DeRoyal Laprador Specimen Retrieval System

K171475 · Deroyal Industries, Inc. · GCJ · Aug 17, 2017 · Gastroenterology, Urology

Device Facts

• Record ID: K171475
• Device Name: DeRoyal Laprador Specimen Retrieval System
• Applicant: Deroyal Industries, Inc.
• Product Code: GCJ · Gastroenterology, Urology
• Decision Date: Aug 17, 2017
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 876.1500
• Device Class: Class 2

Intended Use

The DeRoyal Laprador Specimen Retrieval System is a sterile device intended to be used for collection and extraction of tissue, organs, and calculi during laparoscopic surgical procedures.

Device Story

Sterile specimen retrieval system for laparoscopic surgery; used in operating rooms by surgeons. Device consists of handle, cylindrical tube, string, and ripstop nylon bag. Surgeon introduces device through trocar; deploys bag to enclose tissue, organs, or calculi; retrieves specimen. Bag loading and separation mechanisms differ from predicate, utilizing pull tail hook loop and rotating hook. Device facilitates safe removal of surgical specimens from body cavity.

Clinical Evidence

Bench testing only. Evaluated device pressure leak rate, bag leakage/volume, puncture resistance, burst resistance, retraction/deployment functionality, and cinch string strength. Compared against Anchor Laparoscopic Tissue Retrieval System and Applied Medical Specimen Retrieval System. All tests passed, demonstrating performance comparable to predicate/competitor devices.

Technological Characteristics

Ripstop nylon bag, polyester stitching, ABS handles/shaft, stainless steel rod/spring. Sterilized via Ethylene Oxide per ISO 11135-1:2014. Biocompatibility per ISO 10993-1:2009. Mechanical deployment/retraction system for laparoscopic use.

Indications for Use

Indicated for collection and extraction of tissue, organs, and calculi during laparoscopic surgical procedures. Contraindicated when, in the judgment of the licensed clinician, use of the device would not be in the best interest of the patient.

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

• Anchor Laparoscopic Tissue Retrieval System (K091930)

Reference Devices

• Applied Medical Specimen Retrieval System (K100959)

Submission Summary (Full Text)

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

August 17, 2017

DeRoyal Industries. Inc. Ms. Sarah Bennett Regulatory Affairs Specialist 200 DeBusk Lane Powell, Tennessee 37849

Re: K171475

Trade/Device Name: DeRoyal Laprador Specimen Retrieval System Regulation Number: 21 CFR 876.1500 Regulation Name: Endoscope and Accessories Regulatory Class: Class II Product Code: GCJ Dated: August 11, 2017 Received: August 14, 2017

Dear Ms. Bennett:

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 Actinclude 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 device-

Image /page/0/Picture/11 description: The image is a seal for the Department of Health & Human Services - USA. The seal is circular and contains the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is an abstract image of three faces in profile, stacked on top of each other. The faces are stylized and appear to be connected.

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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 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,

Jennifer R. Stevenson -S3

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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### DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

## Indications for Use

Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below.

510(k) Number (if known)

### K171475

Device Name

DeRoyal Laprador Specimen Retrieval System

#### Indications for Use (Describe)

The DeRoyal Laprador Specimen Retrieval System is a sterile device intended to be used for collection of tissue, organs, and calculi during laparoscopic surgical procedures.

#### Contraindications

The DeRoyal Laprador Specimen Retrieval System is contraindicated for use when, in the judgment of the licensed clinician, use of such a device would not be in the best interest of the patient.

Type of Use (Select one or both, as applicable)

> Prescription Use (Part 21 CFR 801 Subpart D)

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

#### CONTINUE ON A SEPARATE PAGE IF NEEDED.

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## *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.*

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Image /page/3/Picture/2 description: The image shows the logo for DeRoyal. The logo features a stylized blue swoosh above the text "DeRoyal" in a matching blue color. A registered trademark symbol is located to the right of the word "Royal".

Corporate 200 DeBusk Lane Powell, TN 37849 USA 865.938.7828 800.251.9864 www.deroyal.com

DeRoyal Industries, Inc. Traditional 510(k) Submission – DeRoyal Laprador Specimen Retrieval System May 18, 2017

