The Intuitive Surgical Endoscopic Instrument Control System (da Vinci SP Surgical System, Model SP1098) is intended to assist in the accurate control of Intuitive Surgical EndoWrist SP Instruments during urologic surgical procedures that are appropriate for a single port approach and transoral otolaryngology surgical procedures in the oropharynx restricted to benign tumors and malignant tumors classified as T1 and T2. The system is indicated for adult 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.

EndoWrist SP Instruments:

Intuitive Surgical EndoWrist SP Instruments are controlled by the da Vinci SP Surgical System, Model SP1098, and include flexible endoscopes, blunt and sharp endoscopic dissectors, scissors, 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, and suturing through a single port. The system is indicated for urologic surgical procedures that are appropriate for a single port approach and transoral otolaryngology surgical procedures in the oropharynx restricted to benign tumors and malignant tumors classified as T1 and T2. The system is indicated for adult 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.

Device Description

The da Vinci SP Surgical System is designed to enable complex surgery using a minimally invasive approach. The system consists of a Surgeon Console, a Vision Cart, and a Patient Cart and is used with a camera, instruments, and accessories.

The surgeon seated at the Surgeon Console controls all movement of the instruments and camera by using two hand controls and a set of foot pedals. The surgeon views the camera image on a three-dimensional (3D) viewer, which provides a view of patient anatomy and instrumentation, along with icons and other user interface features.

The Vision Cart includes supporting electronic equipment, such as the camera light source, video and image processing, and the networking hardware. The Vision Cart also has a touchscreen to view the camera image and adjust system settings.

The Patient Cart is the operative component of the da Vinci SP Surgical System. Its primary function is to support the positioning of the surgical port and to manipulate the surgical instruments and camera. The Patient Cart is positioned at the operating room table and contains an instrument arm that is positioned with respect to the target patient anatomy. The instrument arm contains four instrument drives that hold up to three surgical instruments and the camera. The patient-side assistant installs and removes the camera and instruments intra-operatively.

The design modifications included in this submission are limited to updated system software, specifically changes to the control algorithms to damp system structural vibrations.

AI/ML Overview

The provided document is an FDA 510(k) clearance letter for the da Vinci SP Surgical System. It primarily focuses on the regulatory approval process and states that the device is substantially equivalent to a predicate device. The document mentions "verification and validation testing" but does not provide specific details about the acceptance criteria or results of a study that proves the device meets specific performance criteria in a quantitative manner as would typically be seen in a clinical study for an AI/ML device.

This document refers to a surgical system (a robotic surgical device), not an AI/ML device for diagnosis or prognosis that relies on analyzing medical images or data. Therefore, many of the requested details about acceptance criteria, ground truth, sample size for test/training sets, expert adjudication, and MRMC studies, which are standard for the assessment of AI/ML devices, are not explicitly provided or relevant in the context of this traditional medical device clearance.

However, based on the information provided, here's an attempt to address the prompt, highlighting what is (and isn't) present in the text:

The document details the FDA 510(k) clearance for the da Vinci SP Surgical System (SP1098). The core of this clearance is the demonstration of substantial equivalence to a previously cleared predicate device (da Vinci SP Surgical System, K202968). The primary modification in this submission relates to updated system software, specifically changes to control algorithms designed to damp system structural vibrations.

There is no detailed study described in this document that explicitly proves the device meets quantitative acceptance criteria in the manner typically expected for an AI/ML diagnostic or prognostic device (e.g., sensitivity, specificity, AUC). Instead, the focus is on demonstrating that the software changes do not adversely affect safety or effectiveness and that the modified device maintains performance comparable to its predicate.

Here's an analysis based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance:

The document states: "The subject device met the same acceptance criteria as the predicate device." However, it does not provide a specific table of these acceptance criteria or quantitative performance metrics. The general implied acceptance criteria for this software update are that the system continues to operate safely and effectively, and that the "dampening" of vibrations improves the surgeon's experience (faster stabilization) without negatively impacting control or patient safety.

