Predicate Devices

Reference Devices

AI/ML (Artificial Intelligence / Machine Learning)

No
The document describes a robotic surgical system with image processing capabilities but does not mention or imply the use of AI or ML for decision-making, image analysis beyond basic processing, or control algorithms. The focus is on surgeon control and mechanical manipulation.

Therapeutic

Yes
The device is a surgical system intended to assist in the accurate control of surgical instruments during various surgical procedures, which directly supports the treatment or management of diseases/conditions.

Diagnostic

No

The device is described as a surgical system intended to assist in the control of surgical instruments for performing procedures, not for diagnosing conditions. While it captures images that aid the surgeon, its primary function is intervention, not diagnosis.

SaMD (Software as a Medical Device)

No

The device description clearly outlines hardware components including a Surgeon Console, Vision Cart, and Patient Cart, in addition to instruments and accessories. This is not a software-only device.

IVD (In Vitro Diagnostic)

Based on the provided information, the Intuitive Surgical Endoscopic Instrument Control System (da Vinci SP Surgical System, Model SP1098) is not an In Vitro Diagnostic (IVD) device.

Here's why:

Intended Use: The intended use clearly states that the system is intended to assist in the accurate control of surgical instruments during surgical procedures. It is a tool used during surgery to manipulate tissues and perform surgical tasks.
Device Description: The description details a robotic system with a surgeon console, vision cart, and patient cart that controls surgical instruments and a camera. This is consistent with a surgical assistance system, not a device used to examine specimens in vitro.
Lack of IVD Characteristics: There is no mention of the device being used to test or analyze biological specimens (blood, tissue, urine, etc.) outside of the body. The system's function is to facilitate surgical intervention within the body.
Performance Studies: The performance studies focus on surgical outcomes, adverse events during and after surgery, and the ability to perform surgical tasks in cadaver and animal models, and in clinical trials on human subjects undergoing surgery. These are typical performance metrics for surgical devices, not IVDs.

In summary, the da Vinci SP Surgical System is a surgical robotic system designed to aid surgeons in performing minimally invasive procedures. It does not perform tests on biological samples in vitro, which is the defining characteristic of an IVD.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

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 and general thoracoscopic 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 and general thoracoscopic 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.

Product codes

NAY

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 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.

This 510(k) is for a labeling modification only, to add "general thoracoscopic surgical procedures" to the indications, and to add "lobectomy, segmentectomy, wedge resection, segmentectomy, lymphadenectomy, thymectomy, and mediastinal mass resection" as new representative, specific procedures in the Professional Instructions for Use.

Mentions image processing

Yes

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

oropharynx, urologic, general thoracoscopic

Indicated Patient Age Range

adult

Intended User / Care Setting

trained physicians in an operating room environment

Description of the training set, sample size, data source, and annotation protocol

Not Found

Description of the test set, sample size, data source, and annotation protocol

Comparative animal and cadaver testing was conducted to demonstrate the equivalence of the SP1098 System to the multiport da Vinci Xi system, Model IS4000 for performing thoracoscopic surgical procedures. Cadavers were used to demonstrate device performance for anatomical access and reach. Live animals were used to assess safety and performance in cases where live tissue model was appropriate. These models replicate factors experienced during normal clinical use, including operating on perfused organs, normal tissue manipulation, and ensuring that appropriate hemostasis is achieved and maintained.

Three (3) independent practicing surgeons participated in a pre-clinical study using the SP1098 system to perform a set of general thoracoscopic surgical procedures. Each surgeon performed five (5) procedures in a cadaver model and one (1) procedure in a porcine model, for a total of 18 surgical procedures performed. Success criteria for each procedure are listed in Table 1. In addition, surgeons completed questionnaires that evaluated their ability to perform surgical tasks of the SP1098 and the multiport system, IS4000, which is cleared for use in general thoracoscopic surgical procedures (K153276) and serves as a reference device for this 510(k).

A prospective, multicenter, single-arm, clinical study was conducted to confirm the preclinical safety and performance of SP1098 da Vinci Surgical System, Instruments, and Accessories in general thoracoscopic surgical procedures. This study also confirms that use of the SP1098 system in thoracoscopic surgical procedures does not raise different questions of safety or effectiveness. The study included 32 subjects at six (6) institutions in the United States and 13 thymectomy procedures and 19 lobectomy procedures were performed.

Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)

Pre-clinical study type: Comparative animal and cadaver testing.
Pre-clinical study sample size: 18 surgical procedures performed by 3 surgeons.
Pre-clinical study key results: The study demonstrated equivalence of the SP1098 System to the multiport da Vinci Xi system for thoracoscopic procedures. Success criteria for each procedure were met.

Clinical study type: Prospective, multicenter, single-arm.
Clinical study sample size: 32 subjects (13 thymectomy, 19 lobectomy) at 6 institutions in the United States.
Clinical study key results:
Safety was demonstrated by incidence of intra-operative and post-operative adverse events reported through 30-day follow-up. Performance was demonstrated by the rate of conversion from da Vinci SP surgery to open, VATS, or multi-port robotic surgery.

Device-related adverse event rate was 0%.
No conversions were reported.
The study met its safety and performance endpoints.

Thymectomy Results:

All 13 thymectomy procedures completed using da Vinci SP Surgical System without conversion. Conversion rate 0%.
No intraoperative adverse events, no unanticipated device-related adverse effects (UADE), no serious adverse events (SAE).
4 subjects experienced 5 AEs, all classified as minor (Clavien-Dindo Grade I and II). None deemed device-related.

