Pelican Sling Retractor by Beacon Surgical, Inc.

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 Description

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.

AI/ML Overview

The provided text pertains to a 510(k) premarket notification for the "Pelican Sling Retractor" and does not describe acceptance criteria for an AI/ML device or a study proving that an AI/ML device meets such criteria. Therefore, most of the requested information cannot be extracted from this document.

The document describes a medical device, a surgical retractor, and its substantial equivalence to predicate devices, focusing on its physical characteristics, materials, and intended use as a traditional medical device, not an AI/ML product.

Here's a breakdown of what can be inferred or explicitly stated based on the provided text, and what cannot:

1. A table of acceptance criteria and the reported device performance

Cannot be extracted. The document does not define specific "acceptance criteria" in terms of performance metrics like sensitivity, specificity, or accuracy that would be relevant for an AI/ML device. It discusses the device's functional characteristics and strength, but not in a quantifiable way that would represent acceptance criteria for an AI/ML model.

2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)

Cannot be extracted. The document mentions "in vitro and in vivo" testing for the critical functions of the device, but it does not specify sample sizes for these tests, the type of data used (e.g., patient data for an AI model), or the provenance of any data (country, retrospective/prospective).

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience)

Cannot be extracted. This information is irrelevant for a physical surgical retractor device. There is no "ground truth" establishment in the context of an AI/ML model for this type of device.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set

Cannot be extracted. Adjudication methods are not applicable to the testing described for this physical device.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

Cannot be extracted. An MRMC study is relevant for AI/ML diagnostic or interpretive devices involving human readers. This document describes a surgical tool, not an AI/ML system, so such a study would not be performed.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

Cannot be extracted. This question is specific to AI algorithms. The device is a physical retractor, not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

Cannot be extracted. As mentioned, "ground truth" in the context of AI/ML is not applicable to this device.

8. The sample size for the training set

Cannot be extracted. There is no AI/ML model described that would require a training set.

9. How the ground truth for the training set was established

Cannot be extracted. There is no AI/ML model described that would require a ground truth for a training set.

Summary of available information related to performance (not AI/ML specific):

The document states:

"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."

These statements indicate that mechanical and biocompatibility tests were conducted to demonstrate the device's safety and effectiveness, and its substantial equivalence to predicate devices. However, they do not provide quantitative acceptance criteria or specific performance metrics that would be relevant for an AI/ML device.

Summary

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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 (800) 638-2041 or (301) 796-7100 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 (800) 638-2041 or (301) 796-7100 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:

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:

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: 914-479-5108

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:

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™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 haveapplications in a variety of gynecologic,general, urologic, thoracic, colorectal,laparoscopic, and endoscopic proceduresfor the temporary retracting of internalstructures such as organs or tissue.	The EZaxess is intended for use increating and maintaining a port ofentry in gynecologic, general,urologic and thoracic procedures.The A-Lap™ retractor hasapplication for use in the creationand maintenance of an operativecavity such as the gynecologic,general, urologic and thoracicprocedures. The device may beused in procedures requiringtemporary retracting of tissue.The A-Lap™ set has application foruse in the creation and maintenanceof an operative cavity such as thegynecologic, general, urologic andthoracic procedures. The set may beused in procedures to create andmaintain a port of entry and fortemporary retracting of tissue.	The instrument hasapplication in a variety ofgynecologic, general,urologic, thoracic,colorectal and otherendoscopic procedures forretracting internalstructures, e.g., the bowel,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 x9 cm	12 cm X 12 cm	Approximately 9 cm x 9cm
Device length	Approximately 30 cm	Approximately 30 cm	Approximately 30 cm
MaterialComposition	Medical Grade Stainless Steels andmedical grade polymers.	Medical Grade Stainless Steels andmedical grade polymers.	Medical Grade StainlessSteels and medical gradepolymers.
Sterilization	Gamma, sterile single use disposable	Unknown, sterile single usedisposable	ETO, sterile single usedisposable
Sling, Paddle FabricMaterial	Polymer ( Nylon) mesh, polyurethanesheet	Polymer (Polyester) Mesh	Polymer (Nylon) typemesh

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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.

Regulation Number and Section

§ 876.1500 Endoscope and accessories.

(a)
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.(b)
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.