Predicate Devices

Reference Devices

AI/ML (Artificial Intelligence / Machine Learning)

No
The summary describes a robotic surgical system controlled by a surgeon and mentions image processing, but there is no mention of AI or ML being used for decision-making, automation, or image analysis beyond standard processing. The focus is on the surgeon's control and the system's mechanical and visual capabilities.

Therapeutic

Yes

The da Vinci SP Surgical System is intended to assist in surgical procedures, which are a form of therapy.

Diagnostic

No

The device is a surgical system intended to assist in the control of surgical instruments for performing various surgical procedures. It does not perform diagnostic functions.

SaMD (Software as a Medical Device)

No

The device description clearly outlines hardware components including a Surgeon Console, Vision Cart, and Patient Cart, along with instruments and accessories. This is a complex surgical robotic system, not a software-only device.

IVD (In Vitro Diagnostic)

Based on the provided information, the da Vinci SP Surgical System 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 Intuitive Surgical da Vinci SP Instruments during urologic, colorectal, and general thoracoscopic surgical procedures" and "transoral otolaryngology surgical procedures". This describes a surgical robotic system used for performing surgical procedures on the patient's body.
Device Description: The description details a system with a Surgeon Console, Vision Cart, and Patient Cart, used with instruments and a camera to manipulate tissues and provide visualization during surgery. This is consistent with a surgical device, not a device used to examine specimens outside the body.
Anatomical Site: The anatomical sites listed (urologic, colorectal, general thoracoscopic, oropharynx) are all locations within the human body where surgical procedures are performed.
Performance Studies: The performance studies involve cadaver and animal testing, and a clinical study on human subjects undergoing surgical procedures. This type of testing is typical for surgical devices, not IVDs which would involve testing of biological specimens.
Key Metrics: The key metrics reported (operative time, blood loss, conversion rate, adverse event rates, etc.) are all related to the performance and safety of a surgical procedure, not the accuracy or reliability of a diagnostic test performed on a specimen.

In Vitro Diagnostic devices are defined as those intended for use in the collection, preparation, and examination of specimens taken from the human body (such as blood, urine, tissue) to provide information for the diagnosis, treatment, or prevention of disease. The da Vinci SP Surgical System does not fit this definition. It is a surgical instrument control system used to perform procedures directly on the patient.

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 da Vinci SP Instruments during urologic, colorectal, 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.

da Vinci SP Instruments:

Intuitive Surgical da Vinci 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, colorectal, 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 (comma separated list FDA assigned to the subject device)

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 "colorectal surgical procedures" to the indications, and to add "Low anterior resection / total mesorectal excision (LAR/TME), Colectomy (Right, Left, Transverse, Total, Hemi), Sigmoidectomy, and Abdominoperineal Resection (APR)" 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

urologic, colorectal, general thoracoscopic, oropharynx

Indicated Patient Age Range

adult use

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

Not Found

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

Cadaver and Animal Performance Testing:

Study Type: Comparative animal and cadaver testing.
Sample Size: Cadaver models and porcine models. Three independent practicing surgeons participated. Each surgeon performed two (2) procedures in a cadaver model and one (1) procedure in a porcine model, for a total of 9 surgical procedures performed per system.
Key Results: Demonstrated device performance for anatomical access and reach in cadavers. Assessed safety and performance in live animals, replicating factors experienced during normal clinical use, including operating on perfused organs, normal tissue manipulation, and ensuring appropriate hemostasis. Surgeons completed questionnaires evaluating their ability to perform surgical tasks of the SP1098 compared to the da Vinci Xi system. Success criteria were met for each procedure.

Clinical Study:

Study Type: Prospective, multicenter, single-arm clinical study under an Investigational Device Exemption (IDE).
Sample Size: 60 subjects (40 in the United States and 20 in South Korea) at eight (8) institutions in the United States and two (2) institutions in South Korea.
- LAR/TME cohort: 29 subjects (19 U.S., 10 South Korea).
- Right Colectomy cohort: 28 subjects (18 U.S., 10 South Korea).
Key Results (LAR/TME):
- All procedures completed without conversion to open or alternative approach (0% conversion rate).
- No intraoperative adverse events.
- No unanticipated device-related adverse effects (UADE).
- Eight (8) serious adverse events (SAE) reported, all deemed related to the colorectal procedure only and not to the device. Three (3) SAEs were classified as major (Clavien-Dindo III).
- Mean operative time: 273.6 ± 14.84 minutes.
- Mean estimated blood loss: 75.2 ± 16.12 mL.
- Blood transfusion rate: 0%.
- Serious adverse event rate: 17.2%.
- Device-related serious adverse event rate: 0%.
- Intraoperative adverse event rate: 0%.
- Subjects with major AE (Clavien-Dindo Grade III/IV/V): 3 (10.3%).
- Mean length of hospital stay: 4.6 ± 3.69 days.
- Rate of positive surgical margin: 0%.
- Readmission rate: 4 (14.3%), all related to SAEs and none device-related.
- Reoperation rate: 0%.
- Mortality rate: 0%.
Key Results (Right Colectomy):
- All procedures completed without conversion to open or alternative approach (0% conversion rate).
- One (1) intraoperative adverse event (corneal abrasion) deemed not related to colorectal procedure or device.
- No unanticipated device-related adverse effects (UADE).
- Two (2) subjects experienced one (1) serious adverse event each, all related to the colorectal procedure only and none classified as major AE complications (Clavien-Dindo Grade I).
- Mean operative time: 208.2 ± 11.43 minutes.
- Mean estimated blood loss: 37.0 ± 8.4 mL.
- Transfusion rate: 0%.
- Conversion to open rate: 0%.
- Serious adverse event rate: 7.1%.
- Device-related serious adverse event rate: 0%.
- Intraoperative adverse event: 3.6%.
- Subjects with major adverse events (Clavien-Dindo Grade III/IV/V): 0%.
- Mean length of hospital stay: 3.5 ± 0.38 days.
- Rate of positive surgical margins: 0%.
- Readmission rate: 0%.
- Reoperation rate: 0%.
- Mortality rate: 0%.

