(109 days)
No
The document explicitly states "There are no changes to the technological characteristics of the cleared da Vinci Xi or X Surgical Systems proposed in this submission." and there are no mentions of AI, DNN, or ML in the text. The focus is on expanding the indicated procedures for existing, software-controlled electromechanical systems.
Yes
The device assists in surgical procedures that directly treat medical conditions, which falls under the definition of a therapeutic device.
No.
The device is described as a surgical system intended to assist in the accurate control of surgical instruments for various procedures, not for diagnosis.
No
The device description explicitly states that the da Vinci Xi and X Surgical Systems are "software-controlled, electro-mechanical systems" and consist of hardware components like a Surgeon Console, Patient Side Cart, and Vision Side Cart. This indicates it is not a software-only device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly describes a surgical system designed to assist surgeons in performing various surgical procedures on patients. This involves direct interaction with the patient's body and tissues during surgery.
- Device Description: The device description details a software-controlled, electro-mechanical system consisting of a Surgeon Console, Patient Side Cart, and Vision Side Cart, used with instruments and accessories for surgical manipulation. This is consistent with a surgical robot, not a device used to examine specimens in vitro.
- Lack of IVD Characteristics: There is no mention of the device being used to test or examine specimens (blood, tissue, urine, etc.) outside of the body to provide information for diagnosis, monitoring, or treatment.
IVD devices are specifically designed to perform tests on samples taken from the human body. This device is designed to perform surgical procedures on the human body.
N/A
Intended Use / Indications for Use
The Intuitive Surgical Endoscopic Instrument Control System (da Vinci Surgical System. Model 184000) is intended to assist in the accurate control of Intuitive Surgical Endoscopic Instruments including rigid endoscopes, blunt and sharp endloscopic dissectors, scalpels, forceps/pick-ups, needle holders, endoscopic retractors, electrocautery and accessories for endoscopic manipulation of tissue, including grasping, cutting, blunt and sharp dissection, approximation, ligation, electrocautery, suturing, and delivery and placement of microwave and cryogenic ablation probes and accessories, during urologic surgical procedures, general laparoscopic surgical procedures, gynecologic laparossopic surgical procedures, general thoracoscopic surgical procedures and thoracoscopically-assisted cardiotomy procedures. The system can also be employed with adjunctive mediastinotomy to perform coronary anastomosis during cardiac revascularization. The system is indicated for adult and pediatic use. It is intended to be used by trained physicians in an operating room environment in accordance with the representative, specific procedures set forth in the Professional Instructions for Use.
Product codes (comma separated list FDA assigned to the subject device)
NAY
Device Description
This 510(k) is for expansion of the representative, specific procedures via labeling modification, to include the following additional representative, specific procedures under the previously cleared "general laparoscopic surgical procedures" indication for the da Vinci Xi Surgical System (K131861) and the da Vinci X Surgical System (K171294) : Colectomy (Right, Left, Transverse, Total, Hemi & Sigmoidectomy);- Small Bowel Resection; Rectopexy; Intersphincteric Resection (ISR); and Low Anterior Resection/Total Mesorectal Excision (LAR/TME) and Abdominoperineal Resection (APR). There are no changes to the technological characteristics of the cleared da Vinci Xi or X Surgical Systems proposed in this submission. The da Vinci Xi and X Surgical Systems, Models IS4000 and IS4200, are softwarecontrolled, electro-mechanical systems designed for surgeons to perform minimally invasive surgery. The Model IS4000 and Model IS4200 Surgical Systems consist of a Surgeon Console, a Patient Side Cart (PSC), and a Vision Side Cart (VSC) and are used with an Endoscope, EndoWrist Instruments, and Accessories.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
adult and pediatric 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)
Pre-Clinical Animal Study Data:
Animal performance data were provided in this premarket notification, including the results from seven (7) evaluations in a total of 32 animals demonstrating use of da Vinci Xi Surgical System in the following procedures: Nephrectomy, Pyeloplasty, Hysterectomy and Salpingectomy/Oophorectomy (Adnexectomy), Nissen Fundoplication, Colectomy, Mitral Valve Repair and Small Bowel Anastomosis. These data were previously submitted in support of the da Vinci Xi Surgical System (K131861), the da Vinci Xi Stapler 45 (K140553) and the da Vinci Xi labeling modification to add specific procedures under the gynecologic laparoscopic surgical procedures general indication (K152578); general thoracoscopic surgical procedures and thoracoscopically-assisted cardiotomy procedures indication (K153276); and urologic surgical procedures general indication (K161178). These data also support inclusion of the additional representative, specific procedures.
