FLEXIBLE HYSTEROSCOPE WITH ENDOSHEATH SYSTEM

K071127 · Vision-Sciences, Inc. · HIH · Nov 16, 2007 · Obstetrics/Gynecology

Device Facts

• Record ID: K071127
• Device Name: FLEXIBLE HYSTEROSCOPE WITH ENDOSHEATH SYSTEM
• Applicant: Vision-Sciences, Inc.
• Product Code: HIH · Obstetrics/Gynecology
• Decision Date: Nov 16, 2007
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 884.1690
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The CST-2000A and Slide-On® EndoSheath® System provides for endoscopic access and examination of the lower urinary tract including the bladder, and using additional accessories, to perform various diagnostic and therapeutic procedures. The CST-2000A and Slide-One EndoSheath® System is used to permit direct viewing of the cervical canal and the uterine cavity for the purpose of performing diagnostic and therapeutic/surgical procedures. Note: The CST-2000A and Slide-On Endosheath System is not indicated for electrosurgical procedures.

Device Story

System comprises flexible fiberoptic endoscope and sterile, single-use protective sheath (EndoSheath®). Device enables direct visualization of lower urinary tract, cervical canal, and uterine cavity. Used by clinicians for diagnostic and therapeutic/surgical procedures. Sheath isolates scope from patient environment, facilitating reuse of scope without traditional high-level disinfection between patients. Output is direct optical visualization for the clinician to guide procedures. Benefits include reduced reprocessing requirements and maintained sterility during examinations.

Clinical Evidence

Bench testing only. Performance testing included sheath burst/leak testing, sheath tensile/elongation testing, sheathed scope articulation testing, sheathed scope image quality evaluation, and scope cycle testing.

Technological Characteristics

Flexible fiberoptic endoscope with sterile, single-use protective sheath. System utilizes optical fiber bundles for image transmission. No electronic or software-based image processing described. Mechanical articulation mechanism. Sterilization of sheath is single-use; scope is reusable.

Indications for Use

Indicated for endoscopic access and examination of the lower urinary tract (bladder) and direct visualization of the cervical canal and uterine cavity for diagnostic and therapeutic/surgical procedures. Not indicated for electrosurgical procedures.

Regulatory Classification

Identification

A hysteroscope is a device used to permit direct viewing of the cervical canal and the uterine cavity by a telescopic system introduced into the uterus through the cervix. It is used to perform diagnostic and surgical procedures other than sterilization. This generic type of device may include obturators and sheaths, instruments used through an operating channel, scope preheaters, light sources and cables, and component parts.

Predicate Devices

• VSI Flexible Cystoscope with Slide-On EndoSheath® System (K040215 & K053560)
• Olympus HYF-P Flexible Fiberoptic Hysteroscope (K891451)

Submission Summary (Full Text)

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## 510(k) Summary

| Trade Name: | Vision-Sciences Flexible Cystoscope with EndoSheath® System<br>(with additional Hysteroscope Indications for Use) | |
|-------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------|
| Sponsor: | Vision-Sciences, Inc.<br>9 Strathmore Road<br>Natick, MA 01760<br>Registration #1223490 | NOV 1 6 2007 |
| Device Common Name: | Hysteroscope with sheath | |
| Regulation &<br>Product Code: | 21 CFR 884.1690 / HIH | |
| Classification: | According to Section 513 of the Federal Food, Drug, and<br>Cosmetic Act, the device classification is Class II. | |
| Predicate Devices: | K040215 & K053560 - VSI Flexible Cystoscope with Slide-On EndoSheath® System<br>Manufactured by:<br>Vision-Sciences, Inc.<br>9 Strathmore Road<br>Natick, MA 01760<br>Olympus HYF-P Flexible Fiberoptic Hysteroscope (K891451) | |

Product Description: The device system described in this 510(k) consists of a flexible, fiberoptic endoscope and sterile, single use protective sheath. This 510(k) adds a hysteroscopy indication to the currently marketed VSI Cystoscope with EndoSheath® System.

#### Indications for Use:

The CST-2000A and Slide-On® EndoSheath® System provides for endoscopic access and examination of the lower urinary tract including the bladder, and using additional accessories, to perform various diagnostic and therapeutic procedures.

The CST-2000A and Slide-One EndoSheath® System is used to permit direct viewing of the cervical canal and the uterine cavity for the purpose of performing diagnostic and therapeutic/surgical procedures.

Note: The CST-2000A and Slide-On Endosheath System is not indicated for electrosurgical procedures.

### Safety and Performance:

Substantial equivalence for scope and sheath for hysteroscopy indications was based on design characteristics, comparison to legally marketed predicate devices, and performance testing included sheath burst/leak testing, sheath tensile/elongation testing, sheathed scope articulation testing, sheathed scope image quality evaluation and scope cycle testing.

#### Conclusion:

Based on the indications for use. technological characteristics, performance testing and comparison to predicate devices, the proposed scope and sheath system has been shown to be safe and effective for its intended use.

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### DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is an abstract symbol resembling an eagle or a stylized human figure, composed of three curved lines.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

# NOV 1 6 2007

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

Re: K071127

Trade Name: Flexible Hysteroscope with EndoSheath® System Regulation Number: 21 CFR §884.1690 Regulation Name: Hysteroscope and accessories Regulatory Class: II Product Code: HIH Dated: October 26, 2007 Received: October 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.

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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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510(k) Number (if known):

Device Name: Flexible Hysteroscope with EndoSheath® System

Indications for Use:

The CST-2000A and Slide-On® EndoSheath® System provides for endoscopic access and examination of the lower urinary tract including the bladder, and using additional accessories, to perform various diagnostic and therapeutic procedures.

The CST-2000A and Slide-On® EndoSheath® System is used to permit direct viewing of the cervical canal and the uterine cavity for the purpose of performing diagnostic and therapeutic/surgical procedures.

Note: The CST-2000A and Slide-On Endosheath System is not indicated for electrosurgical procedures.

Prescription Use AND/OR (Part 21 CFR 801 Subpart D)

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

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Julius Reiner

Division of Reproductive, Abdominal a Radiological Devices 510(k) Number

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