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

See "Summary of Performance Studies" for detailed metrics including operative time, estimated blood loss, conversion rates, adverse event rates, readmission rates, reoperation rates, and mortality rates. Confidence intervals (95% CI) are provided for most parameters when comparing to literature.

Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.

K240502

Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.

K171632

Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).

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

0

Image /page/0/Picture/0 description: The image contains 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 FDA logo is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

November 26, 2024

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

Re: K242318

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: November 1, 2024 Received: November 1, 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:

1

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 urological, colorectal, 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 (OS) 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 (OS) 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.

All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Re").

2

The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-device-advicecomprehensive-regulatory-assistance/unique-device-identification-system.

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.

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,

BLETA
VUNIQI -S
Digitally signed by
BLETA VUNIQI -S
Date: 2024.11.26
15:28:57 -05'00'

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

3

Indications for Use

Submission Number (if known)

K242318

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 da Vinci SP Instruments during urologic, colorectal, 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.

da Vinci SP Instruments:

Intuitive Surgical da Vinci 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, colorectal, 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: November 15, 2024

SUBMITTER INFORMATION II.

| Trade Name: | da Vinci SP® Surgical System, Model SP1098,
da Vinci 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,
da Vinci SP Instruments, and Accessories (K240502) |
|-------------------|--------------------------------------------------------------------------------------------------|
| Reference Device: | da Vinci Xi Surgical System, Model IS4000,
EndoWrist Instruments, and Accessories (K171632) |

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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 "colorectal surgical procedures" to the indications, and to add "Low anterior resection / total mesorectal excision (LAR/TME), Colectomy (Right, Left, Transverse, Total, Hemi), Sigmoidectomy, and Abdominoperineal Resection (APR)" as new representative, specific procedures in the Professional Instructions for Use.

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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, colorectal, 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.

da Vinci SP Instruments:

Intuitive Surgical da Vinci 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, colorectal, 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. TECHNOLOGICAL CHARACTERISTICS WITH THE PREDICATE DEVICE

The da Vinci SP Surgical System, Model SP1098 and da Vinci 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 "colorectal surgical procedures" to the indication statement and to add "Low anterior resection / total mesorectal excision (LAR/TME), Colectomy (Right, Left, Transverse, Total, Hemi), Sigmoidectomy, and Abdominoperineal Resection (APR)" as new representative, specific procedures in the Professional Instructions for Use.

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VI. PERFORMANCE DATA

The addition of colorectal 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), transoral surgery (K182371) or general thoracoscopic surgical procedures (K240502).

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 colorectal 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 colorectal surgical procedures. Each surgeon performed two (2) procedures in a cadaver model and one (1) procedure in a porcine model, for a total of 9 surgical procedures performed per system. 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 da Vinci Xi system, which is cleared for use in colorectal surgical procedures (K171632) and serves as a reference device for this 510(k).

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Table 1

| Surgical

Procedure	Subject	Procedure Completion Acceptance Criteria
Low Anterior
Resection / Total
Mesorectal
Excision	Cadaver	Sufficient colon mobilization to ensure tension-free anastomosis Complete mesorectal dissection (e.g., intact mesorectal fascial envelope, circumferential resection, distal dissection to levator ani) Critical anatomy identified (e.g., gonadal vessels, inferior mesenteric vessels, ureter, hypogastric nerves, pelvic nerves) Appropriate vessel ligation (e.g., inferior mesenteric or superior rectal vessels) Anastomosis complete and deemed surgically acceptable upon visual inspection Acceptable leak test (i.e., no air bubbles observed during leak test)
Right
Hemicolectomy	Cadaver	Sufficient colon mobilization to ensure tension-free anastomosis Critical anatomy identified (e.g., gonadal vessels, ureter, ileocolic vessels, colic vessels, duodenum) Appropriate vessel ligation (e.g., right colic, ileocolic, right branch of middle colic vessels) Anastomosis complete and deemed surgically acceptable upon visual inspection Acceptable leak test (i.e., no air bubbles observed during leak test)
Low Anterior
Resection / Total
Mesorectal
Excision	Porcine	Sufficient colon mobilization to ensure tension- free anastomosis Anastomosis complete and deemed surgically acceptable upon visual inspection Acceptable leak test (i.e. no air bubbles observed during leak test) Hemostasis maintained

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Clinical Study

Intuitive conducted a prospective, multicenter, single-arm clinical study under an Investigational Device Exemption (IDE) to confirm the clinical safety and performance of the da Vinci SP Surgical System. Instruments and Accessories in colorectal surgical procedures. This study also confirms that use of the da Vinci SP Surgical System in colorectal surgical procedures does not raise different questions of safety or effectiveness. The study included 60 subjects (40 subjects in the United States and 20 subjects in South Korea) at eight (8) institutions in the United States and two (2) institutions in South Korea. The da Vinci SP Surgical System was used to perform the following procedures in this study:

Low Anterior Resection with/without Total Mesorectal Excision (LAR/TME) (N = 29) .
Right Colectomy (N = 28) ●
Other colorectal procedures (N = 3) .
- Sigmoid Colectomy (N = 2) o
- Transverse Colectomy (N=1) O

LAR/TME Results

Twenty-nine (29) subjects were enrolled in the study for LAR/TME with nineteen (19) subjects enrolled in the U.S. and ten (10) subjects enrolled in South Korea. Of these 29 subjects, 26 (89.7%) were malignant indications and 3 (10.3%) were benign indications. The mean BMI observed in the LAR/TME cohort was 25.7, with BMI in U.S. population was slightly higher (26.3) than the South Korean population (24.4).

All LAR/TME procedures in the study were completed using a da Vinci SP Surgical System without conversion to open or an alternative approach. Therefore, the conversion rate is 0% in the study for in the LAR/TME cohort.

