← Product Code [EOX](/submissions/EN/subpart-e%E2%80%94surgical-devices/EOX) · K072088 # FLEXIBLE TRANS-NASAL VIDEO ESOPHAGOSCOPE WITH DIGITAL VIDEO PROCESSOR AND DISPOSABLE ENDOSHEATH SYSTEMS (K072088) _Vision-Sciences, Inc. · EOX · Aug 29, 2007 · Ear, Nose, Throat · SESE_ **Canonical URL:** https://fda.innolitics.com/submissions/EN/subpart-e%E2%80%94surgical-devices/EOX/K072088 ## Device Facts - **Applicant:** Vision-Sciences, Inc. - **Product Code:** [EOX](/submissions/EN/subpart-e%E2%80%94surgical-devices/EOX.md) - **Decision Date:** Aug 29, 2007 - **Decision:** SESE - **Submission Type:** Special - **Regulation:** 21 CFR 874.4710 - **Device Class:** Class 2 - **Review Panel:** Ear, Nose, Throat ## Intended Use The flexible trans-nasal video esophagoscope with EndoSheath® System is intended for use in endoscopic access and examination of the larynx, esophagus and gastroesophageal junction. The system may also be used to aid in intubation. The digital video processor is intended for use with the VSI flexible video scope. ## Device Story The device is a flexible trans-nasal video esophagoscope used with a digital video processor and sterile, single-use EndoSheath® systems. The EndoSheath covers the insertion tube to provide a protective barrier. The system connects to a display monitor for real-time visualization. It is operated by clinicians in a clinical setting to perform endoscopic examinations of the larynx, esophagus, and gastro-esophageal junction, or to assist in intubation. The video processor captures and displays images, allowing the physician to visualize anatomy, guide the scope, and make clinical decisions based on the visual findings. The disposable sheath design aims to reduce cross-contamination risks between patients. ## Clinical Evidence No clinical data. Substantial equivalence is supported by bench testing, including functional and performance testing of the scope, sheath, and processor system, and software validation conducted under design control requirements. ## Technological Characteristics Flexible endoscope with digital video processor and sterile, single-use protective EndoSheath® systems. Features include video image capture and display capabilities. Complies with 21 CFR 820.30 design control requirements. ## Regulatory 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 - Flexible Fiberoptic Trans-Nasal Esophagoscope with EndoSheath® Systems ([K031786](/device/K031786.md)) ## Submission Summary (Full Text) > This content was OCRed from public FDA records by [Innolitics](https://innolitics.com). If you use, quote, summarize, crawl, or train on this content, cite Innolitics at https://innolitics.com. > > Innolitics is a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices, including [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/). {0}------------------------------------------------ KO 72088 Vision-Sciences, Inc. Special 510(k) Premarket Notification: Device Modification July 27, 2007 Modified Trans-Nasal Esophagoscope with Digital Video Processor and Disposable EndoSheath® Systems # 510(k) Summary AUG 2 9 2007 | Owner's Name: | Vision-Sciences, Inc. | |-------------------------|----------------------------------------------------------------------------------------------------------------| | Address: | 40 Ramland Road South
Orangeburg, NY 10962 | | Telephone Number: | (845) 365-0600 | | Fax Number: | (845) 365-0620 | | Contact Person: | Lillian Quintero; Director QA/RA | | Subject Device Name: | Modified Flexible Trans-Nasal Esophagoscope with Digital Video
Processor and Disposable EndoSheath® Systems | | Common/Usual Name: | Flexible video endoscope with video processor and disposable sheaths | | Product Codes: | EOX | | FDA Regulations: | 21 CFR 874.4710 | | Device Classification: | Class II | | Predicate Device Name: | Flexible Fiberoptic Trans-Nasal Esophagoscope with EndoSheath®
