(246 days)
The transGlide Expandable Introducer is intended to be inserted into the femoral artery, over a guidewire, and once expanded, to provide a guide for catheters and/or devices introduced into the femoral iliac arteries.
The transGlide Expandable Introducer consists of an expandable Mesh Assembly and a flexible Sheath Assembly. The Mesh Assembly, with an indwelling Dilator, is inserted into the femoral artery over a 0.035" (or smaller) guidewire. The Mesh Assembly is introduced at a small diameter of 13F inner diameter (ID) and is designed with a hydrophilic coating on the outer diameter (OD) of the usable length (effective length), thus facilitating passage through the femoral artery. The proximal 11cm of the Mesh is sealed to prevent blood loss at the access site. Once at the target location, the Mesh Dilator is removed and the Sheath Assembly is inserted, with an indwelling Dilator, through the Mesh Assembly over the guidewire.
Prior to removal, the Sheath Assembly is withdrawn through the Mesh Assembly until the Sheath Removal Indicator is visible just proximal to the Docking Port, leaving 8cm of Sheath usable length in place to prevent blood loss while the entire assembly is withdrawn and removed from the patient.
The Mesh consists of a polymer braid, which expands to accommodate the profile of the Sheath. The Mesh provides a bearing surface for the Sheath, which is designed to reduce the axial forces applied to the artery wall while the Sheath is being inserted. The Sheath Assembly Dilator is removed leaving a large (16F, 18F or 20F) central lumen extending from the proximal end to the distal end of the Sheath with a usable length of 30cm.
The transGlide Expandable Introducer is a sterile, non-pyrogenic, single-use prescription device. The transGlide Expandable Introducer does not supply but recommends use with commercially available 0.035" (or smaller) Guidewires.
The provided text describes the transGlide Expandable Introducer and its substantial equivalence to a predicate device, the Terumo SoloPath® Balloon Expandable TransFemoral Introducer (K100819). However, the document does not contain the specific acceptance criteria and detailed device performance results in a table format as requested in point 1 of your prompt. It lists the types of tests performed but not the quantitative pass/fail criteria or the actual results.
Therefore, the following information will be provided based on what is available in the document, and will explicitly state what is not present.
1. Table of Acceptance Criteria and Reported Device Performance
As noted above, the document does not provide a table of acceptance criteria with specific quantitative pass/fail values, nor does it present detailed numerical device performance results for most of the listed tests. It generally states that "the safety acceptance criteria for the study were met" for the animal study, and that non-clinical testing "demonstrate[s] that the device is substantially equivalent... and functions as intended and meets design specifications."
Here's a summary of the types of performance evaluated:
| Test Category | Specific Tests Performed | Acceptance Criteria / Reported Performance |
|---|---|---|
| Biocompatibility | - Cytotoxicity: MEM Elution (L-929) |
- Sensitization: Magusson-Kligman Method
- Irritation: Intracutaneous Toxicity (ISO)
- Systemic Toxicity: Systemic Injection (ISO)
- Hemocompatibility (Thrombogenicity, Complement Activation C3a and SC5b-9, Partial Thromboplastin Time, Hemolysis - Direct and Extract)
- Pyrogenicity (Material Mediated Pyrogen, Bacterial Endotoxins-Limulus Amebocyte Lysate (LAL)) | The implication is that the device met the biocompatibility requirements for substantial equivalence. Specific criteria and results are not provided. |
| Bench Testing | - Visual Inspection and Dimensional Verification - Flush Testing
- Simulated Use: Advancement, Dilator Removal, Retraction & Inspection
- Leak Testing (BS EN 11070:1999)
- Bend/Kink Resistance Testing
- Radiopacity Testing
- Interventional Device Advancement and Removal
- Hydrophilic Coating Lubricity
- Hydrophilic Coating Durability
- Hydrophilic Coating Particulate Characterization
- Hub to Sheath Rotation
- Tensile Tests (BS EN 11070:1999)
- Corrosion Testing (BS EN 11070:1999)
- Packaging Validation (BS EN ISO 11607-111607-112009 + A1:2014)
- Sterilization Validation (ANSI/AAMI/ISO 11137-2:2013)
- Shelf Life | The document states these tests were performed to "verify and validate the performance of the device and ensure the transGlide Expandable Introducer functions as intended and meets design specifications." Specific criteria and results are not provided. |
| Animal Studies | GLP animal study in an ovine model, comparing transGlide against the predicate (Terumo SoloPath® K100819). Evaluated safety and performance. | "Based on pathology and histopathology results, the safety acceptance criteria for the study were met. Performance observations were made based on detailed characteristics of the device. No untoward observations were found by the clinician." |
2. Sample Size Used for the Test Set and the Data Provenance
- Test Set Sample Size:
- Animal Study: The document states "A GLP animal study was performed... in an ovine model." It does not specify the number of animals (sample size) used in this study.
- Bench Testing: For individual bench tests (e.g., tensile tests, leak tests), the sample sizes are not provided.
- Data Provenance: The document does not specify the country of origin for the data for the animal study or bench testing, but the context implies it was likely conducted in the US or under US regulatory standards (given the FDA submission). It is not stated whether the animal study was purely prospective or if any retrospective data was included. Bench testing is typically prospective, performed specifically for regulatory submission.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
- Animal Study: The document mentions "pathology and histopathology results" and "observations were made by the clinician." This implies input from veterinary pathologists and clinicians, but it does not specify the number of experts or their detailed qualifications (e.g., specific years of experience, board certifications).
- Bench Testing: Ground truth for bench testing is generally based on engineering standards and measurement accuracy, not typically human expert consensus in the same way clinical data is.
4. Adjudication Method for the Test Set
- Animal Study: The document does not specify an adjudication method (e.g., 2+1, 3+1) for the pathology, histopathology, or clinical observations. It simply states the results met safety acceptance criteria and no untoward observations were found.
- Bench Testing: Adjudication methods are not typically applicable to the objective measurements derived from bench testing.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
- No, an MRMC comparative effectiveness study was not done. This type of study typically involves multiple human readers interpreting medical images or data, with and without an AI algorithm's assistance, to measure the AI's impact on human performance. The device described (transGlide Expandable Introducer) is a physical medical device, not an AI/software as a medical device (SaMD), so an MRMC study is not relevant here.
6. Standalone (Algorithm Only) Performance Study
- No, a standalone (algorithm only) performance study was not done. As mentioned above, this device is a physical medical device, not an AI algorithm. Therefore, an "algorithm only" performance study is not applicable.
7. Type of Ground Truth Used
- Animal Study: The ground truth for the animal study seems to be based on a combination of histopathology results and clinical observations by experts (veterinary pathologists and clinicians) following GLP guidelines. This is a form of expert assessment integrated with objective pathological findings.
- Bench Testing: The ground truth for bench testing is based on established engineering standards and measurements.
8. Sample Size for the Training Set
- This question is not applicable as the transGlide Expandable Introducer is a physical medical device, not an AI algorithm that requires a "training set" in the machine learning sense.
9. How the Ground Truth for the Training Set Was Established
- This question is not applicable for the same reason as point 8; there is no AI training set.
§ 870.1340 Catheter introducer.
(a)
Identification. A catheter introducer is a sheath used to facilitate placing a catheter through the skin into a vein or artery.(b)
Classification. Class II (performance standards).