There were no intraoperative adverse events and no unanticipated device-related adverse effects (UADE) reported for the LAR/TME cohort. There were eight (8) serious adverse events (SAE) reported, all deemed related to the colorectal procedure only and not related to the device. Of those eight (8) SAEs, three (3) were classified as major (all within Clavien-Dindo III classification). "Major" is defined by Clavien-Dindo Classification Grade IIIa or higher. Table 2 summarizes the study results and Table 3 lists the serious adverse events and major complications reported in the LAR/TME cohort.

10

Clinical Study Parameter	K242318
Number of Subjects, n	29
Operative time (minutes), mean ± SE	273.6 ± 14.84
Estimated blood loss (mL), mean ± SE	75.2 ± 16.12
Blood transfusion rate, %	0
Conversion rate, %	0
Serious adverse event rate	17.2%
Device-related serious adverse event rate, %	0
Intraoperative adverse event rate, %	0
Subjects with major AE
(Clavien-Dindo Grade III/IV/V, n (%))a	3 (10.3%)
Length of hospital stay (days)b, mean ± SE	4.6 ± 3.69
Rate of positive surgical margin, %, n= 7	0
Readmission rate, %c	4 (14.3%)
Reoperation rate, %	0
Mortality rate%	0
Notes:
a. There were no grade IV or V events.
b. Mean length of hospital stay in the U.S. was 2.9 days and the mean length of
hospital stay in South Korea was 7.7 days.
c. 4 subjects had unplanned re-admissions related to a SAE (3 classified as major and
1 classified as minor). None of the unpanned re-admissions were related to the da Vinci SP system.

Table 2. Results Summary (LAR/TME)

Table 3. Postoperative Serious Adverse Events and Major Complications (LAR/TME)

Type	Total study N= 29
Subjects experiencing SAEs	5
Subject Experiencing Major AE Complications	3
Total Number of SAEs by Minor/Major Classification	8
Minor (All Clavien-Dindo Grade I)
Acute Renal Failure	1
Dehydration	1
High Ileostomy Output	1
Ileus	2
Major (within Clavien-Dindo Grade III)
Anastomotic Dehiscence	1
Bowel Obstruction	1
Hematoma of Presacral Space	1

11

Right Colectomy Results

Twenty-eight (28) subjects were enrolled in the study for right colectomy, with eighteen (18) subjects enrolled in the U.S. and ten (10) subjects enrolled in South Korea. Of these 28 subjects, 22 (78.6%) were malignant indications and 6 (21.4%) was for a benign indication. The mean BMI observed in the Right Colectomy cohort was 25.8, with BMI in U.S. population was slightly higher (26.9) than the South Korean population (23.8), there was no statistical significance between the two regions.

All right colectomy procedures in the study were completed using a da Vinci SP Surgical System without conversion to open or an alternative approach, therefore, the conversion rate is 0% in the study for in the right colectomy cohort.

There was one (1) intraoperative adverse event (corneal abrasion) deemed not related to the colorectal procedure and/or device. There were no unanticipated device-related adverse effects (UADE). Two (2) Subjects experienced one (1) serious adverse event each, all relate to the colorectal procedure only and none classified as major AE complications (all Clavien-Dindo Grade I). Table 4 summarizes the study results and Table 5 lists the serious adverse events and major complications reported in the right colectomy cohort.

Clinical Study Parameter	K242318
Number of Subjects, n	28
Operative time (min), mean ± SE	208.2 ± 11.43
Estimated blood loss (mL), mean ± SE	37.0 ± 8.4
Transfusion rate, %	0
Conversion to open rate, %	0
Serious adverse event rate, %	7.1
Device-related serious adverse event rate, %	0
Intraoperative adverse event, %	3.6%
Subjects with major adverse events, AE
(Clavien-Dindo Grade III/IV/V), n (%)	0
Length of hospital stay (days), mean ± SE a	3.5 ± 0.38
Rate of positive surgical margins, n (%)	0
Readmission rate, n (%)	0
Reoperation rate%	0
Mortality rate, %	0
Notes:
a. Mean length of hospital stay in the U.S. was 2.3 days and the mean
length of hospital stay in South Korea was 5.8 days.

Table 4. Results Summary (Right Colectomy)

12

Type	Total study N=19
Subjects experiencing SAEs	2
Subject Experiencing Major AE Complications	0
Total Number of SAEs	2
Minor (Clavien-Dindo Grade I)
Acute Renal Failure	1
Ileus	1

Table 5. Postoperative Adverse Events (Right Colectomy)

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

Results of this study of da Vinci SP were compared to recently published clinical literature between 2010 and March 2024 on multiport robotic systems for LAR/TME and right colectomy procedures. Systematic literature searches were done for LAR/TME, and right colectomy 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 LAR/TME. Table 7 summarizes the comparison in right colectomy. 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 (CI) 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 LAR/TME and right colectomy. 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.