Lobectomy Results:

All 19 lobectomy procedures completed using da Vinci SP Surgical System without conversion. Conversion rate 0%.
No intraoperative adverse events, no unanticipated device-related adverse effects (UADE).
9 subjects experienced at least one adverse event, 4 subjects experienced Serious Adverse Events (SAEs) (Clavien Dindo Grade IIIa or higher). None deemed device-related.

Comparison to literature on Multiport Robotic-assisted Thoracic Surgery:

Comparison of results from da Vinci SP Surgical System to published clinical literature on multiport robotic systems for thymectomy and lobectomy procedures (2010-2022).
The 95% confidence intervals for all 12 clinical parameters in the SP study overlap the 95% CIs calculated from the published clinical literature on da Vinci Multiport systems for both thymectomy and lobectomy.
This comparison demonstrates that the da Vinci SP Surgical System is as safe and effective as the predicate device and does not raise different questions of safety or effectiveness.

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Thymectomy Results (N=13):

Operative time (minutes), mean ± SD: 193.3 ± 56.51
Estimated blood loss (mL), mean ± SD: 11.9 ± 12.66
Blood transfusion rate, %: 0
Conversion rate, %: 0
Device-related adverse event rate, %: 0
Intraoperative adverse event rate, %: 0
Subjects with major AE (Clavien-Dindo Grade III/IV/V), n (%): 0
Subjects with minor AE (Clavien-Dindo Grade I/II), n (%): 4 (30.8%)
Length of hospital stay (days), mean ± SD: 1.6 ± 0.51
Rate of positive surgical margin, %, n=7: 0
Readmission rate, %: 0
Reoperation rate, %: 0
Mortality rate %: 0

Lobectomy Results (N=19):

Operative time (min), mean ± SD: 229.6 ± 64.14
Estimated blood loss (mL), mean ± SD: 47.9 ± 47.41
Transfusion rate, %: 0
Conversion to open rate, %: 0
Device-related adverse event rate, %: 0
Intraoperative adverse event, %: 0
Subjects with major adverse events, AE (Clavien-Dindo Grade III/IV/V), n (%): 3 (15.8%)
Subjects with Minor adverse events, AE (Clavien-Dindo Grade I/II), n (%): 6 (31.6%)
Length of hospital stay (days), mean ± SD: 3.8 ± 1.60
Rate of positive surgical margins, n (%): 0
Readmission rate, n (%): 1 (5.3%)
Reoperation rate %: 0
Mortality rate, %: 0

Predicate Device(s)

K231798

Reference Device(s)

K153276

Predetermined Change Control Plan (PCCP) - All Relevant Information

Not Found

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.

Summary

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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

8 July 2024

Intuitive Surgical Inc. Mike Yramategui Fellow Regulatory Engineer 1020 Kifer Road Sunnyvale, California 94086

Re: K240502

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: June 3, 2024 Received: June 3, 2024

Dear Mike Yramategui:

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 (the 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 available at

https://www.accessdata.fda.gov/scripts/cdrh/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

1

urological and general thoracoscopic surgical 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.

Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).

Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).

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 Part 803) for devices or postmarketing safety reporting (21 CFR Part 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 Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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.

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

Barton Sachs -S 2024.07.08 17:08:09 -04'00' Barton L. Sachs, M.D., MBA, F.A.C.S. 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

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Indications for Use

Submission Number (if known)

K240502

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 and general thoracoscopic 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 and general thoracoscopic 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.

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 [21 CFR § 807.92(c)]

SUBMITTER INFORMATION I.

| Submitter: | Intuitive Surgical, Inc.
1266 Kifer Road
Sunnyvale, CA 94086 |
|------------|--------------------------------------------------------------------|
| Contact: | Mike Yramategui |
| | Fellow Regulatory Engineer |
| | Phone Number: 408-523-2145 |
| | Fax Number: 408-523-8907 |
| | Email: Mike.Yramategui@intusurg.com |

Date Summary Prepared: July 1, 2024

SUBMITTER INFORMATION II.

| Trade Name: | da Vinci SP® Surgical System, Model SP1098,
EndoWrist SP® Instruments, and Accessories |
|----------------------|-------------------------------------------------------------------------------------------|
| Common Name: | System, Surgical, Computer Controlled Instrument |
| Classification Name: | Endoscope and Accessories (21 CFR §876.1500) |
| Regulatory Class: | Class II |
| Product Code: | NAY (System, Surgical, Computer Controlled Instrument) |
| Submission Type: | Traditional 510(k) |

III. PREDICATE DEVICE INFORMATION

| Predicate Device: | da Vinci SP Surgical System, Model SP1098,
EndoWrist SP Instruments, and Accessories (K231798) |
|-------------------|---------------------------------------------------------------------------------------------------|
| Reference Device: | da Vinci Xi Surgical System, Model IS4000,
EndoWrist Instruments, and Accessories (K153276) |

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IV. 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 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.

This 510(k) is for a labeling modification only, to add "general thoracoscopic surgical procedures" to the indications, and to add "lobectomy, segmentectomy, wedge resection, segmentectomy, lymphadenectomy, thymectomy, and mediastinal mass resection" as new representative, specific procedures in the Professional Instructions for Use.

INDICATIONS FOR USE

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 and general thoracoscopic 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

6

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 and general thoracoscopic 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

COMPARISON OF INTENDED USE, INDICATIONS FOR USE AND V. TECHNOLOGAL CHARACTERISTICS WITH THE PREDICATE DEVICE

The da Vinci SP Surgical System, Model SP1098 and EndoWrist SP Instruments and Accessories are unchanged from the predicate device in terms of intended use, design, performance, and technological characteristics. The labeling has been changed to add "general thoracoscopic surgical procedures" to the indication statement and to add "lobectomy, segmentectomy, wedge resection, segmentectomy, lymphadenectomy, thymectomy, and mediastinal mass resection" as new representative, specific procedures in the Professional Instructions for Use.

