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Date Cleared

2025-07-23

(96 days)

Product Code

Regulation Number

Type

Panel

da Vinci Surgical System (IS5000)

Reference & Predicate Devices

K232610

Intended 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.

Device Description

The da Vinci Surgical System, Model IS5000 (da Vinci 5) is a software-controlled, electro-mechanical system designed to enable complex surgery using a minimally invasive approach. The system consists of a Console, Robot, and Tower and is used with an endoscope, instruments, and accessories.

The basis for this submission is a modification to the da Vinci Surgical System, Model IS5000, cleared under K232610. The device software has been modified to include a new "force gauge" graphical user interface element, which provides a visual representation of forces applied while completing tasks with the da Vinci Force Feedback instruments.¹ The modification also includes changes to the device labeling.

AI/ML Overview

The provided FDA 510(k) clearance letter and summary for the Da Vinci Surgical System (IS5000) focuses on a software modification, specifically the addition of a "force gauge" graphical user interface (GUI) element. The document does not provide detailed information about clinical performance studies with acceptance criteria in the sense of diagnostic accuracy or clinical outcomes directly tied to the new GUI feature.

Instead, the performance data presented is related to software verification and validation and human factors. This is typical for device modifications where the core functionality of the device remains unchanged, and the modification primarily affects the user interface or internal software operations.

Here's a breakdown of the requested information based only on the provided text, recognizing the limitations of this type of submission:

1. Table of Acceptance Criteria and Reported Device Performance

Since the primary modification is a software change and the addition of a GUI element, the acceptance criteria are not clinical performance metrics but relate to the software's adherence to design specifications and usability.

Acceptance Criteria Category	Reported Device Performance (Summary)
Software Verification & Validation	All testing passed; continues to meet design specifications and user needs. Software documentation provided according to FDA guidance.
Human Factors Validation	Based on Comparative Task Analysis (CTA) and Use-Related Risk Analysis (URRA), human factors validation conducted for impacted critical tasks. All testing passed.

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

Software Verification & Validation: The document states "unit, subsystem integration, and system level" testing. This typically involves internal testing by engineers. It does not specify a "sample size" in terms of patient data or clinical cases. The provenance is internal development and testing.
Human Factors Validation: While a "human factors validation" was conducted, the document does not specify the number of users (the "test set" in this context) involved in these studies. The provenance would be from internal usability testing.

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

Not applicable in the context of this software modification submission. The "ground truth" for software verification is adherence to design specifications and functional requirements. For human factors, it relates to usability and safety of interaction, which is assessed through user testing and expert review of the interface. The document does not specify the number or qualifications of "experts" involved in establishing this ground truth.

4. Adjudication Method for the Test Set

Not applicable for the types of testing described. Adjudication methods like "2+1" typically apply to diagnostic studies where multiple readers interpret cases and a consensus or tie-breaker is needed to establish ground truth.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done

No, an MRMC comparative effectiveness study was not explicitly mentioned or implied to be done for this submission. The submission focuses on verification of the software change and human factors, not on comparing clinical effectiveness with and without the AI assistance (which the force gauge isn't explicitly defined as, but rather a new GUI element for an existing force feedback instrument).

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was Done

Not applicable. The force gauge is a graphical user interface element that provides visual feedback to the human operator using the Da Vinci Surgical System. It inherently functions "with human-in-the-loop."

7. The Type of Ground Truth Used

Software Verification & Validation: The "ground truth" is the design specifications and functional requirements of the software. The tests verify that the software performs as designed.
Human Factors Validation: The "ground truth" is adherence to usability principles and mitigation of use-related risks, assessed through task analysis and user studies against established human factors engineering principles.

8. The Sample Size for the Training Set

Not applicable. This submission concerns a modification to an existing surgical system's software GUI. It does not describe an AI/ML algorithm that requires a "training set" in the conventional sense for model development. The "force gauge" is a visual representation of existing force feedback data, not a new predictive or analytical algorithm trained on data.

9. How the Ground Truth for the Training Set was Established

Not applicable, as there is no mention of a "training set" for an AI/ML model.

