(269 days)
Intermittent urinary catheterization by inserting through the urethra to pass urine from the bladder.
The subject device is intended used for drainage of the urinary system, sterile and for single use. Duration of use ≤ 24 hours. The subject device is supplied in four forms: Uncoated type, Normal type, Water sachet type, Ready-to-use type. The Disposable Intermittent Catheter is made from the TPU, and the hydrophilic coating (optional). The surface hydrophilic coating is made from polyvinyl pyrrolidone. The free contact sleeve is optional.
The provided FDA 510(k) clearance letter and summary describe a Disposable Intermittent Catheter (TPU Catheter). This document focuses on the substantial equivalence of the new device to a predicate device based on non-clinical performance testing.
It is crucial to understand that this document does not describe a study involving algorithms, human readers, or image analysis. Therefore, many of the requested categories related to AI performance, expert review, and ground truth for such studies are not applicable. The information provided pertains to the physical and material characteristics, sterility, and biocompatibility of a medical device (a catheter).
Here's an analysis of the acceptance criteria and supporting studies as presented in the document, with explanations for the unapplicable sections:
Acceptance Criteria and Device Performance
The acceptance criteria for this device are based on compliance with various international standards for medical devices, particularly those for urethral catheters, sterilization, packaging, and biocompatibility. The "reported device performance" is the statement that the device met these criteria.
| Acceptance Criteria Category | Specific Acceptance Criteria (Standard Compliance) | Reported Device Performance |
|---|---|---|
| Physical/Mechanical Performance | ISO 20696: Sterile urethral catheters for single use | Met requirements |
| ISO 8295: Determination of the coefficients of friction | Met requirements | |
| ISO 13868: Test methods for kinking of single lumen catheters and medical tubing | Met requirements | |
| Leak resistance testing | Met requirements | |
| Sterilization | ISO 11137-1: Requirements for development, validation and routine control of a sterilization process for medical devices | Met requirements (Radiation sterilization dose 18.7-30.0kGy) |
| ISO 11137-2: Establishing the sterilization dose | Met requirements | |
| ISO 11737-1: Determination of a population of microorganisms on product | Met requirements | |
| ISO 11737-2: Tests of sterility performed in the definition, validation and maintenance of a sterilization process | Met requirements | |
| Packaging Integrity | ASTM F88/F88M: Seal Strength of Flexible Barrier Materials | Met requirements |
| ASTM F1929: Detecting Seal Leaks in Porous Medical Packaging by Dye Penetration | Met requirements | |
| ASTM F1140/F1140M: Internal Pressurization Failure Resistance of Unrestrained Packages | Met requirements | |
| Shelf Life | ASTM F1980: Accelerated Aging of Sterile Barrier Systems for Medical Devices | Met requirements (Supported 3-year shelf life) |
| Biocompatibility | ISO 10993-1: Biological Evaluation of Medical Devices - Part 1: Evaluation and testing within a risk management process | Met requirements |
| ISO 10993-5: Tests For In Vitro Cytotoxicity | Met requirements | |
| ISO 10993-10: Tests For Skin Sensitization | Met requirements | |
| ISO 10993-23: Tests For Irritation (Intracutaneous Reactivity) | Met requirements | |
| ISO 10993-11: Tests for systemic toxicity (Acute) | Met requirements | |
| ISO 10993-11: Tests for systemic toxicity (Sub-Acute) | Met requirements |
Study Details (Non-AI/Software Device)
Since this is a physical medical device (catheter) and not an AI/software device, most of the requested fields related to AI study design are not applicable.
-
Sample sized used for the test set and the data provenance:
- Sample Size for Test Set: Not explicitly stated in terms of a "test set" as understood in AI/software evaluation. Each test (e.g., kinking, seal strength, biocompatibility, sterility) would have its own sample size of catheters or materials, but these specific numbers are not provided in the summary.
- Data Provenance: Not applicable in the context of an AI/software device. The tests are performed on the manufactured catheters themselves.
-
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):
- Not Applicable. Ground truth, in the context of human expert review for AI, is not relevant here. The "ground truth" for these performance tests is established by adhering to the methodologies and pass/fail criteria defined in the referenced international standards. The evaluation is conducted by qualified laboratory technicians and scientists in accordance with these standards.
-
Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not Applicable. This concept is for resolving discrepancies in expert opinion for ground truth establishment in studies involving diagnostic/interpretive tasks. This device undergoes standardized physical and biological testing, not interpretive adjudication.
-
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:
- Not Applicable. This device is an intermittent urinary catheter, not an AI-assisted diagnostic tool. No MRMC study was performed.
-
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not Applicable. This is a physical medical device, not an algorithm.
-
The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- Standardized Test Results / Compliance with ISO/ASTM Standards. For example, "ground truth" for sterility is the absence of microbial growth as determined by ISO 11737-2 methods. For biocompatibility, it's the lack of adverse biological responses per ISO 10993 series. These are objective measurements against defined criteria, not expert consensus on an interpretation.
-
The sample size for the training set:
- Not Applicable. This is not an AI/software device with a "training set."
-
How the ground truth for the training set was established:
- Not Applicable. This is not an AI/software device with a "training set."
Summary of the Device and Study from the Document:
The Disposable Intermittent Catheter (TPU Catheter) underwent non-clinical performance testing to demonstrate its safety and effectiveness and substantial equivalence to a legally marketed predicate device (K200134). The studies involved a series of tests to ensure the device complies with relevant international standards for physical characteristics (e.g., kinking resistance, friction), sterilization (radiation processing, sterility assurance, bioburden), packaging integrity, shelf life, and biocompatibility. All tests met their predetermined acceptance criteria, leading to the conclusion that the device is as safe and effective as the predicate. The changes in material (TPU instead of PVC) and sterilization method (radiation instead of ethylene oxide, though both achieve SAL 10-6) were supported by specific testing, especially biocompatibility.
N/A