VI. PERFORMANCE DATA

The addition of general thoracoscopic surgical procedures to the SP1098 Indications does not change any of the safety or performance requirements that were previously verified and / or validated for the SP1098 regarding cleaning, sterilization, packaging, shelf life, biocompatibility, software, cybersecurity, electrosurgical performance, electromagnetic compatibility, electrical safety, mechanical and electrical performance, reliability, or human factors for use in urologic (K173906) and transoral surgery (K182371).

Cadaver and Animal Performance Testing

Comparative animal and cadaver testing was conducted to demonstrate the equivalence of the SP1098 System to the multiport da Vinci Xi system, Model IS4000 for performing thoracoscopic surgical procedures. Cadavers were used to demonstrate device performance for anatomical access and reach. Live animals were used to assess safety and performance in cases where live tissue model was appropriate. These models replicate factors experienced during normal clinical use, including operating on perfused organs, normal tissue manipulation, and ensuring that appropriate hemostasis is achieved and maintained.

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Three (3) independent practicing surgeons participated in a pre-clinical study using the SP1098 system to perform a set of general thoracoscopic surgical procedures. Each surgeon performed five (5) procedures in a cadaver model and one (1) procedure in a porcine model, for a total of 18 surgical procedures performed. Success criteria for each procedure are listed below (Table 1). In addition, surgeons completed questionnaires that evaluated their ability to perform surgical tasks of the SP1098 and the multiport system, IS4000, which is cleared for use in general thoracoscopic surgical procedures (K153276) and serves as a reference device for this 510(k).

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Table 1

| Surgical

Procedure	Subject	Procedure Completion Acceptance Criteria
Right Upper
Lobectomy with
Lymphadenectomy	Cadaver	• Complete right upper lobe hilar dissection
• Sufficient lymph node dissection
• Exposure of vasculature, airway, and fissure for division
complete and deemed surgically acceptable upon visual
inspection
• Suture closure of proximal bronchial stump complete and deemed
surgically acceptable upon visual inspection
• Critical anatomy identified
Right Lower
Lobectomy with
Lymphadenectomy	Cadaver	• Complete right lower lobe hilar dissection
• Sufficient lymph node dissection
• Exposure of vasculature, airway, and fissure for division
complete and deemed surgically acceptable upon visual
inspection
• Critical anatomy identified
Left Upper
Lobectomy with
Lymphadenectomy	Cadaver	• Complete left upper lobe hilar dissection
• Sufficient lymph node dissection
• Exposure of vasculature, airway, and fissure for division
complete and deemed surgically acceptable upon visual
inspection
• Critical anatomy identified
Left Lower
Lobectomy with
Lymphadenectomy	Cadaver	• Complete left lower lobe hilar dissection
• Sufficient lymph node dissection
• Exposure of vasculature, airway, and fissure for division
complete and deemed surgically acceptable upon visual
inspection
• Critical anatomy identified
Thymectomy	Cadaver	• Sufficient mobilization of thymic tissue
• Sufficient lateral dissection boundaries reached
• Critical anatomy identified
• Appropriate vessel ligation
Right Upper
Lobectomy	Porcine	• Complete right upper lobe hilar dissection
• Sufficient lymph node dissection
• Exposure of vasculature, airway, and fissure for division
complete and deemed surgically acceptable upon visual
inspection
• Suture closure of proximal bronchial stump complete and deemed
surgically acceptable upon visual inspection
• Hemostasis maintained

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Clinical Study

A prospective, multicenter, single-arm, clinical study was conducted to confirm the preclinical safety and performance of SP1098 da Vinci Surgical System, Instruments, and Accessories in general thoracoscopic surgical procedures. This study also confirms that use of the SP1098 system in thoracoscopic surgical procedures does not raise different questions of safety or effectiveness. The study included 32 subjects at six (6) institutions in the United States and 13 thymectomy procedures and 19 lobectomy procedures were performed.

Safety was demonstrated by the incidence of intra-operative and post-operative adverse events reported through the 30-day follow-up. Performance was demonstrated by the rate of conversion from da Vinci SP surgery to an open, video-assisted thoracoscopic surgery (VATS), or a multi-port robotic (da Vinci Si/X/Xi) surgery. Results show that the devicerelated adverse event rate was 0% and there were no conversions. The study met its safety and performance endpoints.

Thymectomy Results

Thirteen (13) subjects were enrolled in the study for thymectomy for benign (N=6) and malignant conditions (N=7). Forty-six percent (46.2%) of thymectomy subjects enrolled in the study had at least one comorbidity, with hypertension being the most prevalent (83.3%). In addition, 33.3% of subjects had a prior history of cancer, and 16.7% had COPD.

All thymectomy procedures in the study were completed using a da Vinci SP Surgical System without conversion to open, VATS, or multiport robotic-assisted surgery, therefore, the conversion rate is 0% in the study for in the thymectomy cohort.

There were no intraoperative adverse events and no unanticipated device-related adverse effects (UADE) and no serious adverse events (SAE) reported. A total of four (4) subjects experienced 5 AEs with all of the AEs classified as minor (Clavien-Dindo Grade I and II) and no adverse event was classified as "Major" (Clavien-Dindo Grade III or higher). None (0) of the adverse events were deemed to be device related. Table 2 summarizes the study results and Table 3 lists the adverse events reported in the lobectomy cohort.

Table 2 summarizes the study data and Table 3 provides a list of the adverse events reported in the thymectomy cohort.

