(59 days)
The device is intended for the retrieval and removal of excised gallbladders, or other similar tissue specimens, during the course of laparoscopic surgery.
The device consists of a polyurethane specimen container used in conjunction with a stainless steel cone retractor. The excised gallbladder, or other similar tissue specimen, is placed within the specimen bag. The bag is then brought within the confines of the cone retractor. The cone retractor is then used to shield the specimen during trans-abdominal extraction. The device can operate through a variety of trocar port sizes down to 5mm. The device is manually powered and controlled. It is composed of biologically safe materials. It is supplied sterile and intended for single use only.
The provided text describes a 510(k) submission for the DeGall II Laparoscopic Gallbladder Extractor. However, it does not include detailed acceptance criteria or a specific study proving the device meets those criteria in the format requested.
The document states: "The device has been subjected to in-vitro and in-vivo testing which demonstrate the ability of the device to withdraw and contain specimens under conditions in excess of those encountered during normal clinical use." This is a general statement about testing without detailing specific acceptance criteria, method, or results.
Therefore, I cannot provide a table of acceptance criteria and reported device performance, nor can I answer questions 2 through 9 as the necessary information is not present in the provided text.
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DEC 1 9 2003
510(k) SUMMARY OF SAFETY & EFFECTIVENESS
9 9 K
| SUBMITTER | Surgicon, Inc.400 Long Beach Blvd. - Stratford, CT 06615 |
|---|---|
| CONTACT PERSON | Curt RaymondDirector, Regulatory & QualitySurgicon, Inc.400 Long Beach Blvd. - Stratford, CT 06615 |
| DATE PREPARED | October 16, 2003 |
| CLASSIFICATION | Applicable product code(s): GCIApplicable CFR reference(s): 21 CFR 876.1500Classification: Class II |
| COMMON NAME | Laparoscopic specimen container |
| PROPRIETARYNAME | DeGall II Laparoscopic Gallbladder Extractor |
| PREDICATE DEVICE | Surgicon DeGall Gallbladder Extractor (K021747) |
| DEVICEDESCRIPTION | The device consists of a polyurethane specimen containerused in conjunction with a stainless steel cone retractor. Theexcised gallbladder, or other similar tissue specimen, isplaced within the specimen bag. The bag is then broughtwithin the confines of the cone retractor. The cone retractoris then used to shield the specimen during trans-abdominalextraction. The device can operate through a variety oftrocar port sizes down to 5mm. The device is manuallypowered and controlled. It is composed of biologically safematerials. It is supplied sterile and intended for single useonly. |
| INTENDED USE | The device is intended for the retrieval and removal ofexcised gallbladders, or other similar tissue specimens,during the course of laparoscopic surgery. |
| TESTING | The device has been subjected to in-vitro and in-vivo testingwhich demonstrate the ability of the device to withdraw andcontain specimens under conditions in excess of thoseencountered 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 (301) 594-4659. 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 (800) 638-2041 or (301) 443-6597 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
er
gic
K03354
§ 876.1500 Endoscope and accessories.
(a)
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.(b)
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.