Pelican Sling Retractor

K153542 · Beacon Surgical, Inc. · GCJ · Sep 7, 2016 · Gastroenterology, Urology

Device Facts

• Record ID: K153542
• Device Name: Pelican Sling Retractor
• Applicant: Beacon Surgical, Inc.
• Product Code: GCJ · Gastroenterology, Urology
• Decision Date: Sep 7, 2016
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 876.1500
• Device Class: Class 2
• Attributes: Therapeutic

Indications for Use

The Pelican Sling Retractors have applications in a variety of gynecologic, general, urologic, thoracic, colorectal, laparoscopic and endoscopic procedures for the temporary retracting of internal structures such as organs or tissue.

Device Story

Pelican Sling Retractor is a sterile, single-use surgical instrument for temporary tissue/organ retraction. Device consists of a shaft with a blunt tip, a deployment dial, and a flexible polymer mesh or film sling. Operator rotates the dial to deploy or retract the sling; sling opening is maintained by a tube and metallic band. Available in straight and curved shaft configurations (4.5 mm or 6.5 mm diameter). Can be inserted through a trocar/cannula or directly into an abdominal opening. Used by surgeons in OR settings to create space or improve visualization during minimally invasive procedures. Benefits include reduced trauma compared to larger-diameter retractors and flexible insertion options. Output is the physical retraction of tissue, allowing the surgeon to perform procedures more effectively.

Clinical Evidence

Bench testing only. Evaluation included in vitro and in vivo testing of ergonomics, mechanical strength of the sling and shaft, and deployed sling dimensions. Biocompatibility verified per ISO 10993-1 for external communicating, blood contact, short duration (<24 hours) devices.

Technological Characteristics

Materials: Medical grade stainless steel and medical grade polymers (nylon mesh, polyurethane film). Dimensions: 4.5 mm or 6.5 mm shaft diameter; 30 cm length. Deployment: Manual dial-actuated mechanical system. Sterilization: Gamma radiation (ISO 11137, SAL 10^-6). Connectivity: None (mechanical device).

Indications for Use

Indicated for temporary retraction of internal structures (organs/tissue) during gynecologic, general, urologic, thoracic, colorectal, laparoscopic, and endoscopic procedures. No specific age or gender contraindications provided.

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.

