(298 days)
Reprocessed Endoscopic Trocars are indicated for use to establish a port of entry for endoscopic instruments in patients requiring minimally invasive surgical procedures.
Reprocessed Endoscopic Trocars and Cannulas are designed to establish a port of entry for endoscopic instruments used during minimally invasive surgery. 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.
Acceptance Criteria and Study for Reprocessed Endoscopic Trocars and Cannulas
1. Table of Acceptance Criteria and Reported Device Performance:
The document describes the submission as a "Traditional 510(k)" and focuses on demonstrating substantial equivalence to predicate devices rather than setting and meeting specific quantitative acceptance criteria for novel performance. Therefore, the "acceptance criteria" here are qualitative, based on the device performing "as originally intended" and being "safe and effective."
| Acceptance Criteria (Qualitative) | Reported Device Performance (Qualitative) |
|---|---|
| Device performs as originally intended. | "Performance testing demonstrates that Reprocessed Endoscopic Trocars and Cannulas perform as originally intended." |
| Device is safe and effective. | "Ascent Healthcare Solutions concludes that the modified devices (Reprocessed Endoscopic Trocars and Cannulas) are safe, effective, and substantially equivalent to the predicate devices as described herein." This is supported by bench and laboratory testing in the following areas: Biocompatibility, Validation of reprocessing, Sterilization Validation, Function test(s), Packaging Validation. The device retains the same design, materials, intended use, mechanism of action, performance specifications, and method of operation as the original (predicate) devices. Reprocessing includes removal of visible soil and decontamination. |
| Substantial equivalence to predicate devices (K041795, K032889, K012884, K012968). | "The design, materials, and intended use of Reprocessed Technological Endoscopic Trocars and Cannulas are identical to the predicate characteristics: devices. The mechanism of action of Reprocessed Endoscopic Trocars and Cannulas is identical to the predicate devices in that the same standard mechanical design, materials, and sizes are utilized. There are no changes to the claims, intended use, clinical applications, patient population, performance specifications, or method of operation." |
2. Sample Size Used for the Test Set and Data Provenance:
The document does not specify a numerical sample size for "test sets" in the traditional sense of a clinical trial. Instead, it refers to "bench and laboratory testing." The provenance of the data is from laboratory testing conducted by Ascent Healthcare Solutions. It is retrospective in the sense that the goal is to demonstrate that reprocessed devices match the performance of already-marketed devices. No information on country of origin of the data is provided beyond the applicant being a US-based company.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts:
This information is not provided in the document. The nature of the testing (biocompatibility, reprocessing validation, sterilization validation, function tests, packaging validation) suggests internal engineering and scientific expertise rather than clinical expert consensus on a test set of cases.
4. Adjudication Method for the Test Set:
This information is not provided and is not applicable to the type of bench and laboratory testing described. Adjudication methods like 2+1 or 3+1 are typically used for clinical image interpretation or diagnostic decisions, which is not what was performed for this device.
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:
An MRMC comparative effectiveness study was not performed, nor is it applicable. This device is a reprocessed medical instrument (trocar and cannula), not an AI-powered diagnostic or assistive tool.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done:
Standalone algorithm performance studies were not performed, nor are they applicable. This device is a physical medical instrument, not an algorithm.
7. The Type of Ground Truth Used:
The "ground truth" for this submission is implicitly the performance of the original, new predicate devices. The testing aims to demonstrate that the reprocessed devices achieve the same level of performance and safety characteristics as the original devices. This is established through:
- Biocompatibility testing: To ensure the materials remain safe after reprocessing.
- Validation of reprocessing: To confirm the reprocessing methods effectively clean and prepare the device.
- Sterilization Validation: To confirm the device is sterile after reprocessing.
- Function test(s): To ensure mechanical and operational integrity matches the original device.
- Packaging Validation: To ensure the device remains sterile and functional until use.
8. The Sample Size for the Training Set:
This information is not provided and is not applicable. This submission concerns a reprocessed medical device, not a machine learning model that requires a training set. The "training" for this device would refer to the validation of the reprocessing protocol itself, which would involve a sufficient number of devices to demonstrate consistency in the reprocessing method's effectiveness.
9. How the Ground Truth for the Training Set Was Established:
This information is not provided and not applicable as there is no "training set" in the machine learning sense. The "ground truth" for validating the reprocessing process would be established through industry standards, regulatory guidelines (e.g., for sterilization and cleaning), and laboratory measurements indicating the absence of contaminants, proper material integrity, and functionality that matches the new device.
§ 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.