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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 modifications being proposed in this current Special 510(k) Premarket Notification are to change the latex formulation of the rubber ligating bands and to expand the product line to include 6 and 8 band variations.

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 or Latex Free Rubber Bands
Available in 5, 6, 7, 8 or 10 band configurations

AI/ML Overview

The provided 510(k) summary for the Scandimed International Auto-Band Ligator (K083556) is for a Special 510(k) Premarket Notification to address a material formulation change to the ligation bands and to expand the product line to include 6 and 8 band variations. This type of submission typically focuses on demonstrating that the modifications do not negatively impact the safety and effectiveness established for the predicate device.

Therefore, the study described is primarily performance testing to confirm the continued safety and effectiveness of the modified device.

Here's an analysis of the available information:

1. Table of Acceptance Criteria and the Reported Device Performance

Acceptance Criteria (Inferred)	Reported Device Performance	Comments
Safety and Effectiveness of the device (general regulatory standard)	"The results of the performance testing demonstrated the safety and effectiveness of the device."	This is a high-level statement. Specific quantitative criteria and results are not detailed in this summary. For a Special 510(k), the criteria would likely relate to maintaining the performance characteristics of the predicate device.
Performance characteristics (e.g., band release mechanism, fixation system, material integrity)	Stated that "technological characteristics such as materials, performance characteristics and packaging are identical or substantially equivalent to the currently marketed predicate devices."	Implies that the modified device met the established performance standards of the predicate, but specific tests or numerical results are not provided.
Material compatibility/formulation change	Implied through "performance testing" that the new latex formulation met safety and performance standards.	No specific tests for material properties or biocompatibility are listed, though these would have been part of the underlying testing.
Functionality of new 6 and 8 band configurations	Implicitly confirmed through "performance testing" and comparison to predicate.	No specific tests for these new configurations are explicitly detailed.

2. Sample Size Used for the Test Set and the Data Provenance

Sample Size: Not specified.
Data Provenance: Not specified (e.g., country of origin, retrospective or prospective).

3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts

This type of information is not applicable to the performance testing described. The summary indicates physical performance tests of the device itself, not clinical studies requiring expert interpretation of data.

4. Adjudication Method for the Test Set

Not applicable. The summary refers to performance testing of the device, not a clinical study involving human assessment and adjudication.

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

No, an MRMC comparative effectiveness study was not done. This 510(k) is for a physical device (ligator), not a diagnostic AI algorithm.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

No, a standalone (algorithm only) performance study was not done. This is a physical medical device, not an algorithm.

7. The Type of Ground Truth Used

For the described performance testing, the "ground truth" would be the engineering specifications and established performance characteristics of the predicate device. The tests would confirm that the modified device's performance aligns with these objective standards.

8. The Sample Size for the Training Set

Not applicable. This device is not an AI/ML algorithm that requires a training set. The performance testing involves physical samples of the device.

9. How the Ground Truth for the Training Set Was Established

Not applicable. As above, there is no "training set" for this type of device.

Summary of Device Performance and Study:

The 510(k) summary states that "The Auto-Band Ligator was subjected to relevant performance testing. The results of the performance testing demonstrated the safety and effectiveness of the device." For a Special 510(k) for a material change and product line expansion, "performance testing" would typically involve:

Functional testing: To ensure the band release mechanism, snap fixation system, and other features work correctly with the new band material and in the new 6/8 band configurations.
Material properties testing: To ensure the new latex formulation meets required physical properties (e.g., elasticity, strength, durability) and biocompatibility standards.
Dimensional verification: To confirm the new 6 and 8 band configurations fit and function as intended within the existing device design.

The claim of substantial equivalence relies on demonstrating that these modifications do not alter the fundamental technological characteristics, safety, or effectiveness established by the predicate device (Scandimed International Auto-Band Ligator #K031236 and #K081142). The details of these tests, including sample sizes and specific criteria, are not provided in this public summary.

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K Number

K081142

Device Name

AUTO-BAND LIGATOR

Manufacturer

SCANDIMED INTERNATIONAL

Date Cleared

2008-05-16

(24 days)

Product Code

MND

Regulation Number

876.4400

Type

Special

Panel

Gastroenterology/Urology

Reference & Predicate Devices

K031236

Intended Use

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

Device Description

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.

AI/ML Overview

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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