SURGISTEER SCISSORS, SURGISTEER DISSECTOR / GRASPER, SURGISTEER HOOK

K111412 · Steerable Technologix · GEI · Sep 30, 2011 · General, Plastic Surgery

Device Facts

• Record ID: K111412
• Device Name: SURGISTEER SCISSORS, SURGISTEER DISSECTOR / GRASPER, SURGISTEER HOOK
• Applicant: Steerable Technologix
• Product Code: GEI · General, Plastic Surgery
• Decision Date: Sep 30, 2011
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4400
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The SurgiSteer electrocautery laparoscopic Instruments are sterile, single-use devices intended for use in a variety of minimally invasive surgical procedures to facilitate grasping, mobilization, dissection, and transection of tissue.

Device Story

SurgiSteer electrocautery laparoscopic instruments are sterile, single-use, disposable devices for minimally invasive surgery. System consists of proximal handle, rigid 5.0 mm outer tube, and flexible distal end segment. End effectors (scissors, dissector/grasper, or hook) are rotationally mounted. Handle features rotation knob, bend wheel (>90 degrees left/right), and actuating trigger for end effector operation. Device connects to standard electrosurgical generators via monopolar cable; footswitch-activated. Used by surgeons in OR to cut or coagulate tissue. Provides mechanical articulation to facilitate tissue manipulation and energy delivery for hemostasis or dissection.

Clinical Evidence

Bench testing only. Evaluations included ergonomics of handle, rotation knob, bend wheel, dissecting/grasping ability, and electrical insulation requirements. Testing demonstrated acceptable reliability and design performance relative to the predicate device.

Technological Characteristics

Monopolar electrosurgical instrument; 5.0 mm rigid shaft with flexible distal segment; sterile, single-use. Materials: insulated components for monopolar use. Energy: footswitch-operated via external electrosurgical generator. Mechanical: manual articulation (rotation, bending, actuation).

Indications for Use

Indicated for use in minimally invasive surgical procedures for grasping, mobilization, dissection, and transection of tissue. Prescription use only.

Regulatory Classification

Identification

An electrosurgical cutting and coagulation device and accessories is a device intended to remove tissue and control bleeding by use of high-frequency electrical current.

Predicate Devices

• pureWrist™ electrocautery laparoscopic instruments (K061425)

Submission Summary (Full Text)

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Image /page/0/Picture/0 description: The image shows the logo for "Steerable Technologix". The word "Steerable" is in a bold, sans-serif font, with a thick black line above it that curves around the right side of the word. Below "Steerable" is the word "Technologix" in a smaller, italicized font. To the right of "Technologix" is a stylized image of a surgical instrument.

SEP 3 0 2011

## K111412

# 510(k) Summary May 15, 2011

Steerable Technologix, LLC EIN 26-1348126 Reg # 3004588227 1. Applicant: 10301 Deerwood Park Boulevard, Suite 209 Jacksonville, FL 32256 Phone: [phone] Fax [phone] Contact: Glen Jorgensen [e-mail]

#### 2. Device Name:

Proprietary Name: SurgiSteer™ electrocautery laparoscopic instruments. Common/Usual Name: electrocautery scissors, dissector/grapser, or hook Classification Name: 878.4400 Electrosurgical cutting and coagulation device and accessories.

### 3. Identification of Predicate or Legally Marketed Device

The SurgiSteer™ electrocautery laparoscopic instruments by Steerable Technologix, LLC are substantially equivalent to the "pureWrist™ electrocautery laparoscopic instruments by Cambridge Endoscopis Devices, Inc under K061425

#### 4. Device Desciption:

The SurgiSteer™ line of electrocautery laparoscopic instruments are sterile, single-use disposable instruments intended for use through appropriately sized surgical trocars and consist of a proximal handle and a flexible distal end segment interconnected with a rigid 5.0 mm outer tube, all safely insulated for monoplolar electrocautery use. Distal to the distal end segment of the shaft is one of the end effectors (scissors, dissector/grasper, or hook) rotationally mounted independent of the outer tube and flexible end segment . Proximal to the end of the rigid shaft is an ergonomically shaped handle which contains: 1) a rotation knob that causes the end effector to rotate freely in both CW and CCW directions, 2) a bend wheel that causes the flexible end segment to bend >90 degrees in both left and right directions, and, 3) the actuating trigger that causes the articulating components of the end effector, if any, to open and close with sufficient force to either dissect or transect tissue. Each instrument has a monopolar energy supply cable that extends from the bottom of the handle and that can be plugged into the "the universal monopolar receptacle for footswitch-activated accessories on any commercially available generator.

