(143 days)
No
The document describes "video and image processing" but does not mention AI, ML, or DNN, nor does it provide a description of any training or test set, which would be expected for an AI model. The system is described as being controlled by a human surgeon.
Yes
The device is intended to assist in surgical procedures (urologic, colorectal, general thoracoscopic, and transoral otolaryngology), which are therapeutic interventions. Its function includes manipulating tissue (grasping, cutting, dissection, approximation, ligation, electrocautery, and suturing) to treat conditions.
No
The da Vinci SP Surgical System is intended to assist in surgical procedures by providing accurate control of surgical instruments. Its function is to perform surgery, not to diagnose medical conditions.
No
The device is a surgical system consisting of hardware components (Surgeon Console, Vision Cart, Patient Cart, instruments, camera, accessories) that physically operate on patients. While it includes software for control and image processing, it is not solely a software device. The description explicitly details multiple hardware components and their functions.
No
Explanation: This device is a surgical system intended for assisting in surgical procedures, not for in vitro examination of specimens derived from the human body.
N/A
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 "transanal local excision (TALE)" as a new representative, specific procedure 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, and 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)
Bench Performance Testing:
Design validation was performed in a male cadaver to confirm the clinical performance of the da Vinci SP Surgical System, including the SP Access Port Kit and SP Cannula with a third-party port under its intended use. Evaluation of the ability to provide robotic and laparoscopic instrument access to the rectum while remaining securely installed during use with either the SP Access Port Kit or compatible third-party port was confirmed. Assessment of instrument motion throughout the TALE procedure, and ability to reach targeted anatomy and complete the procedure was also confirmed. Two complete TALE procedures were performed, one with the SP Access Port kit and another with a third-party port, and covers all issues of safe and effective use of the da Vinci SP Surgical System, with either the SP Access Port Kit or third-party port in the following representative procedure: Transanal local excision (TALE), also known as transanal local resection (TALR) or transanal minimally invasive surgery (TAMIS).
Design verification testing was performed to confirm that insufflation leakage between the SP Cannula when used with the compatible third-party port was within specification.
Published Clinical Data:
Published clinical data comparing transanal local excision (TALE) using the da Vinci SP system to existing hand-held instruments performing the same procedure (referred to as TEM, TAMIS and TEO for handheld devices) were also provided. Peer-reviewed literature published between January 2018 and October 2024 on robotic-assisted TALE using the da Vinci SP system were identified by systematically searching the PubMed, Scopus and Embase databases. After systematic screening, 10 publications including one additional recent publication (submitted manuscript) reporting relevant clinical outcomes for TALE were identified for data review, and 4 of the 10 publications with high LOE (Level of Evidence 4 or better) were included for comparison. Publications for handheld devices performing TEM, TAMIS and TEO were similarly searched and screened, and after inclusion and exclusion criteria were applied, 42 studies for transanal local excisions/resections with Level of Evidence (LOE) 1-3 were identified and included for comparison. Table 1 includes the ranges of average values or rates extracted for each clinical outcome for comparison between approaches and demonstrates similar ranges of outcomes between the surgical approaches listed and a listing of the publications is provided in the bibliography below.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
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.
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.
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
§ 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.
U.S. Food & Drug Administration 510(k) Clearance Letter
Page 1
U.S. Food & Drug Administration
10903 New Hampshire Avenue
Silver Spring, MD 20993
www.fda.gov
Doc ID # 04017.07.05
April 24, 2025
Intuitive Surgical, Inc.
Mike Yramategui
Fellow Regulatory Engineer
1020 Kifer Road
Sunnyvale, California 94086
Re: K243714
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: March 26, 2025
Received: March 26, 2025
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. 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.
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.
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K243714 - Mike Yramategui Page 2
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 (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-reporting-combination-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.
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 Rule"). 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-devices/device-advice-comprehensive-regulatory-assistance/unique-device-identification-system-udi-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-devices/medical-device-safety/medical-device-reporting-mdr-how-report-medical-device-problems.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-
Page 3
K243714 - Mike Yramategui Page 3
assistance/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,
Mark Trumbore -S Digitally signed by Mark Trumbore -S Date: 2025.04.24 11:41:08 -04'00'
Mark Trumbore, Ph.D.
