← Product Code [GCJ](/productcode/GCJ) · K100180 # SURGIQUEST ANCHORPORT SIL KIT (K100180) _Surgiquest, Inc. · GCJ · May 5, 2010 · Gastroenterology, Urology · SESE_ **Canonical URL:** https://fda.innolitics.com/device/K100180 ## Device Facts - **Applicant:** Surgiquest, Inc. - **Product Code:** [GCJ](/productcode/GCJ.md) - **Decision Date:** May 5, 2010 - **Decision:** SESE - **Submission Type:** Traditional - **Regulation:** 21 CFR 876.1500 - **Device Class:** Class 2 - **Review Panel:** Gastroenterology, Urology - **Attributes:** Therapeutic ## Indications for Use The AnchorPort® SIL Kit has applications in abdominal minimally invasive surgical procedures and specifically where the surgeon will make a single skin incision in order to facilitate the use of multiple trocars to establish a port of entry for operating endoscopic instruments. ## Device Story AnchorPort SIL Kit is a disposable surgical trocar and cannula system used in abdominal minimally invasive surgery. Device features an expandable elastomer sheath designed to hold the cannula vertically in place within a single skin incision. System facilitates the creation and maintenance of a port of entry for multiple endoscopic instruments. Used in clinical settings by surgeons; device provides a stable access point while maintaining pneumoperitoneum. Performance is evaluated by surgeons during procedures like cholecystectomy; output is the physical access port itself. Benefits include secure instrument manipulation and efficient port establishment through a single incision. ## Clinical Evidence No human clinical data. Evidence consists of bench testing and in vivo animal studies. Bench testing evaluated leak rates, insertion/removal forces, fixation, and pneumoperitoneum maintenance. Animal study (porcine cholecystectomy) performed by surgeons confirmed device safety and efficacy, demonstrating successful procedure completion with no adverse effects or complications, and performance metrics (insertion, anchoring, pneumoperitoneum maintenance) comparable or superior to predicate devices. ## Technological Characteristics Disposable trocar and cannula kit constructed from biosafe materials. Features an expandable elastomer sheath for vertical cannula fixation. Operates via mechanical insertion into abdominal wall. No energy source required. Standalone device; non-electronic. Sterilization method not specified. ## Regulatory 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. In combination with the general controls of the FD&C Act, the integrated operating table-electromechanical surgical system is subject to the following special controls: 1. (1) Premarket clinical performance testing, or a combination of premarket clinical performance testing and postmarket surveillance (in accordance with special control (2)), must include the following: 1. (i) Objective performance measures (e.g., rate and number of conversions to other surgical modalities, rate of device related adverse events (including tissue injury, hematoma, and increased blood loss), and their severity, cause, and outcomes) must be reported with relevant descriptive comparator performance measures. 2. (ii) The data must demonstrate the performance of the device for providing accurate and precise control of attached surgical instruments in range of clinical conditions relevant to the device's intended use. 3. (iii) The test dataset must include data collected from a patient population representative of the intended patient population under anticipated conditions of use. 2. (2) Data obtained from postmarket surveillance must demonstrate, in consideration of the premarket data obtained in accordance with special control (1), that the device performs in accordance with special control (1), unless FDA determines, based on the totality of the premarket data, that data from postmarket surveillance is not required to demonstrate that the device performs as intended. Such postmarket surveillance must be conducted per a protocol determined appropriate by FDA to demonstrate that the device performs as intended (in consideration of the premarket data obtained in accordance with special control (1)), and must include initiation, enrollment, and reporting requirements to ensure timely periodic updates to FDA on post-market surveillance progress and outcomes. 3. (3) Animal performance testing must evaluate the extent of port site trauma due to repositioning of table during surgical procedures when utilizing robotic minimally invasive and laparoscopic approaches 4. (4) The device manufacturer must develop, and update as necessary, a device-specific use training program that ensures proper device setup/use/shutdown, accurate control of instruments to perform the intended surgical procedures, troubleshooting and handling during unexpected events or emergencies, and safe practices to mitigate use error. 