(60 days)
The introduction of various types of pacing/defibrillator leads and catheters into the venous vasculature.
The Prelude Pursuit™ Splittable Sheath Introducer is a splittable introducer system indicated for the introduction of various types of pacing/defibrillator leads and catheters into the venous vasculature. The "splittable” function allows the introducer to be withdrawn over a diagnostic/therapeutic catheter (e.g. peripherally inserted central catheter, totally implantable venous access device/port, dialysis, drainage, hemodynamic line, etc.) or pacing/defibrillator lead and from the vessel while maintaining said device in place. The product is available in 16 French sizes, from 5 F through 16 F, and in two different lengths, 13 cm and 25 cm. It is packaged either as a kit with optional accessory components (introducer needle, syringe, guide wire), or as a stand-alone (sheath-dilator) set. The device is provided sterile and intended for single use only. It is for use in hospitals or healthcare facilities. The splittable sheath introducer is lubricated with a silicone dispersion and its hub has a threaded locking mechanism for dilator engagement. The dilator is designed to conform to the inner diameter of the introducer and has a tapered tip for ease of insertion.
The document provided describes a 510(k) premarket notification for a medical device called the "Prelude Pursuit Splittable Sheath Introducer". It does not describe an AI/ML powered device, therefore, many of the requested categories (e.g., sample sizes for training/test sets, ground truth establishment, expert qualifications, MRMC studies) are not applicable.
Here's an analysis based on the information provided, focusing on the device's performance given its classification as a medical device (not an AI/ML product):
1. Table of Acceptance Criteria and Reported Device Performance
As this is a physical medical device (catheter introducer) and not an AI/ML product, the "acceptance criteria" are related to its physical and functional properties, as well as safety standards. The "reported device performance" refers to the successful completion of these tests, demonstrating compliance with the predicate device and established standards.
| Acceptance Criteria Category | Specific Test/Standard | Reported Device Performance |
|---|---|---|
| Dimensional Tests | Introducer sheath tube outer diameter (OD) | Tested and met specifications |
| Introducer tip inner diameter (ID) | Tested and met specifications | |
| Introducer free length | Tested and met specifications | |
| Dilator tube outer diameter (OD) | Tested and met specifications | |
| Dilator tip inner diameter (ID) | Tested and met specifications | |
| Dilator protrusion from introducer when assembled | Tested and met specifications | |
| Functional Tests | Introducer hub break force | Tested and met specifications |
| Introducer sheath peel force | Tested and met specifications | |
| Introducer tube to hub joint strength | Tested and met specifications | |
| Dilator tube to hub joint strength | Tested and met specifications | |
| Mating dilator ISO 594-2 compliance | Tested and met specifications (compliant with ISO 594-2:1998) | |
| Simulated Use Test | Introducer sheath / dilator insertion - synthetic tissue | Tested and met specifications |
| Sheath - dilator assembly - kink & flexibility | Tested and met specifications | |
| Mating dilator to introducer engagement | Tested and met specifications | |
| Visual Tests | Introducer soft touch pad attachment | Tested and met specifications |
| Sterilization | Sterilization validation | Validated (compliant with ISO 11135-1:2007, AAMI TIR28:2009) |
| Biocompatibility | Cytotoxicity (in vitro) | Tested (compliant with ISO 10993-5:2009) |
| Sensitization | Tested (compliant with ISO 10993-10:2010) | |
| Irritation | Tested (compliant with ISO 10993-10:2010) | |
| Acute Systemic Toxicity | Tested (compliant with ISO 10993-11:2006) | |
| Pyrogenicity | Tested (compliant with USP 40, NF 35, ) | |
| Hemolysis | Tested (compliant with ASTM F756-13:2013) | |
| Thrombogenicity | Tested (compliant with ISO 10993-4:2002/Amd.1:2006, ISO 10993-4:2017) | |
| Complement Activation | Tested (compliant with ISO 10993-4:2002/Amd.1:2006, ISO 10993-4:2017) | |
| Packaging & Labeling | Packaging integrity | Tested (compliant with ASTM D4169-16, ISO 11607-1, ISO 2233, ASTM F2096, ASTM F1140, ASTM F1980, ASTM F88, ASTM F1929) |
| Labeling | Compliant with ISO 15223-1:2016 | |
| Risk Management | Application of risk management | Applied (compliant with ISO 14971:2012) |
2. Sample size used for the test set and the data provenance
This information is not provided in the document. For physical device testing, sample sizes are typically determined by statistical rationale for verification and validation (V&V) testing based on product specifications and standards, but the specific numbers are not disclosed here. The "data provenance" for such a device would refer to the testing being performed in a laboratory setting under controlled conditions, not from patient data.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This is not applicable as the device is a physical medical instrument, not an algorithm requiring expert-established ground truth from medical images or data. Ground truth for physical properties is established through validated measurement techniques and adherence to engineering specifications and international standards.
4. Adjudication method for the test set
Not applicable for a physical device. Performance is judged against objective physical and safety standards.
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, as this is not an AI/ML device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable, as this is not an AI/ML device. "Standalone" performance for this device would refer to its physical function as tested against its specifications.
7. The type of ground truth used
For this physical device, the "ground truth" is defined by:
- Engineering Specifications: Designed dimensions, material properties, and functional performance targets derived from the device's intended use.
- International Standards (e.g., ISO, ASTM, USP): These standards (listed in the document) provide objective, established benchmarks for safety, biocompatibility, sterilization, and functional performance of medical devices. Failure to meet these standards would indicate the device does not meet "ground truth" for safe and effective use.
8. The sample size for the training set
Not applicable, as this is not an AI/ML device. There is no "training set" in the context of physical medical device development in this manner.
9. How the ground truth for the training set was established
Not applicable, as this is not an AI/ML device.
§ 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).