(72 days)
The Patton Endo-Bag is a single use retrieval bag designed to temporarily contain organs or tissues and facilitates their removal from the patient without contamination, during laparoscopic surgery.
The Patton Endo-Bag™ is a single-use retrieval bag designed to temporarily contain organs or stones, and facilitate their removal from the patient without contamination during laparascopic surgery.
The provided text describes a 510(k) submission for the "Patton Endo-Bag™," a laparoscopic specimen retrieval system. This type of submission relies on demonstrating substantial equivalence to a legally marketed predicate device, rather than explicit acceptance criteria with specific performance thresholds that a device must meet through a new study.
Therefore, the information requested regarding acceptance criteria, a study proving the device meets them, sample sizes, expert involvement, and ground truth establishment is not applicable to this 510(k) summary. The approval is based on demonstrating that the new device has the same intended use and similar technological characteristics to previously approved devices, without raising new questions of safety or effectiveness.
Here's how to interpret the provided document in the context of your request:
1. Table of acceptance criteria and the reported device performance:
- Not Applicable. The 510(k) summary does not describe specific numerical acceptance criteria (e.g., minimum tensile strength, maximum leakage rate) or report performance data against such criteria. The "performance" demonstrated is substantial equivalence to the 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. No test set or data from a study demonstrating performance against acceptance criteria is described in this 510(k) summary. The submission focuses on comparison to predicate devices.
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. No experts or ground truth establishment for a test set are mentioned, as there is no performance study described.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not Applicable. No test set or adjudication method is described.
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 device is a physical medical device (specimen retrieval bag), not an AI imaging or diagnostic tool. Therefore, an MRMC study or AI-related effectiveness study is not relevant.
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):
- Not Applicable. No performance study with ground truth data is described.
8. The sample size for the training set:
- Not Applicable. This is a physical device, not a machine learning algorithm requiring a training set.
9. How the ground truth for the training set was established:
- Not Applicable. As above, no training set or ground truth establishment is relevant to this device.
Summary of the 510(k) for Patton Endo-Bag™:
The submission demonstrates substantial equivalence to predicate devices (ENDOPOUCH SPECIMEN RETRIEVAL BAG and PLEATMAN SAC SPECIMEN CONTAINER) by highlighting that the Patton Endo-Bag™ shares the same:
- Intended Use: Temporarily contain organs or stones to facilitate removal during laparoscopic surgery without contamination.
- Technological Characteristics: Implied to be similar by the substantial equivalence claim, although specific technical details for comparison are not provided in this summary.
The FDA's letter confirms that the device is substantially equivalent to legally marketed predicate devices, allowing its marketing subject to general controls. No new clinical or performance studies with acceptance criteria were required for this type of submission.
§ 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.