(193 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 malignant 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 Intuitive Surgical da Vinci Harmonic ACE™ Device is intended for soft tissue incisions when bleeding control and minimal thermal injury are desired. It is designed to be used in conjunction with the da Vinci Surgical Systems (Model IS1200, IS2000 and IS3000) and the Ethicon Endo-Surgery Generator 300 (Model GEN04) and Hand Piece (Model HP054).
The Flared Cannulae are intended to be used with the da Vinci Surgical System (da Vinci S (Model 1S2000) or da Vinci Si (Model 1S3000) to serve as a port of entry during da Vinci procedures that do not require maintenance of insufflation.
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/pickups, 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 ablation probes and accessories during urologic surgical procedures, general laparoscopic surgical procedures, gynecologic surgical procedures, general noncardiovascular thoracoscopic surgical procedures and thoracoscopically assisted cardiotomy procedures. The system can also be employed, with adjunctive mediastinotomy to perform coronary anastomosis during cardiarization. The system is indicated for adult and pediatric use. It is intended for use by trained physicians in an operating room environment in accordance with the representative specific procedures set forth in the Professional Instructions for Use.
The Intuitive Surgical Endoscopic Instrument Control System (Intuitive Surgical® da Vinci Si Surgical System Model IS3000) is intended to assist in the accurate control of Intuitive Surgical Endoscopic Instruments including rigid endoscopes, blunt and sharp endoscopic dissectors, 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, gynecological laparoscopic surgical procedures, general cardiovascular and non-cardiovascular thoracoscopic surgical procedures, and thoracoscopically assisted cardiotomy procedures. The system is indicated for adult and pediatric use. The system can also be employed, with adjunctive mediastinotomy to perform coronary anastomosis during cardiac revascularization. It is intended for use 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 IS2000 (S) and IS3000 (Si) Surgical Systems are used in conjunction with reusable Instruments and Accessories to achieve their intended use. This 510(k) is submitted for changes to Reprocessing Instructions for all reusable da Vinci S and da Vinci Si Instruments and Accessories.
S2000/IS3000 5mm and 8mm Instruments can be used only with the da Vinci S (IS2000) and Si (IS3000) Surgical Systems. Most instruments have a unique articulating design at their distal tips that mimics the human wrist. While seated at the Surgeon Console of the Surgical System, the surgeon can precisely control movements of the end effectors/instrument tips.
The Harmonic ACE Curved Shears Instrument (5mm/8mm) consists of a proximal reusable instrument housing and a distal disposable insert. The reusable instrument housing, when assembled with the disposable insert, is attached to the da Vinci IS2000/IS3000 System and delivers ultrasonic energy for transection (cutting) and coagulation of tissue.
The Endowrist Stabilizer is a reusable instrument similar to the da Vinci S/ Si EndoWrist Instruments. It is mounted on a PSM arm and is positioned, controlled, and held in place by the da Vinci IS2000/IS3000 System.
da Vinci S/ Si Accessories mainly consist of: Cannulae, which are essentially hollow tubes that provide a path for instruments to access the surgical site; Obturators, which provide a means of initially inserting the seal and cannula assemblies through the body wall by providing a fitted tip that extends beyond the cannula's most distal point; "Other" Accessories include PK Cables, instrument release kit (IRK), Blade Protectors and Insertion tools (used with the Snap-FitTM Scalpel Instrument), a Blank Cartridge (used with the Endopass Delivery instrument), cannula mounts, light guide cable and cannula gage pins. These accessories have simple geometries with no long narrow lumens.
The Flared Cannula consists of a tapered hollow tubular shaft with a flared distal tip and a bowl with an integral electrical receptacle. The hollow shaft serves as the port of entry, the bowl is used to attach the cannula to the da Vinci S/Si Surgical System and the receptacle allows for attachment of commercially available dispersive electrode grounding pad via a 2-pin grounding connector.
The 8.5 mm Endoscope Cannula is made of stainless steel components and is used to establish a port of entry for the 8.5mm Endoscope and provide an outlet for insufflation and/or smoke evacuation.
The Endoscope Alignment Target is used during stereo endoscope set-up to align the left and right images from the endoscope to provide a stereo image to the console surgeon. It does not have any long narrow lumens.
The provided document describes a 510(k) premarket notification for changes to the reprocessing instructions for various da Vinci S/Si EndoWrist Instruments and Accessories, not a new device or an AI-powered device. Therefore, the information typically requested for AI/machine learning device studies (such as sample sizes for test/training sets, expert qualifications, and MRMC studies) is not applicable here as this submission focuses on the effectiveness of the reprocessing instructions rather than the diagnostic or therapeutic performance of the instruments themselves.