## 510(k) Summary

| Date prepared: | May 18, 2017 |
|------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 510(k) Owner: | DeRoyal Industries, Inc.<br>200 DeBusk Lane<br>Powell, TN 37849<br>Owner/Operator #1044833 |
| 510(k) Contact: | Sarah Bennett<br>Regulatory Affairs Specialist<br>P: 865-362-6112<br>F: 865-362-3741<br>[e-mail] |
| Contract Manufacturer: | DeRoyal Intercontinental, S.R.L.<br>Km 7, Autopista Joaquin Balaguer<br>Pisano Free Zone, Building 49<br>Santiago Santiago, DO<br>FDA Establishment #3004605321 |
| Trade Name: | DeRoyal Laprador Specimen<br>Retrieval System |
| Common Name: | Specimen Retrieval Bag |
| Classification Name: | Laparoscope, General &<br>Plastic Surgery (21 CFR 876.1500) |
| Regulatory Class: | Class II |
| Device Product Code: | GCJ |
| Classification Panel: | General & Plastic Surgery |
| Predicate Devices: | Anchor Laparoscopic Tissue<br>Retrieval System [K091930] |

## Device Description

The DeRoyal Laprador Specimen Retrieval System consists of a handle, a cylindrical tube, a string, and a ripstop nylon bag. The system deploys and retracts the nylon bag, which encloses tissue specimens for retrieval during laparoscopic surgical procedures.

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Image /page/4/Picture/0 description: The image shows the logo for DeRoyal. The logo consists of a blue swoosh-like graphic on the left, followed by the company name "DeRoyal" in blue lettering. A registered trademark symbol is located to the right of the word "Royal".

Corporate 200 DeBusk Lane Powell, TN 37849 USA 865.938.7828 800.251.9864 www.deroyal.com

## K171475

The device is designed for introduction and use through appropriately sized trocars. The device is sterilized by ethylene oxide.

# Intended Use

The DeRoyal Laprador Specimen Retrieval System is a sterile device intended to be used for collection and extraction of tissue, organs, and calculi during laparoscopic surgical procedures.

# Summary of Technological Characteristics

The intended use and design are identical to the predicate devices. The proposed device is sterilized by ethylene oxide and utilizes a rip-stop nylon material for the bag construction. This sterilization method and bag material are identical to the method and bag material utilized by the Anchor Tissue Retrieval System (K091930). The mechanisms to load the tissue bag into the introducer shaft and separate the bag from the deployment shaft are different; however, bench test results demonstrate these differences do not raise new issues of safety and effectiveness. The proposed device is substantially equivalent as it poses no new changes that could impact safety and effectiveness.

| Characteristic | DeRoyal Laprador<br>Specimen Retrieval System | Predicate<br>Device<br>Anchor<br>K091930 |
|-------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------|
| Intended Use | Intended for collection and<br>extraction of tissue, organs,<br>and calculi during<br>laparoscopic surgical<br>procedures. | Same |
| Where Used | Operating Room | Same |
| Prescription<br>Only | Yes | Same |
| Design | Specimen bag and a delivery<br>system consisting of an<br>introducer shaft and<br>deployment handle | Same |
| Materials | Nylon bag and cinch string,<br>polyester stitching, ABS<br>handles and shaft, and<br>stainless steel rod and spring | Nylon bag,<br>plastic<br>handles<br>tubes and<br>rods |
| Mechanism to<br>load tissue bag<br>into introducer<br>shaft | Pull Tail hook loop | Hook and<br>spring<br>mechanism<br>at distal end. |
| Mechanism to | Rotating hook | Push button |

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Image /page/5/Picture/2 description: The image features the logo for "DeRoyal". The logo consists of a stylized blue swoosh above the text "DeRoyal", also in blue. A registered trademark symbol is located to the right of the word "Royal".

Corporate 200 DeBusk Lane Powell, TN 37849 USA 865.938.7828 800.251.9864 www.deroyal.com

| separate bag | | |
|------------------|--------------------------------|------|
| from deployment | | |
| shaft | | |
| Performance | There are no FDA | Same |
| | performance standards for this | |
| | device. Therefore, bench | |
| | testing was performed. | |
| Sterilization | Ethylene Oxide per ISO | Same |
| | 11135-1: 2014 | |
| Biocompatibility | According to ISO 10993-1: | Same |
| | 2009 | |

# Summary of Performance Tests

Bench testing was completed to ensure the device meets its performance specifications and functions effectively. Device characteristics tested included device pressure leak rate, bag leakage and volume, bag puncture resistance, bag burst resistance, retraction and deployment functionality, and cinch string strength. All tests were performed on the DeRoyal Laprador Specimen Retrieval system, the predicate device, and an additional competitor, Applied Medical Specimen Retrieval System (K100959). The proposed device passed all design verification tests and performed comparable to at least one competitor device, thus demonstrating it meets performance specifications and functions safe and effectively.

# Conclusion

The results of the performance and comparative testing demonstrate the DeRoyal Laprador Specimen Retrieval System is substantially equivalent to the predicate devices, the Anchor Tissue Retrieval System cleared under K091930.