← Product Code [GCJ](/submissions/GU/subpart-b%E2%80%94diagnostic-devices/GCJ) · K071571 # SURGIQUEST AIRSEAL OPTICAL TROCAR & CANNULA SYSTEM (K071571) _Surgiquest, Inc. · GCJ · Jul 30, 2007 · Gastroenterology, Urology · SESE_ **Canonical URL:** https://fda.innolitics.com/submissions/SU/subpart-b%E2%80%94diagnostic-devices/GCJ/K071571 ## Device Facts - **Applicant:** Surgiquest, Inc. - **Product Code:** [GCJ](/submissions/GU/subpart-b%E2%80%94diagnostic-devices/GCJ.md) - **Decision Date:** Jul 30, 2007 - **Decision:** SESE - **Submission Type:** Traditional - **Regulation:** 21 CFR 876.1500 - **Device Class:** Class 2 - **Review Panel:** Gastroenterology, Urology ## Intended Use The SurgiQuest AirSeal™ Optical Trocar & Cannula System has applications in abdominal and thoracic minimally invasive surgical procedures to establish a path of entry for endoscopic instruments. The trocar may be used with or without visualization for primary and secondary insertions. ## Device Story Device is a surgical trocar and cannula system for endoscopic surgery; creates/maintains port of entry. Incorporates gas seal using CO2 to maintain pneumoperitoneum; includes reusable recirculation and filtration pump to minimize CO2 consumption. Trocar/cannula and tube set are disposable/single-use. Used in OR by surgeons. System maintains pneumoperitoneum during surgery, facilitating instrument access and visualization. ## Clinical Evidence Bench testing only. Device tested for ability to create and maintain port of entry and maintain adequate pneumoperitoneum during simulated laparoscopic surgery. Sterility validation performed per ISO 11137:2006 and AAMI TIR 27:2001 to achieve SAL of 10^-6. ## Technological Characteristics Medical grade materials; disposable trocar/cannula; reusable recirculation/filtration pump. CO2 gas seal mechanism. Standards: IEC60601-1 (safety), IEC60601-1-2 (EMC), ISO 11137:2006 (sterilization), AAMI TIR 27:2001 (radiation sterilization). ## 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. ## Predicate Devices - Surgiport™ Blunt Tip Trocar ([K903419](/device/K903419.md)) - EndoPath III Trocar System ([K032676](/device/K032676.md)) - Elastomeric Optical Trocar & Cannula ([K063859](/device/K063859.md)) - LapEvac Filtration Device for the Pneumoperitoneum ([K052797](/device/K052797.md)) - Sun Medical Smoke / Fluid Evacuation System ([K911154](/device/K911154.md)) ## Related Devices - [K083211](/device/K083211.md) — AIRSEAL OPTICAL TROCAR & CANNULA SYSTEM · Surgiquest, Inc. · Dec 15, 2008 - [K960810](/device/K960810.md) — BALLOON CANNULA 15MM X 35MM,15MM X 55MM, 10/12MM X 55MM,10/12MM X 35MM,5MM X 35MM,2MM X 35MM · Marlo Surgical Technology · Oct 21, 1996 - [K964123](/device/K964123.md) — REUSABLE TROCAR WITH SLEEVE (COMMON) · Pilling Weck Group · Dec 12, 1996 - [K223593](/device/K223593.md) — Inno-Port Disposable Bladeless Trocar, Inno-Port Disposable Optical Trocar · Taiwan Surgical Corporation · Mar 22, 2023 - [K981941](/device/K981941.md) — MULTAPORT CANNULA REDUCER AND ACCESSORIES · Dexide, Inc. · Jul 29, 1998 ## Submission Summary (Full Text) {0}------------------------------------------------ K071571/ SurgiQuest, Inc. AirSeal™ Optical Trocar & Cannula System 510(k) Notification ## 510(k) SUMMARY OF SAFETY & EFFECTIVENESS | SUBMITTER | SurgiQuest, Inc.<br>12 Cascade Blvd. - Suite 2B<br>Orange, CT 06477 | JUL 30 2007 | |------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------| | CONTACT PERSON | Kourosh Azarbarzin<br>Founder & C.E.O. - SurgiQuest, Inc. | | | DATE PREPARED | May 25, 2007 | | | CLASSIFICATION | Laparoscopic trocar, GCJ<br>Class: II | | | COMMON NAME | Disposable Endoscopic Trocar & Cannula | | | PROPRIETARY NAME | SurgiQuest™ AirSeal™ Optical Trocar & Cannula System<br>(Trademark name to be determined) | | | PREDICATE<br>DEVICE(S) | Surgiport™ Blunt Tip Trocar<br>U.S. Surgical Corp. (Norwalk, CT)<br>K903419 | | | | EndoPath III Trocar System<br>Ethicon Endo-Surgery, Inc. (Cincinnati, OH)<br>K032676 | | | | Elastomeric Optical Trocar & Cannula<br>SurgiQuest, Inc. (Orange, CT)<br>K063859 | | | | LapEvac Filtration Device for the Pneumoperitoneum<br>Buffalo Filter (Buffalo, NY)<br>K052797 | | | | Sun Medical Smoke / Fluid Evacuation System<br>Sun Medical Inc. (Arlington, TX)<br>K911154 | | | DEVICE DESCRIPTION | The subject is a surgical trocar and cannula composed of<br>medical grade materials. The device is used to create and<br>maintain a port of entry during endoscopic surgery. It<br>incorporates a gas seal utilizing CO2, to maintain<br>pneumoperitoneum during the course of surgery. It is supplied<br>with a re-circulation and filtration pump designed-to maintain<br>pneumoperitoneum and minimize CO2 consumption during | | {1}------------------------------------------------ ## SurgiQuest, Inc. AirSeal™ Optical Trocar & Cannula System 510(k) Notification minimally invasive surgery. The recirculation and filtration pump is reusable. The AirSeal™ Trocar & Cannula and Tube Set are fully disposable and are intended for single use only. TESTING The device has been tested to show its ability to create and maintain a port of entry during simulated laparoscopic surgery. It has also been tested to show its ability to maintain adequate pneumoperitoneum during the course of simulated laparoscopic surgery. > The unit will be tested for safety and emissions in accordance with IEC60601-1, General Requirements for Safety 1: Collateral Standard: Safety Requirements for Medical Electrical Systems and IEC60601-1-2, General Requirements for Safety -Collateral Standard: Electromagnetic Compatibility -Requirements and Tests. > Sterility validation is in accordance with ISO 11137:2006 Sterilization of health care products -- Radiation -- Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices and AAMI TIR 27:2001, Sterilization of Healthcare Products - Radiation Sterilization - Substantiation of 25kGY as a Sterilization Dose - Method VD Max A Sterility Assurance Level (SAL) of 10-6 is achieved. {2}------------------------------------------------ Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & 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 a stylized symbol that resembles a caduceus, a traditional symbol of medicine, but with three wavy lines instead of snakes. Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850 SurgiQuest, Inc. % Mr. Kourosh Azarbarzin Founder & CEO 12 Cascade Blvd., Suite 2B Orange, CT 06477 JUL 3 0 2007 Re: K071571 Trade/Device Name: SurgiQuest™ AirSeal™ Optical Trocar & Cannula System Regulation Number: 21 CFR 876.1500 Regulation Name: Endoscope and accessories Regulatory Class: II Product Code: GCJ Dated: June 6, 2007 Received: June 8, 2007 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. 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 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); 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. {3}------------------------------------------------ Page 2 – Mr. Kourosh Azarbarzin 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html. Sincerely yours, Mark A. Millican Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {4}------------------------------------------------ ## SurgiQuest, Inc. AirSeal™ Optical Trocar & Cannula System 510(k) Notification ## STATEMENT FOR INDICATIONS FOR USE 510(k) Number: Prescription Use: Yes Device Name: SurgiQuest™ AirSeal™ Optical Trocar & Cannula System (Trademark name to be determined) Indications for Use: The SurgiQuest AirSeal™ Optical Trocar & Cannula System has applications in abdominal and thoracic minimally invasive surgical procedures to establish a path of entry for endoscopic instruments. The trocar may be used with or without visualization for primary and secondary insertions. Mark A. Milken (Division Sign=Off) Division of General, Restorative, and Neurological Devices ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ Koz 1571 510(k) Number DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED Concurrence of CDRH, Office of Device Evaluation --- **Source:** [https://fda.innolitics.com/submissions/SU/subpart-b%E2%80%94diagnostic-devices/GCJ/K071571](https://fda.innolitics.com/submissions/SU/subpart-b%E2%80%94diagnostic-devices/GCJ/K071571) **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. 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