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The G2 Filter 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 (subject) description is identical to the Recovery Filter System (predicate) description and indications for use. The modifications made to the predicate filter device and delivery system are primarily dimensional. No material changes or additional components have been incorporated. The predicate filter device has been modified as a result of continued product improvement. The predicate delivery system has been modified to accommodate the geometry modifications of the predicate filter.

The provided text describes a G2 Filter System, a medical device intended for permanent placement in the vena cava to prevent recurrent pulmonary embolism. However, it does not contain any information regarding specific acceptance criteria, a study proving device performance against such criteria, sample sizes, expert involvement, adjudication methods, MRMC studies, or standalone algorithm performance. The document is a 510(k) premarket notification summary, which focuses on demonstrating substantial equivalence to a predicate device rather than presenting new clinical study data with performance metrics.

Therefore, I cannot fulfill your request for:

1. A table of acceptance criteria and reported device performance.
2. Sample sizes and data provenance for a test set.
3. Number and qualifications of experts for ground truth.
4. Adjudication method for the test set.
5. MRMC comparative effectiveness study results.
6. Standalone algorithm performance.
7. Type of ground truth used.
8. Sample size for the training set.
9. How ground truth for the training set was established.

What the document does state is:

• Subject Device Name: G2 Filter System
• Intended Use: Prevention of recurrent pulmonary embolism via permanent placement in the vena cava in situations where anticoagulants are contraindicated, anticoagulant therapy fails, or after massive pulmonary embolism.
• Substantial Equivalence: The G2 Filter System is asserted to be substantially equivalent to the Recovery Filter System (predicate device K022236, cleared 11/27/02) based on:
  • Same intended use.
  • Same filter and delivery system materials.
  • Same operating principle.
  • Same fundamental scientific technology.
  • Same packaging configuration and materials.
  • Same sterility assurance level and method of sterilization.
  • The modifications made were primarily dimensional to the filter and delivery system for continued product improvement; no material changes or additional components were incorporated.
• Regulatory Classification: Class II with Special Controls.
• Special Controls Compliance: Compliant with FDA's "Guidance for Cardiovascular Intravascular Filter 510(k) Submissions" (Nov 26, 1999) and BS EN 12006-3:1999 "Non-Active Surgical Implants Particular Requirements for Cardiac and Vascular Implants - Part 3: Endovascular Devices".
• FDA Labeling Limitation: "The safety and effectiveness of the G2 Filter System for use as a retrievable or temporary filter have not been established." This indicates that the device's safety and effectiveness were only reviewed for permanent placement.

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