(86 days)
The paracentesis catheter is a device used for the therapeutic or diagnostic aspiration of fluid or air from the abdominal cavity.
The paracentesis "catheter over the needle" is comprised of a Radiopague Polyurethane Catheter over a needle with stopcock, self-sealing valve and 5 cc syringe attached.
This document is a 510(k) summary for a Paracentesis Catheter and does not contain detailed information about specific acceptance criteria or an efficacy study in the manner typically expected for AI/ML device submissions. Instead, it focuses on substantial equivalence to a predicate device and biocompatibility testing.
Here's an analysis based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria Category | Specific Criteria (from document) | Reported Device Performance (from document) |
|---|---|---|
| Intended Use | Same as predicate device (therapeutic or diagnostic aspiration of fluid or air from the abdominal cavity). | The proposed device's intended use is the same as the currently marketed Allegiance Paracentesis Catheter. |
| Performance Attributes | Same as predicate device. | The proposed device's performance attributes are the same as the currently marketed Allegiance Paracentesis Catheter. |
| Biocompatibility | Meet testing requirements for cytotoxicity, sensitization, irritation or intracutaneous reactivity, systemic toxicity (acute), and hemocompatibility for materials used. | All materials used were evaluated through biological qualification safety tests and met the testing requirements. They were found to be acceptable for the intended use. |
| Substantial Equivalence | Demonstrated by identical intended use and performance attributes to the predicate device (K870704). | Substantial equivalence was claimed and accepted by the FDA based on identical intended use and performance attributes. |
2. Sample Size Used for the Test Set and Data Provenance:
- The document does not describe an efficacy or performance study with a "test set" in the context of an AI/ML device.
- For biocompatibility, the "sample size" is implied to be of the materials used in the device. The provenance is internal to Allegiance Healthcare Corporation (manufacturer). The testing is described as "biological qualification safety tests," which are typically laboratory-based tests on material samples, not a clinical study on a patient population.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts:
- This information is not applicable as there is no "test set" and "ground truth" establishment in the context of clinical interpretation by experts for this type of device submission. The evaluation focused on material safety and equivalence to an existing device.
4. Adjudication Method for the Test Set:
- Not applicable. There was no "test set" requiring adjudication by experts.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done:
- No, an MRMC study was not done. This submission is for a physical medical device (catheter) and not an AI/ML diagnostic or assistive device that would involve human readers interpreting cases.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable. This is not an algorithm-based device.
7. The Type of Ground Truth Used:
- For biocompatibility: The "ground truth" was established by standardized laboratory tests and recognized safety criteria for cytotoxicity, sensitization, irritation, systemic toxicity, and hemocompatibility, as applied to the device materials.
- For substantial equivalence: The "ground truth" was the characteristics (intended use, performance attributes) of the predicate device (K870704).
8. The Sample Size for the Training Set:
- Not applicable. There is no "training set" in the context of AI/ML for this device.
9. How the Ground Truth for the Training Set Was Established:
- Not applicable. No training set was involved.
Summary of the Study that Proves the Device Meets the Acceptance Criteria:
The "study" or rather, the evidence provided to prove the device meets acceptance criteria, focuses on two main aspects:
- Substantial Equivalence Demonstration: The manufacturer asserted that the proposed Paracentesis Catheter is substantially equivalent to a legally marketed predicate device (K870704, also owned by Allegiance Healthcare Corporation). This was "proved" by demonstrating that its intended use and performance attributes are the same as the predicate device. This is a foundational regulatory pathway for many medical devices.
- Biocompatibility Testing: The materials used in the fabrication of the paracentesis device underwent a battery of biological qualification safety tests. These tests covered:
- Cytotoxicity
- Sensitization
- Irritation or intracutaneous reactivity
- Systemic toxicity (acute)
- Hemocompatibility
The document states that these materials met the testing requirements and were found to be acceptable for the intended use. This indicates internal lab testing against established biocompatibility standards.
In essence, the "study" for this 510(k) submission primarily consisted of a comparison to a predicate device and laboratory-based material safety testing, rather than a clinical performance study with human subjects, which is common for physical devices demonstrating substantial equivalence.
§ 878.4200 Introduction/drainage catheter and accessories.
(a)
Identification. An introduction/drainage catheter is a device that is a flexible single or multilumen tube intended to be used to introduce nondrug fluids into body cavities other than blood vessels, drain fluids from body cavities, or evaluate certain physiologic conditions. Examples include irrigation and drainage catheters, pediatric catheters, peritoneal catheters (including dialysis), and other general surgical catheters. An introduction/drainage catheter accessory is intended to aid in the manipulation of or insertion of the device into the body. Examples of accessories include adaptors, connectors, and catheter needles.(b)
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 878.9.