(140 days)
The ENDOCOLLECT Specimen Retrieval Bag is indicated for use in laparoscopic procedures to capture organs or tissue to be removed from the body cavity.
The ENDOCOLLECT Specimen Retrieval Bag ("ENDOCOLLECT") is a disposable device used as a receptacle for the collection and extraction of tissue specimens during laparoscopic surgery and is intended to be used with an endoscopic trocar. ENDOCOLLECT is comprised of a flexible plastic bag with a large, easily accessible opening, a spring finger, deployment shaft, shaft handle, and an insertion tube. In the fully deployed condition, the specimen bag opening is maintained during the retrieval of a specimen. When the specimen is placed in the bag, the bag is closed with the cinch cord and the device may be removed from the body.
This document is an FDA 510(k) clearance letter for a medical device called the "ENDOCOLLECT Specimen Retrieval Bag." It details the regulatory process and the determination of substantial equivalence to a predicate device.
Based on the provided text, the device in question is a physical medical device (specimen retrieval bag) and not an AI/software-based medical device. Therefore, many of the requested points related to AI/MRMC studies, ground truth establishment, and training/test sets are not applicable to this submission.
The document primarily focuses on the nonclinical performance testing to demonstrate the device's safety and effectiveness compared to a legally marketed predicate device.
Here's an analysis of the provided information in the context of the requested points, noting where information is not applicable due to the nature of the device:
Device Type: ENDOCOLLECT Specimen Retrieval Bag (a physical, disposable device for laparoscopic tissue retrieval). This is NOT an AI/software device.
1. A table of acceptance criteria and the reported device performance
The document does not provide a direct table of specific numerical acceptance criteria and reported performance values. Instead, it offers a summary of the types of nonclinical bench testing conducted:
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Force and Volume Testing | Meets established specifications necessary for consistent performance during its intended use. |
| Durability Testing | Meets established specifications necessary for consistent performance during its intended use. |
| Puncture Testing | Meets established specifications necessary for consistent performance during its intended use. |
| Spring Finger Deflection Testing | Meets established specifications necessary for consistent performance during its intended use. |
| Weight Capacity and Air Leak Testing | Meets established specifications necessary for consistent performance during its intended use. |
| Sterilization Validation | Meets established specifications. |
| Shelf-Life Testing | Meets established specifications. |
| Transportation Testing | Meets established specifications. |
| Biocompatibility Testing | Meets established specifications (materials chosen are suitable). |
| Usability Validation Testing | Meets established specifications. |
Overall Conclusion: "The collective results of the nonclinical testing demonstrate that the materials chosen, the manufacturing processes, and design of the ENDOCOLLECT Specimen Retrieval Bag meet the established specifications necessary for consistent performance during its intended use."
2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)
- Sample Size: Not explicitly stated for each test. The testing is described as "Nonclinical Bench Testing," implying laboratory-based tests of physical specimens of the device.
- Data Provenance: Not specified, but generally, bench testing would be conducted in a controlled lab environment. Given the applicant's address (Providence, RI, USA), it's likely conducted in the USA.
- Retrospective/Prospective: Not applicable. These are bench tests, not clinical studies involving patient data.
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. The "ground truth" for a physical device like this is established through engineering and material science testing against predefined specifications, not human expert consensus on interpretations of images or data. Usability validation might involve human evaluators, but they wouldn't be establishing "ground truth" in the diagnostic sense.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
Not applicable. This concept is relevant for studies involving human interpretation or consensus, such as clinical trials or image labeling. Bench testing relies on objective measurements against engineering specifications.
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 is a physical device, not an AI/software device, and no MRMC study was conducted or required. The document explicitly states: "Clinical testing was not required to demonstrate substantial equivalence to the predicate device."
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
Not applicable. This is a physical device, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
For this physical device, the "ground truth" is defined by engineering specifications and validated testing methods. For example:
- Force and Volume Testing: The "ground truth" is the measured force or volume achieved by the device, compared against a target specification.
- Puncture Testing: The "ground truth" is whether the device withstands a specified puncture force without failure.
- Biocompatibility Testing: The "ground truth" is established by standard biological safety tests demonstrating the materials are non-toxic and biocompatible according to recognized standards (e.g., ISO 10993).
8. The sample size for the training set
Not applicable. This is a physical device, not a machine learning model that requires a training set.
9. How the ground truth for the training set was established
Not applicable. See 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.