The Beacon Bag Specimen Retrieval Bag System consists of a family of impervious bags that are sterile, single use, disposable devices having applications as a receptacle for the safe encapture and removal of tissue specimens, organs and calculi during laparoscopic surgical procedures that can be used alone or with a dedicated introducer system.

Device Description

The Beacon Bag Specimen Retrieval Bags are comprised of an introducer tube with a blunt tip, flexible fiber reinforced plastic bag with a large, easily accessible opening. With the blunt tip the instruments can be introduced percutaneously to the intended surgical site directly through an opening in the abdomen or through a conduit cannula/trocar for sizes under 16 mm, after which the working portion of the instrument can be deployed. The deployment systems consists of either a push/pull rod with thumb ring (similar to a syringe), finger ring handle, or a back handle and a push button with an internal push rod, all instruments have a blunt tip nose used for direct insertion into the abdomen. In the fully deployed condition, the bag opening is maintained in an open position by metallic rings. A suture with a slipknot and perforations of the bag under where the bag is attached to the rings facilitates closure of the specimen bag after the specimen has been collected into the bag, the suture or purse string is connected to an external part (string ring).. The specimen bag has a series of perforations around the perimeter so when the purse string suture is pulled and the bag starts to cinch and separates from the metallic rings, this is accomplished by pulling the external string ring.

The larger sized Beacon Bag Specimen Retrieval Bags, 16mm and 20mm come with a side access tube which allows for additional access into the bag without compromising the integrity of the bag opening to visualize the specimen inside the bag. This is accomplished by using a 5 mm or less sized instruments and scopes to be introduced directly into the bag for additional visualization and manipulation where required.

AI/ML Overview

The provided text describes a 510(k) premarket notification for the Beacon Bag Specimen Retrieval Bag System. This is a medical device clearance document, not a clinical study report for an AI model. Therefore, the document does not contain the information requested regarding acceptance criteria and study proving an AI device meets those criteria.

Specifically, the document discusses:

Acceptance Criteria for a Physical Device: The document states "The Beacon Bag Specimen Retrieval Bag utilizes technologies that are currently found in legally marketed predicate devices. Based upon testing and comparison with the predicate devices, the Beacon Surgical Specimen retrieval bag system presents no additional adverse indications or results. We have found that the Beacon Bag Specimen Retrieval Bag system does not present any new risks to the patient and that it is safe and performs within its design specifications." This indicates the acceptance criteria are related to safety, performance within design specifications, and equivalence to predicate devices, which are typical for traditional medical devices.
Study Proving Device Meets Criteria: The document mentions "The devices components being utilized from the predicate device K111845 have been subjected to and passed a variety of bench tests along with sterilization and aging. Additionally, the critical functions of the device have been tested for verification under protocol's BS-0101 and BS-0102 and have met the stated requirements." This refers to bench testing for a physical medical device, not a study involving AI model evaluation.

Therefore, I cannot provide the requested information in the form of the table and the detailed study parameters because the source material does not describe a study related to an AI device's performance against acceptance criteria. The document is for a physical specimen retrieval bag, not an AI or software as a medical device.

Summary

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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "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

October 26, 2015

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

Re: K151489

Trade/Device Name: Retrieval Bag System Regulation Number: 21 CFR 876.1500 Regulation Name: Endoscope and Accessories Regulatory Class: Class II Product Code: GCJ Dated: September 17, 2015 Received: September 23, 2015

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 of medical devicerelated 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.

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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,

David Krause -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: K151489

Device Name: Beacon Bag Specimen Retrieval Bag

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) Prepared September 17, 2015

Device Name: Beacon Bag Specimen Retrieval Bag

Intended Use:

Establishment Registration Number: 3011666923

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

Sponsor/Manufacturer Beacon Surgical Inc. 145 Palisade Street Dobbs Ferry, NY 10522 Tel: 914.591.8400

Device Trade or Proprietary Names:

The device trade names are: Beacon Bag Specimen Retrieval Bag

Device Common, Usual or Classification Names:

Laparoscopic Instruments. Specimen bag.