Summary of Device and Study Context:

The Da Vinci Surgical System (IS5000) submission (K251213) is a Traditional 510(k) for a software modification to an already cleared device (K232610). The modification adds a "force gauge" graphical user interface (GUI) element that visually represents forces applied by existing Da Vinci Force Feedback instruments.

The study described is not a clinical effectiveness trial but rather a set of engineering verification and validation activities to ensure the software modification is safe and functions as intended, and that the new GUI element does not introduce new use-related risks. The FDA's clearance is based on the determination that the modified device is substantially equivalent to its predicate device, and the performance data provided (software V&V, human factors) supports this equivalence for the specific modification.

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K Number

K251202

Device Name

Manufacturer

Date Cleared

2025-07-16

(89 days)

Product Code

Regulation Number

Type

Panel

da Vinci Surgical System (IS5000)

Reference & Predicate Devices

K242427,K232610

Intended 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.

Device Description

The da Vinci Surgical System, Model IS5000, is a software-controlled, electro-mechanical system designed to enable complex surgery using a minimally invasive approach. The system consists of a Console (Surgeon Console or SSC), a Robot (Patient Side Cart or PSC), and a Tower (Vision Side Cart or VSC) and is used with an endoscope, instruments, and accessories.

The basis for this submission is the modification of the da Vinci Surgical System, Model IS5000, cleared under K232610. The device software is being modified to include a new feature called "Networked Central Configuration Management" which enables Intuitive technical support to remotely push configuration data to a system connected to the network for user to update the system. The configuration data includes customer site preference settings and system feature enabling or disabling. The modification also includes changes to the device labeling.

AI/ML Overview

The provided FDA 510(k) clearance letter for the da Vinci Surgical System (IS5000), K251202, describes a submission for a modification to an already cleared medical device, not a completely novel device. The core of this submission revolves around software changes, specifically the addition of a "Networked Central Configuration Management" feature and associated cybersecurity updates.

As such, the detailed information typically found for a new device's performance study (MRMC, expert ground truth, extensive sample sizes for training/test sets, etc.) is not present in this type of 510(k) submission. The FDA clearance is based on demonstrating that the modifications do not adversely affect the device's safety and effectiveness and that the new features function as intended without introducing new risks.

Therefore, the response below will focus on what can be inferred or reasonably assumed from the provided document regarding performance criteria and how the device meets them in the context of this specific modification.

Acceptance Criteria and Device Performance for da Vinci Surgical System (IS5000) K251202

Given that this 510(k) submission (K251202) is for a modification to an already cleared device (K232610), the performance data provided focuses on verifying the safety and functionality of the changes rather than re-establishing the fundamental efficacy of the surgical system itself. The core acceptance criteria revolve around ensuring that the new software feature ("Networked Central Configuration Management") and associated cybersecurity updates do not introduce new risks or degrade the existing performance of the device.

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria Category	Specific Criteria (Inferred from Submission Type)	Reported Device Performance (as per 510(k) Summary)
Software Functionality	The "Networked Central Configuration Management" feature enables remote pushing of configuration data and updates settings as intended.	Software verification and validation conducted at unit, integration, and system levels confirmed the subject device continues to meet design requirements and user needs.
Software Safety	The software changes do not introduce new hazards or adverse events related to device operation.	Software verification and validation confirmed the device continues to meet design requirements and user needs. (Implying safety)
Cybersecurity	The device is resilient against identified cybersecurity threats; risk controls are adequate.	Cybersecurity verification and validation conducted confirmed risk control measures based upon the cybersecurity threat model are adequate.
Unchanged Performance	The fundamental surgical capabilities (accurate control of instruments, tissue manipulation, etc.) remain unaffected.	"The principles of operation are unchanged." The submission implies no degradation of the original device's performance due to the software modifications.
Labeling Accuracy	Device labeling accurately reflects the modified features and any associated warnings/contraindications.	"The modification also includes changes to the device labeling." (Implies accuracy and completeness have been addressed).

