MEDIVISION LAPAROSCOPE

K984434 · Medivision Scope Service Center, Inc. · GCJ · Mar 17, 1999 · Gastroenterology, Urology

Device Facts

• Record ID: K984434
• Device Name: MEDIVISION LAPAROSCOPE
• Applicant: Medivision Scope Service Center, Inc.
• Product Code: GCJ · Gastroenterology, Urology
• Decision Date: Mar 17, 1999
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 876.1500
• Device Class: Class 2

Intended Use

The MediVision Laparoscope is intended to be used by qualified physicians to provide access, illumination and visualization of body cavities, hollow organs and canals during closed, or minimally-invasive surgical procedures. These include, but are not limited to, laparoscopic, procedures such as cholecystectomy, colon resection or therapeutic thoracoscopy applications with appropriate thoracoscopic cannulas. The laparoscope may be attached to hand --held camera so that the surgical area may be effectively visualized by the physician on a remote color monitor. The laparoscope is designed to pass through standard laparoscopic and thoracoscopic 10mm cannulas to gain access to the subject surgical site.

Device Story

MediVision Laparoscope is a rigid endoscope designed for minimally-invasive surgery. Device provides illumination and visualization of internal body cavities, organs, and canals. Operates by passing through standard 10mm laparoscopic or thoracoscopic cannulas. Features an interface for attachment to a handheld camera, allowing real-time visualization on a remote color monitor for the surgeon. Used in clinical settings (OR) by physicians to facilitate surgical procedures like cholecystectomy or colon resection. Enhances surgical precision by providing direct visual access to the operative site.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Rigid endoscope; 10mm diameter form factor compatible with standard cannulas; optical illumination and visualization system; designed for integration with external handheld camera and remote monitor systems.

Indications for Use

Indicated for use by qualified physicians for access, illumination, and visualization of body cavities, hollow organs, and canals during minimally-invasive surgical procedures, including cholecystectomy, colon resection, and therapeutic thoracoscopy.

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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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAR 1 7 1999

Mr. Wayne Sterner Regulatory Affairs Manager Medivision Scope Service Center, Inc. 1440 South State College Boulevard, Suite 1D Anaheim, California 92806

K984434 Re: Trade Name:MediVision Laparoscope Regulatory Class: II Product Code: GCJ Dated: February 15, 1999 Received: February 19, 1999

Dear Mr Sterner:

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 Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act). 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 895. A substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (OS) 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 the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

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## Page 2 - Mr. Wayne Sterner

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,

Celia M. Witten, Ph.D., M.D.
Director

Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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510(k) Number (if known):

Device Name: MEDI VISION LAPAROSCOPE

Indications For Use:

## INDICATIONS FOR USE-MEDIVISION LAPAROSCOPE

The MediVision Laparoscope is intended to be used by qualified physicians to provide access, illumination and visualization of body cavities, hollow organs and canals during closed, or minimally-invasive surgical procedures. These include, but are not limited to, laparoscopic, procedures such as cholecystectomy, colon resection or therapeutic thoracoscopy applications with appropriate thoracoscopic cannulas. The laparoscope may be attached to hand --held camera so that the surgical area may be effectively visualized by the physician on a remote color monitor. The laparoscope is designed to pass through standard laparoscopic and thoracoscopic 10mm cannulas to gain access to the subject surgical site.

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Concurrence of CDRH, Office of Device Evaluation (ODE)

| (Division Sign-Off) | |
|-----------------------------------------|---------|
| Division of General Restorative Devices | |
| 510(k) Number | K984434 |

Prescription Use (Per 21 CFR 801.109)

OR

Over-The-Counter Use

(Optional Formal 1-2-96)