(268 days)
The Intuitive Surgical Endoscopic Instrument Control System (da Vinci Surgical System, Model IS4000) 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.
This 510(k) is for a labeling modification only, to include the following additional representative, specific procedures under the cleared "urologic surgical procedures" general indication for the da Vinci Xi Surgical System (K131861): Prostatectomy (Radical), Nephrectomy (Partial, Radical), and Cystectomy (Radical, Partial), Donor Nephrectomy, Cyst Removal, Ureteral Implantation, Lysis of Adhesions and Lymphadenectomy. There are no changes to the technological characteristics of the cleared da Vinci Xi Surgical System proposed in this submission. The da Vinci Xi Surgical System, Model IS4000 is a software-controlled, electro-mechanical system designed for surgeons to perform minimally invasive surgery. The Model IS4000 Surgical System consists of a Surgeon Console, a Patient Side Cart (PSC), and a Vision Side Cart (VSC) and is used with an Endoscope, EndoWrist Instruments, and Accessories.
The provided text describes a 510(k) submission for a labeling modification to the da Vinci Xi Surgical System, Model IS4000 (K161178), to include additional urologic surgical procedures. This is not a study that establishes acceptance criteria for a new device's performance, but rather a submission seeking to expand the indications for use of an already cleared device based on existing clinical literature.
Therefore, the sections related to acceptance criteria, sample sizes for test and training sets, expert adjudication, MRMC studies, standalone performance, and ground truth establishment for a novel AI/device performance study are not applicable in the context of this document. This document focuses on demonstrating substantial equivalence to predicate devices using existing performance data (published clinical studies and prior animal studies).
However, I can extract and organize the information that is present in the document which relates to performance data and the comparison of the da Vinci Xi Surgical System to other surgical methods for the "umbrella" procedures.
1. Table of Acceptance Criteria and Reported Device Performance:
Since this is a 510(k) submission for a labeling modification, there are no explicit "acceptance criteria" defined in the typical sense of a de novo device performance study with specific metrics and thresholds. Instead, the document demonstrates "substantial equivalence" based on various clinical outcomes from published literature comparing the da Vinci system to open and laparoscopic procedures. The reported performance is a summary of these extensive literature reviews for the "umbrella procedures."
Below is a summary table compiled from the provided text, focusing on key clinical outcomes for the "umbrella procedures" (Prostatectomy (Radical), Nephrectomy (Partial, Radical), and Cystectomy (Radical)) as compared to open and laparoscopic surgical procedures. The data are presented comparatively rather than as meeting specific numerical acceptance thresholds.
| Outcome Measure | Da Vinci-assisted Procedures (Compared to Open/Laparoscopic) |
|---|---|
| For Prostatectomy (Radical): | |
| Mortality Rates | Comparable or Lower |
| Blood Transfusion Rates | Comparable or Lower |
| EBL Volumes | Comparable or Lower |
| Length of Hospital Stay | Comparable or Shorter |
| Intraoperative Complication Rates | Comparable or Lower (one report higher vs. open) |
| Postoperative Complication Rates | Comparable or Lower (one report higher vs. laparoscopic) |
| Positive Surgical Margins | Comparable Rates (one report higher vs. laparoscopic but similar overall) |
| Potency and Continence Rates | Comparable or Higher |
| Operative Times | Comparable or Shorter (several noted increased vs. open but without increased mortality/complications) |
| Conversion Rates | Comparable or Lower (vs. laparoscopic) |
| For Nephrectomy (Partial): | |
| Mortality Rates | Comparable or Lower |
| Blood Transfusion Rates | Comparable or Lower |
| EBL Volumes | Comparable or Lower |
| Length of Hospital Stay | Comparable or Shorter |
| Intraoperative Complication Rates | Comparable or Lower |
| Postoperative Complication Rates | Comparable or Lower |
| Positive Surgical Margins | Comparable Rates |
| Warm Ischemia Times | Comparable or Shorter (two noted higher vs. open but within safe limits) |
| Operative Times | Comparable or Shorter (several noted increased vs. open but without increased mortality/complications) |
| Conversion Rates | Comparable or Lower (vs. laparoscopic) |
