(51 days)
The Disposable Laparoscope Trocar has applications 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 proposed device is a basic equipment used during laparoscopic surgical, and the surgical device will enter into abdominal cavity via the passage established by the trocar. The proposed device is available in 5mm, 10mm, 12mm, 15mm four diameters to accommodate different sizes surgical instrument.
The document provided is a 510(k) Summary for a medical device called "Disposable Laparoscope Trocar." This summary describes the device and its equivalence to predicate devices, focusing on non-clinical testing. It does not contain information about acceptance criteria for a device performance study in the context of diagnostic accuracy, AI, or human reader performance.
Instead, the "acceptance criteria" discussed are related to standard engineering and biocompatibility tests for a surgical instrument. The study described is a series of non-clinical bench tests and an in-vivo animal study to demonstrate the safety and foundational performance characteristics of the trocar.
Therefore, many of the requested categories (such as sample size for test set, data provenance, number of experts for ground truth, adjudication methods, MRMC studies, standalone performance, training set details, etc.) are not applicable to this type of submission.
Here's a breakdown of the available information:
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria are implicitly defined by the benchmarks set by the predicate and reference devices, and by compliance with relevant ISO and ASTM standards. The reported device performance is mainly comparative to these existing devices and standards.
| Acceptance Criteria (Implied by Predicate/Standards) | Reported Device Performance (Subject Device K201641) |
|---|---|
| Biocompatibility: Complied with ISO 10993 standards for Cytotoxicity, Sensitization, Intracutaneous, System Toxicity, Pyrogen. | Comply with ISO 10993 standards (for Cytotoxicity, Sensitization, Intracutaneous, System Toxicity, Pyrogen) |
| Insertion Force: Comparable to predicate/reference devices (e.g., BLTC12 Average 4.2 N, B5LT Average 2.35 N) | RJTC-A5: Average 2.25 N |
| RJTC-A15: Average 4.08 N | |
| Removal Force: Comparable to predicate/reference devices (e.g., BLTC12 Average 10.19 N, B5LT Average 6.27 N) | RJTC-A5: Average 6.37 N |
| RJTC-A15: Average 10.31 N | |
| Leak Resistance: No Leakage | No Leakage |
| Snap Feature Retention Force: Comparable to predicate/reference devices (e.g., BLTC12 Average 11.98 N, B5LT Average 1.69 N) | RJTC-A5: Average 1.8 N |
| RJTC-A15: Average 11.8 N | |
| Sterilization Assurance Level (SAL): 10^-6 | 10^-6 |
| Endotoxin Limit: 20 EU per device | 20 EU per device |
| Ethylene Oxide Sterilization Residuals: Complies with ISO 10993-7:2008 | (Tested, implied compliance) |
| Bacterial Endotoxin Limit: Complies with USP | (Tested, implied compliance) |
| Seal Strength: Complies with ASTM F88/F88M-15 | (Tested, implied compliance) |
| Seal Leaks (Dye Penetration): Complies with ASTM F1929-15 | (Tested, implied compliance) |
| Tip Integrity: Maintained after insertion (from in vivo study) | (Evaluated, implied satisfactory) |
| Visualization Performance (for optical type): Adequate (from in vivo study) | (Evaluated, implied satisfactory) |
2. Sample Size Used for the Test Set and Data Provenance
- Test Set Sample Size: Not explicitly stated for each specific bench test, but implied to be sufficient for statistical validity in engineering tests. For the in vivo study, it mentions a "porcine model," implying a number of animal subjects were used, but the exact count is not given.
- Data Provenance: Not specified where these tests were conducted, beyond the applicant being Beijing Biosis Healing Biological Technology Co., Ltd. (China). The tests are presumably retrospective data collected during device development.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
- This is not applicable as the evaluation involves physical and chemical property testing, not subjective expert assessment of clinical data or images.
4. Adjudication Method for the Test Set
- This is not applicable. Objective measurements and established testing protocols are used.
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
- This is not applicable as the device is a physical surgical tool (trocar), not an AI-powered diagnostic or assistive technology.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done
- This is not applicable as the device is a physical surgical tool and does not involve an algorithm.
7. The Type of Ground Truth Used
- The "ground truth" for these tests are the established definitions and methodologies within the cited ISO and ASTM standards, as well as the performance characteristics of legally marketed predicate devices. For biocompatibility, it's the biological response as per standardized tests. For mechanical properties, it's the quantifiable physical measurements.
- For the in vivo study, the ground truth would be the direct observation of insertion force, fixation force, visualization, and tip integrity in a live biological model.
8. The Sample Size for the Training Set
- This is not applicable as there is no "training set" in the context of a physical medical device. This is not an AI/machine learning device.
9. How the Ground Truth for the Training Set Was Established
- This is not applicable for the same reason as above.
§ 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.