(66 days)
This catheter is recommended for Percutaneous Transluminal Angioplasty (PTA) of the femoral, iliac, and renal arteries. These catheters are not designed to be used in the coronary arteries.
The Mini Ghost PTA Catheter is a coaxial catheter indicated for PTA of small vessels outside of the heart. This catheter is not intended for use in the corronary arteries. The catheter consists of a 3.5F polyamide outer shaft with a distally mounted balloon. The catheter terminates proximally in a bifurcated Y sleeve with mounted bandem. For the balloon and the guidewire. The inner tubing extends through the balloon and accommodates a 0.018" guidewire. The lumen has radiopaque platinum marker bands under the balloon shoulders for placement using fluoroscopy. The catheter balloon diameter is stamped onto the Y sleeve and the balloon extension is labeled with balloon diameter x balloon length x introducer size x shaft size x usable length x guidewire size and the catheter lot number. The catheter is packaged in a polyethylene sheath and is double packed in two heat sealed Tyvek pouches.
The provided text describes a 510(k) summary for the NuMED Mini Ghost PTA Catheter. This type of submission is for demonstrating substantial equivalence to a predicate device, not typically a study proving performance against specific acceptance criteria.
Therefore, the document does not contain the following information regarding acceptance criteria and a study proving a device meets them in the way usually associated with novel device performance evaluation:
- A table of acceptance criteria and the reported device performance: No such table is presented. The comparison table focuses on device specifications (shaft size, guidewire size, materials, etc.) rather than performance metrics with acceptance limits.
- Sample size used for the test set and the data provenance: Not mentioned.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable as there's no clinical performance study described.
- Adjudication method for the test set: Not applicable.
- 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, as this is not an AI-based diagnostic device.
- If a standalone (i.e. algorithm only without human-in-the loop performance) was done: Not applicable, as this is not an AI-based diagnostic device.
- The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not applicable.
- The sample size for the training set: Not applicable.
- How the ground truth for the training set was established: Not applicable.
However, the document does describe the performance evaluation conducted for device clearance, which is primarily focused on bench testing and biocompatibility testing to establish substantial equivalence.
Here's a breakdown of the relevant information from the provided text regarding device performance evaluation:
Biocompatibility Testing:
- Acceptance Criteria: Implicitly, the materials must demonstrate biocompatibility in compliance with the Tripartite Biocompatibility Guidance for Medical Devices.
- Reported Device Performance: "Test results indicate that all materials demonstrate the biocompatibility of the NuMED catheter and are on file at NuMED, Inc."
- Study Description: The materials used in the Mini Ghost PTA Catheter are the same as those used in the predicate device, NuMED Z-MED PTA Catheter (K931009), which were tested for biocompatibility.
Laboratory (Bench) Testing:
- Acceptance Criteria: Implicitly, the device must meet design specifications and functional requirements typical for PTA catheters. No specific numerical acceptance criteria are listed in the summary.
- Reported Device Performance: "All bench testing was performed in accordance with GMP's and the results are kept on file at NuMED, Inc."
- Study Description: Bench testing was performed. No further details on specific tests or results are provided in the 510(k) summary (they are stated to be on file).
Substantial Equivalence Comparison (Functional and Material Performance):
While not a "study" in the traditional sense of a clinical trial, the 510(k) submission relies on a comparison table to the predicate device to demonstrate that the new device performs similarly or is safe and effective for its intended use.
| Feature | NuMED Z-MED PTA Catheter (Predicate) | NuMED MINI GHOST PTA Catheter (New Device) | Comparison/Performance Implication |
|---|---|---|---|
| Indications | This catheter is recommended for Percutaneous Transluminal Angioplasty (PTA) of the femoral, iliac, and renal arteries. These catheters are not designed to be used in the coronary arteries. | This catheter is recommended for Percutaneous Transluminal Angioplasty (PTA) of the femoral, iliac, and renal arteries. These catheters are not designed to be used in the coronary arteries. | Identical indications for use, suggesting similar functional expectations for PTA. |
| Materials | Shaft: Pebax | ||
| Balloon: PES2 | |||
| Image Band: Platinum | Shaft: Pebax | ||
| Balloon: PES2 | |||
| Image Band: Platinum | Identical materials, supporting the biocompatibility claim and suggesting similar material performance (e.g., strength, flexibility). | ||
| Construction | Coaxial construction with distally mounted non-compliant balloons. | Coaxial construction with distally mounted non-compliant balloon. | Identical construction principle, indicating similar mechanical behavior and delivery mechanism. |
| Shaft Size | 5F - 9F | 3.5F | Smaller shaft size, indicating suitability for smaller vessels, which is consistent with the "Mini Ghost" name and suggests an expansion of utility rather than a change in core function. |
| Guidewire Size | 0.025" and 0.035" | 0.018" | Smaller guidewire size, aligning with the smaller shaft size for use in smaller vessels. |
| Usable Length | 75cm - 120cm | 40cm - 120cm | Wider range, including shorter lengths, providing more options for different anatomical access points. |
| Balloon Diameter | 2mm - 25mm | 2mm - 6mm | Smaller range of balloon diameters, consistent with the device being for "small vessels" PTA. |
| Balloon Length | 1cm - 15cm | 2cm - 10cm | Smaller range of balloon lengths, also consistent with small vessel applications. |
In summary, the provided text describes a 510(k) submission that demonstrates substantial equivalence primarily by:
- Stating identical biocompatible materials to a previously cleared predicate device.
- Confirming bench testing was performed according to GMPs, with results on file (but not detailed in the summary).
- Providing a comparison table highlighting that the new device shares the same intended use, materials, and fundamental construction as the predicate, with modifications (smaller sizes) that are consistent with its "Mini Ghost" designation for small vessel PTA. The changes are presented as variations within the same device category, not as requiring new performance studies to prove efficacy or safety in a new domain.
§ 870.1250 Percutaneous catheter.
(a)
Identification. A percutaneous catheter is a device that is introduced into a vein or artery through the skin using a dilator and a sheath (introducer) or guide wire.(b)
Classification. Class II (performance standards).