(15 days)
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.
Here's an analysis of the provided text in the context of device acceptance criteria and studies, as requested:
Device: Applied Medical Specimen Retrieval Bag
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Specific Criteria (Inferred from text) | Reported Device Performance (Inferred from text) |
|---|---|---|
| Functional Integrity | Ability to collect and extract tissue, organs, and calculi. | "Mechanical...tests were performed to verify functional and structural integrity..." |
| Structural Integrity | Device components (stylet, introducer sheath, retrieval bag, locking seal, dual lumen) maintain their form and function. | "...tests were performed to verify functional and structural integrity..." |
| Material Safety (Biocompatibility) | Materials used are safe for human contact and do not elicit adverse biological responses. | "...biocompatibility tests were performed to verify...material safety." |
| Equivalence to Predicate Device | Functionally identical or superior to the predicate device (Endopouch™ Specimen Retrieval Bag) without introducing new safety/effectiveness issues. | "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." |
| Pneumoperitoneum Maintenance | Locking seal effectively maintains positive pressure in the peritoneal cavity during laparoscopic procedures. | "The locking seal serves as a mechanism for maintaining positive pressure in the peritoneal cavity during laparoscopic procedures." (Performance is implied by its design function and statement of no new safety/effectiveness issues.) |
| Ease of Use (Single Trocar) | Dual lumen design allows use of a single trocar for placement and retrieval. | "The dual lumen design allows the use of a single trocar for placement and retrieval of tissue, organs and calculi." (Performance is implied by its design function and statement of no new safety/effectiveness issues.) |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: The document does not specify the sample size for any tests. It only states that "Mechanical and biocompatibility tests were performed."
- Data Provenance: The document does not provide information on data provenance (e.g., country of origin, retrospective/prospective). It describes laboratory-based mechanical and biocompatibility tests, not clinical data involving human subjects.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
- This information is not applicable to this submission. The device is a physical medical device (specimen retrieval bag) and its performance is evaluated through engineering and biocompatibility testing, not through expert review of data like imaging or clinical assessments. Ground truth in this context would be defined by engineering specifications and biocompatibility standards.
4. Adjudication Method for the Test Set
- This information is not applicable. Adjudication methods are typically used in studies involving human interpretation or clinical endpoints. This submission describes physical and material property testing.
5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was Done
- No, an MRMC comparative effectiveness study was not done. This type of study assesses human reader performance, often with and without AI assistance, which is not relevant to a physical specimen retrieval bag.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was Done
- No, a standalone study in the context of an algorithm's performance was not done. This device is a physical tool, not an algorithm. Its "standalone" performance would be its inherent functional and structural integrity, which was tested.
7. The Type of Ground Truth Used
- The ground truth for this device's evaluation would be based on:
- Engineering Specifications: Defined parameters for strength, sealing capability, lumen dimensions, etc.
- Biocompatibility Standards: Established international standards (e.g., ISO 10993 series) for material safety testing and acceptable biological responses.
- Predicate Device Performance: The functional and safety characteristics of the legally marketed predicate device (Endopouch™ Specimen Retrieval Bag) served as a benchmark for "comparability."
8. The Sample Size for the Training Set
- This concept is not applicable. A "training set" is relevant for machine learning algorithms. This submission describes testing of a physical medical device.
9. How the Ground Truth for the Training Set Was Established
- This concept is not applicable for the same reason as point 8.
§ 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.