(88 days)
The FemoStop®IIPLUS System is indicated in the compression of the femoral artery or vein after catheterization.
The FemoStop II "65 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.
Here's an analysis of the provided text regarding the FemoStop®II PLUS System.
Important Note: The provided document is a 510(k) summary for a medical device (Femoral Compressor Device). These types of summaries primarily aim to demonstrate substantial equivalence to a predicate device rather than providing detailed, comprehensive performance studies with specific statistical acceptance criteria and extensive ground truth establishment as would be seen for complex diagnostic AI/ML algorithms. Therefore, much of the requested information (especially regarding statistical methods, expert consensus, multi-reader studies, and AI-specific ground truth) is not present in this type of document.
Acceptance Criteria and Reported Device Performance
The 510(k) summary for the FemoStop®II PLUS System focuses on demonstrating substantial equivalence to its predicate device, the FemoStop®II System. The "acceptance criteria" here are implicitly tied to showing that the new device is as safe and effective as the predicate, especially given a change in materials.
| Acceptance Criteria (Implicit) | Reported Device Performance |
|---|---|
| Biocompatibility: The new materials used in the FemoStop®II PLUS System are safe for human contact and do not elicit adverse biological responses. | "The change in materials has been tested according to suggestions in: ISO 10993-1, Biological evaluation of medical devices." This implies that the tests performed met the recommendations of this standard, indicating acceptable biocompatibility. |
| Functional Equivalence: The FemoStop®II PLUS System performs its intended function (compression of femoral artery/vein after catheterization) as effectively as the predicate device. | "The FemoStop®IIPLUS System is very similar to FemoStop®II System, regarding materials, construction, packaging, sterilization and indication for use." This statement is the primary assertion of functional equivalence. The 510(k) process accepts this similarity as sufficient evidence of comparable performance for this type of device, especially when the core mechanism of action remains the same. The FDA letter confirms the device is "substantially equivalent" for the stated indications for use. |
| Manufacturing Quality: The device is manufactured under appropriate quality systems. | The FDA letter mentions: "A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions." This is an implicit acceptance criterion assumed to be met. |
Study Details (Based on available information)
1. A table of acceptance criteria and the reported device performance:
* See the table above.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
* Sample Size (Test Set): Not specified. The document describes material safety testing (ISO 10993-1), but does not detail human clinical trials or a specific "test set" in the context of diagnostic accuracy.
* Data Provenance: Not specified for the performance data. The manufacturer is based in Uppsala, Sweden. The biocompatibility testing reference (ISO 10993-1) is an international standard.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience):
* Not applicable / Not specified. This type of medical device (a mechanical compression system) does not typically require expert labeling of "ground truth" images or data in the same way an AI diagnostic algorithm would. The "ground truth" for this device would be its physical properties, biocompatibility, and functional performance in reducing bleeding after catheterization. The document focuses on demonstrating substantial equivalence based on materials, construction, and design, not on diagnostic accuracy.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
* Not applicable / Not specified. No adjudication method is described as this device does not involve subjective interpretation or diagnostic labeling.
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:
* Not applicable. No MRMC study was performed or is relevant for this non-diagnostic, non-AI medical device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
* Not applicable. This device is not an algorithm or AI system.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):
* The "ground truth" for this device would primarily be:
* Biocompatibility test results: Conformance to ISO 10993-1 standards (e.g., cytotoxicity assays, irritation tests).
* Material properties: Chemical composition, physical strength, durability, etc.
* Functional performance: The ability of the device to apply and maintain pressure, as designed, to achieve hemorrhage control. This is implicitly linked to the "very similar" construction and materials to the predicate.
* No expert consensus, pathology, or specific outcomes data is detailed in this summary.
8. The sample size for the training set:
* Not applicable / Not specified. This device does not use an AI model that requires a "training set."
9. How the ground truth for the training set was established:
* Not applicable / Not specified. No AI training set is involved.
§ 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).