In combination with the general controls of the FD&C Act, the integrated operating table-electromechanical surgical system is subject to the following special controls: 1. (1) Premarket clinical performance testing, or a combination of premarket clinical performance testing and postmarket surveillance (in accordance with special control (2)), must include the following: 1. (i) Objective performance measures (e.g., rate and number of conversions to other surgical modalities, rate of device related adverse events (including tissue injury, hematoma, and increased blood loss), and their severity, cause, and outcomes) must be reported with relevant descriptive comparator performance measures. 2. (ii) The data must demonstrate the performance of the device for providing accurate and precise control of attached surgical instruments in range of clinical conditions relevant to the device's intended use. 3. (iii) The test dataset must include data collected from a patient population representative of the intended patient population under anticipated conditions of use. 2. (2) Data obtained from postmarket surveillance must demonstrate, in consideration of the premarket data obtained in accordance with special control (1), that the device performs in accordance with special control (1), unless FDA determines, based on the totality of the premarket data, that data from postmarket surveillance is not required to demonstrate that the device performs as intended. Such postmarket surveillance must be conducted per a protocol determined appropriate by FDA to demonstrate that the device performs as intended (in consideration of the premarket data obtained in accordance with special control (1)), and must include initiation, enrollment, and reporting requirements to ensure timely periodic updates to FDA on post-market surveillance progress and outcomes. 3. (3) Animal performance testing must evaluate the extent of port site trauma due to repositioning of table during surgical procedures when utilizing robotic minimally invasive and laparoscopic approaches 4. (4) The device manufacturer must develop, and update as necessary, a device-specific use training program that ensures proper device setup/use/shutdown, accurate control of instruments to perform the intended surgical procedures, troubleshooting and handling during unexpected events or emergencies, and safe practices to mitigate use error. 5. (5) The device manufacturer may only distribute the device to facilities that implement and maintain the device-specific use training program and ensure that users of the device have completed the device-specific use training program. (6) Human factors assessment must demonstrate that the user can correctly use the device system across all intended use environments with the provided instructions and training materials, including patient access during normal operating conditions and emergency situations, and effects arising from the integrated nature of the operating table and robotic surgical arms. (7) Labeling must include: (i) A detailed summary of clinical performance testing conducted with the device, including study population, results, adverse events, and comparisons to any comparator groups identified; (ii) A statement in the labeling that the safety and effectiveness for the representative specific procedures was based on evaluation of the device as a surgical tool and did not include evaluation of outcomes related to the treatment of the patient's underlying disease or condition, unless FDA determines that it can be removed or modified based on clinical performance data submitted to FDA; (iii) Identification of compatible devices; (iv) The list of surgical procedures for which the device has been determined to be safe with clinical justification; (v) Reprocessing instructions for reusable components; (vi) A shelf life for any sterile components; (vii) A description of the device-specific use training program; (viii) A statement that the device is only for distribution to facilities that implement and maintain the device-specific use training program and ensure that users of the device have completed the device-specific use training program; and (ix) A summary of any completed postmarket surveillance data collected as required by special control (2), including updated labeling to accurately reflect outcomes observed in postmarket surveillance. (8) Non-clinical performance testing must demonstrate that the device performs as intended under anticipated conditions of use and must include: (i) Device motion accuracy and repeatability; (ii) System testing; (iii) Instrument reliability; (iv) Crosstalk; (v) Table motion control; (vi) Thermal effects on tissue; (vii) User-device interface performance; (viii) Workspace access testing; and (ix) Performance testing with compatible devices. (9) Software verification, validation, and hazard analysis must be performed. (10) Electromagnetic compatibility and electrical, thermal, and mechanical safety testing must be performed. (11) Performance data must demonstrate the sterility of all patient-contacting device components. (12) Performance data must support the shelf life of the device components provided sterile by demonstrating continued sterility and package integrity over the labeled shelf life. (13) Performance data must validate the reprocessing instructions for the reusable components of the device. (14) Performance data must demonstrate that all patient-contacting components of the device are biocompatible. (15) Performance data must demonstrate that all patient-contacting components of the device are non-pyrogenic. (16) The device manufacturer must submit a report to the FDA annually on the anniversary of initial marketing authorization for the device, until such time as FDA may terminate such reporting, which comprises the following information: (i) Cumulative summary, by year, of complaints and adverse events since date of initial marketing authorization; and (ii) Identification and rationale for changes made to the device, labeling, or device specific use training program, which did not require submission of a premarket notification during the reporting period.

Predicate Devices

• A-Lap™ Set, the A-Lap™ Retractor and EZaxess (EZ Surgical) (K082291)
• Covidien: Auto suture Endo paddle retractor (Auto suture)

Submission Summary (Full Text)

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Image /page/0/Picture/1 description: The image is a logo for the Department of Health & Human Services - USA. 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 three human profiles facing to the right, stacked on top of each other.

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

September 7, 2016

Beacon Surgical, Inc. Mr. Allan Alward Vice President Research and Development 145 Palisade Street, Suite 101 Dobbs Ferry, New York 10522

Re: K153542

Trade/Device Name: Pelican Sling Retractor Regulation Number: 21 CFR 876.1500 Regulation Name: Endoscope and Accessories Regulatory Class: Class II Product Code: GCJ Dated: August 2, 2016 Received: August 4, 2016

Dear Mr. Alward:

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 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 devicerelated adverse events) (21 CFR Part 803); good manufacturing practice requirements as set forth

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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 Parts 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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 Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

Christopher J. Ronk -S

For Binita S. Ashar, M.D., M.B.A., F.A.C.S. Director Division of Surgical Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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### Indications for Use

510(k) Number: Not Assigned

Device Name: Pelican Sling Retractor

Indications for Use:

The Pelican Sling Retractors have applications in a variety of gynecologic, general, urologic, thoracic, colorectal, laparoscopic and endoscopic procedures for the temporary retracting of internal structures such as organs or tissue.