10

| Clinical Study Parameter | Study Data
K240502 |
|----------------------------------------------------------------|-----------------------|
| Number of Subjects, n | 13 |
| Operative time (minutes), mean ± SD | 193.3 ± 56.51 |
| Estimated blood loss (mL), mean ± SD | 11.9 ± 12.66 |
| Blood transfusion rate, % | 0 |
| Conversion rate, % | 0 |
| Device-related adverse event rate, % | 0 |
| Intraoperative adverse event rate, % | 0 |
| Subjects with major AE
(Clavien-Dindo Grade III/IV/V, n (%) | 0 |
| Subjects with minor AE
(Clavien-Dindo Grade I/II), n (%) | 4 (30.8%) |
| Length of hospital stay (days), mean ± SD | 1.6 ±0.51 |
| Rate of positive surgical margin, %, n= 7 | 0 |
| Readmission rate, % | 0 |
| Reoperation rate, % | 0 |
| Mortality rate% | 0 |

Table 2. Results Summary (Thymectomy)

Table 3. Postoperative Adverse Events (Thymectomy)

Type	Total study N= 13
Subjects experiencing AEs	4
Total Number of AEs	5
Minor (Clavien-Dindo Grade I/II)
Corneal abrasion	1
Delayed phrenic nerve, elevated left hemidiaphragm	1
Fatigue	1
Neuropathy	1
Pleural effusion	1

Lobectomy Results

Nineteen (19) subjects were enrolled in the study for lobectomy. Of these 19 subjects, 18 (94.7%) were malignant indications and 1 (5.3%) was for a benign indication. Seventyfour percent (73.7%) of lobectomy subjects had at least one comorbidity, with hypertension being the most prevalent comorbidity within the population of subjects (57.1%). In addition, 35.7% of the subjects had a prior history of cancer, 35.7% had COPD, 28.6% had diabetes, and 7.1% had cardiopulmonary disease and 7.1% had a history of cerebrovascular accidents.

All lobectomy procedures in the study were completed using a da Vinci SP Surgical System without conversion to open, VATS, or multiport robotic-assisted surgery, therefore, the conversion rate is 0% in the study for in the lobectomy cohort.

11

There were no intraoperative adverse events and no unanticipated device-related adverse effects (UADE) . Nine (9) subjects experienced at least one adverse event of which 4 subjects experienced Serious Adverse Events (SAEs), classified as "major" (Clavien Dindo Grade IIIa or higher). None (0) of the adverse events were deemed to be device related. Table 4 summarizes the study results and Table 5 lists the adverse events reported in the lobectomy cohort.

| Clinical Study Parameter | Study Data
K240502 |
|---------------------------------------------------------------------------------|-----------------------|
| Number of Subjects, n | 19 |
| Operative time (min), mean ± SD | 229.6 ± 64.14 |
| Estimated blood loss (mL), mean ± SD | 47.9 ± 47.41 |
| Transfusion rate, % | 0 |
| Conversion to open rate, % | 0 |
| Device-related adverse event rate, % | 0 |
| Intraoperative adverse event, % | 0 |
| Subjects with major adverse events, AE
(Clavien-Dindo Grade III/IV/V), n (%) | 3 (15.8%) |
| Subjects with Minor adverse events, AE
(Clavien-Dindo Grade I/II), n (%) | 6 (31.6%) |
| Length of hospital stay (days), mean ± SD | 3.8 ± 1.60 |
| Rate of positive surgical margins, n (%) | 0 |
| Readmission rate, n (%)* | 1 (5.3%) |
| Reoperation rate% | 0 |
| Mortality rate, % | 0 |

Table 4. Results Summary (Lobectomy)
--------------------------------------	--	--

1 subject had re-admission related to the AE

Table 5. Postoperative Adverse Events (Lobectomy)

Type	Total study N=19
Subjects experiencing AEs	9
Total number of AEs	13
Minor (Clavien-Dindo Grade I/II)
Air leakage (extended chest tube duration)	1
Constipation	1
Exacerbation of pre-existing COPD	1
Fatigue	1
Hypoglycemia	1
Neuropathy	1
Pain/dyspnea associated with chest tube	1
Pneumothorax	1
Urinary retention	1
Major (Clavien-Dindo Grade III/IV)
Acute Respiratory Failure	1
Air leakage (new chest tube or bronchial valve placed)	2
Atelectasis	1

12

Comparison of da Vinci SP Study Results to Literature on Multiport Roboticassisted Thoracic Surgery

Results of this study of da Vinci SP were compared to recently published clinical literature between 2010 and 2022 on multiport robotic systems for thymectomy and lobectomy procedures. The multiport robotic system, IS4000, serves as a reference device for this comparison. Systematic literature searches were done for thymectomy. and lobectomy published literature in this time period, were conducted according to PRISMA (Preferred Reporting Items for Systematic Reviews and Meta-Analyses) methods. Table 6 summarizes the comparison in thymectomies. Table 7 summarizes the comparison in lobectomies. Each parameter from the literature is shown based on the pooled sample size from multiple publications and 95% confidence interval based on estimated weighted average and weighted standard deviation from multiple publications. Table 8 provides a bibliography of the literature on multiport articles used for the comparison.