Systems | | Common/Usual Name: | Flexible fiberoptic endoscope with sheaths and accessories | | Product Codes: | EOX | | FDA Regulations: | 21 CFR 874.4710 | | Device Classification: | Class II | | Premarket Notification: | K031786 | ### Device Description The VSI flexible endoscope is a flexible endoscope with connections to a video processor and display monitor. The EndoSheath® Systems are sterile, single-use protective sheath systems, with or without a working channel, that are intended to cover the entire insertion tube of the videoscope. The digital video processors are used with the flexible videoscope for image visualization and capture. ### Intended Use The flexible trans-nasal video esophagoscope with digital video processor and disposable sheath system is intended for use in endoscopic access and examination of the larynx, esophagus and gastro-esophageal junction. The system can also be used to aid in intubation. ## Performance Testing This submission is a Special 510(k): Device Modification as described in FDA's guidance document entitled "The New 510(k) Paradigm - Alternate Approaches to Demonstrating Substantial Equivalence in Premarket Notifications." In support of this 510(k), Vision-Sciences has provided certification of compliance to 21 CFR 820.30 Design Control requirements, and a description of the internal Risk Analysis procedure. V & V activities, including scope/sheath/processor system functional and performance testing, and software validation was addressed through comprehensive Design Validation and Verification planning. #### Conclusion Based on the indications for use, technological characteristics, performance testing and comparison to predicate devices, the VSI flexible video TNE endoscope with digital video processors and disposable EndoSheath® Systems have been shown to be safe and effective for their intended use. {1}------------------------------------------------ Image /page/1/Picture/1 description: The image shows the seal of the Department of Health & Human Services - USA. The seal is circular, with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. In the center of the seal is a stylized image of a caduceus, a symbol often associated with medicine and healthcare. The caduceus is depicted with a staff entwined by two snakes and topped with wings. Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850 Vision-Sciences, Inc. c/o Ms. Pamela Papineau, RAC Delphi Medical Device Consulting, Inc. 5 Whitcomb Ave. Ayer, MA 01432 AUG 2 9 2007 Re: K072088 Trade/Device Name: Flexible Trans-Nasal Esophagoscope with Digital Video Processor and Disposable EndoShealth® Systems Regulation Number: 21 CFR 874.4710 Regulation Name: Esophagoscope (flexible or rigid) and accessories Regulatory Class: Class II Product Code: EOX Dated: July 27, 2007 Received: July 30, 2007 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. {2}------------------------------------------------ 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 Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html. Sincerely vours. M.B. Egelkus, MD Malvina B. Eydelman, M.D. Director Division of Ophthalmic and Ear. Nose and Throat Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {3}------------------------------------------------ Vision-Sciences, Inc. cial 510(k) Premarket Notification: Device Modification July 27, 2007 Modified Trans-Nasal Esophagoscope with Digital Video Processor and Disposable EndoSheath® Systems 510(k) Number (if known): Device Name: Flexible Trans-Nasal Video Esophagoscope with Digital Video Processor and Disposable EndoSheath® Systems Indications for Use: The flexible trans-nasal video esophagoscope with EndoSheath® System is intended for use in endoscopic access and examination of the larynx, esophagus and gastroesophageal junction. The system may also be used to aid in intubation. The digital video processor is intended for use with the VSI flexible video scope. Prescription Use _____________________________________________________________________________________________________________________________________________________________ (Per 21 CFR 801 Subpart D) OR Over-the -Counter Use (Per 21 CFR 801 Subpart C) (PLEASE DO NOT WRITE BELOW THIS LINE – CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE) Thabolil (Division Sign-On) Division of Ophthalmic Ear, Division of Nose and Throat Devises K072088 Number **510(k) Number** Page 1 of 1 --- **Source:** [https://fda.innolitics.com/submissions/EN/subpart-e%E2%80%94surgical-devices/EOX/K072088](https://fda.innolitics.com/submissions/EN/subpart-e%E2%80%94surgical-devices/EOX/K072088) **Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices. 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