SURGIQUEST AIRSEAL IFS

K132169 · Surgiquest, Inc. · GCJ · Aug 22, 2013 · Gastroenterology, Urology

Device Facts

• Record ID: K132169
• Device Name: SURGIQUEST AIRSEAL IFS
• Applicant: Surgiquest, Inc.
• Product Code: GCJ · Gastroenterology, Urology
• Decision Date: Aug 22, 2013
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 876.1500
• 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, plus non-sterile, reusable micro-processor-controlled insufflation, recirculation, and filtration unit (DPIS 2000). Device distends peritoneal cavity with gas (CO2), maintains pneumoperitoneum, provides instrument access, and evacuates surgical smoke. Operated by surgeons in clinical/OR settings. Modification allows simultaneous operation of one AirSeal trocar and one conventional trocar. Micro-processor manages insufflation and smoke evacuation parameters to maintain stable cavity pressure. Output provides stable surgical field for endoscopic visualization and instrument manipulation; benefits include improved visibility and smoke-free environment.

Clinical Evidence

No clinical data. Evidence consists of bench testing, including engineering studies (0627131045 01 and 0627131059 01) evaluating smoke evacuation and CO2 consumption with filtered tube sets during simulated laparoscopic surgery.

Technological Characteristics

System includes reusable micro-processor-controlled insufflation/recirculation/filtration unit and single-use trocar/cannula/tube sets. Sterilization of reusable components per ISO 11137:2006 and AAMI TIR 27:2001 (SAL 10^-6). Connectivity involves integrated pneumatic and electronic control of gas flow and smoke evacuation.

Indications for Use

Indicated for patients undergoing diagnostic or therapeutic endoscopic procedures requiring peritoneal cavity distension, establishment of instrument entry paths, 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

• SurgiQuest AirSeal® Optical Trocar & Cannula System with integrated Insufflator DPIS2000 (K103692)
• Modified SurgiQuest AirSeal® Optical Trocar & Cannula System with Integrated Insufflator DPIS 2000 (K121336)

Submission Summary (Full Text)

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## K132169

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

.. '

| SUBMITTER | SurgiQuest, Inc.<br>333 Quarry Road<br>Milford, CT 06460 | |
|------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------|
| CONTACT PERSON | Daniel Donovan<br>Sr. Director of Operations - SurgiQuest, Inc.<br>Phone:[phone] ext 202 | AUG 2 2 2013 |
| DATE PREPARED | July 9, 2013 | |
| CLASSIFICATION | 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 | SurgiQuest AirSeal® iFS (Name subject to change) | |
| PREDICATE<br>DEVICE(S) | SurgiQuest AirSeal® Optical Trocar & Cannula System with<br>integrated Insufflator DPIS2000<br>SurgiQuest, Inc. (Orange, CT)<br>K103692<br><br>Modified SurgiQuest AirSeal® Optical Trocar & Cannula<br>System with Integrated Insufflator DPIS 2000<br>SurgiQuest, Inc. (Milford, CT)<br>K121336 | |
| 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. The subject device of this filing is a<br>modification to the original filing. The modification is to<br>allow the operation of two trocars simultaneously, one<br>AirSeal trocar and one conventional trocar. The predicate<br>filing was a modification to allow the simultaneous operation<br>of two AirSeal* trocars.<br><br>The device has met the criteria for acceptance, safety and<br>effectiveness and is substantially equivalent to the predicate. | |

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The SurgiQuest AirSeal Optical Trocar & Cannula System INDICATIONS FOR with integrated Insufflator DPIS 2000 (the "DPIS 2000 USE 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.

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

Engineering test summaries accompany this filing:

- 1. Engineering Test 0627131045 01, "iFS with Smoke Evac PLUS filtered tube set study"3
- Engineering Test 0627131059 01, "Smoke Evac 2. PLUS filtered tube set Co2 Consumption Study"

Sterility validation of reusable devices 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 106 is achieved.

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

August 22, 2013

Daniel Donovan Senior Director of Operations SurgiQuest, Incorporated 333 Quarry Road Milford, Connecticut 06460

Re: K132169

Trade/Device Name: 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: August 1, 2013 Received: August 6, 2013

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 ffor 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. 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 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical

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Page 2 - Daniel Donovan

device-related adverse events) (21 CFR 803); 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.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801); please contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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/ResourcesforYou/Industry/default.htm.

Sincerely vours,

## Mark N. Melkerson -S

Mark N. Melkerson Acting Director Division of Surgical Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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## IX. STATEMENT FOR INDICATIONS FOR USE

| 510(k) Number: | K132169 |
|----------------|---------|
|----------------|---------|

Device Name: 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: Yes

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

Concurrence of CDRH, Office of Device Evaluation

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(Division Sign-Off) Division of Surgical Devices 510 (k) Number: K132169