LAPORT

K092584 · Mgb Endoskopische Gerate GmbH (Berlin) · GCJ · Mar 22, 2010 · Gastroenterology, Urology

Device Facts

• Record ID: K092584
• Device Name: LAPORT
• Applicant: Mgb Endoskopische Gerate GmbH (Berlin)
• Product Code: GCJ · Gastroenterology, Urology
• Decision Date: Mar 22, 2010
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 876.1500
• Device Class: Class 2

Intended Use

The MGB LAPORT sterile Trocars for Endoscopic surgery are intended to establish a path of entry for endoscopic abdominal, for use during general, gynaecological and thoracic minimally invasive procedures or to gain access through tissue planes and/or potential spaces for endoscopic instruments.

Device Story

LAPORT is a sterile trocar system designed to establish a port of entry for endoscopic instruments during minimally invasive abdominal, gynecological, and thoracic surgeries. The device facilitates access through tissue planes and potential spaces. It is intended for use by trained surgeons in an operating room environment. The device functions as a mechanical access tool; it does not involve electronic processing, software, or automated analysis. It provides a stable conduit for the insertion and manipulation of endoscopic instruments, enabling visualization and surgical intervention while maintaining pneumoperitoneum or access integrity. The device benefits patients by enabling minimally invasive surgical techniques, which typically result in reduced trauma, faster recovery, and smaller incisions compared to open surgery.

Clinical Evidence

Bench testing only.

Technological Characteristics

Mechanical trocar system for endoscopic access. Materials and dimensions are standard for surgical instrumentation. Non-powered, manual device. Sterilization is required for clinical use.

Indications for Use

Indicated for patients undergoing general, gynecological, or thoracic minimally invasive endoscopic procedures requiring a path of entry for instruments.

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 10903 New Hampshire Avenue Document Control Room W-O66-0609 Silver Spring, MD 20993-0002

MGB Endoskopische Gerate % Mr. Patrick Gaensicke Schwarzschildstrasse 6 D-12489 Berlin, Germany

MAR 2 2 2010

Re: K092584

Trade/Device Name: LAPORT Regulation Number: 21 CFR 876.1500 Regulation Name: Endoscope and accessories Regulatory Class: Class II Product Code: GCJ Dated: March 11, 2010 Received: March 15, 2010

Dear Mr. Gaensicke:

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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you; however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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); medical device reporting (reporting of medical

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Page 2 - Mr. Patrick Gaensicke

device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

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/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

Mark N. Molkerson

Mark N. Melkerson Director Division of Surgical, Orthopedic And Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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## Indications for Use

510(k) Number (if known): K092584

LAPORT / Trocar for laparoscopic procedures Device Name:

Indications For Use: The MGB LAPORT sterile Trocars for Endoscopic surgery are intended to establish a path of entry for endoscopic abdominal, for use during general, instruments gynaecological and thoracic minimally invasive procedures or to gain access through tissue planes and/or potential spaces for endoscopic instruments.

MGB Endoskopische Geräte GmbH Berlin Schwarzschildstraße B D-12489 Berlin, Germany

Prescription Use (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use (21 CFR 801 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Ned R.P. Gilen for nxm

(Division Sign-Off) Division of Surgical, Orthopedic, and Restorative Devices

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510(k) Number K092584