13

| Clinical Study Parameter | K242318 | da Vinci Multi-port
Literature |
|---------------------------------------|------------------|-----------------------------------|
| Operative time | | |
| Sample Size | N = 29 | N = 11340 |
| Mean ± SE | 273.6 ± 14.84 | 282.3 ± 12.38 |
| 95% CI | [243.18, 303.99] | [256.43, 308.10] |
| Length of stay | | |
| Sample Size | N = 29 | N = 26500 |
| Mean ± SE | 4.6 ± 0.69 | 7.7 ± 0.79 |
| 95% CI | [3.15, 5.96] | [6.12, 9.37] |
| Estimated blood loss | | |
| Sample Size | N = 29 | N = 5055 |
| Mean ± SE | 75.2 ± 16.12 | 63.0 ± 14.66 |
| 95% CI | [42.22, 108.26] | [31.29, 94.63] |
| Intra-operative adverse event | | |
| Sample Size | N = 29 | N = 1739 |
| Proportion | 0% | 5.8% |
| 95% CI | [0%, 11.94%] | [2.95%, 8.72%] |
| Major adverse event complication rate | | |
| (Clavien-Dindo III, IV, V) a | | |
| Sample Size | N = 29 | N = 9928 |
| Proportion | 10.3% | 8.1% |
| 95% CI | [2.19%, 27.35%] | [6.47%, 9.82%] |
| Anastomotic complication rate b | | |
| Sample size | N = 29 | N=17204 |
| Proportion | 10.3% | 6.4% |
| 95% CI | [2.19%, 27.35%] | [4.75%, 7.97%] |
| Transfusion rate | | |
| Sample Size | N = 29 | N = 10332 |
| Proportion | 0% | 2.3% |
| 95% CI | [0%, 11.94%] | [1.35%, 3.22%] |
| Conversion rate | | |
| Sample Size | N = 29 | N = 48348 |
| Proportion | 0% | 6.2% |
| 95% CI | [0%, 11.94%] | [5.39%, 6.92%] |
| Mortality rate c | | |
| Sample Size | N = 28 | N = 36974 |
| Proportion | 0% | 0.6% |
| 95% CI | [0%, 12.34%] | [0.41%, 0.72%] |
| Readmission rate c | | |
| Sample Size | N = 28 | N = 30954 |
| Proportion | 14.3% | 7.1% |
| 95% CI | [4.03%, 32.67%] | [4.96%, 9.14%] |
| Reoperation rate c | | |
| Sample Size | N = 28 | N = 8107 |
| Proportion | 0% | 5.5% |
| 95% CI | [0%, 12.34%] | [4.37%, 6.59%] |

Table 6. da Vinci SP LAR/TME versus da Vinci Multiport Literature Comparison

14

| Notes: | a. There were no grade IV or V events.
b. Anastomoses were created using handheld, third-party laparoscopic staplers or were hand-sewn.
c. One subject missed their Day 42 visit due to a SAE. |

--------	------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------

Table 7. da Vinci SP Right Colectomy versus da Vinci Multiport Literature Comparison

| Clinical Parameter | K242318 | da Vinci Multi-port
Literature |
|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------|-----------------------------------|
| Operative time | | |
| Sample Size | N = 28 | N = 10907 |
| Mean ± SE | 208.2 ± 11.43 | 285.5 ± 26.92 |
| 95% CI | [184.76, 231.67] | [210.74, 360.25] |
| Length of stay (days) | | |
| Sample Size | N = 28 | N = 11164 |
| Mean ± SE | 3.5 ± 0.38 | 5.1 ± 0.28 |
| 95% CI | [2.75, 4.32] | [4.37, 5.81] |
| Estimated blood loss | | |
| Sample Size | N = 28 | N = 394 |
| Mean ± SE | 37.0 ± 8.40 | 98.7 ± 19.65 |
| 95% CI | [19.73, 54.20] | [0, 348.40] |
| Intra-operative adverse event rate | | |
| Sample Size | N = 28 | N = 520 |
| Proportion | 3.6% | 2.8% |
| 95% CI | [0.09%, 18.35%] | [0%, 29.23%] |
| Major adverse event rate
(Clavien-Dindo III, IV, V) | | |
| Sample Size | N = 28 | N = 3203 |
| Proportion | 0% | 6.7% |
| 95% CI | [0%, 12.34%] | [5.55%, 7.93%] |
| Anastomotic complication rate ª | | |
| Sample size | N=28 | N=14926 |
| Proportion | 0% | 4.2% |
| 95% CI | [0%, 12.34%] | [2.53%, 5.79%] |
| Transfusion rate | | |
| Sample Size | N = 28 | N = 2883 |
| Proportion | 0% | 7.3% |
| 95% CI | [0%, 12.34%] | [4.47%, 10.11%] |
| Conversion rate | | |
| Sample Size | N = 28 | N = 25893 |
| Proportion | 0% | 6.0% |
| 95% CI | [0%, 12.34%] | [5.12%, 6.88%] |
| Mortality rate | | |
| Sample Size | N = 28 | N = 11684 |
| Proportion | 0% | 0.6% |
| 95% CI | [0%, 12.34%] | [0.33%, 0.89%] |
| Readmission rate | | |
| | | |
| Sample Size | N = 28 | N = 11236 |
| Proportion | 0% | 6.8% |
| 95% CI | [0%, 12.34%] | [5.53%, 8.01%] |
| Reoperation rate | | |
| Sample Size | N = 28 | N = 9382 |
| Proportion | 0% | 5.8% |
| 95% CI | [0%, 12.34%] | [4.96%, 6.56%] |
| The 95% confidence intervals for 9 discrete variables from the literature data are based on pooled
proportions and exact method. The weighted averages and 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). | | |
| Notes: a. Third-party handheld laparoscopic staplers were used in the creation of the
anastomosis. | | |

15

VII. CONCLUSION

The Performance test data demonstrates that the ability of the subject device (SP1098) to perform colorectal surgical procedures, LAR/TME and right colectomy. The Clinical Study results confirm that there are no different issues of safety or effectiveness as compared to the multiport da Vinci system when performing colorectal surgical procedures, LAR/TME and right colectomy.

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 LAR/TME (n=55)