Comparison of the results from the da Vinci SP Surgical System to the published literature demonstrate that the 95% confidence intervals for all 12 clinical parameters in the SP study overlap the 95% Cls calculated from the published clinical literature on da Vinci Multiport systems for both thymectomy and lobectomy. This comparison demonstrates that the da Vinci SP Surgical System is as safe and effective as the predicate device and does not raise different questions of safety or effectiveness.

| Clinical Study Parameter |-------------------------------|------- | Operative time | | Sample Size | N = 13 | Mean +- SE | 193.3 +- 15.67 | 95% CI | [159.16, 227.46] | Length of stay | | Sample Size | N = 13 | Mean +- SE | 1.6 +- 0.14 | 95% CI | [1.31, 1.92] | Estimated blood loss | | Sample Size | N = 13 | Mean +- SE | 11.9 +- 3.51 | 95% CI | [4.24, 19.53] | Intra-operative adverse event | | Sample Size | N = 13 | Proportion | 0.0% | 95% CI | [0%, 24.71%] | Major adverse event rate | | (Clavien-Dindo III and IV) | | Sample Size | N = 13 | Study Data
target="_blank" rel="noopener noreferrer" class="text-primary hover:underline break-words">K240502 | da Vinci Multi
----------------|-----------------------------------|
| |
| N = 919 |
| 133.1 +- 9.05 |
| [114.16, 152.03] |
| |
| N = 1897 |
| 3.6 +- 0.28 |
| [3.02, 4.17] |
| |
| N = 520 |
| 63.95 +- 7.84 |
| [46.69, 81.21] |
| |
| N = 73 |
| 4.1% |
| [0.58%, 7.58%] |
| |
| |
| N = 185 |

Table 6. da Vinci SP Thymectomy versus da Vinci Multiport Literature Comparison

13

| Clinical Study Parameter | Study Data
K240502 | da Vinci Multi-
port Literature |
|------------------------------------------------------|-----------------------|------------------------------------|
| Proportion | 0.0% | 1.6% |
| 95% CI | [0%, 24.71%] | [0%, 4.75%] |
| Minor adverse event rate
(Clavien/Dindo I and II) | | |
| Sample Size | N = 13 | N = 144 |
| Proportion | 30.8% | 4.2% |
| 95% CI | [9.09%, 61.43%] | [0%, 18.84%] |
| Transfusion rate | | |
| Sample Size | N = 13 | N = 126 |
| Proportion | 0% | 0% |
| 95% CI | [0%, 24.71%] | NA |
| Conversion rate | | |
| Sample Size | N = 13 | N = 1322 |
| Proportion | 0.00% | 3.4% |
| 95% CI | [0%, 24.71%] | [2.03%, 4.72%] |
| Mortality rate | | |
| Sample Size | N = 13 | N = 1778 |
| Proportion | 0.00% | 0.3% |
| 95% CI | [0%, 24.71%] | [0.04%, 0.51%] |
| Readmission rate | | |
| Sample Size | N = 13 | N = 576 |
| Proportion | 0.00% | 3.8% |
| 95% CI | [0%, 24.71%] | [0%, 13.02%] |
| Reoperation rate | | |
| Sample Size | N = 13 | N = 256 |
| Proportion | 0% | 0.5% |
| 95% CI | [0%, 24.71%] | [0%, 2.04%] |

Table 7. da Vinci SP Lobectomy versus da Vinci Multiport Literature Comparison

| Clinical Parameter | SP Thoracic
Lobectomy Data
K240502 | da Vinci Multi-port
Literature |
|--------------------------------------------------------|------------------------------------------|-----------------------------------|
| Operative time | | |
| Sample Size | N = 19 | N = 9482 |
| Mean +- SE | 229.6 +- 14.71 | 255.7 +- 10.68 |
| 95% CI | [198.72, 260.55] | [233.05, 278.35] |
| Length of stay (days) | | |
| Sample Size | N = 19 | N = 94381 |
| Mean +- SE | 3.8 +- 1.02 | 4.98 +- 0.18 |
| 95% CI | [1.70, 5.98] | [4.61, 5.35] |
| Estimated blood loss | | |
| Sample Size | N = 19 | N = 381 |
| Mean +- SE | 47.9 +- 10.88 | 91.9 +- 7.90 |
| 95% CI | [25.04, 70.75] | [66.76, 117.03] |
| Clinical Parameter | SP Thoracic
Lobectomy Data
K240502 | da Vinci Multi-port
Literature |
| Intra-operative adverse event rate | | |
| Sample Size | N = 19 | N = 7637 |
| Proportion | 0% | 3.84% |
| 95% CI | [0%, 17.65%] | [2.65%, 5.03%] |
| Major adverse event rate
(Clavien-Dindo III and IV) | | |
| Sample Size | N = 19 | N = 2581 |
| Proportion | 15.8% | 7.06% |
| 95% CI | [3.38%, 39.58%] | [1.48%, 12.65%] |
| Minor adverse event rate
(Clavien/Dindo I and II) | | |
| Sample Size | N = 19 | N = 2581 |
| Proportion | 31.64% | 35.27% |
| 95% CI | [20.25%, 66.50%] | [27.10%, 43.44%] |
| Transfusion rate | | |
| Sample Size | N = 19 | N = 20447 |
| Proportion | 0% | 2.80% |
| 95% CI | [0%, 17.65%] | [0.78%, 4.82%] |
| Conversion rate | | |
| Sample Size | N = 19 | N = 9684 |
| Proportion | 0% | 6.6% |
| 95% CI | [0%, 17.65%] | [5.47%, 7.75%] |
| Mortality rate | | |
| Sample Size | N = 19 | N = 69004 |
| Proportion | 0% | 1.25% |
| 95% CI | [0%, 17.65%] | [1.05%, 1.45%] |
| Readmission rate | | |
| Sample Size | N = 19 | N = 37972 |
| Proportion | 5.3% | 5.57% |
| 95% CI | [0.13%, 26.03%] | [4.54%, 6.60%] |
| Reoperation rate | | |
| Sample Size | N = 19 | N = 9420 |
| Proportion | 0% | 2.75% |
| 95% CI | [0%, 17.65%] | [1.50%, 4.00%] |

14

Exact 95% confidence intervals are provided for 9 discrete variables of the 12 parameters in the da Vinci SP system study.

