(222 days)
The 8F Modified Sheath System is indicated for the introduction of interventional devices into the peripheral and neuro vasculature.
The 8F Modified Sheath System is comprised of a Sheath, a Navigating Catheter, and an RHV (rotating hemostasis valve). The Sheath is a single-lumen, variable stiffness catheter with a radiopaque marker on the distal end. The inner lumen of the catheter is compatible with 8F or smaller catheters. The Dilator may be placed within the Sheath to facilitate percutaneous introduction of the Sheath into a femoral artery. The Dilator has a radiopaque marker at the distal tip. The Navigating Catheter is a singlelumen, variable stiffness catheter with a radiopaque marker at the distal tip. The Navigating Catheter is compatible with the Sheath and has a shaped distal end to facilitate placement. All of the catheters are coated with hydrophilic coating.
The provided text describes the 8F Modified Sheath System and its substantial equivalence to a predicate device (Base Camp® Sheath System, K191717) for FDA clearance. The document focuses on non-clinical testing to demonstrate performance.
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1. Table of Acceptance Criteria and Reported Device Performance
The document lists various performance tests and their outcomes, uniformly indicating "PASS" and that "The pre-determined acceptance criteria were met." However, it does not explicitly state the specific quantitative acceptance criteria for each test. It only reports that the device met them.
| Test | Test Method | Reported Device Performance |
|---|---|---|
| Dimensional Verification | Device dimensions were measured to confirm conformance to the specifications. | PASS |
| Luer Integrity | Tested per ISO 80369-7:2016. | PASS |
| Tensile Strength | The tensile strength of the catheter sections and bonds was tested. | PASS |
| Kink Resistance | Test specimen segments were formed into a defined bend diameter to evaluate kink resistance. | PASS |
| Torsion Resistance | The test specimens were rotated to evaluate integrity after rotation. | PASS |
| Tip Flexibility | Test specimens were tested for tip flexibility. | PASS |
| Air Leakage | Tested per ISO 10555-1:2013 Annex D. | PASS |
| Liquid Leakage | Tested per ISO 10555-1:2013 Annex C. | PASS |
| Hydrophilic Coating Integrity | The integrity of the hydrophilic coating was evaluated after multiple insertion and withdrawal cycles in a vascular model. | PASS |
| Simulated Use Testing | Deliverability and compatibility with accessory devices were evaluated in a vascular model. | PASS |
| Static Burst Pressure Testing | Tested per ISO 10555-1:2013 Annex F. | PASS |
| Particulate Testing | The size and quantity of particulate matter generated during simulated use testing were determined. | PASS |
| Delivery/Retrieval Force Testing | The forces to deliver and retrieve the subject device in an anatomical model were measured. | PASS |
Biocompatibility Testing Acceptance
For biocompatibility, the acceptance criteria are generally qualitative for these types of tests and are implicitly met when the "Conclusion" states no adverse reactions or that requirements were met.
| Test | Conclusion |
|---|---|
| Sensitization | Test article did not elicit a sensitization response. |
| Irritation | Requirements of the ISO intracutaneous reactivity test have been met for the test article. |
| Acute Systemic Toxicity | Requirements of the ISO acute systemic injection test have been met for the test article. |
| Material Mediated Pyrogenicity | The test article met the requirements for the absence of pyrogens. |
| Cytotoxicity | The test article is non-cytotoxic. |
| Hemocompatibility – ASTM Hemolysis | The test article is considered non-hemolytic. |
| Hemocompatibility - Thrombogenicity: ASTM Partial Thromboplastin Time Assay | The test article met the requirements of the test. |
| Hemocompatibility - Complement Activation Assay | The test article is a non-activator of the complement system. |
| Hemocompatibility - Thrombogenicity: ASTM Platelet/Leukocyte Count | The test article met the requirements of the test. |
| Hemocompatibility - Thrombogenicity: Comparative Surface Assessment | The test article does not have any features that would increase thrombogenicity risk. |
2. Sample Size Used for the Test Set and the Data Provenance
The document does not explicitly state the sample sizes used for each of the performance or biocompatibility tests. It refers to "test specimens" or animals (e.g., "guinea pig," "rabbits," "mice") for biocompatibility, but without specific numbers.
- Data Provenance: The data provenance is from non-clinical bench testing and laboratory animal testing. There is no information provided about the country of origin, but given it's an FDA submission, the tests were conducted to international standards (e.g., ISO, ASTM) which are globally recognized. All testing appears to be prospective (conducted specifically for this submission).
3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts
Not applicable. This is a submission for a medical device (catheter system) where "ground truth" in the clinical sense (e.g., diagnosis, outcome) is not relevant for the non-clinical and biocompatibility studies presented. The "truth" or acceptance is determined by predefined engineering specifications and regulatory standards (ISO, ASTM). The document does not mention the use of human experts to establish ground truth for this type of testing.
4. Adjudication Method for the Test Set
Not applicable. Adjudication methods (like 2+1, 3+1) are typically used in clinical studies or studies involving human interpretation of data (e.g., medical imaging) to resolve discrepancies. The studies described are objective performance and biocompatibility tests where a result either meets or does not meet a predefined standard.
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 physical medical device (catheter system), not an AI/software device. No MRMC study was conducted or is relevant.
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 an algorithm or AI system.
7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc)
As mentioned in point 3, the concept of "ground truth" in the clinical diagnostic sense is not applicable here. For the performance and biocompatibility studies, the "ground truth" is defined by:
- Pre-determined engineering specifications: For dimensional verification, tensile strength, kink resistance, etc.
- International standards and regulatory guidelines: Such as ISO 80369-7:2016 for Luer Integrity, ISO 10555-1:2013 for leakage and burst pressure, and ISO 10993-1 for biocompatibility.
8. The Sample Size for the Training Set
Not applicable. There is no "training set" in the context of this traditional medical device submission. Training sets are relevant for machine learning or AI models.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as there is no training set.
§ 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).