Assistant Director
DHT4A: Division of General Surgery Devices
OHT4: Office of Surgical and Infection Control Devices
Office of Product Evaluation and Quality
Center for Devices and Radiological Health
Enclosure
Page 4
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
Form Approved: OMB No. 0910-0120
Expiration Date: 07/31/2026
See PRA Statement below.
Indications for Use
Submission Number (if known)
K243714
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)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services
Food and Drug Administration
Office of Chief Information Officer
Paperwork Reduction Act (PRA) Staff
PRAStaff@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
Page 5
510(k) Summary [21 CFR § 807.92(c)]
510(k) Summary K243714 Page 1 of 12
I. SUBMITTER INFORMATION
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: April 23, 2024
II. SUBMITTER INFORMATION
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 (K242318)
Reference Device: Applied Medical GelPOINT Path Transanal Access Platform (K171701)
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510(k) Summary K243714 Page 2 of 12
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 "transanal local excision (TALE)" as a new representative, specific procedure 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, 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.
Page 7
510(k) Summary K243714 Page 3 of 12
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.
V. COMPARISON OF INTENDED USE, INDICATIONS FOR USE AND 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 "transanal local excision (TALE)" to the labeling as new representative, specific procedure in the Professional Instructions for Use.
VI. PERFORMANCE DATA
The addition of transanal local excision (TALE) to the labeling 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), general thoracoscopic surgical procedures (K240502) or colorectal surgical procedures (K242318).
Bench Performance Testing
Design validation was performed in a male cadaver to confirm the clinical performance of the da Vinci SP Surgical System, including the SP Access Port Kit and SP Cannula with a third-party port under its intended use. Evaluation of the ability to provide robotic and laparoscopic instrument access to the rectum while remaining securely installed during use with either the SP Access Port Kit or compatible third-party port was confirmed. Assessment of instrument motion throughout the TALE procedure, and ability to reach targeted anatomy and complete the procedure was also confirmed. Two complete TALE procedures were performed, one with the
Page 8
510(k) Summary K243714 Page 4 of 12
SP Access Port kit and another with a third-party port, and covers all issues of safe and effective use of the da Vinci SP Surgical System, with either the SP Access Port Kit or third-party port in the following representative procedure:
- Transanal local excision (TALE), also known as transanal local resection (TALR) or transanal minimally invasive surgery (TAMIS)
Design verification testing was performed to confirm that insufflation leakage between the SP Cannula when used with the compatible third-party port was within specification.
Published Clinical Data
Published clinical data comparing transanal local excision (TALE) using the da Vinci SP system to existing hand-held instruments performing the same procedure (referred to as TEM, TAMIS and TEO for handheld devices) were also provided. Peer-reviewed literature published between January 2018 and October 2024 on robotic-assisted TALE using the da Vinci SP system were identified by systematically searching the PubMed, Scopus and Embase databases. After systematic screening, 10 publications including one additional recent publication (submitted manuscript) reporting relevant clinical outcomes for TALE were identified for data review, and 4 of the 10 publications with high LOE (Level of Evidence 4 or better) were included for comparison. Publications for handheld devices performing TEM, TAMIS and TEO were similarly searched and screened, and after inclusion and exclusion criteria were applied, 42 studies for transanal local excisions/resections with Level of Evidence (LOE) 1-3 were identified and included for comparison. Table 1 includes the ranges of average values or rates extracted for each clinical outcome for comparison between approaches and demonstrates similar ranges of outcomes between the surgical approaches listed and a listing of the publications is provided in the bibliography below.
VII. CONCLUSION
The da Vinci SP Surgical System has the same technological characteristics as it is unmodified from the predicate device, and there are no changes to the intended use or indications for use for these labeling changes.
