The Vision-Sciences Trans-Nasal Esophagoscope with EndoSheath® System is indicated for use in endoscopic access and examination of the larynx, esophagus and gastro-esophageal junction. The System may also be used to assist in intubation.

Device Description

The device system described in this 510(k) consists of a flexible, fiberoptic esophagoscope and sterile, single use protective sheath.

AI/ML Overview

The provided text is a 510(k) Premarket Notification for a medical device (Trans-Nasal Esophagoscope with EndoSheath® System). This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than proving the device meets specific acceptance criteria through a clinical study in the way an AI/ML device would.

Therefore, the requested information elements related to AI model evaluation (acceptance criteria, test set, ground truth, MRMC study, training set) are not applicable to this document.

The document discusses "Safety and Performance" which states: "Substantial equivalence for the new device was based on design characteristics, comparison to legally marketed predicate devices, and performance testing. Performance testing included sheath burst/leak testing, sheath tensile/elongation testing, sheathed scope articulation testing, sheathed scope image quality evaluation and scope cycle testing." However, specific acceptance criteria values and the reported device performance for these tests are not detailed within the provided text. The table in Section {1} compares design characteristics and indications for use between the proposed device and various predicate devices, but it does not present performance data against acceptance criteria.

In summary:

Table of acceptance criteria and reported device performance: Not provided in the document. The document lists types of performance tests conducted (e.g., sheath burst/leak, tensile/elongation, articulation, image quality, scope cycle testing) but does not present the specific acceptance criteria for these tests nor the detailed results obtained.
Sample size used for the test set and data provenance: Not applicable as no clinical study for an AI/ML device is described. This device is an endoscope system.
Number of experts used to establish the ground truth for the test set and qualifications of those experts: Not applicable.
Adjudication method: Not applicable.
Multi Reader Multi Case (MRMC) comparative effectiveness study: Not applicable. This is not an AI/ML device requiring such a study.
Standalone performance (algorithm only without human-in-the loop performance): Not applicable.
Type of ground truth used: Not applicable.
Sample size for the training set: Not applicable.
How the ground truth for the training set was established: Not applicable.

Summary

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031786

5 2003

510(k) Premarket Notification: Traditional Trans-Nasal Esophagoscope with EndoSheath® System

510(k) Summary

Trade Name:	Vision-Sciences Trans-Nasal Esophagoscope with EndoSheath®System
Sponsor:	Vision-Sciences, Inc.9 Strathmore RoadNatick, MA 01760Registration #1223490
Device CommonName:	Esophagoscope with sheath
Classification:	According to Section 513 of the Federal Food, Drug, andCosmetic Act, the device classification is Class II.
Predicate Devices:	K990354 – Slide-On EndoSheath® for Flexible ENT ScopesK012543 - EndoSheath® System for Flexible ENT ScopesK021344 - EndoSheath® System for Flexible Fiberoptic Bronchoscope
	Manufactured by:Vision-Sciences, Inc.9 Strathmore RoadNatick, MA 01760

Product Description: The device system described in this 510(k) consists of a flexible, fiberoptic esophagoscope and sterile, single use protective sheath.

Indications for Use:

Safety and Performance:

Substantial equivalence for the new device was based on design characteristics, comparison to legally marketed predicate devices, and performance testing. Performance testing included sheath burst/leak testing, sheath tensile/elongation testing, sheathed scope articulation testing, sheathed scope image quality evaluation and scope cycle testing

Conclusion:

Based on the indications for use, technological characteristics, performance testing and comparison to predicate devices, the proposed VSI Trans-Nasal Esophagoscope with EndoSheath® System has been shown to be safe and effective for its intended use.

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510(k) Premarket Notification: Tradition: Tradition: Tradition

