(260 days)
The Gelbfish Endo-Vac System is intended for the percutaneous aspiration of thrombus from acutely clotted AV grafts as a part of a percutaneous thrombectomy procedure. The device incorporates an anti-clogging/selfcleaning mechanism to maintain its uninterrupted function.
The device is not (by itself) intended to restore function to clotted AV grafts. It is only used in conjunction with standard percutaneous thrombectomy procedures to facilitate the aspiration of clot from the graft. The arterial and venous anastomotic plug/clot and pathology must still be addressed by standard Fogarty and/or balloon catheter procedures. Expertise in traditional pharmoco-mechanical techniques is necessary, and may be used in conjunction with the Endo-Vac System.
The enclosed device is indicated for use to remove thrombus in clotted synthetic ePTFE grafts only. Its short length makes it suitable for aspiration of clot from the "body" of the graft. It is NOT intended to cross arterial or venous anastomoses or to be used on clot contained in native artery or vein.
The Gelbfish EndoVac System consists of a set of three main groups of components: (1) an introducer sheath with side-port for suction connection (with three-way stopcock), plus dilator and guidewire (used for initial sheath insertion), (2) a stainless steel anti-clogging/self-cleaning unit with connector for saline injection, dual check valve, tubing and syringe for saline irrigation, and (3) suction components--a fail-safe trumpet suction valve, and suction tubing. All but the stainless part are components that are presently marketed as medical devices or components. Only the stainless steel self-cleaning unit is new, and it is fabricated from medical grade stainless steel components used for blood contact applications.
Here's an analysis of the provided text regarding the GELBFISH ENDOVAC SYSTEM, focusing on the acceptance criteria and the study used to demonstrate it:
Given the limited information in a 510(k) summary, specific details for several requested fields are not available. A 510(k) is a premarket submission made to FDA to demonstrate that the device to be marketed is at least as safe and effective, that is, substantially equivalent, to a legally marketed predicate device. It typically focuses on equivalency rather than establishing de novo performance criteria with extensive clinical trials.
Acceptance Criteria and Device Performance for GELBFISH ENDOVAC SYSTEM
1. Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Mechanical Strength: Stainless steel cleaning mechanism withstands pull test. | "Mechanical testing has demonstrated that the stainless steel cleaning mechanism, which is laser welded together, can withstand a pull test of 20 lbs." |
| Clinical Efficacy (Thrombus Clearance): Device successfully clears thrombus from AV grafts. | "A clinical study of the device showed that in 47/47 thrombectomy procedures, the EndoVac device successfully cleared thrombus from the graft." |
| Clinical Integration/Non-interference: Device does not interfere with other standard thrombectomy instruments and techniques. | "The study also demonstrated that the EndoVac device does not interfere in any way with the use of the other instruments and techniques which are required to complete the interventional radiology thrombectomy procedure." |
| Intended Use Equivalence: Device has the same intended use as predicate devices (aspiration of clot). | "The Gelbfish EndoVac System has the same intended use, notably the aspiration of clot, as the predicate devices." (Implied acceptance criterion: substantial equivalence in intended use). |
| Technological Characteristics Equivalence: Device is similar to predicate devices. | The document extensively describes the "Anti-clogging/self-cleaning mechanism" as an enhancement and its integration into existing procedures, implying its technological characteristics were deemed equivalent or superior without posing new safety/efficacy concerns compared to existing devices. (Implied acceptance criterion: substantial equivalence in technological characteristics). |
2. Sample Size Used for the Test Set and the Data Provenance:
- Sample Size: 47 (47 thrombectomy procedures)
- Data Provenance: The document does not explicitly state the country of origin. It refers to "Dr. Gelbfish's clinical study," implying it was conducted by the sponsor. Given the sponsor's address in New York, NY, and the FDA submission context, it is highly likely to be United States data.
- Retrospective or Prospective: Not explicitly stated. Clinical studies conducted for 510(k) submissions can vary, but this sounds like a prospective observational study series where efficacy was tracked during the use of the device in a clinical setting.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts:
- Number of Experts: Not specified.
- Qualifications of Experts: Not specified. However, the study involved "thrombectomy procedures" in "interventional radiology," suggesting the cases were assessed by interventional radiologists or vascular surgeons who would typically perform and evaluate these procedures. The success criteria (successful clearance of thrombus, non-interference) would have been judged by the treating clinicians.
4. Adjudication Method for the Test Set:
- Not specified. Given it's a small clinical series referenced in a 510(k), it's highly probable that the evaluation of "successful clearance of thrombus" was determined by the treating physician(s). There's no mention of an independent adjudication panel or formal consensus method beyond the direct observation and judgment of the clinicians involved in the 47 procedures.
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:
- No, an MRMC comparative effectiveness study was not done. This device is a mechanical medical device (endovascular suction catheter), not an AI/software as a medical device (SaMD). Therefore, the concept of "human readers improve with AI vs without AI assistance" is not applicable here.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable. As stated above, this is a mechanical medical device. It does not operate as an "algorithm only" or a standalone AI system. Its performance is directly tied to its use by a human operator during a procedure.
7. The Type of Ground Truth Used:
- The ground truth for the clinical study was based on clinical observation of successful thrombus clearance during the thrombectomy procedure and the observed non-interference with other instruments/techniques. This would be considered clinical observation/outcomes data as judged by the treating clinicians.
8. The Sample Size for the Training Set:
- Not applicable. As a mechanical device, there is no "training set" in the context of machine learning or AI. The device's design and functionality are based on engineering principles and existing medical practice, not data-driven algorithmic training.
9. How the Ground Truth for the Training Set Was Established:
- Not applicable. See point 8.
§ 870.4875 Intraluminal artery stripper.
(a)
Identification. An intraluminal artery stripper is a device used to perform an endarterectomy (removal of plaque deposits from arterisclerotic arteries.)(b)
Classification. Class II (performance standards).