(43 days)
The FemoStop®IIPLUS System is indicated in the compression of the femoral artery or vein after catheterization.
The FemoStop IIruss System consists of a single use compression dome attached to an arch which is located on the patient together with a belt. The pump is connected to the dome to manually control the pressure over the femoral artery/vein puncture site. The bilateral adapter facilitates simultaneous compression of both the left and right side.
The provided 510(k) summary for the FemoStop®II PLUS System does not contain detailed information regarding acceptance criteria or a specific study proving the device meets those criteria. Instead, it relies on demonstrating substantial equivalence to a predicate device.
Here's a breakdown of the available information and what is not present:
1. Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Not explicit: The document states "Safety and performance testing was performed to demonstrate that the FemoStop®IIPLUS System." However, no specific performance metrics or acceptance criteria (e.g., maximum allowable leakage, pressure stability over time, or clinical success rates) are provided. | The document states: "The minor change in packaging has addressed in an identical as the predicate device which the same satisfying results." This implies that the performance is considered "satisfying" and equivalent to the predicate, but no quantitative results are presented. |
2. Sample Size for the Test Set and Data Provenance:
- Sample Size: Not specified.
- Data Provenance: Not specified. The document only mentions "safety and performance testing was performed." It does not indicate if this involved human subjects, animal studies, or purely bench testing, nor does it mention the country of origin or whether it was retrospective or prospective.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications:
- Not Applicable. Given the nature of a 510(k) summary that emphasizes substantial equivalence mainly through technical characteristics and a "minor change in packaging," expert-established ground truth for a clinical test set is not discussed. There is no mention of a clinical study that would require such expert assessment.
4. Adjudication Method for the Test Set:
- Not Applicable. No clinical test set requiring adjudication is described.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done:
- No. An MRMC study is typically associated with AI/imaging devices and involves human readers evaluating cases with and without AI assistance. This device is a mechanical compression system, and an MRMC study is not relevant to its evaluation.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- Not Applicable. This is not an algorithmic device. Performance for this device would relate to its mechanical function, material compatibility, and effectiveness in achieving compression.
7. The Type of Ground Truth Used:
- Not explicitly stated for performance testing. For mechanical and material checks, the "ground truth" would likely be established through engineering specifications, material safety standards, and physical measurements. For clinical effectiveness, the "ground truth" (if a study were performed beyond equivalence) would be successful hemostasis or closure of the vessel, typically assessed by clinical observation. However, the document does not detail this.
8. The Sample Size for the Training Set:
- Not Applicable. This device, being a mechanical compression system, does not involve a training set as would be found in machine learning or AI-based devices.
9. How the Ground Truth for the Training Set was Established:
- Not Applicable. As no training set is involved, this question is not relevant.
Summary of the Study (as described in the 510(k) summary):
The 510(k) summary for the FemoStop®II PLUS System indicates that "Safety and performance testing was performed to demonstrate that the FemoStop®IIPLUS System" is safe and effective. However, the main thrust of the submission for demonstrating this is through substantial equivalence to an existing predicate device, the FemoStop®II System.
The document explicitly states: "The FemoStop IIruss System is very similar to FemoStop II System, rearding materials, construction, packaging, sterilization and indication for use." It further mentions: "The minor change in packaging has addressed in an identical as the predicate device which the same satisfying results."
This implies that the "study" demonstrating performance was primarily an equivalence assessment, comparing the new device's technical characteristics to its predicate, particularly noting a "minor change in packaging." No distinct clinical trial or detailed performance study results are described; rather, the safety and effectiveness are inferred from its similarity to a legally marketed and presumably safe and effective predicate device.
§ 870.4450 Vascular clamp.
(a)
Identification. A vascular clamp is a surgical instrument used to occlude a blood vessel temporarily.(b)
Classification. Class II (performance standards).