(63 days)
A single use retrieval bag designed to temporarily contain organs or stones and facilitate their removal from the patient without contamination during laparoscopic surgery such as the appendix, an ectopic pregnancy, gallbladder, gallstones, lymph nodes, ovaries, fibroid tumors, small sections of bowel and other tissue structures.
The LiNA-Bag is a laparoscopic instrument consisting of a collapsible pouch attached and placed within a long slender multi-part tube allowing for introduction of said pouch through a laparoscopic trocar. Opening and closing of the pouch is activated by manual manipulation in a push and pull motion of the attached tube that has a corresponding nylon drawstring attached to the pouch.
The provided text describes a 510(k) premarket notification for a medical device called the LiNA-Bag. It focuses on demonstrating substantial equivalence to predicate devices rather than proving performance against specific acceptance criteria through a study. Therefore, much of the requested information (such as study details, sample sizes, expert qualifications, and MRMC studies) is not present in the provided document.
Here's a breakdown of the available information:
1. A table of acceptance criteria and the reported device performance
The document does not explicitly state formal acceptance criteria with numerical targets. The "performance" being demonstrated is primarily substantial equivalence to predicate devices. The implicit criteria for substantial equivalence are based on:
| Acceptance Criteria (Implicit from 510(k) Process) | Reported Device Performance (as stated in document) |
|---|---|
| Intended Use Equivalence: Device's intended use is the same as predicate devices. | The LiNA-Bag is a sterile, single-use bag designed to contain tissue, small organic matter temporarily in order to facilitate the removal of this matter without wound contamination during laparoscopic procedures. This is consistent with the general intended use of specimen retrieval bags. |
| Technological Characteristics Equivalence: Device has similar materials, design, energy source, or other features as predicate devices. | The description indicates a laparoscopic instrument with a collapsible pouch, multi-part tube, and manual manipulation for opening/closing, activated by a nylon drawstring. This design is consistent with laparoscopic specimen retrieval bags. The device is also single-use and sterile. Specific material compositions are not detailed but are implied to be similar to legally marketed devices. |
| Performance Data (if applicable): While no specific performance study is detailed, the demonstration of substantial equivalence implies that the device is expected to perform safely and effectively for its intended use, similar to its predicates. | No specific performance study data (e.g., strength, burst pressure, tear resistance, retrieval rates) are provided in this summary. The 510(k) relies on the inherent safety and effectiveness of the existing predicate devices. |
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
Not applicable. The document describes a 510(k) submission based on substantial equivalence, not a clinical or performance study with a test set. There are no test subjects or data provenance mentioned for performance evaluation.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
Not applicable. This information pertains to a study or clinical trial, which is not described in this 510(k) summary. Ground truth establishment for a test set is not part of this type of submission.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. As no test set performance study is detailed, there is no mention of an adjudication method.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
Not applicable. This type of study (MRMC, AI assistance) is for comparative effectiveness of diagnostic tools, which is not relevant to a laparoscopic specimen retrieval bag.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This device is a physical surgical instrument, not an algorithm or AI.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
Not applicable. No ground truth was established as this is not a diagnostic device or a study involving such. The "ground truth" for the 510(k) process is the safety and effectiveness of the legally marketed predicate devices.
8. The sample size for the training set
Not applicable. This document does not describe a training set for an algorithm or AI model.
9. How the ground truth for the training set was established
Not applicable. As there is no training set described, the method for establishing its ground truth is also not applicable.
§ 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.