#### 5. Intended Use

The SurgiSteer electrocautery laparoscopic Instruments are sterile, single-use devices intended for use in a variety of minimally invasive surgical procedures to facilitate grasping, mobilization, dissection, and transection of tissue.

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Image /page/1/Picture/0 description: The image shows the logo for Steerable Technologies. The word "Steerable" is in a bold, sans-serif font, with a thick black line above it that curves around the word. Below "Steerable" is the word "Technologies" in a smaller, italicized font. To the right of "Technologies" is a graphic of a surgical instrument at the end of a cable.

## 6. Comparison of Technological Characteristics

The SurgiSteer electrocautery laparoscopic instruments have the same technological and functional characteristics as the predicate device, the "pureWrist™ electrocautery laparoscopic instruments" by Cambridge Endoscopic Devices, Inc. Each of the devices has an end effector (scissors, graspers /dissectors, or hook) that can cut or coagulate tissue using monopolar electrocautery technology. Each use sharp objects to permit the surgeon to cut or dissect tissue. Each of the devices is connected to the same or similar electrosurgical generator and use similar power ranges for operation. Each are footswitch operated and can be used in the CUT mode by depressing the CUT pedal or the COAG mode by depressing the COAG pedal. Typically, in the CUT mode a sharp edge is used to focus the energy for cutting. Conversely, in the COAG mode, a broad, flat face is preferable for the coagulation of bleeders. The devices have the same intended use, indications for use, and technological features including equivalent mechanical movement (bend, rotate, and actuate), equivalent electrical characteristics (monopolar) and equivalent surgical end effectors all of which yield equivalent performance. The devices have the same or similar materials of construction, packaging, and labeling. The total of these similarities supports the claim of substantial equivalence.

## 7. Performance Testing

Pre-clinical testing was used to evaluate performance to ensure that the device can be used as designed. The testing evaluated ergonomics of the handle, rotate knob, bend wheel, and the dissecting grasping ability and electrical insulation requirements. The studies demonstrated acceptable reliability and design performance relative to the predicate device.

## 8. Statement of Equivalency

Based on the design, intended use, and performance testing comparisons, the SurgiSteer line of laparoscopic instruments by Steerable Technologix, LLC are substantially equivalent to the Cambridge Endoscopic Devices, Inc. pureWrist™ laparoscopic instruments approved under K061425.

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Food and Drug Administration 10903 New Hampshire Avenue Document Control Room - WO66-G609 Silver Spring, MD 20903-0002

Steerable Technologix LLC % Mr. Glen Jorgensen 10302 Deerwood Park Boulevard Suite 209 Jacksonville, FL 32256

SEP 3 0 201

Re: K111412

Trade Name: SurgiSteerIM electrocautery laparoscopic instruments Regulation Number: 21 CFR 878.4400 Regulation Name: Electrosurgical cutting and coagulation device and accessories Regulatory Class: II Product Code: GEI Dated: August 15, 2011

Received: August 19, 2011

Dear Mr. Jorgensen:

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 (IMA). 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

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Page 2 - Mr. Glen Jorgensen

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/Safeiy/Reportal?roblem/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 Statement

# 510(k) Number (if known): K | | | 4 | 2

Device Name: SurgiSteer Electrocautery Laparoscopic Instruments

Indications for Use:

The SurgiSteer™ line of of electrocautery laparoscopic instruments are sterile, single-use devices intended for use in a variety of minimally invasive surgical procedures to facilitate grasping, mobilization, dissection, and transection of tissue.

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

Over-The-Counter Use (21 CFR 801 Subpart C)

(Please do not write below this line. Continue on another page if needed)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Kandace R. Clark

(Division S Division of Surgical, Orthopedic, and Restorative Devices

510(k) Number K111412