Clinical Study Data:
Published clinical data support use of the da Vinci Xi and X Surgical Systems in the subject representative, specific procedures that fall under the cleared "general laparoscopic surgical procedures" Indication for Use. Clinical data were not provided for all of the representative, specific procedures. Instead, clinical data were provided only for the most complex/highest risk representative, specific procedures of Low Anterior Resection / Total Mesorectal Excision "LAR/TME" and Intersphincteric Resection "ISR" (referred to as the "umbrella" procedures). The published data on these "umbrella" procedures were deemed sufficient to cover the less complex/lower risk procedures (referred to as "covered" procedures), so published clinical data on the covered procedures were not provided.
Umbrella Procedure 1: Low Anterior Resection/Total Mesorectal Excision
Study Type: Published clinical data, including a prospective randomized controlled trial, meta-analyses, systematic reviews and large database comparative studies.
Sample Size: Ranges from 25 to 5935 subjects across 11 publications.
Key Results:
- Mortality: associated with comparable mortality rates,
- Transfusions: comparable or lower blood transfusion rates and EBL volumes,
- Length of Stay: comparable or shorter lengths of hospital stay,
- Complications: comparable or lower complication rates,
- Surgical Margins: comparable rates of positive surgical margins
- Anastomotic Leak: comparable anastomotic leak rates; and,
- ED: comparable or lower erectile dysfunction ED rates as compared to both open and laparoscopic surgical procedures.
- Operative Time: Increased operative times were associated with da Vinci procedures as compared to open and laparoscopic procedures. However, this increase was not associated with an increase in the mortality or complication rates.
- Urologic Function: Additionally, these publications reported comparable urologic function and comparable or lower conversion rates for da Vinci-assisted procedures as compared to laparoscopic procedures.
Umbrella Procedure 2: Intersphincteric Resection
Study Type: Published clinical data from two (2) publications, one retrospective comparative cohort study and one prospective comparative cohort study.
Sample Size: Ranges from 40 to 114 subjects in the two publications.
Key Results:
- Mortality: comparable mortality rates,
- Transfusions: comparable blood transfusion rates and EBL volumes,
- Length of Stay: comparable lengths of hospital stay,
- Complications: comparable complication rates,
- Surgical Margins: comparable rates of positive surgical margins,
- Anastomotic Leak: comparable anastomotic leak rates,
- ED: lower erectile dysfunction ED rates; and,
- Continence: comparable or higher fecal continence rates as compared to both open and laparoscopic surgical procedures.
- Operative Time: Increased operative times were associated with da Vinci procedures as compared to open and laparoscopic procedures. However, this increase was not associated with an increase in the mortality or complication rates.
- Urologic Function: Additionally, these publications reported comparable urologic function and comparable conversion rates for da Vinci-assisted procedures as compared to laparoscopic procedures.
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.
K131861, K152578, K153276, K161178, K170713, K171294, K081137, K123463, K090993
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.
Not Found
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.