Acceptance Criteria (Inferred from text)	Reported Device Performance (Inferred from text)
Safety and Effectiveness: No new issues of safety or effectiveness identified with software changes.	"Verification and validation testing on the subject device confirmed that no issues of safety or effectiveness and no additional unexpected risks were identified."
Functional Equivalence: Device continues to function as intended, controlling surgical instruments and camera accurately.	"Regression testing of the software was performed to verify that the embedded software and user interface continued to meet specifications." "The system control algorithms were verified by unit testing, the verification of surgeon control mode accuracy and fault distances, and the verification of joint controller performance."
Improved Performance (Software Damping): Enhanced control algorithms decrease settling time of surgeon transitions; endoscope view and instruments stabilize more quickly after moving.	"The enhanced control algorithms decrease the settling time of the surgeon transitions between control modes, so that the endoscope view and instruments stabilize more quickly after moving." "The algorithm does not impact the physical feel of the surgeon's manipulations at the Surgeon Console, nor the feel of a user clutching the Instrument Arm on the Patient Cart."
Maintenance of Predicate Device Performance: Meets the same standards as the previously cleared predicate device.	"The subject device met the same acceptance criteria as the predicate device. Therefore, the test results demonstrate that the subject device is substantially equivalent to its predicate device."

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

The document mentions validation testing using an "animal model."

Sample Size: Not specified.
Data Provenance: Not specified (e.g., country of origin). The phrase "animal model" suggests prospective testing, but details are absent. The nature of the device (surgical robot) means the "test set" here refers to real-world performance testing, rather than an image dataset for AI.

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

Not applicable or specified in this document. For a robotic surgical system, "ground truth" would be related to the device's mechanical and software performance, often assessed against engineering specifications and validated through simulated or animal studies, and observed by engineers and potentially surgeons, rather than through expert consensus on diagnostic images.

4. Adjudication Method for the Test Set:

Not applicable or specified. This concept is for diagnostic interpretation, not for evaluating a surgical robot's performance.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, and effect size:

No, an MRMC study was not conducted as described. This type of study is specific to evaluating AI in diagnostic image interpretation where multiple human readers interpret cases with and without AI assistance. The document refers to the effect of the software change as: "The enhanced control algorithms decrease the settling time of the surgeon transitions between control modes, so that the endoscope view and instruments stabilize more quickly after moving." This describes an improvement in user experience/system responsiveness, not an effect size quantifiable in an MRMC study.

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

The software changes involve control algorithms that directly influence the physical operation of the surgical system, which is inherently a human-in-the-loop device. While "unit testing" of algorithms was performed, it's not a standalone diagnostic performance evaluation in the usual AI/ML sense. The performance is tied to the integrated system and surgeon interaction.

7. The Type of Ground Truth Used:

For system control algorithms, "ground truth" would be derived from engineering specifications, sensor data, and observed mechanical stability/responsiveness. The document mentions:

"System control algorithms were verified by unit testing" (likely against predefined specifications).
"Verification of surgeon control mode accuracy and fault distances" (against engineering tolerances).
"Verification of joint controller performance" (against design specifications).
"Validation testing using an animal model" (real-world performance observed by experts).

8. The Sample Size for the Training Set:

Not applicable. This is not an AI/ML device that learns from a "training set" of data in the conventional sense (e.g., image datasets). The software updates are based on control engineering principles, not machine learning from a large dataset.

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

Not applicable. There is no training set in the context of this device's software.

In summary, this FDA clearance document describes a software update for a robotic surgical system. The review process is focused on demonstrating that the changes maintain the safety and effectiveness of the device and its substantial equivalence to a predicate, rather than detailing the performance of an AI/ML algorithm against a diagnostic ground truth dataset.

Summary

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June 23, 2021

Intuitive Surgical, Inc. Connor McCarty Sr. Regulatory Engineer 1266 Kifer Road Sunnyvale, California 94086

Re: K211595

Trade/Device Name: da Vinci SP Surgical System (SP1098) Regulation Number: 21 CFR 876.1500 Regulation Name: Endoscope And Accessories Regulatory Class: Class II Product Code: NAY Dated: May 20, 2021 Received: May 24, 2021

Dear Connor Mccarty:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act and the limitations described below. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at

https://www.accessdata.fda.gov/scripts/cdth/cfdocs/cfpmn/pmn.cfm identifies.combination.product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

The OHT4: Office of Surgical and Infection Control Devices has determined that there is a reasonable likelihood that this device will be used for an intended use not identified in the proposed labeling and that such use could cause harm. Therefore, in accordance with Section 513(i)(1)(E) of the Act, the following limitation must appear in the device's labeling:

The safety and effectiveness of this device for use in the performance of general laparoscopic surgery procedures have not been established. This device is only intended to be used for single port

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urological procedures and for transoral otolaryngology surgical procedures in the oropharynx for benign tumors and malignant tumors classified as T1 and T2 with the da Vinci EndoWrist SP Instruments and the da Vinci SP Surgical System (SP1098).

