VISION-SCIENCES ENT-5000 VIDEO ENT SCOPE WITH ENDOSHEATH TECHNOLOGY, VISION-SCIENCES DPU-5000/DPU-5050 VIDEO PROCESSOR

K102733 · Vision-Sciences, Inc. · EOB · May 18, 2011 · Ear, Nose, Throat

Device Facts

• Record ID: K102733
• Device Name: VISION-SCIENCES ENT-5000 VIDEO ENT SCOPE WITH ENDOSHEATH TECHNOLOGY, VISION-SCIENCES DPU-5000/DPU-5050 VIDEO PROCESSOR
• Applicant: Vision-Sciences, Inc.
• Product Code: EOB · Ear, Nose, Throat
• Decision Date: May 18, 2011
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 874.4760
• Device Class: Class 2

Intended Use

The flexible ENT-5000 Video ENT Scope with EndoSheath® Technology is intended for use in flexible endoscopic examination of the upper airway, vocal cords and/or nasal passages; and for use in diagnostic arthroscopic and endoscopic procedures to provide illumination and visualization of an interior cavity of the body through either a natural or surgical opening. The digital video processor is intended for use with the VSI flexible video scope.

Device Story

Flexible ENT-5000 video endoscope system; includes digital video processor, display monitor, and optional sterile, single-use EndoSheath® technology. EndoSheath covers insertion tube to provide barrier protection. System captures and displays real-time video images of internal body cavities. Used by clinicians in clinical settings for diagnostic endoscopic and arthroscopic procedures. Provides illumination and visualization of upper airway, vocal cords, nasal passages, and other body cavities. Output viewed on monitor to assist physician in diagnostic assessment. Benefits include enhanced visualization and reduced cross-contamination risk via disposable sheath.

Clinical Evidence

Bench testing only. No clinical data provided. Device passed electrical safety, thermal, and EMC testing requirements. Patient contact materials verified as identical to predicate device (K072073).

Technological Characteristics

Flexible video endoscope with digital video processor and disposable sheath. Materials identical to K072073. Illumination and visualization via fiber optics/digital sensor. Connectivity to external display monitor. System includes optional sterile, single-use protective sheath (with or without working channel).

Indications for Use

Indicated for flexible endoscopic examination of upper airway, vocal cords, and nasal passages; and diagnostic arthroscopic and endoscopic procedures requiring illumination and visualization of body cavities via natural or surgical openings. No specific age or gender restrictions stated.

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

• Modified Flexible ENT Scopes with Digital Video Processor and Disposable EndoSheath® Technology (K072073)
• Avis Surgical Technologies, Inc.: C-MOR Visualization System (K093717)
• Biomet InnerVue™ Diagnostic Scope System (K072879)
• Smith & Nephew Arthroscope (K043395)
• SpineView SpineVu Endoscopic Spine System (SESS™) and SpineVu MiniScope (K081051)

Submission Summary (Full Text)

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Vision-Sciences, Inc. September 16, 2010

Kbiา

ditional Indication 510(k) Premarket Notification: Flexible ENT Scopes with Digital Video Processor and Disposable EndoSheath® Technology

# 510(k) Summary

# Date Prepared (21 CFR 807.92(a)(1): September 8, 2010

1 8 2011 MAY

Owner's Name (21 CFR 807.92(a)(1):

| | Vision-Sciences, Inc. |
|-------------------|----------------------------------|
| Address: | 40 Ramland Road South |
| | Orangeburg, NY 10962 |
| Telephone Number: | [phone] |
| Fax Number: | [phone] |
| Contact Person: | Lillian Quintero; Director QA/RA |

# Trade Name, Common Name, Classification (21 CFR 807.92(a)(2))

| Subject Device Name: | Flexible ENT-5000 Scopes with Digital Video Processor and<br>Disposable EndoSheath® Technology |
|------------------------|------------------------------------------------------------------------------------------------|
| Common/Usual Name: | Flexible Video Endoscope with Sheath and Video Processor |
| Product Codes: | EOB, HRX |
| FDA Regulations: | 21CFR874.4760, 21CFR888.1100 |
| Device Classification: | Class II |

