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510(k) Data Aggregation
(24 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 coronary 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 separate extensions 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.
This document is a 510(k) summary for a medical device called the NuMED Mini Ghost PTA Catheter. It focuses on demonstrating substantial equivalence to a predicate device, rather than proving performance against specific acceptance criteria through a clinical study. Therefore, most of the requested information regarding acceptance criteria and study details cannot be extracted from this document.
Here's what can be extracted and inferred:
1. A table of acceptance criteria and the reported device performance
The document does not state explicit numerical acceptance criteria for device performance in the way one might see for a diagnostic AI device (e.g., sensitivity > X%, specificity > Y%). Instead, the acceptance criteria are largely implied by establishing "substantial equivalence" to a predicate device, meaning the new device should perform similarly and be as safe and effective.
The reported device performance is conveyed through a comparison with the predicate device, focusing on shared characteristics and intended use.
| Acceptance Criterion (Implied) | Reported Device Performance |
|---|---|
| Biocompatibility: Materials are biocompatible. | Materials are the same as those used in already cleared predicate devices (Mini Ghost PTA Catheter K051343 and Z-MED Catheter K931009) which were tested for biocompatibility in compliance with the Tripartite Biocompatibility Guidance for Medical Devices. Test results indicate biocompatibility and are on file. |
| Functional Performance (Bench Testing): Device meets functional specifications. | "All bench testing was performed in accordance with GMP's and the results are kept on file at NuMED. Inc." (Specific performance metrics are not detailed in this summary but are referenced as being on file and meeting GMPs). This implies physical characteristics like balloon inflation/deflation, guidewire compatibility, shaft flexibility, etc., would have been tested to ensure the device performs as intended and is comparable to the predicate. |
| Intended Use: Similar indications for use as predicate. | NuMED Mini Ghost PTA Catheter: "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 is identical to the indications for the predicate devices mentioned. |
| Technical Specifications: (Shaft Size, Guidewire Size, Usable Length, Balloon Diameter, Balloon Length, Materials, Construction) are equivalent or within acceptable range of predicate. | All listed technical specifications (Shaft Size: 3.5F, Guidewire Size: 0.018", Usable Length: 40cm-150cm, Balloon Diameter: 2mm-6mm, Balloon Length: 1cm-10cm, Materials: Shaft: Pebax, Balloon: PES2, Image Band: Platinum, Construction: Coaxial with distally mounted non-compliant balloon) are either identical to the predicate device, or in the case of "Balloon Length", the additional lengths are within the established safe and effective parameters, demonstrating equivalence to the predicate. The document presents two columns for "NuMED Mini Ghost PTA Catheter" and "NuMED Mini Ghost PTA Catheter - Addt'l Lengths" which are almost identical, indicating the "addt'l lengths" are simply extensions of the existing product line. |
| Safety: Device is as safe as legally marketed predicate devices. | Biocompatibility and the use of the same materials as previously cleared devices, along with bench testing performed under GMPs, are presented as evidence of safety. A "Risk Analysis" is mentioned as attached, implying identified risks are managed. |
Regarding the "study that proves the device meets the acceptance criteria":
Based on the provided text, no clinical study proving the device meets numerical performance acceptance criteria was conducted for this 510(k) submission. Instead, the submission relies on:
- Bench Testing: Laboratory (Bench) Testing was performed according to GMPs, and results are on file. This testing would verify the physical and mechanical properties of the device against design specifications.
- Biocompatibility Testing: The materials used are identical to previously cleared devices which underwent biocompatibility testing in compliance with established guidance.
- Comparison to Predicate: The primary "proof" for 510(k) clearance is demonstrating substantial equivalence to an already legally marketed device (the predicate). This means showing the new device has the same intended use, similar technological characteristics, and is as safe and effective as the predicate.
Given this context, the following information cannot be extracted or is not applicable:
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Not applicable; no clinical test set described. Bench testing sample sizes would be internal to NuMED.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
- Not applicable; no clinical test set or ground truth described.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable; no clinical test set described.
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 medical device (catheter) 510(k), not an AI diagnostic algorithm.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable; this is a medical device (catheter) 510(k), not an AI diagnostic algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- For biocompatibility, the ground truth was the established standards and testing methods.
- For bench testing, the ground truth was the engineering specifications and performance expectations for the device.
- No clinical ground truth as no clinical study was conducted for this 510(k).
8. The sample size for the training set
- Not applicable; this is not an AI/ML device requiring a training set.
9. How the ground truth for the training set was established
- Not applicable; this is not an AI/ML device.
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