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510(k) Data Aggregation
(73 days)
VASCUTEK BRANCHED GELWEAVE
Gelweave "M branched vascular graffs: "Repair of replacentent of damaged and diseased vessels of the abdomen and thoracic aorta in cases of anewrysm, dissection or courclation". Sicua TM grafts vascular with and without Gelweave radiopaque markers: "Repair or replacement of damaged and diseased vessels of the thoracie aorta in cases of anew ysm, dissection or coarctation". "Gelweave" brunched vascular grafts, including Siena" grafts can also be used for debranching i.e. reconstruction of the aortic vessels and associated Hybrid procediires".
The design and all other properties of the Vascutek Gelweave™ branched vascular grafts and Gelweave Siena™ vascular grafts with and without radiopaque markers remain unchanged. The Vascutek Gelweave™ branched vascular grafts and Gelweave Siena™ vascular grafts with and without radiopaque markers function as vascular grafts manufactured from standard polyester and gelatin sealant technologies.
The provided document describes the Vascutek Gelweave™ branched vascular grafts and Gelweave Siena™ vascular grafts with and without radiopaque markers. This submission (K090987) is for an expanded indication for use of existing devices, not a new device. Therefore, the "acceptance criteria" and "device performance" are focused on demonstrating that the expanded indication does not compromise the safety and effectiveness of the unchanged device.
Here's a breakdown based on your request:
1. Table of Acceptance Criteria and Reported Device Performance
Since this is an expanded indication for an existing device with no changes in design, materials, or manufacturing, the acceptance criteria are not in terms of specific performance metrics for the device itself (e.g., accuracy, sensitivity, specificity). Instead, the acceptance criteria revolve around demonstrating that the device's fundamental performance characteristics (sealing properties) are maintained even with procedures related to the expanded indication.
| Acceptance Criteria Category | Specific Criteria | Reported Device Performance |
|---|---|---|
| Maintenance of Sealing Properties | The insertion and manipulation of an endovascular delivery catheter through a side branch of the graft should not alter the sealing properties of the graft or cause structural damage leading to blood leakage. This is within the context of forces and procedures that exceed those expected in an operating room. | For verification, a 26 F introducer was inserted into the 10mm side branch of 21 Gelweave grafts. The introducer and side branch were tied to allow back and forth movement. The graft was then pressurized with citrated horse blood to 120 mm/Hg. During pressurization, the delivery catheter was deliberately pushed into the main body of the Gelweave graft (i.e., forced onto the graft body wall) 10 times over a 2-minute period. This force and number of manipulations far exceeded what a surgeon would use in the operating room. Any blood lost was collected and weighed. Results showed that the insertion of the delivery catheter under these exaggerated conditions did not alter the sealing properties of the graft (i.e., did not cause damage resulting in blood leakage). |
| Clinical Equivalence to Predicates | The use of the device for debranching and hybrid procedures, as an expanded indication, should be considered standard clinical practice and not introduce new safety or effectiveness concerns compared to existing practices and predicate devices. | A comprehensive review of the literature regarding the clinical use of standard branched polyester vascular grafts for debranching and associated hybrid procedures was provided. The document states that these procedures are considered standard clinical practice and an alternative treatment option for aortic repair, especially for high-risk patients who cannot tolerate conventional open surgical repair. The submission argues that the expanded indication does not change the overall intended use or affect the safety and effectiveness of the device when used as labelled. |
| No Material/Design Changes | There should be no changes to the design, materials, packaging, sterilization, shelf life, or any other parameters of the device itself. | The submission explicitly states: "There are no other changes to the products i.e. there are no changes to the design, materials, packaging, sterilisation, shelf life or any other parameters. The only change is a request for an expanded indication for use." And "These devices have the same technological characteristics as the predicates i.e. there are no changes to the Vascutek Gelweave™ branched vascular grafts and Gelweave Siena™ vascular grafts with and without radiopaque markers other than the request for an expanded indication." |
2. Sample Size Used for the Test Set and Data Provenance
- Test Set Sample Size: 21 Gelweave grafts were used for the bench testing.
- Data Provenance: The bench testing was conducted by Vascutek Ltd. (Scotland, United Kingdom). The clinical information provided was a "comprehensive review of the literature in relation to clinical use of standard branched polyester vascular grafts," implying retrospective data from published studies and clinical opinions globally.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications
- Number of Experts: Not explicitly stated as a defined number of individual experts for establishing a ground truth. Instead, the submission relies on "clinical opinion" and "available literature" for the clinical context of the expanded indications.
- Qualifications of Experts: Not specified. It refers to "clinical opinion" generally, implying established consensus within the surgical community regarding debranching and hybrid procedures.
4. Adjudication Method for the Test Set
- Adjudication Method: Not applicable in the context of this submission. The bench testing involved objective measurement of blood leakage, not a qualitative assessment requiring adjudication. The clinical justification relied on a literature review, not individual case adjudication.
5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study Was Done
- No. An MRMC comparative effectiveness study was not done. This submission focuses on expanding the indications for an existing physical device, not on the performance of a diagnostic algorithm or a device requiring human reader interpretation.
6. If a Standalone Study Was Done
- Yes, a standalone bench test was done to assess the physical integrity and sealing properties of the device under conditions related to the expanded indication. This test measured blood leakage after mechanical manipulation of a delivery catheter through the graft's side branch.
- The clinical justification was a standalone literature review, not a clinical study involving human subjects for this specific submission.
7. The Type of Ground Truth Used
- For the bench testing, the "ground truth" was quantifiable physical measurement (weight of blood lost) to determine if the graft's sealing properties were maintained.
- For the clinical justification, the "ground truth" was established by expert consensus and outcomes data as reflected in the "available literature and clinical opinion" regarding the standard practice of debranching and hybrid procedures with similar grafts.
8. The Sample Size for the Training Set
- Not applicable. This submission is for an expanded indication of an existing physical medical device, not an AI/ML algorithm that requires a training set.
9. How the Ground Truth for the Training Set Was Established
- Not applicable. As stated above, this is not an AI/ML algorithm submission.
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