(342 days)
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.
| Acceptance Criterion (Implicit) | Reported Device Performance |
|---|---|
| Material Safety & Biocompatibility: Materials are safe for patient contact (indirectly, as a barrier). | Not explicitly stated but assumed to be equivalent to predicate, which would have passed these tests. The device is a "protective covering." |
| Sterility: Device is sterile for single-use application. | "Sterile, disposable, protective sheath" is stated. |
| Protective Barrier Function: Effectively covers the patient contact portion of the scope. | "Protective covering for the scope during endoscopic examination." |
| Ease of Use/Disposability: Removed and disposed of following each procedure. | "Sheath is removed and disposed of following each procedure." |
| Functional Equivalence: Performs its intended function similar to predicate. | "Conclusion: Based on the indications for use, technological characteristics, and comparison to predicate devices, the EndoSheath® Systems... have been shown to be safe and effective for their intended use." |
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.
§ 874.4760 Nasopharyngoscope (flexible or rigid) and accessories.
(a)
Identification. A nasopharyngoscope (flexible or rigid) and accessories is a tubular endoscopic device with any of a group of accessory devices which attach to the nasopharyngoscope and is intended to examine or treat the nasal cavity and nasal pharynx. It is typically used with a fiberoptic light source and carrier to provide illumination. The device is made of materials such as stainless steel and flexible plastic. This generic type of device includes the antroscope, nasopharyngolaryngoscope, nasosinuscope, nasoscope, postrhinoscope, rhinoscope, salpingoscope, flexible foreign body claw, flexible biopsy forceps, rigid biopsy curette, flexible biospy brush, rigid biopsy forceps and flexible biopsy curette, but excludes the fiberoptic light source and carrier.(b)
Classification. Class II.