Design validation testing provided demonstrates the ability of the da Vinci SP Surgical System to perform transanal local excision (TALE). A review of the published literature provides additional confirmation that outcomes of TALE with the da Vinci SP Surgical System are substantially equivalent to existing hand-held devices for performing TALE and do not raise different questions of safety or effectiveness.
Thus, these labeling changes to the da Vinci SP Surgical System are substantially equivalent to the cleared predicate device.
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510(k) Summary K243714 Page 5 of 12
Table 1: SP TALE and Hand-held Devices Literature Comparison
| SP Transanal Local Excision (TALE)ᵃ | Transanal Procedures with Hand-held Devices (TEM/TEO/TAMIS)ᵇ | |
|---|---|---|
| Full and Partial-thickness Resectionᶜ | Partial-thickness Resection Onlyᵈ | |
| # Included Publications (Total Patient Count) | 2 publications¹'³, 43 patients | 2 publications²'⁴, 38 patients |
| Study Type | Prospective, Retrospective | Prospective, Retrospective |
| Level of Evidence (LOE) | 4 | 4 |
| Port/Other instruments used | Da Vinci SP system and SP instruments. Access device: GelPOINT Path Transanal Access Platform (Applied Medical, Rancho Santa Margarita, CA) (n=26), or SP Access Port (n=17) | Da Vinci SP system and SP instruments. Access device: GelPOINT Path Transanal Access Platform (Applied Medical, Rancho Santa Margarita, CA) (n=38) |
| Depth of Dissection | Full-thickness excision in 70.6%³ – 84.6%¹ of patients, partial-thickness resection in 15.4%¹ –29.4%³ of patients | 100%²'⁴ partial-thickness resection |
Patient and Lesion Characteristics
| Average Age | 63.9³ | 60.5⁴ – 68² | 43³⁸ – 76¹⁵ |
| Sex (Male) | 50%¹ – 76%³ | 67.8%⁴ – 86%² | 23%³⁹ – 82.9%¹ |
| Average BMI (range) | 21.0¹ – 38.1¹ | 28.2⁴ – 29.38² | 22.88³⁶ – 28.2¹ |
| ASA Class | I: 3.8%¹ II: 69.2%¹ III: 26.9%¹ | I: 20%² II: 50%² III: 30%² II-III: 82%⁴ | I: 0.8%³⁴ – 45%⁵ II: 45%³⁴ – 85.2%²⁰ III: 0%⁸'²⁰ – 42.4%³⁴ IV: 3.85%²⁶ – 12%³⁴ III-IV: 15.8%² – 31%²² |
| Lesion Type | 29%³ – 38.5%¹ malignant (rectal adenocarcinoma), 61.5%¹ – 71%³ benign preop indication; 29%³ malignant at final pathology | 100%²'⁴ preop benign rectal neoplasms (non-malignant polyps); 20%² – 21.4%⁴ malignant (adenocarcinoma) at final pathology | Benign, Malignant |
| Tumor Staging | T0 to T4 at presentation¹; T1 to T3 at final pathology¹'³ | Benign at preop²'⁴; T1² to unspecified-stage adenocarcinoma⁴ at final pathology | Tis, T1, T2, T3 |
| Average Lesion/Adenoma/Tumor Size (cm) | 2.9¹ | 3.8⁴ – 4.23² | 0.6¹⁴ – 6.7⁷ |
| Average Distance from Anal Verge (cm) | 4.8¹ – 5³ | 7.3² – 9⁴ | 3.3²⁰ – 17³⁴ |
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510(k) Summary K243714 Page 6 of 12
