(85 days)
This catheter is recommended for Percutaneous Transluminal Valvuloplasty (PTV) of the pulmonary valve.
- A patient with isolated pulmonary stenosis
- A patient with valvular pulmonary stenosis with other minor congenital heart disease that does not require surgical intervention.
The NuMED, Inc. Tyshak II PTV catheter is a coaxial catheter for use in PTV applications where a small introduction site is necessary. The catheter inner and outer shafts are constructed of polymeric tubing. The catheter features a molded proximal end bifurcate with two distinct luminal passages. The inflation lumen terminates into a distally mounted balloon made of polymeric material. This balloon is of the non-compliant variety and will have a typical single wall thickness of 0.0004". This balloon is designed to insert through the smallest possible introduction sleeve. Both the shaft size and the guidewire size varies according to balloon diameter with the Tyshak II catheter. The distal lumen terminates at the tip of the catheter and will accept the passage of the appropriate guidewire. This lumen has radiopaque platinum marker bands under the balloon shoulders for placement using fluoroscopy. The catheter is white in color and the balloon material is clear. The catheter balloon diameter is stamped onto the Y connector and the inflation 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 loop and is double packed in two heat sealed Tyvek pouches. This catheter is very similar in construction to the Tyshak PTV catheters except for the thinner balloon and lower profile. The Tyshak II catheter is available in standard diameters from 4mm to 30mm in standard lengths of 2cm, 3cm, 4cm, 5cm, 6cm, 8cm and 10cm. Guidewire sizes will vary from 0.021" to 0.035" and shaft sizes from 4F to 9F.
The NuMED, Inc. Z-MED II PTV catheter is a coaxial catheter for use in PTV applications. The catheter inner and outer shafts are constructed of polymeric tubing. The catheter features a molded proximal end bifurcate with two distinct luminal passages. The inflation lumen terminates into a distally mounted balloon made of polymeric material. This balloon is of the non-compliant variety. This balloon is designed to insert through the smallest possible introduction sleeve. Both the shaft size and the guidewire size varies according to balloon diameter with the Z-MED II catheter. The distal lumen terminates at the tip of the catheter and will accept the passage of the appropriate guidewire. This lumen has radiopaque platinum marker bands under the balloon shoulders for placement using fluoroscopy. The catheter is white in color and the balloon material is clear. The catheter balloon diameter is stamped onto the Y connector and the inflation 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 loop and is double packed in two heat sealed Tyvek pouches. This catheter is very similar in construction to the Z-MED PTV catheter except for the thicker balloon material. The Z-MED II catheter is available in standard diameters from 4 mm to 30 mm in standard lengths of 2 cm to 10 cm. Guidewire sizes will vary from 0.025" to 0.035" and shaft sizes will vary from 5F to 9F.
The provided document describes a 510(k) premarket notification for the NuMED Tyshak II and Z-Med II PTV Catheters, which modifies previously approved devices by introducing new lengths. Since this is a 510(k) submission, the primary goal is to demonstrate substantial equivalence to a predicate device, rather than proving performance against specific acceptance criteria through a clinical trial or extensive standalone algorithm testing.
Therefore, many of the typical sections you'd expect for AI/algorithm performance studies (like sample size for test sets, number of experts, adjudication methods, MRMC studies, standalone performance with metrics like sensitivity/specificity, or training set details) are not applicable or explicitly mentioned in this type of submission. The focus is on demonstrating that the new device (with extended lengths) is as safe and effective as the predicate device already on the market.
Here's an analysis based on the provided text, addressing your points where possible:
1. Table of Acceptance Criteria and Reported Device Performance
For a 510(k) submission focused on modifications to an existing device, "acceptance criteria" are typically related to maintaining the same performance characteristics as the predicate device. The document states that the new models are "very similar in construction" to the predicate devices, with specific differences (thinner balloon for Tyshak II, thicker balloon material for Z-MED II) and new lengths.
The primary "performance" demonstrated here is the meeting of biocompatibility and bench testing standards, implying that the modified devices perform equivalently to the predicate devices in these aspects. There are no explicit performance metrics (e.g., success rates in procedures) measured against numerical acceptance criteria presented in this specific document.
| Feature/Test | Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|---|
| Biocompatibility | Compliance with Tripartite Biocompatibility Guidance for Medical Devices (as per predicate devices) | All materials demonstrate biocompatibility |
| Bench Testing | Performed in accordance with GMPs (similar to predicate devices) | Performed in accordance with GMPs; results on file |
| Indications for Use | Identical to predicate devices | Identical to predicate devices |
| Materials | Unchanged from previously approved devices | Materials used have not changed |
| Construction | Coaxial construction with distally mounted non-compliant balloon | Coaxial construction with distally mounted non-compliant balloon |
| Balloon Length | Expanded range (2cm-10cm) while maintaining safety/effectiveness of predicate | Tyshak II: 2cm-10cm; Z-MED II: 2cm-10cm |
2. Sample Size Used for the Test Set and Data Provenance
Not applicable for this type of submission. There is no mention of a "test set" in the context of clinical data for AI/algorithm performance. The biocompatibility and bench testing are presumably performed on a sample of the manufactured devices, but specific sample sizes for these tests are not provided and are internal to NuMED, Inc. The document states "Test results indicate that all materials demonstrate the biocompatibility... and are on file at NuMED, Inc." and "All bench testing was performed in accordance with GMP's and the results are kept on file at NuMED, Inc." This indicates the provenance is internal data from NuMED's labs from their testing.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of those Experts
Not applicable. This device is a catheter, not an AI or diagnostic algorithm requiring expert-established ground truth from medical images or clinical outcomes in a test set.
4. Adjudication Method for the Test Set
Not applicable, as there is no "test set" in the context of clinical data requiring expert adjudication.
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 catheter, not an AI-assisted diagnostic tool.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
Not applicable. This is a physical medical device.
7. The Type of Ground Truth Used
For biocompatibility, the "ground truth" is compliance with established biological safety standards for medical device materials. For bench testing, the "ground truth" is adherence to engineering specifications and performance parameters demonstrated as safe and effective for the predicate device. These are established through standardized testing protocols (e.g., ISO, ASTM).
8. The Sample Size for the Training Set
Not applicable. There is no AI algorithm involved, thus no "training set."
9. How the Ground Truth for the Training Set was Established
Not applicable.
§ 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).