(59 days)
The Versaport™ Bladeless Low Profile trocar is intended for use in a variety of gynecologic, general, thoracic and urologic endoscopic procedures to create and maintain a port of entry.
The Versaport™ Bladeless low profile housing design is available in 2mm-3mm to 5mm in various lengths with radiolucent fixation sleeve. The 2mm-3mm to 5mm Versaport™ seal system accommodates 2mm-3mm to 5mm instrumentation respectively. There is a luer lock with cap for insufflation and rapid desufflation (in place of a stopcock).
This looks like a 510(k) summary for a medical device called the "Versaport™ Bladeless Low Profile Trocar." It's important to note that this document is a summary and likely doesn't contain all the detailed performance study information typically found in a full submission to the FDA. Based on the provided text, I can extract the following information:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly state numerical acceptance criteria for specific performance metrics. Instead, it makes a general statement about substantial equivalence to a predicate device.
| Performance Metric / Study Type | Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|---|
| In-vitro tests | Substantially equivalent to predicate device(s) | Verified that performance is substantially equivalent to predicate device(s) and performs as intended. |
| In-vivo tests | Substantially equivalent to predicate device(s) | Verified that performance is substantially equivalent to predicate device(s) and performs as intended. |
2. Sample Size Used for the Test Set and Data Provenance
The document states "In-vitro and in-vivo tests were performed," but it does not specify the sample sizes used for these tests. The provenance of the data is not mentioned (e.g., country of origin, retrospective or prospective).
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. For a physical medical device like a trocar, ground truth would typically be established through direct observation of performance in controlled environments (in-vitro) and/or in animal or human studies (in-vivo), rather than expert review of data like in an AI/diagnostic device.
4. Adjudication Method for the Test Set
This information is not provided. This concept is usually more relevant for diagnostic devices where multiple experts might independently assess results and then adjudicate disagreements.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No. An MRMC study is relevant for diagnostic devices where human readers interpret medical images or data. This document describes a surgical instrument, not a diagnostic tool that relies on human interpretation of outputs.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
No. This device is a physical surgical instrument. The concept of "standalone algorithm performance" is not applicable; the device is intended to be used by a human surgeon.
7. The Type of Ground Truth Used
For a physical device like this, the "ground truth" for performance would be based on:
- Direct observation of physical properties and function (e.g., ability to create and maintain a port of entry, seal integrity, instrument insertion/withdrawal, insufflation/desufflation).
- Comparison against the predicate device's established performance.
- Compliance with relevant standards (e.g., ISO Standard 10993-1 for materials).
The document states that in-vitro and in-vivo tests were performed to "verify that the performance of the Versaport™ Bladeless Low Profile trocar is substantially equivalent to the predicate device(s), and to validate that the Versaport™ Bladeless Low Profile trocar will perform as intended." This implies the ground truth was derived from the physical performance outcomes in these tests, evaluated against known performance characteristics of the predicate.
8. The Sample Size for the Training Set
This information is not applicable as this is not an AI/machine learning device that requires a training set.
9. How the Ground Truth for the Training Set Was Established
This information is not applicable as this is not an AI/machine learning device that requires a training set.
§ 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.