The 95% confidence intervals for 9 discrete variables from the literature data are based on pooled proportions and exact method. The 95% confidence intervals for 3 continuous variables of the 12 variables from the literature data are based on weighted averages and weighted standard deviations where the sample means and standard deviations for each publication are taken as reported or estimated using quantiles as reported (McGrath et al. 2020).

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VII. CONCLUSION

The Performance test data demonstrates that the ability of the subject device (SP1098) to perform general thoracoscopic surgical procedures, lobectomy and thymectomy. The Clinical Study results confirm that there are no different issues of safety or effectiveness as compared to the multiport IS4000 system when performing general thoracoscopic surgical procedures, lobectomy and thymectomy.

Thus, these labeling changes to the da Vinci SP Surgical System are substantially equivalent to the cleared predicate device.

16

Table 8. Bibliography of Clinical Literature on da Vinci Multiport Thymectomy

Azenha, L. F., R. Deckarm, F. Minervini, P. Dorn, J. Lutz and G. J. Kocher (2021). "Robotic vs. 1. Transsternal Thymectomy: A Single Center Experience over 10 Years." J Clin Med 10(21).
1. Burt, B. M., X. Yao, J. Shrager, A. Antonicelli, S. Padda, J. Reiss, H. Wakelee, S. Su, J. Huang and W. Scott (2017). "Determinants of Complete Resection of Thymoma by Minimally Invasive and Open Thymectomy: Analysis of an International Registry." J Thorac Oncol 12(1): 129-136.
Casiraghi, M., D. Galetta, A. Borri, A. Tessitore, R. Romano, D. Brambilla, P. Maisonneuve and L. 3. Spaggiari (2018). "Robotic-assisted thymectomy for early-stage thymoma: a propensity-score matched analysis." J Robot Surg 12(4): 719-724.
1. Chiba, Y., M. Miyajima, Y. Takase, K. Tsuruta, Y. Shindo, Y. Nakamura, D. Ishii, T. Sato, M. Aoyagi, T. Shiraishi, T. Sonoda and A. Watanabe (2022). "Robot-assisted and video-assisted thoracoscopic surgery for thymoma: comparison of the perioperative outcomes using inverse probability of treatment weighting method." Gland Surgery 11(8): 1287-1300.
న్. El-Akkawi, A. I. and J. Eckardt (2021). "Comparison of surgical outcomes after robotic assisted thoracic surgery, video-assisted thoracic surgery and open resection of thymoma." Mediastinum 5: 11l 1 .
1. Holleran, T. J., M. A. Napolitano, H. R. Crowder, A. D. Sparks, J. L. Antevil and G. D. Trachiotis (2022). "Clinical Outcomes and Technical Approach of Thymectomy in the Veterans Health Administration." Ann Thorac Surg 113(5): 1648-1655.
1. Imielski, B., C. Kurihara, A. Manerikar, S. Chaudhary, S. Kosterski, D. Odell, S. Kim and A. Bharat (2020). "Comparative effectiveness and cost-efficiency of surgical approaches for thymectomy." Surgery (United States) 168(4): 737-742.
Jiang, B., Q. Y. Tan, B. Deng, L. Y. Mei, Y. D. Lin and L. F. Zhu (2023). "Robot-assisted thymectomy 8. in large anterior mediastinal tumors: A comparative study with video-assisted thymectomy and open surgery." Thorac Cancer 14(3): 267-273. Epub: 11/27/2022.
Jun, Y., L. Hao, L. Demin, D. Guohua, J. Hua and S. Yi (2014). "Da Vinci robot-assisted system for 9. thymectomy: experience of 55 patients in China." Int J Med Robot 10(3): 294-299.
1. Kamel, M. K., J. Villena-Vargas, M. Rahouma, B. Lee, S. Harrison, B. M. Stiles, A. M. Abdelrahman, N. K. Altorki and J. L. Port (2019). "National trends and perioperative outcomes of robotic resection of thymic tumours in the United States: a propensity matching comparison with open and video-assisted thoracoscopic approaches." Eur J Cardiothorac Surg 56(4): 762-769.
1. Kamel, M. K., M. Rahouma, B. M. Stiles, A. Nasar, N. K. Altorki and J. L. Port (2017). "Robotic Thymectomy: Learning Curve and Associated Perioperative Outcomes." J Laparoendosc Adv Surg Tech A 27(7): 685-690.
1. Kang, C. H., Y. Hwang, H. J. Lee, I. K. Park and Y. T. Kim (2016). "Robotic Thymectomy in Anterior Mediastinal Mass: Propensity Score Matching Study With Transsternal Thymectomy." Ann Thorac Surg 102(3): 895-901.
1. Kauppi, J., S. Atula, D. Strbian, E. Robinson, H. Alho, E. Sihvo, I. Ilonen and J. Räsänen (2020). "Improvement in symptom rate following robotic thymectomy in patients with myasthenia gravis." Interactive cardiovascular and thoracic surgery 30(6): 827-833.
1. Kneuertz, P. J., M. K. Kamel, B. M. Stiles, B. E. Lee, M. Rahouma, A. Nasar, N. K. Altorki and J. L. Port (2017). "Robotic Thymectomy Is Feasible for Large Thymomas: A Propensity-Matched Comparison." Ann Thorac Surg 104(5): 1673-1678.
1. Li, X. K., Y. Xu, Z. Z. Cong, H. Zhou, W. J. Wu and Y. Shen (2020). "Comparison of the progressionfree survival between robot-assisted thymectomy and video-assisted thymectomy for thymic epithelial tumors: a propensity score matching study." J Thorac Dis 12(8): 4033-4043.
1. Luzzi, L., R. Corzani, M. Ghisalberti, F. Meniconi, L. De Leonibus, F. Molinaro and P. Paladini (2021). "Robotic surgery vs. open surgery for thymectomy, a retrospective case-match study." Journal of Robotic Surgery 15(3): 375-379.
1. Marulli, G., G. M. Comacchio, M. Schiavon, A. Rebusso, M. Mammana, D. Zampieri, E. Perissinotto and F. Rea (2018). "Comparing robotic and trans-sternal thymectomy for early-stage thymoma: a propensity score-matching study." Eur J Cardiothorac Surg 54(3): 579-584.
1. Minervini. F., L. Boschetti. M. Gregor. M. Provencio. V. Calvo. P. B. Kestenholz. S. Lampridis. D. Patrini. P. Bertoglio, L. F. Azenha, C. M. Sergi and G. J. Kocher (2021). "Thymic tumours: a single

