(70 days)
The CROSSER System is indicated to facilitate the intra-luminal placement of conventional guidewires beyond peripheral artery chronic total occlusions. The device is contraindicated for use in carotid arteries.
The CROSSER Catheter is only intended for use with the CROSSER Electronics System. Refer to the CROSSER Electronics System Manual of Operations for proper use.
The CROSSER System consists of a re-usable electronic Generator, Foot Switch, highfrequency Transducer, and single-use CROSSER Catheter. The CROSSER Catheter is available in three sizes:
- CROSSER 14P (014 guidewire compatible), .
- CROSSER 14S (014 guidewire compatible supportive), .
- CROSSER 18 (018 guidewire compatible). .
Each Catheter is connected to the electronic Generator through the Transducer. The Foot Switch is used to activate the system. The Generator and Transducer convert AC power into high-frequency mechanical vibrations which are propagated through a Nitinol core wire to the Titanium tip of the CROSSER Catheter. The main body of the catheter is constructed from Pebax and a hydrophilic coating which covers the distal end of the catheter.
Here's an analysis of the provided text regarding the acceptance criteria and study for the CROSSER System, as much as can be extracted from the given document:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Specific Test/Characteristic | Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|---|---|
| Physical Test Data | Tensile Strength | Met relevant guidance documents | Performed similarly to predicate device |
| Torque Strength | Met relevant guidance documents | Performed similarly to predicate device | |
| Torqueability | Met relevant guidance documents | Performed similarly to predicate device | |
| Tip Flexibility | Met relevant guidance documents | Performed similarly to predicate device | |
| Coating Adherence/Integrity | Met relevant guidance documents | Performed similarly to predicate device | |
| Biocompatibility | Met relevant guidance documents | Performed similarly to predicate device | |
| Benchtop Simulated Efficiency | Met relevant guidance documents | Performed similarly to predicate device | |
| Catheter Fatigue Testing | Met relevant guidance documents | Performed similarly to predicate device | |
| Shelf Life and Package Integrity Testing | Met relevant guidance documents | Performed similarly to predicate device | |
| Dimensional Verification | Met relevant guidance documents | (Implied to be met for substantial equivalence) | |
| Clinical Test Data | Intended Use | Facilitate intra-luminal placement of guidewires beyond peripheral artery CTOs. | "The clinical performance of the CROSSER System was verified through a human clinical study designed to demonstrate the intended use of the device." (Specific performance metrics are not detailed in this summary.) |
Important Note: The document heavily relies on "performed similarly to the predicate device" and "met the acceptance criteria" without explicitly stating numerical or qualitative thresholds for each specific test. This is common in 510(k) summaries where detailed raw data and specific thresholds are typically in the full submission, not the public summary.
2. Sample Size for the Test Set and Data Provenance
- Sample Size for Test Set: The document mentions "a human clinical study" but does not specify the sample size for this study.
- Data Provenance: The document does not specify the country of origin of the data. It indicates the study was a "human clinical study," implying prospective human data.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications
The document does not provide any information about experts used to establish ground truth in the clinical study, nor their number or qualifications. Given the nature of the device (facilitating guidewire placement), the primary "ground truth" would likely be successful guidewire crossing and subsequent procedural outcomes, observed and documented by the interventionalists performing the procedures.
4. Adjudication Method for the Test Set
The document does not describe any adjudication method.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done
No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. The device is not an imaging AI diagnostic system that would typically involve a multi-reader study. The clinical study was designed to verify the performance of the device itself in facilitating guidewire placement.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was Done
This question is not applicable to the CROSSER System. The device is a physical medical device (catheter system), not a standalone algorithm. Its function is to be used with a human operator (interventionalist).
7. The Type of Ground Truth Used
The ground truth for the clinical study was likely procedural success and outcomes data. The "intended use" of the device is to facilitate guidewire placement beyond peripheral artery chronic total occlusions. Therefore, a successful outcome would be the ability to achieve this objective. This would be clinical observation by the treating physicians, rather than pathology or expert consensus on image interpretation.
8. The Sample Size for the Training Set
The document does not mention or imply a "training set" as this is not an AI/machine learning device. The design, bench, and biocompatibility testing inform the device's development (analogous to "training" in a broad sense), but there isn't a specific data set called a "training set" in the context of this traditional device submission.
9. How the Ground Truth for the Training Set Was Established
This question is not applicable as there is no "training set" in the context of an AI/machine learning algorithm for which ground truth would be established. The "ground truth" for the device's design and manufacturing revolves around meeting established engineering, material science, and safety standards during its development.
§ 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).