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 System may also be used in conjunction with the Pentax AP-4000 Air Pulse Sensory Stimulator to elicit Laryngeal Closure Reflex (Swallow) and to measure the sensory discrimination threshold at which the reflex occurs in the area of the Upper Airway innervated by the Superior Laryngeal Nerve.

Device Description

The device system described in this 510(k) consists of a sterile, single use protective sheath for use with the VSI ENT-2000 scope.

AI/ML Overview

The provided submission is for a medical device called the "Slide-On™ EndoSheath® System for Sensory Testing." This device is a sterile, single-use protective sheath for an endoscope. The submission states that substantial equivalence was based on design characteristics, comparison to legally marketed predicate devices, and performance testing. However, the document does not describe specific acceptance criteria with numerical targets or a detailed study proving the device met those criteria in a way that aligns with the specific questions about AI/algorithm performance and ground truth establishment.

The provided text focuses on demonstrating substantial equivalence to predicate devices for regulatory approval, rather than presenting a performance study with detailed acceptance criteria and results in the manner requested. The device is a physical sterile sheath, not an AI or algorithmic diagnostic tool, therefore many of the requested fields are not applicable.

Here's an attempt to answer the questions based only on the provided text, highlighting where information is not available or not applicable for this type of device submission:

1. A table of acceptance criteria and the reported device performance

The submission does not provide a table of numerical acceptance criteria for specific performance metrics in the way one would expect for an AI/diagnostic algorithm. Instead, it lists types of performance testing conducted to demonstrate safety and effectiveness for a physical device (sheath). The "acceptance criteria" for a physical device like this are generally that it functions as intended without failure and maintains the integrity required for its purpose (e.g., sterility, protective barrier). The "reported device performance" is a general statement that the testing supported substantial equivalence.

Performance Characteristic	Acceptance Criteria (Implied)	Reported Device Performance
Sheath Burst/Leak Testing	Sheath maintains integrity; no leaks or bursts during use.	Testing conducted to support safety and effectiveness.
Sheath Tensile/Elongation Testing	Sheath material demonstrates adequate strength and flexibility.	Testing conducted to support safety and effectiveness.
Sheathed Scope Articulation Testing	Scope maintains intended articulation while sheathed.	Testing conducted to support safety and effectiveness.
Air Pulse Testing	Device functions correctly with Pentax AP-4000 for sensory testing.	Testing conducted to support safety and effectiveness.
Microbial Barrier Claim	Yes (must function as a microbial barrier).	Yes (claimed in comparison table).
Sheath Installation Method	Easy and effective "slide-on" installation.	Slides on and off (no vacuum/pressure source required).

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

Sample Size for Test Set: Not specified. The document mentions "performance testing" but does not detail the number of units tested for each specific test (burst, tensile, articulation, air pulse).
Data Provenance: Not specified. It's internal company testing (Vision-Sciences, Inc.) but location, retrospective/prospective nature, and specific data origin are not provided.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

Number of Experts & Qualifications: Not applicable. This device is a physical sheath, not an AI or diagnostic algorithm that requires expert-established ground truth for its performance evaluation (e.g., interpreting images or signals). The performance testing described (mechanical integrity, functional use with an endoscope) does not involve expert consensus on diagnostic interpretations.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Adjudication Method: Not applicable for this type of device. Adjudication methods like 2+1 or 3+1 are typically used in clinical studies or performance evaluations for diagnostic algorithms where there is ambiguity in "ground truth" labels. Here, the tests are primarily objective physical or functional assessments.

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

MRMC Study: No. This device is a sterile protective sheath for an endoscope, not an AI system. Therefore, an MRMC comparative effectiveness study involving human readers and AI assistance is not relevant or applicable.

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

Standalone Study: No. This refers to the performance of an algorithm without human interaction. As the product is a physical medical device (sheath), this concept is not applicable.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

Type of Ground Truth: Not applicable in the context of diagnostic performance evaluation. For a physical device like an endosheath, "ground truth" would relate to objectively measurable properties such as material strength, impermeability, or proper mechanical fit, rather than diagnostic labels from expert consensus or pathology. The "ground truth" for these tests are the physical standards and functional requirements of the device.

8. The sample size for the training set

Sample Size for Training Set: Not applicable. This device is a physical product and does not involve a "training set" in the context of machine learning.

9. How the ground truth for the training set was established

Ground Truth for Training Set Establishment: Not applicable, as there is no training set for a physical device like this.

Summary

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K031790

2 2003 JUL

Vision-Sciences, Inc. June 9, 2003

510(k) Premarket Notification: Traditional Slide-On™ EndoSheath® System for Sensory Testing

510(k) Summary

Trade Name:	Vision-Sciences Slide-On™ EndoSheath® System for SensoryTesting
Sponsor:	Vision-Sciences, Inc.9 Strathmore RoadNatick, MA 01760Registration #1223490
Device CommonName:	Endoscope and Accessories - 77EOB
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 ScopesK024095 - Slide-On™ EndoSheath® System for Flexible ENT ScopesManufactured by:Vision-Sciences, Inc.9 Strathmore RoadNatick, MA 01760K964815 - AP-4000 Air Pulse Sensory StimulatorManufactured by:Pentax Precision Instrument Corp.3117 Commerce ParkwayMiramar, FL 33025

Product Description: The device system described in this 510(k) consists of a sterile, single use protective sheath for use with the VSI ENT-2000 scope.

