SPECIMEN RETRIEVAL BAG

K962395 · Applied Medical Resources · GCJ · Jul 5, 1996 · Gastroenterology, Urology

Device Facts

• Record ID: K962395
• Device Name: SPECIMEN RETRIEVAL BAG
• Applicant: Applied Medical Resources
• Product Code: GCJ · Gastroenterology, Urology
• Decision Date: Jul 5, 1996
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 876.1500
• Device Class: Class 2

Intended Use

The Specimen Retrieval Bag 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

Specimen retrieval bag for general/laparoscopic surgery; used to collect/extract tissue, organs, calculi. Device comprises stylet, introducer sheath with locking pneumoperitoneal seal, and distal retrieval bag. Sheath features dual-lumen design: large lumen for grasping instruments; small lumen for bag activation wire (positioning, opening, closing). Enables single-trocar access for tissue retrieval. Maintains pneumoperitoneum via locking seal. Operated by surgeons in OR. Benefits: facilitates minimally invasive tissue removal; maintains cavity pressure.

Clinical Evidence

Bench testing only; mechanical and biocompatibility tests performed to verify functional and structural integrity and material safety.

Technological Characteristics

Dual-lumen introducer sheath; locking pneumoperitoneal seal; retrieval bag; stylet. Mechanical operation via activation wire. Biocompatible materials.

Indications for Use

Indicated for patients undergoing general or 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

• Endopouch™ Specimen Retrieval Bag (Ethicon)

Submission Summary (Full Text)

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K962395

JUL - 5 1996

# APPENDIX VIII

## 510(k) SUMMARY

### 510(k) NUMBER:
PENDING

### SUBMITTED BY:
Applied Medical Resources Corporation
26051 Merit Circle, Unit# 103
Laguna Hills, California 92653
[phone] EXT. 310

### CONTACT PERSON:
Howard V. Rowe

### DATE OF PREPARATION:
June 19, 1996

### NAME OF DEVICE:
Applied Medical Specimen Retrieval Bag

### CLASSIFICATION NAME:
Organ bag

### TRADE NAME:
Not Determined

### SUMMARY STATEMENT:
The Applied Medical Specimen Retrieval Bag is substantially equivalent to the predicate device (Endopouch™ Specimen Retrieval Bag) manufactured by Ethicon. The Specimen Retrieval Bag is indicated for use as a receptacle for the collection and extraction of tissue, organs and calculi during general and laparoscopic surgical procedures. The Applied Medical Specimen Retrieval Bag consists of a stylet, an introducer sheath with a locking pneumoperitoneal seal at the proximal end and a retrieval bag sealed radially on the distal end. The locking seal serves as a mechanism for maintaining positive pressure in the peritoneal cavity during laparoscopic procedures. The sheath contains a dual lumen, where the larger of the two lumens acts as the working channel for the insertion and removal of grasping instruments while the second and smaller lumen contains the bag activation wire for positioning, opening and closing of the bag. The dual lumen design allows the use of a single trocar for placement and retrieval of tissue, organs and calculi. Mechanical and biocompatibility tests were performed to verify functional and structural integrity and material safety. All testing demonstrated the Applied Medical Specimen Retrieval Bag is comparable to the predicate devices and introduces no new safety and effectiveness issues when used as indicated.