(109 days)
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.
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.
The provided document is a 510(k) summary for the da Vinci Surgical System, Model IS4000 and IS4200. This submission seeks to expand the "general laparoscopic surgical procedures" indication to include specific additional procedures. The core of the submission revolves around demonstrating substantial equivalence to predicate devices, focusing on clinical outcomes from existing literature rather than new device performance testing.
Here's an analysis of the provided information based on your questions:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly state "acceptance criteria" in a quantitative, pre-defined manner for device performance as would be seen in a typical medical device study. Instead, it relies on demonstrating comparable outcomes to existing surgical methods (open and laparoscopic) for the new indications. The "reported device performance" is the aggregated clinical outcomes from published literature for the da Vinci-assisted procedures (specifically LAR/TME and ISR), compared against open and laparoscopic procedures. The acceptance criterion is essentially that the da Vinci system should at least be comparable to or better than the existing methods across various clinical metrics.
Acceptance Criteria/Clinical Outcomes for Comparison:
| Clinical Metric | Da Vinci-Assisted Procedures vs. Open/Laparoscopic Procedures (LAR/TME Umbrella Procedure) | Da Vinci-Assisted Procedures vs. Open/Laparoscopic Procedures (ISR Umbrella Procedure) |
|---|---|---|
| Mortality | Comparable mortality rates | Comparable mortality rates |
| Transfusions | Comparable or lower blood transfusion rates and EBL volumes | Comparable blood transfusion rates and EBL volumes |
| Length of Stay | Comparable or shorter lengths of hospital stay | Comparable lengths of hospital stay |
| Complications | Comparable or lower complication rates | Comparable complication rates |
| Surgical Margins | Comparable rates of positive surgical margins | Comparable rates of positive surgical margins |
| Anastomotic Leak | Comparable anastomotic leak rates | Comparable anastomotic leak rates |
| Erectile Dysfunction | Comparable or lower ED rates | Lower erectile dysfunction ED rates |
| Operative Time | Increased operative times (but not associated with increased mortality/complications) | Increased operative times (but not associated with increased mortality/complications) |
| Urologic Function | Comparable urologic function and comparable or lower conversion rates | Comparable urologic function and comparable conversion rates |
| Fecal Continence | Not reported in LAR/TME summary | Comparable or higher fecal continence rates |
Note: The tables (1A, 1B, 2A, 2B) provide detailed numerical data from various publications supporting these summary findings. For instance, in LAR/TME, operative times for da Vinci systems ranged from 191 to 337.9 minutes, while open procedures were 124 to 273.8 minutes and laparoscopic were 158.1 to 298.8 minutes, showing the reported "increased operative times" for da Vinci. Similarly, mortality rates were largely comparable across modalities.
2. Sample Size Used for the Test Set and Data Provenance
The document does not describe a single "test set" in the traditional sense of a prospective clinical trial for algorithm validation. Instead, it relies on a literature review of published clinical studies.
-
Sample Sizes (for "Umbrella" Procedures):
- Low Anterior Resection/Total Mesorectal Excision (LAR/TME): Data from 11 publications. The sample sizes within these publications varied significantly, with "da Vinci" cohorts ranging from 25 to 1217 patients, "Open" cohorts from 25 to 4403 patients, and "Laparoscopic" cohorts from 156 to 5935 patients (as seen in Tables 1A and 1B).
- Intersphincteric Resection (ISR): Data from 2 publications. Sample sizes for "da Vinci" cohorts were 40 and 108 patients; for "Open" cohorts, 114 patients; and for "Laparoscopic" cohorts, 40 patients (as seen in Tables 2A and 2B).
-
Data Provenance: The data comes from published clinical studies. While specific countries are not mentioned, published literature tends to be international in scope, potentially including data from various countries. The types of studies included a prospective randomized controlled trial, meta-analyses, systematic reviews, and large database comparative studies. This indicates a mix of retrospective and prospective studies, predominantly observational or comparative in nature.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
The concept of "experts used to establish ground truth" is not directly applicable here. This is because:
- The device being assessed (da Vinci Surgical System) is a surgical tool, not an AI or diagnostic imaging device that produces classifications requiring expert labeling.
- The "performance data" is derived from clinical outcomes published in medical literature. The "ground truth" for these outcomes (e.g., mortality, complications, length of stay, surgical margins) was established by the original research teams and clinical record-keeping within those studies, performed by trained medical professionals (surgeons, pathologists, nurses, etc.) according to their respective clinical practices.
- The FDA review team evaluates the submitted evidence, but they do not create ground truth for the performance assessment.
