(49 days)
The Disposable Trocar has applications in endoscopic procedures to provide a port of entry for endoscopic instruments.
The disposable Trocar has application in abdominal, thoracic and gynecologic minimally invasive surgical procedures to establish a path of entry for endoscopic instruments. The trocar may be used with or without visualization for primary and secondary insertions. The Disposable trocar is mainly composed of Obturator with bladeless tip, Outer Seal Release Lever, Trocar Stability Sleeve, Obturator Locking Button, etc.
The document provided describes a 510(k) premarket notification for a Class II medical device, the "Disposable Trocar," manufactured by Wuxi Shukang Medical Appliance Co., Ltd. This type of submission aims to demonstrate that a new device is substantially equivalent to a legally marketed predicate device, rather than proving its safety and effectiveness from scratch. Therefore, the information provided focuses on comparative testing against a predicate, rather than a full, de novo study with acceptance criteria in the traditional sense of a clinical trial.
Here's an breakdown of the provided information:
1. Table of Acceptance Criteria and Reported Device Performance
The device is a Disposable Trocar, and the "acceptance criteria" here are demonstrating equivalency to the predicate device in various non-clinical performance tests and biocompatibility.
| Test Type | Acceptance Criteria (Implied: Demonstrate equivalency/compliance with standards) | Reported Device Performance |
|---|---|---|
| Visual Inspection | Meet design specifications | Conducted and met design specifications (conclusion implies). |
| Insertion and Removal Force | Comparable to predicate device | Conducted and demonstrated substantial equivalency (conclusion implies). |
| Leakage | Comparable to predicate device | Conducted and demonstrated substantial equivalency (conclusion implies). |
| In Vitro Penetration Force | Comparable to predicate device | Conducted and demonstrated substantial equivalency (conclusion implies). |
| In Vitro Retention Force | Comparable to predicate device | Conducted and demonstrated substantial equivalency (conclusion implies). |
| Biocompatibility (ISO 10993) | Compliance with standards for: In Vitro Cytotoxicity, Skin Sensitization, Intracutaneous Reactivity, Acute Systemic Toxicity, Pyrogen Test | Evaluated and supports that the subject devices are biocompatible. |
| Sterilization (ISO 11737-2) | Validation of Gamma irradiation process | Validation report provided. |
| Shelf Life (Accelerated Aging) | 3 Years Shelf Life | Test of Sterile Barrier System validated for 3 years. |
2. Sample Size Used for the Test Set and Data Provenance
The document does not specify the exact sample sizes used for each non-clinical test (e.g., how many disposable trocars were tested for insertion force). It only states that "Performance tests were conducted."
- Data Provenance: The tests were conducted internally by the manufacturer or by contract labs on behalf of the manufacturer, to demonstrate conformance with various international standards and equivalency to the predicate device. The country of origin of the data is not explicitly stated beyond the manufacturer being based in China. The data is from non-clinical (bench and lab) studies.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
Not applicable in the context of this 510(k) submission. This is a non-clinical evaluation, not a clinical study involving human reads or expert consensus for "ground truth." The "ground truth" here is objective physical measurements and biochemical test results compared against established standards and predicate device performance.
4. Adjudication Method for the Test Set
Not applicable. This is not a clinical study requiring adjudication of expert opinions. The assessment of test results would be based on comparison to pre-defined acceptance criteria (e.g., within a certain range of the predicate, or passing a specific threshold in a standard).
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
No MRMC study was done, as this is a medical device (trocar) and not an AI/imaging diagnostic device.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
Not applicable, as this is a physical medical device, not an algorithm or AI.
7. The Type of Ground Truth Used (Expert Consensus, Pathology, Outcomes Data, etc.)
The "ground truth" in this context is based on:
- Objective physical measurements: For bench performance tests like insertion force, leakage, penetration force, and retention force, the ground truth is the measured values themselves, compared against the predicate device or a defined specification.
- Established
biocompatibility standards (ISO 10993): For biocompatibility, the ground truth is defined by the results of specific standardized assays (e.g., cell viability in cytotoxicity tests), which determine if the material is biocompatible according to the standard. - Sterilization validation standards (ISO 11737-2): For sterilization, the ground truth is the validated sterility assurance level (SAL).
- Accelerated aging protocols: For shelf life, the ground truth is determined by testing product performance after simulated aging, demonstrating it maintains its functionality for the claimed shelf life.
8. The Sample Size for the Training Set
Not applicable. This device does not involve a "training set" in the context of machine learning.
9. How the Ground Truth for the Training Set Was Established
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.