0
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September 19, 2017
Intuitive Surgical, Inc. % Ms. Cindy Domecus Principal, Domecus Consulting Services, LLC & Chief Regulatory Advisor, Intuitive Surgical Domecus Consulting Services LLC 1171 Barroilhet Drive Hillsborough, California 94010
Re: K171632
Trade/Device Name: da Vinci Xi Surgical System Regulation Number: 21 CFR 876.1500 Regulation Name: Endoscope and Accessories Regulatory Class: Class II Product Code: NAY Dated: August 11, 2017 Received: August 15, 2017
Dear Ms. Domecus:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Actinclude 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.
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
1
Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education (DICE) at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education (DICE) at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerelv.
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For Binita S. Ashar, M.D., M.B.A., F.A.C.S. Director Division of Surgical Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known)
Device Name
da Vinci Surgical System, Model IS4000, and EndoWrist Instruments and Accessories
Indications for Use (Describe)
The Intuitive Surgical Endoscopic Instrument Control System (da Vinci Surgical System. Model 184000) is intended to assist in the accurate control of Intuitive Surgical Endoscopic Instruments including rigid endoscopes, blunt and sharp endloscopic dissectors, scalpels, forceps/pick-ups, needle holders, endoscopic retractors, electrocautery and accessories for endoscopic manipulation of tissue, including grasping, cutting, blunt and sharp dissection, approximation, ligation, electrocautery, suturing, and delivery and placement of microwave and cryogenic ablation probes and accessories, during urologic surgical procedures, general laparoscopic surgical procedures, gynecologic laparossopic surgical procedures, general thoracoscopic surgical procedures and thoracoscopically-assisted cardiotomy procedures. The system can also be employed with adjunctive mediastinotomy to perform coronary anastomosis during cardiac revascularization. The system is indicated for adult and pediatic use. It is intended to be used by trained physicians in an operating room environment in accordance with the representative, specific procedures set forth in the Professional Instructions for Use.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| X Prescription Use (Part 21 CER 801 Subnart D) | Over-The-Counter Use (21 CFR 801 Subnart C) |
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3
510(k) Summary (21 CFR § 807.92(c))
I. SUBMITTER INFORMATION
| Submitter: | Intuitive Surgical, Inc.
1266 Kifer Road
Sunnyvale, CA 94086 |
|------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact: | Cindy Domecus, R.A.C. (US & EU)
Principal, Domecus Consulting Services LLC
Chief Regulatory Advisor to Intuitive Surgical
Telephone: 650.343.4813
Fax: 650.343.7822
Email: domecusconsulting@comcast.net |
| Date Summary Prepared: | September 19, 2017 |
II. SUBJECT DEVICE INFORMATION
| Device Trade Name: | da Vinci® Surgical Systems, Model IS4000 and Model IS4200 |
|---|---|
| Common Name: | System, Surgical, Computer Controlled Instrument |
| Classification Name: | Endoscope and Accessories (21 CFR §876.1500) |
| Regulatory Class: | II |
| Product Code: | NAY |
| Submission Type: | Traditional 510(k) |
III. PREDICATE DEVICE INFORMATION:
Intuitive Surgical da Vinci Surgical Systems, Models IS4000 and IS4200 Predicate Device: (K131861, K152578, K153276, K161178, K170713, K171294) Intuitive Surgical da Vinci Surgical System, Model IS3000 (K081137, K123463, K090993)
IV. DEVICE DESCRIPTION:
This 510(k) is for expansion of the representative, specific procedures via labeling modification, to include the following additional representative, specific procedures under the previously cleared "general laparoscopic surgical procedures" indication for the da Vinci Xi Surgical System (K131861) and the da Vinci X Surgical System (K171294) : Colectomy (Right, Left, Transverse, Total, Hemi & Sigmoidectomy);- Small Bowel Resection; Rectopexy; Intersphincteric Resection (ISR); and Low Anterior Resection/Total Mesorectal Excision (LAR/TME) and Abdominoperineal Resection (APR). There are no changes to the technological characteristics of the cleared da Vinci Xi or X Surgical Systems proposed in this submission. The da Vinci Xi and X Surgical Systems, Models IS4000 and IS4200, are softwarecontrolled, electro-mechanical systems designed for surgeons to perform minimally invasive surgery. The Model IS4000 and Model IS4200 Surgical Systems consist of a Surgeon Console, a Patient Side Cart (PSC), and a Vision Side Cart (VSC) and are used with an Endoscope, EndoWrist Instruments, and Accessories.