| For Nephrectomy (Radical): | |
| Mortality Rates | Comparable or Lower |
| Blood Transfusion Rates | Comparable or Lower (one report higher vs. open/lap) |
| EBL Volumes | Comparable |
| Length of Hospital Stay | Comparable or Shorter (one report longer vs. lap) |
| Intraoperative Complication Rates | Comparable or Lower |
| Postoperative Complication Rates | Comparable or Lower (one report higher vs. lap) |
| Operative Times | Comparable or Shorter (comparable vs. laparoscopic) |
| Conversion Rates | Comparable (vs. laparoscopic) |
| For Cystectomy (Radical): | |
| Mortality Rates | Comparable or Lower |
| Blood Transfusion Rates | Comparable or Lower |
| EBL Volumes | Comparable or Lower |
| Length of Hospital Stay | Comparable or Shorter |
| Intraoperative Complication Rates | Comparable or Lower |
| Postoperative Complication Rates | Comparable or Lower (one report higher 90-day rate vs. open, but lower mortality) |
| Positive Surgical Margins | Comparable Rates |
| Operative Times | Comparable (several noted increased vs. open/lap but without increased mortality/complications) |
| Conversion Rates | Reported but not explicitly compared |
2. Sample Size Used for the Test Set and Data Provenance:
- Sample Size for Test Set: This submission relies on data from multiple published clinical studies comparing the da Vinci system to predicate surgical techniques. The "test set" is, therefore, the aggregate of patients included in these published studies. For the "umbrella procedures" (Prostatectomy (Radical), Nephrectomy (Partial, Radical), and Cystectomy (Radical)), 61 publications were identified. The tables (TABLE 1, TABLE 2, TABLE 3, TABLE 4) show a wide range of sample sizes for individual studies, ranging from as low as 13 patients (e.g., Boger (2010), da Vinci arm for Nephrectomy (Radical)) to as high as 167,184 patients (e.g., Tewari (2012), Open arm for Prostatectomy (Radical)). The total number of unique patients across all 61 studies is not aggregated in this document, but it represents a substantial number.
- Data Provenance: The data is retrospective and prospective, originating from published clinical literature. The countries of origin are not specified, but the use of meta-analyses and large database studies implies a broad geographical range. The studies are categorized as:
- Prospective randomized controlled trials
- Meta-analyses
- Systematic reviews
- Health Technology Assessments (HTAs)
- Large database studies
- Comparative studies
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts:
- This is not applicable as the "ground truth" for the performance data comes from published clinical outcomes, which are established by the medical community and researchers who conducted the original studies. The FDA review process itself involves experts (e.g., medical officers and scientific reviewers) who critically evaluate the submitted data, but they are not establishing ground truth for the device's performance in the same way an expert panel would adjudicate images for an AI algorithm.
4. Adjudication Method for the Test Set:
- Not applicable in the context of this 510(k) submission, as it relies on literature review for clinical outcomes rather than a specific test set requiring adjudication in the context of a de novo performance study. The publications chosen based on "specific search criteria and filters" underwent a form of selection and review by Intuitive Surgical, Inc. and subsequently by the FDA.
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:
- Not applicable. This is not an AI-assisted diagnostic device where "human readers improve with AI." The da Vinci Xi Surgical System is a surgical robot intended to assist surgeons in performing minimally invasive surgery. The comparison is between different surgical techniques (robot-assisted vs. open vs. laparoscopic), not human diagnostic performance with and without AI.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- Not applicable. The da Vinci system is inherently a "human-in-the-loop" device, requiring a trained physician to operate it. It does not perform any task standalone in the medical context discussed.
7. The Type of Ground Truth Used:
- The "ground truth" is based on clinical outcomes data reported in peer-reviewed medical publications. This includes metrics like mortality rates, blood transfusion rates, length of hospital stay, intraoperative and postoperative complication rates, positive surgical margins, potency and continence rates, warm ischemia times, and operative times.
