Search Results

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 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 Monopolar and Bipolar Cautery Cords are intended for connecting monopolar/bipolar electrosurgical instruments to an electrosurgical generator to provide transmission of high frequency current from the electrosurgical generator to the surgical instrument.

The da Vinci Xi Hasson Cone has applications in laparoscopic surgery to establish a port of entry for Intuitive Surgical da Vinci Xi EndoWrist Instruments, endoscopes, or compatible accessories.

Device Description

The da Vinci IS4000 (Xi) Surgical Systems are used in conjunction with reusable da Vinci Instruments and Accessories to achieve their intended use. This 510(k) is submitted for changes to Reprocessing Instructions for all reusable da Vinci Xi Instruments and Accessories.

The da Vinci Xi EndoWrist Instruments (8mm), have an articulating design at their distal tips that mimics the human wrist. Each instrument is used to perform one or more specific surgical tasks e.g., grasping, suturing, cutting, cauterizing, or tissue manipulation.

da Vinci Xi Accessories mainly consists 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 an instrument release kit (IRK), an Insertion tool and Instrument introducer. These accessories have simple geometries with no long narrow lumens.

The Monopolar and Bipolar Cautery Cords are accessories to electrosurgical instruments where monopolar or bipolar electrosurgical cutting and coagulation is desired during surgery. The Monopolar and Bipolar Cautery Cords are insulated cords with an instrument-mating connector on one end and generator-mating connector on the other end.

The Hasson Cone, is a cone-shaped device which is intended to be used in endoscopic surgery to assist in establishing a port of entry through the abdominal wall for Intuitive Surgical da Vinci Xi EndoWrist Instruments, endoscopes, and compatible accessories. The Hasson Cone is available in two sizes; 8 mm and 12 mm & Stapler.

AI/ML Overview

The provided 510(k) summary (K170645) is for changes to the reprocessing instructions for da Vinci Xi Instruments and Accessories, Monopolar and Bipolar Cautery Cords, and da Vinci Xi Hasson Cones. It focuses on validating that the updated instructions effectively clean and disinfect the devices and are usable by healthcare personnel.

Here's an analysis of the acceptance criteria and study that proves the device meets them, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance:

Criteria Type	Acceptance Criteria (from standards/guidance)	Reported Device Performance
Cleaning Efficacy	Efficacy of the cleaning process (as described in the Reprocessing Instructions) with qualitative visual inspection and quantitative endpoints. Specific contaminants and reduction levels are implied by references to AAMI TIR 30: 2011.	Cleaning validation testing was performed on devices representing the greatest challenge. The cleaning process was evaluated using qualitative visual inspection and quantitative endpoints. (The document states this was done and implies success by concluding substantial equivalence without reporting specific quantitative results.)
Thermal Disinfection Efficacy	Efficacy of the disinfection process (as described in the Reprocessing Instructions) using a quantitative endpoint of 6-log10 reduction of typical vegetative organisms (e.g., Pseudomonas aeruginosa, Staphylococcus aureus, Escherichia coli, Klebsiella-Enterobacter group).	Thermal disinfection efficacy testing was performed on devices representing significant challenges. The process was evaluated using a quantitative endpoint of 6-log10 reduction of typical vegetative organisms (Pseudomonas aeruginosa, Staphylococcus aureus, Escherichia coli, and representatives of the Klebsiella-Enterobacter group). (Similar to cleaning, the document states this was done and implies success.)
Human Factors/Usability	The Reprocessing Instructions should be useable, effective, and safe. (Implicitly, the instructions should lead to successful cleaning and disinfection without significant user error).	A rigorous Human Factors testing process was completed, including: Preliminary Evaluation, Usability Risk Analysis (URA), Design Team Participation, Formative Testing, and Validation Testing. This validation study assessed usability, effectiveness, and use safety. (The document states this was done and implies success.)

