(118 days)
The Terumo Aspiration Catheter is indicated for the removal of fresh, soft emboli and thrombi from vessels in the coronary and peripheral vasculature.
The Terumo Aspiration Catheter is a dual lumen rapid exchange catheter. The guidewire lumen is used to facilitate passage of a guide wire which must not exceed 0.014" (0.36 mm) in diameter. The larger extraction lumen allows the removal of thrombus (thrombi) by use of the included aspiration syringe through the extension line. The catheter has a proximal stiff region and a distal flexible region that is coated with hydrophilic polymer which generates lubricity when wet. On the distal tip a radiopaque marker band is incorporated. The proximal end of the catheter is equipped with a standard luer adapter to facilitate the attachment of the included extension line, stopcock and syringes. The provided stylet can be inserted in the catheter to assist in the delivery of the catheter to the vascular lesion. The included flushing tool is used to flush the guide wire lumen in preparation for use. A filter basket is included for assistance in filtering the blood removed during the procedure for laboratory analysis or any thrombosis.
The Terumo Aspiration Catheter is indicated for the removal of fresh, soft emboli and thrombi from vessels in the coronary and peripheral vasculature. The acceptance criteria and supporting studies are outlined below.
1. Table of Acceptance Criteria and Reported Device Performance
| Test | Acceptance Criteria (Bench Testing) | Reported Device Performance |
|---|---|---|
| ISO 10555-1 Conformance Tests | ||
| Surface inspection | Conformance to ISO 10555-1 standards | Passed |
| Corrosion resistance | Conformance to ISO 10555-1 standards | Passed |
| Force at break (shaft, hub) | Minimal force at break of 4N (more stringent than 3N requirement of ISO 10555-1) | Passed |
| Freedom from leakage | Conformance to ISO 10555-1 standards | Passed |
| Shelf Life Performance Tests (t=0 vs. t=shelf life) | ||
| Catheter force at break | No significant changes in performance | Met all specifications; no significant changes observed |
| Catheter lubricity | No significant changes in performance | Met all specifications; no significant changes observed |
| Dimensional verification | No significant changes in performance | Met all specifications; no significant changes observed |
| Stylet coil bond tensile strength | No significant changes in performance | Met all specifications; no significant changes observed |
| Stylet to connector tensile strength | No significant changes in performance | Met all specifications; no significant changes observed |
| Extension line tensile strength | No significant changes in performance | Met all specifications; no significant changes observed |
| In-House Comparative Performance Tests | ||
| Kink resistance | Equivalent or superior to predicate devices (PRONTO V3, Medtronic Export XT) | Equivalent or superior to predicate devices |
| Aspiration rate | Equivalent or superior to predicate devices | Equivalent or superior to predicate devices |
| Thrombus aspiration capability | Equivalent or superior to predicate devices | Equivalent or superior to predicate devices |
| Pushability | Equivalent or superior to predicate devices | Equivalent or superior to predicate devices |
| Trackability | Equivalent or superior to predicate devices | Equivalent or superior to predicate devices |
| Accessory Conformance Tests | ||
| Stylet | Conformance to ISO 10555-1 standards | Passed |
| Stylet connector | Conformance to ISO 594-1 & 2 standards | Passed |
| Aspiration syringe | Conformance to ISO 7886-1 standards | Passed |
| Aspiration syringe luer | Conformance to ISO 594-1 & 2 standards | Passed |
| Extension Line | Conformance to ISO 10555-1 standards | Passed |
| Extension Line luers and stopcock | Conformance to ISO 594-1 & 2 standards | Passed |
| Flushing tool | Conformance to ISO 594-1 & 2 standards | Passed |
| Biocompatibility Tests | ||
| Sensitization | Meets the requirements of ISO 10993-10 | Meets the requirements |
| Hemolysis | Non-hemolytic (ASTM F756) | Non-hemolytic |
| Dog thrombo-resistance | Non-thrombogenic (ISO 10993-4) | Non-thrombogenic |
| Complement Activation | Meets the requirements of ISO 10993-4 | Meets the requirements |
| Ames Assay | Meets the requirements of ISO 10993-3 | Meets requirements |
| Lymphoma Forward Mutation | Non-mutagenic (ISO 10993-3) | Non-mutagenic |
| Bone Marrow Micronucleus | Non-clastogenic (ISO 10993-3) | Non-clastogenic |
| Rabbit Pyrogen | Non-pyrogenic (ISO 10993-11) | Non-pyrogenic |
| Cytotoxicity | Non-cytotoxic (ISO 10993-5) | Non-cytotoxic |
