(38 days)
The Kendall Curity Thoracentesis Tray is intended to be used to drain fluid from the pleural cavity.
The proposed Kendall Curity Thoracentesis Tray is a sterile, single use procedural tray containing the components required to perform a thoracentesis. This submission covers proposed changes to the aspirating needle and thoracentesis catheter. An ergonomically designed polycarbonate hub will be insert molded onto the needle cannula and a polyurethane hub insert molded onto the catheter shaft. In addition, the catheter shaft material will change from Teflon® to polyurethane. There will be no changes to the current dimensions or performance specifications.
In addition, a new product code will incorporate Kendall's thoracentesis catheter-over-needle with an automatic valve that acts to occlude the proximal end of the catheter lumen. The valve is an integral part of the catheter. Once the needle is withdrawn from the valve, a spring mechanism occludes the catheter lumen.
This document describes a 510(k) submission for the Kendall Curity Thoracentesis Tray. It is a pre-amendment device, therefore much of the information you have requested about acceptance criteria and study design is not applicable or not provided. Here's a breakdown of the available information:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Acceptance Criteria (from text) | Reported Device Performance (from text) |
|---|---|---|
| Biocompatibility | ISO-10993 Biological Evaluation of Medical Devices | Found the material contained no toxic diffusible substances. |
| Functional/Mechanical: Hub Pull-off Force | Not explicitly stated (implied to meet existing performance) | Tested |
| Functional/Mechanical: Leakage | Not explicitly stated (implied to meet existing performance) | Tested |
| Functional/Mechanical: Siphoning Capability of Automatic Valve | Not explicitly stated (implied to meet existing performance) | Tested |
| General Performance | No changes to current dimensions or performance specifications (for existing components) | Stated as unchanged |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: Not specified for any of the functional or biocompatibility tests.
- Data Provenance: Not specified, but implied to be from internal Kendall Healthcare Products Company testing. The document is silent on country of origin or whether it's retrospective/prospective.
3. Number of Experts Used to Establish Ground Truth and Qualifications
- Not Applicable. This device is a medical instrument (thoracentesis tray), not an AI/diagnostic tool. "Ground truth" in the context of expert consensus, pathology, or outcomes data is not relevant for this type of submission. The performance is assessed through material and functional testing against specified engineering parameters.
4. Adjudication Method
- Not Applicable. See point 3.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
- No. This is not a diagnostic device or imaging modality that would involve human readers.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study
- Not Applicable. This is a physical medical device, not an algorithm or AI.
7. Type of Ground Truth Used
- Engineering Specifications/Standards: The "ground truth" for this device's performance is adherence to established engineering specifications, safety standards (like ISO-10993 for biocompatibility), and functional requirements (e.g., no leakage, sufficient pull-off force for the hub).
8. Sample Size for the Training Set
- Not Applicable. This is not an AI/machine learning device that requires a training set.
9. How the Ground Truth for the Training Set Was Established
- Not Applicable. See point 8.
Summary of Device and Evidence:
The Kendall Curity Thoracentesis Tray is seeking 510(k) clearance based on substantial equivalence to existing predicate devices. The submission focuses on changes to the aspirating needle and thoracentesis catheter (material change and hub design) and the incorporation of a new automatic valve. The evidence provided is primarily from nonclinical testing:
- Biocompatibility testing to ISO-10993 standards confirmed no toxic diffusible substances.
- Functional/Mechanical testing was performed for hub pull-off force, potential for leakage, and siphoning capability of the automatic valve.
The document explicitly states that there will be "no changes to the current dimensions or performance specifications" for the existing components, implying that the new or modified components also meet the established performance levels of the predicate devices. The 510(k) pathway relies on demonstrating that the new device is as safe and effective as a legally marketed predicate device, often by showing similar technological characteristics and performance.
§ 880.6740 Vacuum-powered body fluid suction apparatus.
(a)
Identification. A vacuum-powered body fluid suction apparatus is a device used to aspirate, remove, or sample body fluids. The device is powered by an external source of vacuum. This generic type of device includes vacuum regulators, vacuum collection bottles, suction catheters and tips, connecting flexible aspirating tubes, rigid suction tips, specimen traps, noninvasive tubing, and suction regulators (with gauge).(b)
Classification. Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 880.9.