| SP Transanal Local Excision (TALE)ᵃ | Transanal Procedures with Hand-held Devices (TEM/TEO/TAMIS)ᵇ | |
|---|---|---|
| Full and Partial-thickness Resectionᶜ | Partial-thickness Resection Onlyᵈ |
Key Outcomes
| Average Operative Time (minutes) | 32.1³– 198.8¹ | 87.5⁴ – 91.3² | 38²⁹ – 192²⁰ |
| Average EBL (mL) | 5³ – 24.21¹ | NR | 5.00⁴ – 143²³ |
| Transfusion Rate (%) | 0%¹'³ | 0%⁴ | 4.3%¹⁶ – 5.3%¹⁶ |
| Conversion to Open Surgery (%) | 0%¹'³ | 0%⁴ | 0%⁴'²¹ – 5.13%²⁸ |
| Negative Surgical Margin (%) | 100%¹'³ | 100%² | 66%⁵ – 100%⁴'³⁶ |
| Intraoperative Complication Rate (%) | 0%¹'³ | 0%²'⁴ | 0%⁷'²⁷ – 1.8%³¹ |
| 30-day Postoperative Complication Rate (%) | 11.8%³ – 15.4%¹ | 7.1%⁴ – 20%² | 5%¹⁸ – 40%³⁹ |
| Major (C-D grade ≥ III) Complication Rate (%) | NR | NR | 0%²¹'³⁸ – 11%³⁹ |
| Average Length of Hospital Stay (days) | 0³ – 1¹ | 0²'⁴ | 0.4²² – 6.0²⁰ |
| Re-admission/Reoperation rate (%) | Re-admission: 11.8%³ Re-operation: 0%¹'³ | Re-admission: 10%² | 0%³⁶ – 9.1%² |
| Overall Mortality Rate (%) | 0%¹'³ | 0%²'⁴ | 0%¹⁹'²⁸'²⁹'³¹'³⁹'⁴¹ – 7.1%¹² |
Postoperative and Oncological Outcomes
| Delayed or Long-term Postoperative Complication Rate (more than 30 days after surgery) (%) | 0%¹ | NR | 25.9%²⁰ |
| Bleeding | 0%¹– 5.9%³ | 3.6%⁴ – 10%² | 0%⁴'³⁶ – 17%⁵'³⁹ |
| Perforation | NR | NR | 0%⁶'¹⁴'¹⁹'³⁶'³⁸ – 5.5%³² |
| Strictures/Stenosis | NR | NR | 0%⁴'²³'⁴¹ – 4.5%⁵ |
| Wound Dehiscence | 0%³ – 11.5%¹ | 0%²'⁴ | 0%⁵ – 17.6%³¹ |
| Other Complications reported >1% | Pelvic abscess: 3.8%¹ Pain: 5.9%³ | Urinary retention: 3.6%⁴ ─ 10%² | Post-polypectomy syndrome: 22.2%⁶ Infection/abscess: 1.8%²⁸ – 20%¹⁹ Illeus/gastroparesis: 1.1%⁵ Myocardial infarction: 1.1%⁵ Respiratory failure: 1.1%⁵ Urinary tract infection: 3.4%⁵ – 4.3%¹⁶ Urinary retention: 2.6%²⁸ – 13.6%³⁶ |
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510(k) Summary K243714 Page 7 of 12
| SP Transanal Local Excision (TALE)ᵃ | Transanal Procedures with Hand-held Devices (TEM/TEO/TAMIS)ᵇ | |
|---|---|---|
| Full and Partial-thickness Resectionᶜ | Partial-thickness Resection Onlyᵈ | |
| Average Follow-up time (month) | 5.9¹ | 6² |
| Recurrence rate (%) | Local recurrence: 0%¹ | Local recurrence: 0%² |
Peritoneal Entry-related Outcomes
| Peritoneal entry | In one paper¹, the peritoneal cavity was entered in 19% patients (all closed uneventfully with the SP robot; these were all in full-thickness excision cases)¹ In one other paper³, no mention of peritoneal entry³ | No mention of peritoneal entry²'⁴ | 0%⁸ – 23.7%³⁴ |
ᵃ Four publications with LOE 4 or better from 01 Jan 2018 – 22 Oct 2024 including one paper in peer review on SP TALE procedures with the SP Access Port or GelPOINT Path Transanal Access Platform were included as SP TALE Literature.
ᵇ Publications from 01 Jan 2018 – 16 Dec 2023 on TEM/TEO/TAMIS with LOE 1-3 and relevant results were included for this subgroup.
