(14 days)
The LV-1 Hemostasis Valve with the Wire Guide is indicated for maintaining a seal around the LV-1 lead terminal pin while flushing the lead lumen and/or during introduction/withdrawal of interventional devices.
The LV-1 HEMOSTASIS VALVE, Model 6789 is a delivery system accessory for use in the implant of a GUIDANT left ventricular (LV-1) lead through the coronary sinus. The tip of the valve attaches to the LV-1 lead terminal pin and maintains a seal. A side arm port allows the lumen seal to be flushed and a bleedback control seal allows the introduction of an appropriately sized guide wire through an inside diameter of 0.070" (1.8 mm) while providing a seal.
The bleedback control seal is a diaphragm seal that forms around a guide wire as it moves into and out of the lead lumen, catheter, and vasculature. This seal restricts fluid loss without significantly inhibiting wire movement. The bleedback control seal is easily penetrated by the wire guide, a small plastic funnel accessory that facilitates the introduction of a guide wire.
Here's an analysis of the provided documents regarding the acceptance criteria and study for the GUIDANT LV-1 HEMOSTASIS VALVE:
Acceptance Criteria and Device Performance:
The provided documents do not contain a table of acceptance criteria or reported device performance metrics. The 510(k) summary only states that the device is "substantially equivalent" to a predicate device based on its design, materials, method of operation, and intended use. This implies that the device is expected to perform similarly to the predicate, but specific quantifiable acceptance criteria and performance data are not disclosed in these public summaries.
Detailed Study Information (Based on available documents):
Given the provided text, a comprehensive response to many of the detailed study questions cannot be fully constructed because the 510(k) summary format does not typically include the granular detail of a full study report. However, I can extract and infer information where possible and explicitly state what is not available.
1. Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Not provided | Not provided |
| (No specific quantitative or qualitative criteria are detailed in the 510(k) summary for this device.) | (No specific performance data is reported in the 510(k) summary.) |
Explanation: The 510(k) summary states "The design, materials, method of operation, and intended use features of the GUIDANT LV-1™ Bleedback Control Valve are substantially equivalent to those of the predicate device, the GUIDANT COPILOT™ Bleedback Control Valve (K991102)." This is the primary "finding" of the review, but it does not present specific acceptance criteria or performance numbers for the LV-1 valve itself.
2. Sample Size Used for the Test Set and Data Provenance:
- Sample Size for Test Set: Not provided. The 510(k) summary does not mention any specific test set or clinical study with a defined sample size for the LV-1 Hemostasis Valve. The substantial equivalence claim is based on comparing the device's features to a predicate.
- Data Provenance (Country of Origin, Retrospective/Prospective): Not provided. No clinical data is presented, so data provenance is not applicable here.
3. Number of Experts Used to Establish Ground Truth and Qualifications:
- Number of Experts: Not applicable. No expert ground truth establishment for a test set is discussed in these documents. The substantial equivalence hinges on design and intended use comparison.
- Qualifications of Experts: Not applicable.
4. Adjudication Method for the Test Set:
- Adjudication Method: Not applicable. No test set or related adjudication method is mentioned.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
- MRMC Study Done: No. The documents do not indicate that a MRMC comparative effectiveness study was performed. These types of studies are typically for image analysis or diagnostic devices where human reader performance is a key metric. This device is a mechanical accessory.
- Effect Size: Not applicable.
6. Standalone (Algorithm Only) Performance Study:
- Standalone Study Done: No. This device is a mechanical accessory (hemostasis valve), not an algorithm or software. Therefore, an "algorithm only" standalone performance study is not relevant or described.
7. Type of Ground Truth Used:
- Type of Ground Truth: Not applicable. Since no clinical studies or evaluations generating performance data are detailed, there is no discussion of ground truth in this context. The "ground truth" for substantial equivalence is the functional characteristics and safety profile of the predicate device.
8. Sample Size for the Training Set:
- Sample Size for Training Set: Not applicable. This device is a mechanical accessory undergoing a 510(k) submission based on substantial equivalence to a predicate. Machine learning or AI models requiring a training set are not mentioned as part of its development or evaluation.
9. How Ground Truth for the Training Set Was Established:
- How Ground Truth Was Established: Not applicable. As no training set or AI model is described, this question is not relevant.
Summary of What Can Be Inferred from 510(k) Submissions:
It is crucial to understand that 510(k) summaries, by their nature, are relatively brief overviews provided by the applicant to demonstrate substantial equivalence to a legally marketed predicate device. They often do not contain the detailed study protocols, raw data, or comprehensive performance metrics that would be found in a full clinical trial report or a more extensive PMA (Premarket Approval) application.
For devices like the LV-1 Hemostasis Valve, which are considered accessories and rely on physical function, the "proof" often comes from:
- Bench testing: Demonstrating sealing capabilities, fluid flow, wire compatibility, and material integrity under various conditions (though not detailed here).
- Biocompatibility testing: Ensuring the materials are safe for human contact.
- Sterility validation: Ensuring the device can be sterilized and maintained sterile.
- Comparison to predicate: Highlighting identical or similar design features, materials, and intended use as a device already on the market.
The provided documents confirm that the FDA found the device "substantially equivalent" to the predicate, meaning it is considered as safe and effective as the predicate device for its stated indications for use.
§ 870.4290 Cardiopulmonary bypass adaptor, stopcock, manifold, or fitting.
(a)
Identification. A cardiopulmonary bypass adaptor, stopcock, manifold, or fitting is a device used in cardiovascular diagnostic, surgical, and therapeutic applications to interconnect tubing, catheters, or other devices.(b)
Classification. Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 870.9.