(209 days)
Tearaway introducer sheath: These introducers are used for the percutaneous introduction of diagnostic or therapeutic devices, such as catheters and pacing leads, into the vasculature.
MicroSlide™ Tearaway introducers are used for the procedures to introduce catheters and other intravascular devices into the coronary and peripheral vasculature of adult and pediatric patients of all ages.
The Galt Medical Tearaway Introducer Sheath assembly consists of an outer peelable sheath and a dilator. The tear-away sheath has a winged hub to initiate the tear in the sheath. The design of the tearaway introducer sheath is unchanged from the current line of Tearaway Introducer Sheaths (K000313), and the pediatric version MicroSlide™ Tearaway Introducer (K123430). The subject and current marketed predicate devices are identical with the exception of the material used in the sheath hub.
The provided text is a 510(k) premarket notification for a medical device called the "Tearaway Introducer Sheath and MicroSlide Tearaway Introducer." The purpose of this submission is to demonstrate that the device with a new hub material is substantially equivalent to previously marketed predicate devices.
Acceptance Criteria and Study for the Device:
The core of this submission revolves around demonstrating that changing the hub material of an already cleared device does not negatively impact its safety and effectiveness. Therefore, the "acceptance criteria" are essentially the established performance specifications of the predicate devices. The study conducted is a series of non-clinical tests to show that the new device meets these specifications.
1. Table of Acceptance Criteria and Reported Device Performance:
The document doesn't present a formal table of "acceptance criteria" with explicit numerical targets, but rather lists the functional tests performed to demonstrate substantial equivalence to the predicate devices. The "reported device performance" is implied to have met these predicate device specifications, as the conclusion states substantial equivalence.
| Acceptance Criterion (Implied: Meet Predicate Device Performance) | Reported Device Performance (Implied: Met) |
|---|---|
| Hub Break Force | Passed |
| Perpendicular Pull Force | Passed |
| Dilator Insertion Test | Passed |
| Hub Dimensional | Passed |
| Biocompatibility (Cytotoxicity, Sensitivity, Irritation, Systemic Toxicity, Hemocompatibility, Pyrogen, EO Residuals) | Passed |
| Sterilization Cycle Performance | Verified |
| Packaging Performance (Shelf Life) | Unchanged from predicate, previously verified |
2. Sample Size Used for the Test Set and Data Provenance:
The document does not specify the exact sample sizes (e.g., number of units tested) for each non-clinical test. It only states that functional testing was conducted on "aged product."
- Sample Size: Not specified.
- Data Provenance: The tests were conducted internally by Galt Medical Corporation ("Galt Medical requirements") according to protocols "based on international standards." This indicates that the data is from prospective testing performed by the manufacturer to support this specific 510(k) submission. There is no indication of country of origin of the data beyond the manufacturer being in the USA.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts:
This is a non-clinical device submission focused on performance and material equivalence. Therefore, there are no "experts" in the clinical sense (e.g., radiologists) used to establish ground truth. The "ground truth" for the test set is established by recognized international standards and the performance specifications of the predicate devices. The expertise involved would be in engineering, materials science, and testing methodology, likely performed by the manufacturer's qualified personnel.
4. Adjudication Method for the Test Set:
Not applicable. This is not a study requiring human interpretation or adjudication for the test set. The tests are objective, measurable physical and chemical properties.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done:
No. This is a non-clinical submission for a physical medical device. MRMC studies are typically for diagnostic imaging devices or software.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done:
Not applicable. This is a physical medical device, not a software algorithm.
7. The Type of Ground Truth Used:
The ground truth used for these non-clinical tests is based on:
- Device specifications: Established performance parameters for the device (e.g., specific force values for hub break, dimensional tolerances).
- International standards: Adherence to relevant ISO or other recognized standards for medical device testing.
- Predicate device performance: The performance of the previously cleared Galt Tearaway Introducer Sheath (K000313) and Galt MicroSlide™ Tearaway Introducer (K123430) serves as the benchmark.
8. The Sample Size for the Training Set:
Not applicable. There is no "training set" as this is not an artificial intelligence/machine learning device. The "training" for the device, in a manufacturing sense, would be the established manufacturing process and quality control, which is addressed by the quality system regulation (21 CFR Part 820).
9. How the Ground Truth for the Training Set was Established:
Not applicable. As there is no training set as understood in AI/ML, there's no ground truth established for it in that context.
§ 870.1340 Catheter introducer.
(a)
Identification. A catheter introducer is a sheath used to facilitate placing a catheter through the skin into a vein or artery.(b)
Classification. Class II (performance standards).