17

center surgical experience and literature review on the current diagnosis and management of thymic malignancies." Gland Surgery 10(11): 3128-3140.

1. Qian, L., X. Chen, J. Huang, H. Lin, F. Mao, X. Zhao, Q. Luo and Z. Ding (2017). "A comparison of three approaches for the treatment of early-stage thymomas: robot-assisted thoracic surgery, videoassisted thoracic surgery, and median sternotomy." J Thorac Dis 9(7); 1997-2005.
1. Raja, S. M., J. T. Guptill, A. McConnell, H. R. Al-Khalidi, M. G. Hartwig and J. A. Klapper (2022). "Perioperative Outcomes of Thymectomy in Myasthenia Gravis: A Thoracic Surgery Database Analysis." Ann Thorac Surg 113(3): 904-910.
1. Ruckert, J. C. S., M.; Ismail, M. (2011). "Comparison of robotic and nonrobotic thoracoscopic thymectomy: A cohort study." Journal of Thoracic and Cardiovascular Surgery 141(3): 673-677.
1. Salfity, H. V., L. Timsina, D. P. Ceppa and T. J. Birdas (2021). "Minimally invasive surgery in the management of resectable thymoma: a retrospective analysis from the National Cancer Database." J Thorac Dis 13(11): 6353-6362.
1. Sehitogullari, A., A. Nasır, R. Anbar, K. Erdem and C. Bilgin (2020). "Comparison of perioperative outcomes of videothoracoscopy and robotic surgical techniques in thymoma." Asian Journal of Surgery 43(1): 244-250.
1. Seo, Y. J., N. Christian-Miller, E. Aguayo, Y. Sanaiha, P. Benharash and J. Yanagawa (2022). "National Use and Short-term Outcomes of Video and Robot-Assisted Thoracoscopic Thymectomies." Annals of Thoracic Surgery 113(1): 230-236.
1. Seong, Y. W., C. H. Kang, J. W. Choi, H. S. Kim, J. H. Jeon, I. K. Park and Y. T. Kim (2014). "Early clinical outcomes of robot-assisted surgery for anterior mediastinal mass: its superiority over a conventional sternotomy approach evaluated by propensity score matching." Eur J Cardiothorac Surg 45(3): e68-73; discussion e73.
1. Soder, S. A., C. Pollock, P. Ferraro, E. Lafontaine, J. Martin, B. Nasir and M. Liberman (2023). "Post-Onerative Outcomes Associated With Onen Versus Robotic Thymectomy: A Propensity Matched Analysis." Semin Thorac Cardiovasc Surg 35(1): 189-199. Epub: 11/29/2022.
1. Yang, C. J., J. Hurd, S. A. Shah, D. Liou, H. Wang, L. M. Backhus, N. S. Lui, T. A. D'Amico, J. B. Shrager and M. F. Berry (2020). "A national analysis of open versus minimally invasive thymectomy for stage I to III thymoma." J Thorac Cardiovasc Surg 160(2): 555-567 e515.
1. Ye, B., J. C. Tantai, W. Li, X. X. Ge, J. Feng, M. Cheng and H. Zhao (2013). "Video-assisted thoracoscopic surgery versus robotic-assisted thoracoscopic surgery in the surgical treatment of Masaoka stage I thymoma." World J Surg Oncol 11: 157.
1. Ye, B., W. Li, X. X. Ge, J. Feng, C. Y. Ji, M. Cheng, J. C. Tantai and H. Zhao (2014). "Surgical treatment of early-stage thymomas: robot-assisted thoracoscopic surgery versus transsternal thymectomy." Surg Endosc 28(1): 122-126.

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Table 9. Bibliography of Clinical Literature on da Vinci Multiport Lobectomy