The study presented focuses entirely on the validation of the revised reprocessing instructions.
1. A table of acceptance criteria and the reported device performance:
| Acceptance Criteria Category | Specific Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Cleaning Validation | Efficacy of cleaning process in reprocessing instructions in accordance with: |
- FDA Guidance, "Reprocessing Medical Devices in Health Care Settings: Validation Methods and Labeling" (March 17, 2015)
- AAMI TIR 12:2010 (Designing, testing, and labeling reusable medical devices for reprocessing in health care facilities)
- AAMI TIR 30: 2011 (A compendium of processes, materials, test methods, and acceptance criteria for cleaning reusable medical devices)
- Qualitative visual inspection
- Quantitative endpoints | Cleaning Efficacy test evaluated the cleaning process for the devices using qualitative visual inspection and quantitative endpoints, demonstrating compliance with standards. |
| Thermal Disinfection Validation | Efficacy of disinfection process in reprocessing instructions in accordance with: - FDA Guidance, "Reprocessing Medical Devices in Health Care Settings: Validation Methods and Labeling" (March 17, 2015)
- FDA Guidance, "Class II Special Controls Guidance Document: Medical Washers and Medical Washer-Disinfectors" (February 7, 2002)
- Quantitative endpoint: 6-log10 reduction of typical vegetative organisms (e.g., Pseudomonas aeruginosa, Staphylococcus aureus, Escherichia coli, Klebsiella-Enterobacter group) | Thermal disinfection efficacy testing evaluated the efficacy of the disinfection process, achieving a quantitative endpoint of 6-log10 reduction of typical vegetative organisms. |
| Human Factors Testing | Usability, effectiveness, and use safety of the Reprocessing Instructions, evaluated through: - Preliminary Evaluation
- Usability Risk Analysis (URA)
- Design Team Participation
- Formative Testing
- Validation Testing with representative end users | The Reprocessing Instructions underwent a rigorous Human Factors testing process, including preliminary evaluation, URA, design team participation, formative testing, and validation testing, assessing usability, effectiveness, and safety. |
2. Sample size used for the test set and the data provenance:
- Test Set Sample Size: The document does not specify a numerical sample size for the devices tested for cleaning and thermal disinfection. It states that "devices within the product family that represent the greatest challenge for the cleaning process" and "devices within the product family that represent significant challenges to the disinfection step" were used. For Human Factors testing, "representative end users" were involved, but no number is given.
- Data Provenance: The studies were conducted by Intuitive Surgical, Inc. as part of their 510(k) submission. The nature of these validation studies (e.g., cleaning, disinfection, human factors) implies they were prospective experiments or evaluations designed specifically for this submission. The country of origin of the data is not specified but would typically be where the manufacturer conducts its testing (likely the US, given the FDA submission).
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Number of Experts: Not explicitly stated. For cleaning and thermal disinfection, the "ground truth" and acceptance criteria are based on established regulatory guidance and industry standards (FDA guidance, AAMI TIRs). For Human Factors, "Human Factors Engineers" participated in the design and evaluation, and "representative end users" participated in validation testing. No specific number or individual qualifications are provided beyond these roles.
4. Adjudication method for the test set:
- No specific adjudication method (e.g., 2+1, 3+1) is mentioned as relevant for these types of validation studies. The assessments for cleaning and disinfection are based on objective measures against defined standards (visual inspection, quantitative reduction of microorganisms). The Human Factors studies involved direct observation and feedback during usability testing.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, and the effect size of how much human readers improve with AI vs without AI assistance:
- No, an MRMC comparative effectiveness study was not done. This submission is for changes to reprocessing instructions for surgical instruments, not an AI or imaging device that would typically involve human "readers." The concept of improving human readers with AI assistance is not applicable here.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- No, a standalone (algorithm-only) performance study was not done. The device in question (surgical instruments) is not an algorithm. The "performance" being evaluated is the effectiveness of the reprocessing instructions for cleaning and disinfecting physical medical devices, and the usability of these instructions by human users.
7. The type of ground truth used:
- Cleaning and Thermal Disinfection: Ground truth is established by adherence to recognized industry standards and regulatory guidance documents (e.g., FDA guidance, AAMI TIRs) for sterility, cleanliness, and disinfection efficacy, which include quantitative microbiological reduction targets.
- Human Factors: Ground truth is established by the usability, effectiveness, and safety of the instructions as determined through detailed ergonomic and human factors analyses and validation studies with representative users, aiming to identify and mitigate potential use errors.
8. The sample size for the training set:
- Not applicable. This is not an AI/machine learning device, so there is no "training set" in the context of algorithm development.
9. How the ground truth for the training set was established:
- Not applicable, as there is no training set for an 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.