X 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 OF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

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510(k) Summary (as specified by 21 CFR 807.92) Revised September 1, 2016

### Device Name: Pelican Sling Retractor

### Intended Use:

The Pelican Sling Retractors have applications in a variety of gynecologic, general, urologic, thoracic, colorectal, laparoscopic and endoscopic procedures for the temporary retracting of internal structures such as organs or tissue.

### No Previous NSE Decision:

This device has not been the subject of a previous NSE decision nor has there been other submissions or communication to the FDA regarding this device.

### Establishment Registration Number:

Regulatory Contact Allan Alward 145 Palisade Street, Suite 101 Dobbs Ferry, NY 10522 914-479-5108

Sponsor/Manufacturer Beacon Surgical LLC. 145 Palisade Street, Suite 101 Dobbs Ferry, NY 10522 Tel: [phone]

### Device Trade or Proprietary Names:

The device trade names are: Pelican Sling Retractor.

### Device Common, Usual or Classification Names:

Laparoscopic Retractor, Tissue Retractor.

### Review Panel:

Classification of this device falls under the responsibility of the General and Plastic Surgery Panel. Class:

Class 2 device under the following product codes/regulations: GCJ, 21 CFR 876.1500

### Compliance with Section 514 of the Food, Drug and Cosmetic Act

None. Section 514 has not established performance standards for this device.

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### Device Description:

### Summary of the function of the device and its major components:

The Pelican Sling Retractors are comprised of a tube with a blunt tip, a flexible polymer mesh, or a flexible polymer film used for the sling, for use during retraction of tissue. The deployment system consists of a dial that when turned deploys or closes the sling portion of the instrument. All sizes have a Blunt tip for ease of insertion, and to protect the end of the instrument during insertion. All Pelican Sling Retractors have a removable sheath that protects the sling portion of the instrument. When the instrument is fully deployed, the sling opening is maintained in an open position by a tube on one side and a metallic band on the other. The size of the sling can be varied by the amount of rotation of the dial during deployment or closing. The smallest instrument has a straight shaft and can be inserted with or without a trocar/cannula used as a conduit for insertion. The larger sizes have both a straight and curved shaft. The straight shaft can be used with the aid of a correctly sized trocar/cannula, whereas the curved can only be used with a correctly sized flexible trocar/cannula.

Either unit can be used without a trocar/cannula the only requirement is an opening into the abdomen. The Pelican Sling Retractor instruments have variations in the diameter of the shaft and the size of the Sling portion. The smallest size has a 4.5 mm diameter shaft and a sling that is approximately 9 cm x 6 cm, and can be used through a 5 mm trocar/cannula. The larger size devices have straight and curved shafts with a diameter of 6.5 mm for both. Both instruments slings when fully deployed open to approximately 15 cm x 9 cm. The large straight instrument can be inserted through an appropriately sized normal fixed trocar whereas the curved when used with a trocar can only be used with an appropriately sized flexible trocar.

#### Cleaning, Disinfection, Sterilization:

The Pelican Sling Retractors are a family of sterile disposable, single patient use devices packaged in a sterile barrier pouch which will be sterilized using gamma radiation, validated in production to a SAL of 106 per ISO 11137, Method 1, in order to reduce gamma exposure/aging. When applicable, the VDmax provisions of 11137 will be used to substantiate the standard 25-to-40 kGy dose.

#### Predicate Device:

The following devices have been identified as a predicate device:

- The A-Lap™ Set, the A-Lap™ Retractor and EZaxess (EZ Surgical) K082291.
- Covidien: Auto suture Endo paddle retractor (Auto suture); 510(k) exempt.

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### Predicate Device Comparison:

The Pelican Sling Retractors are in principal and function, identical to existing technologies. A variety of fabric and or polymeric type retractors are already manufactured and used in surgical procedures and share many similarities with the Pelican Sling Retractors.

