(48 days)
The reprocessed endoscopic trocars are designed to provide a pathway for entry of minimally invasive instruments to a body organ or cavity during general, abdominal, thoracic, gynecologic or other minimally invasive surgical procedures such as observation, dissecting, cutting, repairing, and removal or manipulation of internal tissues and/or organs.
The reprocessed endoscopic trocar is a sterile instrument consisting of a sleeve and obturator that is available in varying lengths and diameters. The obturator may be bladeless or dilating tip. Reprocessed trocars are devices that provide a pathway for entry of minimally invasive instruments to a body organ or cavity during general, abdominal, thoracic, gynecologic, or other minimally invasive surgical procedures.
This document describes the 510(k) premarket notification for Reprocessed Endoscopic Trocars by Sterilmed, Inc. The submission aims to demonstrate substantial equivalence to a predicate device.
Here's an analysis of the provided information, focusing on acceptance criteria, study details, and ground truth establishment:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly present a table of quantitative acceptance criteria with corresponding reported device performance metrics in the format typically seen for algorithm performance (e.g., sensitivity, specificity, AUC). Instead, the acceptance criteria are implicitly defined by demonstrating that the reprocessed devices perform "as originally intended" and are "substantially equivalent" to the predicate device in terms of functional and safety characteristics.
The reported device performance is described qualitatively and through validation studies.
| Acceptance Criteria Category | Reported Device Performance (Summary of Non-clinical Tests Conducted) |
|---|---|
| Cleaning Validation | Cleaning validation was performed. |
| Sterilization Validation | Sterilization validation was performed (ISO 11135, USP ). |
| Biocompatibility | Biocompatibility testing was performed (ISO 10993). |
| Ethylene Oxide Residual | Ethylene oxide residual testing was performed (ISO 10993-7). |
| Packaging Validation | Packaging validation was performed (ASTM D 4169, ASTM F 88, ASTM F 2096). |
| Shelf Life Validation | Shelf life validation was performed (ASTM 1980-07). |
| Functional Performance | Validation of functional performance (bench testing) was performed through simulated use, visual inspection, fatigue testing, and function testing. "Performance testing shows the reprocessed endoscopic trocar to perform as originally intended." |
| Substantial Equivalence | "Sterilmed concludes that the reprocessed endoscopic trocars are safe, effective, and substantially equivalent to the predicate devices, Ethicon Endo-Surgery ENDOPATH® XCEL™ With OPTIVIEW® Technology Trocars (K032676), as described in this premarket notification submission." |
| Technological Equivalence | The reprocessed trocars are "identical to the predicate devices in design, materials of construction (except for the absorbent ring which is non-patient contact), and intended use. There are no changes to the clinical applications, patient population, performance specifications, or method of operation." |
2. Sample Size Used for the Test Set and Data Provenance
The document states "Representative samples of reprocessed endoscopic trocars were tested to demonstrate appropriate functional characteristics." However, it does not provide a specific numerical sample size for the test set used for functional and safety testing. Similarly, the data provenance (country of origin, retrospective/prospective) is not explicitly stated, but the submission is from Sterilmed, Inc. in Maple Grove, MN, implying testing likely occurred in the US. The nature of the validation (cleaning, sterilization, functional bench testing) suggests these were performed in a controlled laboratory or manufacturing environment, rather than being clinical trial data.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This type of information is not applicable to this submission. The validation of reprocessed medical devices focuses on engineering and scientific testing (e.g., microbiology for sterilization, chemical analysis for residuals, mechanical testing for function), not on expert clinical interpretation of results against a "ground truth" established by human experts in the way AI/ML medical devices are assessed.
4. Adjudication Method for the Test Set
This is not applicable as the evaluation relies on objective laboratory and bench testing rather than clinical interpretation requiring adjudication.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done
No, a MRMC comparative effectiveness study was not done. This type of study is relevant for evaluating the impact of AI on human reader performance, typically for diagnostic imaging. This submission concerns the reprocessing and functional validation of physical medical devices.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
This is not applicable. This is a submission for a reprocessed physical medical device, not a software algorithm.
7. The Type of Ground Truth Used
The "ground truth" in this context is established through objective scientific and engineering standards and methods. This includes:
- Established standards: ISO 11135, USP for sterilization, ISO 10993 for biocompatibility, ISO 10993-7 for ethylene oxide residuals, ASTM D 4169, ASTM F 88, ASTM F 2096 for packaging, ASTM 1980-07 for shelf life.
- Bench testing: Functional performance is assessed against the original performance specifications of the predicate device.
- Visual inspection: Conformance to physical and material specifications.
- Simulated use and fatigue testing: Evaluation of performance under conditions mimicking clinical use.
The ground truth is that the reprocessed device must meet the same performance, safety, and material characteristics as the new predicate device, and these are verified through the outlined non-clinical tests.
8. The Sample Size for the Training Set
This is not applicable. There is no "training set" in the context of validating a reprocessed physical medical device as there is no AI/ML model being developed. The processes (cleaning, sterilization) are validated, not trained.
9. How the Ground Truth for the Training Set was Established
This is not applicable for the reasons stated in 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.