(256 days)
The IMDS NHancer™ Guide Wire Support Catheter with Hydrophilic Coating is a guidewire exchange and infusion device designed for use in the vascular system. The IMDS NHancer™ guidewire support catheter is intended to support a guidewire during access of vasculature and allows for exchange of guidewires and provides a conduit for the delivery of diagnostic contrast agents.
The purpose of the NHancer™ guidewire support catheter is to facilitate the placement of a guide wire through an occluded vessel during Percutane Transluminal Coronary Intervention procedures. The NHancer™ is a single use device, consisting of a shaft, a distal tip and a female luer (hub) on the proximal end. On the shaft are two depth markings applied to indicate the length of the device that is in the body. On the distal tip of the device a radiopaque marker band is applied. The distal part of the shaft is fitted with a hydrophilic coating. On the shaft a torquer is placed. With this component the catheter can be locked on to the guide wire that is in the device. The torquer is initially placed on a strain relief which is located on the proximal end of the shaft, near the female luer (hub).
The provided text describes the 510(k) submission for the NHancer™ guidewire support catheter. The device is a traditional guidewire support catheter, not an AI/ML device, and therefore the acceptance criteria and study information typically associated with AI/ML device submissions are not directly applicable.
However, I can extract the performance criteria and the study approach used to demonstrate substantial equivalence to a predicate device, which is the regulatory pathway for this type of medical device.
1. Table of Acceptance Criteria and Reported Device Performance:
The document broadly states that the NHancer™ guidewire support catheter met all acceptance criteria. Specific quantitative acceptance criteria are not detailed in the provided text. Instead, the document focuses on demonstrating that the NHancer™ performed similarly or was substantially equivalent to the predicate device, the Spectranetics QuickCross® Support Catheter, for a range of performance characteristics.
| Performance Characteristic | Acceptance Criteria (Implicit) | Reported Device Performance (NHancer™) |
|---|---|---|
| Crossability (in-vitro & in-vivo) | Substantially equivalent to predicate | Met acceptance criteria (similar to predicate) |
| Guidewire friction (in-vitro) | Substantially equivalent to predicate | Met acceptance criteria (similar to predicate) |
| Guidewire Torqueability (in-vitro & in-vivo) | Substantially equivalent to predicate | Met acceptance criteria (similar to predicate) |
| Flow rate (in-vitro) | Substantially equivalent to predicate | Met acceptance criteria (similar to predicate) |
| Marker visibility (in-vivo) | Substantially equivalent to predicate | Met acceptance criteria (similar to predicate) |
| Guidewire exchangeability (in-vivo) | Substantially equivalent to predicate | Met acceptance criteria (similar to predicate) |
| Contrast medium administration (in-vivo) | Substantially equivalent to predicate | Met acceptance criteria (similar to predicate) |
| Usable length | Defined specification met | Met acceptance criteria |
| Length of coated part | Defined specification met | Met acceptance criteria |
| Tip inner diameter | Defined specification met | Met acceptance criteria |
| Tip length | Defined specification met | Met acceptance criteria |
| Outer diameter | Defined specification met | Met acceptance criteria |
| Pull strength after 5 rotations | Defined specification met | Met acceptance criteria |
| Burst strength after 5 rotations | Defined specification met | Met acceptance criteria |
| Flow rate testing (bench) | Defined specification met | Met acceptance criteria |
| System Burst testing | Defined specification met | Met acceptance criteria |
| 6% taper Luer testing | Defined specification met | Met acceptance criteria |
| Screw connection Luer testing | Defined specification met | Met acceptance criteria |
| Female Hub | Defined specification met | Met acceptance criteria |
| Exit marker location | Defined specification met | Met acceptance criteria |
| Radiopaque marker location | Defined specification met | Met acceptance criteria |
| Visual appearance | Defined specification met | Met acceptance criteria |
| Force at break: shaft | Defined specification met | Met acceptance criteria |
| Force at break: shaft/hub connection | Defined specification met | Met acceptance criteria |
| Force at break: tip/shaft connection | Defined specification met | Met acceptance criteria |
| Outer diameter radiopaque marker | Defined specification met | Met acceptance criteria |
