(17 days)
Endo Wrist Stapler 45 and Stapler 45 Reloads: The Intuitive Surgical Endo Wrist Stapler 45, Stapler 45 Reloads and other Stapler Accessories (including the bladeless obturators) are intended to be used with a compatible da Vinci Surgical System for resection, transection and/or creation of anastomoses in General. Thoracic. Gynecologic and Urologic surgery. The device can be used with staple line or tissue buttressing material (natural or synthetic).
EndoWrist Stapler 30 and Stapler 30 Reloads: The Intuitive Surgical Endo Wrist Stapler 30 Instrument and Stapler 30 Reloads are intended to be used with a compatible da Vinci Surgical System for resection and or creation of anastomoses in General. Thoracic. Gynecologic, and Urologic surgery. The device is indicated for adult and pediatric use. The device can be used with staple line or tissue buttressing material.
EndoWrist Stapler 45 and Stapler 45 Reloads: The Intuitive Surgical EndoWrist Stapler 45, Stapler 45 Reloads, and Accessories are components of a reusable surgical stapler system designed for use with a compatible da Vinci Surgical System. This stapler system is intended for resection, transection of anastomoses in General, Thoracic, Gynecologic, and Urologic surgery by placing multiple staggered rows of implantable staples in the target tissues (stapling) followed by cutting of the target tissue along the middle of the staple line (transection).
EndoWrist Stapler 30 and Stapler 30 Reloads: The Intuitive Surgical EndoWrist Stapler 30 and Stapler 30 Reloads are components of a reusable surgical stapler system designed for use with a compatible da Vinci Surgical System. This stapler system is intended for resection, transection and/or creation of anastomoses in surgery. The instrument achieves its intended use by placing multiple staggered rows of implantable staples in the target tissues (stapling) followed by cutting of the target tissue along the middle of the staple line (transection).
This document is a 510(k) summary for the Intuitive Surgical EndoWrist Stapler 45 and 30, and their respective reloads. It primarily discusses updates to the Indications for Use statements due to changes in compatible da Vinci Surgical Systems.
Here's an analysis of the acceptance criteria and study information based on the provided text:
1. A table of acceptance criteria and the reported device performance
The document does not explicitly state quantitative acceptance criteria or detailed performance results in the format of a table. Instead, it makes a general statement about substantial equivalence.
| Acceptance Criteria (Quantitative) | Reported Device Performance (Quantitative) |
|---|---|
| Not explicitly stated | Not explicitly stated |
| Device is found substantially equivalent to predicate devices. |
2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)
The document states: "Design verification and design validation testing were not required since design inputs were not changed." This indicates that no new testing (and therefore no new test set or data provenance) was performed to support this 510(k) submission, as the changes were limited to labeling/indications for use and not the fundamental design or performance of the device.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience)
Since no new verification or validation testing was conducted, there are no experts mentioned for establishing ground truth for a test set.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
Since no new verification or validation testing was conducted, there is no adjudication method mentioned.
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 MRMC comparative effectiveness study was mentioned or performed. This device is a surgical stapler, not an AI-assisted diagnostic tool, so such a study would not be applicable.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
Not applicable. This device is a surgical stapler, not an algorithm, so standalone performance in that context is not relevant. The device operates with a human surgeon in the loop.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
As no new performance testing was conducted, no specific ground truth type is mentioned or implied for this submission. The basis of the submission is the substantial equivalence to predicate devices whose performance was previously established.
8. The sample size for the training set
The document does not mention a training set because the submission is about updating indications for use for an existing physical device, not a machine learning algorithm.
9. How the ground truth for the training set was established
Not applicable, as no training set for a machine learning algorithm is discussed.
§ 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.