Search Results
Found 1 results
510(k) Data Aggregation
(252 days)
This device is intended to be used in axillary arterial perfusion during cardiopulmonary bypass procedures. These devices are indicated for up to 6 hours of use.
The Vascutek Cannula Graft is a modified device design. It is a combination of a Terumo Soft-Flow® Aortic Cannula (K934127) and a Vascutek SEALPTFE Wrap graft (K041528). It is intended for use in perfusion during cardiopulmonary bypass procedures. The reason for the modification is summarised as follows. Direct introduction of a cannula tip into a patient's blood vessel may cause tissue trauma during attachment of the patient to a cardiopulmonary bypass machine. Replacement of the cannula tip with a softer, SEALPTFE Wrap vascular graft, maybe less traumatic and be preferred by some surgeons. This is the design rationale for the Vascutek Cannula Graft.
There are no new materials used in the Vascutek Cannula Graft, other than the use of medical grade adhesive to create the bond between the Terumo Soft-Flow® Cannula (K934127) and Vascuteks SEALPTFE Wrap graft (K041528). Both predicate devices use materials with an extensive history of use in cardiovascular and other medical applications and have been thoroughly tested historically for their respective 510(k) clearances. All materials used in the manufacture of the Vascutek Cannula Graft are biocompatible and non-toxic.
The physical properties of the combined predicate devices i.e. the Terumo Soft-Flow® Aortic Cannula (K934127) and the Vascutek SEALPTFE Wrap graft (K041528) remain unchanged and the point of attachment of the component devices has been tested and shown to be suitable for the intended use.
The Vascutek Cannula Graft is a finished product, provided sterile for single use only.
The overall length of the Vascutek Cannula Graft is approximately 50 cm and the cannula and graft portions are both 8 mm in diameter. The Vascutek Cannula Graft is only available in a single model i.e. a CGS2008S.
The provided text is a 510(k) summary for a medical device (Vascutek Cannula Graft) and does not describe a study involving an AI/CADe device with acceptance criteria, human readers, or ground truth establishment in the way requested.
The document discusses the substantial equivalence of the Vascutek Cannula Graft to existing predicate devices based on:
- Intended Use: Axillary arterial perfusion during cardiopulmonary bypass procedures for up to 6 hours.
- Design and Materials: A combination of a Terumo Soft-Flow® Cannula and a Vascutek SEALPTFE Wrap graft, with medical grade adhesive at the attachment point.
- Performance: Studies focused on the attachment site, specifically tensile strength and leak testing.
- Principles of Operation and Technology: Used in open-heart surgery to return oxygenated blood to the patient.
Here's an attempt to answer your questions based only on the provided text, acknowledging that many details you requested (especially those related to AI/CADe studies) are not present:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Tensile Strength: Strength of the attachment site | Demonstrated that the strength of the attachment of the two combined devices was greater than the tensile strength of the predicate Terumo Soft-Flow® Cannula itself (K934127). This was also demonstrated after 2 years accelerated aging. |
| Leakage: Absence of leaks at the attachment site | No leakage was observed, demonstrating equivalence to both predicate devices. This was also demonstrated after 2 years accelerated aging. |
| Biocompatibility/Non-toxicity: For new materials (adhesive) | The medical grade adhesive used at the point of attachment has undergone comprehensive biocompatibility testing, which demonstrates that it is biocompatible and non-toxic. |
| Stability: Over the product's expiry (2 years) | Testing on aged and non-aged Vascutek Cannula Grafts found the device to be stable over the expiry of the product (2 years). |
| Substantial Equivalence: In intended use, design, materials, performance, principles of operation, and technology to predicate devices. | The document concludes that the Vascutek Cannula Graft is substantially equivalent to the predicate devices. |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document does not specify the sample size (e.g., number of devices tested) for the tensile strength, leakage, or accelerated aging tests. The provenance of the data is not explicitly mentioned (e.g., country of origin, retrospective/prospective), but the manufacturer is based in Renfrewshire, Scotland, United Kingdom.
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)
This is a physical device, not an AI/CADe system. Therefore, the concept of "experts used to establish ground truth" related to image interpretation or diagnosis does not apply. The performance tests (tensile strength, leak testing) would have been conducted using established engineering and laboratory methods.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable, as this is not an AI/CADe study involving subjective assessments or interpretation.
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. This is a physical medical device (cannula graft), not an AI/CADe system designed to assist human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is a physical medical device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
Not applicable in the context of AI/CADe systems. For this physical device, the "ground truth" for the performance criteria would be objective measurements from laboratory tests (e.g., force required for material failure, observation of liquid leakage, chemical analysis for biocompatibility).
8. The sample size for the training set
Not applicable. This is not a machine learning or AI device.
9. How the ground truth for the training set was established
Not applicable. This is not a machine learning or AI device.
Ask a specific question about this device
Page 1 of 1