(236 days)
The SOFIA® EX Catheter is indicated for general intravascular use, including the neuro and peripheral vasculature. The SOFIA® EX Catheter can be used to facilitate introduction of diagnostic agents or therapeutic devices. The SOFIA® EX Catheter is not intended for use in coronary arteries.
The SOFIA® EX Catheter is a single-lumen, flexible catheter equipped with the coil and the braid reinforcement. The distal segment is designed to facilitate vessel selection with 55-65cm of distal shaft hydrophilic coating for navigation through the vasculatures. The radiopaque marker is located at the distal end of the catheter for visualization under fluoroscopy. The device is provided sterile and for single use. The catheter is placed in a dispenser tube (HDPE) and is placed on a packaging card (polyethylene) that is provided in a sterile barrier tyvek pouch and placed in a carton box.
The provided document is a 510(k) premarket notification for the SOFIA® EX Intracranial Support Catheter. It describes the device, its intended use, comparison to predicate devices, and performance data used to demonstrate substantial equivalence.
Here's the breakdown of the acceptance criteria and the study proving the device meets them, as extracted from the document:
1. A table of acceptance criteria and the reported device performance:
The document presents the performance data in a table format under section "VII. Performance Data" (pages 7-8). Each "Test" listed implicitly defines an acceptance criterion (e.g., "Device met acceptance criteria"). Because the document is a 510(k) summary, the specific quantitative acceptance criteria values are not explicitly stated, but the results confirm that the "Device met acceptance criteria" for each test.
| Test Name | Test Method Summary | Reported Device Performance |
|---|---|---|
| Dimensional Inspection | The usable length, proximal and distal outer diameters, distal length and inner diameters were measured and recorded. | Device met acceptance criteria for length, inner and outer diameters. The device size (5F) comparable to the 5F predicate and reference devices. The inner diameter is larger than the predicate device, while the outer diameter is larger, but still compatible with tested 6F guiding sheaths. |
| Catheter Tip Stability | Simulated use of the delivery of a braided device is performed in a tortuous anatomical benchtop model and the movement of the subject device is measured and recorded. | Device met acceptance criteria for tip stability. The device is able to support the delivery of braided devices and stent-retrievers without losing distal tip position. The stability of the distal tip was better (less movement) than the predicate device. |
| Simulated Use and Physician Simulated Use | The device is put through simulated use. The device is navigated through a tortuous benchtop model to assess preparation, introduction, tracking, and support of the device. | Device met acceptance criteria. |
| Dynamic Burst Testing | Device hub is connected to a pressure control machine and was tested under pressures experienced during worst-case dynamic injections. | Device met acceptance criteria and was able to withstand pressures experienced during worst-case dynamic injections. |
| Liquid Leakage | Device was tested per ISO 10555-1, Annex C liquid leakage testing. Device is connected at hub and is pressurized with fluid and maintains the pressure for a specified duration of time. | Device met acceptance criteria. |
| Liquid Leakage at Rated Burst Pressure | Device was tested per ISO 10555-2 Annex A, liquid leakage testing. Device is connected at hub and is pressurized with fluid and maintains rated burst pressure for a specified duration of time. | Device met acceptance criteria and does not leak fluids at rated burst pressure. |
| Air Leakage | Device was tested per ISO 594-2. Device is connected at hub and subjected to negative pressure and any air leaking into the device is recorded. | Device met acceptance criteria. Device does not allow air to leak into the device when subjected to negative pressure. |
| Static Burst | Device was connected at hub and tested under full-length static conditions to burst. | Device met acceptance criteria. All devices burst above the rated burst pressure and had better results than the predicate device. |
| Tensile Strength | Device was tested per ISO 11070. The device is tensile tested to failure and the force at break is measured and recorded. | Device met acceptance criteria. |
| Tip Buckling | Distal tip buckling force under compressive load was evaluated for stiffness. | Device met acceptance criteria. Device has a softer distal tip than the reference device. |
| Torque Response | Device was tested for full-length torque response. The device is tracked through a tortuous benchtop model and the proximal hub is turned, the distal tip torque response is measured and recorded. | Device met acceptance criteria. Device has better torque response than the reference device. |
| Radio-detectability | Device is put under fluoroscope to assess visibility. | Device met acceptance criteria. Device is visible under fluoroscopy. |
| Coating Lubricity and Durability | Device coating was evaluated for frictional force and durability. | Device met acceptance criteria. Average friction is comparable to predicate device. |
| Particulate Testing | Device was evaluated for particulate generation under simulated use in a representative tortuous anatomical model per USP. | Number of particulates generated met acceptance criteria and is within the limits per USP and is comparable to the predicate and reference devices. |
| Kink Resistance | Device is evaluated for kink resistance by subjecting the device to bending experienced in tortuous anatomy. | Device met acceptance criteria. Results matched results of the predicate device. |
| Corrosion Resistance | Device is tested per ISO 10555-1, Annex A and ISO 11070, Annex B to evaluate corrosion resistance. | Device met acceptance criteria. Device is resistant to corrosion. |
| Cytotoxicity (ISO Medium Eluate Method) | 1x CMEM Cell Growth Medium (MEM supplemented with 10% fetal bovine serum extract) L929 Mouse Fibroblast Cell Line (Extracted at 37°C/24 hrs, 6.0 cm²/mL) | Non-cytotoxic. The test article is considered non-cytotoxic to cells. |
| Sensitization (ISO Kligman Maximization Test) | Normal Saline and Vegetable (Cottonseed) Oil Extracts Hartley Guinea Pigs (Extracted at 50°C/72 hrs, 6.0 cm²/mL) | Non-sensitizing. The test article did not elicit a sensitization response. |
| Irritation/Intracutaneous Toxicity | Normal Saline and Vegetable (Cottonseed) Oil Extracts (Extracted at 50°C/72 hrs, 6.0 cm²/mL) | Non-irritant. No evidence of irritation. |
| Systemic Toxicity (ISO Systemic Injection Test) | Normal Saline and Vegetable (Cottonseed) Oil Extracts Albino Swiss Mice (Extracted at 50°C/72 hrs, 6.0 cm²/mL) | Non-cytotoxic (sic, likely meant non-toxic per the test type). No weight loss, mortality, or evidence of systemic toxicity from the extract exposure to the mice. |
| Systemic Toxicity (ISO Rabbit Pyrogen Test) | Normal Saline New Zealand White Rabbits (2 Male and 2 Female - non-pregnant and nulliparous) (Extracted at 50°C/72 hrs, 6.0 cm²/mL) | Non-pyrogenic. All individual rabbits for both the test article and negative control showed a total rise in temperature of |
§ 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).