5. (5) The device manufacturer may only distribute the device to facilities that implement and maintain the device-specific use training program and ensure that users of the device have completed the device-specific use training program. (6) Human factors assessment must demonstrate that the user can correctly use the device system across all intended use environments with the provided instructions and training materials, including patient access during normal operating conditions and emergency situations, and effects arising from the integrated nature of the operating table and robotic surgical arms. (7) Labeling must include: (i) A detailed summary of clinical performance testing conducted with the device, including study population, results, adverse events, and comparisons to any comparator groups identified; (ii) A statement in the labeling that the safety and effectiveness for the representative specific procedures was based on evaluation of the device as a surgical tool and did not include evaluation of outcomes related to the treatment of the patient's underlying disease or condition, unless FDA determines that it can be removed or modified based on clinical performance data submitted to FDA; (iii) Identification of compatible devices; (iv) The list of surgical procedures for which the device has been determined to be safe with clinical justification; (v) Reprocessing instructions for reusable components; (vi) A shelf life for any sterile components; (vii) A description of the device-specific use training program; (viii) A statement that the device is only for distribution to facilities that implement and maintain the device-specific use training program and ensure that users of the device have completed the device-specific use training program; and (ix) A summary of any completed postmarket surveillance data collected as required by special control (2), including updated labeling to accurately reflect outcomes observed in postmarket surveillance. (8) Non-clinical performance testing must demonstrate that the device performs as intended under anticipated conditions of use and must include: (i) Device motion accuracy and repeatability; (ii) System testing; (iii) Instrument reliability; (iv) Crosstalk; (v) Table motion control; (vi) Thermal effects on tissue; (vii) User-device interface performance; (viii) Workspace access testing; and (ix) Performance testing with compatible devices. (9) Software verification, validation, and hazard analysis must be performed. (10) Electromagnetic compatibility and electrical, thermal, and mechanical safety testing must be performed. (11) Performance data must demonstrate the sterility of all patient-contacting device components. (12) Performance data must support the shelf life of the device components provided sterile by demonstrating continued sterility and package integrity over the labeled shelf life. (13) Performance data must validate the reprocessing instructions for the reusable components of the device. (14) Performance data must demonstrate that all patient-contacting components of the device are biocompatible. (15) Performance data must demonstrate that all patient-contacting components of the device are non-pyrogenic. (16) The device manufacturer must submit a report to the FDA annually on the anniversary of initial marketing authorization for the device, until such time as FDA may terminate such reporting, which comprises the following information: (i) Cumulative summary, by year, of complaints and adverse events since date of initial marketing authorization; and (ii) Identification and rationale for changes made to the device, labeling, or device specific use training program, which did not require submission of a premarket notification during the reporting period. ## Predicate Devices - SurgiQuest Elastomeric Optical trocar & Cannula ([K063859](/device/K063859.md)) - GelPOINT System ([K090275](/device/K090275.md)) - SILSTM Port ([K082619](/device/K082619.md)) - Surgiport™ Blunt Tip Trocar ([K903419](/device/K903419.md)) - EndoPath III™ Trocar System ([K032676](/device/K032676.md)) ## Submission Summary (Full Text) > This content was OCRed from public FDA records by [Innolitics](https://innolitics.com). If you use, quote, summarize, crawl, or train on this content, cite Innolitics at https://innolitics.com. > > Innolitics is a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices, including [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/). {0}------------------------------------------------ 100180 PAGE 1 of (3) .. SurgiQuest, Inc. 510(K) Notification SurgiQuest AnchorPort® Optical Trocar & Cannula SIL Kit # 510(k) SUMMARY OF SAFETY & EFFECTIVENESS | SUBMITTER | SurgiQuest, Inc.
12 Cascade Boulevard, Suite 2B
Orange, CT 06477
Phone: 203.799.2400 | MAY - 5 2016 | |--------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------| | CONTACT PERSON | Kourosh Azarbarzin
Founder & C.E.O. - SurgiQuest, Inc. | | | DATE PREPARED | January 8, 2010 | | | CLASSIFICATION | Laparoscopic trocar, GCJ
Class: II | | | COMMON NAME | Disposable Endoscopic Optical Trocar & Cannula Kit | | | PROPRIETARY NAME | SurgiQuest AnchorPort® SIL Kit | | | PREDICATE DEVICE | SurgiQuest Elastomeric Optical trocar & Cannula
SurgiQuest, Inc. (Orange, CT)
K 063859 | | | | GelPOINT System
Applied Medical (Rancho Santa Margarita, CA)
k090275 | | | | SILSTM Port
Covidien LP (North Haven, CT)
K082619 | | | | Surgiport™ Blunt Tip Trocar
U.S. Surgical Corp. (Norwalk, CT)
K903419 | | | | EndoPath III™ Trocar System
Ethicon Endo-Surgery, Inc. (Cincinnati, OH)
K032676 | | | DEVICE DESCRIPTION | The subject is a surgical trocar and cannula kit is composed of
biosafe materials. The device incorporates an expandable
elastomer sheath, which serves to hold the cannula vertically in
place during endoscopic surgery. The device is used to create
and maintain a port of entry during endoscopic surgery. It is
