DEGALL II GALLBLADDER EXTRACTOR

K033359 · Surgicon, Inc. · GCJ · Dec 19, 2003 · Gastroenterology, Urology

Device Facts

• Record ID: K033359
• Device Name: DEGALL II GALLBLADDER EXTRACTOR
• Applicant: Surgicon, Inc.
• Product Code: GCJ · Gastroenterology, Urology
• Decision Date: Dec 19, 2003
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 876.1500
• Device Class: Class 2

Intended Use

The device is intended for the retrieval and removal of excised gallbladders, or other similar tissue specimens, during the course of laparoscopic surgery.

Device Story

DeGall II Laparoscopic Gallbladder Extractor is a manual surgical instrument used during laparoscopic procedures. It consists of a polyurethane specimen container and a stainless steel cone retractor. During surgery, the surgeon places the excised gallbladder or tissue into the specimen bag, which is then drawn into the cone retractor. The retractor shields the specimen during trans-abdominal extraction through trocar ports (5mm or larger). The device is single-use and sterile. It facilitates safe tissue removal, minimizing potential contamination or trauma to the port site during extraction.

Clinical Evidence

No clinical data. Bench testing (in-vitro and in-vivo) demonstrated the device's ability to withdraw and contain specimens under conditions exceeding those encountered during normal clinical use.

Technological Characteristics

Materials: Polyurethane (specimen container), stainless steel (cone retractor). Operation: Manually powered and controlled. Form factor: Compatible with trocar port sizes down to 5mm. Sterilization: Supplied sterile. Single-use.

Indications for Use

Indicated for the retrieval and removal of excised gallbladders or similar tissue specimens during laparoscopic surgery in patients undergoing such procedures.

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

• Surgicon DeGall Gallbladder Extractor (K021747)

Submission Summary (Full Text)

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DEC 1 9 2003

## 510(k) SUMMARY OF SAFETY & EFFECTIVENESS
9 9 K

| SUBMITTER | Surgicon, Inc.<br>400 Long Beach Blvd. - Stratford, CT 06615 |
|-----------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| CONTACT PERSON | Curt Raymond<br>Director, Regulatory & Quality<br>Surgicon, Inc.<br>400 Long Beach Blvd. - Stratford, CT 06615 |
| DATE PREPARED | October 16, 2003 |
| CLASSIFICATION | Applicable product code(s): GCI<br>Applicable CFR reference(s): 21 CFR 876.1500<br>Classification: Class II |
| COMMON NAME | Laparoscopic specimen container |
| PROPRIETARY<br>NAME | DeGall II Laparoscopic Gallbladder Extractor |
| PREDICATE DEVICE | Surgicon DeGall Gallbladder Extractor (K021747) |
| DEVICE<br>DESCRIPTION | The device consists of a polyurethane specimen container<br>used in conjunction with a stainless steel cone retractor. The<br>excised gallbladder, or other similar tissue specimen, is<br>placed within the specimen bag. The bag is then brought<br>within the confines of the cone retractor. The cone retractor<br>is then used to shield the specimen during trans-abdominal<br>extraction. The device can operate through a variety of<br>trocar port sizes down to 5mm. The device is manually<br>powered and controlled. It is composed of biologically safe<br>materials. It is supplied sterile and intended for single use<br>only. |
| INTENDED USE | The device is intended for the retrieval and removal of<br>excised gallbladders, or other similar tissue specimens,<br>during the course of laparoscopic surgery. |
| 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. |

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Image /page/1/Picture/1 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 text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is an abstract symbol resembling an eagle or bird in flight, composed of three curved lines.

Public Health Service

DEC 1 9 2003

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Mr. Curt Raymond Director, Regulatory and Quality Surgicon, Inc. 400 Long Beach Boulevard Stratford, Connecticut 06615

Re: K033359

Trade/Device Name: DeGall II Laparoscopic Gallbladder Extractor Regulation Number: 21 CFR 876.1500 Regulation Name: Endoscope and accessories Regulatory Class: II Product Code: GCJ Dated: October 20, 2003 Received: October 21, 2003

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 rer assession to May 28, 1976, the enactment date of the Mcdical 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 Codc 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 or any I vith all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 ClFR Part 801); good manufacturing practice requirements as sct 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.

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Page 2 - Mr. Curt 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 premated 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 [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 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/dsma/dsmamain.html

Sincerely yours,

Mark N Millman

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

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## Indications for Use

510(k) Number: K033359

Device Name: Surgicon DeGall II Laparoscopic Gallbladder Extractor

Indications for Use: The device is intended to assist in the retrieval and removal of excised gallbladders, or other similar tissue specimens, during the course of laparoscopic surgery.

Prescription Use: Yes

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

for Murle N Milham

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K03354