MODIFIED ENDOSHEATH SYSTEM FOR VSI FLEXIBLE CYSTOSCOPE

K053560 · Vision-Sciences, Inc. · FAJ · Mar 16, 2006 · Gastroenterology, Urology

Device Facts

• Record ID: K053560
• Device Name: MODIFIED ENDOSHEATH SYSTEM FOR VSI FLEXIBLE CYSTOSCOPE
• Applicant: Vision-Sciences, Inc.
• Product Code: FAJ · Gastroenterology, Urology
• Decision Date: Mar 16, 2006
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 876.1500
• Device Class: Class 2

Intended Use

The Vision-Sciences Flexible Fiberoptic Cystoscope with EndoSheath® System is indicated 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.

Device Story

System comprises flexible fiberoptic cystoscope and sterile, single-use protective EndoSheath. Device provides visual access to lower urinary tract; clinician operates cystoscope to navigate bladder/urethra. Sheath isolates scope from patient environment, facilitating sterile procedure without traditional high-level disinfection between uses. Output is direct visualization via fiberoptic bundle. Used in clinical settings by urologists/physicians. Benefits include reduced reprocessing time and cross-contamination risk.

Clinical Evidence

Bench testing only. No clinical data provided. Substantial equivalence supported by design verification and validation activities per 21 CFR 820.30.

Technological Characteristics

Flexible fiberoptic cystoscope; sterile single-use protective sheath. Mechanical design for endoscopic access. No electronic or software components described.

Indications for Use

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

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

• VSI CST-Dx Slide-On Cystoscope Sheath (K040215)
• VSI TNE-BxD Slide-On EndoSheath® (K031786)

Submission Summary (Full Text)

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Vision-Sciences, Inc. December 15, 2005

## 510(k) Summary

| Trade Name: | Vision-Sciences Flexible Cystoscope with EndoSheath® System |
|---------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Sponsor: | Vision-Sciences, Inc.<br>9 Strathmore Road<br>Natick, MA 01760<br>Registration #1223490 |
| Device Common Name: | Cystoscope with sheath |
| Classification: | According to Section 513 of the Federal Food, Drug, and<br>Cosmetic Act, the device classification is Class II. |
| Predicate Devices: | K040215 - VSI CST-Dx Slide-On Cystoscope Sheath for use with VSI<br>Flexible Cystoscope<br>K031786 - VSI TNE-BxD Slide-On EndoSheath® for use with VSI<br>Flexible Trans-Nasal Esophagoscope |
| Manufactured by: | 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 cystoscope and sterile, single use protective sheath.

## Indications for Use:

The Vision-Sciences Flexible Fiberoptic Cystoscope with EndoSheath® System is indicated 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.

## Safety and Performance:

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 included modified device labeling, and was addressed through Design Validation and Verification planning.

## Conclusion:

Based on the indications for use, technological characteristics, performance testing and comparison to predicate devices, the proposed modified EndoSheath® System for use with VSI Flexible Cystoscope has been shown to be safe and effective for its intended use.

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MAR 1 6 2006

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Vision-Sciences, Inc. % Ms. Pamela Papineau, RAC Consultant Delphi Medical Device Consulting, Inc. 5 Whitcomb Avenue AYER MA 01432

Re: K053560 Trade/Device Name: Modified EndoSheath® System for VSI Flexible Cystoscope Regulation Number: 21 CFR §876.1500 Regulation Name: Endoscope and accessories Regulatory Class: II Product Code: FAJ Dated: February 27, 2006 Received: March 1, 2006

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 donot 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 (Premarket Approval), 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.

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This letter will allow you to begin marketing your device as described in your Section 510(k) This letter will and w you to begin maneling of substantial equivalence of your device to a legally premarked notification: "The PDA mailig sification 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 If you desire specific advice for your do rochers, 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" (21 CFR Also, picase note the regulation emisor, formation on your responsibilities under the Act from the 807.97). Tou may obtain other general missis. Inc. 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 yours,

Nancy C. Higdon

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. December 15, 2005

510(k) Number (if known):

Device Name: Modified EndoSheath® System for VSI Flexible Cystoscope

Indications for Use:

For endoscopic access and examination of the lower urinary tract including the bladder and, using additional accessories, to perform various diagnostic and therapeutic procedures.

Prescription Use X (Part 21 CFR 801 Subpart D)

ANDIOR

Over-the -Counter Use (21 CFR 807 Subpart D)

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

David A. Larson

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

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