ี "Colectomy" is already a cleared, representative, specific procedure under K131861. This application requests a revision to the labeling to specify "Right, Left, Transverse, Total, Hemi and Sigmoidectomy" colectomy procedures.
4
V. INDICATIONS FOR USE
The Intuitive Surgical Endoscopic Instrument Control System (da Vinci Surgical System, Models: IS4000 and IS4200) is intended to assist in the accurate control of Intuitive Surgical Endoscopic Instruments including rigid endoscopes, blunt and sharp endoscopic dissectors, scalpels, forceps/pick-ups, needle holders, endoscopic retractors, electrocautery and accessories for endoscopic manipulation of tissue, including grasping, cutting, blunt and sharp dissection, approximation, ligation, electrocautery, suturing, and delivery and placement of microwave and cryogenic ablation probes and accessories, during urologic surgical procedures, general laparoscopic surgical procedures, gynecologic laparoscopic surgical procedures, general thoracoscopic surgical procedures and thoracoscopically-assisted cardiotomy procedures. The system can also be employed with adjunctive mediastinotomy to perform coronary anastomosis during cardiac revascularization. The system is indicated for adult and pediatric use. It is intended to be used by trained physicians in an operating room environment in accordance with the representative, specific procedures set forth in the Professional Instructions for Use.
Precaution for Representative Uses
The demonstration of safety and effectiveness for the representative specific procedures was based on evaluation of the device as a surgical tool and did not include evaluation of outcomes related to the treatment of cancer (overall survival, disease-free survival, local recurrence) or treatment of the patient's underlying disease/condition. Device usage in all surgical procedures should be guided by the clinical judgment of an adequately trained surgeon.
VI. COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE PREDICATE DEVICE
There are no changes to the technological characteristics of the cleared da Vinci Xi or X Surgical Systems (IS4000 and IS4200) proposed in this submission.
VII. PERFORMANCE DATA
Pre-Clinical Animal Study Data
Animal performance data were provided in this premarket notification, including the results from seven (7) evaluations in a total of 32 animals demonstrating use of da Vinci Xi Surgical System in the following procedures: Nephrectomy, Pyeloplasty, Hysterectomy and Salpingectomy/Oophorectomy (Adnexectomy), Nissen Fundoplication, Colectomy, Mitral Valve Repair and Small Bowel Anastomosis. These data were previously submitted in support of the da Vinci Xi Surgical System (K131861), the da Vinci Xi Stapler 45 (K140553) and the da Vinci Xi labeling modification to add specific procedures under the gynecologic laparoscopic surgical procedures general indication (K152578); general thoracoscopic surgical procedures and thoracoscopically-assisted cardiotomy procedures indication (K153276); and urologic surgical procedures general indication (K161178). These data also support inclusion of the additional representative, specific procedures.
5
Clinical Study Data
Published clinical data support use of the da Vinci Xi and X Surgical Systems in the subject representative, specific procedures that fall under the cleared "general laparoscopic surgical procedures" Indication for Use. Clinical data were not provided for all of the representative, specific procedures. Instead, clinical data were provided only for the most complex/highest risk representative, specific procedures of Low Anterior Resection / Total Mesorectal Excision "LAR/TME" and Intersphincteric Resection "ISR" (referred to as the "umbrella" procedures). The published data on these "umbrella" procedures were deemed sufficient to cover the less complex/lower risk procedures (referred to as "covered" procedures), so published clinical data on the covered procedures were not provided.
