SURGIQUEST ELASTOMERIC OPTICAL TROCAR & CANNULA

K063859 · Surgiquest, Inc. · GCJ · Mar 14, 2007 · Gastroenterology, Urology

Device Facts

• Record ID: K063859
• Device Name: SURGIQUEST ELASTOMERIC OPTICAL TROCAR & CANNULA
• Applicant: Surgiquest, Inc.
• Product Code: GCJ · Gastroenterology, Urology
• Decision Date: Mar 14, 2007
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 876.1500
• Device Class: Class 2

Intended Use

The SurgiQuest™ Elastomeric Optical Trocar and Cannula 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

Disposable endoscopic trocar and cannula; used to create and maintain port of entry during abdominal and thoracic minimally invasive surgery. Device features expandable elastomer sheath to secure cannula position vertically within abdominal wall. Operated by surgeons in clinical settings. Insertion and removal forces comparable to predicate devices. Benefits include stable access for endoscopic instrumentation.

Clinical Evidence

No clinical data. Bench top and animal testing confirmed that insertion and removal forces are substantially equivalent to predicate devices and the device maintains its position within the abdominal wall during laparoscopic surgery.

Technological Characteristics

Disposable trocar and cannula; features expandable elastomer sheath for vertical stabilization. Constructed from biosafe materials. Single-use. Mechanical device; no energy source or software.

Indications for Use

Indicated for patients undergoing abdominal or thoracic minimally invasive surgical procedures requiring a port of entry for endoscopic instruments.

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)

Submission Summary (Full Text)

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K063859

SurgiQuest, Inc.

510(k) Notification for SurgiQuest™ Elastomeric Optical Trocar & Cannula

## 510(k) SUMMARY OF SAFETY & EFFECTIVENESS

| SUBMITTER | SurgiQuest, Inc.<br>12 Cascade Boulevard, Suite 2B<br>Orange, CT 06477 |
|--------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| CONTACT PERSON | Kourosh Azarbarzin<br>Founder & C.E.O. - SurgiQuest, Inc.<br>MAR 14 2007 |
| DATE PREPARED | December 29, 2006 |
| CLASSIFICATION | Laparoscopic trocar, GCJ<br>Class: II |
| COMMON NAME | Disposable Endoscopic Optical Trocar & Cannula |
| PROPRIETARY NAME | SurgiQuest™ Elastomeric Optical Trocar & Cannula<br>(Trademark name to be determined) |
| PREDICATE DEVICE | 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 |
| DEVICE DESCRIPTION | The subject is a surgical trocar and cannula composed of<br>biosafe materials. The device incorporates an expandable<br>elastomer sheath, which serves to hold the cannula vertically in<br>place during endoscopic surgery. The device is used to create<br>and maintain a port of entry during endoscopic surgery. It is<br>fully disposable and is intended for single use only. |
| TESTING | The device has been tested to show its ability to adequately<br>maintain its position within the abdominal wall during<br>laparoscopic surgery. Also, bench top and animal testing has<br>confirmed that insertion and removal forces are substantially<br>equivalent to the predicate devices. |

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

SurgiQuest, Inc. % Kourosh Azarbarzin Founder & CEO 12 Cascade Boulevard, Suite 2B Orange, Connecticut 06477

MAR 1 4 2807

Re: K063859

Trade/Device Name: SurgiQuest™ Elastomeric Optical Trocar & Cannula (Trademark name to be determined)

Regulation Number: 21 CFR 876.1500 Regulation Name: Endoscope and accessories Regulatory Class: II Product Code: GCJ Dated: March 5, 2007 Received: March 5, 2007

Dear Kourosh 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

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Page 2 - Kourosh Azarbarzin

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.

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 [phone]. 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 [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Mark N. Mell

Mark N. Melkerson Director Division of General. Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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## SurgiQuest, Inc.

510(k) Notification for SurgiQuest144 Elastomeric Optical Trocar & Cannula

## STATEMENT FOR INDICATIONS FOR USE

510(k) Number:

Device Name: SurgiQuest™ Elastomeric Optical Trocar & Cannula (Trademark name to be determined)

Indications for Use: The SurgiQuest™ Elastomeric Optical Trocar and Cannula 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.

Prescription Use: Yes

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

Concurrence of CDRH, Office of Device Evaluation

(Division Sign-Off Division of General, Restorative, and Neurological Devices

510(k) Number L063859