(15 days)
Endopouch™ Specimen Retrieval Bag
Not Found
No
The device description and performance studies focus on mechanical and material properties, with no mention of AI/ML or related concepts like image processing, training/test sets, or performance metrics typically associated with AI/ML algorithms.
No.
The device is used for collecting and extracting tissue, organs, and calculi during surgical procedures, not for treating a disease or condition.
No
Explanation: The device is described as a "receptacle for the collection and extraction of tissue, organs and calculi during general and laparoscopic surgical procedures." Its function is to retrieve specimens, not to identify, monitor, or determine the presence of a disease or condition.
No
The device description clearly outlines physical components like a stylet, introducer sheath, and retrieval bag, indicating it is a hardware device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for the collection and extraction of tissue, organs, and calculi during surgical procedures. This is a surgical tool used in vivo (within the body) to handle specimens after they have been removed.
- Device Description: The description details a physical device used for containing and removing specimens from the body. It does not describe a test or assay performed in vitro (outside the body) on a biological sample to diagnose a condition.
- Lack of Diagnostic Function: There is no mention of the device being used to analyze or test the collected specimens for diagnostic purposes. Its function is purely for retrieval and containment.
IVD devices are used to examine specimens (like blood, urine, tissue) outside the body to provide information for diagnosis, monitoring, or screening. This device's function is entirely within the surgical procedure itself.
N/A
Intended Use / Indications for 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.
Product codes
Not Found
Device Description
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies
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.
Key Metrics
Not Found
Predicate Device(s)
Endopouch™ Specimen Retrieval Bag
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.
0
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 | |
| (714) 582-6120 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.