fully disposable and is intended for single use only. | | {1}------------------------------------------------ 100180 Page 2 of (3) ### SurgiQuest, Inc. 510(K) NOTIFICATION SurgiQuest AnchorPort® Optical Trocar & Cannula SIL Kit. INDICATIONS The AnchorPort® SIL Kit has applications in abdominal minimally invasive surgical procedures to include single skin incision applications and specifically where the surgeon anticipates using at least three 5mm cannula ports to establish a path of entry for operating endoscopic instruments. NONCLINICAL TESTS SUBMITTED, REFERENCED OR RELIED UPON FOR A DETERMINATION OF SUBSTANTIAL EQUIVALENCE Nonclinical test protocols were designed in order to test the critical performance and safety features of the device. The following bench top tests were performed in order to prove substantial equivalence and test reports are included in the filing: #### Bench Data: - Leak rate without trocars in place, after multiple trocars . in place and after vigorous manipulation of trocars. - . Device insertion and removal evaluation - Minimum size of skin incision . - . Device fixation - . Rigidity / Flexibility - Size / Dimension ● - Sealing Instrument for maintaining insufflation . - Deployment method . In vitro bench top testing has confirmed that the device is substantially equivalent in all manner of operation to the predicate devices sighted in this filing. The tests performed and submitted are those tests sighted in the above section and include method of deployment, fixation, insertion and removal forces, and maintenance of pneumoperitoneum during ordinary use and severe manipulation and incision size. In each case, the device was at least as safe and effective as the predicate. In vivo animal studies were performed, including a porcine cholecysectomy, by surgeons familiar with the predicate device(s). The in vivo testing with the AnchorPort® device demonstrates that the AnchorPort® is safe and effective. In each aspects of device performance the AnchorPort® performed as well as or better than the predicate(s) in the aspects of insertion and removal forces, anchoring and fixation and maintenance of pneumoperitoneum. The clinical outcome of the porcine cholecysectomy was a success with no adverse effects or complications. #### Animal Data: - Ease of port insertion, suturing and time to insert . - . Ease of insertion and withdrawal - . Ability to maintain pneumoperitoneum CONCLUSIONS DRAWN FROM THE NONCLINICAL AND CLINICAL TESTS THAT DEMONSTRATE THAT THE DEVICE IS SAFE, AS EFFECTIVE AND PERFORMS AT LEAST AS SAFELY AND EFFECTIVELY AS THE PREDICATE(S) {2}------------------------------------------------ 100180 Page 3. (3) ### SurgiQuest, Inc. 510(K) NOTIFICATION SurgiQuest AnchorPort® Optical Trocar & Cannula SIL Kit - Ability to manipulate instruments for laparoscopic . surgery - . Ability to conduct a typical laparoscopic procedure: cholecystectomy - . Ability of anchoring plate to hold the ports in position In conclusion, extensive in vivo (animal) testing and in vitro (bench top) testing demonstrates conclusively that the device is substantially equivalent. The device performance was validated using robust engineering test methods and living tissue models and performed at least as safely and effectively as the legally marketed devices sighted in this 510(k) submission. {3}------------------------------------------------ Image /page/3/Picture/0 description: The image shows the text "DEPARTMENT OF HEALTH & HUMAN SERVICES". The text is in all caps and is in a sans-serif font. The text is black and the background is white. The text is centered in the image. Image /page/3/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" around the perimeter. Inside the circle is an abstract image of an eagle. #### Public Health Service Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002 SurgiQuest, Inc. % Mr. Kourosh Azarbarzin C.E.O. 12 Cascade Boulevard, Suite 2B Orange, Connecticut 06477 Re: K100180 Trade/Device Name: SurgiQuest AnchorPort® Single Incision Laparoscopic Kit (SILK) Regulation Number: 21 CFR 876.1500 Regulation Name: Endoscope and accessories Regulatory Class: Class II Product Code: GCJ Dated: April 01, 2010 Received: April 02, 2010 MAY - 5 "010 Dear Mr. Azarbarzin: 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 {4}------------------------------------------------ ### Page 2 - Mr. Kourosh Azarbarzin CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); 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. 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 (800) 638-2041 or (301) 796-7100 or at its Internet address, http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Sincerely yours, for Mark N. Melkerson Director Division of Surgical, Orthopedic And Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {5}------------------------------------------------ PAGE 1 of (1) SURGIQUEST, INC. 510(K) Notification SurgiQuest AnchorPort® Optical Trocar & Cannula SH. Kit ## STATEMENT FOR INDICATIONS FOR USE 510(k) Number: K 100180 Device Name: SurgiQuest AnchorPort® Single Incision Laparoscopic Kit (SILK) Indications for Use: The AnchorPort® SIL Kit has applications in abdominal minimally invasive surgical procedures and specifically where the surgeon will make a single skin incision in order to facilitate the use of multiple trocars to establish a port of entry for operating endoscopic instruments. Prescription Use: Yes DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED Concurrence of CDRH, Office of Device Evaluation Neil R. Dylan Forman Division of Surgical, Orthopedic, and Restorative Devices 510(k) Number K100180 --- **Source:** [https://fda.innolitics.com/device/K100180](https://fda.innolitics.com/device/K100180) **Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices. If you're preparing [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/), [get in touch](https://innolitics.com/contact). **Cite:** Innolitics at https://innolitics.com