(102 days)
The GUIDEZILLA™ Guide Extension Catheter is intended to be used in conjunction with guide catheters to access discrete regions of the coronary and/or peripheral vasculature, and to facilitate placement of interventional devices.
The Boston Scientific GUIDEZILLA™ Guide Extension Catheter acts as an extension to a traditional guide catheter. GUIDEZILLA consists of a proximal stainless steel hypotube with a tab used for device identification and a distal guide catheter segment through which interventional devices may be delivered. The guide catheter segment incorporates two radiopaque marker bands to aid in positioning the device during the procedure. A hydrophilic coating is applied to the distal polymer segment of the device. GUIDEZILLA is a 5F catheter compatible with a 6F guide catheter. The effective length of the device is 145 cm.
Here's a breakdown of the acceptance criteria and the study details for the GUIDEZILLA™ Guide Extension Catheter, based on the provided 510(k) summary:
1. Table of Acceptance Criteria and Reported Device Performance:
The document doesn't explicitly state quantitative acceptance criteria with specific threshold values (e.g., "radiopacity must be X or better"). Instead, it lists the types of tests performed. The "Reported Device Performance" column reflects that these tests were "completed" and their results provided "reasonable assurance" of conformance.
| Acceptance Criteria (Test Type) | Reported Device Performance |
|---|---|
| Biocompatibility Tests: | - All tests completed successfully, providing reasonable assurance of safety. No new safety concerns were identified. |
| Cytotoxicity | Completed |
| Sensitization | Completed |
| Intracutaneous Reactivity | Completed |
| Acute Systemic Toxicity | Completed |
| Materials Mediated Pyrogenicity | Completed |
| USP Physicochemical | Completed |
| Direct Contact Hemolysis | Completed |
| Hemolysis Extract | Completed |
| Complement Activation | Completed |
| Partial Thromboplastin Time | Completed |
| In Vitro Hemocompatibility | Completed |
| Latex | Completed (Likely testing for presence/absence of latex, or reactivity to latex) |
| In-Vitro Performance Tests: | - All tests completed successfully, providing reasonable assurance of performance. No new performance issues were identified. |
| Effective Length | Completed |
| Outer Diameter | Completed |
| Inner Diameter | Completed |
| Full Unit Tensile | Completed |
| Kink Resistance | Completed |
| Tip Deflection | Completed |
| Torque Strength | Completed |
| Radiopacity | Completed |
| Dye Flow | Completed |
| Coating Integrity | Completed |
| Particulate Evaluation | Completed |
| Corrosion Resistance | Completed |
| Device Compatibility (with 6F guide catheter) | Completed (Stated in device description: "GUIDEZILLA is a 5F catheter compatible with a 6F guide catheter.") |
| Packaging Integrity | Completed |
2. Sample Size Used for the Test Set and Data Provenance:
- Sample Size: The document does not specify the exact sample sizes (number of units/samples) used for each individual bench or biocompatibility test. It broadly states that "bench testing and biocompatibility testing were performed."
- Data Provenance: The data is likely from retrospective testing conducted by Boston Scientific Corporation, the manufacturer. The country of origin of the data is not specified, but given the submitter's address in Maple Grove, MN, USA, it is presumed to be conducted within the manufacturer's facilities or outsourced to labs in the US or other compliant regions.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts:
This information is not applicable as the provided documentation describes a device/engineering performance study (bench testing and biocompatibility), not a clinical study involving experts to establish ground truth for a diagnostic device.
4. Adjudication Method for the Test Set:
This information is not applicable for the same reason as point 3. Adjudication is typically used in clinical studies or studies where subjective interpretation is involved.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done:
No. A MRMC comparative effectiveness study was not performed for this device. The documentation explicitly states: "Clinical Evaluation was not required for these devices."
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Study Was Done:
This question is not applicable as the GUIDEZILLA™ Guide Extension Catheter is a physical medical device, not an algorithm or AI software. Therefore, the concept of "standalone performance" for an algorithm doesn't apply.
7. The Type of Ground Truth Used:
The "ground truth" for this device's performance is based on engineering specifications, industry standards, and established biocompatibility testing protocols. The tests performed (e.g., measuring effective length, outer diameter, kink resistance, cytotoxicity) have objective, measurable endpoints defined by these standards.
8. The Sample Size for the Training Set:
This information is not applicable. The GUIDEZILLA™ Guide Extension Catheter is a physical medical device and does not involve AI or machine learning, thus there is no "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.
§ 870.1250 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).