Search Results

The EndoSheath® System provides a sterile, disposable protective covering for the scope to be used during flexible endoscopic examination of the upper airway, vocal cords and/or nasal passages.

The device system described in this 510(k) consists of modified sterile, disposable sheaths designed to fit various models of flexible fiberoptic ENT scopes. The use of an EndoSheath® eliminates the need for high-level disinfection of the scope following each procedure. The disposable sheath features a specially designed working channel that allows a "visual-only" diagnostic flexible ENT scope to be utilized as a multipurpose diagnostic and therapeutic device

The Vision-Sciences EndoSheath® System for use with Flexible ENT Scopes is a Class II device. This 510(k) submission is a Special 510(k), representing a device modification. The device is intended to provide a sterile, disposable protective covering for scopes used in flexible endoscopic examination of the upper airway, vocal cords, and/or nasal passages, eliminating the need for high-level disinfection of the scope after each procedure.

1. Table of Acceptance Criteria and Reported Device Performance

The study that proves the device meets the acceptance criteria is detailed as a Special 510(k): Device Modification. This approach relies on demonstrating that the modified device remains substantially equivalent to already legally marketed predicate devices, with testing focused on the changes and ensuring they do not raise new questions of safety or effectiveness.

Evidence of Compliance:

• Design/Materials Comparison (Table D.2): This table directly compares the proposed modified device against the two types of predicate devices (unmodified ENT EndoSheath® Systems and the Bronchoscope EndoSheath® System) across various parameters (material, dimensions, attachment, compatibility, indications for use). The "Same as VSI predicate devices" or "Identical to VSI predicate devices" entries indicate that for those characteristics, the modified device maintains the established performance and safety profiles of the predicates. Where there are differences (e.g., the addition of a working channel and its specific dimensions), the comparison highlights how the modified device aligns with elements already present in other predicate devices (like the bronchoscope sheath which has a working channel).
• Validation Testing: The submission states that "Validation testing including microbial barrier testing, sheath tensile/elongation testing and sheath leak/burst testing is included in Design Validation and Verification planning." This indicates that these critical performance aspects, which directly relate to the primary function of a protective barrier, were specifically assessed for the modified device. While specific results are not provided in this summary, the inclusion in rigorous "Design Validation and Verification planning" implies that the tests were conducted with predefined acceptance criteria.
• Compliance to Design Control Requirements: The certification of compliance to 21 CFR 820.30 Design Control requirements and the description of the internal Risk Analysis procedure are fundamental in demonstrating that the device development process followed established regulatory standards for ensuring safety and performance of medical devices.

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

The provided text does not specify a numerical sample size for any test set.
The data provenance is not explicitly stated as a country of origin. The study is described as a "Special 510(k): Device Modification," which typically involves internal validation testing by the manufacturer (Vision-Sciences, Inc., located in Natick, MA, USA, based on the sponsor address) to demonstrate compliance with design control requirements and substantial equivalence to predicate devices. The studies mentioned (microbial barrier, tensile/elongation, leak/burst testing) would have been conducted to evaluate the device's physical properties and barrier integrity. The data would likely be prospective as it involves new testing on the modified device, but the comparison to predicate devices draws on previously established data.

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

This document does not mention the involvement of experts for establishing ground truth in the context of a "test set" for performance evaluation related to clinical outcomes or interpretation. The evaluation focuses on physical and functional characteristics of the device and its equivalence to predicates.

4. Adjudication Method for the Test Set

Not applicable. The document describes engineering and performance validation tests (e.g., microbial barrier, tensile strength, leak/burst) rather than a clinical study requiring human interpretation 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

Not applicable. This device is a disposable sheath for an endoscope; it is not an AI-powered diagnostic or assistive tool for human readers.

6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done

Not applicable. This device is a medical device (sheath) and not an algorithm.

7. The Type of Ground Truth Used

The "ground truth" for the performance evaluation in this context is based on engineering specifications, material science, and established performance characteristics of the predicate devices. For example, the ground truth for "sheath thickness" is a precise measurement (.002"). For "microbial barrier," the ground truth would be the ability to prevent microbial passage under specified test conditions, typically against a known standard or regulatory requirement for sterilizing barriers. The ground truth for tensile/elongation and leak/burst tests would be predefined mechanical strength and integrity thresholds.