1. Arron, M. N. N. N. G. Greijdanus, R. P. G. Ten Broek, J. W. T. Dekker, F. van Workum, H. van Goor, P. J. Tanis and J. H. W. de Wilt (2021). "Trends in risk factors of anastomotic leakage after colorectal cancer surgery (2011-2019): A Dutch population-based study." Colorectal Dis 23(12): 3251-3261.
1. Arron, M. N. N., N. G. Greijdanus, S. Bastiaans, P. A. J. Vissers, R. H. A. Verhoeven, R. P. G. ten Broek, H. M. W. Verheul, P. J. Tanis, H. van Goor and J. H. W. de Wilt (2022). "Long-Term Oncological Outcomes After Colorectal Anastomotic Leakage A Retrospective Dutch Population-based Study." Annals of Surgery 276(5): 882-889.
Bedrikovetski, S., N. N. Dudi-Venkata, H. M. Kroon, J. W. Moore, R. A. Hunter and T. 3. Sammour (2020). "Outcomes of Minimally Invasive Versus Open Proctectomy for Rectal Cancer: A Propensity-Matched Analysis of Bi-National Colorectal Cancer Audit Data." Dis Colon Rectum 63(6): 778-787.
Bertani, E., A. Chiappa, R. Biffi, P. P. Bianchi, D. Radice, V. Branchi, E. Cenderelli, I. 4. Vetrano, S. Cenciarelli and B. Andreoni (2011). "Assessing appropriateness for elective colorectal cancer surgery: clinical, oncological, and quality-of-life short-term outcomes employing different treatment approaches." Int J Colorectal Dis 26(10): 1317-1327.
1. Bhangu, A. and g. European Society of Coloproctology collaborating (2018). "An international multicentre prospective audit of elective rectal cancer surgery; operative approach versus outcome, including transanal total mesorectal excision (TaTME)." Colorectal Dis 20 Suppl 6: 33-46.
Bliznakova, K., N. Kolev, A. Zlatarov, T. Kalinov and T. Georgiev (2023). "Feasibility and 6. Safety of Robotic-Assisted Surgery for Rectal Cancer: Short-Term Outcomes of a Pilot Study with da Vinci Xi Platform During COVID-19." Chirurgia (Bucur) 118(1): 27-38.
1. Burghgraef, T. A., J. C. Hol. M. L. Rutgers, R. Crolla, A. A. W. van Geloven, R. Hompes, J. W. A. Leijtens, F. Polat, A. Pronk, A. B. Smits, J. B. Tuynman, E. G. G. Verdaasdonk, P. M. Verheijen, C. Sietses and E. C. J. Consten (2022). "Laparoscopic Versus Robot-Assisted Versus Transanal Low Anterior Resection: 3-Year Oncologic Results for a Population-Based Cohort in Experienced Centers." Ann Surg Oncol 29(3): 1910-1920.
Cheong, J. Y., C. J. Young and C. Byrne (2021). "Does the body mass index impact lymph 8. node yield for colorectal cancer resection, and does operative approach influence this: a review of bi-national colorectal cancer audit database." ANZ Journal of Surgery 91(12): 2707-2713.
1. Corrigan, N., H. Marshall, J. Croft, J. Copeland, D. Jayne and J. Brown (2018). "Exploring and adjusting for potential learning effects in ROLARR: a randomised controlled trial comparing robotic-assisted vs. standard laparoscopic surgery for rectal cancer resection." Trials 19(1): 339.
1. Debakey, Y., A. Zaghloul, A. Farag, A. Mahmoud and I. Elattar (2018). "Robotic-Assisted versus Conventional Laparoscopic Approach for Rectal Cancer Surgery, First Egyptian Academic Center Experience, RCT." Minimally Invasive Surgery 2018: 5836562.

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1. Del Gutierrez Delgado. M. P., S. Mera Velasco. J. D. Turino Luque. I. Gonzalez Poveda. M. Ruiz Lopez and J. Santoyo Santoyo (2022). "Outcomes of robotic-assisted vs conventional laparoscopic surgery among patients undergoing resection for rectal cancer: an observational single hospital study of 300 cases." J Robot Surg 16(1): 179-187.
1. Ellebæk, M. B., S. K. Perdawood, S. Steenstrup, S. Khalaf, J. Kundal, S. Möller, J. C. Bang, J. Støvring and N. Qvist (2023). "Early versus late reversal of diverting loop ileostomy in rectal cancer surgery: a multicentre randomized controlled trial." Scientific Reports 13(1).
1. Emile, S. H., N. Horesh, M. R. Freund, Z. Garoufalia, R. Gefen, E. Silva-Alvarenga, G. Dasilva and S. D. Wexner (2022). "Outcomes of laparoscopic versus robotic-assisted resection of T4 rectal cancer: propensity score-matched analysis of a national cancer database." The British journal of surgery 110(2): 242-250.
1. Farah, E., A. A. Abreu, B. Rail, J. Salgado, G. Karagkounis, H. J. Zeh, 3rd and P. M. Polanco (2023). "Perioperative outcomes of robotic and laparoscopic surgery for colorectal cancer: a propensity score-matched analysis." World J Surg Oncol 21(1): 272.
1. Feng, Q., W. Tang, Z. Zhang, Y. Wei, L. Ren, W. Chang, D. Zhu, F. Liang, G. He and J. Xu (2022). "Robotic versus laparoscopic abdominoperineal resections for low rectal cancer: A single-center randomized controlled trial." Journal of Surgical Oncology 126(8): 1481-1493.
1. Feng, Q., W. Yuan, T. Li, B. Tang, B. Jia, Y. Zhou, W. Zhang, R. Zhao, C. Zhang, L. Cheng, X. Zhang, F. Liang, G. He, Y. Wei and J. Xu (2022). "Robotic versus laparoscopic surgery for middle and low rectal cancer (REAL): short-term outcomes of a multicentre randomised controlled trial." The lancet. Gastroenterology & hepatology 7(11): 991-1004.
1. Giesen, L. J. X., J. W. T. Dekker, M. Verseveld, R. M. P. H. Crolla, G. P. van der Schelling, C. Verhoef and P. B. Olthof (2023). "Implementation of robotic rectal cancer surgery: a cross-sectional nationwide study." Surgical Endoscopy 37(2): 912-920.
1. Gilmore, B., M. A. Adam, K. Rhodin, M. C. Turner, B. Ezekian, C. R. Mantyh and J. Migaly (2021). "Evolution of minimally invasive surgery for rectal cancer: update from the national cancer database." Surgical Endoscopy 35(1): 275-290.
1. Glencer, A. C., J. A. Lin, K. Trang, A. Greenberg, K. S. Kirkwood, M. A. Adam and A. Sarin (2022). "Assessing the role of robotic proctectomy in obese patients: a contemporary NSQIP analysis." J Robot Surg 16(6): 1391-1399.
1. Horsey, M. L., S. A. Parascandola, A. D. Sparks, S. Hota, M. Ng and V. Obias (2022). "The impact of surgical approach on short- and long-term outcomes after rectal cancer resection in elderly patients: a national cancer database propensity score matched comparison of robotic, laparoscopic, and open approaches." Surgical Endoscopy 36(2): 1269-1277.
1. Horvath, P., C. Steidle, C. Yurttas, I. Baur, A. Königsrainer and I. Königsrainer (2023). "Possible Advantages of Minimal-Invasive Approaches in Rectal Cancer Surgery: A Nationwide Analysis." Journal of Clinical Medicine 12(14).
1. Hu. K. Y., R. Wu, A. Szabo, T. J. Ridolfi, K. A. Ludwig and C. Y. Peterson (2020). "Laparoscopic Versus Robotic Proctectomy Outcomes: An ACS-NSQIP Analysis." J Surg Res 255: 495-501.

