FLEXILUX II CYSTOSCOPE AND HYSTEROSCOPE

K060899 · Schoelly Imaging, Inc. · FAJ · Mar 2, 2007 · Gastroenterology, Urology

Device Facts

• Record ID: K060899
• Device Name: FLEXILUX II CYSTOSCOPE AND HYSTEROSCOPE
• Applicant: Schoelly Imaging, Inc.
• Product Code: FAJ · Gastroenterology, Urology
• Decision Date: Mar 2, 2007
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 876.1500
• Device Class: Class 2

Intended Use

The Cystoscope is used to visualize the body cavities, hollow organs and canals during diagnostic and, in conjunction with additional instruments, therapeutic procedures. The Hysteroscope is used to permit direct viewing of the cervical canal and the uterine cavity for the purpose of performing diagnostic and surgical procedures.

Device Story

Flexilux II Endoscope is a rigid endoscope featuring a compact objective and rod-lens system. Device consists of an eyepiece, body, light guide, and rod-lens system. Body constructed of surgical stainless steel tubes with light-carrying fibers sandwiched between. Used by physicians in clinical settings for direct visualization of male urethra, prostate, bladder, cervical canal, and uterine cavity during diagnostic and surgical procedures. Device provides optical visualization to the clinician to facilitate surgical intervention or diagnosis. Benefits include direct internal visualization for minimally invasive procedures.

Clinical Evidence

Bench testing only. Compliance established via testing against medical endoscope and medical electrical equipment standards (DIN 58105; IEC 60601-2-18). No clinical data provided.

Technological Characteristics

Rigid endoscope; surgical stainless steel construction; rod-lens optical system; light-carrying fibers. Conforms to ISO standards for biocompatibility. Standards: DIN 58105, IEC 60601-2-18. Non-sterile; requires user sterilization.

Indications for Use

Indicated for visualization of body cavities, hollow organs, and canals (cystoscope) or cervical canal and uterine cavity (hysteroscope) for diagnostic and surgical procedures. Patient population includes individuals requiring urological or gynecological endoscopic examination.

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

• Schölly Laparoscope for General and Plastic Surgery (K992437)
• ASAP Endoscope for Obstetrics and Gynecology (K031974)
• ASAP Endoscope for Gastroenterology and Urology (K031141)

Submission Summary (Full Text)

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Schoelly Imaging, Inc. March 31, 2006

510(k) Premarket Notification (Tra

# 510(k) Summary

# General Company Information

Schoelly Imaging, Inc.

173 Grove Street Worcester, MA 01605 Boni S. Bonneville, Office Administrator 508-425-6989

# General Device Information

| Product Name: | Flexilux II Endoscope |
|-------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Common Name: | Endoscope |
| Classification: | Cystoscope, Diagnostic, Product Code: FAJ, Regulation number<br>876.1500<br>Hysteroscope and Accessories Product code: HIH, Regulation<br>number 884.1720 |
| Predicate Devices | Schölly Laparoscope for General and Plastic Surgery (K992437)<br>ASAP Endoscope for Obstetrics and Gynecology (K031974)<br>ASAP Endoscope for Gastroenterology and Urology (K031141) |

# Indications for Use:

The Flexilux II Cystoscope is - like the predicate device - used to permit direct viewing of the male urethra, prostate, and bladder for purpose of performing diagnostic and surgical procedures.

The Flexilux II Hysteroscope is - like the predicate device - used to illuminate and visualize the cervical canal and the uterine cavity for the purpose of performing diagnostic and surgical procedures.

#### Product Description:

The Flexilux II Hysteroscope and Cystoscope (herein after; Flexilux II Endoscope) are rigid type endoscopes with traditional compact objectives and rod-lens system.

The basic design of the Flexilux II Endoscope is similar to those legally available for sale in the U.S.A... It consists of an eyepiece and the body with light guide and rod-lens system. The body is designed of an outer and an inner tube of surgical stainless steel. The light carrying fibers are sandwiched between these tubes. The inner tube of the body contains the rod-lens system.

# Safety and Performance:

The specifications and intended use of the Flexilux II Endoscope is the same to those of the claimed predicate devices. There are no significant differences between the Flexilux II Endoscope and the claimed predicates in design or conditions of intended use.

MAR 0 2 2007

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K060899
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The Flexilux II Endoscope is constructed of materials of the same specifications as the The Flexilux II Endoscope conforms to predicate devices to ensure biocompatibility. applicable ISO standards.

The device will be sold non-sterilized prior to each procedure by the user. Substantial equivalence for this device was based on a comparison of labeling, physical and performance design characteristics as compared to the predicate devices, as well as on the results of testing to establish compliance with the standards for medical endoscopes and medical electrical equipment (DIN 58105; IEC 60601-2-18).

# Conclusion:

In all respects, the Flexilux II Endoscope is substantially equivalent to one or more rigid endoscopes currently marketed in the USA. It is constructed of materials of the same specifications as the predicate devices to ensure biocompatibility and it conforms to applicable ISO standards.

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Image /page/2/Picture/0 description: The image shows the logo for the U.S. Department of Health and 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 a stylized image of an eagle with its wings spread, symbolizing the department's mission to protect the health of all Americans.

Food and Drug Administration 9200 Corporate Blvd. Rockville MD 20850

Mr. James Bonneville Operations Manager Schoelly Imaging, Inc. 173 Grove Street WORCESTER MA 01605

# MAR 0 2 2007

Re: K060899

Trade/Device Name: Flexilux II Endoscope Regulation Number: 21 CFR §884.1690 Regulation Name: Hysteroscope and accessories Product Code: HIH Regulation Number: 21 CFR §876.1500 Regulation Name: Endoscope and accessories Product Code: FAJ Regulatory Class: II Dated: February 11, 2007 Received: February 13, 2007

Dear Mr. Bonneville:

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 (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.

Image /page/2/Picture/10 description: The image shows a circular logo with the text "1906-2006" at the top. Below the text is a large "FDA" abbreviation. The word "Centennial" is written below the abbreviation. The logo is surrounded by text that is difficult to read due to the image quality.

Protesting and Promoting Public Health

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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 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" (21 CFR 807.97). 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 yours,

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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Schoelly Imaging, Inc. March 31, 2006

510(k) Premarket Notification (Traditional) Flexilux II Endoscope

Page 1 __ of

510(k) Number (if known): K060899

Flexilux II Endoscope Device Name:

Indications for Use:

The Cystoscope is used to visualize the body cavities, hollow organs and canals during diagnostic and, in conjunction with additional instruments, therapeutic procedures.

The Hysteroscope is used to permit direct viewing of the cervical canal and the uterine cavity for the purpose of performing diagnostic and surgical procedures.

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

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 b. lezman
Division Sign Off

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

000008