MVM 7.5 FRENCH FLEXIBLE CHOLEDOCHOSCOPE

K972926 · KARL STORZ Endoscopy-America, Inc. · FBN · Oct 8, 1997 · Gastroenterology, Urology

Device Facts

• Record ID: K972926
• Device Name: MVM 7.5 FRENCH FLEXIBLE CHOLEDOCHOSCOPE
• Applicant: KARL STORZ Endoscopy-America, Inc.
• Product Code: FBN · Gastroenterology, Urology
• Decision Date: Oct 8, 1997
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 876.1500
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The KSEA MVM 7.5 French Choledochoscope is designed to be used by qualified surgeons and physicians for general cholecystic and choledochal surgical procedures.

Device Story

The Karl Storz MVM 7.5 French Choledochoscope is a flexible, fiber optic endoscope designed for visualization of the gall bladder and bile duct. It consists of an endoscope module and a video module that connects to a camera control unit. Used by surgeons and physicians in clinical settings, the device facilitates diagnostic and therapeutic procedures when paired with additional accessories. The device provides real-time visual feedback to the clinician, aiding in surgical decision-making and enabling minimally invasive interventions within the biliary system.

Clinical Evidence

No clinical data provided; substantial equivalence is based on design and intended use comparisons.

Technological Characteristics

Flexible fiber optic endoscope; body contact portions composed of medical grade polyurethane; connects to external camera control unit for video imaging.

Indications for Use

Indicated for examination of the gall bladder and bile duct, and, using additional accessories, to perform various diagnostic and therapeutic procedures in patients requiring cholecystic and choledochal surgical intervention.

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.

Submission Summary (Full Text)

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Image /page/0/Picture/0 description: The image shows the logo for Karl Storz Endoscopy. The logo consists of the word "STORZ" in a stylized font, with a circle in the middle of the "O". Below the word "STORZ" is the text "Karl Storz Endoscopy" in a smaller, simpler font. The background of the image is black, and the logo and text are white.

## 510(k) SUMMARY OF SAFETY AND EFFECTIVENESS

This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of the Safe Medical Devices Act (SMDA) of 1990 and 21 CFR 807.92. All data included in this document is accurate and complete to the best of KSEA's knowledge.

| Applicant: | Karl Storz Endoscopy - America, Inc.<br>600 Corporate Pointe Drive<br>Culver City, CA 90230<br>[phone] |
|------------------------|---------------------------------------------------------------------------------------------------------------|
| Contact: | Kevin Kennan<br>Senior Regulatory Affairs Specialist |
| Device Identification: | Common Name:<br>Video Endoscope |

Trade Name: (optional) Karl Storz MVM 7.5 French Choledochoscope

Indication: The KSEA MVM 7.5 French Choledochoscope is designed to be used by qualified surgeons and physicians for general cholecystic and choledochal surgical procedures.

Device Description: The KSEA MVM 7.5 French Choledochoscope is comprised of a video module, and a endoscope module. The endoscope module is a flexible, fiber optic endoscope. The video module is an imaging device which connects to a camera control unit. The body contact portions of the KSEA MVM 7.5 French Choledochoscope are composed of medical grade polyurethane, which is commonly used in medical devices for a wide range of applications and has a long history of biocompatibility for human use.

Substantial Equivalence: The KSEA MVM 7.5 French Choledochoscope is substantially equivalent to the predicate devices since the basic features, design and intended uses are the same. The minor differences between the KSEA MVM 7.5 French Choledochoscope and the predicate devices raise no new issues of safety and effectiveness, as these design differences have no affect on the performance, function or intended use of the devices.

Signed:
Kevin Kennan

Senior Regulatory Affairs Specialist

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

OCT - 8 1997

Mr. Kevin Kennan Senior Regulatory Affairs Specialist Karl Strorz Endoscopy-America, Inc. 600 Corporate Pointe Culver City, California 90230-7600

Re: K972926

MVM 7.5 French Flexible Choledochoscope Dated: August 6, 1997 Received: August 8, 1997 Regulatory class: II 21 CFR §876.1500/Product code: 78 FBN

Dear Mr. Kennan:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act). You may, therefore, 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 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 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under Radiation Control provisions, or other Federal laws or regulations.

This letter will allow you to begin marketing your device as described in your 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 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/dsmamain.html".

Sincerely yours.

William Yu

Lillian Yin, Ph.D. Director, Division of Reproductive, Abdominal, Ear, Nose and Throat, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Image /page/2/Picture/0 description: The image shows the logo for Storz Karl Storz Endoscopy. The logo is in black and white and features the word "STORZ" in large, bold letters. Below the word "STORZ" is the phrase "Karl Storz Endoscopy" in smaller letters. The logo is simple and easy to read.

510(k) Number (if known): Not yet assigned

Device Name: MVM 7.5 French Flexible Choledochoscope

Indications for Use: This instrument is indicated for examination of the gall bladder and bile duct, and, using additional accessories, to perform various diagnostic and therapeutic procedures.

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------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------Concurrence of CDRH, Office of Device Evaluation (ODE) (Division Sign-Off) Division of Reproductive, Abdominal, ENT, and Radiological Devices K972926 510(k) Number_ OR Over-The-Counter Use: Prescription Use: (Per 21 CFR 801.109) (Optional Format 1-2-96)

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