(203 days)
The Intuitive Surgical Endoscopic Instrument Control System is intended to assist in the accurate control of Intuitive Surgical Endoscopic Instruments including rigid endoscopes, blunt and sharp endoscopic dissectors, scissors, scalpels, ultrasonic shears, forceps/pick-ups, needle holders, endoscopic retractors, stabilizers, 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, transoral otolaryngology surgical procedures restricted to benign and tumors classified as TI and T2, and for benign base of tongue resection 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 (except for transoral otolaryngology surgical procedures). 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 Fluorescence Imaging Vision System is intended to provide real-time endoscopic visible and near-infrared fluorescence imaging. The da Vinci Fluorescence Imaging Vision System enables surgeons to perform minimally invasive surgery using standard endoscopic visible light as well as visual assessment of vessels. blood flow and related tissue perfusion, and at least one of the major extra-hepatic bile duct, common bile duct and common hepatic duct), using near infrared imaging. Fluorescence imaging of biliary ducts with the da Vinci Fluorescence Imaging Vision System is intended for use with standard of care white light and, when indicated, intraoperative cholangiography. The device is not intended for standalone use for biliary duct visualization.
The Intuitive Surgical Endoscopic Instrument Control System (da Vinci Surgical System, Model IS4000) 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 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 revasularization. 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® Firefly™ Imaging System is intended to provide real-time endoscopic visible and near-infrared fluorescence imaging. The da Vinci Firefly Imaging System enables surgeons to perform minimally invasive surgery using standard endoscopic visible light as well as visual assessment of vessels, blood flow and related tissue perfusion, and at least one of the major extra-hepatic bile ducts (cystic duct, common bile duct or common hepatic duct), using near infrared imaging. Fluorescence imaging of biliary ducts with the da Vinci Firefly Imaging System is intended for use with standard of care white light and, when indicated, intraoperative cholangiography. The device is not intended for standalone use for biliary duct visualization.
The da Vinci IS2000 (S), IS3000 (Si), and IS4000 (Xi) Surgical Systems are used in conjunction with reusable da Vinci Endoscopes to achieve their intended use. This 510(k) is submitted for changes to Reprocessing Instructions for all reusable da Vinci Endoscopes.
The IS2000/IS3000 Endoscopes are used to provide an image of the surgical field to the surgeon side console and assistant monitors on the IS2000/IS3000 system. There are two diameters of the endoscopes (12mm or 8.5mm) with either a straight (0°) or angled (30°) tip.
da Vinci Endoscopes, 8.5mm/12mm are a part of the da Vinci Fluorescence Imaging Vision System which is an imaging system for high definition (HD) visible light and near-Infrared fluorescence Imaging during minimally invasive surgery. There are two diameters for the endoscopes (12mm or 8.5mm) with either a straight (0°) or angled (30°) tip.
The IS4000 Endoscope (8mm) is used to provide an image of the surgical field to the surgeon side console and assistant monitors on the IS4000 System. The IS4000 8 mm endoscope is available with either a straight (0°) or angled (30°) tip.
This document describes the reprocessing instructions for da Vinci S/Si Endoscopes, da Vinci Xi Endoscopes, and da Vinci Endoscopes used with the da Vinci Firefly Imaging system. The submission (K170641) addresses modifications to the reprocessing instructions for these multiple-use endoscopes. No changes were made to the design or materials of the devices themselves.
Here's an analysis of the provided information regarding acceptance criteria and the supporting study:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly present a table of acceptance criteria alongside reported device performance in a summary format with specific quantitative metrics for all performance data types. However, based on the descriptions of the validation studies, we can infer the general acceptance criteria and the successful outcome for the different types of testing.
