TNE-2000 ESOPHAGOSCOPE WITH ECS-D ENDOSHEATH SYSTEM
Device Facts
| Record ID | K031786 |
|---|---|
| Device Name | TNE-2000 ESOPHAGOSCOPE WITH ECS-D ENDOSHEATH SYSTEM |
| Applicant | Vision-Sciences, Inc. |
| Product Code | EOX · Ear, Nose, Throat |
| Decision Date | Aug 5, 2003 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 874.4710 |
| Device Class | Class 2 |
Indications for Use
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 Story
System comprises flexible fiberoptic esophagoscope and sterile, single-use protective EndoSheath®; provides endoscopic visualization of larynx, esophagus, and gastro-esophageal junction; assists in intubation. Sheath slides over scope to provide microbial barrier; no vacuum/pressure source required for installation. Used in clinical settings by physicians; provides direct visualization via fiberoptic pathway. Sheath protects scope from patient contact, reducing reprocessing requirements. Benefits include efficient access and examination of upper GI tract and airway.
Clinical Evidence
Bench testing only. Testing included sheath burst/leak testing, sheath tensile/elongation testing, sheathed scope articulation testing, sheathed scope image quality evaluation, and scope cycle testing.
Technological Characteristics
Flexible fiberoptic esophagoscope with thermoplastic elastomer single-use sheath. Sheath wall thickness 0.002". Scope working length 685 mm; insertion tube OD 3.6 mm (un-sheathed) / 4.8 mm (sheathed). Articulation 180°/90°. Field of view 90°. Microbial barrier provided by sheath. No working channel. Manual installation (slide-on).
Indications for Use
Indicated for endoscopic access and examination of the larynx, esophagus, and gastro-esophageal junction; may assist in intubation. Patient population not explicitly defined by age or gender.
Regulatory Classification
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 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)
- EndoSheath® System for Flexible Fiberoptic Bronchoscope (K021344)
Reference Devices
- Pentax EE-1540 Trans-Nasal Esophagoscope
- Olympus PEF-V Trans-Nasal Esophagoscope
Submission Summary (Full Text)
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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®<br>System |
|------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Sponsor: | Vision-Sciences, Inc.<br>9 Strathmore Road<br>Natick, MA 01760<br>Registration #1223490 |
| Device Common<br>Name: | Esophagoscope with sheath |
| 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>K021344 - EndoSheath® System for Flexible Fiberoptic Bronchoscope |
| | Manufactured by:<br>Vision-Sciences, Inc.<br>9 Strathmore Road<br>Natick, 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:
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.
### 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-2000<br>Trans-Nasal<br>Esophagoscope<br>with EndoSheath®<br>System<br>(Current Submission) | Currently Marketed<br>VSI ENT-2000 with<br>EndoSheath® System<br>(K990354, K012534,<br>K024095) | Currently Marketed<br>VSI Bronchoscope with<br>EndoSheath® System<br>(K021344) | Pentax EE-1540<br>Trans-Nasal<br>Esophagoscope<br>(510(k) # unknown) | Olympus PEF-V<br>Trans-Nasal<br>Esophagoscope<br>(510(k) # unknown) |
|----------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------|
| Sheath material | Same as VSI predicate<br>devices | Thermoplastic elastomer | Thermoplastic elastomer | N/A -- No sheath | N/A -- No sheath |
| Window material | Same as VSI predicate<br>devices | Thermoplastic polymer | Thermoplastic polymer | N/A -- No sheath | N/A -- No sheath |
| Luer connector material | Same as VSI predicate<br>devices | N/A - no luer connector | Thermoplastic polymer | N/A -- No sheath | N/A -- No sheath |
| Proximal connector<br>tubing material | Same as VSI predicate<br>devices | 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 channel<br>materials | N/A - no working channel | N/A - no working channel | Thermoplastic polymer | Unknown | Unknown |
| Adhesives | Same as VSI predicate<br>devices | UV curable | UV curable | Unknown | Unknown |
| Microbial barrier claim | Yes | Yes | Yes | N/A -- No sheath | N/A -- No sheath |
| Sheath installation<br>method | Slides on and off (no<br>vacuum/pressure source<br>required) | Slides on and off (no<br>vacuum/pressure source<br>required) | Slides on and off (no<br>vacuum/pressure source<br>required) | N/A -- No sheath | N/A -- No sheath |
| Sheath Working Length | 27" | 12" | 24" | N/A -- No sheath | N/A -- No sheath |
| Minimum sheath wall<br>thickness | .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 Tube<br>OD | 3.6 mm (w/out sheath)<br>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° (sheathed<br>scope) | 170°/120° (sheathed<br>scope) | 210°/120° | Unknown |
| Angle of View | 90° | 75° | 90° | 140° | Unknown |
| Characteristic | | | | | |
| | Currently Marketed | Currently Marketed | | | |
| Proposed VSI TNE-2000<br>Trans-Nasal<br>Esophagoscope<br>with EndoSheath® System<br>(Current Submission) | VSI ENT-2000 with<br>EndoSheath® System<br>(K990354, K012534,<br>K024095) | VSI Bronchoscope with<br>EndoSheath® System<br>(K021344) | Pentax EE-1540<br>Trans-Nasal<br>Esophagoscope<br>(510(k) # unknown) | Olympus PEF-V<br>Trans-Nasal<br>Esophagoscope<br>(510(k) # unknown) | |
| Indications for Use | For use in endoscopic<br>access and examination of<br>the larynx, esophagus and<br>gastro-esophageal<br>junction. The System<br>may also be used to assist<br>in intubation. | For use in flexible,<br>endoscopic examination<br>of the upper airway, vocal<br>chords and/or nasal<br>passages. | Is used during flexible<br>endoscopic examination<br>of the trachea and other<br>major passages of the<br>lungs, to gather<br>specimens, and/or to find<br>and endoscopically<br>remove foreign objects<br>from the lungs. | For use in endoscopic<br>examination of the<br>larynx, esophagus and<br>gastro-esophageal<br>junction. | For use in endoscopic<br>examination of the<br>larynx, esophagus and<br>gastro-esophageal<br>junction. |
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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:
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 intubation.
(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)
OR
Over-the-Counter Use
Ahalst
Division Slan-Off Nose and Throat De
510(k) Number
