SINGLE SITE FLEXIBLE BLADELESS OBTURATOR

K101671 · Teleflexmedical, Inc. · GCJ · Jun 25, 2010 · Gastroenterology, Urology

Device Facts

• Record ID: K101671
• Device Name: SINGLE SITE FLEXIBLE BLADELESS OBTURATOR
• Applicant: Teleflexmedical, Inc.
• Product Code: GCJ · Gastroenterology, Urology
• Decision Date: Jun 25, 2010
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 876.1500
• Device Class: Class 2

Intended Use

The Single-Site™ Flexible Bladeless Obturator 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

Single-use, 5mm diameter, 304mm length sterile dilating obturator; used with Intuitive Surgical DaVinci SI robot Curved Cannula. Obturator features proximal cap locking onto cannula rim. Used in OR by surgeons during minimally invasive procedures to create access pathway for endoscopic instruments. Device facilitates smooth transition between cannula and obturator tip. Benefits include safe, atraumatic tissue penetration and stable port assembly for robotic surgery.

Clinical Evidence

Bench testing only. Verification testing demonstrated successful insertion and removal from the Curved Cannula without material degradation.

Technological Characteristics

Sterile, single-use, 5mm diameter, 304mm length dilating obturator. Materials are identical to predicate K010007. Mechanical locking mechanism for cannula interface. No energy source. No software.

Indications for Use

Indicated for patients undergoing thoracic, abdominal, or gynecologic minimally invasive surgical procedures requiring endoscopic device access. Contraindicated where minimally invasive techniques are not appropriate.

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

• ADAPT™ Laparoscopic Port and Accessory (K010007)

Submission Summary (Full Text)

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KC01671

#### Single-Site™ Flexible Bladeless Obturator Special 510(k) Section 8 - Summary of Safety and Effectiveness

#### 510(k) SUMMARY OF SAFETY AND EFFECTIVENESS

#### Single-Site™ Flexible Bladeless Obturator

JUN 25 2010

### 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

Angela Bouse Sr. Regulatory Affairs Specialist

#### C. Date Prepared

June 11, 2010

### D. Device Name

Trade Name: Single-Site™ Flexible Bladeless Obturator

Common Name: Surgical Trocar

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

#### E. Device Description

The Single-Site™ Flexible Bladeless Obturator is a sterile, single-use 5mm diameter X 304 mm length dilating obturator that is used in conjunction with a 5mm Curved Cannula. The Obturator has a cap at the proximal end that locks onto the Curved Cannula rim. The Curved Cannula is designed by Intuitive Surgical, Inc. (ISI) for use with their DaVinci SI robot model.

## F. Indications for Use

The Single-Site™ Flexible Bladeless Obturator is indicated for use in thoracic, abdominal, and gynecologic minimally invasive surgical procedures to provide a pathway for the introduction of endoscopic surgical devices.

CONFIDENTIAL

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# G. Contraindications

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

# H. Substantial Equivalence

The proposed Single-Site™ Flexible Bladeless Obturator is substantially equivalent to the predicate device:

| Predicate Device | Manufacturer | 510(k) No. | Date Cleared |
|------------------------------------------------|----------------------------------------|------------|--------------|
| The ADAPTTM Laparoscopic<br>Port and Accessory | Teleflex Medical, Inc. /<br>Taut, Inc. | K010007 | 02/22/2001 |

# I. Comparison To Predicate Device

The tip design and function of the proposed Single-Site™ Flexible Bladeless Obturator is identical to the predicate device's Obturator component except that the Single-Site™ Flexible Bladeless Obturator has the following changes:

- 304mm obturator length; .
- The Tip Length is longer, this insures a smooth transition area between the . distal cannula end and the obturator tip. The Tip Length is described as the section of the obturator tip that protrudes from the cannula after the obturator is inserted into the cannula;
- The Obturator Cap designed to lock and unlock from the Curved Cannula rim . to support obturator / cannula assembly:
- IFU revision for clarity to insure proper use of the Obturator with the Curved . Cannula.

# J. Materials

All materials that have patient contact have been cleared in predicate device under 510(k) K010007. There are no new patient contact materials used in Single-Site™ Flexible Bladeless Obturator.

# K. Performance Data

Verification testing was performed to demonstrate that the proposed Single-Site™ Flexible Bladeless Obturator is inserted and removed from the Curved Cannula without any evidence of material degradation.

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# L. Conclusion

The test results demonstrate the proposed Single-Site™ Flexible Bladeless Obturator is compatible with the ISI Curved Cannula. The changes made to the proposed Single-Site™ Flexible Bladeless Obturator do not introduce any new issues of safety and effectiveness.

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

# JUN 2 5 2010

Teleflex Medical, Inc. % Ms. Angela Bouse Senior Regulatory Affairs Specialist 2917 Weck Drive Research Triangle Park, North Carolina 27709

Re: K101671

K101071
Trade/Device Name: Single-Site™ Flexible Bladeless Obturator Regulation Number: 21 CFR 876.1500 Regulation Name: Endoscope and accessories Regulatory Class: Class II Product Code: GCJ Dated: June 11, 2010 Received: June 14, 2010

Dear Ms. Bouse:

We have reviewed your Section 510(k) premarket notification of intent to market the device we nave reviewed your becamed the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for use stated in the encreate) to regard the Medical Device Amendments, or to commerce pror to this 2011/2017 11:23 accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application and Cosment Act (110) market the device, subject to the general controls provisions of the (1 MA). Tou may, morelere, mainer of the Act include requirements for annual registration, Act. The general controls provision of practice, labeling, and prohibitions against misbranding Irsung of devices, good manazavaning possible information related to contract liability alle adultion. Thease now 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 If your device is blassified (bee arone). Existing major regulations affecting your device can be may be subject to additional controller and the 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 i lease oc advisod may be results at your device complies with other requirements of the Act

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Page 2 - Ms. Angela Bouse

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,

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

510(k) Number:

K101671_

Device Name:

Single-Site™ Flexible Bladeless Obturator

Indications for Use:

The Single-Site™ Flexible Bladeless Obturator 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)

Niel R. Oshrin Sir m.kin

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

510(k) Number K101671

: