MODIFIED SURGIQUEST AIRSEAL OPTICAL TROCAR & CANNULA SYSTEM WITH INTEGRATED INSUFFLATOR DPIS 2000

K121336 · Surgiquest, Inc. · HIF · Jul 3, 2012 · Obstetrics/Gynecology

Device Facts

• Record ID: K121336
• Device Name: MODIFIED SURGIQUEST AIRSEAL OPTICAL TROCAR & CANNULA SYSTEM WITH INTEGRATED INSUFFLATOR DPIS 2000
• Applicant: Surgiquest, Inc.
• Product Code: HIF · Obstetrics/Gynecology
• Decision Date: Jul 3, 2012
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 884.1730
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The SurgiQuest AirSeal Optical Trocar & Cannula System with integrated Insufflator DPIS 2000 (the "DPIS 2000 System") is intended for use in diagnostic and/or therapeutic endoscopic procedures to distend the peritoneal cavity by filling it with gas, to establish and maintain a path of entry for endoscopic instruments, and to evacuate surgical smoke. The trocar of the DPIS 2000 System is indicated for use with or without visualization.

Device Story

System comprises sterile, single-use trocar, cannula, and tube sets; non-sterile, reusable micro-processor controlled insufflation, recirculation, and filtration unit (DPIS 2000). Used in clinical settings for laparoscopic surgery; operated by surgeons/clinical staff. Device functions by filling peritoneal cavity with gas to distend cavity, maintaining pneumoperitoneum, and evacuating surgical smoke during procedures. Trocar allows instrument entry with or without visualization. Micro-processor unit manages insufflation and filtration parameters. Output provides stable surgical field and smoke-free environment, facilitating endoscopic visualization and instrument manipulation. Benefits include improved surgical access and visibility.

Clinical Evidence

Bench testing only. Testing confirmed ability to create/maintain port of entry, maintain adequate pneumoperitoneum during simulated laparoscopic surgery, and evacuate surgical smoke. Sterility validation performed per ISO 11137:2006 and AAMI TIR 27:2001.

Technological Characteristics

System includes trocar, cannula, tube sets, and micro-processor controlled insufflation/recirculation/filtration unit. Sterilization via radiation (ISO 11137:2006, AAMI TIR 27:2001) to SAL 10^-6. Micro-processor controlled operation.

Indications for Use

Indicated for patients undergoing diagnostic or therapeutic endoscopic procedures requiring peritoneal cavity distension, establishment of instrument access, and surgical smoke evacuation.

Regulatory Classification

Identification

A laparoscopic insufflator is a device used to facilitate the use of the laparoscope by filling the peritoneal cavity with gas to distend it.

Predicate Devices

• SurgiQuest AirSeal® Optical Trocar & Cannula System with integrated Insufflator DPIS2000 (K103692)

Submission Summary (Full Text)

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# K 121 336

公

SurgiQuest, Inc. , Modified SurgiQuest AirSeal® Optical Trocar & Cannula System with integrated Insufflator DPIS 2000 Special 510(k) Notification

## XI. 510(k) SUMMARY OF SAFETY & EFFECTIVENESS

2012

| SUBMITTER | SurgiQuest, Inc.<br>333 Quarry Road<br>Milford, CT 06460 | JUL | 3 |
|--------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----|---|
| CONTACT PERSON | Daniel Donovan<br>Sr. Director of Operations - SurgiQuest, Inc. | | |
| DATE PREPARED | February 24, 2012 | | |
| CLASSIFICATION | Endoscope and accessories under 21 C.F.R. 876.1500;<br>Laparoscopic Insufflator under 21 C.F.R. 884.1730<br>Product Code: GCJ and HIF<br>Class: II | | |
| COMMON NAME | Disposable Endoscopic Trocar and Cannula;<br>Carbon Dioxide Insufflator for Laparoscopy | | |
| PROPRIETARY NAME<br>PREDICATE<br>DEVICE(S) | SurgiQuest AirSeal® iFS (Name subject to change)<br>SurgiQuest AirSeal® Optical Trocar & Cannula System with<br>integrated Insufflator DPIS2000<br>SurgiQuest, Inc. (Orange, CT)<br>K103692 | | |
| DEVICE DESCRIPTION | The SurgiQuest AirSeal® Optical Trocar & Cannula System<br>with integrated Insufflator DPIS 2000 (the "DPIS 2000<br>System") consists of the following major components: (1) a<br>trocar, (2) a cannula, (3) tube sets, and (4) a micro-processor<br>controlled insufflation, recirculation and filtration unit (the<br>"DPIS 2000 Unit"). The cannula, trocar and tube sets are<br>sterile, single-use products. The DPIS 2000 Unit is non-<br>sterile and reusable. | | |
| INDICATIONS FOR<br>USE | The SurgiQuest AirSeal Optical Trocar & Cannula System<br>with integrated Insufflator DPIS 2000 (the "DPIS 2000<br>System") is intended for use in diagnostic and/or therapeutic<br>endoscopic procedures to distend the peritoneal cavity by<br>filling it with gas, to establish and maintain a path of entry<br>for endoscopic instruments, and to evacuate surgical smoke.<br>The trocar of the DPIS 2000 System is indicated for use with<br>or without visualization. | | |
| TESTING | The device has been tested to show its ability to create and<br>maintain a port of entry during simulated laparoscopic surgery.<br>It has also been tested to show its ability to maintain adequate<br>pneumoperitoneum during the course of laparoscopic surgery<br>and to aid in the evacuation of smoke. | | |
| | Sterility validation is in accordance with ISO 11137:2006 | | |
| | | 21 | |

6/20/2012

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### SurgiQuest, Inc.

#### Modified SurgiQuest AirSeal® Optical Trocar & Cannula System with integrated Insufflator DPIS 2000 Special 510(k) Notification

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.

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#### DEPARTMENT OF HEALTH & HUMAN SERVICES

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 stylized eagle with its wings outstretched, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" are arranged in a circle around the eagle. The eagle is depicted in black, and the text is also in black. The logo is simple and recognizable, and it is often used on official documents and websites related to the Department of Health & Human Services.

#### · Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002

Surgiquest, Incorporated % Mr.Daniel Donovan Senior Director of Operations 333 Quarry Road Milford, Connecticut 06460

3 2012 JUL

Re: K121336

Trade/Device Name: Modified SurgiQuest AirSeal®Optical Trocar & Cannula System with Integrated Insufflator DPIS 2000 Regulation Number: 21 CFR 884.1730 Regulation Name: Laparoscopic insufflator Regulatory Class: Class II Product Code: HIF, GCJ

Dated: June 18, 2012

Received: June 22, 2012

Dear Mr. Donovan:

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.

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Page 2- Mr. Daniel Donovan

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 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 [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely yours,

Eunel Keith

ForMark 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): K121336

Device Name: Modified SurgiQuest AirSeal® Optical Trocar & Cannula System with integrated Insufflator DPIS 2000

Indications For Use:

The SurgiQuest AirSeal Optical Trocar & Cannula System with integrated Insufflator DPIS 2000 (the "DPIS 2000 System") is intended for use in diagnostic and/or therapeutic endoscopic procedures to distend the peritoneal cavity by filling it with gas, to establish and maintain a path of entry for endoscopic instruments, and to evacuate surgical smoke. The trocar of the DPIS 2000 System is indicated for use with or without visualization.

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

Over-The-Counter Use (21 CFR 807 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Neil R. O'aide forman

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(Division Sign-Of (Division Sign-On)
Division of Surgical, Orthopedic, Avishorative Devices

510(k) Number K121336