(128 days)
The TOTAL across™ crossing support catheter is intended to guide and support a guidewire during the access of peripheral arteries, allow for wire exchanges, and provide a conduit for the infusion of saline solutions or diagnostic contrast agents.
The TOTAL across is an over the wire (OTW) single lumen catheter composed of a spiral hypotube which provides a smooth transition from proximal to distal part, a proximal female hub and a distal flexible part with an atraumatic tapered tip.
The distal end of the catheter features a lubricious, hydrophilic coating and 2 radiopaque markers. The TOTAL across is 0.014" (0.36mm) guidewire compatible, and features working lengths of 100cm and 150cm.
Here's an analysis of the acceptance criteria and the study proving device performance, based on the provided text:
Acceptance Criteria and Device Performance
1. Table of Acceptance Criteria and Reported Device Performance
The provided text details various tests performed on the TOTAL across™ crossing support catheter. For each test, the general statement is made that "All of the pre-determined acceptance criteria were met and the testing passed." Specific numerical acceptance criteria are not explicitly stated in this summary, but the successful completion of each test implies adherence to predefined standards.
| Test Category | Reported Device Performance |
|---|---|
| Surface Inspection and Device Dimensions | Met pre-determined acceptance criteria; testing passed. |
| Device Preparation | Met pre-determined acceptance criteria; testing passed. |
| Trackability | Met pre-determined acceptance criteria; testing passed. |
| Flexibility | Met pre-determined acceptance criteria; testing passed. |
| Kink test | Met pre-determined acceptance criteria; testing passed. |
| Introducer Sheath Compatibility | Met pre-determined acceptance criteria; testing passed. |
| Guidewire Compatibility | Met pre-determined acceptance criteria; testing passed. |
| Catheter Bond Strength | Met pre-determined acceptance criteria; testing passed. |
| Tip Pull | Met pre-determined acceptance criteria; testing passed. |
| Torque Strength | Met pre-determined acceptance criteria; testing passed. |
| Radiopacity | Satisfactory and comparable to predicate device's visibility. |
| Coating Evaluation | Met pre-determined acceptance criteria; testing passed. |
| Particulate evaluation | Met pre-determined acceptance criteria; testing passed. |
| Catheter Body Burst Pressure | Met pre-determined acceptance criteria; testing passed. |
| Contrast Media and Saline Flow Rate | Met pre-determined acceptance criteria; testing passed. |
| Hub Test (ISO 594-1:1986 & 594-2:1998) | Met pre-determined acceptance criteria; testing passed. |
| Crossability | Met pre-determined acceptance criteria; testing passed. |
| Biocompatibility Studies: | |
| Cytotoxicity Study (ISO MEM Elution) | Met pre-determined acceptance criteria; testing passed. |
| ISO Guinea Pig Maximization Sensitization | Met pre-determined acceptance criteria; testing passed. |
| ISO Intracutaneous Study in Rabbits | Met pre-determined acceptance criteria; testing passed. |
| ISO Systemic Toxicity Study in Mice | Met pre-determined acceptance criteria; testing passed. |
| USP Pyrogen study | Met pre-determined acceptance criteria; testing passed. |
| Bacteria Reverse Mutation Study | Met pre-determined acceptance criteria; testing passed. |
| ASTM Hemolysis Study | Met pre-determined acceptance criteria; testing passed. |
| C3a Complement Activation Assay | Met pre-determined acceptance criteria; testing passed. |
| SC5b-9 Complement Activation Assay | Met pre-determined acceptance criteria; testing passed. |
| In-vivo Thromboresistance Study | Met pre-determined acceptance criteria; testing passed. |
| ASTM Partial Thromboplastin time | Met pre-determined acceptance criteria; testing passed. |
2. Sample Size Used for the Test Set and Data Provenance
The document does not provide specific numerical sample sizes for the "test set" (bench testing or biocompatibility testing). It refers to the tests being conducted on "the TOTAL across" and "the finished TOTAL across," implying samples of the device were used.
The data provenance is described as "bench testing" and "biocompatibility testing." This typically implies laboratory-based, controlled studies, not human clinical trials. The country of origin of the data is not specified, but the applicant (Medtronic Vascular) is based in Santa Rosa, CA, USA, and an alternate contact is based in Roncadelle, ITALY. The testing was conducted in accordance with FDA guidance documents and ISO standards, which are internationally recognized. The studies are prospective in nature, as they involve testing new iterations of the device to ensure conformity to standards.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This information is not applicable to this submission. The "ground truth" for the performance and biocompatibility studies of a medical device like this catheter is based on established engineering principles, international standards (ISO, ASTM), and FDA guidance documents, not on human expert consensus derived from image interpretations or clinical assessments. The "experts" involved would be the engineers, scientists, and technicians conducting the testing and verifying the results against the predefined specifications. Their qualifications are inherent in their ability to perform and interpret these specialized tests.
4. Adjudication Method for the Test Set
This is not applicable to this type of device and testing. Adjudication methods like 2+1 or 3+1 are used in clinical trials or studies involving human assessment (e.g., image interpretation) where there might be disagreement among experts. For bench and biocompatibility testing, the results are typically quantitative and objective, measured against predefined acceptance criteria. Any discrepancies would be resolved through re-testing or thorough investigation of the testing methodology, not through expert adjudication in the traditional sense.
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
A Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This type of study is relevant for AI-powered diagnostic devices that assist human readers in interpreting medical images or data. The TOTAL across™ is a physical medical device (a crossing support catheter), and its performance is evaluated through bench testing and biocompatibility studies, not through human-in-the-loop diagnostic tasks. Therefore, there is no AI component or human reader improvement effect size to report.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was Done
A standalone performance evaluation (algorithm only) was not done as this device does not contain an AI algorithm. Its performance is assessed through its physical and material properties in a standalone manner (i.e., the device itself is tested without human intervention in its function, unlike, for example, a surgical tool where human skill is key to its performance).
7. The Type of Ground Truth Used
The "ground truth" for the performance tests relies on:
- Established engineering specifications and design requirements: These are the inherent standards the device is designed to meet, such as specific dimensions, strength, flexibility, etc.
- Applicable FDA guidance documents and ISO/ASTM standards: These provide the methodologies and acceptance criteria for evaluating various characteristics (e.g., ISO 594 for hub tests, ANSI/AAMI/ISO 10993 for biocompatibility).
- Comparison to predicate devices: For some characteristics, the ground truth for "acceptable" performance is established by demonstrating comparability to legally marketed predicate devices. For example, radiopacity was considered "satisfactory and comparable to the predicate device's visibility."
8. The Sample Size for the Training Set
This is not applicable. The TOTAL across™ is a physical medical device and not an AI/machine learning model, so there is no "training set" in the context of data for an algorithm. The "training" in the manufacturing context refers to the manufacturing process that creates the device, but not a data set.
9. How the Ground Truth for the Training Set Was Established
This is not applicable for the reasons stated in point 8. There is no training set for an AI algorithm.
§ 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).