The VentiV 7Fr – 12Fr MP Mechanical Thrombectomy System and VentiV Mechanical Aspirator are indicated for the removal of fresh soft emboli and thrombi from vessels in the peripheral vasculature.
The VentiV Mechanical Thrombectomy System devices are single-use, sterile, short-term use medical devices designed to remove fresh soft emboli, debris, and thrombi from the peripheral vasculature. The System includes (1) VentiV Mechanical Aspirator and (1) VentiV 7Fr - 12Fr catheters and dilators.
Based on the provided text, the device in question is the VentiV 7Fr - 12Fr MP Mechanical Thrombectomy System. This is a medical device, not an AI/ML powered device, therefore no acceptance criteria related to AI/ML device performance (like sensitivity, specificity, AUC, human reader studies etc.) are mentioned.
The information provided describes the regulatory submission for premarket notification (510(k)) of a medical device, asserting its substantial equivalence to a legally marketed predicate device. The document details the physical and functional characteristics of the device and how they compare to the predicate, as well as the non-clinical testing performed.
Therefore, the specific information requested in the prompt about acceptance criteria and study proving AI/ML device performance (e.g., acceptance criteria for AI performance metrics, sample size for test sets, expert adjudication, MRMC studies, standalone AI performance, ground truth establishment for AI models, training set details) is not applicable to this document as it pertains to a mechanical medical device, not an AI/ML powered one.
However, I can extract the general acceptance criteria and the type of study performed to prove this mechanical device meets its intended use, based on the non-clinical testing conducted.
Acceptance Criteria and Study for the VentiV 7Fr - 12Fr MP Mechanical Thrombectomy System
Given that the device is a mechanical thrombectomy system and not an AI/ML powered device, the "acceptance criteria" discussed in this document relate to the performance and safety of the physical device compared to its predicate, rather than AI-specific metrics. The "study" refers to non-clinical bench testing.
1. Table of Acceptance Criteria (Implied) and Reported Device Performance (Non-Clinical)
While an explicit, quantifiable table of acceptance criteria for performance metrics is not provided in a format typical for AI/ML devices, the document states that all necessary verification steps met "pre-determined acceptance criteria" to demonstrate substantial equivalence. The reported performance refers to the device passing simulated use tests.
| Acceptance Criteria (Implied through Substantial Equivalence and Testing) | Reported Device Performance (Non-Clinical Testing) |
|---|---|
| Intended Use Equivalence: Comparable to predicate in removing fresh soft emboli and thrombi from peripheral vasculature. | Same intended use as the predicate. |
| Same indications for use as the predicate. | |
| Fundamental Scientific Technology Equivalence: Operates on the same principle as the predicate. | Same fundamental scientific technology (over-the-wire intravascular catheters, aspiration for thrombectomy). |
| Same operating principle (manual syringe action to create vacuum). | |
| Material Properties Equivalence: Materials are comparable to the predicate for safe and effective use. | Same material properties as the predicate. |
| Performance Specifications Equivalence: Meets similar functional specifications as the predicate. | Same performance specifications as the predicate. |
| Same maximum vacuum potential (-760mmHg, -1ATM, -14.69PSI). | |
| Physical Design Equivalence: Catheter dimensions, tip shape, aspiration lumen, guidewire compatibility are within comparable ranges to the predicate. | Catheter Shaft OD: Added 12Fr (predicate 7-11Fr). Otherwise, 7Fr-11Fr are same. |
| Usable Lengths: Range expanded to 60-100cm (predicate 60-90cm). | |
| Tip Shape: Multipurpose (predicate Straight). | |
| Aspiration Lumen Shape: Round (Same). | |
| Guidewire: 0.035" (Same). | |
| Integrated Radiopaque Marker: Yes (Same). | |
| Sterilization and Packaging Equivalence: Uses similar methods for sterilization and packaging. | Sterilization: ETO (Same). |
| Packaging: Catheter in Hoop and Tyvek Tray (Same). | |
| Biocompatibility: Meets established biocompatibility standards. | Biocompatibility: ISO 10993 compliant (Same). |
| Simulated Use Performance: Successfully tracks, aspirates in simulated peripheral vasculature. | Device "passes simulated use tracking, simulated aspiration, and simulated thrombectomy in the peripheral vasculature." |
| Accelerated Aging Performance: Performs as intended after accelerated aging. | Device "passes..." tests with accelerated aging up to 3-years. |
2. Sample Size Used for the Test Set and Data Provenance:
- Sample Size for Test Set: The document mentions "non-clinical testing" and refers to "test units" without specifying precise numerical sample sizes. This typically refers to a number of physical device units tested in a lab setting.
- Data Provenance: The data is generated from non-clinical bench testing rather than patient data. Therefore, concepts like "country of origin of the data," "retrospective," or "prospective" are not applicable. It's laboratory-generated data.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications:
- Not Applicable. As this is a mechanical device, there is no "ground truth" established by experts in the context of image interpretation or clinical diagnosis. The "ground truth" for performance is based on direct physical measurements, simulations, and engineering specifications.
4. Adjudication Method for the Test Set:
- Not Applicable. There is no "adjudication" in the sense of reconciling expert opinions for a test set, as this is bench testing of a physical device. Performance is objectively measured against specifications.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
- No. An MRMC study is not mentioned because this is a mechanical device, not an AI/ML diagnostic system intended to assist human readers with interpretation.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study:
- Not Applicable. This is a mechanical medical device, not an algorithm, so independent algorithmic performance is not relevant.
7. The Type of Ground Truth Used:
- For this mechanical device, the "ground truth" for performance and substantial equivalence is established through:
- Bench Testing: Direct physical measurements, engineered simulations (e.g., simulated vessels, simulated thrombi), and performance against predefined engineering specifications.
- Regulatory Standards: Compliance with relevant international standards (e.g., ISO 10993 for biocompatibility) and FDA guidance for medical device testing.
- Predicate Device Performance: The predicate device itself serves as a "ground truth" benchmark for demonstrating substantial equivalence in function and safety.
8. The Sample Size for the Training Set:
- Not Applicable. This is not an AI/ML device that requires a "training set" of data.
9. How the Ground Truth for the Training Set Was Established:
- Not Applicable. As there is no training set for an AI/ML model, the concept of establishing ground truth for it does not apply.
§ 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).