A comparison is presented in the table below:

| Characteristic | Beacon Surgical | EZ Surgical Inc. | Covidien |
|----------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | Pelican Sling Retractors | A-Lap™ Set, the A-Lap™<br>Retractor, and the EZaxess | Endo paddle retractor |
| 510(k) | K153542 | K082291 | Not Assigned , Exempt |
| Device classification | Class 2 | Class 2 | Class 1 |
| Indications for use. | The Pelican Sling Retractors have<br>applications in a variety of gynecologic,<br>general, urologic, thoracic, colorectal,<br>laparoscopic, and endoscopic procedures<br>for the temporary retracting of internal<br>structures such as organs or tissue. | The EZaxess is intended for use in<br>creating and maintaining a port of<br>entry in gynecologic, general,<br>urologic and thoracic procedures.<br>The A-Lap™ retractor has<br>application for use in the creation<br>and maintenance of an operative<br>cavity such as the gynecologic,<br>general, urologic and thoracic<br>procedures. The device may be<br>used in procedures requiring<br>temporary retracting of tissue.<br>The A-Lap™ set has application for<br>use in the creation and maintenance<br>of an operative cavity such as the<br>gynecologic, general, urologic and<br>thoracic procedures. The set may be<br>used in procedures to create and<br>maintain a port of entry and for<br>temporary retracting of tissue. | The instrument has<br>application in a variety of<br>gynecologic, general,<br>urologic, thoracic,<br>colorectal and other<br>endoscopic procedures for<br>retracting internal<br>structures, e.g., the bowel,<br>stomach, or liver. |
| Outer shaft diameter | Approximately 4.5 mm and 6.5 mm | Approximately 6.5 mm | Approximately 12mm |
| Retractor size | Approximately 9 cm x 6 cm and 15 cm x<br>9 cm | 12 cm X 12 cm | Approximately 9 cm x 9<br>cm |
| Device length | Approximately 30 cm | Approximately 30 cm | Approximately 30 cm |
| Material<br>Composition | Medical Grade Stainless Steels and<br>medical grade polymers. | Medical Grade Stainless Steels and<br>medical grade polymers. | Medical Grade Stainless<br>Steels and medical grade<br>polymers. |
| Sterilization | Gamma, sterile single use disposable | Unknown, sterile single use<br>disposable | ETO, sterile single use<br>disposable |
| Sling, Paddle Fabric<br>Material | Polymer ( Nylon) mesh, polyurethane<br>sheet | Polymer (Polyester) Mesh | Polymer (Nylon) type<br>mesh |

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### Discussion on Comparison:

The main differences between the Pelican Sling Retractors and the Endo paddle (No k number), the A-Lap™ Retractor (K082291) is that the Beacon instrument can be used with or without the need for a trocar/cannula as a conduit to enter the body cavity when used laparoscopically. Whereas the Endo paddle and the A-Lap™ Retractor are designed for introduction and use through appropriately sized trocars/cannulas in order to gain access to the body cavity. The products are similar in respect to the deployment of the retractor system (sling, paddle, and the materials used in the construction of the devices are similar.

To deploy the Pelican sling retractors a dial is rotated in the handle portion of the instrument which allows the sling to be extended or retracted. The deployment of the Endo Paddle is similar where a knob is rotated that is situated at the back of the instrument to deploy and retract and the A-Lap™ Retractor is extended by manipulation of the finger grips.

One other major difference is that the Endo paddle requires the use of a larger trocar and thus creates more trauma to the body; the shaft diameter is almost twice as large as the Pelican Sling and A-Lap™ retractors which are similar in diameter.

### Performance Data [21 CFR 807.92(b) (1)]:

The critical functions of the device have been tested both in vitro and in vivo and the data confirms the safety and effectiveness of the device and that the basic functional characteristics for ergonomics and strength, are substantially equivalent to the predicate devices cited. Device evaluation included flexibility, mechanical strength tests for the sling portion, and shaft along with the deployed size of the slings.

Biocompatibility of the Pelican Sling Retractor materials has been verified in accordance with ISO 10993-1. Biological evaluation of Medical Devices - Part 1. Materials test results confirmed biocompatibility of the subject device when tested as an external communicating, blood contact, short duration (<24 hours) device.

### Conclusion [21 CFR 807.92(b) (3)]:

Based on the indications for use, technological characteristics, and performance testing. We believe the Pelican Sling Retractors meet the minimum requirements that are considered adequate for intended use and is substantially equivalent in design, materials, principles of operation and indications for use and conclude that the subject device is as safe and effective as the predicate device.