DEGALL LAPAROSCOPIC GALLBLADDER EXTRACTOR

K021747 · Surgicon, Inc. · GCI · Aug 15, 2002 · Gastroenterology, Urology

Device Facts

• Record ID: K021747
• Device Name: DEGALL LAPAROSCOPIC GALLBLADDER EXTRACTOR
• Applicant: Surgicon, Inc.
• Product Code: GCI · Gastroenterology, Urology
• Decision Date: Aug 15, 2002
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 876.1500
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The subject device is intended for the retrieval and removal of the gallbladder in laparoscopic cholecystectomies.

Device Story

DeGall Laparoscopic Gallbladder Extractor consists of introducer and polyurethane specimen container; used during laparoscopic cholecystectomies. Surgeon places excised gallbladder into container; device withdrawn through abdominal access wound created by trocar. Operates through access ports down to 5mm. Manually powered and controlled; single-use; sterile. Facilitates safe removal of gallbladder from abdominal cavity; minimizes risk of specimen spillage during extraction.

Clinical Evidence

Bench testing only. In-vitro and in-vivo testing performed to demonstrate device ability to withdraw and contain specimens under conditions exceeding those encountered during normal clinical use.

Technological Characteristics

Materials: Polyurethane specimen container, biologically safe materials. Form factor: Introducer and container system compatible with 5mm access ports. Energy source: Manually powered. Sterilization: Supplied sterile. Single-use.

Indications for Use

Indicated for patients undergoing laparoscopic cholecystectomy requiring gallbladder retrieval and removal.

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

• Auto Suture Endo Catch Specimen Pouch
• Minogue Xtractor Specimen Retrieval

Submission Summary (Full Text)

{0}------------------------------------------------

## AUG 1 5 2002

SURGICON, INC. E : 099 No Tiploa non

## K021747 510(k) SUMMARY OF SAFETY & EFFECTIVENESS

| SUBMITTER | Surgicon, Inc.<br>400 Long Beach Blvd. - Stratford, CT 06615 |
|-----------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| CONTACT PERSON | Curt Raymond |
| DATE PREPARED | May 21, 2002 |
| CLASSIFICATION | Accessory to laparoscope |
| COMMON NAME | Laparoscopic specimen container |
| PROPRIETARY NAME | DeGall Laparoscopic Gallbladder Extractor |
| PREDICATE DEVICES | Auto Suture Endo Catch Specimen Pouch<br>Minogue Xtractor Specimen Retrieval |
| DEVICE<br>DESCRIPTION | The device consists of an introducer and a polyurethane<br>specimen container into which the excised gallbladder is<br>placed. The device, with the specimen held within, is then<br>withdrawn through the abdominal access wound (previously<br>created by the trocar). The device can operate through a<br>variety of access port sizes down to 5mm. The device is<br>manually powered and controlled. It is composed of<br>biologically safe materials. It is supplied sterile and intended<br>for single use only. |
| INTENDED USE | The subject device is intended for the retrieval and removal<br>of the gallbladder in laparoscopic cholecystectomies. |
| TESTING | The device has been subjected to in-vitro and in-vivo testing<br>which demonstrate the ability of the device to withdraw and<br>contain specimens under conditions in excess of those<br>encountered during normal clinical use. |

{1}------------------------------------------------

Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle or bird symbol, with three curved lines representing the bird's head and body. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular pattern around the bird symbol.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

AUG 1 5 2002

Surgicon, Inc. Curtis Raymond Director, Regulatory & Quality 400 Long Beach Boulevard Stratford, Connecticut 06615

Re: K021747

Trade/Device Name: DeGall Laparoscopic Gallbladder Extractor Regulation Number: 876.1500 Regulation Name: Endoscope and accessories Regulatory Class: Class II Product Code: GCI Dated: May 24, 2002 Received: May 28, 2002

Dear Mr. Raymond:

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.

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.

{2}------------------------------------------------

Page 2 - Mr. Curtis Raymond

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 and additionally 21 CFR Part 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 Part 807.97). Other general information on your responsibilities under the Act may be obtained 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/dsma/dsmamain.html

Sincerely yours,

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

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

Enclosure

{3}------------------------------------------------

## SURGICON. INC. 5 100K) Notification

## KO21747 STATEMENT FOR INDICATIONS FOR USE

The subject device is intended for the retrieval and removal of the gallbladder in laparoscopic cholecystectomies.

Styd Purcle

(Division Sign-Off) Division of General, Restorative and Neurological Devices

510(k) Number__KO ² 1747