8. The Sample Size for the Training Set

Not applicable. This device is not an AI/algorithm-based system requiring a training set.

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

Not applicable. This device is not an AI/algorithm-based system requiring a training set.

Ask a specific question about this device

The Vision Sciences EndoSheath® Systems are indicated for use as a protective covering for the scope during endoscopic examination of the upper airway, vocal chords and/or nasal passages.
The EndoSheath® System provides a sterile, disposable protective covering for the scope to be used during flexible endoscopic examination of the upper airway, vocal chords and/or nasal passages.

The VSI ENT EndoSheath® System consists of a sterile, disposable, protective sheath which covers the patient contact portion of the scope during a clinical procedure. The sheath is removed and disposed of following each procedure. This 510(k) addresses modifications to the EndoSheath® System Instruction Manual.

This 510(k) premarket notification for the Vision Sciences EndoSheath® System for Flexible ENT Scopes does not contain information regarding traditional acceptance criteria and detailed study results as one might find for a software or AI/ML-driven medical device.

Instead, this submission is centered on demonstrating substantial equivalence to a previously cleared predicate device, the EndoSheath® System for use with ENT Scopes (K990354), and other cover devices like thermometer and transesophageal ultrasound probe covers. The "study" here is essentially a comparison to predicate devices, focusing on the system's design, materials, and intended use as a protective barrier.

Therefore, many of the requested categories (e.g., sample size for test set, number of experts, MRMC studies, standalone performance, training set details) are not applicable in the context of this device and submission type.

Here’s a breakdown based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

Given that this is a 510(k) for a device demonstrating substantial equivalence to a predicate, and the device is a sterile, disposable protective sheath, the "acceptance criteria" are implicitly tied to maintaining the barrier function and not introducing new safety or effectiveness concerns compared to the predicate. No explicit numerical acceptance criteria for performance metrics (like sensitivity, specificity, accuracy) are reported in this document, as it's not a diagnostic or AI/ML device.

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

• Sample Size: Not applicable. This submission relies on demonstrating substantial equivalence to predicate devices, not on a clinical "test set" in the traditional sense for performance evaluation.
• Data Provenance: Not applicable. The "data" are primarily descriptive (device characteristics, intended use) and comparative to existing predicate devices. No patient data or geographical data provenance is discussed.

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

• Not applicable. This submission does not involve expert-established ground truth for a diagnostic test set.

4. Adjudication Method for the Test Set

• Not applicable. There is no "test set" and thus no adjudication method described.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

• No, not applicable. MRMC studies are typically performed for diagnostic imaging devices or AI/ML systems to assess reader performance with and without assistance. This device is a sterile sheath.

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

• No, not applicable. This is not an algorithm or AI/ML device. Its function is as a physical barrier.

7. The Type of Ground Truth Used

• Not applicable. No ground truth in the context of diagnostic accuracy is relevant or discussed for this device. The "ground truth" for substantial equivalence is the safety and effectiveness profile of the predicate device.

8. The Sample Size for the Training Set

• Not applicable. This is not an AI/ML device and therefore does not have a "training set."

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

• Not applicable. As above, no training set.

Summary Rationale for "Not Applicable" Responses:

This 510(k) submission for the Vision Sciences EndoSheath® System for Flexible ENT Scopes is for a Class II medical device (a protective, disposable sheath). The core of a 510(k) submission, especially for a relatively simple device like this, is to demonstrate substantial equivalence to legally marketed predicate devices. This means showing that the new device has the same intended use as a predicate, and the same technological characteristics, or if the technological characteristics are different, that they do not raise new questions of safety and effectiveness and the device is as safe and effective as the predicate.

Therefore, the submission focuses on description and comparison rather than extensive clinical trials or performance studies involving patient cohorts, expert adjudication, or AI model performance metrics. The study referenced "comparison to predicate devices" focuses on the physical and functional attributes relevant to its use as a protective barrier.

Ask a specific question about this device