VSI Trans-Nasal Esophagoscope with EndoSheath® System

System

Characteristic	Proposed VSI TNE-2000Trans-NasalEsophagoscopewith EndoSheath®System(Current Submission)	Currently MarketedVSI ENT-2000 withEndoSheath® System(K990354, K012534,K024095)	Currently MarketedVSI Bronchoscope withEndoSheath® System(K021344)	Pentax EE-1540Trans-NasalEsophagoscope(510(k) # unknown)	Olympus PEF-VTrans-NasalEsophagoscope(510(k) # unknown)
Sheath material	Same as VSI predicatedevices	Thermoplastic elastomer	Thermoplastic elastomer	N/A -- No sheath	N/A -- No sheath
Window material	Same as VSI predicatedevices	Thermoplastic polymer	Thermoplastic polymer	N/A -- No sheath	N/A -- No sheath
Luer connector material	Same as VSI predicatedevices	N/A - no luer connector	Thermoplastic polymer	N/A -- No sheath	N/A -- No sheath
Proximal connectortubing material	Same as VSI predicatedevices	Thermoplastic polymer	Thermoplastic polymer	N/A -- No sheath	N/A -- No sheath
Working channel ID	N/A - no working channel	N/A - no working channel	2.1 mm	2.0 mm	2.0 mm
Working channelmaterials	N/A - no working channel	N/A - no working channel	Thermoplastic polymer	Unknown	Unknown
Adhesives	Same as VSI predicatedevices	UV curable	UV curable	Unknown	Unknown
Microbial barrier claim	Yes	Yes	Yes	N/A -- No sheath	N/A -- No sheath
Sheath installationmethod	Slides on and off (novacuum/pressure sourcerequired)	Slides on and off (novacuum/pressure sourcerequired)	Slides on and off (novacuum/pressure sourcerequired)	N/A -- No sheath	N/A -- No sheath
Sheath Working Length	27"	12"	24"	N/A -- No sheath	N/A -- No sheath
Minimum sheath wallthickness	.002"	.002"	.002"	N/A -- No sheath	N/A -- No sheath
Sheath Packaging	Tyvek/Mylar pouch	Tyvek/Mylar pouch	Tyvek/Mylar pouch	N/A -- No sheath	N/A -- No sheath
Scope Working Length	685 mm	300 mm	550 mm	650 mm	650 mm
Scope Insertion TubeOD	3.6 mm (w/out sheath)4.8 mm (with sheath)	3.6 mm	6.0 mm	5.1 mm	5.3 mm
Articulation (Up/Down)	180°/90° (sheathed scope)	135°/135° (sheathedscope)	170°/120° (sheathedscope)	210°/120°	Unknown
Angle of View	90°	75°	90°	140°	Unknown
Characteristic
	Currently Marketed	Currently Marketed
Proposed VSI TNE-2000Trans-NasalEsophagoscopewith EndoSheath® System(Current Submission)	VSI ENT-2000 withEndoSheath® System(K990354, K012534,K024095)	VSI Bronchoscope withEndoSheath® System(K021344)	Pentax EE-1540Trans-NasalEsophagoscope(510(k) # unknown)	Olympus PEF-VTrans-NasalEsophagoscope(510(k) # unknown)
Indications for Use	For use in endoscopicaccess and examination ofthe larynx, esophagus andgastro-esophagealjunction. The Systemmay also be used to assistin intubation.	For use in flexible,endoscopic examinationof the upper airway, vocalchords and/or nasalpassages.	Is used during flexibleendoscopic examinationof the trachea and othermajor passages of thelungs, to gatherspecimens, and/or to findand endoscopicallyremove foreign objectsfrom the lungs.	For use in endoscopicexamination of thelarynx, esophagus andgastro-esophagealjunction.	For use in endoscopicexamination of thelarynx, esophagus andgastro-esophagealjunction.

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Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized symbol that resembles three abstract human figures or flowing lines.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

AUG - 5 2003

Vision-Sciences, Inc. c/o Pamela Papineau. RAC Delphi Medical Device Consulting, Inc. 5 Whitcomb Avenue Ayer, MA 01432

Re: K031786

Trade/Device Name: Trans-Nasal Esophagoscope with EndoSheath® System Regulation Number: 21 CFR 874.4710 Regulation Name: Esophagoscope (flexible or rigid) and accessories Regulatory Class: Class II Product Code: EOX Dated: June 6, 2003 Received: June 10, 2003

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 (OS) 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 - Pamela Papineau, RAC

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), please contact the Office of Compliance at (301) 594-4613. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act 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. Palgyi kire.. Tbal

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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510(k) Premarket Notification: Traditional Trans-Nasal Esophagoscope with EndoSheath® System

Page of

510(k) Number (if known): 上の3/フ 86

Trans-Nasal Esophagoscope with EndoSheath® System Device Name:

Indications for Use:

(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)

Over-the-Counter Use

Ahalst

Division Slan-Off Nose and Throat De

510(k) Number

Regulation Number and Section

§ 874.4710 Esophagoscope (flexible or rigid) and accessories.

(a)
Identification. An esophagoscope (flexible or rigid) and accessories is a tubular endoscopic device with any of a group of accessory devices which attach to the esophagoscope and is intended to examine or treat esophageal malfunction symptoms, esophageal or mediastinal disease, or to remove foreign bodies from the esophagus. When inserted, the device extends from the area of the hypopharynx to the stomach. It is typically used with a fiberoptic light source and carrier to provide illumination. The device is made of materials such as stainless steel or flexible plastic. This generic type of device includes the flexible foreign body claw, flexible biopsy forceps, rigid biopsy curette, flexible biopsy brush, rigid biopsy forceps and flexible biopsy curette, but excludes the fiberoptic light source and carrier.(b)
Classification. Class II.