(127 days)
The Manan™ General Utility Drainage Catheter is for percutaneous nephrostomy, abcess, cyst, and other small fluid collection drainage.
Manan drainage catheters are made from a biocompatible implantable urethane (Tecoflex) that has been used extensively in both short and long term implantable medical devices. This material softens at body temperature thus minimizing tissue trauma. The catheters come in various end configurations: Pigtailloop(Locking and non-locking), and "J" type. Also included with the catheters are stiffening cannula and trocar sets.
The provided document is a 510(k) summary for the Manan™ General Utility Drainage Catheter. It primarily focuses on demonstrating substantial equivalence to a predicate device for marketing purposes. This type of regulatory submission does not typically include detailed performance studies with acceptance criteria in the same way a clinical trial or a novel AI/software medical device submission would.
Therefore, many of the requested elements for describing "acceptance criteria and the study that proves the device meets the acceptance criteria" are not present in this document. This submission relies on demonstrating similarity to an already approved device rather than presenting new performance data against specific, pre-defined acceptance criteria.
However, I can extract the information that is available:
1. A table of acceptance criteria and the reported device performance
This document does not define specific "acceptance criteria" for performance metrics like sensitivity, specificity, or accuracy, as it is a 510(k) submission for a physical medical device (a drainage catheter) based on substantial equivalence, not a software or AI device. The "performance" demonstrated is primarily through comparison to a predicate device.
2. Sample size used for the test set and the data provenance
Not applicable. There is no "test set" in the context of performance evaluation for an AI or diagnostic device. The substantial equivalence is based on device description (materials, configurations, intended use) to an existing predicate device.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. There is no ground truth establishment in this type of submission.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable.
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
Not applicable. This is a physical medical device, not an AI or diagnostic tool involving human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
Not applicable.
8. The sample size for the training set
Not applicable.
9. How the ground truth for the training set was established
Not applicable.
Summary of available information relevant to "performance" in this 510(k) context:
The document describes the device's technical characteristics and intended use, comparing it to an already approved device to demonstrate substantial equivalence.
- Identified Predicate Device: Manan Medical Products General Utility Drainage Catheter (K953713)
- Device Description:
- Made from biocompatible implantable urethane (Tecoflex).
- Material softens at body temperature.
- Comes in various end configurations: Pigtail-loop (locking and non-locking), and "J" type.
- Includes stiffening cannula and trocar sets.
- Indications for Use: Percutaneous nephrostomy, abscess, cyst, and other small fluid collection drainage.
The "study" in this context is the submission of documentation to the FDA demonstrating that the new device is sufficiently similar to the predicate device in terms of materials, design, technological characteristics, and intended use to be considered safe and effective for its stated purpose. This does not involve clinical performance data or AI model evaluation.
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