2. Sample Size Used for the Test Set and Data Provenance:

Sample Size for Cleaning and Disinfection Validation: The document states that testing was performed "using 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." However, specific sample sizes (number of devices tested, number of cycles) are not provided.
Sample Size for Human Factors Testing: Not explicitly stated. It mentions "representative end users" for validation testing but does not quantify them.
Data Provenance: The document does not specify the country of origin for the data or whether the studies were retrospective or prospective. Given the nature of validation studies for reprocessing, they would typically be prospective laboratory-based studies conducted in a controlled environment.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts:

For Cleaning and Disinfection: The "experts" are the methodologies and acceptance criteria outlined in the referenced standards and guidance documents (FDA Guidance, AAMI TIR 12, AAMI TIR 30). The ground truth is established by these pre-defined scientific criteria for microbial reduction and cleanliness. There isn't information on human experts establishing ground truth beyond the scientific rigor of adhering to these standards.
For Human Factors: "Human Factors Engineers participated in design meetings" and "representative end users" were involved in validation testing. No specific number or explicit qualifications (e.g., "nurses with 5+ years of experience reprocessing surgical instruments") are provided for these individuals.

4. Adjudication Method for the Test Set:

Cleaning and Disinfection: The adjudication method is based on pre-defined scientific and quantitative acceptance criteria from the referenced standards. For cleaning, it involves qualitative visual inspection and quantitative endpoints. For disinfection, it specifically requires a 6-log10 reduction of vegetative organisms. There is no mention of a human consensus or committee method like 2+1 or 3+1.
Human Factors: The Usability Risk Analysis (URA) conducted for Reprocessing likely involved identifying potential use errors and assessing their severity. The "Validation Testing" likely involved observing users and documenting issues or successful completion of tasks, but the specific adjudication method (e.g., how "usability" or "effectiveness" was formally judged) is not detailed beyond stating it "assessed the usability, effectiveness, and use safety."

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 510(k) is for updated reprocessing instructions for existing surgical instruments and accessories, not for an AI-powered diagnostic or interpretive device. Therefore, the concept of "human readers improving with AI assistance" is not applicable to this submission.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:

No, this is not applicable. This submission is not for an algorithm or AI-based device. It is about the physical instruments and the instructions for their handling. The performance evaluated here is the efficacy of the reprocessing instructions by humans using those instructions, not an algorithm's standalone performance.

7. The Type of Ground Truth Used:

Expert Consensus/Standardized Criteria:
- For cleaning validation, the ground truth is based on the efficacy criteria and test methods outlined in AAMI TIR 12:2010 and AAMI TIR 30:2011, as well as FDA guidance. This represents an expert consensus on what constitutes adequate cleaning for medical devices.
- For thermal disinfection validation, the ground truth is a quantitative microbial reduction target (6-log10 reduction of specific vegetative organisms) established by FDA guidance and industry standards.
- For human factors testing, the ground truth is the successful and safe completion of reprocessing tasks by representative users, and the absence of critical use errors, as determined through usability testing methodologies guided by regulatory recommendations.

8. The Sample Size for the Training Set:

Not Applicable. This submission is not for a machine learning or AI device that requires a training set. The "training" here refers to the development and refinement of the reprocessing instructions themselves through formative testing and design team participation, not a data-driven model.

9. How the Ground Truth for the Training Set Was Established:

Not Applicable. As there is no training set in the context of machine learning, this question does not apply. However, if interpreted as how the "truth" for developing the reprocessing instructions was established, it would be through a combination of:
- Knowledge of the device design and materials (the "design and materials of the subject devices" are identical to predicates, K170645).
- Adherence to recognized standards and guidance documents for reprocessing (AAMI TIRs, FDA Guidance).
- Iterative design and testing processes (Formative Testing) informed by Human Factors best practices and risk analysis. The "ground truth" for these iterations would be identifying potential issues and refining instructions to overcome them.

Ask a Question

Ask a specific question about this device

Page 1 of 1