| Acceptance Criteria (Inferred from study descriptions) | Reported Device Performance |
|---|---|
| Cleaning Validation: | The cleaning validation testing summarized in this submission validates the efficacy of the cleaning process in the Reprocessing Instructions in accordance with the specified standards and guidance documents. This implies that the cleaning process was effective and met the standards. |
| Efficacy of cleaning process (qualitative visual inspection and quantitative endpoints). Conformance to FDA Guidance"Reprocessing Medical Devices in Health Care Settings: Validation Methods and Labeling", AAMI TIR 12:2010, and AAMI TIR 30: 2011. | |
| Chemical Disinfection Efficacy Validation: | The disinfection validation testing summarized in this submission validates the efficacy of the chemical disinfection process in the Reprocessing Instructions in accordance with the specified guidance documents. Efficacy was evaluated using a quantitative endpoint of 6-log10 reduction of typical vegetative organisms. This indicates that the disinfection process achieved the required reduction in microorganisms. |
| Efficacy of chemical disinfection process: Quantitative endpoint of 6-log10 reduction of typical vegetative organisms (e.g., Pseudomonas aeruginosa, Staphylococcus aureus, Escherichia coli, Klebsiella-Enterobacter group). Conformance to FDA Guidance "Reprocessing Medical Devices in Health Care Settings: Validation Methods and Labeling" and "Class II Special Controls Guidance Document: Medical Washers and Medical Washer-Disinfectors". | |
| Chemical Disinfection Compatibility Validation: | The chemical disinfection compatibility validation testing summarized in this submission validates the compatibility of the da Vinci Endoscopes with the chemical disinfection process. Devices were subjected to multiple chemical disinfection cycles and visually inspected for material changes and degradation. This suggests that the endoscopes remained compatible without material degradation. |
| Compatibility of endoscopes with chemical disinfection process: No material changes or degradation after multiple cycles (assessed via visual inspection). | |
| Human Factors Testing: | This validation study assessed the usability, effectiveness, and use safety of the Reprocessing Instructions. The summary states that validation testing was "completed with representative end users," implying a successful outcome regarding usability, effectiveness, and safety of the instructions. |
| Usability, effectiveness, and use safety of the Reprocessing Instructions (evaluated through Preliminary Evaluation, Usability Risk Analysis, Design Team Participation, Formative Testing, and Validation Testing). |
Overall Summary of Performance: "Performance test data demonstrates that the subject device is substantially equivalent to the predicate device and that the design output meets the design input requirements."
2. Sample size used for the test set and the data provenance
- Sample Size for Test Set: The document does not specify exact sample sizes for the test sets used in cleaning, disinfection, or human factors validation. It mentions "devices within the product family that represent the greatest challenge" for cleaning, and "devices that represent significant challenges to the disinfection step" for chemical disinfection efficacy. For human factors, it states "Validation test of representative Reprocessing Instructions was completed with representative end users."
- Data Provenance: The document does not explicitly state the country of origin of the data. Given it's an FDA submission, the tests were likely conducted in accordance with US regulatory standards, implying US-based or internationally recognized testing facilities. The studies are described as nonclinical tests and validation studies, indicating they are prospective tests designed to prove the efficacy and safety of the reprocessing instructions.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- The document does not mention the use of "experts" in the sense of clinical specialists establishing a ground truth for a diagnostic or clinical performance. Instead, the "ground truth" for the reprocessing instructions' effectiveness is established through adherence to recognized scientific standards and guidance documents (AAMI, FDA guidances) and objective measurements (e.g., quantitative reduction of microorganisms, visual inspection for cleanliness/degradation).
- For Human Factors Testing, "Human Factors Engineers" participated in design and content development, and "representative end users" were involved in validation testing. Their specific qualifications (e.g., years of experience) are not detailed.
4. Adjudication method for the test set
- Adjudication methods (like 2+1, 3+1) are typically used in studies where human readers or experts are interpreting results (e.g., medical imaging). This document describes validation studies for reprocessing instructions, which are primarily objective performance tests and human factors assessments. Therefore, traditional adjudication methods are not applicable here. Performance is assessed against defined technical standards and criteria as detailed above.
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, a multi-reader multi-case (MRMC) comparative effectiveness study was not conducted. This submission is for reprocessing instructions for surgical endoscopes, not for an AI-powered diagnostic or predictive device that would involve human readers or AI assistance.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- This question is not applicable. The device described is a surgical endoscope, and the studies reported concern the validation of its reprocessing instructions, not an algorithm's standalone performance.
7. The type of ground truth used
The "ground truth" for the validation of the reprocessing instructions comes from:
- Technical Standards and Guidance Documents: Adherence to established industry standards (AAMI TIR 12, AAMI TIR 30) and FDA guidance documents related to medical device reprocessing, cleaning, and disinfection.
- Objective Quantitative and Qualitative Measurements:
- Cleaning: Qualitative visual inspection and quantitative endpoints (specific metrics not detailed but implied to meet standards).
- Disinfection: Quantitative endpoint of 6-log10 reduction of vegetative organisms.
- Compatibility: Visual inspection for material changes and degradation.
- Usability Feedback: From "representative end users" for the human factors testing, assessing effectiveness and safety of the instructions themselves.
8. The sample size for the training set
- This question is not applicable. The document describes validation studies for medical device reprocessing instructions, not a machine learning or AI model that requires a training set.
9. How the ground truth for the training set was established
- This question is not applicable, as there is no training set mentioned or implied in the provided document.
§ 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.