(145 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.
Reprocessed endoscopic 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 such as observation, dissecting, cutting, repairing, and removal or manipulation of internal tissues and/or organs. Reprocessed endoscopic trocars are of varying lengths and diameters, and may have either a blunt or bladed obturator tip.
Here's a breakdown of the acceptance criteria and study information based on the provided document:
Acceptance Criteria and Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Appropriate functional characteristics | Bench testing demonstrated appropriate functional characteristics. |
| Biocompatibility | Biocompatibility testing demonstrated compatibility of the device materials. |
| Validated cleaning and sterilization procedures | Process validation testing validated the cleaning and sterilization procedures. |
| Validated device packaging | Process validation testing validated the device packaging. |
| Visual and functional quality (during manufacturing) | The manufacturing process includes visual and functional testing of all products produced. |
Note: The document states that the reprocessed endoscopic trocars are "substantially equivalent" to predicate devices. This implies that the acceptance criteria are met if the reprocessed device performs comparably to the original, legally marketed devices. Specific numerical thresholds or detailed performance metrics for "appropriate functional characteristics" or "biocompatibility" are not provided.
Study Details
This submission is for a reprocessed device, and the "study" described focuses on demonstrating equivalence to predicate devices through functional, biocompatibility, and process validation testing rather than a traditional comparative clinical trial with human subjects.
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Sample sizes used for the test set and the data provenance:
- Test set sample size: Not explicitly stated as a single numerical value. The document mentions "Representative samples of reprocessed endoscopic trocars" were used for bench testing. The specific number of trocars tested is not provided.
- Data provenance: Not specified, but likely from internal laboratory testing conducted by SterilMed, Inc. It is retrospective in the sense that they are re-evaluating existing devices after reprocessing, but the testing itself is prospective (performed for this submission).
- Country of origin of the data: Not explicitly stated, but the submitter (SterilMed, Inc.) is based in Minneapolis, Minnesota, USA, implying the data is likely from the USA.
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- This type of information is generally not applicable to a premarket notification (510(k)) for a reprocessed device where the focus is on functional equivalence and safety rather than a diagnostic performance study. The "ground truth" here is the established performance and safety profile of the predicate devices. Experts involved would likely be those conducting the functional, biocompatibility, and process validation testing (e.g., engineers, microbiologists, quality control specialists), but their number and specific qualifications are not detailed.
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Adjudication method for the test set:
- Not applicable/described. Adjudication methods like 2+1 or 3+1 are typically used in clinical studies involving interpretation of medical images or patient outcomes, which is not the nature of this submission. The "adjudication" here would be the scientific assessment by the testing personnel and quality assurance to determine if the test results meet internal and regulatory standards.
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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:
- No. An MRMC comparative effectiveness study is not applicable as this is a medical device for surgical procedures (trocars), not an AI-powered diagnostic tool for human readers.
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If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- No. This is a physical medical device, not an algorithm or AI system.
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The type of ground truth used:
- The "ground truth" for this submission is implicitly the established performance and safety of the predicate devices (Ethicon Endopath EP Disposable Surgical Trocar and AutoSuture Surgiport® Endoscopic Trocar). The reprocessed device is deemed acceptable if its functional characteristics, biocompatibility, and sterilization/packaging validation data demonstrate that it performs substantially equivalently to these legally marketed devices.
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The sample size for the training set:
- Not applicable. This is not an AI/machine learning device that requires a training set. The "training" for the reprocessing procedures would involve process development and validation, but not in the context of a dataset for an algorithm.
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How the ground truth for the training set was established:
- Not applicable. See point 7.
§ 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.