Umbrella Procedures
Umbrella Procedure 1: Low Anterior Resection/Total Mesorectal Excision
Published clinical data were provided for the "Low Anterior Resection/Total Mesorectal Excision" umbrella procedure. Eleven (11) publications were identified for this umbrella procedure based on specific search criteria and filters. These publications included a prospective randomized controlled trial, meta-analyses, systematic reviews and large database comparative studies. A detailed summary of the published clinical data on this procedure is provided in Tables 1A and 1B below.
The findings from the LAR/TME publications show that da Vinci-assisted procedures are:
- Mortality: associated with comparable mortality rates,
- Transfusions: comparable or lower blood transfusion rates and EBL volumes,
- Length of Stay: comparable or shorter lengths of hospital stay,
- Complications: comparable or lower complication rates,
- Surgical Margins: comparable rates of positive surgical margins
- Anastomotic Leak: comparable anastomotic leak rates; and,
- ED: comparable or lower erectile dysfunction ED rates as compared to both open and ● laparoscopic surgical procedures.
- . Operative Time: Increased operative times were associated with da Vinci procedures as compared to open and laparoscopic procedures. However, this increase was not associated with an increase in the mortality or complication rates.
- . Urologic Function: Additionally, these publications reported comparable urologic function and comparable or lower conversion rates for da Vinci-assisted procedures as compared to laparoscopic procedures.
Umbrella Procedure 2: Intersphincteric Resection
Published clinical data were provided for the "Intersphincteric Resection" umbrella procedure. Two (2) publications provided ISR data. One (1) publication reported the results from a retrospective comparative cohort study and one (1) publication reported the results from a prospective comparative
6
cohort study. A summary of the published clinical data on this procedure is provided in Tables 2A and 2B below.
The findings from the ISR publications show that da Vinci-assisted procedures are associated with:
- Mortality: comparable mortality rates,
- Transfusions: comparable blood transfusion rates and EBL volumes,
- Length of Stay: comparable lengths of hospital stay,
- Complications: comparable complication rates,
- Surgical Margins: comparable rates of positive surgical margins,
- Anastomotic Leak: comparable anastomotic leak rates,
- ED: lower erectile dysfunction ED rates; and,
- Continence: comparable or higher fecal continence rates? as compared to both open and laparoscopic surgical procedures.
- . Operative Time: Increased operative times were associated with da Vinci procedures as compared to open and laparoscopic procedures. However, this increase was not associated with an increase in the mortality or complication rates.
- Urologic Function: Additionally, these publications reported comparable urologic function and comparable conversion rates for da Vinci-assisted procedures as compared to laparoscopic procedures.
Covered Procedures
The published data on the above cited LAR/TME and ISR umbrella procedures were extrapolated to support clearance of the following covered procedures:
- . Colectomy (Right, Left, Transverse, Total, Hemi & Sigmoidectomy),4
- . Small Bowel Resection,
- Rectopexy, and
- Abdominoperineal Resection (APR).
VIII. CONCLUSION
Based on the information provided in this premarket notification for expansion of the representative, specific procedures, the inclusion of the following additional representative, specific procedures under the da Vinci Xi and X Surgical Systems "general laparoscopic surgical procedure" indication is substantially equivalent to the predicate devices (da Vinci Xi and X Surgical Systems): Colectomy (Right, Left, Transverse, Total, Hemi & Sigmoidectomy); $ Small Bowel Resection; Rectopexy; Intersphincteric Resection (ISR); and Low Anterior Resection/Total Mesorectal Excision (LAR/TME) and Abdominoperineal Resection (APR).
4 "Colectomy" is already a cleared, representative, specific procedure under K131861. This application requests a revision to the labeling to specify "Right, Left, Transverse, Total, Hemi and Sigmoidectomy" colectomy procedures.
