(29 days)
The GelPort Blunt Tip Trocar System is indicated for use in general, abdominal, gynecological and thoracic minimally invasive surgical procedures to establish a path of entry or to gain access through tissue planes, extraperitoneal spaces and/or potential spaces for endoscopic instruments.
The GelPort Blunt Tip Trocar System is a sterile single use device, intended for use in conjunction with Applied's currently marketed Trocar products. A standard trocar assembly consists of an obturator, a seal and a cannula system.
The provided text is a 510(k) summary for a medical device (GelPort Blunt Tip Trocar System) and related FDA correspondence. It does not contain information about acceptance criteria, device performance metrics, or study details (like sample sizes, ground truth establishment, expert qualifications, or MRMC studies) for demonstrating the device meets performance criteria.
Instead, this document focuses on demonstrating substantial equivalence to a predicate device based on performance and functional testing. The key statement is:
"The performance and functional testing of the GelPort Blunt Tip Trocar System compared to its predicate device demonstrated that the GelPort Blunt Tip Trocar System is substantially equivalent to its predicate device and it introduces no new safety and effectiveness issues when used as instructed."
This implies that the device was tested to ensure it functions similarly to the predicate device, but the specific acceptance criteria and results of these tests are not detailed in this summary. The FDA's 510(k) clearance process often relies on demonstrating equivalence rather than establishing new performance benchmarks with clinical studies, especially for devices like trocars.
Therefore, I cannot provide the requested information from the given text.
To answer your prompt, I would need a document that specifically outlines the performance study, its methodology, and its results against predefined acceptance criteria.
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APR 7 2006
510(K) SUMMARY
510(k) NUMBER: PENDING
- SUBMITTED BY: Applied Medical Resources Corporation 22872 Avenida Empresa Rancho Santa Margarita, CA-92688 (949) 713-8000
- CONTACT PERSON: Cheryl Blake Vice President, Regulatory Affairs and Quality Systems
DATE OF PREPARATION: February 7, 2006
NAME OF DEVICE: Blunt Tip Trocar System
CLASSIFICATION NAME: Laparoscope, General & Plastic Surgery (21CFR 876.1500)
TRADE NAME: GelPort® Blunt Tip Trocar System
PREDICATE DEVICE: United States Surgical Blunt Tip Trocar (K924011) Originally filed under Origin Medsystems, Incorporated
INTENDED USE: The GelPort Blunt Tip Trocar System is indicated for use in general, abdominal, gynecological and thoracic minimally invasive surgical procedures to establish a path of entry or to gain access through tissue planes, extraperitoneal spaces and/or potential spaces for endoscopic instruments.
DEVICE DESCRIPTION: The GelPort Blunt Tip Trocar System is a sterile single use device, intended for use in conjunction with Applied's currently marketed Trocar products. A standard trocar assembly consists of an obturator, a seal and a cannula system.
PERFORMANCE DATA SUMMARY: The performance and functional testing of the GelPort Blunt Tip Trocar System compared to its predicate device demonstrated that the GelPort Blunt Tip Trocar System is substantially equivalent to its predicate device and it introduces no new safety and effectiveness issues when used as instructed.
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Image /page/1/Picture/1 description: The image shows a logo with a circular border containing text, surrounding a stylized graphic. The graphic consists of three curved lines that resemble a series of waves or abstract human figures. The text around the border is small and difficult to read, but it appears to be arranged in a circular fashion, following the curve of the border. The logo is black and white.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
APK 7 2006
Applied Medical Resources Corp. c/o Underwriters Laboratories, Inc. Mr. Morten Simon Christensen Staff Engineer & FDA Office Coordinator 455 E. Trimble Road San Jose, California 95131-1230
Re: K060629
Trade/Device Name: GellPort® Blunt Tip Trocar System Regulation Number: 21 CFR 876.1500 Regulation Name: Endoscope and accessories Regulatory Class: II Product Code: GCJ Dated: March 28, 2006 Received: March 29, 2006
Dear Mr. Christensen:
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. Iisting 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 Revister.
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
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Page 2 – Mr. Morten Simon Christensen
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. 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), please contact the Office of Compliance at (240) 276-0115. 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. Melk 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 (if known): __________
Device Name: ___GelPort® Blunt Tip Trocar System
Indications for Use:
The GelPort Blunt Tip Trocar System is indicated for use in general, abdominal, gynecological and thoracic minimally invasive surgical procedures to establish a path of entry or to gain access through tissue planes, extraperitoneal spaces and/or re potin spaces for endoscopic instruments.
Prescription Use X (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 OF
NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
'Malli
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Division of General, Restorative. and Neurological Devices
510(k) Number_Koco629
§ 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.