(685 days)
The NeoSci Medical Endoluminal Brush is intended to collect a sample, which is suitable for microbiological analysis, from the inner lumen surface of an indwelling central venous catheter. The proximal nitinol shaft is encased in a polytetrafluoroethylene sheath with a hydrophilic coating applied to reduce friction.
The device is contraindicated for patients with known, or suspected, allergies to nitinol, PTFE Teflon®, Nylon, stainless steel, gold, or hydrophilic coatings.
The NeoSci Medical (NSM) Endoluminal Brush (EB) is a device similar to a very small diameter bottlebrush that can be inserted into the lumen of partially obstructed central venous catheters to collect a sample. The distal end of the device consists of a flexible tip equivalent to that of a floppy guide wire tip. Immediately proximal to the flexible tip is a segment of bristles wound into flexible. twisted (braided) stainless steel wires. The outer diameter of the bristle is selected by the user. Instructions for use recommend that the EB size be 1.2 to 2.0 times the inner diameter of the lumen to be sampled. The stainless steel wires are bonded to a nitinol shaft that extends to the proximal end of the device. The proximal nitinol shaft is encased in a polvtetrafluoroethylene sheath with a hydrophhilic coating applied to reduce friction.
Here's an analysis of the provided text, focusing on the acceptance criteria and the study used to prove the device meets them:
1. Table of Acceptance Criteria and Reported Device Performance
| Performance Metric | Acceptance Criteria (Implicit) | Reported Device Performance |
|---|---|---|
| Tensile Strength | Suitable for intended use | Suitable |
| Torque Strength | Suitable for intended use | Suitable |
| Torqueability | Suitable for intended use | Suitable |
| Tip Flexibility | Suitable for intended use | Suitable |
| Coating Adherence / Integrity | Suitable for intended use | Suitable |
| Catheter Compatibility | Suitable for intended use | Suitable |
| Biocompatibility | Suitable for intended use | Suitable |
| Fracture and Flex Resistance | Suitable for intended use | Suitable |
| Effectiveness of Sampling (Microbiological) | Suitable for intended use | Effectively collects a sample suitable for microbiological analysis. |
| Compliance with ISO 11070 | Meets relevant requirements | Meets relevant requirements |
| Substantial Equivalence to Predicate | Equivalent to predicate device in safety and efficacy | Substantially equivalent |
| No New Safety/Efficacy Issues | No new issues raised | No new issues raised |
Note: The document states that "Results indicate that NSM EB Tensile Strength, Torque Strength, Torqueability, Tip Flexibility, Coating Adherence / Integrity, Catheter Compatibility, Biocompatibility, Fracture and Flex Resistance, and Effectiveness of Sampling are suitable for the EB's intended use." The acceptance criteria are therefore implicitly "suitable for its intended use" for each of these performance aspects.
2. Sample Size Used for the Test Set and Data Provenance
The provided document does not specify a sample size for any test set or the data provenance (e.g., country of origin, retrospective or prospective). The performance data is summarized in a general statement without detailing the specific studies or cohort sizes.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications
The document does not mention the use of experts to establish ground truth for any test set, nor does it specify the number or qualifications of any such experts. The evaluation appears to be based on engineering and performance testing.
4. Adjudication Method for the Test Set
The document does not describe any adjudication method for a test set. This type of methodology is not typically mentioned in a 510(k) summary for this kind of device, which focuses on physical and material performance rather than diagnostic accuracy or human interpretation.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
An MRMC comparative effectiveness study was not done or is not mentioned in this document. This type of study is more common for diagnostic imaging or interpretation devices where human readers are involved in assessing output with and without AI assistance. This device is a mechanical sampling tool.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study
The device is a physical, mechanical sampling tool, not an algorithm. Therefore, a standalone (algorithm only) performance study is not applicable and was not performed/mentioned. The "effectiveness of sampling" would be evaluated in terms of its ability to physically collect a sample suitable for downstream microbiological analysis, which is an inherent function of the device itself rather than an AI algorithm.
7. Type of Ground Truth Used
Based on the nature of the device and the tests mentioned:
- Engineering/Physical Testing: For metrics like Tensile Strength, Torque Strength, Tip Flexibility, etc., the "ground truth" would be established by objective measurements against defined engineering specifications or industry standards (e.g., ISO 11070).
- Effectiveness of Sampling: For "Effectiveness of Sampling," the ground truth would likely be established by microbiological analysis of the samples collected by the brush, demonstrating that the collected material is indeed suitable for such analysis (e.g., sufficient quantity, viable microbes if present).
8. Sample Size for the Training Set
The document does not mention a training set. This is because the device is a physical medical instrument, not a machine learning algorithm that requires a training set.
9. How the Ground Truth for the Training Set Was Established
As there is no training set, this question is not applicable.
§ 880.5970 Percutaneous, implanted, long-term intravascular catheter.
(a)
Identification. A percutaneous, implanted, long-term intravascular catheter is a device that consists of a slender tube and any necessary connecting fittings, such as luer hubs, and accessories that facilitate the placement of the device. The device allows for repeated access to the vascular system for long-term use of 30 days or more, and it is intended for administration of fluids, medications, and nutrients; the sampling of blood; and monitoring blood pressure and temperature. The device may be constructed of metal, rubber, plastic, composite materials, or any combination of these materials and may be of single or multiple lumen design.(b)
Classification. Class II (special controls) Guidance Document: “Guidance on Premarket Notification [510(k)] Submission for Short-Term and Long-Term Intravascular Catheters.”