(74 days)
The Banyan Medical Disposable Secondary Cannula and Trocar for Laparoscopic Use is indicated for applications in abdominal and gynecologic minimally invasive laparoscopic surgical procedures to establish a port of entry for endoscopic and laparoscopic instruments. The trocar is used with visualization for secondary insertions.
The Banyan Medical line of Disposable Secondary Cannula and Trocars for Laparoscopic Use consists of a trocar, cannula sleeve and a silicone seal. The design has two possible trocars, a sharp faceted tip and a conical tip. An insufflation adapter, when supplied, is compatible with standard luer lock fittings and provides for insufflation of the abdominal cavity. The Cannula and Trocar will be sold in 5mm, 8mm, 10mm and 12mm sizes.
The provided document describes the 510(k) summary for the "Banyan Medical Disposable Secondary Cannula and Trocar for Laparoscopic Use." This device is a medical instrument, not an AI/ML powered device, and therefore the provided Input does not contain the information required to populate most of the sections of this response.
Here's a breakdown of the available information and how it relates to your request:
1. Table of acceptance criteria and the reported device performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Non-Clinical Performance Data | |
| Compression testing of the cannula | Demonstrated performance as intended |
| Tensile testing of the knob to shaft of trocar | Demonstrated performance as intended |
| Puncture testing of the trocar tip | Demonstrated performance as intended |
| Shelf life testing | Demonstrated performance as intended |
| Accelerated age testing | Demonstrated performance as intended |
| Ship testing | Demonstrated performance as intended |
| Luer testing (gauging, liquid leakage, separation force, unscrewing torque, ease of assembly, resistance to overriding, stress cracking per ISO 594-1 and 594-2) | Demonstrated performance as intended |
| Sterilization Validation | |
| Sterilization according to ISO 11135:2007 (Part 1) and ISO 10993-7:2008 (Ethylene Oxide sterilization residuals) | Achieved a sterility assurance level (SAL) of ≥ 10⁻⁶ |
| Sterilization data meets requirements of draft documents: "Submission and Review of Sterility Information in Premarket Notification (510(k) Submissions for Devices Labeled as Sterile" | Met requirements |
| Package and Product Integrity | |
| Testing according to ISO 11607-1:2006 and ASTM-F-1980-07(2011) | Demonstrated integrity |
| Biocompatibility | |
| Determined by guidelines in ISO 10993-1:2009 | Materials determined to be biocompatible |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document specifies "Non-Clinical Performance Data" and "bench testing." It does not provide specific sample sizes for these tests, nor does it mention data provenance in terms of country of origin or whether it was retrospective or prospective.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
This information is not applicable. The device is a physical medical instrument (trocar and cannula), not an AI/ML-based diagnostic or imaging device that would require expert-established ground truth for a test set.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not applicable due to the nature of the device (physical medical instrument).
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 information is not applicable. The device is a physical medical instrument, not an AI/ML system.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This information is not applicable. The device is a physical medical instrument, not an AI/ML algorithm. The performance evaluation focuses on the physical and material characteristics of the device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
For the non-clinical performance and bench testing, the "ground truth" or acceptance criteria were based on established engineering and materials standards (e.g., ISO, ASTM) and the device's ability to perform its intended mechanical functions (e.g., compression strength, tensile strength, sterility level).
8. The sample size for the training set
This information is not applicable. The device is a physical medical instrument; there is no "training set" in the context of AI/ML.
9. How the ground truth for the training set was established
This information is not applicable. There is no training set for this type of 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.