VIDEO SCIENCES BRS-5000 VIDEO BRONCHOSCOPE WITH ENDOSHEATH SYSTEM, DPU-5000/DPU-5050 VIDEO PROCESSOR & ACCESSORIES

K091768 · Vision-Sciences, Inc. · EOQ · Aug 3, 2009 · Ear, Nose, Throat

Device Facts

• Record ID: K091768
• Device Name: VIDEO SCIENCES BRS-5000 VIDEO BRONCHOSCOPE WITH ENDOSHEATH SYSTEM, DPU-5000/DPU-5050 VIDEO PROCESSOR & ACCESSORIES
• Applicant: Vision-Sciences, Inc.
• Product Code: EOQ · Ear, Nose, Throat
• Decision Date: Aug 3, 2009
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 874.4680
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The bronchoscope and EndoSheath® Technology are designed to be used for upper airway management: including endoscopic treatment, diagnosis, and intubation of the airways. The digital video processor is intended for use with the VSI flexible video scope.

Device Story

The BRS-5000 is a flexible video bronchoscope 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 captures visual data from the airway, which is transmitted to the digital video processor for display on a monitor. It is intended for use by clinicians in clinical settings for airway management, diagnosis, and treatment. The output allows the physician to visualize the airway anatomy in real-time to guide diagnostic or therapeutic procedures and facilitate intubation. The use of a disposable sheath aims to reduce the risk of cross-contamination between patients.

Clinical Evidence

No clinical data. Bench testing only, including electrical safety, thermal, and EMC testing.

Technological Characteristics

Flexible video bronchoscope with digital video processor and disposable EndoSheath® protective barrier. Patient contact materials are identical to K072088. System includes image visualization and capture capabilities. Sterilization is not required for the single-use EndoSheath®; the scope is designed for compatibility with the sheath system.

Indications for Use

Indicated for patients requiring upper airway management, including endoscopic treatment, diagnosis, and intubation of the airways.

Regulatory Classification

Identification

A bronchoscope (flexible or rigid) and accessories is a tubular endoscopic device with any of a group of accessory devices which attach to the bronchoscope and is intended to examine or treat the larynx and tracheobronchial tree. 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 rigid ventilating bronchoscope, rigid nonventilating bronchoscope, nonrigid bronchoscope, laryngeal-bronchial telescope, flexible foreign body claw, bronchoscope tubing, flexible biopsy forceps, rigid biopsy curette, flexible biopsy brush, rigid biopsy forceps, flexible biopsy curette, and rigid bronchoscope aspirating tube, but excludes the fiberoptic light source and carrier.

Predicate Devices

• Flexible Trans-Nasal Esophagoscope with Digital Video Processor and Disposable EndoSheath® Systems (K072088)
• Flexible Fiberoptic Bronchoscope with Disposable EndoSheath (K021344)

Reference Devices

• Olympus Tracheal Intubation Fiberscope (K981543)
• Olympus Tracheal Intubation Fibervideoscope (K082720)

Submission Summary (Full Text)

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KO 91768

1100 0 700

510(k) Premarket Notification: Device Modification Video Bronchoscope with Digital Video Processor and BV Slide-On® EndoSheath® Systems

: . . . .

# 510(k) Summary

Date Prepared (21 CFR 807.92(a)(1): June 6, 2009

AUG 0 8 2009

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

| | Vision-Sciences, Inc. |
|-------------------|-----------------------------------------------|
| Address: | 40 Ramland Road South<br>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: | BRS-5000 Video Bronchoscope and BV Slide-On® EndoSheath®<br>Systems with Digital Video Processor |
|------------------------|--------------------------------------------------------------------------------------------------|
| Common/Usual Name: | Flexible Video Bronchoscope with Sheath and Video Processor |
| Product Codes: | EOQ |
| FDA Regulations: | 21 CFR 874.4680 |
| Device Classification: | Class II |

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

K072088 Flexible Trans-Nasal Esophagoscope with Digital Video Processor and Disposable EndoSheath® Systems

K021344 Flexible Fiberoptic Bronchoscope with Disposable EndoSheath

Intubation of the airways for Bronchoscopes has received FDA marketing clearance in the following 510(k) Premarket Notifications:

K981543 Olympus Tracheal Intubation Fiberscope K082720 Olympus Tracheal Intubation Fibervideoscope

Common/Usual Name: Product Codes: FDA Regulations: Device Classification; Premarket Notification: Flexible fiberoptic endoscopes with sheaths and accessories EOB. EOO 21 CFR 874.4760 Class II K050972 / K040984 / K024095 / K942265

#### Device Description

The VSI flexible endoscopes are flexible endoscopes 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 avver 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 bronchoscope and EndoSheath® Technology are designed to be used for upper airway management: including endoscopic treatment, diagnosis, and intubation of the airways.

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K091768

Vision-Sciences, Inc. June 9, 2009

#### 510(k) Premarket Notification: Device Modification Video Bronchoscope with Digital Video Processor and BV Slide-On® EndoSheath® Systems

#### Technological Characteristics

Vision Sciences believes that the subject device is substantially equivalent to the Vision Sciences' predicate devices. The subject device has very similar material composition and working dimensions; and identical viewing direction, image size, bending, re-processing/sterilization method and working dimensions as In addition, the subject device uses the same video processor as Vision Sciences other the predicate. videoscopes.

### Performance Testing

The subject device has been subjected to and passed electrical safety, thermal, and ECM testing requirements. The patient contact materials in the endoscope are identical to the materials used in predicate device (Vision Sciences' TNE-5000 (K072088)).

#### Conclusion

Based on the indications for use, technological characteristics, performance testing and comparison to predicate devices, the VSI flexible video endoscopes with digital video processors and disposable EndoSheath® Systems have been shown to be safe and effective for their intended use.

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### DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle or bird-like figure with three curved lines representing its body and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the bird figure.

## Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

# AUG 0 3 2009

Vision Sciences, Inc c/o Stacie Geffner-Ativa 40 Ramland Road, South Orangeburg, NY 10962

Re: K091768

Trade/Device Name: Flexible Video Bronchoscope Regulation Number: 21 CFR 874.4680 Regulation Name: Bronchoscope and accessories Regulatory Class: Class II Product Code: EOQ Dated: June 11, 2009 Received: June 16, 2009

Dear Ms. Geffner-Atiya:

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 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); medical device reporting of medical device-related adverse events) (21 CFR 803); 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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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/ResourcesforYou/Industry/default.htm.

Sincerely yours,

Signature

Malvina B. Eydelman, M.D. · Director Division of Ophthalmic, Neurological, and Ear, Nose and Throat Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Vision-Sciences, Inc. June 9, 2009

510(k) Premarket Notification: Device Modification Video Bronchoscope with Digital Video Processor and BV Slide-On® EndoSheath® Systems

510(k) Number (if known):

K091718

Video Bronchoscope with Digital Video Processor and BV Slide-On® Device Name: EndoSheath® Systems

The bronchoscope and EndoSheath® Technology are designed to be Indications for Use: used for upper airway management: including endoscopic treatment, diagnosis, and intubation of the airways.

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

Prescription Use X OR Over-the -Counter Use (Per 21 CFR 801 Subpart D) (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)

Page 1 of 1

Karen H. Baker

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

510(k) Number K091768