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

Test Set Sample Size: The document does not specify a quantitative "sample size" in terms of patient cases or surgical procedures for the performance testing of these software modifications. This is typical for software-only changes. Instead, testing would involve a comprehensive set of software validation tests, unit tests, integration tests, and system-level tests for the new functionalities and cybersecurity.
Data Provenance: Not specified in terms of country of origin. The testing would have been performed by the manufacturer (Intuitive Surgical, Inc.) in a controlled development and testing environment. The data is retrospective in the sense that it's derived from internal validation activities, not a prospective clinical trial for these specific changes.

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

Number of Experts: Not explicitly stated. For software and cybersecurity validation, "experts" would likely be:
- Software engineers and quality assurance (QA) testers experienced in medical device software.
- Cybersecurity experts (e.g., ethical hackers, penetration testers, network security specialists).
- Clinical subject matter experts (e.g., surgeons, clinical engineers) might be involved in reviewing use cases and validating clinical workflows impacted by the new features, but this is not detailed.
Qualifications of Experts: Not specified. It's assumed they would possess relevant engineering, software development, cybersecurity, and potentially clinical experience for their respective roles in the verification and validation process.

4. Adjudication Method for the Test Set

Adjudication Method: Not applicable or specified. For software and cybersecurity testing, "adjudication" typically refers to the process of resolving discrepancies in expert interpretations of data (e.g., image reads). In software testing, the "ground truth" is adherence to design specifications and user requirements, as well as absence of bugs and security vulnerabilities. Test results are compared against expected outcomes, not expert consensus.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

MRMC Study: No, an MRMC study was not performed. MRMC studies are typically conducted to evaluate the impact of a new diagnostic imaging AI algorithm on human reader performance (e.g., radiologists improving detection rates). This 510(k) is for a surgical system's software modification, not a diagnostic AI.

6. If a Standalone (Algorithm Only) Performance Study Was Done

Standalone Performance Study: Not in the traditional sense of an AI algorithm's diagnostic performance (e.g., sensitivity/specificity for a disease). However, the "Software Testing" and "Cybersecurity Testing" sections represent the standalone performance evaluation of the new software feature and its security aspects in isolation from the full clinical context. This involves testing the software's ability to correctly manage configurations, push updates, and maintain data integrity and security, independent of a specific surgical procedure.

7. The Type of Ground Truth Used

Type of Ground Truth: For this type of submission, the ground truth is established by:
- Design Specifications and User Requirements: The software is tested against whether it correctly implements the defined functionalities (e.g., "Networked Central Configuration Management" remotely pushes data, updates settings as specified).
- Cybersecurity Threat Models: The security measures are validated against identified threats and vulnerabilities to ensure they provide adequate protection.
- Existing Validated Performance: The ground truth for the core surgical system's performance is assumed from its prior clearance (K232610), and the current testing aims to ensure this performance is not degraded.

8. The Sample Size for the Training Set

Training Set Sample Size: Not applicable. The "Networked Central Configuration Management" feature is a conventional software function, not a machine learning or AI algorithm that requires a "training set."

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

Ground Truth for Training Set Establishment: Not applicable, as there is no training set for a machine learning model in this submission.

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K Number

K243641

Device Name

Manufacturer

Date Cleared

2024-12-16

(20 days)

Product Code

Regulation Number

Type

Panel

da Vinci Surgical System (IS5000)

Reference & Predicate Devices

K232610,K241284

Intended Use

The Intuitive Surgical Endoscopic Instrument Control System (da Vinci Surgical System, Model IS5000) shall assist in the accurate control of Intuitive Surgical Endoscopic Instruments including rigid endoscopes, blunt and sharp endoscopic dissectors, 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 and general thoracoscopic surgical procedures. The system is indicated for adult 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.

Contraindication:

Use of the force feedback needle driver is contraindicated in hysterectomy and myomectomy due to the risk of vaginal bleeding requiring hospital readmission and/or the need for additional procedures. The use of non-force feedback needle drivers is recommended for suturing in these procedures.

