SPECIMEN RETRIEVAL SYSTEM

K100959 · Applied Medical Resources · GCJ · Apr 22, 2010 · Gastroenterology, Urology

Device Facts

• Record ID: K100959
• Device Name: SPECIMEN RETRIEVAL SYSTEM
• Applicant: Applied Medical Resources
• Product Code: GCJ · Gastroenterology, Urology
• Decision Date: Apr 22, 2010
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 876.1500
• Device Class: Class 2
• Attributes: 3rd-Party Reviewed

Intended Use

The Applied Medical specimen Retrieval System is indicated for use as a receptacle for the collection and extraction of tissue, organs and calculi during general and laparoscopic surgical procedures.

Device Story

Disposable specimen retrieval system for laparoscopic surgery; consists of flexible polymer bag and introducer structure. Device inserted through trocar port; extracorporeal activation of handle ejects bag, which automatically opens to receive tissue, organs, or calculi. Used by surgeons in clinical settings to facilitate tissue extraction. Downsized version of predicate; smaller introducer tube diameter and bag volume to accommodate smaller trocars. Benefits include safe, contained removal of specimens during minimally invasive procedures.

Clinical Evidence

Bench testing only. Testing focused on functionality, robustness, and bag strength. Results demonstrated performance equivalent to the predicate device.

Technological Characteristics

Constructed of polymers and stainless steel. Consists of flexible bag, introducer tube, and ejection handle. Sterilized via gamma irradiation per AAMI/ISO guidelines. Designed for manual operation through trocar ports.

Indications for Use

Indicated for patients undergoing general and laparoscopic surgical procedures requiring collection and extraction of tissue, organs, and calculi.

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

• Applied Medical Inzii110 Retrieval System (K060051)

Submission Summary (Full Text)

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Kiouss

APR 2 2 2010

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## 510(k) SUMMARY

Applied Medical Resources Corporation SUBMITTED BY: 22872 Avenida Empresa Rancho Santa Margarita, CA 92688 [phone] [phone] (FAX)

CONTACT PERSON: Frans VandenBroek

DATE OF PREPARATION: February 9, 2010

TRADE NAME: Retrieval System

COMMON NAME: Tissue bags

CLASSIFICATION NAME: Laparoscope, General & Plastic Surgery (21CFR 876.1500. product code GCJ)

PREDICATE DEVICE: Applied Medical Inzii110 Retrieval System

DEVICE DESCRIPTION: The Applied medical specimen Retrieval System is a disposable receptacle used to collect and extract tissue, organs and calculi during laparoscopic procedures. It consists of a flexible polymer bag and an introducer structure that fits through a trocar port. Extracorporeal activation of the introducer handle ejects the flexible bag which automatically opens in preparation for receipt of the specimen. The device is constructed of various polymers and stainless steel. It is packaged in a Tyvek/Mylar peel pouch and a product shelf pack. The shelf pack will be sterilized using gamma irradiation per AAMI/ISO guidelines. Sterility Assurance Level will be 10°.

INTENDED USE: The Applied Medical specimen Retrieval System is indicated for use as a receptacle for the collection and extraction of tissue, organs and calculi during general and laparoscopic surgical procedures.

SUMMARY OF TECHNOLOGICAL CHARACTERISTICS: The new device is a downsized version of the predicate and is designed to broaden Applied Medical's retrieval system product line. Both predicate and subject device a tissue bag and a delivery system consisting of an introducer tube and an ejection handle. Predicate and new device are constructed of the same materials and the design is similar except for a reduction in introducer tube diameter to accommodate placement through a smaller trocar. The subject device bag also has a smaller volume.

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DISCUSSION OF NONCLINICAL TESTS SUBMITTED: Applied Medical created a dedicated test method designed to confirm safety and efficacy of the subject device relative to the predicate device of K060051. These tests focused on functionality, robustness and bag strength. Test results for predicate and new device are essentially the same.

CONCLUSIONS DRAWN FROM TESTING: Applied's performance and functional testing demonstrated that the subject specimen retrieval system is substantially equivalent to the predicate device of K060051 and introduces no new safety and effectiveness issues.

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Image /page/2/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. 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 symbol that resembles an abstract representation of a human figure or a caduceus, rendered in black.

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

Applied Medical Resources % Underwriters Laboratories, Inc. Casey Conry Senior Project Engineer 1285 Walt Whitman Road Melville, New York 11747

APR 2 2 2010

Re: K100959

Trade/Device Name: Specimen Retrieval System Regulation Number: 21 CFR 876.1500 Regulation Name: Endoscope and accessories Regulatory Class: Class II Product Code: GCJ Dated: April 05, 2010 Received: April 07, 2010

Dear Casey Conry:

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

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Page 2 - Casey Conry

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/CDRH/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/ResourcesforYou/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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## INDICATIONS FOR USE

510(k) Number (if known): Not yet assigned

Device Name: Specimen Retrieval System

Indications for Use: The Applied Medical Specimen Retrieval System is indicated for use as a receptacle for the collection and extraction of tissue, organs and calculi during general and laparoscopic surgical procedures.

X Prescription Use (Part 21 CFR 801 Subpart D)

: : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : :

AND/OR

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Neil R.P. Doylen for MKM
(Division Sign-Off)

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Division of Surgical, Orthopedic, and Restorative Devices

510(k) Number K100959

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