WECK VISTA OPTICAL BLADELESS LAPAROSCOPIC ACCESS PORT

K121380 · Teleflexmedical, Inc. · GCJ · May 25, 2012 · Gastroenterology, Urology

Device Facts

• Record ID: K121380
• Device Name: WECK VISTA OPTICAL BLADELESS LAPAROSCOPIC ACCESS PORT
• Applicant: Teleflexmedical, Inc.
• Product Code: GCJ · Gastroenterology, Urology
• Decision Date: May 25, 2012
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 876.1500
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Weck® Vista™ Optical Bladeless Laparoscopic Access Port is indicated for use in thoracic, abdominal, and gynecologic minimally invasive surgical procedures to provide a pathway for the introduction of endoscopic surgical devices.

Device Story

Weck® Vista™ Optical Bladeless Laparoscopic Access Port is a surgical trocar used to establish abdominal cavity access during minimally invasive surgery. Device consists of a cannula with stability ridges for fixation and an obturator with a clear dilating tip. Obturator allows insertion of a camera for visualization during entry. Floating top seal modified into a funnel shape to guide surgical instruments. Used by trained physicians in clinical settings to maintain insufflation and provide a pathway for endoscopic instruments. Benefits include enhanced port fixation and improved visualization during initial entry.

Clinical Evidence

Bench testing only.

Technological Characteristics

Stainless steel shaft; cyrolite asymmetrical tissue separating tip; cannula with stability ridges; funnel-shaped floating top seal. Patient-contacting materials compliant with ISO 10993-1. Mechanical device; no software or energy source.

Indications for Use

Indicated for use in thoracic, abdominal, and gynecologic minimally invasive surgical procedures to provide a pathway for the introduction of endoscopic surgical devices.

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

• ADAPtTM Laparoscopic Port and Accessory (K010007)
• ADAPtTM Universal Laparoscopic Port (K082156)

Submission Summary (Full Text)

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Page 1 of

MAY 2 5 2012

Veck® Vista™ Optical Bladeless Laparoscopic Access Port Special 510(k) Section 8 - Summary of Safety and Effectiveness

# K121380

# 510(k) SUMMARY OF SAFETY AND EFFECTIVENESS

Weck® Vista™ Optical Bladeless Laparoscopic Access Port

# A. Name, Address, Phone and Fax Number of Applicant

Teleflex Medical, Incorporated 2917 Weck Drive Research Triangle Park, NC 27709 USA Phone: [phone] Fax: [phone]

#### B. Contact Person

Natalie Smith Regulatory Affairs Specialist

#### C. Date Prepared

May 7, 2012

#### D. Device Name

Trade Name: Weck® Vista™ Optical Bladeless Laparoscopic Access Port

Common Name: Surgical Trocar

Classification Name: Endoscope and Accessories (21 CFR 876.1500, Product Code GCJ)

#### E. Device Description

Weck® Vista™ Optical Bladeless Laparoscopic Access Port is used to establish a port of entry into the abdominal cavity, facilitating the access of various diameter devices, while maintaining insufflation at the surgical site. The port is positioned into the peritoneum during minimally invasive surgical procedures, in order to provide a pathway for the insertion and removal of various sized surgical devices. The obturator of the Optical Bladeless Laparoscopic Access Port provides a channel for the insertion of a camera. At the proximal end of the obturator is a clear dilating tip for initial port entry to have visibility of the fasical layers. Additional stability ridges have been added to the outer cannula wall to enhance port fixation during surgery. Weck® Vista™ Optical Bladeless Laparoscopic Access Port is intended to be used by trained physicians.

Teleflex Medical, Inc.

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K121380

Page 2 of 2

Weck® Vista™ Optical Bladeless Laparoscopic Access Port Special 510(k) Section 8 - Summary of Safety and Effectiveness

### F. Indications for Use

The Optical Bladeless Laparoscopic Access Port is indicated for use in thoracic, abdominal, and gynecologic minimally invasive surgical procedures to provide a pathway for the introduction of endoscopic surgical devices.

