(66 days)
The G2™ Filter System – Jugular/Subclavian Delivery Kit is indicated for use in the prevention of recurrent pulmonary embolism via permanent placement in the vena cava in the following situations:
- Pulmonary thromboembolism when anticoagulants are contraindicated. .
- Failure of anticoagulant therapy for thromboembolic disease. .
- Emergency treatment following massive pulmonary embolism where anticipated . benefits of conventional therapy are reduced.
- Chronic, recurrent pulmonary embolism where anticoagulant therapy has failed . or is contraindicated.
The G2™ Filter System - Juqular/Subclavian Delivery Kit allows for placement of the G2TM Filter via a Jugular or Subclavian vein approach. The G2™ Filter System -Jugular/Subclavian Delivery Kit consists of a dilator and introducer set and a delivery device with a preloaded filter. The dilator accepts a 0.038" guidewire and enables a contrast medium power injection up to 800 psi maximum pressure. The 10 French I.D. introducer sheath contains a radiopaque tip and hemostasis valve with a side port for injecting contrast medium via a syringe. The delivery device fits within the introducer sheath and consists of a side port for saline infusion and a delivery mechanism to deplov the G2™ Filter. The delivery device contains a spline cap that mechanically separates the filter hooks from one another in a unique pattern to prevent leg entanglement.
Here's a breakdown of the acceptance criteria and study information for the G2™ Filter System – Jugular/Subclavian Delivery Kit, based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The provided document [K052578](https://510k.innolitics.com/search/K052578) is a 510(k) Summary of Safety and Effectiveness for a medical device. It states that the device "met all the predetermined acceptance criteria of design verification and validation as specified by applicable standards, guidance, test protocols and/or customer inputs." However, the document does not explicitly list the quantitative acceptance criteria or specific reported device performance results in a table format. It primarily focuses on demonstrating substantial equivalence to a predicate device.
The "Conclusions" section (page 3) is the most relevant:
| Acceptance Criteria Category | Reported Device Performance |
|---|---|
| Design Verification and Validation | "met all the predetermined acceptance criteria of design verification and validation as specified by applicable standards, guidance, test protocols and/or customer inputs." |
Without access to the full design verification and validation reports, the specific quantitative acceptance criteria (e.g., specific tensile strength values, deployment success rates, filter migration rates, etc.) cannot be extracted from this summary.
2. Sample Size Used for the Test Set and Data Provenance
The provided document does not contain information about the sample size used for a specific test set or the data provenance (e.g., country of origin, retrospective/prospective). The 510(k) summary focuses on design verification and validation, implying bench testing and potentially pre-clinical animal studies, but doesn't detail human subject testing for this specific submission, as it claims substantial equivalence based on an additional delivery system for an already cleared filter component.
3. Number of Experts Used to Establish Ground Truth and Qualifications
This information is not provided in the given document. The document describes a regulatory submission for substantial equivalence based on design verification and validation, not a study involving human readers or ground truth established by experts in that context.
4. Adjudication Method for the Test Set
This information is not provided in the given document, as it does not describe a study involving adjudication of a test set by human readers.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study and Effect Size
No MRMC comparative effectiveness study is mentioned or detailed in the provided document. The submission is for a modified delivery kit for an existing filter system, relying on design verification and validation, and demonstrating substantial equivalence, not a comparative effectiveness study with human readers.
6. Standalone (Algorithm Only) Performance Study
No standalone performance study for an algorithm is described or mentioned. This document pertains to a physical medical device (vena cava filter and its delivery system), not an AI or algorithmic device.
7. Type of Ground Truth Used
Given that this is a submission for a physical medical device (vena cava filter delivery kit) and not an AI or diagnostic imaging device that typically uses expert consensus or pathology for ground truth, the "ground truth" in this context would likely refer to objective engineering and performance specifications. This would involve:
- Bench testing results: Measuring physical properties (e.g., filter strength, deployment accuracy, flow rates).
- Pre-clinical (animal) study results: Assessing in-vivo performance (e.g., filter migration, clot trapping efficacy, vessel integrity) against established biological and mechanical standards.
The document refers to "applicable standards, guidance, test protocols and/or customer inputs" which would define this "ground truth." Specific details of what these "ground truths" entailed (e.g., specific quantitative measurements or observations) are not provided in the summary.
8. Sample Size for the Training Set
This information is not applicable as this document relates to a physical medical device (vena cava filter and delivery system), not a machine learning or AI algorithm that requires a "training set."
9. How Ground Truth for the Training Set Was Established
This information is not applicable for the same reason as point 8.
§ 870.3375 Cardiovascular intravascular filter.
(a)
Identification. A cardiovascular intravascular filter is an implant that is placed in the inferior vena cava for the purpose of preventing pulmonary thromboemboli (blood clots generated in the lower limbs and broken loose into the blood stream) from flowing into the right side of the heart and the pulmonary circulation.(b)
Classification. Class II. The special controls for this device are:(1) “Use of International Standards Organization's ISO 10993 ‘Biological Evaluation of Medical Devices Part I: Evaluation and Testing,’ ” and
(2) FDA's:
(i) “510(k) Sterility Review Guidance and Revision of 2/12/90 (K90-1)” and
(ii) “Guidance for Cardiovascular Intravascular Filter 510(k) Submissions.”