(81 days)
The device is indicated for use as a receptacle for the collection of tissue, organs and calculi during general and laparoscopic procedures.
The EzCatch Tissue Retrieval Bag consists of a long cylindrical tube (Deployer Handpiece) and a polyurethane bag (Tissue Retrieval Bag) that minimizes spillage and intraoperative contamination by isolating and containing specimens. This device is designed for introduction and use through all appropriately sized trocar sleeve (of generally 10mm size). The EzCatch Tissue Retrieval Bag has application for safe, convenient removal of tissue specimens such as the appendix, an ectopic pregnancy, gallbladder, gallstones, lymph nodes, ovaries, small sections of bowel and other tissue structures.
The medical device in question is the Ez Catch Auto, Ez Catch YR, and Ez Catch TR, which are tissue retrieval bags indicated for use as a receptacle for the collection of tissue, organs, and calculi during general and laparoscopic procedures.
Acceptance Criteria and Device Performance:
The document does not explicitly state acceptance criteria in a table format with corresponding reported device performance metrics for the tested parameters. However, it lists several non-clinical tests performed, implying that the device successfully met the internal criteria for these tests to support a claim of substantial equivalence.
Based on the information provided, here's a table summarizing the tests performed, which indirectly represent areas where the device needed to perform acceptably:
| Test/Criteria Category | Reported Device Performance (Implied by successful testing) |
|---|---|
| Leak Test | Met internal specifications for leak integrity |
| Force to push out retracted bag test | Met internal specifications for deployment force |
| Force to withdraw retracted bag test | Met internal specifications for retraction force |
| Penetration force test | Met internal specifications for resistance to penetration |
| Tightening Line Tensile Strength Test | Met internal specifications for tensile strength |
| Retracted Bag Peeling Force Test | Met internal specifications for peeling force |
| Sterilization validation | Successfully validated for sterilization effectiveness |
| EO, ECH residues | Levels within acceptable limits |
| Shelf Life testing | Demonstrated acceptable shelf life |
| Biocompatibility testing (ISO 10993-1) | Met biocompatibility standards |
Study Information:
The document describes a series of non-clinical tests conducted on the subject device to demonstrate its performance and safety, and to support its substantial equivalence to a predicate device (K201243 - Disposable Specimen Retrieval Bag).
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Sample sizes used for the test set and the data provenance:
The document does not explicitly state the specific sample sizes used for each of the non-clinical tests (e.g., number of bags tested for the leak test). It only states that "non-clinical tests were performed in the subject device." The data provenance is implied to be from internal testing conducted by the manufacturer, Veol Medical Technologies Pvt Ltd, given the submission is for their device. The tests are "retrospective" in the sense that they were conducted for regulatory submission, not as a prospective clinical trial. -
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
This information is not applicable to the non-clinical tests described. Ground truth and expert consensus are typically associated with clinical studies involving human interpretation or pathology, which are not outlined here. The "ground truth" for non-clinical tests would be the established engineering specifications and regulatory standards (e.g., ISO 10993-1). -
Adjudication method for the test set:
Not applicable. Adjudication methods like 2+1 or 3+1 refer to independent review of cases, typically in clinical studies, to establish ground truth or resolve discrepancies in interpretations. For non-clinical tests, performance is measured against predefined, objective specifications. -
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. The document describes a medical device (tissue retrieval bag), not an AI-powered diagnostic or assistive tool. Therefore, an MRMC study related to AI assistance is irrelevant to this submission. -
If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
Not applicable, as this is not an AI/algorithm-based device. -
The type of ground truth used:
For the non-clinical tests, the "ground truth" is defined by established engineering specifications, performance standards, and regulatory requirements (e.g., ISO 10993-1 for biocompatibility). The success of the tests indicates that the device met these objective criteria. -
The sample size for the training set:
Not applicable. This is a medical device, not a machine learning model, so there is no concept of a "training set." -
How the ground truth for the training set was established:
Not applicable, as there is no training set for this device.
§ 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.