Device Description

The da Vinci Force Feedback Instruments are 8 mm, multi-use, endoscopic instruments intended for use with the da Vinci Surgical System, Model IS5000. These instruments have been designed with an articulating wrist that gives surgeons natural dexterity and range of motion, and have the ability to render forces measured at the instrument tip to the hand controls at the system Console.

The basis for this submission is a modification to the reprocessing instructions, in addition to an increase in the number of surgical uses (lives) and reprocessing cycles for the da Vinci Force Feedback Instrument family as listed in Table 1, which Intuitive intends to introduce into interstate commerce in accordance with 21 CFR Section 807.81.

AI/ML Overview

The provided document is an FDA 510(k) summary for a medical device. It focuses on demonstrating substantial equivalence to predicate devices, particularly regarding changes to reprocessing instructions and increasing the number of surgical uses (lives) and reprocessing cycles for the da Vinci Force Feedback Instruments.

Here's an analysis of the acceptance criteria and the study information based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance:

The document describes performance testing conducted to support the changes. While it doesn't explicitly state "acceptance criteria" with numerical thresholds, it details the types of tests performed and implies that passing these tests demonstrates acceptable performance. The "reported device performance" is generally stated as "All testing passed and supports the subject device changes."

Performance Test Category	Implied Acceptance Criteria (Based on document)	Reported Device Performance
Cleaning Validation	Efficacy of manual cleaning process in accordance with ANSI/AAMI ST98, AAMI TIR12, ASTM F3208, and FDA Guidance.	Passed
Reliability (Life) Verification	Instrument mechanical and sensor performance maintained after sufficient reprocessing and simulated surgical use cycles (simulating design life).	Passed (benchtop measurements, visual inspection, functional performance)
Dielectric Strength Testing	Compliance with IEC 60601-2-2:2017 and FDA Guidance for Electrosurgical Devices, after instruments have undergone design life cycles.	Passed
Jaw Force to Failure Verification	Verification of jaw force to failure after instruments have undergone design life cycles, in compliance with FDA Guidance for Electrosurgical Devices.	Passed

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

The document does not specify the exact sample sizes used for each of the performance tests (Cleaning Validation, Reliability Verification, Dielectric Strength Testing, Jaw Force to Failure Verification). It generally refers to "instruments" being subjected to tests.

The data provenance (country of origin, retrospective/prospective) is not explicitly stated. The testing appears to be internal validation performed by the manufacturer, Intuitive Surgical, Inc., located in Sunnyvale, California.

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

The document describes engineering-based performance testing rather than studies involving human interpretation or expert ground truth establishment in the traditional sense (e.g., for diagnostic algorithms). The "ground truth" for these tests would be the established engineering specifications and regulatory standards. Therefore, the concept of a "number of experts" establishing ground truth in this context is not directly applicable. The experts involved would be the engineers and regulatory specialists who designed and conducted the tests and interpreted the results against established standards.

4. Adjudication Method for the Test Set:

Not applicable, as this is engineering performance testing, not a study requiring expert adjudication of results.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done:

No, an MRMC comparative effectiveness study was not done. The document describes benchtop and laboratory testing of the instruments' physical and functional performance, not a study evaluating human reader performance with or without AI assistance.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done:

Not applicable. The device, the da Vinci Force Feedback Instruments, is a physical surgical instrument that assists a human surgeon. It is not an AI algorithm in the standalone sense. The performance tests are for the instruments themselves, not an algorithm's output.

7. The Type of Ground Truth Used:

The "ground truth" for the performance tests is based on engineering specifications, regulatory standards, and established industry guidelines. For example:

Cleaning validation against ANSI/AAMI ST98.
Dielectric strength testing against IEC 60601-2-2.
Jaw force to failure verification against FDA guidance.
Reliability (life) verification against internal design life specifications.

8. The Sample Size for the Training Set:

Not applicable. This document is about a physical medical device (surgical instruments) undergoing performance validation, not a machine learning model that requires a training set.

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

Not applicable, as there is no machine learning model or training set involved.

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K Number

K241284

Device Name

Manufacturer

Date Cleared

2024-07-03

(57 days)

Product Code

Regulation Number

Type

Panel