ᶜ Among the four papers in SP TALE literature, two papers with mixed full-thickness excision and partial-thickness resections were included for this subgroup.
ᵈ Among the four papers in SP TALE literature, two papers with all partial-thickness resections were included for this subgroup.
ASA: American Society of Anesthesiologists; BMI: Body mass index; C-D: Clavien-Dindo; EBL: Estimated Blood Loss; LOE: Level of Evidence; NR: Not Reported; TAMIS: Transanal minimally invasive surgery; TEM: Transanal endoscopic microsurgery; TEO: transanal endoscopic operation.
Data represent the smallest ─ largest Mean/Median (for numerical variables) or Rate (for categorical variables) from all publications that reported relevant results for each data category.
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510(k) Summary K243714 Page 8 of 12
Bibliography for SP Transanal Literature (n=4)
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Marks JH, Kunkel E, Salem JF, Martin CT, Anderson B, Agarwal S. First Clinical Experience With Single-Port Robotic Transanal Minimally Invasive Surgery: Phase II Trial of the Initial 26 Cases. Dis Colon Rectum. 2021;64(8):1003-13.
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Ozgur I, Cheong JY, Liska D, Holubar S, Valante MA, Steele SR, et al. Endorobotic submucosal dissection of rectal lesions using the single port robot DaVinci-SP: initial experience of the first 10 cases. ANZ J Surg. 2024;94(4):691-6.
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Friedman G and Specht K. Robotic Trans-Anal Minimally Invasive Surgery (TAMIS) with Da Vinci Single Port (SP) Platform and SP Access Port (AP). Diseases of the Colon & Rectum (submitted August 2024, in peer review)
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Alipouriani A, Ozgur I, Bhatt A, Steele SR, Sommovilla J, Gorgun E. Early Experience with EndoRobotic Submucosal Dissection (ERSD): Pathologic and Short-term Outcomes in the First 28 Patients. Annals of surgery. 2024.
Bibliography for Hand-held Devices Literature (n=42)
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Altaf K, Slawik S, Sochorova D, Gahunia S, Andrews T, Kehoe A, et al. Long-term outcomes of open versus closed rectal defect after transanal endoscopic microscopic surgery. Colorectal Disease. 2021;23(11):2904-10.
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Arezzo A, Lo Secco G, Passera R, Esposito L, Guerrieri M, Ortenzi M, et al. Individual participant data pooled-analysis of risk factors for recurrence after neoadjuvant radiotherapy and transanal local excision of rectal cancer: the PARTTLE study. Tech Coloproctol. 2019;23(9):831-42.
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Atallah C, Taylor JP, Lo BD, Stem M, Brocke T, Efron JE, et al. Local excision for T1 rectal tumours: are we getting better? Colorectal Disease. 2020;22(12):2038-48.
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Bai X, Zhou W, Li Y, Lin G. Transanal endoscopic microsurgery with alternative neoadjuvant imatinib for localized rectal gastrointestinal stromal tumor: a single center experience with long-term surveillance. Surgical Endoscopy. 2021;35(7):3607-17.
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Barendse RM, Musters GD, De Graaf EJR, Van Den Broek FJC, Consten ECJ, Doornebosch PG, et al. Randomised controlled trial of transanal endoscopic microsurgery versus endoscopic mucosal resection for large rectal adenomas (TREND Study). Gut. 2018;67(5):837-46.
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Bisogni D, Manetti R, Talamucci L, Coratti F, Naspetti R, Valeri A, et al. Comparison among different techniques for en-bloc resection of rectal lesions: transanal endoscopic surgery vs. endoscopic submucosal dissection vs. full-thickness resection device with Over-The-Scope Clip® System. Minerva chirurgica. 2020;75(4):234-43.
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Brand M, Reimer S, Reibetanz J, Flemming S, Kornmann M, Meining A. Endoscopic full thickness resection vs. transanal endoscopic microsurgery for local treatment of rectal neuroendocrine tumors - a retrospective analysis. International Journal of Colorectal Disease. 2021;36(5):971-6.