# Predicate Device Names (21 CFR 807.92(a)(3))

Modified Flexible ENT Scopes with Digital Video Processor and Disposable EndoSheath® Technology (K072073)

Avis Surgical Technologies, Inc .: C-MOR Visualization System (K093717)

Biomet InnerVue™ Diagnostic Scope System (K072879)

Smith & Nephew Arthroscope (K043395)

SpineView SpineVu Endoscopic Spine System (SESS™) and SpineVu MiniScope (K081051)

| Common/Usual Name: | Flexible video endoscopes with sheaths and accessories |
|-------------------------|--------------------------------------------------------|
| Product Codes: | EOB, HRX |
| FDA Regulations: | 21CFR874.4760, 21CFR888.1100 |
| Device Classification: | Class II |
| Premarket Notification: | K072073/K093717/K072879/K043395/K081051 |

### Device Description

The VSI endoscopes are flexible endoscopes with connections to a video processor and display monitor. The EndoSheath® Techology for the ENT-5000 are optional, 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 videoscopes for image visualization and capture.

#### Intended Use

The flexible ENT Videoscope with EndoSheath® Technology is intended for use in flexible endoscopic examination of the upper airway, vocal cords and/or nasal passages; and for use in diagnostic arthroscopic and endoscopic procedures to provide illumination and visualization of an interior cavity of the body through either a natural or surgical opening.

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Vision-Sciences, Inc. September 16, 2010

510(k) Premarket Notification: Flexible ENT Scopes with Digital Video Processor and Disposable EndoSheath® Technology

# Technological Characteristics

Vision Sciences believes that the subject device is substantially equivalent to both the Vision Sciences' predicate device, as well as those of other manufacturers, as outlined in this submission. The subject device has very similar functionality and indications as the predicate devices.

# Performance Testing

The subject device has been subjected to and passed electrical safety, thermal, and EMC testing requirements. The patient contact materials in the endoscope are identical to the materials used in predicate device Vision Sciences' ENT-5000 (K072073).

### Conclusion

Based on this request for additional indications for use, and the comparison to predicate devices, the VSI flexible video endoscopes with digital video processor and disposable EndoSheath® Technology have been shown to be safe and effective for their intended use.

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Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002

Vision-Sciences, Inc. % Ms. Lillian Quintero 40 Ramland Road, South Orangeburg, New York 10962

MAY 18 2011

Re: K102733

Trade/Device Name: Flexible ENT-5000 Video ENT Scope with Video Processor and EndoSheath® Regulation Number: 21 CFR 876.1500 Regulation Name: Endoscope and accessories Regulatory Class: Class II Product Code: GCJ, HRX, EOB Dated: April 27, 2011 Received: April 29, 2011

Dear Ms. Quintero:

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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you; however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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

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Page 2 - Ms. Lillian Quintero

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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); 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.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

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/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely yours.

A.g B. nk
for

Mark N. Melkerson Director Division of Surgical, Orthopedic And Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Vision-Sciences, Inc. September 16, 2010

Additional Indications - 510(k) Premarket Notification: Flexible ENT Scopes with Digital Video Processor and Disposable EndoSheath® Technology

510(k) Number (if known):

Flexible ENT-5000 Video ENT Scope with Video Processor and EndoSheath® Device Name: Technology

Indications for Use: The flexible ENT-5000 Video ENT Scope with EndoSheath® Technology is intended for use in flexible endoscopic examination of the upper airway, vocal cords and/or nasal passages; and for use in diagnostic arthroscopic and endoscopic procedures to provide illumination and visualization of an interior cavity of the body through either a natural or surgical opening.

The digital video processor is intended for use with the VSI flexible video scope.

Prescription Use X (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)

Net RP Ogden for mkm
(Division Sign Off)

Division of Surgical, Orthopedic, and Restorative Devices

510(k) Number

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