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The Auto Band Ligator is used to band esophageal varices or hemorrhoids in the colon. For single use only.

The Scandimed Auto-Band Ligator consists of a ligator wheel head mounted on a scope fixation arm and connected by a stainless steel thread to the band barrel. The only change being proposed in this current Special 510(k) Premarket Notification is to convert the original latex rubber ligating bands to latex free rubber ligating bands. The Auto-Band Ligator incorporates the following product features: Automatic Reverse Movement to START position after each release. Snap Fixation system ensures stable fixation on the scope. Adjustable Snap Fixation System facilitates fixation on all brands of scopes. Precision One-Step Release Mechanism of bands. Only a single band can be released at a time. Latex Free Rubber Bands. Available in 5, 7 or 10 band configurations.

This document is a 510(k) Premarket Notification for the Scandimed International Auto-Band Ligator. The purpose of this notification is to introduce a material change from latex ligation bands to latex-free ligation bands.

As such, this document does not contain information related to acceptance criteria, specific device performance data in a quantifiable manner, sample sizes, ground truth establishment, or multi-reader multi-case studies typically associated with AI/ML device evaluations. This submission is for a medical device that has undergone a material change (latex to latex-free bands) and is not an AI/ML powered device.

Therefore, the requested information cannot be extracted from the provided text.

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The Auto-Band Ligator are used to band esophageal varices or haemorrhoids in the colon. For single use only.

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The provided 510(k) summary (K031236) for the Scandimed International Auto-Band Ligator is a clearance letter from the FDA. It declares the device substantially equivalent to legally marketed predicate devices.

Crucially, this document is a regulatory clearance letter and does not contain the details of a study proving the device meets specific acceptance criteria. This type of FDA clearance relies on demonstrating substantial equivalence to a predicate device, rather than requiring new clinical trials to establish de novo performance criteria.

Therefore, I cannot provide the information requested in your bullet points because the provided text does not contain a study report or clinical trial data.

To clarify what this document does provide:

• Device Name: Scandimed International Auto-Band Ligator
• Intended Use: Used to band esophageal varices or hemorrhoids in the colon. For single use only.
• Regulatory Classification: Class II, Product Code: 78 MND
• Predicate Device: Not explicitly named in this letter, but implied by the "substantial equivalence" determination.

Without a detailed clinical study report, it's impossible to answer your specific questions regarding acceptance criteria, sample sizes, expert qualifications, ground truth, or comparative effectiveness.

Ask a specific question about this device