7
| Publications | Sample Size (N) | | Operative Time
(minutes) | Estimated Blood
Loss "EBL" (ml) | Length of Stay
(days) | PostOp
Complications (%) | IntraOp
Complications (%) | Mortality Rate
(%) | Transfusion Rate
(%) | Publications | | Sample Size (N) | PSM Rate (%) | Urologic
Function | Conversion
Rate (%) | No. of Lymph
Nodes Harvested | CRM /
Positive CRM
Rate (%) | DRM /
Positive DRM
Rate (%) | Anastomotic
Leak Rate (%) | Erectile
Dysfunction | |
|--------------------------|-----------------|------|-----------------------------|------------------------------------|--------------------------|-----------------------------|------------------------------|-----------------------|-------------------------|----------------|----------|-----------------|--------------|-------------------------------------------------------|------------------------|---------------------------------|-----------------------------------|-----------------------------------|------------------------------|-----------------------------------|--------------|
| 1. Midura
(2015) | da Vinci | 331 | Not Reported | Not Reported | 5 | Not Reported | Not Reported | 1.20 | Not Reported | 1. Midura | da Vinci | 331 | 4.30 | | | 71.6% ≥12 | | | | | |
| | Open | 4403 | | | 6 | | | 1.70 | | (2015) | Open | 4403 | 6.10 | Not Reported | Not
Reported | 66.3% ≥12 | Not Reported | Not Reported | Not Reported | Not Reported | |
| | Lap | 5935 | | | 5 | | | 1.20 | | | Lap | 5935 | 4.70 | | | 68.7% ≥12 | | | | | |
| 2. Liao
(2016) | da Vinci | 498 | 191 - 337.9 | 0 – 187.51 | 6 – 10.8 | 25.7 | Not Reported | 1.1 | 4.6 | 2. Liao | da Vinci | 498 | | | Not
Reported | 17.4 | 8.41 | 2.08 | 6.63 | | |
| | Open | 576 | 124 - 273.8 | 120 – 275.481 | 7 - 16 | 26.6 | | 1.5 | 7.9 | (2016) | Open | 576 | Not Reported | Not Reported | | 16.5 | 8.62 | 2.02 | 4.51 | Not Reported | |
| 3. Somashekhar
(2015) | da Vinci | 25 | 310.3 | 165.14 | 7.52 | 0/02 | 4 | 0 | Not Reported | 3. Somashakher | da Vinci | 25 | 0 | | 0 | 16.88 | 0 | 3.6 cm / 0% | 0 | 18%1 | |
| | Open | 25 | 246.3 | 406.04 | 13.24 | 16/42 | 0 | 0 | | (2015) | Open | 25 | 0 | Not Reported | N/A | 15.2 | 0 | 2.4 cm / 0% | 4 | 26%1 | |
| 4. Lee
(2015) | da Vinci | 1043 | 202 – 396.5 | 45.7 – 188.8 | 2.9 – 11.9 | Not Reported | Not Reported | Not Reported | Not Reported | 4. Lee | da Vinci | 1043 | | 3mo:3.6 - 8.364
6mo: 3.5 - 84
12mo: 3.53 - 64 | 1.19 | 10.3 - 20 | Not Reported | Not Reported | 0 - 20 | 3mo:3.8 – 8.02
6mo:2.4 – 4.52 | |
| | Lap | 1181 | 158.1 - 298.8 | 59.2 - 229.2 | 3.9 - 13.5 | | | | | (2015) | Lap | 1181 | Not Reported | 3mo: 5.5 - 11.74
6mo: 3.2 - 8.24
12mo: 4.2 - 84 | 6.50 | 11.07 - 17.4 | | | 2.7 - 14 | 3mo: 5.9 – 132
6mo: 4.5 – 6.82 | |
| 5. Lin
(2011) | da Vinci | 268 | 202 – 232.6 | 100 – 137.40 | 6.9 – 11.9 | 22.01 | Not Reported | Not Reported | Not Reported | 5. Lin | da Vinci | 268 | | | 1.87 | 15.3 | 1.69% | 2.8 | | | |
| | Lap | 393 | 158.10 - 208 | 127 – 150 | 8.7 – 9.8 | 19.34 | | | | (2011) | Lap | 393 | Not Reported | Not Reported | 7.63 | 13.8 | 3.17% | 3.6 | Not Reported | Not Reported | |