4. Adjudication Method for the Test Set
Since there isn't a "test set" or a direct human-in-the-loop diagnostic process in this context, an adjudication method for establishing ground truth is not described or relevant. The "adjudication" in this case would be the critical review of the scientific literature by the sponsor and subsequently by the FDA to determine if the presented evidence supports substantial equivalence.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
No MRMC study was done, nor would it be relevant for this type of medical device submission. The da Vinci Surgical System is a robotic surgical platform, not an AI-powered diagnostic or interpretive tool that assists human "readers" (e.g., radiologists, pathologists). Its purpose is to assist surgeons during procedures, not to interpret medical images or data. The study focuses on clinical outcomes of using the system versus traditional surgical methods.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
No standalone algorithm performance study was done. The da Vinci system is inherently a human-in-the-loop system, as it is controlled by a surgeon. It is a surgical instrument, not an autonomous algorithm. The "performance data" describes the clinical outcomes when used by a human surgeon.
7. The Type of Ground Truth Used
The "ground truth" for the performance data in this submission consists of clinical outcomes data from published literature. This includes:
- Mortality rates
- Blood transfusion rates and estimated blood loss (EBL)
- Length of hospital stay
- Post-operative and intra-operative complication rates
- Rates of positive surgical margins (PSM)
- Anastomotic leak rates
- Erectile dysfunction (ED) rates
- Urologic function scores
- Conversion rates (from da Vinci to open or laparoscopic)
- Number of lymph nodes harvested/retrieved
- Circumferential Resection Margin (CRM) / Distal Resection Margin (DRM) involvement
- Fecal continence rates (for ISR)
These outcomes are generally established through clinical follow-up, pathology reports, and patient questionnaires in the original studies.
8. The Sample Size for the Training Set
This submission does not involve a "training set" in the context of machine learning or AI. The da Vinci Surgical System is a hardware/software system, and its "training" per se would involve engineering development and rigorous testing, not data-driven machine learning in the conventional sense. The "performance data" presented is clinical evidence of its use in patients, not data used to train a model. Therefore, a training set size is not applicable to this 510(k) submission.
9. How the Ground Truth for the Training Set Was Established
As there is no "training set" in the context of this 510(k) submission, the method for establishing its ground truth is not applicable. The device's "ground truth" development would be tied to its design specifications, engineering verification, and validation testing during its product development lifecycle, prior to clinical use and regulatory submission. The clinical data presented here is evidence of its performance, not its training.
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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
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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
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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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510(k) Summary (21 CFR § 807.92(c))
I. SUBMITTER INFORMATION
| Submitter: | Intuitive Surgical, Inc.1266 Kifer RoadSunnyvale, CA 94086 |
|---|---|
| Contact: | Cindy Domecus, R.A.C. (US & EU)Principal, Domecus Consulting Services LLCChief Regulatory Advisor to Intuitive SurgicalTelephone: 650.343.4813Fax: 650.343.7822Email: 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.
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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.
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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
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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.
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| Publications | Sample Size (N) | Operative Time(minutes) | Estimated BloodLoss "EBL" (ml) | Length of Stay(days) | PostOpComplications (%) | IntraOpComplications (%) | Mortality Rate(%) | Transfusion Rate(%) | Publications | Sample Size (N) | PSM Rate (%) | UrologicFunction | ConversionRate (%) | No. of LymphNodes Harvested | CRM /Positive CRMRate (%) | DRM /Positive DRMRate (%) | AnastomoticLeak Rate (%) | ErectileDysfunction | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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 | NotReported | 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 | NotReported | 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 - 8.3646mo: 3.5 - 8412mo: 3.53 - 64 | 1.19 | 10.3 - 20 | Not Reported | Not Reported | 0 - 20 | 3mo:3.8 – 8.026mo: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 - 11.746mo: 3.2 - 8.2412mo: 4.2 - 84 | 6.50 | 11.07 - 17.4 | 2.7 - 14 | 3mo: 5.9 – 1326mo: 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 BloodLoss "EBL" (ml) | Length of Stay(days) | PostOpComplications (%) | IntraOpComplications (%) | Mortality Rate(%) | Transfusion Rate(%) |
|---|---|---|---|---|---|---|---|---|
| 1. Park (2012) | da VinciLap | 235.5185.4 | 45.759.2 | 10.611.3 | 1512.5 | Not Reported | 00 | 00 |
| 2. Kim (2014) | da VinciOpen | 191124 | Not Reported | 77.6 | 22.217.5 | 1.94.4 | 00 | 4.67.0 |
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
§ 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.