(189 days)
The Endo Wrist Monopolar Curved Scissors is intended to be used with the da Vinci Xi System or the da Vinci X Surgical System for endoscopic manipulation of tissue, including: cutting, blunt and sharp dissection, electrocautery.
The Intuitive Surgical Endoscopic Instrument Control System (da Vinci Surgical System, Model IS4000 and da Vinci Surgical System, Model IS4200) is intended to assist in the accurate control of Intuitive Surgical Endoscopic Instruments including rigid endoscopes, blunt and sharp endoscopic dissectors, scissors, scalpels, forceps/pick-ups, needle holders, endoscopic retractors, electrocautery and accessories for endoscopic manipulation of tissue, including grasping, cutting, blunt and sharp dissection, approximation, ligation, electrocautery, suturing, and delivery and placement of microwave and cryogenic ablation probes and accessories, during urologic surgical procedures, general laparoscopic surgical procedures, gynecologic laparoscopic surgical procedures, general thoracoscopic surgical procedures and thoracoscopically assisted cardiotomy procedures. The system can also be employed with adjunctive mediastinotomy to perform coronary anastomosis during cardiac revascularization. The system is indicated for adult and pediatric use. It is intended to be used by trained physicians in an operating room environment in accordance with the representative, specific procedures set forth in the Professional Instructions for Use.
The da Vinci X/Xi 8 mm monopolar scissors instrument (470179) is used in conjunction with its intended surgical robot for cutting, cauterizing, coagulation, manipulating and blunt dissue. This instrument consists of the housing, shaft, wrist, and tip. The shaft and wrist allow for different axis of rotation, and the instrument with the patient tissue. This instrument is reusable and is provided non-sterile. The instrument is used with a single use tip cover accessory.
Endo Wrist Instruments are designed to provide surgeons with natural dexterity and a greater range of motion than even the human hand. This allows for greater precision in a minimally invasive environment. EndoWrist instruments, in conjunction with the applicable surgical robot, are designed to support rapid and precise suturing, dissection, and tissue manipulation in surgical procedures.
The design, materials, and intended use of the Reusable Surgical Instruments, after an additional ten (10) reuse cycles, are substantially equivalent to the predicate device in form, fit, and function. The reusable device is identical to the predicate device in that the same standard mechanicals, and size are utilized. There are no changes to the claims, intended use, clinical applications, patient population, performance specifications, or method of operation.
The provided text is a 510(k) premarket notification for a medical device: an 8mm Monopolar Curved Scissors (470179) for use with the da Vinci Xi/X Surgical System. The notification states that the device is a remanufactured/reprocessed version of an existing device, increasing its usability from 10 to 20 cycles through a refurbishment process.
The document discusses acceptance criteria and testing, but not in the context of an AI-powered diagnostic or assistive technology. Instead, the acceptance criteria and study described relate to the safety and effectiveness of the remanufactured physical surgical instrument itself.
Therefore, most of the requested information regarding AI device performance (e.g., sample size for test set, data provenance, number of experts, adjudication method, MRMC study, standalone performance, type of ground truth, training set size, ground truth for training set) is not applicable to this submission.
Here's a breakdown of the relevant information provided:
1. A table of acceptance criteria and the reported device performance:
| Acceptance Criteria (Tests Performed) | Reported Device Performance / Conclusion |
|---|---|
| Biocompatibility | Concluded that the reprocessed devices are as safe and effective as the predicate. |
| Functional Performance Testing | Concluded that the reprocessed devices are as safe and effective as the predicate and operate as originally intended. |
| Bioburden, Cleaning, and Bacterial Endotoxins | Concluded that the reprocessed devices are as safe and effective as the predicate. |
| Electrical Safety | Concluded that the reprocessed devices are as safe and effective as the predicate. |
| Validation of Reprocessing | Implicitly met, as performance testing demonstrates reprocessed devices are safe and effective. |
2. Sample size used for the test set and the data provenance:
- Sample Size for Test Set: Not explicitly stated. The document refers to "design verification and design validation testing." This typically involves testing a representative number of units, but the specific count is not provided.
- Data Provenance: Not applicable in the context of clinical data for an AI device. The data comes from laboratory and engineering testing of the physical remanufactured surgical instruments. The country of origin of the data is not specified, but it would be from the manufacturer's testing facilities. The tests are prospective in nature, as they are conducted on the remanufactured devices to prove their performance.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable. The "ground truth" here is objective physical and electrical properties, and biological safety, measured through standardized tests, not expert interpretation of medical images or data. Engineering and quality control personnel would be involved in conducting and evaluating these tests.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not applicable. Adjudication methods like 2+1 are used for expert consensus on subjective assessments. The tests described are objective and rely on measurement against predefined specifications.
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:
- No. This device is a physical surgical instrument, not an AI-powered diagnostic or assistive technology. Therefore, an MRMC study is not relevant.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable. This is a remanufactured physical surgical tool.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- The "ground truth" used for this device's acceptance is based on predefined engineering specifications, material properties, electrical safety standards, and biocompatibility requirements, as well as the performance characteristics of the predicate device. It's objective, measurable criteria from a combination of regulatory standards and the original device's design.
8. The sample size for the training set:
- Not applicable. This is not an AI/machine learning device.
9. How the ground truth for the training set was established:
- Not applicable. This is not an AI/machine learning device.
In summary: The provided FDA submission for the 8mm Monopolar Curved Scissors focuses on demonstrating the substantial equivalence and safety/effectiveness of a remanufactured physical surgical instrument. The acceptance criteria and studies are related to the physical, electrical, and biological performance of this instrument, not to the performance of an AI algorithm.
§ 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.