| 6. Memon
(2012) | da Vinci | 353 | 190.1 - 385.3 | Not Reported | 5.7 - 11.9 | 10.7 – 32.2 | Not Reported | Not Reported | Not Reported | Not Reported | 6. Memon | da Vinci | 353 | | | 1.42 | MD5:-0.9 | 3.1 | 2.0 - 4.0 | | |
| | Lap | 401 | 168.6 - 315.0 | | 6 - 14.4 | 18.9 – 27.1 | | | | | (2012) | Lap | 401 | Not Reported | Not Reported | 7.73 | [-1.94, 1.80] | 3.2 | 2.0 - 4.5 | Not Reported | Not Reported |
| 7. Sun Y
(2016) | da Vinci | 1217 | Not Reported | Not Reported | 5 | 16 | Not Reported | 0.40 | Not Reported | 7. Sun Y | da Vinci | 1217 | 7 | | 8.22 | 16.8 | 4.76 | 3.5% | | | |
| | Lap | 4700 | | | 5 | 19.1 | | 0.76 | | (2016) | Lap | 4700 | 7 | Not Reported | 15.76 | 16.4 | 9.3 | 4% | Not Reported | Not Reported | |
| 8. Sun Z
(2015) | da Vinci | 324 | 190.1 - 325.5 | | 4 - 8 | Not Reported | Not Reported | Not Reported | Not Reported | 8. Sun Z | da Vinci | 324 | Not Reported | Not Reported | 0 | 15 | 5 | Not Reported | Not Reported | Not Reported | |
| | Lap | 268 | 190 - 280 | Not Reported | 3.6 - 10 | | | | | (2015) | Lap | 268 | | | 7.94 | 14 | 5 | | | | |
| 9. Trastulli
(2012) | da Vinci | 125 | 190.1 - 385.3 | | 5.7 - 11.9 | 29.30 | Not Reported | 0 | Not Reported | 9. Trastulli | da Vinci | 125 | | | 2.8 | 13.1 - 19.4 | 2.8 | 2 - 3.6 | 8 | | |
| | Lap | 156 | 158.1 - 297.3 | Not Reported | 6.6 - 14.4 | 23.10 | | 0 | | (2012) | Lap | 156 | Not Reported | Not Reported | 6.7 | 15.9 - 17 | 4.0 | 2 – 3.8 | 6.3 | Not Reported | |
| 10. Xiong
(2014) | da Vinci | 554 | 202 - 309.7 | 100 – 200 | 6.5 - 11.9 | 10 – 32.4 | Not Reported | 0 | Not Reported | 10. Xiong | da Vinci | 554 | | | 1.08 | 10.3 - 19.4 | 2.74 | 1.9 - 2.8 | 4 - 11 | 3.3 – 5.53 | |
| | Lap | 675 | 158.1 - 315 | 126.2 - 300 | 6 - 13.5 | 12.2 – 27.9 | | 0 | | (2015) | Lap | 675 | Not Reported | Not Reported | 5.19 | 11.1 - 17 | 5.78 | 2 - 4.5 | 2.7 - 14 | 16.6 – 43.33 | |
| 11. Yang
(2012) | da Vinci | 300 | 190.1 - 296 | 100 – 200 | 5.7 - 11.9 | 10.7 – 32.2 | Not Reported | Not Reported | Not Reported | 11. Yang | da Vinci | 300 | | Not Reported | 1.67 | 10.3 - 20 | 0 - 7.1 | 2 - 4 | 1.8 - 13.6 | | |
| | Lap | 426 | 158.1 - 315 | 127 - 300 | 6 – 9.8 | 12.2 – 27.1 | | | | (2012) | Lap | 426 | Not Reported | | 7.98 | 11.1 - 21 | 0 - 8.8 | 2 – 4.5 | 2.7 – 10.2 | Not Reported | |
TABLE 1A: da Vinci vs. Open and da Vinci vs. Laparoscopic Low Anterior Resection/Total Mesorectal Excision
1 Intraoperative Transfusions were also reported (robotic cohort: 1.9 - 5.4%, open cohort: 0 – 12.4%)
2Minor and Major Complications Reported
8
TABLE 1B: da Vinci vs. Open and da Vinci vs. Laparoscopic Low Anterior Resection/Total Mesorectal Excision
" Erectle dysfunction and retrograde ejaculation were patients during follow-up using the European Organization for Research and Treatment of Cancer (EORTC) questionnaire QLQ-C38. A total of 18 % of male patients in the RA group had sexual dysfunction features.
