(33 days)
Vessel Sealer Extend is a bipolar electrosurgical instrument for use with a compatible da Vinci Surgical System and a compatible electrosurgical generator. It is intended for grasping and blunt dissection of tissue and for bipolar coagulation and mechanical transection of vessels up to 7 mm in diameter and tissue bundles that fit in the jaws of the instrument. Vessel Sealer Extend has not been shown to be effective for tubal sterilization or tubal coagulation for sterilization procedures, and should not be used for these procedures.
The Vessel Sealer Extend is a sterile, single-use (disposable), 8 mm instrument with an integrated cord that connects to the instrument housing and an Erbe VIO dV generator. The Vessel Sealer Extend device consists of a distal wristed end effector and a proximal housing connected by a tubular shaft. The housing contains mechanisms to actuate the end effector when attached to a compatible da Vinci Surgical System. An integrated cord attached to the housing is connected to a receptacle in the IESU. An electrode sealing surface and a cutting blade within the jaws of the instrument enable sealing of vessels and cutting of sealed vessels and other tissues. The sealing and cutting functions are controlled using the compatible da Vinci Surgical System foot pedals.
Modifications from the predicate include a labeling change to remove references to using a specific electrosurgical generator (ERBE VIO dV electrosurgical generator) from the Indications for Use Statement that is listed as compatible with the Vessel Sealer Extend instrument. Additionally, "EndoWrist", has been removed from the Indications for Use for product branding reasons.
This 510(k) premarket notification (K183107) for the Intuitive Surgical Vessel Sealer Extend received FDA clearance based on its substantial equivalence to a predicate device (K173337). This submission did not involve new performance studies because the changes were limited to labeling. Therefore, the information typically requested about acceptance criteria, study design, and performance metrics for a new device study is largely absent.
Here's a breakdown of the available information based on your request:
1. Table of Acceptance Criteria and Reported Device Performance
This information is not provided in the document as no new performance studies were conducted for this specific 510(k) submission. The document explicitly states:
"There were no design changes made to the subject Vessel Sealer Extend instrument as a result of the labeling change. Thus, the previously submitted bench testing reports and explanations demonstrating that the cleared predicate device (K173337) meet design specifications and performance requirements, apply to the subject device."
Therefore, the acceptance criteria and reported device performance would refer to those established and met by the predicate device (K173337). To obtain detailed information on those criteria and performance, one would need to review the K173337 submission.
2. Sample Size Used for the Test Set and Data Provenance
This information is not provided for this specific submission as no new test set was generated. The previous testing for K173337 would contain this detail.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Experts
This information is not provided for this specific submission as no new ground truth was established. This would be relevant to the K173337 submission's performance data.
4. Adjudication Method for the Test Set
This information is not provided for this specific submission as no new test set adjudication was performed. This would be relevant to the K173337 submission's performance data.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done, and Effect Size of AI Improvement
This type of study is not applicable to this device. The Intuitive Surgical Vessel Sealer Extend is a surgical instrument, not an AI-powered diagnostic or assistive technology for human readers.
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study was Done
This type of study is not applicable to this device. It is a surgical instrument, not a standalone algorithm.
7. The Type of Ground Truth Used
This information is not provided for this specific submission. For a surgical instrument like this, ground truth in performance testing typically involves objective measurements from bench testing (e.g., burst pressure, seal integrity, tissue transection effectiveness), which would have been established for the predicate device (K173337).
8. The Sample Size for the Training Set
This information is not applicable as this device does not involve a training set as would be found in machine learning or AI algorithm development.
9. How the Ground Truth for the Training Set was Established
This information is not applicable for the same reason as above.
Summary of the K183107 Substantial Equivalence Determination:
The FDA's review of K183107 focused on the modifications from the predicate device (K173337), which were limited to:
- Removal of references to a specific electrosurgical generator (ERBE VIO dV) from the Indications for Use, meaning it is now compatible with "a compatible electrosurgical generator."
- Removal of "EndoWrist" from the Indications for Use for branding reasons.
Since there were no design changes that would impact the safety or effectiveness of the instrument, Intuitive Surgical leveraged the existing performance data from the predicate device (K173337). The FDA determined that the device is substantially equivalent based on the unchanged fundamental scientific technology, intended use, and existing performance data (from the predicate).
§ 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.