AIRSEAL OPTICAL TROCAR & CANNULA SYSTEM

K083211 · Surgiquest, Inc. · GCJ · Dec 15, 2008 · Gastroenterology, Urology

Device Facts

• Record ID: K083211
• Device Name: AIRSEAL OPTICAL TROCAR & CANNULA SYSTEM
• Applicant: Surgiquest, Inc.
• Product Code: GCJ · Gastroenterology, Urology
• Decision Date: Dec 15, 2008
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 876.1500
• Device Class: Class 2

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 and to evacuate smoke. The trocar may be used with or without visualization for primary and secondary insertions.

Device Story

System comprises disposable optical trocar/cannula and reusable recirculation/filtration pump. Device creates/maintains port of entry for endoscopic instruments during minimally invasive surgery; utilizes CO2 gas seal to maintain pneumoperitoneum; provides active smoke evacuation. Used in OR by surgeons. Pump recirculates gas through filtration system to clear smoke while maintaining pressure. Benefits include stable pneumoperitoneum and improved visualization via smoke removal.

Clinical Evidence

Bench testing only. Testing confirmed ability to create/maintain port of entry, maintain pneumoperitoneum during simulated laparoscopic surgery, and evacuate smoke. Electrical safety and EMC testing performed per IEC 60601-1 and IEC 60601-1-2. Sterility validated per ISO 11137:2006 and AAMI TIR 27:2001.

Technological Characteristics

Medical grade materials; disposable trocar/cannula; reusable recirculation/filtration pump. Energy source: electrical (pump). Sterilization: radiation (ISO 11137, AAMI TIR 27, SAL 10^-6).

Indications for Use

Indicated for patients undergoing abdominal and thoracic minimally invasive surgical procedures requiring endoscopic instrument access and surgical smoke evacuation.

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.

Predicate Devices

• Surgiport™ Blunt Tip Trocar (K903419)
• EndoPath III Trocar System (K032676)
• Elastomeric Optical Trocar & Cannula (K063859)
• LapEvac Filtration Device for the Pneumoperitoneum (K052797)
• Sun Medical Smoke / Fluid Evacuation System (K911154)

Submission Summary (Full Text)

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K0832.11

SurgiQuest, Inc. AirSeal™ Optical Trocar & Cannula System Special 510(k) Notification

DEC 1 5 2008

## 510(k) SUMMARY OF SAFETY & EFFECTIVENESS

| SUBMITTER | SurgiQuest, Inc.<br>12 Cascade Blvd. - Suite 2B<br>Orange, CT 06477 |
|------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 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<br><br>EndoPath III Trocar System<br>Ethicon Endo-Surgery, Inc. (Cincinnati, OH)<br>K032676<br><br>Elastomeric Optical Trocar & Cannula<br>SurgiQuest, Inc. (Orange, CT)<br>K063859<br><br>LapEvac Filtration Device for the Pneumoperitoneum<br>Buffalo Filter (Buffalo, NY)<br>K052797<br><br>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 and<br>evacuate surgical smoke. It incorporates a gas seal utilizing<br>CO2, to maintain pneumoperitoneum during the course of<br>surgery. It is supplied with a re-circulation and filtration pump |

## 10/20/2008

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### SurgiQuest, Inc. AirSeal™ Optical Trocar & Cannula System Special 510(k) Notification

designed-to maintain pneumoperitoneum and minimize CO2 consumption during 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 laparoscopic surgery and to aid in the evacuation of smoke.

(See Addendum 3 for test data regarding smoke evacuation)

The unit has been 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- is achieved.

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Image /page/2/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three tail feathers, representing the three levels of government: federal, state, and local. The eagle is surrounded by the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" in a circular arrangement.

#### DEPARTMENT OF HEALTH & HUMAN SERVICES

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

## DEC 1 5 2008

Mr. Kourosh Azarbarzin Founder & CEO SurgiQuest, Incorporated 12 Cascade Boulevard, Suite 2B ORANGE CT 06477

Re: K083211

Trade/Device Name: SurgiQuest™ AirSeal™ Optical Trocar and Cannula System Regulation Number: 21 CFR 876.1500 Regulation Name: Endoscope and accessories Regulatory Class: II Product Code: GCJ Dated: October 1, 2008 Received: October 31, 2008

Dear Mr. Azarbarzin:

We have reviewed vour 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.

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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 (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.

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 one of the following numbers, based on the regulation number at the top of this letter:

| 21 CFR 876.xxx | (Gastroenterology/Renal/Urology) | 240-276-0115 |
|----------------|----------------------------------|--------------|
| 21 CFR 884.xxx | (Obstetrics/Gynecology) | 240-276-0115 |
| 21 CFR 894.xxx | (Radiology) | 240-276-0120 |
| Other | | 240-276-0100 |

Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometrics' (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. 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/cdrh/industry/support/index.html.

Sincerely vours.

Voque M. Whang

Joyce M. Whang, Ph.D. Acting Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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## SurgiQuest, Inc. AirSeal™ Optical Trocar & Cannula System Special 510(k) Notification

# STATEMENT FOR INDICATIONS FOR USE

083211

510(k) Number:

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 and to evacuate smoke. The trocar may be used with or without visualization for primary and secondary insertions. (Note: This Indication has been expanded to include smoke evacuation)

Prescription Use: Yes

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

Concurrence of CDRH, Office of Device Evaluation

eld lema

(Division Sign-Off) Division of Reproductive, Abdominal. and Radiological Device 510(k) Number

29