2 Publications utilized IIEF Questionnaires
3 One publication used a non-standardized questionnaire to assess ED and the IIEF Questionnaire
4Publication reported the IPSS score for Urologic function.
5 Mean difference reported with 95% confidence interval.
°PSM = Positive Surgical Margin
7CRM = Circumferential Resection Margin
ೆDRM = Distal Resection Margin
9
10
TABLE 2A: da Vinci vs. Open vs. Laparoscopic Intersphincteric Resection (ISR)
| Publications | Sample Size (N) | Operative Time
(minutes) | Estimated Blood
Loss "EBL" (ml) | Length of Stay
(days) | PostOp
Complications (%) | IntraOp
Complications (%) | Mortality Rate
(%) | Transfusion Rate
(%) |
|----------------|-------------------------|-----------------------------|------------------------------------|--------------------------|-----------------------------|------------------------------|-----------------------|-------------------------|
| 1. Park (2012) | da Vinci
Lap | 235.5
185.4 | 45.7
59.2 | 10.6
11.3 | 15
12.5 | Not Reported | 0
0 | 0
0 |
| 2. Kim (2014) | da Vinci
Open | 191
124 | Not Reported | 7
7.6 | 22.2
17.5 | 1.9
4.4 | 0
0 | 4.6
7.0 |
TABLE 2B: da Vinci vs. Open vs. Laparoscopic Intersphincteric Resection (ISR)
| Publications | Sample Size (N) | PSM Rate (%) | Urologic Function | Conversion Rate (%) | No. of Lymph Nodes Retrieved | CRM (cm) | DRM (cm) | Anastomotic Leak Rate (%) | Erectile Dysfunction | Fecal Incontinence |
|---|---|---|---|---|---|---|---|---|---|---|
| 1. Park (2012) | da Vinci 40 | Not Reported | 3.6/3.51 | 0 | 12.9 | 6.2 mm | 1.4 | 7.5 | 11.6/13.0* | 8.2/7.82 |
| Lap 40 | Reported | 5.5/3.21 | 0 | 13.3 | 6.9 mm | 1.3 | 5 | 7.6/9.0* | 11.2/8.42 | |
| 2. Kim (2014) | da Vinci 108 | Not Reported | 0 | 18.6 | 0.9%4 | 1.4 | 4.6 | 12.53 | 12.5/7.75 | |
| Open 114 | N/A | 16.7 | 0%4 | 1.2 | 4.4 | 34.13 | 14.2/10.35 |
*IIEF-5 at 3 and 6 months
4 IPSS at 3 and 6 months
² Wexner Scores at 3 and 6 months
ි Sewal dysfunction represented >1,3 functional in ejaculatory potency in male patients aged ≤ 65 years. These parameters were assessed in 40 patients (R group) and 44 patients (open group), respectively, at 6 months after surgery or chemoradiotherapy.
4CRM involvement, ≤1 mm
్ Assessed at 6 and 12 months