# G. Contraindications

Where minimally invasive techniques are contraindicated, other methods and instrumentation should be employed.

#### H. Substantial Equivalence

The proposed Optical Bladeless Laparoscopic Access Port is substantially equivalent to the predicate devices:

| Predicate Device | Manufacturer | 510(k) No. | Date Cleared |
|--------------------------------------------|----------------------------------------|------------|--------------|
| ADAPtTM Laparoscopic Port<br>and Accessory | Teleflex Medical, Inc. /<br>Taut, Inc. | K010007 | 02/22/01 |
| ADAPtTM Universal<br>Laparoscopic Port | Teleflex Medical, Inc. | K082156 | 09/10/2008 |

#### I. Comparison To Predicate Devices

This proposed change is to enhance the previously approved features from K010007; ADAPt™ Laparoscopic Port and Accessory and K082156; ADAPt™ Universal Laparoscopic Port, to produce an Optical Port with a stability feature.

The new design adds stability ridges along the length of the cannula to enhance port fixation during surgery. The obturator was modified to accommodate the use with a camera. The shaft will be composed of stainless steel with the cyrolite asymmetrical tissue separating tip as the predicate devices. The obturator cap will also be modified for the insertion of the camera. The floating top seal will be modified to form a funnel (conical entry feature) that will assist and guide surgical instruments into the port.

#### J. Materials

All patient contacting materials are in compliance with ISO10993-1.

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Weck® Vista™ Optical Bladeless Laparoscopic Access Port Special 510(k) Section 8 - Summary of Safety and Effectiveness

#### K. Technological Characteristics

A comparison of the technological characteristics of the proposed Weck® Vista™ Optical Bladeless Laparoscopic Access Port and the predicate has been performed. The results of this comparison demonstrate that the Weck® Vista™ Optical Bladeless Laparoscopic Access Port is equivalent to the marketed predicate devices in performance characteristics.

#### L. Performance Data

The bench testing has been performed to verify that the performance of the proposed Weck® Vista™ Optical Bladeless Laparoscopic Access Port is substantially equivalent to the predicate devices, and that the Weck® Vista™ Optical Bladeless Laparoscopic Access Port will perform as intended.

# L. Conclusion

Based upon the comparative test results, the proposed Weck® Vista™ Optical Bladeless Laparoscopic Access Port is substantially equivalent in performance to the predicate devices cleared to market via 510(k) K010007 and K082156. The modifications made to the Weck® Vista™ Optical Bladeless Laparoscopic Access Port do not introduce any new issues of safety and effectiveness.

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Image /page/3/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of an eagle with its wings spread, symbolizing the department's mission to protect the health of all Americans.

# DEPARTMENT OF HEALTH & HUMAN SERVICES

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

MAY 2 5 2012

Teleflex Medical, Inc % Ms. Natalie Smith Regulatory Affairs Specialist 2917 Weck Drive Research Triangle Park, North Carolina 27709

Re: K121380

Trade/Device Name: Weck® Vista™ Optical Bladeless LaParoscopic Access Port Regulation Number: 21 CFR 876.1500 Regulation Name: Endoscope and accessories Regulatory Class: Class II Product Code: GCJ Dated: May 07, 2012 Received: May 08, 2012

Dear Ms. Natalie Smith

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 - Ms. Natalie Smith

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 (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 go to http://www.fda.gov/AboutFDA/CentersOffices/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,

Mark 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

Page 1 of 1

# 21380

510(k) Number:

Device Name:

Weck® Vista™ Optical Bladeless Laparoscopic Access Port

Indications for Use:

The Weck® Vista™ Optical Bladeless Laparoscopic Access Port is indicated for use in thoracic, abdominal, and gynecologic minimally invasive surgical procedures to provide a pathway for the introduction of endoscopic surgical devices.

# Prescription Use XX (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 P. O'Shea Luxmore

(Division Sign-Off) Division of Surgical, Orthopedic, and Restorative Devices

510(k) Number K21380