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510(k) Data Aggregation
(189 days)
The Simpl Cath™, Female Urethra Catheterization-Assisting Device, is intended for urological use only. It is designed for use by healthcare personnel for catheterization of the female bladder. The device is to be inserted into the vagina before catheterization of the urethra.
SimplCath, the Female Urethra Catheterization-Assisting Device, is made of MD-105, a biocompatible thermoplastic elastomer. It has a mushroom shape and is intended to be inserted into the vagina for facilitating catheterization of the female urethra. It does so by: 1) retracting the vulvar labia, 2) blocking the vaginal entrance to prevent catheter contamination, and 3) providing a guide or landmark for the female urethral opening. SimplCath is compatible with all catheter sizes.
SimplCath is provided in boxes of 25 or 50 individually sealed, sterile units.
In use, the SimplCath inserts into the vagina, blocking the vaginal opening, spreading the labia, and exposing the female urethra. which falls into the top groove, and guides catheter placement.
This is a medical device 510(k) premarket notification for a device called "SimplCath". The document does not contain a study that proves the device meets specific acceptance criteria in terms of performance metrics like sensitivity, specificity, or accuracy, as would be common for AI/ML-based diagnostic devices.
Instead, the submission focuses on demonstrating substantial equivalence to a legally marketed predicate device (Asta-Cath) through comparisons of regulatory parameters, device features, and use parameters, along with basic testing such as package integrity and biocompatibility.
Therefore, many of the requested points related to AI/ML study design and performance metrics cannot be found in this document.
Here's a breakdown of what can be extracted based on the provided text, with "N/A" for information not present or not applicable to this type of device submission:
1. A table of acceptance criteria and the reported device performance
Since this is a submission for a urological catheter-assisting device, the "acceptance criteria" and "device performance" are primarily demonstrated through substantial equivalence to a predicate device and basic safety testing, rather than performance metrics typically associated with AI/ML algorithms.
| Feature/Test | Acceptance Criteria (Demonstrated Equivalence/Compliance) | Reported Device Performance |
|---|---|---|
| Regulatory Parameters | ||
| Common/Usual Name | Female catheter guide (Identical to Predicate) | Female catheter guide |
| Classification Name | Urological catheter and accessories (Identical to Predicate) | Urological catheter and accessories |
| Product Code (GBM) | GBM (Identical to Predicate) | GBM |
| Classification (Class II) | Class II (Identical to Predicate) | Class II |
| Device Features | ||
| Homogenous single piece of molded plastic | Yes (Identical to Predicate) | Yes |
| Inserted into vaginal opening | Yes (Identical to Predicate) | Yes |
| Aligns catheter with urinary meatus | Yes (Identical to Predicate) | Yes |
| Remains in place during catheter use | Yes (Identical to Predicate) | Yes |
| Functions with variety of catheter sizes | Yes (Identical to Predicate) | Yes |
| Can be used with lubricants | Yes (Identical to Predicate) | Yes |
| Not made of natural rubber latex | Yes (Identical to Predicate) | Yes |
| Provided sterile | Provided sterile (Difference from Predicate, but not a safety/efficacy concern) | Yes |
| Intended for reprocessing and re-use | No (Difference from Predicate, but not a safety/efficacy concern) | No |
| Use Parameters | ||
| Intended use environment | Health care environment (Differs from Predicate's home use, but considered minor) | Health care environment |
| Intended user | Health care professional (Differs from Predicate's layperson, but considered minor) | Health care professional |
| Intended patient population | Adults (Identical to Predicate) | Adults |
| Comparative Performance Evaluations | ||
| Package integrity testing | Supports substantial equivalence | Performed, results support substantial equivalence |
| Biocompatibility testing | Supports substantial equivalence | Performed, results support substantial equivalence |
| Clinical performance evaluations | Not necessary to demonstrate substantial equivalence | Not performed/not necessary |
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
N/A - This document does not describe a clinical performance study with a test set in the context of an AI/ML algorithm. The "test set" here would refer to the device itself undergoing package integrity and biocompatibility testing. The size for these specific tests is not provided, nor is the provenance of "data" in the AI/ML sense.
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 document does not pertain to AI/ML software where expert ground truth establishment is typically required.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
N/A - Not applicable to this type of device submission.
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 - Not applicable. The SimplCath is a physical medical device, not an AI-assisted diagnostic tool for human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
N/A - Not applicable. This is a physical device, not an algorithm.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)
N/A - Not applicable. The "ground truth" here is the established safety and efficacy profile of the predicate device, and the basic safety and performance (biocompatibility, package integrity) of the new device relative to its intended function.
8. The sample size for the training set
N/A - Not applicable. This device is not an AI/ML algorithm that requires a training set.
9. How the ground truth for the training set was established
N/A - Not applicable.
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