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1. Hyde, L. Z., O. Baser, S. Mehendale, D. Guo, M. Shah and R. P. Kiran (2019). "Impact of surgical approach on short-term oncological outcomes and recovery following low anterior resection for rectal cancer." Colorectal disease : the official journal of the Association of Coloproctology of Great Britain and Ireland 21(8): 932-942.
1. Jayne, D., A. Pigazzi, H. Marshall, J. Croft, N. Corrigan, J. Copeland, P. Quirke, N. West, T. Rautio, N. Thomassen, H. Tilney, M. Gudgeon, P. P. Bianchi, R. Edlin, C. Hulme and J. Brown (2017). "Effect of Robotic-Assisted vs Conventional Laparoscopic Surgery on Risk of Conversion to Open Laparotomy Among Patients Undergoing Resection for Rectal Cancer: The ROLARR Randomized Clinical Trial." JAMA - Journal of the American Medical Association 318(16): 1569-1580.
1. Kethman, W. C., K. E. Bingmer, A. Ofshteyn, R. Charles, S. L. Stein, D. Dietz and E. Steinhagen (2022). "Effects of surgical approach on short- and long-term outcomes in earlystage rectal cancer: a multicenter, propensity score-weighted cohort study." Surg Endosc 36(8): 5833-5839.
1. Kim, J. C., S. B. Lim, Y. S. Yoon, I. J. Park, C. W. Kim and C. N. Kim (2014). "Completely abdominal intersphincteric resection for lower rectal cancer: feasibility and comparison of robot-assisted and open surgery." Surg Endosc 28(9): 2734-2744.
1. Kim, J. C., S. S. Yang, T. Y. Jang, J. Y. Kwak, M. J. Yun and S. B. Lim (2012). "Open versus robot-assisted sphincter-saving operations in rectal cancer patients: techniques and comparison of outcomes between groups of 100 matched patients." Int J Med Robot 8(4): 468-475.
1. Kim, J. Y., N. K. Kim, K. Y. Lee, H. Hur, B. S. Min and J. H. Kim (2012). "A comparative study of voiding and sexual function after total mesorectal excision with autonomic nerve preservation for rectal cancer: laparoscopic versus robotic surgery." Annals of Surgical Oncology 19(8): 2485-2493.
1. Kim, M. J., S. C. Park, J. W. Park, H. J. Chang, D. Y. Kim, B. H. Nam, D. K. Sohn and J. H. Oh (2018). "Robot-assisted Versus Laparoscopic Surgery for Rectal Cancer: A Phase II Open Label Prospective Randomized Controlled Trial." Ann Surg 267(2): 243-251.
1. Law, W. L. and D. C. C. Foo (2017). "Comparison of short-term and oncologic outcomes of robotic and laparoscopic resection for mid- and distal rectal cancer." Surg Endosc 31(7): 2798-2807.
1. Lei, Y., J. Jiang, S. Zhu, B. Yi and J. Li (2022). "Comparison of the short-term efficacy of two types of robotic total mesorectal excision for rectal cancer." Tech Coloproctol 26(1): 19-28.
1. Matsuyama, T., H. Endo, H. Yamamoto, I. Takemasa, K. Uehara, T. Hanai, H. Miyata, T. Kimura, H. Hasegawa, Y. Kakeji, M. Inomata, Y. Kitagawa and Y. Kinugasa (2021). "Outcomes of robot-assisted versus conventional laparoscopic low anterior resection in patients with rectal cancer: propensity-matched analysis of the National Clinical Database in Japan." BJS Open 5(5).