| Intracutaneous reactivity | Meets the requirements of ISO 10993-10 | Meets requirements |
| Acute Systemic toxicity | Non-toxic (ISO 10993-11) | Non-toxic |
| Physicochemical profile (aged, sterile) | Meets the requirements of USP 661 | Meets the requirements |
| Cytotoxicity (aged, sterile) | Non-cytotoxic (ISO 10993-5) | Non-cytotoxic |
| Hemolysis (aged, sterile) | Non-hemolytic (ASTM F756) | Non-hemolytic |
| Sterilization and Residuals | ||
| Sterility Assurance Level (SAL) | 10⁻⁶ (validated per ANSI/AAMI/ISO 11135) | Achieved 10⁻⁶ SAL |
| Ethylene Oxide (EO) residuals | ≤ 4 mg per device (per ANSI/AAMI/ISO 10993-7) | Will meet requirements (prior to use) |
| Ethylene Chlorohydrin (ECH) residuals | ≤ 9 mg per device (per ANSI/AAMI/ISO 10993-7) | Will meet requirements (prior to use) |
| Shelf Life | 36-months (based on performance testing and package integrity validation) | 36-months |
2. Sample Size Used for the Test Set and Data Provenance
The provided document describes bench testing and biocompatibility testing, not a clinical study with a "test set" in the context of patient data.
- Bench Testing: The sample sizes for each specific bench test (e.g., force at break, aspiration rate) are not explicitly stated. However, the tests were conducted using both real-time aged and accelerated aged samples to assess performance over the specified shelf life.
- Biocompatibility Testing: The number of samples for each biocompatibility test (e.g., Sensitization, Hemolysis, Pyrogen) is not explicitly stated. The tests were performed on non-aged (sterile) and aged (sterile) samples.
- Data Provenance: The studies are described as "in-house bench testing" and "biocompatibility testing." This implies the data were generated in a laboratory setting, likely at the manufacturer's (Terumo Medical Corporation) or a contracted testing facility's site, and are not derived from human patients or a specific country of origin in the clinical sense. These are pre-market studies to demonstrate safety and performance characteristics.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
Not applicable. The reported studies are bench and biocompatibility tests, which do not involve establishing ground truth by human experts in the context of diagnostic interpretation or clinical outcomes. The "ground truth" for these tests refers to established scientific and engineering standards (e.g., ISO, ASTM).
4. Adjudication Method for the Test Set
Not applicable. As these are bench and biocompatibility tests, there is no human adjudication process involved in the data collection or interpretation in the way there would be for a clinical trial or image analysis study. The results are compared against predefined pass/fail criteria from international and industry standards.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No. The provided document details pre-market bench and biocompatibility studies for a physical medical device (aspiration catheter). It does not describe an AI/software as a medical device or diagnostic imaging study that would typically involve an MRMC comparative effectiveness study to assess human reader performance with and without AI assistance.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study
Not applicable. The Terumo Aspiration Catheter is a physical medical device, not an algorithm or software. Therefore, there is no "standalone" algorithm performance study described.
7. Type of Ground Truth Used
The "ground truth" for the various tests were defined by:
- International Standards: ISO 10555-1, ISO 594-1 & 2, ISO 7886-1, ISO 10993 (various parts), ISO 11135, ISO 11607-1, ISO 11607-2.
- National Standards: ASTM F756, ANSI/AAMI/ISO 11135, ANSI/AAMI/ISO 10993-7, USP 661.
- Manufacturer Specifications: In-house bench testing compared the device's performance to predicate devices and likely internal design specifications that reflect expected performance characteristics (e.g., "equivalent or superior to predicate devices" for kink resistance, aspiration rate, etc.).
8. Sample Size for the Training Set
Not applicable. The studies described are for physical device testing and do not involve machine learning algorithms that require a "training set."
9. How the Ground Truth for the Training Set Was Established
Not applicable, for the same reason as above.
§ 870.5150 Embolectomy catheter.
(a)
Identification. An embolectomy catheter is a balloon-tipped catheter that is used to remove thromboemboli, i.e., blood clots which have migrated in blood vessels from one site in the vascular tree to another.(b)
Classification. Class II (performance standards).