AED LAPAROSCOPE

K993688 · National Advanced Endoscopy Devices, Inc. · GCJ · Dec 6, 1999 · Gastroenterology, Urology

Device Facts

• Record ID: K993688
• Device Name: AED LAPAROSCOPE
• Applicant: National Advanced Endoscopy Devices, Inc.
• Product Code: GCJ · Gastroenterology, Urology
• Decision Date: Dec 6, 1999
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 876.1500
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

This device is used to provide visual information about the condition of the interior of the pelvic cavity, and visualization of the interior of the abdominal cavity or areas subject to general or plastic surgery for diagnostic and surgical procedures. This device provides information for diagnosis and/or surgical access with only a small incision. The AED line of rigid Laparoscopes is indicated to provide illumination and visualization in: - Diagnostic and operative laparoscopic procedures.

Device Story

AED Laparoscope is a rigid endoscope providing illumination and visualization of pelvic and abdominal cavities. Device facilitates diagnostic and surgical procedures via small incisions. Operated by physicians in clinical or surgical settings. Provides visual feedback to the surgeon to guide surgical access and diagnosis. Benefits include minimally invasive visualization of internal anatomy.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Rigid laparoscope design; optical illumination and visualization system. No electronic, software, or algorithmic components described.

Indications for Use

Indicated for patients undergoing diagnostic and operative laparoscopic procedures requiring visualization and illumination of the pelvic and abdominal cavities or areas subject to general or plastic surgery.

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

DEC - 6 1999

Ms. Gayle M. Butler Compliance Office National Advanced Endoscopy Devices, Inc. 10801 National Boulevard, Suite 603 Los Angeles, California 90064

Re: K993688 Trade Name: AED Laparoscope Regulatory Class: II Product Code: GCJ Dated: October 27, 1999 Received: November 1, 1999

Dear Ms. Butler:

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 (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 the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

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## Page 2 -- Ms. Gayle M. Butler

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.

Hypt. Quarte

James E. Dillard III Acting Director Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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## ATTACHMENT G

Page 1_ of 1_

510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________ Device Name: AED Laparoscope

Indications for Use:

This device is used to provide visual information about the condition of the interior of the pelvic cavity, and visualization of the interior of the abdominal cavity or areas subject to general or plastic surgery for diagnostic and surgical procedures. This device provides information for diagnosis and/or surgical access with only a small incision.

The instructions enclosed with the device state (see Attachment B):

## INDICATIONS FOR USE:

The AED line of rigid Laparoscopes is indicated to provide illumination and visualization in:

- Diagnostic and operative laparoscopic procedures. .
## (PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDHR, Office of Device Evaluation (ODE)

Prescription Use
(Per 21 CFR 801.109)

(Division Sign-Off)

510(k) Number_

Division of General Restorative

OR

Over-The-Counter Use _ (Optional Format)

G-1