(91 days)
The Wexler Vascular Clamp Series is indicated for use for temporary or partial occlusion of blood vessels during surgical procedures.
The Wexler Vascular Clamp Series is a family of vascular clamps, both stainless steel and titanium alloy, used during surgical procedures. The clips are supplied nonsterile and are chosen based on the dimensions, features and technological characteristics desired.
The provided document is a 510(k) summary for the Wexler Vascular Clamp Series, which is a medical device. This type of regulatory submission is for demonstrating substantial equivalence to a legally marketed predicate device, not for proving a device meets specific performance criteria through a detailed study in the way a novel AI or diagnostic device would.
Therefore, the document does not contain the information requested regarding acceptance criteria and a study demonstrating the device meets those criteria. Specifically:
- No acceptance criteria table or reported device performance: The submission focuses on comparing the new device's characteristics (materials, design, intended use, principle of operation) to an existing predicate device, not on quantitative performance metrics.
- No sample size for test set or data provenance: There is no mention of a test set, as no study was conducted to establish performance metrics in the way a diagnostic algorithm would require.
- No number of experts or qualifications: No expert review for ground truth establishment is described.
- No adjudication method: Not applicable as there's no ground truth establishment process.
- No Multi Reader Multi Case (MRMC) comparative effectiveness study: This type of study is not relevant for a vascular clamp.
- No standalone (algorithm only) performance study: This device is a surgical instrument, not an algorithm.
- No type of ground truth used: Not applicable.
- No sample size for the training set: Not applicable as there is no machine learning component.
- No description of how ground truth for the training set was established: Not applicable.
The submission claims substantial equivalence based on:
- Identical indications for use: "The Wexler Vascular Clamp Series is indicated for use for temporary or partial occlusion of blood vessels during surgical procedures," which is stated to be virtually identical to the predicate.
- Identical principles of operation: "The indications for use, principles of operation, and device design of the Wexler Vascular Clamp Series are virtually identical to those of the predicate device."
- Similar device design: "Both series of devices are made of stainless steel or titanium, and share technological characteristics common to all vascular clamps of their types."
- Similar technological characteristics and performance specifications: "There are no significant differences in either technology or performance specifications."
In essence, the "study" demonstrating the device meets acceptance criteria is the comparison to the predicate device K072834 (manufactured by Surgical Instruments Belgium (SIBEL) SA), and the acceptance criterion is substantial equivalence to that predicate. This is a regulatory pathway, not a clinical or performance study in the context of diagnostic accuracy or AI performance.
§ 870.4450 Vascular clamp.
(a)
Identification. A vascular clamp is a surgical instrument used to occlude a blood vessel temporarily.(b)
Classification. Class II (performance standards).