SPIDER FLEXIBLE BLUNT DISSECTOR AND BAND PASSER

K120403 · Transenterix, Inc. · GCJ · Apr 16, 2012 · Gastroenterology, Urology

Device Facts

• Record ID: K120403
• Device Name: SPIDER FLEXIBLE BLUNT DISSECTOR AND BAND PASSER
• Applicant: Transenterix, Inc.
• Product Code: GCJ · Gastroenterology, Urology
• Decision Date: Apr 16, 2012
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 876.1500
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The SPIDER® Flexible Blunt Dissector and Band Passer is indicated for use with the SPIDER® single port device (SPIDER® Surgical Platform) during laparoscopic surgery to dissect tissue layers, to pull tubing and to generally assist in the placement of gastric bands.

Device Story

The SPIDER® Flexible Blunt Dissector and Band Passer is a single-use, sterile, disposable laparoscopic instrument. It features a flexible shaft with an articulating distal tip, controlled by a proximal ratcheted handle. The blunt tip includes a slot for suture capture and a non-electrical retractable loop for grasping/pulling tissue, tubing, or sutures. Designed for use with the SPIDER® Surgical Platform or other laparoscopic access devices, it is operated by a surgeon in an OR setting. The device facilitates blunt tissue dissection and gastric band positioning. By providing an articulating, flexible tool for single-port access, it assists surgeons in complex laparoscopic procedures, potentially reducing the need for additional incisions.

Clinical Evidence

No clinical data. Evidence consists of bench testing and pre-clinical cadaver model studies. Bench testing evaluated articulation angle, strength, blunt tip/loop function, and cycle reliability. Simulated use testing performed with the SPIDER laparoscopic device and chicken tissue samples confirmed functionality. Biocompatibility testing conducted per ISO 10993-1; sterility and shelf-life validated for the SPIDER Flexible Instruments family.

Technological Characteristics

Flexible shaft with articulating distal tip; proximal ratcheted handle; non-electrical retractable grasping loop; blunt tip with suture slot. Single-use, disposable. Gamma sterilized. Biocompatible materials per ISO 10993-1.

Indications for Use

Indicated for use during laparoscopic surgery to dissect tissue layers, pull tubing, and assist in gastric band placement. Used in conjunction with the SPIDER® Surgical Platform.

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

• Logiflex Laparoscopic Band Positioning Device (K100109)
• Realize Blunt Dissector (previously known as the Obtech Medical Goldfinger Blunt Dissector) (None)
• SPIDER Flexible Grasper (K091697)

Submission Summary (Full Text)

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APR 1 6 2012

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advancing surgery through innovation™

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### 510(k) Summarv

20403

This summary of safety and effectiveness information is being submitted in accordance with requirements of 21 CFR Part 807.92.

Date: April 11, 2012

- 1. Submitter:
Submitted by:

TransEnterix, Inc. 635 Davis Drive, Suite 300 Durham, NC 27713 TEL: [phone] FAX: [phone]

VP Quality and Regulatory Affairs

Contact:

2. Device:

| Propriety Name | SPIDER® Flexible Blunt Dissector and Band Passer |
|----------------------|--------------------------------------------------|
| Common Name | Laparoscopic instrument and accessory |
| Classification Name: | Endoscope and accessories |
| Classification: | Class II 21 CFR 876.1500 |
| Product Code: | GCJ |

Tammy Carrea

#### 3. Predicate Devices:

| Class: | 510(k) Number: | Device Name/Description: |
|--------|----------------|------------------------------------------------------------------------------------------------|
| II | K100109 | Logiflex Laparoscopic Band Positioning Device |
| I | None | Realize Blunt Dissector (previously known as the<br>Obtech Medical Goldfinger Blunt Dissector) |
| II | K091697 | SPIDER Flexible Grasper |

#### 4. Description:

The SPIDER® Flexible Blunt Dissector and Band Passer device is a surgical instrument used to facilitate laparoscopic surgery. It is intended for use with the SPIDER® Single Port Device or other laparoscopic access device that facilitates the use of rigid and/or flexible instrumentation.

The SPIDER® Flexible Blunt Dissector and Band Passer instrument has a flexible shaft with an articulating distal tip is blunt to allow tissue dissection between tissue layers and the articulation is actuated via a proximal ratcheted handle. The blunt

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K120403

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tip includes a shallow slot to grab sutures as applicable. It also includes a non-electrical retractable loop (grasping loop) for grasping and pulling tubing, sutures, or tissue. The instrument is provided sterile and is a single use, disposable device.

#### 5. Indications for Use:

The SPIDER® Flexible Blunt Dissector and Band Passer is indicated for use with the SPIDER® single port device (SPIDER® Surgical Platform) during laparoscopic surgery to dissect tissue layers, to pull tubing and to generally assist in the placement of gastric bands.