Classification 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, Endoscope Accessories

Applicable Standards:

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:

Patient Contact Materials:

The device is composed of biocompatible materials including the patient contact components that have been used in medical devices for many years.

Cleaning, Disinfection, Sterilization and Pyrogenicity:

The Beacon Bag Specimen Retrieval Bags are a family of sterile disposable single patient use devices packaged in a sterile barrier pouch which will be Ethylene oxide (ETO) sterilized. The disposable Beacon Bag Specimen Retrieval Bag will be sterilized using Ethylene oxide (ETO) sterilized, validated in production to a SAL of 10° per ISO 11135:2007.

510(k) Summary of Safety and Effectiveness:

The Beacon Bag Specimen Retrieval Bag utilizes technologies that are currently found in legally marketed predicate devices. Based upon testing and comparison with the predicate devices, the Beacon Surgical Specimen retrieval bag system presents no additional adverse indications or results. We have found that the Beacon Bag Specimen Retrieval Bag system does not present any new risks to the patient and that it is safe and performs within its design specifications. Therefore we believe that it is substantially equivalent to the predicate device and other technologies cleared by the FDA.

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Technological Characteristics:

Beacon Surgical. Inc. believes that the subject device is substantially equivalent to other devices that have previously received FDA 510(k) clearance including the predicate devices.

Predicate Device:

The following devices have been identified as predicate devices:

Espiner Tissue Retrieval System ( K111845). ●
. Anchor Espiner Tissue Retrieval System (K982073).

Predicate Device Comparison:

The Beacon Bag Specimen Retrieval Bag's are, in principal and function, identical to existing technologies. A variety of specimen retrieval bags are already widely manufactured and used in surgical procedures which share many similarities to the Beacon Bag Specimen Retrieval Bag. The predicate device's bags are of the same materials and processes and produced by the same manufacturer which has approval under 510(k) (K111845) for Espiner and (K982073) for Anchor. Espiner is the original manufacturer of the bag family which will be the bag for the Beacon bag specimen retrieval system.

Discussion on Comparison:

The main difference between the Beacon Bag Specimen Retrieval Bags is that the Espiner Medical, K111845 and the Anchor Products K982073 are designed for introduction and use through appropriately sized trocars/cannulas. Whereas the Beacon Bag Specimen Retrieval system can be used without the need for an insertion conduit or cannula, as the product comes with a blunt tip for entering into the body cavity through an entrance wound. The larger sized units have an additional access tube similar to the Espiner larger bag which allows for additional instruments or laparoscope to be used. All three units share the identical bag material and manufacturing processes. The other differences are the deployment system where the Espiner bag has to be loaded into a unit to be deployed, the Beacon Specimen Bag system houses the bag assembly internally and will deploy similar to present systems currently on the market and release from the rings when the bag is cinched through the perforations around the ring channel. The main difference between the Beacon Bag Specimen Retrieval Bags is that the Espiner Medical, K111845, and the Anchor Products K982073 are designed for introduction and use through appropriately sized trocars/cannulas. Whereas the Beacon Bag Specimen Retrieval system can be used without the need for an insertion conduit or cannula, as the product comes with a blunt tip for entering into the body cavity through an entrance wound. The larger sized units have an additional access tube similar to the Espiner larger bag for additional access by another instrument or laparoscope into the bag. All three units utilize the exact same material in the bags, and the method of construction of the Beacon bags, Esacs and the E-sleeves are identical. The differences between the Beacon Bags and the Espiner bags Standard, Super, Master and Eco are only in the methods of deployment, and release from the instrument. The other differences are the deployment system where the Espiner bag has to be loaded into a unit to be deployed, the Beacon Specimen Bag system houses the bag assembly internally and will deploy similar to present systems currently on the market. The beacon bags are all attached to a ring and are inside a tube that when

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deployed will unfurl. Once unfurled the bags can be cinched and have perforations around the bag so that when the bag is cinched closed the perforations allow the bag to separate from the rings internally.

