(76 days)
has applications in open and endoscopic surgery. It is primarily indicated for patients undergoing endoscopic surgery that require ligation or ligation and transection of tissue including blood vessels, ducts and other structures in the extremies, extraperitoneal space, abdominal cavity and the chest wall. It is indicated for patients undergoing surgical procedures in the extremities including but not limited to saphaenous vein harvesting for peripheral or coronary artery bypass grafting.
The Origin Ligator Device is a single-use endoscopic device with dual functions of ligation and transection of isolated vessels and other structures. It consists of a tube, handle assembly, and located at the distal end of the tube is the cutting blade, grasping jaws, and a clip delivery system. The cutting blade is activated independently from the grasping jaws and the clip delivery system. The Origin Ligator Device will allow both clipping and cutting operations to be performed multiple times without removing the device
The provided text is a 510(k) summary for the "ORIGIN Ligator Device," a Class I (later reclassified to Class II by the FDA letter) manual surgical instrument. This submission focuses on establishing substantial equivalence to a predicate device (ORIGIN AcuClip® Endoscopic Multiple Clip Applier, K920599) and does not contain information about the device's technical acceptance criteria or a dedicated study proving performance against those criteria.
The 510(k) summary describes the device's function and intended use, and the FDA letter confirms substantial equivalence without detailing specific performance data. Therefore, I cannot provide a table of acceptance criteria and reported device performance from the given information.
Similarly, the other requested details (sample sizes, ground truth establishment, expert qualifications, adjudication methods, MRMC study results, standalone performance, and training set information) are not included in this type of regulatory submission, which primarily focuses on justifying substantial equivalence based on existing predicate devices.
Summary of what cannot be provided from the given text:
- Table of acceptance criteria and reported device performance: This information is not present in the 510(k) summary or the FDA letter.
- Sample sizes (test, training): Not provided.
- Data provenance: Not provided.
- Number and qualifications of experts: Not provided.
- Adjudication method: Not provided.
- MRMC comparative effectiveness study results: Not mentioned.
- Standalone performance study results: Not mentioned.
- Type of ground truth used: Not discussed.
- How ground truth for training set was established: Not discussed.
Information that can be extracted (though not directly related to performance metrics):
- Device Name: Origin Ligator Device
- Regulatory Class: Initially Class I, then reclassified to Class II by the FDA.
- Intended Use: "It is primarily indicated for patients undergoing endoscopic surgery that require ligation or ligation and transection of tissue including blood vessels, ducts and other structures in the extremities, extraperitoneal space, abdominal cavity and the chest wall. It is indicated for patients undergoing surgical procedures in the extremities including but not limited to saphaenous vein harvesting for peripheral or coronary artery bypass grafting."
- Predicate Device: ORIGIN AcuClip® Endoscopic Multiple Clip Applier, (K920599; 7/15/92).
§ 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.