(89 days)
SCIMED guide catheters are intended for use in general intravascular and coronary applications. They provide a pathway through which medical instruments, such as balloon dilatation catheters, guide wires or other therapeutic devices may be introduced. These devices are not intended for use in the cerebral vasculature
The shaft of the 8 F Wiseguide guide catheter utilizes common biocompatible materials and consists of the following three layers: 1) the inner polytetrafluoroethylene (PTFE) layer that provides a low coefficient of friction and facilitates easy passage of medical devices such as balloon dilatation catheters, guide wires or other therapeutic devices, 2) the middle layer which is made of braided stainless steel wire that extends from the shaft to the tip to provide kink resistance, torque control and support and 3) the outer layer, manufactured from Pebax® and a radiopaque filler, which provides stiffness, memory and radiopacity.
In addition, the distal 5.8 to 17.5 inches (depending on the curve style) of the outer primary catheter shaft is constructed of multiple sections of Pebax. These sections are composed of durometers of Pebax providing a distal curve area of the catheter with transitional flexibility. The catheter is assembled as components over a core mandrel. The catheter shaft is then heat fused, forming a composite catheter shaft. This process results in a continuous inner and middle layer and a seamless outer shaft layer.
The distal tip is made of Pebax and is radiopaque to allow visualization under fluoroscopy during a procedure.
The catheters utilize a one piece Pebax hub/strain relief that is molded to the proximal end of the guide catheter shaft. The 8 F Wiseguide Guide Catheters have a 0.086" ID. The catheters will be available in lengths ranging from 40 to 125 cm, with optional side holes. The devices will be provided sterile and are intended for one procedure use only.
The provided text describes a medical device, the SCIMED® 8 French Wiseguide™ Guide Catheter, and its clearance process, but it does not present specific acceptance criteria or a dedicated study proving the device meets those criteria in the way a diagnostic AI/ML device submission would.
Instead, this document (K970823) is a 510(k) premarket notification for a predicate device. The core of a 510(k) submission is to demonstrate "substantial equivalence" to a legally marketed predicate device, not necessarily to meet pre-defined performance acceptance criteria with a formal study as you might find for a novel diagnostic device.
However, I can extract the relevant information and present it in the requested format, interpreting "acceptance criteria" based on the functional testing mentioned to demonstrate substantial equivalence.
Here's an analysis based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
As this is a 510(k) submission for a physical medical device, not a diagnostic AI/ML system, "acceptance criteria" are not explicitly stated in terms of diagnostic performance metrics (e.g., sensitivity, specificity, AUC). Instead, acceptance is demonstrated by successfully passing functional tests and showing substantial equivalence to predicate devices. The "reported device performance" refers to the verification that these tests were passed.
| Acceptance Criteria (Implied by Functional Testing for Substantial Equivalence) | Reported Device Performance (Verification) |
|---|---|
| Maintain integrity under pressure (Pressure Burst) | Test results verified adequate for intended use. |
| Secure connection of the tip (Tip Bond Tensile) | Test results verified adequate for intended use. |
| Sufficient shaft strength (Shaft Tensile) | Test results verified adequate for intended use. |
| Secure connection of the hub (Hub Tensile) | Test results verified adequate for intended use. |
| Acceptable friction for device passage (Tip Coefficient of Friction) | Test results verified adequate for intended use. |
| Appropriate force transmission (Force Transmitted by Catheter Tip) | Test results verified adequate for intended use. |
| Adequate torque response (Torque Testing) | Test results verified adequate for intended use. |
| Biocompatibility | Biocompatibility testing conducted and passed. |
| Shelf life | Shelf life testing conducted and passed. |
| Overall design and intended use similar to predicate devices | Considered substantially equivalent to predicate devices. |
2. Sample Size Used for the Test Set and Data Provenance
The document does not specify a "test set" in the context of diagnostic data. The evaluation was primarily through non-clinical functional testing of the physical device. The sample size for these specific engineering/functional tests (e.g., number of catheters tested for pressure burst) is not reported in the provided text.
- Data Provenance: Not applicable in the context of patient data. The tests are in-vitro (bench testing).
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
- Not applicable. The "ground truth" for functional testing of a physical device is typically established by engineering specifications and objective measurements, not expert consensus on diagnostic images or pathology.
4. Adjudication Method for the Test Set
- Not applicable. There is no "adjudication method" in the sense of reconciling expert opinions for a ground truth dataset, as the testing involves objective physical measurements.
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
- No. This is a physical medical device (coronary guide catheter), not an AI/ML diagnostic device. Therefore, an MRMC study and AI assistance are not relevant to this submission.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Study Was Done
- No. This is a physical medical device. No algorithm or standalone performance study was conducted.
7. The Type of Ground Truth Used
- For the functional tests, the "ground truth" would be engineering specifications and established test methods (e.g., a certain pressure must be withstood, a certain tensile strength achieved, a specific coefficient of friction measured).
8. The Sample Size for the Training Set
- Not applicable. This being a physical device, there is no "training set" in the context of an AI/ML model. Device development involves design iterations and manufacturing process refinement, not algorithmic training.
9. How the Ground Truth for the Training Set Was Established
- Not applicable. No training set as per AI/ML context.
Summary of the Study that Proves the Device Meets Acceptance Criteria:
The "study" described in the document is a non-clinical test summary focusing on the physical and material properties of the SCIMED® 8 French Wiseguide™ Guide Catheter. This testing was conducted to demonstrate its substantial equivalence to already marketed predicate devices (SCIMED® 8 French Cyber™ Guide Catheters and Cordis® Corporation, 8 French Vista Brite Tip™ Guide Catheters).
The tests performed included:
- Pressure burst
- Tip bond tensile
- Shaft tensile
- Hub tensile
- Tip coefficient of friction
- Force transmitted by the catheter tip
- Torque testing
- Biocompatibility
- Shelf life testing
The results of these in-vitro tests "verified that the 8 F Wiseguide catheter is adequate for its intended use." The conclusion drawn from these tests, along with a comparison of the device's intended use and design, was that the new catheter is substantially equivalent to the predicate devices. This finding of substantial equivalence by the FDA (as indicated in the clearance letter K970823) allows the device to be marketed. There is no mention of a formal clinical trial or a diagnostic performance study as would be required for an imaging or AI/ML device.
§ 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).