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1. Mizoguchi, M., M. Kizuki, N. Iwata, M. Tokunaga, K. Fushimi, Y. Kinugasa and T. Fujiwara (2023). "Comparison of short-term outcomes between robot-assisted and laparoscopic rectal surgery for rectal cancer: A propensity score-matched analysis using the Japanese Nationwide diagnosis procedure combination database." Annals of Gastroenterological Surgery 7(6): 955-967.
1. Myrseth, E., L. S. Nymo, P. F. Gjessing, H. Korner, J. T. Kvaloy and S. Norderval (2022). "Lower conversion rate with robotic assisted rectal resections compared with conventional laparoscopy; a national cohort study." Surgical Endoscopy 36(5): 3574-3584.
1. Ose, I. and S. K. Perdawood (2021). "A nationwide comparison of short-term outcomes after transanal, open, laparoscopic, and robot-assisted total mesorectal excision." Colorectal Disease 23(10): 2671-2680.
1. Parascandola, S. A., S. Hota, A. D. Sparks, S. Boulos, K. Cavallo, G. Kim and V. Obias (2021). "Trends in utilization, conversion rates, and outcomes for minimally invasive approaches to non-metastatic rectal cancer: a national cancer database analysis." Surgical Endoscopy 35(6): 3154-3165.
1. Park, J. S., S. M. Lee, G. S. Choi, S. Y. Park, H. J. Kim, S. H. Song, B. S. Min, N. K. Kim, S. H. Kim and K. Y. Lee (2023). "Comparison of Laparoscopic Versus Robot-Assisted Surgery for Rectal Cancers: The COLRAR Randomized Controlled Trial." Ann Surg 278(1): 31-38.
1. Reyes, R., C. Kindler, K. Smedh and C. Tiselius (2022). "A comparative study of the pathological outcomes of robot-assisted versus open surgery for rectal cancer." Ann Coloproctol.
1. Richards, C. R., S. R. Steele, M. B. Lustik, S. M. Gillern, R. B. Lim, J. T. Brady, A. R. Althans and A. T. Schlussel (2019). "Safe surgery in the elderly: A review of outcomes following robotic proctectomy from the Nationwide Inpatient Sample in a cross-sectional study." Annals of Medicine and Surgery 44: 39-45.
1. Rutgers, M. L., R. Detering, S. X. Roodbeen, R. M. Crolla, J. W. T. Dekker, J. B. Tuynman, C. Sietses, W. A. Bemelman, P. J. Tanis and R. Hompes (2021). "Influence of Minimally Invasive Resection Technique on Sphincter Preservation and Short-term Outcome in Low Rectal Cancer in the Netherlands." Dis Colon Rectum 64(12): 1488-1500.
1. Shah, P. C., A. de Groot, R. Cerfolio, W. C. Huang, C. Song, Y. Li, U. Kreaden and D. S. Oh (2022). "Impact of type of minimally invasive approach on open conversions across ten common procedures in different specialties." Surg Endosc 36(8): 6067-6075.
1. Simon, H. L., T. R. de Paula, M. M. Profeta da Luz, R. P. Kiran and D. S. Keller (2021). "Predictors of Positive Circumferential Resection Margin in Rectal Cancer: A Current Audit of the National Cancer Database." Dis Colon Rectum 64(9): 1096-1105.
1. Simon, H. L., T. Reif de Paula, Z. A. Spigel and D. S. Keller (2022). "National disparities in use of minimally invasive surgery for rectal cancer in older adults." Journal of the American Geriatrics Society 70(1): 126-135.

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1. Smith. H. G., D. Chiranth. C. E. Mortensen and N. H. Schlesinger (2022). "The significance of subdivisions of microscopically positive (R1) margins in colorectal cancer: A retrospective study of a national cancer registry." Colorectal Disease 24(2): 197-209.
1. Somashekhar, S. P., K. R. Ashwin and C. Rohit Kumar (2020). "Robotic Surgery for Rectal Cancer: Hype or Hope? (Indian Experience)." Indian Journal of Surgical Oncology 11(4): 604-612.
1. Somashekhar, S. P., K. R. Ashwin, J. Rajashekhar and S. Zaveri (2015). "Prospective Randomized Study Comparing Robotic-Assisted Surgery with Traditional Laparotomy for Rectal Cancer-Indian Study." Indian J Surg 77(Suppl 3): 788-794.
1. Soriano, C., H. T. Bahnson, J. A. Kaplan, B. Lin, R. Moonka, H. T. Pham, H. F. Kennecke and V. Simianu (2022). "Contemporary, national patterns of surgery after preoperative therapy for stage II/II rectal adenocarcinoma." World Journal of Gastrointestinal Oncology 14(6): 1148-1161.
1. Sujatha-Bhaskar, S., M. D. Jafari, J. V. Gahagan, C. S. Inaba, C. Y. Koh, S. D. Mills, J. C. Carmichael, M. J. Stamos and A. Pigazzi (2017). "Defining the Role of Minimally Invasive Proctectomy for Locally Advanced Rectal Adenocarcinoma." Ann Surg 266(4): 574-581.
1. Sun, Z., J. Kim, M. A. Adam, D. P. Nussbaum, P. J. Speicher, C. R. Mantyh and J. Migaly (2016). "Minimally Invasive Versus Open Low Anterior Resection: Equivalent Survival in a National Analysis of 14,033 Patients With Rectal Cancer." Ann Surg 263(6): 1152-1158.
1. Takemasa, I., A. Hamabe, M. Ito, S. Matoba, J. Watanabe, S. Hasegawa, M. Kotake, M. Inomata, K. Ueda, K. Uehara, K. Sakamoto, M. Ikeda, T. Hanai, T. Konishi, S. Yamaguchi, D. Nakano, S. Yamagishi, K. Okita, A. Ochiai, Y. Sakai and M. Watanabe (2022). "Japanese multicenter prospective study investigating laparoscopic surgery for locally advanced rectal cancer with evaluation of CRM and TME quality (PRODUCT trial)." Ann Gastroenterol Surg 6(6): 767-777.
1. Tang, B., G. Gao, S. Ye, D. Liu, Q. Jiang, J. Ai, X. Lei, J. Shi and T. Li (2022). "Male urogenital function after robot-assisted and laparoscopic total mesorectal excision for rectal cancer: a prospective cohort study." BMC Surg 22(1): 185.
1. Taylor, J. P., M. Stem, A. A. Althumairi, S. L. Gearhart, B. Safar, S. H. Fang and J. E. Efron (2020). "Minimally Invasive Proctectomy for Rectal Cancer: A National Perspective on Short-term Outcomes and Morbidity." World Journal of Surgery 44(9): 3130-3140.
1. Wang, G., Z. Wang, Z. Jiang, J. Liu, J. Zhao and J. Li (2017). "Male urinary and sexual function after robotic pelvic autonomic nerve-preserving surgery for rectal cancer." Int J Med Robot 13(1).
1. Watanabe, J., I. Takemasa, M. Kotake, S. Noura, K. Kimura, H. Suwa, M. Tei, Y. Takano, K. Munakata, S. Matoba, S. Yamagishi, M. Yasui, T. Kato, A. Ishiozawa, Y. Ishii, T. Yabuno, T. Nitta, S. Saito, Y. Saigusa and M. Watanabe (2023). "Blood Perfusion Assessment by Indocyanine Green Fluorescence Imaging for Minimally Invasive Rectal Cancer Surgery (EssentiAL trial): A Randomized Clinical Trial." Annals of Surgery 278(4): E688-E694.

