(34 days)
This catheter is recommended for Percutaneous Transluminal Valvuloplasty (PTV) of the pulmonary valve in Pediatric applications.
- 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 Mini Pediatric PTV catheter is a coaxial catheter for use in PTV applications where a small introduction site is necessary. The catheters 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. 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 blue 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 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. The Tyshak Mini catheter is available in standard diameters from 3mm to 10mm. The lengths available will be 0.8cm - 4cm. The Guidewire size will be 0.014'', and the shaft size will be 2.5Fr and 3.5Fr.
The provided text describes the NuMED Tyshak Mini Pediatric PTV Catheter as a device for Percutaneous Transluminal Valvuloplasty (PTV) of the pulmonary valve in pediatric applications. However, it does not include a study that proves the device meets specific acceptance criteria in terms of performance metrics like accuracy, sensitivity, or specificity.
Instead, the document focuses on:
- Device Description: What the catheter is made of and its specifications.
- Biocompatibility Testing: States that the materials are the same as an already approved device and meet biocompatibility guidance.
- Laboratory (Bench) Testing: Mentions that bench testing was performed in accordance with GMPs and results are on file, but does not provide any specific results or acceptance criteria for these tests.
- Intended Use/Indications For Use: Specifies the medical conditions for which the catheter is intended.
- Comparison Information: Compares the new device (with additional sizes) to the previously approved Tyshak Mini catheter, highlighting expanded size ranges.
- Substantial Equivalence Determination: The FDA letter confirms that the device is substantially equivalent to a legally marketed predicate device, allowing it to be marketed. This is a regulatory pathway, not a performance study proving specific clinical acceptance criteria.
Therefore, many of the requested details about acceptance criteria and a study proving performance cannot be extracted from the provided text because such information is not present. The document primarily serves as a 510(k) submission for substantial equivalence based on prior device approval and bench testing.
Here's an attempt to answer based on the available information, noting where information is explicitly not present:
Acceptance Criteria and Device Performance
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Specific Criteria (as implied or stated) | Reported Device Performance | Source/Comment |
|---|---|---|---|
| Biocompatibility | Compliance with Tripartite Biocompatibility Guidance for Medical Devices. | Materials from the new device are the same as the already approved Tyshak Mini Catheter (510/k #K003276) which were tested for biocompatibility. All materials demonstrate biocompatibility. | Biocompatibility Testing section. Specific test results (e.g., cytotoxicity, sensitization) are not detailed but stated to be on file. |
| Manufacturing Quality | Adherence to Good Manufacturing Practices (GMPs). | All bench testing was performed in accordance with GMP's. | Laboratory (Bench) Testing section. This is an adherence criterion, not a performance metric for the device itself. |
| Material/Design Equivalence | Materials, construction, and principle of operation are substantially equivalent to predicate device. | Materials (Shaft: Pebax, Balloon: PES2, Image Band: Platinum) and construction (Coaxial with distally mounted non-compliant balloons) are identical to the predicate device. | Comparison Information table and Device Description. |
| Dimensional Specifications | Specific ranges for introducer, shaft, guidewire, usable length, balloon diameter, and balloon length. | Introducer: 2.5Fr - 3.5Fr; Shaft Size: 3Fr - 4Fr; Guidewire Size: 0.014"; Usable Length: 20cm - 65cm; Balloon Diameter: 3mm - 10mm; Balloon Length: 0.8cm - 4cm. | Comparison Information table. These are design specifications, not performance acceptance criteria from a study. |
| Clinical Performance | (No specific clinical acceptance criteria, e.g., success rate, complication rate, are provided.) | (No clinical performance data is reported in this document.) | Not provided. |
2. Sample Size for Test Set and Data Provenance
- Test Set Sample Size: Not applicable. This document does not describe a clinical performance study with a test set of patient data. The "bench testing" mentioned refers to laboratory tests, not a clinical study involving patient samples.
- Data Provenance: Not applicable. No clinical data is presented. The document refers to "bench testing" and "biocompatibility testing," which are laboratory tests, not human data.
3. Number of Experts and Qualifications for Ground Truth
- Not applicable. There is no mention of a study involving experts establishing ground truth for a test set. The FDA's substantial equivalence determination is based on comparison to an existing device, not an evaluation of diagnostic or interventional performance against expert ground truth.
4. Adjudication Method
- Not applicable. No study involving human experts and ground truth adjudication is described.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
- No. The document does not describe an MRMC study or any study comparing human reader performance with or without AI assistance. This device is a catheter, not an AI-assisted diagnostic tool.
6. Standalone (Algorithm Only) Performance Study
- No. This device is a physical catheter, not an algorithm, so a standalone algorithm performance study is not relevant or described.
7. Type of Ground Truth Used
- Not applicable. No ground truth for a diagnostic or interventional performance study is mentioned. The "ground truth" implicitly referred to for establishing substantial equivalence is the technical specifications and safety profile of the predicate device (NuMED Tyshak Mini Catheter 510/k #K003276) and compliance with relevant standards (biocompatibility, GMP).
8. Sample Size for Training Set
- Not applicable. This document is for a physical medical device (catheter), not an AI/ML algorithm that employs a "training set."
9. How Ground Truth for Training Set Was Established
- Not applicable. As above, this is not an AI/ML device, so there is no training set or associated ground truth.
§ 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).