(28 days)
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
| Acceptance Criteria / Test | Reported Device Performance |
|---|---|
| Device Characteristics (Comparison to Predicate Devices) | |
| Sheath Material | Proposed Modified VSI Channel ENT EndoSheath® System: Same as VSI predicate devices. |
| Currently Marketed, Unmodified VSI ENT EndoSheath® System (K990354, K012534): Thermoplastic elastomer. | |
| Currently Marketed, Unmodified VSI Bronchoscope EndoSheath® System (K021344): Thermoplastic elastomer. | |
| Working Channel Material | Proposed Modified VSI Channel ENT EndoSheath® System: Same as VSI predicate devices. |
| Currently Marketed, Unmodified VSI ENT EndoSheath® System (K990354, K012534): Thermoplastic polymer (N/A - no working channel). | |
| Currently Marketed, Unmodified VSI Bronchoscope EndoSheath® System (K021344): Thermoplastic polymer. | |
| Luer Connector Material | Proposed Modified VSI Channel ENT EndoSheath® System: Same as VSI predicate devices. |
| Currently Marketed, Unmodified VSI ENT EndoSheath® System (K990354, K012534): N/A - no luer connector. | |
| Currently Marketed, Unmodified VSI Bronchoscope EndoSheath® System (K021344): Thermoplastic polymer. | |
| Working Channel Diameter | Proposed Modified VSI Channel ENT EndoSheath® System: 2.1 mm. |
| Currently Marketed, Unmodified VSI ENT EndoSheath® System (K990354, K012534): N/A - no working channel. | |
| Currently Marketed, Unmodified VSI Bronchoscope EndoSheath® System (K021344): 2.1 mm. | |
| Working Channel Wall Thickness | Proposed Modified VSI Channel ENT EndoSheath® System: Same as VSI predicate devices. |
| Currently Marketed, Unmodified VSI ENT EndoSheath® System (K990354, K012534): N/A - no working channel. | |
| Currently Marketed, Unmodified VSI Bronchoscope EndoSheath® System (K021344): Thermoplastic polymer. | |
| Working Channel Attachment Method | Proposed Modified VSI Channel ENT EndoSheath® System: Same as VSI predicate devices (family of adhesives as VSI predicate devices). |
| Currently Marketed, Unmodified VSI ENT EndoSheath® System (K990354, K012534): Yes (i.e., attached). | |
| Currently Marketed, Unmodified VSI Bronchoscope EndoSheath® System (K021344): Thermoplastic polymer. | |
| Inflation Port Present | Proposed Modified VSI Channel ENT EndoSheath® System: Identical to VSI predicate devices (Yes). |
| Currently Marketed, Unmodified VSI ENT EndoSheath® System (K990354, K012534): Yes. | |
| Currently Marketed, Unmodified VSI Bronchoscope EndoSheath® System (K021344): VSI Bronchoscope (Yes). | |
| Sheath Thickness | Proposed Modified VSI Channel ENT EndoSheath® System: .002". |
| Currently Marketed, Unmodified VSI ENT EndoSheath® System (K990354, K012534): .002". | |
| Currently Marketed, Unmodified VSI Bronchoscope EndoSheath® System (K021344): .002". | |
| Scope Compatibility | Proposed Modified VSI Channel ENT EndoSheath® System: Vision-Sciences ENT-2000/E-F100, Olympus ENF-P4/P3/P2, Pentax VNL-1330 and FNL-10S/10BS/10P2/10RP3/13S, Welch Allyn RL-150, Karl Storz 11101RP/11101 RP1. |
| Currently Marketed, Unmodified VSI ENT EndoSheath® System (K990354, K012534): Vision-Sciences ENT-2000/E-F100, Olympus ENF-P4/P3/P2, Pentax VNL-1330 and FNL-10S/10BS/10P2/10RP3/13S, Welch Allyn RL-150, Karl Storz 11101RP/11101 RP1. | |
| Currently Marketed, Unmodified VSI Bronchoscope EndoSheath® System (K021344): Vision-Sciences ENT-2000/E-F100. | |
| Attachment/Removal Method | Proposed Modified VSI Channel ENT EndoSheath® System: Slides on and off (no vacuum/pressure source required). |
| Currently Marketed, Unmodified VSI ENT EndoSheath® System (K990354, K012534): Slides on and off (no vacuum/pressure source required). | |
| Currently Marketed, Unmodified VSI Bronchoscope EndoSheath® System (K021344): Slides on and off (no vacuum/pressure source required). | |
| Indications for Use | Proposed Modified VSI Channel ENT EndoSheath® System: For use in flexible, endoscopic examination of the upper airway, vocal cords and/or nasal passages. |
| Currently Marketed, Unmodified VSI ENT EndoSheath® System (K990354, K012534): For use in flexible, endoscopic examination of the upper airway, vocal cords and/or nasal passages. | |
| Currently Marketed, Unmodified VSI Bronchoscope EndoSheath® System (K021344): Is used during flexible endoscopic examination of the trachea and other major passages of the lungs, to gather specimens, and/or to find and endoscopically remove foreign objects from the lungs. The current submission's indications are consistent with the ENT predicate devices. | |
| Safety and Performance Testing (mentioned in text) | |
| Microbial Barrier Testing | Included in Design Validation and Verification planning. |
| Sheath Tensile/Elongation Testing | Included in Design Validation and Verification planning. |
| Sheath Leak/Burst Testing | Included in Design Validation and Verification planning. |
| Compliance to 21 CFR 820.30 Design Control Requirements | Certification provided. |
| Internal Risk Analysis Procedure | Description provided. |
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.
§ 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.