in this summary. |
| Biocompatibility (according to ISO 10993-1:2009 and FDA Guidance) | Passed evaluation according to ISO 10993-1:2009 and FDA Guidance for mucosal contacting surfaces with prolonged exposure. Specific test results are not detailed. |
| Sterility Assurance Level (SAL) | Achieved SAL of 1 x 10⁻⁶ via validated EtO sterilization cycle. |
| Accelerated Aging/Shelf Life (simulating 1, 2, and 3 years) | Conformance to ASTM F623-99 (2013) after accelerated aging at 55°C for 1, 2, and 3 years. Specific performance metrics post-aging are not detailed. |
| Packaging Integrity (visual integrity, dye penetration, seal integrity) | Passed packaging tests (visual integrity of seals and package, dye penetration test, and seal integrity). Specific results are not detailed. |
2. Sample size used for the test set and the data provenance
The document describes non-clinical testing rather than a study with a "test set" of patient data. The sample sizes for the various non-clinical tests (functional performance, accelerated aging, packaging) are not specified in this summary. The "data provenance" is derived from laboratory testing of the device itself.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This question is not applicable to the provided document. The ground truth for device performance in this context is established by adherence to recognized engineering standards (like ASTM F623-99) and validated testing methodologies, rather than expert consensus on medical images or patient outcomes.
4. Adjudication method for the test set
This question is not applicable. There is no "test set" in the context of human interpretation requiring adjudication.
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
This question is not applicable. The device is a physical medical catheter, not an AI/ML algorithm that assists human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This question is not applicable. The device is a physical medical catheter, not an AI/ML algorithm.
7. The type of ground truth used
For the non-clinical tests, the "ground truth" is derived from:
- Engineering specifications and standards: Adherence to defined performance limits within ASTM F623-99.
- Biocompatibility standards: Compliance with ISO 10993-1.
- Sterilization validation standards: Achieving a predetermined SAL (1 x 10⁻⁶).
- Packaging integrity tests: Meeting established criteria for seal strength and integrity.
8. The sample size for the training set
This question is not applicable. There is no "training set" in the context of an AI/ML device. The device is a physical product designed and tested against established engineering and medical standards.
9. How the ground truth for the training set was established
This question is not applicable, as there is no training set.
§ 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.