SLIDE-ON ENDOSHEATH SYSTEM FOR SENSORY TESTING

K031790 · Vision-Sciences, Inc. · EOB · Jul 2, 2003 · Ear, Nose, Throat

Device Facts

• Record ID: K031790
• Device Name: SLIDE-ON ENDOSHEATH SYSTEM FOR SENSORY TESTING
• Applicant: Vision-Sciences, Inc.
• Product Code: EOB · Ear, Nose, Throat
• Decision Date: Jul 2, 2003
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 874.4760
• Device Class: Class 2
• Attributes: Pediatric

Intended 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.

Device Story

The Slide-On™ EndoSheath® System is a sterile, single-use protective covering for the VSI ENT-2000 flexible endoscope. It functions as a physical barrier during endoscopic examinations of the upper airway, vocal cords, and nasal passages. When used with the Pentax AP-4000 Air Pulse Sensory Stimulator, the sheathed scope allows clinicians to deliver air pulses to the pyriform sinus and aryepiglottic folds to elicit the laryngeal closure reflex (swallow) and measure sensory discrimination thresholds. The device is used in clinical settings by healthcare providers. It benefits patients by providing a sterile barrier, reducing the need for high-level disinfection of the endoscope between procedures, and enabling diagnostic assessment of laryngeal sensory function in patients with suspected dysphagia.

Clinical Evidence

Bench testing only. Performance testing included sheath burst/leak testing, sheath tensile/elongation testing, sheathed scope articulation testing, and air pulse testing to ensure the sheath does not interfere with the function of the endoscope or the sensory stimulator.

Technological Characteristics

Sterile, single-use thermoplastic elastomer sheath with thermoplastic polymer window and luer connector. 12-inch length, 0.002-inch wall thickness. Designed for use with VSI ENT-2000 scope. Provides microbial barrier. Installation is manual (slide-on/off) without vacuum/pressure requirements. No electronic components; purely mechanical accessory.

Indications for Use

Indicated for adult and pediatric patients with suspected dysphagia requiring flexible endoscopic examination of the upper airway, vocal cords, and nasal passages, and for sensory discrimination threshold testing of the upper airway innervated by the superior laryngeal nerve.

Regulatory Classification

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.

Predicate Devices

• Slide-On EndoSheath® for Flexible ENT Scopes (K990354)
• EndoSheath® System for Flexible ENT Scopes (K012543)
• Slide-On™ EndoSheath® System for Flexible ENT Scopes (K024095)
• AP-4000 Air Pulse Sensory Stimulator (K964815)

Submission Summary (Full Text)

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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 Sensory<br>Testing |
|------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Sponsor: | Vision-Sciences, Inc.<br>9 Strathmore Road<br>Natick, MA 01760<br>Registration #1223490 |
| Device Common<br>Name: | Endoscope and Accessories - 77EOB |
| Classification: | According to Section 513 of the Federal Food, Drug, and<br>Cosmetic Act, the device classification is Class II. |
| Predicate Devices: | K990354 - Slide-On EndoSheath® for Flexible ENT Scopes<br>K012543 - EndoSheath® System for Flexible ENT Scopes<br>K024095 - Slide-On™ EndoSheath® System for Flexible ENT Scopes<br>Manufactured by:<br>Vision-Sciences, Inc.<br>9 Strathmore Road<br>Natick, MA 01760<br><br>K964815 - AP-4000 Air Pulse Sensory Stimulator<br>Manufactured by:<br>Pentax Precision Instrument Corp.<br>3117 Commerce Parkway<br>Miramar, 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-OnTM<br>EndoSheath® System for Sensory<br>Testing<br>(Current Submission) | Currently Marketed VSI ENT<br>2000 with EndoSheath® System<br>(K990354, K012534-K024095) | Pentax ENL-Series ENT Scopes for use<br>with AP-4000 Air Pulse Sensory<br>Stimulator<br>(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 connector<br>tubing 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 installation<br>method | Slides on and off (no vacuum/pressure<br>source required) | Slides on and off (no<br>vacuum/pressure source required) | N/A - No sheath |
| Sheath length | 12" | 12" | N/A - No sheath |
| Minimum sheath wall<br>thickness | .002" | .002" | N/A - No sheath |
| Sheath Packaging | Tyvek/Mylar pouch | Tyvek/Mylar pouch | N/A - No sheath |
| Scope working length<br>(with sheath) | 300 mm | 300 mm | 300 mm |
| Scope insertion tube OD<br>(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™<br>EndoSheath® System for Sensory<br>Testing<br>(Current Submission) | Currently Marketed VSI ENT<br>2000 with EndoSheath® System<br>(K990354, K012534, K024095) | Pentax FNL-Series ENT Scopes for use<br>with AP-4000 Air Pulse Sensory<br>Stimulator<br>(K964815) |
|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| The EndoSheath® System provides a sterile,<br>disposable protective covering for the scope<br>to be used during flexible endoscopic<br>examination of the upper airway, vocal<br>cords and/or nasal passages. The System<br>may also be used in conjunction with the<br>Pentax AP-4000 Air Pulse Sensory<br>Stimulator to elicit Laryngeal Closure<br>Reflex (Swallow) and to measure the<br>sensory discrimination threshold at which<br>the reflex occurs in the area of the Upper<br>Airway innervated by the Superior<br>Laryngeal Nerve. | The EndoSheath® System<br>provides a sterile, disposable<br>protective covering for the scope<br>to be used during flexible<br>endoscopic examination of the<br>upper airway, vocal cords and/or<br>nasal passages. | To elicit Laryngeal Closure Reflex (Swallow)<br>and to measure the sensory discrimination<br>threshold at which the reflex occurs in the<br>area of the Upper Airway innervated by the<br>Superior laryngeal Nerve. The structures<br>being stimulated in the area of the Upper<br>Airway innervated by the Superior Laryngeal<br>Nerve are: the Left and Right Anterior Wall<br>of the Pyriform Sinus and the Left and Right<br>Aryepiglottic Folds. The device is intended<br>to be used with a legally marketed endoscope<br>compatible with the AP-4000, introduced per<br>nasally in Adult and Pediatric patient<br>populations with suspected Dysphagia |

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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 [phone]. 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 [phone] or [phone] 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:

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.

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Concurrence of CDRH, Office of Device Evaluation (ODE)

1 Prescription Use (Per 21 CFR 801.109)

OR

Over-the -Counter Use

C00007

Kunt Horken
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Division of Ophthalmic Ear,
Nose and Throat Devises

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