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.

Device Description

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.

AI/ML Overview

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.

Summary

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K012543

JUL 1 5 2002

Vision Sciences, Inc. 510(k) Premarket Notification

August 3, 2001 EndoSheath® for Flexible ENT Scopes

510(k) Summary

Pursuant to 512(i)(3)(A) of the Food, Drug and Cosmetic Act, Vision-Sciences, Inc. is required to submit with this Premarket Notification either an "...adequate summary of any information respecting safety and effectiveness or state that information will be made available upon request of any person." VSI chooses to submit a summary of the safety and effectiveness information. The summary is as follows:

Trade Name:	EndoSheath® System for use with ENT Scopes
Owner/Operator:	Vision-Sciences, Inc.9 Strathmore Rd.Natick, MA 01760
Manufacturing Site:	Vision-Sciences, Inc.9 Strathmore Rd.Natick, MA 01760Reg. # 1223490
Device Generic Name:	Nasopharyngo-laryngoscope and accessories
Classification:	According to Section 513 of the Federal Food, Drug, and Cosmetic Act, thedevice classification is Class II, Performance Standards 21 CFR 874.4760;77EOB.
Predicate Devices:	EndoSheath® System for use with ENT Scopes (K990354)Manufactured and distributed by:Vision-Sciences, Inc.9 Strathmore Rd.Natick, MA 01760
	Thermometer CoversMarketed by:Becton Dickinson, Stop & Shop
	Transesophageal Ultrasound Probe CoversMarketed by:Hewlett Packard

Product Description:

Indications for Use:

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.

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Vision Sciences, Inc. 510(k) Premarket Notification

Conclusion:

Based on the indications for use, technological characteristics, and comparison to predicate devices, the EndoSheath® Systems for use with Flexible ENT scopes have been shown to be safe and effective for their intended use.

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized image of an eagle with three human profiles embedded within its body. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the eagle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

'JUL 1 5 2002

Vision Sciences, Inc. c/o Pam Papineau, RAC Delphi Medical Device Consulting 5 Whitcomb Avenue Aver. MA 01432

Re: K012543

Trade/Device Name: Endosheath System Regulation Number: 21 CFR 874.4760 Regulation Name: Nasopharyngoscope and accessories Regulatory Class: Class II Product Code: EOB Dated: June 21, 2002 Received: June 26, 2002

Dear Ms. Papineau:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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Page 2 - Pam Papineau, RAC i

This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 21 CFR Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4613. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address . http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely yours,

A. Ralph Rosenthal

A. Ralph Rosenthal, M.D. Director Division of Ophthalmic and Ear, Nose and Throat Devices Office of Device Evaluation Center for Devices and Radiological Health

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Vision Sciences, Inc. 510(k) Premarket Notification

July 20, 2001 EndoSheath® for Flexible ENT Scopes

Page 1

510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________

Device Name: EndoSheath® System for use with Flexible ENT Scopes

Indications for Use:

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.

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use
(Per 21 CFR 801.109)

on Sign-Off
ion of Ophthalmic Ear, and Throat D vises

K-01 259 Number _

Over-the -Counter Use ________________________________________________________________________________________________________________________________________________________

000005

Regulation Number and Section

§ 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.