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Bronzwaer MES, Musters GD, Barendse RM, Koens L, de Graaf EJR, Doornebosch PG, et al. The occurrence and characteristics of endoscopically unexpected malignant degeneration in large rectal adenomas. Gastrointestinal Endoscopy. 2018;87(3):688-94.e2.
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Chan T, Karimuddin AA, Raval MJ, Phang PT, Tang V, Brown CJ. Predictors of rectal adenoma recurrence following transanal endoscopic surgery: a retrospective cohort study. Surg Endosc. 2020;34(8):3398-407.
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Dekkers N, Dang H, van der Kraan J, le Cessie S, Oldenburg PP, Schoones JW, et al. Risk of recurrence after local resection of T1 rectal cancer: a meta-analysis with meta-regression. Surg Endosc. 2022;36(12):9156-68.
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Elhaj A, O' Reilly M, Mulligan E. Transanal Endoscopic Microsurgery (TEM) for Early Rectal Cancer. Ir Med J. 2021;114(9).
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Gascon MA, Aguilella V, Martinez T, Antinolfi L, Valencia J, Ramírez JM. Local full-thickness excision for sessile adenoma and cT1-2 rectal cancer: long-term oncological outcome. Langenbecks Arch Surg. 2022;407(6):2431-9.
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Jin R, Bai X, Xu T, Wu X, Wang Q, Li J. Comparison of the efficacy of endoscopic submucosal dissection and transanal endoscopic microsurgery in the treatment of rectal neuroendocrine tumors ≤ 2 cm. Frontiers in Endocrinology. 2023;13.
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Jones HJS, al-Najami I, Baatrup G, Cunningham C. Local excision after (near) complete response of rectal cancer to neoadjuvant radiation: does it add value? International Journal of Colorectal Disease. 2021;36(5):1017-22.
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Kaymak Ş, Sinan H, Saydam M, Aktaş HH, Gecim E, Demirbas S. Comparison of Transanal Minimally Invasive Surgery (TAMIS) and Transanal Endoscopic Operations (TEO). Indian J Surg. 2020;82(3):319-24.
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Khan K, Hunter IA, Manzoor T. Should the rectal defect be sutured following TEMS/TAMIS carried out for neoplastic rectal lesions? A meta-analysis. Ann R Coll Surg Engl. 2020;102(9):647-53.
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Khoury W, Dauod M, Khalefah M, Duek S, Issa N. The outcome of transanal endoscopic microsurgery and adjuvant radiotherapy in patients with high-risk T1 rectal cancer. Journal of Minimal Access Surgery. 2022;18(2):212-7.
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Kim M, Bareket R, Eleftheriadis NP, Kedia P, Seewald S, Groth S, et al. Endoscopic Submucosal Dissection (ESD) Offers a Safer and More Cost-effective Alternative to Transanal Endoscopic Microsurgery (TEM): An International Collaborative Study. Journal of Clinical Gastroenterology. 2023;57(5):486-9.
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Kimura CMS, Kawaguti FS, Nahas CSR, Marques CFS, Segatelli V, Martins BC, et al. Long-term outcomes of endoscopic submucosal dissection and transanal endoscopic microsurgery for the treatment of rectal tumors. Journal of Gastroenterology and Hepatology (Australia). 2021;36(6):1634-41.
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Kouladouros K, Baral J. Transanal Endoscopic Microsurgical Submucosal Dissection for Recurrent Rectal Adenomas. Dig Dis. 2023;41(1):89-95.
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Lee L, Kelly J, Nassif GJ, Keller D, Debeche-Adams TC, Mancuso PA, et al. Establishing the learning curve of transanal minimally invasive surgery for local excision of rectal neoplasms. Surgical Endoscopy. 2018;32(3):1368-76.
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Li W, Xiang XX, Da Wang H, Cai CJ, Cao YH, Liu T. Transanal endoscopic microsurgery versus radical resection for early-stage rectal cancer: a systematic review and meta-analysis. Int J Colorectal Dis. 2023;38(1):49.