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510(k) Summary

1. Zheng, J., X. Li, J. Wei, Y. Liu and G. Wu (2018). "Short-term quality of life outcomes after robotic versus laparoscopic sphincter preserving resections for rectal cancer." International Journal of Clinical and Experimental Medicine 11(12): 13297-13307.

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Table 9. Bibliography of Clinical Literature on da Vinci Multiport Right Colectomy (n=18)

1. Ahuja, V., L. G. Paredes, I. L. Leeds, M. F. Perkal and J. T. King, Jr. (2023). "Clinical outcomes of elective robotic vs laparoscopic surgery for colon cancer utilizing a large national database." Surg Endosc 37(9): 7199-7205.
1. Anania, G., F. Agresta, E. Artioli, S. Rubino, G. Resta, N. Vettoretto, W. L. Petz, C. Bergamini, A. Arezzo, G. Valpiani, C. Morotti, G. Silecchia and S. CoDIG (2020). "Laparoscopic right hemicolectomy: the SICE (Società Italiana di Chirurgia Endoscopica e Nuove Tecnologie) network prospective trial on 1225 cases comparing intra corporeal versus extra corporeal ileo-colic side-to-side anastomosis." Surg Endosc 34(11): 4788-4800.
1. Chen, S. Y., S. N. Radomski, M. Stem, B. D. Lo, B. Safar, J. E. Efron and C. Atallah (2023). "Safety and Feasibility of ≤24-h Short-Stay Right Colectomies for Primary Colon Cancer." World J Surg 47(9): 2267-2278.
Cheong, J. Y., C. J. Young and C. Byrne (2021). "Does the body mass index impact lymph 4. node yield for colorectal cancer resection, and does operative approach influence this: a review of bi-national colorectal cancer audit database." ANZ Journal of Surgery 91(12): 2707-2713.
1. Clarke, E. M., J. Rahme, T. Larach, A. Rajkomar, A. Jain, R. Hiscock, S. Warrier and P. Smart (2022). "Robotic versus laparoscopic right hemicolectomy: a retrospective cohort study of the Binational Colorectal Cancer Database." J Robot Surg 16(4): 927-933.
1. Dohrn, N., M. F. Klein and I. Gogenur (2021). "Robotic versus laparoscopic right colectomy for colon cancer: a nationwide cohort study." Int J Colorectal Dis 36(10): 2147-2158.
1. Emile, S. H., N. Horesh, Z. Garoufalia, R. Gefen, P. Zhou. V. Strassman and S. D. Wexner (2023). "Robotic and laparoscopic colectomy: propensity score-matched outcomes from a national cancer database." Br J Surg 110(6): 717-726.
1. Farah, E., A. A. Abreu, B. Rail, J. Salgado, G. Karagkounis, H. J. Zeh, 3rd and P. M. Polanco (2023). "Perioperative outcomes of robotic and laparoscopic surgery for colorectal cancer: a propensity score-matched analysis." World J Surg Oncol 21(1): 272.
1. Gomez Ruiz, M., E. Espin-Basany, A. Spinelli, C. Cagigas Fernandez, J. Bollo Rodriguez, J. Maria Enriquez Navascues, T. Rautio, M. Tiskus and G. Mircast Study (2023). "Early outcomes from the Minimally Invasive Right Colectomy Anastomosis study (MIRCAST)." The British journal of surgery 110(9): 1153-1160.
1. Haskins, I. N., T. Ju, M. Skancke, X. Kuang, R. L. Amdur, F. Brody, V. Obias and S. Agarwal (2018). "Right Colon Resection for Colon Cancer: Does Surgical Approach Matter?" J Laparoendosc Adv Surg Tech A 28(10): 1202-1206.
1. Mlambo, B., I. F. Shih, Y. Li and S. M. Wren (2022). "The impact of operative approach on postoperative outcomes and healthcare utilization after colectomy." Surgery (United States) 171(2): 320-327.

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1. Park, J. S., G. S. Choi, S. Y. Park, H. J. Kim and J. P. Ryuk (2012). "Randomized clinical trial of robot-assisted versus standard laparoscopic right colectomy." British Journal of Surgery 99(9): 1219-1226.
1. Park, J. S., H. Kang, S. Y. Park, H. J. Kim, I. T. Woo, I. K. Park and G. S. Choi (2019). "Long-term oncologic after robotic versus laparoscopic right colectomy: a prospective randomized study." Surg Endosc 33(9): 2975-2981.
1. Shah, P. C., A. de Groot, R. Cerfolio, W. C. Huang, C. Song, Y. Li, U. Kreaden and D. S. Oh (2022). "Impact of type of minimally invasive approach on open conversions across ten common procedures in different specialties." Surg Endosc 36(8): 6067-6075.
1. Sorgato, N., E. Mammano, T. Contardo, F. Vittadello, G. Sarzo and E. Morpurgo (2022). "Right colectomy with intracorporeal anastomosis for cancer: a prospective comparison between robotics and laparoscopy." Journal of Robotic Surgery 16(3): 655-663.
1. Sterk, M. F. M., R. Crolla, M. Verseveld, J. W. T. Dekker, G. P. van der Schelling, C. Verhoef and P. B. Olthof (2023). "Uptake of robot-assisted colon cancer surgery in the Netherlands." Surg Endosc 37(11): 8196-8203.
1. Williams, A. D., T. Sun, S. Kakade, S. L. Wong, L. N. Shulman and N. Z. Carp (2021). "Comparison of open and minimally invasive approaches to colon cancer resection in compliance with 12 regional lymph node harvest quality measure." Journal of Surgical Oncology 123(4): 986-996.
1. Wurtz, H. J., L. Bundgaard, H. B. Rahr and E. Frostberg (2022). "Anastomosis technique and leakage rates in minimally invasive surgery for right-sided colon cancer. A retrospective national cohort study." International Journal of Colorectal Disease 37(3): 701-708.