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The Rüsch Blakemore Tube - 3 Lumen, Sterile, is a single use, naso-gastric double balloon tube that can be passed nasally into the stomach suitable for use in management of bleeding esophageal varcis.

The Rusch Blakemore Tube - 3 Lumen, sterile, consists of a radiopaque (BaSQ4), three lumen, soft red rubber, graduated, tube which is rounded and sealed at the distal end and belled out to form a funnel at the proximal end. Four elongated eyes are cut in the tube between the rounded distal (patient) end and the cuffs. Two SILKOLATEX™ cuffs are inflated via separate color identified funnels using any Luer syringe; pilot balloons are provided to indicate cuff inflation. The Rüsch Blakemore Tube - 3 Lumen, sterile, will be available in three (3) sizes designated by outside diameters Ch 14, 16, 18(14, 16, 18 Fr) and three unique part numbers that are yet to be determined. The device will be sold sterile, individually packed in a paper-film pack. Two devices will be packaged in a cardboard box, with one set of instructions for use, and designated as a naso-gastric, double balloon tube that can be passed nasally into the stomach suitable for use in the management of bleeding esophageal varices. The tube works in the principle of applying pressure or tamponade via a latex balloon to the bleeding varix.

The provided document is a 510(k) Pre-Market Notification for a medical device, the Rüsch Blakemore Tube - 3 Lumen, sterile. This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than presenting new clinical study data with detailed acceptance criteria for software performance.

Based on the content, none of the requested information regarding acceptance criteria or specific study details for device performance (such as sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, or training set ground truth) is present.

The document states:

• Acceptance Criteria and Device Performance: Not applicable in this context. The submission is for substantial equivalence, not a new performance evaluation with specific acceptance criteria.
• Study Details: No study is described that proves the device meets specific acceptance criteria in the manner typically expected for AI/software-driven medical devices. The submission indicates the device is substantially equivalent to the Rüsch Blakemore Tube - 3 Lumen, non-sterile. This implies that its performance characteristics are considered the same as the predicate device.
• Sample Size for Test Set and Data Provenance: Not applicable.
• Number of Experts and Qualifications: Not applicable.
• Adjudication Method: Not applicable.
• Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study: Not applicable.
• Standalone Performance: Not applicable.
• Type of Ground Truth Used: Not applicable.
• Sample Size for Training Set: Not applicable.
• How Ground Truth for Training Set was Established: Not applicable.

Summary of the document's relevance to the request:

The document describes a medical device (a Sengstaken-Blakemore tube for managing bleeding esophageal varices) and its intended use. It is a Class II medical device (21 CFR 876.5980) and the submission seeks to market a sterile version of an already legally marketed non-sterile version of the same device. The core of the 510(k) is to demonstrate substantial equivalence to the predicate device, not to establish new performance criteria through a study. Therefore, the detailed questions about acceptance criteria and study methodologies common for AI/software devices are not addressed in this type of regulatory submission.

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