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McCarty TR, Bazarbashi AN, Hathorn KE, Thompson CC, Aihara H. Endoscopic submucosal dissection (ESD) versus transanal endoscopic microsurgery (TEM) for treatment of rectal tumors: a comparative systematic review and meta-analysis. Surg Endosc. 2020;34(4):1688-95.
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Naughton AP, Ryan É J, Bardon CT, Boland MR, Aherne TM, Kelly ME, et al. Endoscopic management versus transanal surgery for early primary or early locally recurrent rectal neoplasms-a systematic review and meta-analysis. Int J Colorectal Dis. 2020;35(12):2347-59.
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Ortenzi M, Arezzo A, Ghiselli R, Allaix ME, Guerrieri M, Morino M. Transanal endoscopic microsurgery after the attempt of endoscopic removal of rectal polyps. Surgical Endoscopy. 2022;36(10):7738-46.
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Ortenzi M, Ghiselli R, Gesuita R, Guerrieri M. Transanal endoscopic microsurgery: indications, tips and long-term results. A single center experience. Minerva chirurgica. 2020;75(3):129-40.
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R DEV, Cianchi F, Coratti F. Non-conventional applications for transanal endoscopic microsurgery. A single center experience and a systematic review of literature. Minerva Surg. 2022;77(2):147-56.
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Ramkumar J, Karimuddin AA, Phang PT, Raval MJ, Brown CJ. Peritoneal perforation during transanal endoscopic microsurgery is not associated with significant short-term complications. Surgical Endoscopy. 2019;33(3):849-53.
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Ramkumar J, Letarte F, Karimuddin AA, Phang PT, Raval MJ, Brown CJ. Assessing the safety and outcomes of repeat transanal endoscopic microsurgery. Surgical Endoscopy. 2019;33(6):1976-80.
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Ran L, Chuanwang Y, Wei S, Wenguang Y, Liang H, Jiancheng Z, et al. Risk factors and treatment of rectal stenosis after transanal endoscopic microsurgery. Colorectal Disease. 2022;24(1):85-92.
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Rizzo G, Pafundi DP, Sionne F, D'Agostino L, Pietricola G, Gambacorta MA, et al. Preoperative chemoradiotherapy affects postoperative outcomes and functional results in patients treated with transanal endoscopic microsurgery for rectal neoplasms. Techniques in Coloproctology. 2021;25(3):319-31.
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Sagae VMT, Ribeiro IB, de Moura DTH, Brunaldi VO, Logiudice FP, Funari MP, et al. Endoscopic submucosal dissection versus transanal endoscopic surgery for the treatment of early rectal tumor: a systematic review and meta-analysis. Surg Endosc. 2020;34(3):1025-34.
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Serra-Aracil X, Badia-Closa J, Pallisera-Lloveras A, Mora-López L, Serra-Pla S, Garcia-Nalda A, et al. Management of intra- and postoperative complications during TEM/TAMIS procedures: a systematic review. Minerva Surg. 2021;76(4):343-9.
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Serra-Aracil X, Flores-Clotet R, Mora-López L, Pallisera-Lloveras A, Serra-Pla S, Navarro-Soto S. Transanal endoscopic microsurgery in very large and ultra large rectal neoplasia. Techniques in Coloproctology. 2019;23(9):869-76.
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Serra-Aracil X, Gràcia R, Mora-López L, Serra-Pla S, Pallisera-Lloveras A, Labró M, et al. How to deal with rectal lesions more than 15cm from the anal verge through transanal endoscopic microsurgery. American Journal of Surgery. 2019;217(1):53-8.
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Shen JM, Zhao JY, Ye T, Gong LF, Wang HP, Chen WJ, et al. Transanal minimally invasive surgery vs endoscopic mucosal resection for rectal benign tumors and rectal carcinoids: A retrospective analysis. World Journal of Clinical Cases. 2020;8(19):4311-9.
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Su MY, Chiu CT. Ligation-assisted endoscopic mucosal resection has high complete resection rate in rectal carcinoid tumor. BMC Gastroenterol. 2021;21(1):464.
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