Please note that the above labeling limitations are required by Section 513(i)(1)(E) of the Act. Therefore, a new 510(k) is required before these limitations are modified in any way or removed from the device's labeling.

The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and permits your device to proceed to the market. This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification if the limitation statement described above is added to your labeling.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21. Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medical

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devices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely.

For Binita Ashar, M.D., M.B.A., F.A.C.S. Director OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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Indications for Use

Submission Number (if known)

K211595

Device Name

da Vinci SP Surgical System (SP1098)

Indications for Use (Describe)

Da Vinci SP Surgical System, Model SP1098:

The Intuitive Surgical Endoscopic Instrument Control System (da Vinci SP Surgical System, Model SP1098) is intended to assist in the accurate control of Intuitive Surgical EndoWrist SP Instruments during urologic surgical procedures that are appropriate for a single port approach and transoral otolaryngology surgical procedures in the oropharvnx restricted to benign tumors and malignant. tumors classified as T1 and T2. The system is indicated for adult 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.

EndoWrist SP Instruments:

Type of Use (Select one or both, as applicable)

Prescription Use (Part 21 CFR 801 Subpart D)

Over-The-Counter Use (21 CFR 801 Subpart C)

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510(k) Summary

[As Required by 21 CFR 807.92(c)]

June 14, 2021

Submitter:	Intuitive Surgical, Inc.1266 Kifer RoadSunnyvale, CA 94086
Official Contact:	Connor McCartySr. Regulatory EngineerPhone: 805-798-4205Fax: 408-523-8907
Trade Name:	Da Vinci SP Surgical System
Common Name:	Endoscope and accessories
Classification:	System, surgical, computer controlled instrument
Predicate Device:	Da Vinci SP Surgical System (K202968)

Device Description:

The design modifications included in this submission are limited to updated system software, specifically changes to the control algorithms to damp system structural vibrations.

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Intended Use/Indications for Use:

Da Vinci SP Surgical System, Model SP1098:

EndoWrist SP Instruments:

Intuitive Surgical EndoWrist SP Instruments are controlled by the da Vinci SP Surgical System, Model SP1098, and include flexible endoscopes, blunt and sharp endoscopic dissectors, 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, and suturing through a single port. The system is indicated for urologic surgical procedures that are appropriate for a single port approach and transoral otolaryngology surgical procedures in the oropharynx restricted to benign tumors classified as T1 and T2. The system is indicated for adult 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.

Indications for Use Comparison:

The indications for use are unchanged from the previously-cleared version of the system (K202968).

Technological Comparison:

The technological differences from the most recent clearance (K202968) are limited to the system software, specifically changes to the control algorithms to damp system structural vibrations. The enhanced control algorithms decrease the settling time of the surgeon transitions between control modes, so that the endoscope view and instruments stabilize more quickly after moving. The algorithm does not impact the physical feel of the surgeon's manipulations at the Surgeon Console, nor the feel of a user clutching the Instrument Arm on the Patient Cart. These modifications do not affect the substantial equivalence of the subject device to the predicate, as verification and validation testing have established there are no new issues of safety or effectiveness.

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Non-Clinical and/or Clinical Tests Summary & Conclusions:

Regression testing of the software was performed to verify that the embedded software and user interface continued to meet specifications. The system control algorithms were verified by unit testing, the verification of surgeon control mode accuracy and fault distances, and the verification of joint controller performance. Validation testing using an animal model was performed to confirm that the system continued to meet its acceptance criteria for safe and effective use.

Verification and validation testing on the subject device confirmed that no issues of safety or effectiveness and no additional unexpected risks were identified. The subject device met the same acceptance criteria as the predicate device. Therefore, the test results demonstrate that the subject device is substantially equivalent to its predicate device.

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Regulation Number and Section

§ 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.