(64 days)
The FlexCath Advance Steerable Sheath is intended for percutaneous catheter introduction into the vasculature and into the chambers of the heart. The sheath deflection facilitates catheter positioning.
The FlexCath Advance Steerable Sheath and Dilator is a sterile, single use percutaneous introducer fitted with a valve to allow for introduction, withdrawal and swapping of catheters and wires while minimizing blood loss. A side-port with stopcock is integrated to allow continuous drip infusion, injection through the center lumen, flushing, aspiration, blood sampling and pressure monitoring. The FlexCath Advance Steerable Sheath and Dilator can be deflected to provide additional maneuverability to catheters that are advanced through the sheath and into the right or left chamber of the heart. The sheath is comprised of two (2) main sections: the shaft and the handle. A dilator is included with each sheath.
This premarket notification presents proposed design and material changes to the hemostasis valve component, located within the handle section. Product performance requirement changes related to the updated hemostasis valve are also being implemented for the subject device. All other aspects of the device (overall design/technology, labeling, etc.) remain unchanged and are identical as compared to the predicate device, the FlexCath Advance Steerable Sheath and Dilator cleared under K183174.
The provided text describes the FlexCath Advance Steerable Sheath and Dilator, which is a medical device for percutaneous catheter introduction. The submission is for design and material changes to the hemostasis valve component of the device.
Here's the information about the acceptance criteria and the study that proves the device meets them:
1. Acceptance Criteria and Reported Device Performance:
| Test Category | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Design Verification | Applicable product requirements (specific criteria for each test are not detailed in the provided text) | Pressure decay and vacuum testing: All acceptance criteria were met. |
| Kink testing: All acceptance criteria were met. | ||
| Pull force testing: All acceptance criteria were met. | ||
| Insertion and retraction force testing: All acceptance criteria were met. | ||
| Biocompatibility Testing | Biologically safe as guided by ISO 10993-1:2018 for use in its intended application | Cytotoxicity testing: Results support biological safety. |
| Sensitization testing: Results support biological safety. | ||
| Irritation or Intracutaneous Reactivity testing: Results support biological safety. | ||
| Systemic Toxicity testing (acute): Results support biological safety. | ||
| Pyrogenicity testing (Material-mediated): Results support biological safety. | ||
| Hemocompatibility (Hemolysis, Complement Activation): Results support biological safety. | ||
| Leveraged from predicate device (Safe History of Use): Thrombogenicity in vivo, Coagulation (PTT test), Platelets, Hematology. | ||
| Sterilization Qualification | Meet respective acceptance criteria with valid assays conducted by qualified laboratories | EO Residual testing: Met respective acceptance criteria. |
| Bioburden testing: Met respective acceptance criteria. | ||
| Bacterial endotoxin testing: Met respective acceptance criteria. |
2. Sample Size Used for the Test Set and Data Provenance:
The document states that "All design verification testing was performed on final finished product incorporating the proposed design and material changes." However, the exact sample sizes for each specific test (e.g., number of devices tested for kink, pull force, etc.) are not provided in the given text.
The data provenance is from Medtronic CryoCath LP, Canada, as indicated by the applicant's address: 9000 Autoroute Transcanadienne, Point-Claire, Quebec H9R 5Z8, Canada. The studies appear to be prospective bench and laboratory testing performed to verify the changes.
3. Number of Experts Used to Establish Ground Truth and Qualifications:
This information is not applicable as the studies described are for design verification, biocompatibility, and sterilization qualification of a physical medical device, not for an AI/algorithm-based diagnostic or assistive system requiring expert ground truth for interpretation.
4. Adjudication Method for the Test Set:
This information is not applicable for the same reason as point 3. The testing involves objective measurements to meet specified product requirements.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
An MRMC study was not done. This type of study is relevant for evaluating the impact of an AI system on human reader performance, which doesn't apply to this medical device submission focused on physical changes to a sheath and dilator.
6. Standalone (Algorithm Only) Performance:
Standalone performance was not done. This concept is specific to AI algorithms operating without human interaction. The FlexCath Advance is a physical medical device.
7. Type of Ground Truth Used:
The "ground truth" for this device, in essence, is the pre-defined product requirements and established regulatory standards (e.g., ISO 10993-1:2018 for biocompatibility). The tests confirm that the device performs according to these engineering and safety specifications.
8. Sample Size for the Training Set:
This information is not applicable as the submission is not for an AI/machine learning device that would require a training set.
9. How the Ground Truth for the Training Set was Established:
This information is not applicable for the same reason as point 8.
§ 870.1280 Steerable catheter.
(a)
Identification. A steerable catheter is a catheter used for diagnostic and monitoring purposes whose movements are directed by a steering control unit.(b)
Classification. Class II (performance standards).