(159 days)
Reprocessed Endoscopic Trocars are indicated for use to establish a port of entry for endoscopic instruments in patients requiring minimally invasive surgical procedures.
The reprocessed device has the same intended use as the original device and does not incorporate new technology, new materials, or design changes. The product code for the original device, GCJ, falls within 21 CFR §876.1500 for Endoscopes and Accessories. An Endoscope and Accessory device is defined within the code as 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. The accessories may assist in gaining access or increase the versatility and augment the capabilities of the devices. The Endoscopic Trocars and Cannulas specified in this submission are used in endoscopic procedures and are considered accessories to the endoscope. Endoscopic Trocars and Cannulas are designed to establish a port of entry for endoscopic instruments used during minimally invasive surgery. Surgical Endoscopic Trocars and Cannulas are available in a variety of configurations and materials as well as trocar and cannula sets. Trocar seals vary between single-port and multi-port seals. Endoscopy generally pertains to the use of a surgical instrument in conjunction with an endoscope inserted into the same body cavity. The endoscope permits visual inspection, with or without magnification, of the interior of the body cavity and permits observation of the surgical instrument during an operation for therapeutic or diagnostic purposes. Endoscopic surgery is conducted through a cannula that extends across the abdominal wall and provides channels where instruments, such as scopes, retractors and staplers, can be inserted to perform surgery. As part of this procedure, the abdominal cavity is inflated with an insufflation gas, such carbon dioxide, to maintain the abdomen in a distended state and provide increased instrument maneuvering capability within the cavity. Valves are typically provided in the trocars to form seals around the instruments to prevent leakage of the insufflation gas.
Here's an analysis of the provided text regarding the acceptance criteria and study for the reprocessed trocars, structured according to your request:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly define quantitative acceptance criteria for the reprocessed trocars. Instead, it describes various tests performed to demonstrate that the reprocessed devices perform as originally intended and are substantially equivalent to predicate devices. The "reported device performance" is a general statement of successful completion of these tests.
| Acceptance Criteria (Implicit) | Reported Device Performance |
|---|---|
| Biocompatibility | Tests conducted to demonstrate performance |
| Validation of reprocessing | Tests conducted to demonstrate performance |
| Sterilization Validation | Tests conducted to demonstrate performance |
| Function test(s) | Tests conducted to demonstrate performance |
| Packaging Validation | Tests conducted to demonstrate performance |
| Overall Goal: Reprocessed Trocars perform as originally intended and are safe, effective, and substantially equivalent to predicate devices. | Conclusion: Reprocessed Trocars perform as originally intended; safe, effective, and substantially equivalent to predicate devices. |
2. Sample Size Used for the Test Set and Data Provenance
The document does not specify the sample size used for the test set for any of the performance tests (Biocompatibility, Reprocessing Validation, Sterilization Validation, Function Tests, Packaging Validation).
The data provenance is not explicitly stated in terms of country of origin or whether the studies were retrospective or prospective. Given the context of a 510(k) submission to the FDA, it is highly likely that the testing was conducted in the US, but this is not confirmed. The description suggests these were laboratory and bench tests.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
The document does not mention the use of experts to establish a "ground truth" for the test set in the context of the device's performance characteristics. The tests described are objective, laboratory-based performance tests (e.g., sterilization efficacy, functional integrity, biocompatibility), which typically rely on established protocols and measurement standards rather than expert consensus on a "ground truth" in the way it might be used for diagnostic imaging or clinical outcomes.
4. Adjudication Method for the Test Set
This information is not applicable as the described performance tests are objective laboratory and bench tests, not assessments requiring adjudication of expert opinions.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, and its effect size
No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. The submission is for a reprocessed medical device, and the testing focuses on the physical, chemical, and functional characteristics of the reprocessed device compared to the original, rather than comparing human reader performance with and without AI assistance.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
The device in question is a physical medical instrument (trocar), not an algorithm or AI system. Therefore, the concept of "standalone (algorithm only) performance" is not applicable.
7. The Type of Ground Truth Used
For the performance tests described (Biocompatibility, Validation of Reprocessing, Sterilization Validation, Function Tests, Packaging Validation), the "ground truth" is provided by:
- Established standards and specifications: Each test would have pre-defined acceptance limits or criteria that the reprocessed device must meet. For example, sterilization validation would aim for a specific sterility assurance level (SAL), and function tests would verify that the mechanical components operate within factory specifications.
- Comparison to predicate device performance: The overall "ground truth" for substantial equivalence is that the reprocessed device performs identically to the new, original predicate device.
The document does not refer to "expert consensus," "pathology," or "outcomes data" as the ground truth for these specific performance tests.
8. The Sample Size for the Training Set
The concept of a "training set" is not applicable here. This submission is for a reprocessed physical medical device, not an AI/machine learning algorithm that requires a training set.
9. How the Ground Truth for the Training Set was Established
As there is no "training set" for this type of device submission, this information is 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.