Predicate Comparison Chart:

Characteristic	Beacon Surgical	Espiner	Anchor ProductsCompany.
	Beacon Bag SpecimenRetrieval Bag	Espiner TissueRetrieval System	Anchor EspinerTissue RetrievalSystem
510(k)	K151489	K111845	K982073
Use	The Beacon BagSpecimen Retrieval BagSystem consists of afamily of imperviousbags that are sterile,single use, disposabledevices havingapplications as areceptacle for the safeencapture and removalof tissue specimens,organs, and calculiduring laparoscopicsurgical procedures thatcan be used alone orwith a dedicatedintroducer system.	The Espiner TissueRetrieval Systemconsists of a family ofimpervious sacs whichare sterile single usedevices that can beused alone or with adedicated introducersystem for theencapture and removalof an organ, tissue orfluid from the bodycavity duringlaparoscopic surgery.	The AnchorEspiner TissueRetrieval system isa sterile disposablepouch that can beused with adedicatedintroducer systemfor the encaptureand removal of anorgan, tissue, orfluid from the bodycavity duringlaparoscopicsurgery.
Outer diameter	7.5mm, 10 mm,12.5mm, 16 mm, 20mm	10 mm, 12 mm and15mm	10 mm, 12mm and15mm
Device length	Approximately 30 cm	Approximately 30 cm	Approximately 30cm
Bag Volume	RBS-7.5 mm, 40 mlRBS- 10 mm, 195 mlRBS-16mm, 1507 ml	EMP-70 INS, 60 mlEMP-200, 200 mlEMP 160 WG, 1500ml	Equivalent
MaterialComposition	Medical Grade type 301Stainless Steel andMedical gradepolymers.	Equivalent	Equivalent
Sterilization	ETO	ETO	Equivalent
Bag/PouchMaterial	Nylon laminatepolyurethane	Nylon laminatepolyurethane	Nylon laminatepolyurethane

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Truthful and Accurate Statement:

A "truthful and accurate" statement regarding all information provided in this premarket notification is present on page.

Confidentiality:

Beacon Surgical, Inc. considers certain information in this premarket notification to be confidential business information, and has taken measures to protect the release of this information. Beacon Surgical, Inc. requests the FDA respect the confidentiality of this information to the extent possible under law. We expect the FDA will consult with Beacon Surgical, Inc. prior to the release of any information in this premarket notification (outside the 510(k) summary) for any reason. including requests under the Freedom of Information Act.

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

The devices components being utilized from the predicate device K111845 have been subjected to and passed a variety of bench tests along with sterilization and aging. Additionally, the critical functions of the device have been tested for verification under protocol's BS-0101 and BS-0102 and have met the stated requirements. All of the components used in the manufacturing of the device are composed of biocompatible materials with a history of usage in the medical device industry. The protocols are in Annex 6

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

We believe the differences are minimal and conclude that the subject device is as safe and effective as the predicate devices.

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.

David Krause -S

Indications for Use

Device Name: Beacon Bag Specimen Retrieval Bag

Intended Use:

Establishment Registration Number: 3011666923

Device Trade or Proprietary Names:

Device Common, Usual or Classification Names:

Classification Panel:

Class:

Applicable Standards:

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

Device Description:

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

Patient Contact Materials:

Cleaning, Disinfection, Sterilization and Pyrogenicity:

510(k) Summary of Safety and Effectiveness:

Technological Characteristics:

Predicate Device:

Predicate Device Comparison:

Discussion on Comparison:

Predicate Comparison Chart:

Table of Contents:

Truthful and Accurate Statement:

Confidentiality:

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

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

§ 876.1500 Endoscope and accessories.