VISION-SCIENCES CST-5000 VIDEO CYSTOSCOPE WITH ENDOSHEATH SYSTEM

K072180 · Vision-Sciences, Inc. · FAJ · Dec 18, 2007 · Gastroenterology, Urology

Device Facts

• Record ID: K072180
• Device Name: VISION-SCIENCES CST-5000 VIDEO CYSTOSCOPE WITH ENDOSHEATH SYSTEM
• Applicant: Vision-Sciences, Inc.
• Product Code: FAJ · Gastroenterology, Urology
• Decision Date: Dec 18, 2007
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 876.1500
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The flexible video cystoscope with digital video processor and disposable sheath system is intended for use in endoscopic access and examination of the lower urinary tract, including the bladder and, using additional accessories, to perform various diagnostic and therapeutic procedures. The digital video processor is intended for use with the VSI flexible video scope.

Device Story

Flexible video cystoscope connects to digital video processor and display monitor; utilizes sterile, single-use EndoSheath® systems to cover insertion tube. Sheaths available with or without working channel. System enables visualization and capture of images during lower urinary tract examinations. Used by clinicians in clinical settings for diagnostic and therapeutic procedures. Output displayed on monitor for real-time physician guidance and clinical decision-making. Benefits include sterile barrier protection and visualization capabilities for urological access.

Clinical Evidence

Bench testing only. Evidence includes biocompatibility testing, system-level functional and performance testing of the scope/sheath/processor assembly, and software validation conducted under 21 CFR 820.30 design controls.

Technological Characteristics

Flexible video cystoscope with digital video processor; sterile, single-use protective EndoSheath® system; video imaging chain; connectivity to display monitor. Design controls per 21 CFR 820.30.

Indications for Use

Indicated for endoscopic access and examination of the lower urinary tract, including the bladder, and for performing diagnostic and therapeutic procedures in patients requiring such urological interventions.

Regulatory Classification

Identification

An endoscope and accessories is a device used to provide access, illumination, and allow observation or manipulation of body cavities, hollow organs, and canals. The device consists of various rigid or flexible instruments that are inserted into body spaces and may include an optical system for conveying an image to the user's eye and their accessories may assist in gaining access or increase the versatility and augment the capabilities of the devices. Examples of devices that are within this generic type of device include cleaning accessories for endoscopes, photographic accessories for endoscopes, nonpowered anoscopes, binolcular attachments for endoscopes, pocket battery boxes, flexible or rigid choledochoscopes, colonoscopes, diagnostic cystoscopes, cystourethroscopes, enteroscopes, esophagogastroduodenoscopes, rigid esophagoscopes, fiberoptic illuminators for endoscopes, incandescent endoscope lamps, biliary pancreatoscopes, proctoscopes, resectoscopes, nephroscopes, sigmoidoscopes, ureteroscopes, urethroscopes, endomagnetic retrievers, cytology brushes for endoscopes, and lubricating jelly for transurethral surgical instruments. This section does not apply to endoscopes that have specialized uses in other medical specialty areas and that are covered by classification regulations in other parts of the device classification regulations.

Special Controls

*Classification* —(1)*Class II (special controls).* The device, when it is an endoscope disinfectant basin, which consists solely of a container that holds disinfectant and endoscopes and accessories; an endoscopic magnetic retriever intended for single use; sterile scissors for cystoscope intended for single use; a disposable, non-powered endoscopic grasping/cutting instrument intended for single use; a diagnostic incandescent light source; a fiberoptic photographic light source; a routine fiberoptic light source; an endoscopic sponge carrier; a xenon arc endoscope light source; an endoscope transformer; an LED light source; or a gastroenterology-urology endoscopic guidewire, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 876.9.(2) Class I for the photographic accessories for endoscope, miscellaneous bulb adapter for endoscope, binocular attachment for endoscope, eyepiece attachment for prescription lens, teaching attachment, inflation bulb, measuring device for panendoscope, photographic equipment for physiologic function monitor, special lens instrument for endoscope, smoke removal tube, rechargeable battery box, pocket battery box, bite block for endoscope, and cleaning brush for endoscope. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807of this chapter, subject to the limitations in § 876.9.

Predicate Devices

• Flexible Fiberoptic Cystoscope with EndoSheath® Systems (K040215)
• Flexible Fiberoptic Cystoscope with EndoSheath® Systems (K053560)

Submission Summary (Full Text)

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Vision-Sciences, Inc. June 27, 2007

Special 510(k) Premarket Notification (Bundled): Device Modification Modified Flexible Videoscopes with EndoSheath® Systems

# 510(k) Summary

K072/80

Owner's Name: Address:

Telephone Number: Fax Number: Contact Person:

#### Subject Device Name:

Common/Usual Name:

Product Codes: FDA Regulations: Device Classification:

#### Predicate Device Name:

Common/Usual Name: Product Codes: FDA Regulations: Device Classification: Premarket Notification:

#### Device Description

Vision-Sciences, Inc. 40 Ramland Road South Orangeburg, NY 10962 [phone] [phone] Lillian Quintero; Director QA/RA

DEC 1 8 2007

Flexible Video Cystosope with Digital Video Processor and Disposable EndoSheath® Systems Flexible video endoscopes with video processor and disposable sheaths FAJ 21 CFR 876.1500 Class II

Flexible Fiberoptic Cystoscope with EndoSheath® Systems Flexible fiberoptic cystoscope with sheaths and accessories FAJ 21 CFR 876.1500 Class II K040215 / K053560

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 video cystoscope with digital video processor and disposable sheath system is intended for use in endoscopic access and examination of the lower urinary tract, including the bladder and, using additional accessories, to perform various diagnostic and therapeutic procedures.

## 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 biocompatibility testing, 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 cystoscope 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

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# Public Health Service

DEC 1 8 2007

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Vision-Sciences, Inc. c/o Pamela Papineau. RAC Delphi Medical Device Consulting 5 Whitcomb Avenue AYER MA 01432

Re: K072180

Trade/Device Name: Video Cystoscope with Digital Video Processor and EndoSheath® Systems Regulation Number: 21 CFR §876.1500 Regulation Name: Endoscope and accessories Regulatory Class: II Product Code: FAJ, FED and FFS Dated: November 16, 2007 Received: November 20, 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, Orug and Cosmetic act (Act) that do not require approval of a premarket approval application (MA), 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.

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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.

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 one of the following numbers, based on the regulation number at the top of this letter.

| 21 CFR 876.xxxx | (Gastroenterology/Renal/Urology) | 240-276-0115 |
|-----------------|----------------------------------|--------------|
| 21 CFR 884.xxxx | (Obstetrics/Gynecology) | 240-276-0115 |
| 21 CFR 892.xxxx | (Radiology) | 240-276-0120 |
| Other | | 240-276-0100 |

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 [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely vours,

Nancy C. Brogdon

Nancy C. Brogdon Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Vision-Sciences, Inc. July 27, 2007

Special 510(k) Premarket Notification: Device Modification Modified Flexible Cystoscope with Digital Video Processor and Disposable EndoSheath® Systems

510(k) Number (if known):

): K 072/80

Flexible Video Cystoscope with Digital Video Processor and Disposable Device Name: EndoSheath® Systems

Indications for Use:

The flexible video cystoscope with EndoSheath® System is intended for use in endoscopic access and examination of the lower urinary tract, including the bladder and, using additional accessories, to perform various diagnostic and therapeutic procedures.

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)

Helena

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(Division Sign-Off) Division of Reproductive, Abdomina Radiological Devices 510(k) Number

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