## 6. Comparison of Technological Characteristics with Predicate:

The SPIDER® Flexible Blunt Dissector and Band Passer device utilizes the same or similar design, dimensions, materials of construction, and sterilization as that of the i SPIDER Flexible Grasper. The flexible design and length of the SPIDER® Flexible Blunt Dissector and Band Passer device is essentially the same as the SPIDER® Flexible Grasper currently marketed.

Similar to the predicate devices the SPIDER® Flexible Blunt Dissector and Band Passer device is provided pre-sterilized, is disposable, and is a single use device, the same as other predicate devices.

The SPIDER® Blunt Dissector and Band Passer device has a blunt tip to facilitate tissue dissection and an articulating distal tip similar to the gastric band predicate devices. All of the devices include a slot to capture and pull a suture. The only technological difference in the SPIDER® Flexible Blunt Dissector and Band Passer device and the gastric band predicate devices is the mechanical mechanism for grabbing a band. The Logiflex Band Positioning Device and the Realize Blunt Dissector (Goldfinger) use a large open slot to capture the band. The SPIDER® Flexible Blunt Dissector and Band Passer device uses a retractable mechanical loop that can be deployed to grab and pull bands. This technological feature has been tested in simulated use bench studies and in a cadaver model to demonstrate that it fulfills its intended use with regard to grabbing and pulling bands.

Any technological differences between the SPIDER® Flexible Blunt Dissector and Band Passer device and the predicates have been mitigated via functional, simulated use, and preclinical testing. Thus the SPIDER® Flexible Blunt Dissector and Band Passer device does not introduce any new issues of safety or effectiveness compared to other similar laparoscopic or endoscopic surgical devices currently marketed.

#### 7. Performance Data:

Functional testing of the SPIDER® Flexible Blunt Dissector and Band Passer device was conducted during bench studies to evaluate the articulation angle, strength, function of the blunt tip, function of loop, cycle testing for reliability, and was tested under simulated use conditions. The simulated use testing was conducted by testing the instrument with the SPIDER® laparoscopic device and tissue samples (chicken tissue). The study found

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that the SPIDER® Flexible Blunt Dissector and Band Passer device performed as a intended and remained functional following cycle testing.

Gamma sterility testing has been conducted for the SPIDER® Flexible Instruments Family which includes the Blunt Dissector and Band Passer device and has been shown to achieve a sterility assurance level of 1x10 °. In addition the sterile barrier packaging has been tested for the Flexible Instruments family and has been found to maintain sterility during shelf life testing.

The SPIDER® Flexible Blunt Dissector and Band Passer device has been tested for biocompatibility in accordance with ISO 10993-1 based on the duration of contact and type of contact. The studies concluded that the instruments are non-toxic, non-irritating, and non-sensitizing.

Pre-clinical testing in a cadaver model study was performed and demonstrated that the SPIDER® Flexible Blunt Dissector and Band Passer device compares to that of standard laparoscopic instruments and predicate devices in terms of performing blunt dissection and band positioning in laparoscopic procedures.

#### Conclusion: 8.

The conclusion drawn from the test data is that the SPIDER® Flexible Blunt Dissector and Band Passer is as safe and effective as the predicate devices, has the same intended use and performs similarly to other legally marketed predicate devices for laparoscopic surgery, and does not raise any new issues of safety or effectiveness.

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#### DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three tail feathers, representing the department's commitment to health, human services, and well-being. The eagle is encircled by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA". The logo is simple and recognizable, conveying the department's role in serving the American people.

#### Public Health Service

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

TransEnterix, Inc. % Ms. Tammy B. Carrea VP Quality and Regulatory Affairs 635 Davis Drive, Suite 300 Durham, North Carolina 27713

Re: K120403

Trade/Device Name: SPIDER® (Single Port Instrument Delivery Extended Reach) Blunt Dissector and Band Passer device

Regulation Number: 21 CFR 876.1500 Regulation Name: Endoscope and accessories Regulatory Class: II Product Code: GCJ Dated: February 8, 2012 Received: February 9, 2012

#### Dear Ms. Carrea:

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.

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

APR 1 6 2012

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#### Page 2 - Ms. Tammy B. Carrea

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/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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#### 510(k) No. K120403

If known

# Indications For Use Statement

Device Name:

## SPIDER® (Single Port Instrument Delivery Extended Reach) Blunt Dissector and Band Passer device

Indications For Use:

The SPIDER® Flexible Blunt Dissector and Band Passer is indicated for use with the SPIDER® single port device (SPIDER® Surgical Platform) during laparoscopic surgery to dissect tissue layers, to pull tubing and to generally assist in the placement of gastric bands.

Prescription Use

AND/OR '

x

Over-The-Counter Use

. (Per 21 CFR 801 Subpart D)

(Per 21 CFR 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE ~ CONTINUE ON ANOTHER PAGE IF NECESSARY)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Nish R.P. Dasler for nxn
(Division Sign-Off)

Division of Surgical, Orthopedic, and Restorative Devices

510(k) Number K120403