| Dimensions of packaging box | Defined specification met | Met acceptance criteria |
| Product integrity after simulated transportation test | Defined specification met | Met acceptance criteria |
| Pouch bubble test | Defined specification met | Met acceptance criteria |
| Liquid dye test | Defined specification met | Met acceptance criteria |
| Pouch seal strength | Defined specification met | Met acceptance criteria |
| Pouch seal width | Defined specification met | Met acceptance criteria |
| Label adhesive retention | Defined specification met | Met acceptance criteria |
| Legibility of product information | Defined specification met | Met acceptance criteria |
| Pouch delamination assessment after opening | Defined specification met | Met acceptance criteria |
| Kink resistance | Defined specification met | Met acceptance criteria |
| Torque testing | Defined specification met | Met acceptance criteria |
| Coating Integrity and Particulate Evaluation | Defined specification met | Met acceptance criteria |
| Biocompatibility (Thrombosis, Hemolysis, Cytotoxicity, Irritation, Sensitization, Systemic Toxicity) | Passed all tests | Successfully passed all tests |
| Sterility (SAL of 10^-6) | Meets ISO 11137 and 11737 standards | Validated in accordance with standards |
| Non-pyrogenicity | Endotoxin Kinetic Turbidimetric test passed | Successfully passed Endotoxin Turbidimetric test |
2. Sample Size Used for the Test Set and Data Provenance:
The document details performance testing for both the NHancer™ and a predicate device. However, it does not specify the sample sizes used for the in-vitro and in-vivo tests. It only states that "Comparison testing was performed on the IMDS NHancer™ guidewire support catheter and the Spectranetics QuickCross Support Catheter" and that various "bench tests were performed on NHancer™ guidewire support catheter."
The data provenance is not explicitly stated in terms of country of origin or whether it was retrospective or prospective. Given the nature of a 510(k) submission for a physical medical device, these tests would typically be laboratory-based (in-vitro) and animal studies (in-vivo) conducted prospectively for the purpose of demonstrating regulatory compliance.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Experts:
This information is not applicable to this type of device and submission. "Ground truth" established by experts is typically a concept used in the evaluation of AI/ML diagnostic or prognostic devices, where human expert labels are used to train and validate AI algorithms. For a guidewire support catheter, the "ground truth" is determined by objective performance measurements against engineering specifications and predicate device performance, not expert consensus on interpretations.
4. Adjudication Method for the Test Set:
This information is not applicable for the same reasons as point 3. Adjudication methods like "2+1" or "3+1" are used in AI/ML studies to resolve disagreements among human labelers for establishing ground truth.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done, and Effect Size of Human Improvement with/without AI Assistance:
This information is not applicable as the NHancer™ is a physical medical device, not an AI/ML diagnostic or prognostic tool. Therefore, there are no "human readers" interpreting data with or without AI assistance, and no MRMC study would be conducted.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Study was Done:
This information is not applicable as the NHancer™ is a physical medical device, not an algorithm.
7. The Type of Ground Truth Used:
For the NHancer, the "ground truth" is based on:
- Engineering specifications: For various dimensions, material properties, and functional tests (e.g., usable length, outer diameter, pull strength, burst strength, flow rate).
- Performance relative to a predicate device: For clinical performance characteristics like crossability, guidewire friction, torqueability, marker visibility, guidewire exchangeability, and contrast administration. The predicate device's established performance serves as the benchmark.
- International Standards: For biocompatibility (ISO 10993), sterility (ISO 11137, ISO 11737), and non-pyrogenicity (Ph. Eur. Chapter 2.6.14 Method C, USP).
8. The Sample Size for the Training Set:
This information is not applicable. The concept of a "training set" refers to data used to train an AI/ML algorithm. The NHancer™ is a physical device and does not involve AI/ML.
9. How the Ground Truth for the Training Set Was Established:
This information is not applicable for the same reasons as point 8.
§ 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).