(29 days)
The VersaOne™ optical trocars are intended for use in a variety of gynecologic, general, thoracic and urologic endoscopic procedures to create and maintain a port of entry. The trocar may be used with or without visualization for primary and secondary insertions.
The VersaOne™ bladeless trocars are intended for use in a variety of gynecologic, general, thoracic and urologic endoscopic procedures to create and maintain a port of entry.
VersaOne™ Optical Trocar 15mm is available in 15mm diameter with a transparent fixation cannula and standard (100mm) length. The VersaOne™ Optical Trocar 15mm consists of an obturator component with a bladeless tip and a cannula assembly. The obturator has a dolphin nose (conical) shaped bladeless tip with transparent window at distal end. The transparent window at distal end of the obturator allows optical entry for visualization of tissue lavers during insertion. The obturator housing contains a scope retention mechanism. The cannula assembly is composed of a seal system, trocar housing, transparent cannula sleeve, and a stopcock. The seal system prevents loss of pneumoperitoneum when instruments are inserted or withdrawn. The seal system accommodates instruments ranging from 5mm to 15mm in diameter. The 15mm trocar housing is removable for specimen retrieval. The cannula sleeve has a bevel shape at the distal end to reduce penetration forces during insertion and transparent for better visualization. The stopcock valve is for insufflation and desufflation. The devices are supplied single-use. The VersaOne™ Optical Trocar 15mm is sterilized via Ethylene Oxide (EtO) sterilization method. The packaging configuration is one device packed in a sealed Nylon / Tyvek breather pouch, six pouches per display box, and both pouch and display box have appropriate labeling.
VersaOne™ Bladeless Trocar 15mm is available in two lengths (long (150mm) and standard (100mm)); both are 15mm in diameter and contain transparent fixation cannulas. VersaOne™ Bladeless Trocar consists of an obturator component with a bladeless tip and a cannula assembly. The obturator has a dolphin nose (conical) shaped bladeless tip. The cannula assembly is composed of a seal system, trocar housing, transparent cannula sleeve, and a stopcock. The seal system prevents loss of pneumoperitoneum when instruments are inserted or withdrawn. The seal system accommodates instruments ranging from 5mm to 15mm in diameter. The 15mm trocar housing is removable for specimen retrieval. The cannula sleeve has a bevel shape at the distal end to reduce penetration forces during insertion and transparent for better visualization. The stopcock valve is for insufflation and desufflation. The devices are supplied sterile single-use. The VersaOne™ Bladeless Trocar 15mm is sterilized via Ethylene Oxide (EtO) sterilization method. The packaging configuration is one device packed in a sealed Nylon / Tyvek breather pouch, six pouches per display box, and both pouch and display box have appropriate labeling.
The provided document is a 510(k) summary for medical devices (trocars) and does not describe an AI medical device. Therefore, it does not contain the specific information requested about acceptance criteria, study details, ground truth, sample sizes, or expert adjudication that would be relevant to an AI/ML medical device.
The document discusses:
- Device Name: VersaOne™ Optical Trocar 15mm and VersaOne™ Bladeless Trocar 15mm
- Intended Use: To create and maintain a port of entry in various endoscopic procedures.
- Modifications: Larger diameter (15mm) and a new seal system.
- Testing: Sterilization assessment, shelf-life assessment, biocompatibility testing, and performance testing (ex vivo and in vivo).
Since the device is a physical medical instrument (trocar) and not an AI/ML-based diagnostic or therapeutic tool, the requested information categories (e.g., sample size for test set, data provenance, number of experts, MRMC studies, standalone performance, training set sample size, ground truth for training set) are not applicable.
The acceptance criteria mentioned are general performance tests for a physical device, such as:
- Leak rate
- Insertion force
- Removal force
- Penetration force
- Fixation force
The conclusion states that "The results of testing demonstrate the modified VersaOne™ Optical Trocar 15mm and VersaOne™ Bladeless Trocar 15mm are substantially equivalent to the legally marketed" predicate devices. This implies that the device met performance criteria comparable to the existing predicate devices. However, specific numerical acceptance criteria (e.g., "leak rate must be below X ml/min") and reported performance values are not detailed in this summary.
§ 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.