Alvarado, C. E., S. G. Worrell, A. L. Sarode, B. Jiang, S. J. Halloran, L. M. Argote-Greene, P. A. 1. Linden and C. W. Towe (2022). "Comparing Thoracoscopic and Robotic Lobectomy Using a Nationally Representative Database." The American surgeon: 31348221148347.
Alwatari, Y., J. Khoraki, L. G. Wolfe, B. Ramamoorthy, N. Wall, C. Liu, W. Julliard, C. A. Puig and 2. R. D. Shah (2022). "Trends of utilization and perioperative outcomes of robotic and video-assisted thoracoscopic surgery in patients with lung cancer undergoing minimally invasive resection in the United States." JTCVS Open 12: 385-398.
1. Baig, M. Z., S. S. Razi, K. Agyabeng-Dadzie, S. Stroever, Z. Muslim, J. Weber, L. J. Herrera and F. Y. Bhora (2022). "Robotic-assisted thoracoscopic Surgery (RATS) Demonstrates a Lower Rate of Conversion to Thoracotomy Than Video-assisted thoracoscopic Surgery (VATS) for Complex Lobectomies." Eur J Cardiothorac Surg 62(3).
1. Bailey, K. L., N. Merchant, Y. J. Seo, D. Elashoff, P. Benharash and J. Yanagawa (2019). "Short-Term Readmissions After Open, Thoracoscopic, and Robotic Lobectomy for Lung Cancer Based on the Nationwide Readmissions Database." World J Surg 43(5): 1377-1384.
న. Cui, Y., E. L. Grogan, S. A. Deppen, F. Wang, P. P. Massion, C. E. Bailey, W. Zheng, H. Cai and X. O. Shu (2020). "Mortality for Robotic- vs Video-Assisted Lobectomy-Treated Stage I Non-Small Cell Lung Cancer Patients." JNCI Cancer Spectr 4(5): pkaa028.
1. Duclos, G., A. Charvet, N. Resseguier, D. Trousse, X. B. D'Journo, L. Zieleskiewicz, P. A. Thomas and M. Leone (2018). "Postoperative morphine consumption and anaesthetic management of patients undergoing video-assisted or robotic-assisted lung resective, propensity score-matched study." Journal of Thoracic Disease 10(6): 3558-3567.
1. Erhunmwunsee, L., P. Bhandari, E. Sosa, M. Sur, P. H. G. Ituarte and N. S. Lui (2020). "Socioeconomic, rural, and insurance-based inequities in robotic lung cancer resections." Video-Assisted Thoracic Surgery 5(june): 1-13.
Glenn, Z. F., M. Zubair, L. Hussain and K. Grannan (2019). "Comparison of pulmonary lobectomies 8. using robotic and video-assisted thoracoscopic approaches: results from 2010-2013 National Inpatient Sample." J Cardiovasc Surg (Torino) 60(4): 526-531.
1. Gonde, H., M. Laurent, A. Gillibert, O. M. Sarsam, R. Varin, G. Grimandi, C. Peillon and J. M. Baste (2017). "The affordability of minimally invasive procedures in major lung resection: a prospective study." Interact Cardiovasc Thorac Surg 25(3): 469-475.
1. Hendriksen, B. S., C. S. Hollenbeak, M. D. Taylor and M. F. Reed (2019). "Minimally Invasive Lobectomy Modality and Other Predictors of Conversion to Thoracotomy." Innovations (Phila) 14(4): 342-352.
1. Hendriksen, B. S., M. F. Reed, M. D. Taylor and C. S. Hollenbeak (2019). "Readmissions After Lobectomy in an Era of Increasing Minimally Invasive Surgery: A Statewide Analysis." Innovations (Phila) 14(5): 453-462.
1. Hennon, M. W., L. H. DeGraaff, A. Groman, T. L. Demmy and S. Yendamuri (2020). "The association of nodal upstaging with surgical approach and its impact on long-term survival after resection of nonsmall-cell lung cancer." Eur J Cardiothorac Surg 57(5): 888-895.
1. Herb. J. N., D. G. Kindell. P. D. Strassle. K. B. Stitzenberg. B. E. Haithcock. G. N. Mody and J. M. Long (2021). "Trends and Outcomes in Minimally Invasive Surgery for Locally Advanced Non-Small Cell Lung Cancer with N2 Disease." Semin Thorac Cardiovasc Surg 33(2): 547-555.
1. Hoeijmakers, F., K. J. Hartemink, A. F. Verhagen, W. H. Steup, E. Marra, W. F. B. Röell, D. J. Heineman, W. H. Schreurs, R. A. E. M. Tollenaar and M. W. J. M. Wouters (2021). "Variation in incidence, prevention and treatment of persistent air leak after lung cancer surgery." Eur J Cardiothorac Surg 61(1): 110-117.
1. Huang, J., C. Li, H. Li, F. Lv, L. Jiang, H. Lin, P. Lu, Q. Luo and W. Xu (2019). "Robot-assisted thoracoscopic surgery versus thoracotomy for c-N2 stage NSCLC: Short-term outcomes of a randomized trial." Translational Lung Cancer Research 8(6): 951-958.
1. Huang, J., Y. Tian, C. Li, Y. Shen, H. Li, F. Lv, H. Lin, C. Lau, R. M. Terra, L. Jiang and O. Luo (2021). "Robotic-assisted thoracic surgery reduces perioperative complications and achieves a similar long-term survival profile as posterolateral thoracotomy in clinical N2 stage non-small cell lung cancer patients: A multicenter, randomized, controlled trial." Translational Lung Cancer Research 10(11): 4281-4292.

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1. Jean, R. A., A., A. S. Chiu, D. J. Boffa, F. C. Detterbeck, A. W. Kim and J. D. Blasberg (2018). "Delayed discharge does not decrease the cost of readmission after pulmonary lobectomy." Surgery (United States) 164(6): 1294-1299.
1. Jin, R., Y. Zheng, Y. Yuan, D. Han, Y. Cao, Y. Zhang, C. Li, J. Xiang, Z. Niu, T. Lerut, J. Lin. A. E. Abbas. A. Pardolesi. T. Suda. D. Amore. S. Schraag. C. Aigner. J. Li. J. Che. J. Hang. J. Ren, L. Zhu and H. Li (2022). "Robotic-assisted Versus Video-assisted Thoracoscopic Lobectomy: Short-term Results of a Randomized Clinical Trial (RVlob Trial)." Ann Surg 275(2): 295-302.
1. Kamel. M. K., A. N. Sholi. S. W. Harrison. B. Lee. J. L. Port. N. K. Altorki and B. M. Stiles (2022). "Minimally Invasive Surgery for Lung Cancer Following Neoadjuvant Therapy in the United States." J Laparoendosc Adv Surg Tech A 32(8): 860-865.
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