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 cords and/or nasal passages. The System may also be used in conjunction with the Pentax AP-4000 Air Pulse Sensory Stimulator to elicit Laryngeal Closure Reflex (Swallow) and to measure the sensory discrimination threshold at which the reflex occurs in the area of the Upper Airway innervated by the Superior Laryngeal Nerve.

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 and air pulse testing.

Conclusion: Based on the indications for use, technological characteristics, performance testing and comparison to predicate devices, the proposed VSI Slide-On™ EndoSheath® System for Sensory Testing has been shown to be safe and effective for its intended use.

000084

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Vision-Sciences, Inc.
June 9, 2003

/SI Trans-Nasal Esophagoscope with EndoSheath® System

Substantial Equivalence Comparison

Characteristic	Proposed VSI Slide-OnTMEndoSheath® System for SensoryTesting(Current Submission)	Currently Marketed VSI ENT2000 with EndoSheath® System(K990354, K012534-K024095)	Pentax ENL-Series ENT Scopes for usewith AP-4000 Air Pulse SensoryStimulator(K964815)
Sheath material	Same as VSI predicate devices	Thermoplastic elastomer	N/A - No sheath
Window material	Same as VSI predicate devices	Thermoplastic polymer	N/A - No sheath
Luer connector material	Same as VSI predicate devices	N/A - no luer connector	N/A - No sheath
Proximal connectortubing material	Same as VSI predicate devices	Thermoplastic polymer	N/A - No sheath
Air channel ID	N/A - no working channel	N/A - no working channel	1.2 mm
Adhesives	Same as VSI predicate devices	UV curable	Unknown
Microbial barrier claim	Yes	Yes	N/A - No sheath
Sheath installationmethod	Slides on and off (no vacuum/pressuresource required)	Slides on and off (novacuum/pressure source required)	N/A - No sheath
Sheath length	12"	12"	N/A - No sheath
Minimum sheath wallthickness	.002"	.002"	N/A - No sheath
Sheath Packaging	Tyvek/Mylar pouch	Tyvek/Mylar pouch	N/A - No sheath
Scope working length(with sheath)	300 mm	300 mm	300 mm
Scope insertion tube OD(distal tip)	4.1 mm (w/sheath)	3.6 mm	3.4 mm
Articulation (Up/Down)	90°/90° (sheathed scope)	135°/135° (sheathed scope)	130°/130°
Angle of View	75°	75°	75°
Depth of Field	3 - 50 mm	3 - 50 mm	Unknown

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Vision-Sciences, Inc.
June 9, 2003

Proposed VSI Slide-On™EndoSheath® System for SensoryTesting(Current Submission)	Currently Marketed VSI ENT2000 with EndoSheath® System(K990354, K012534, K024095)	Pentax FNL-Series ENT Scopes for usewith AP-4000 Air Pulse SensoryStimulator(K964815)
The EndoSheath® System provides a sterile,disposable protective covering for the scopeto be used during flexible endoscopicexamination of the upper airway, vocalcords and/or nasal passages. The Systemmay also be used in conjunction with thePentax AP-4000 Air Pulse SensoryStimulator to elicit Laryngeal ClosureReflex (Swallow) and to measure thesensory discrimination threshold at whichthe reflex occurs in the area of the UpperAirway innervated by the SuperiorLaryngeal Nerve.	The EndoSheath® Systemprovides a sterile, disposableprotective covering for the scopeto be used during flexibleendoscopic examination of theupper airway, vocal cords and/ornasal passages.	To elicit Laryngeal Closure Reflex (Swallow)and to measure the sensory discriminationthreshold at which the reflex occurs in thearea of the Upper Airway innervated by theSuperior laryngeal Nerve. The structuresbeing stimulated in the area of the UpperAirway innervated by the Superior LaryngealNerve are: the Left and Right Anterior Wallof the Pyriform Sinus and the Left and RightAryepiglottic Folds. The device is intendedto be used with a legally marketed endoscopecompatible with the AP-4000, introduced pernasally in Adult and Pediatric patientpopulations with suspected Dysphagia

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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 stylized caduceus symbol, which is a staff with two snakes entwined around it, topped by a circle. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" are arranged in a circular fashion around the caduceus symbol.

2 2003 JUL

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

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

Re: K031790

Trade/Device Name: Slide-On101 EndoSheath System® for Sensory Testing Regulation Number: 21 CFR 874.4760 Regulation Name: Nasopharyngoscope (flexible or rigid) and accessories Regulatory Class: Class II Product Code: EOB Dated: June 9, 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 (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 - Pamela Papineau

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. Paigy 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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Page

510(k) Number (if known): K031790

Slide-On™ EndoSheath® System for Sensory Testing 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)

1 Prescription Use (Per 21 CFR 801.109)

Over-the -Counter Use

C00007

Kunt Horken
Division Sign-Off

(Division Sign-Off)
Division of Ophthalmic Ear,
Nose and Throat Devises

510(k) Number __

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.