8. The Sample Size for the Training Set:
- Not applicable. This document describes a literature review for expanding indications of an already cleared device, not an AI algorithm development where a specific "training set" of data would be used to train the algorithm. The device itself (the da Vinci Xi Surgical System) was developed and refined through engineering, pre-clinical testing, and extensive clinical experience prior to its initial clearance and prior to this labeling modification. Pre-clinical animal study data were provided in the original submissions for the da Vinci Xi Surgical System (K131861, K140189, K152241, K152578, and K153276), which included results from eight (8) evaluations in a total of 31 animals for various procedures. These animal data serve as part of the developmental and validation process for the system's design but do not constitute a "training set" in the context of AI.
9. How the Ground Truth for the Training Set was Established:
- Not applicable, as there is no "training set" in the AI sense for this 510(k) submission. The animal study outcomes were established through direct observation and measurement in the animal models.
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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
January 19, 2017
Intuitive Surgical, Inc. % Ms. Cindy Domecus Chief Regulatory Advisor, Intuitive Surgical Domecus Consulting Services LLC 1171 Barroilhet Drive Hillsborough, California 94010
Re: K161178
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: April 22, 2016 Received: April 26, 2016
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 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.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in
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the quality systems (QS) 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 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 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.
Sincerely yours,
Jennifer R. Stevenson -S
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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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below.
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, 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 laparosopic 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.
Type of Use (Select one or both, as applicable)
| Prescription Use (Part 21 CFR 801 Subpart D) | |
|---|---|
| --------------- | ---------------------------------------------- |
| Over-The-Counter Use (21 CFR 801 Subpart C) | |
|---|---|
| --------------- | --------------------------------------------- |
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510(k) Summary (21 CFR § 807.92(c))
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: | January 18, 2017 |
| II. SUBJECT DEVICE INFORMATION | |
| Device Trade Name: | da Vinci® Surgical System, Model IS4000 |
| 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:
Predicate Device: Intuitive Surgical da Vinci Surgical System, Model IS4000 (K131861, K152578) Intuitive Surgical da Vinci Surgical System, Model IS3000 (K081137, K123463, K090993)
IV. DEVICE DESCRIPTION:
This 510(k) is for a labeling modification only, to include the following additional representative, specific procedures under the cleared "urologic surgical procedures" general indication for the da Vinci Xi Surgical System (K131861): Prostatectomy (Radical), Nephrectomy (Partial, Radical), and Cystectomy (Radical, Partial), Donor Nephrectomy, Cyst Removal, Ureteral Implantation, Lysis of Adhesions and Lymphadenectomy. There are no changes to the technological characteristics of the cleared da Vinci Xi Surgical System proposed in this submission. The da Vinci Xi Surgical System, Model IS4000 is a software-controlled, electro-mechanical system designed for surgeons to perform minimally invasive surgery. The Model IS4000 Surgical System consists of a Surgeon Console, a Patient Side Cart (PSC), and a Vision Side Cart (VSC) and is used with an Endoscope, EndoWrist Instruments, and Accessories.
V. INDICATIONS FOR USE
The Intuitive Surgical Endoscopic Instrument Control System (da Vinci Surgical System, Model IS4000) 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
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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 do Vinci Xi Surgical System (IS4000) 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 eight (8) evaluations in a total of 31 animals demonstrating use of do Vinci Xi Surgical System in the following procedures: Nephrectomy, Pyeloplasty, Hysterectomy and Salpingectomy/Oophorectomy (Adnexectomy), Nissen Fundoplication, Colectomy and Mitral Valve Repair. These data were previously submitted in support of clearance of the da Vinci Xi Surgical System, the da Vinci Xi Vessel Sealer, the da Vinci Xi Stapler 30 and the da Vinci Xi labeling modification to add specific procedures under the gynecologic laparoscopic surgical procedures general indication and the general thoracoscopic surgical procedures and thoracoscopically-assisted cardiotomy procedures general indication (K131861, K140189, K152241, K152578 and K153276) and also support inclusion of the additional representative, specific procedures.
Clinical Study Data
Published clinical data support use of the da Vinci Xi Surgical System for the representative, specific procedures that fall under the cleared "urologic laparoscopic surgical procedures" general Indication for Use. Clinical data were not provided for all of the representative, specific procedures. Instead, clinical data were provided only for the more complex/higher risk representative, specific procedures (referred to as "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
Published clinical data were provided for the following umbrella procedures: Prostatectomy (Radical), Nephrectomy (Partial, Radical), and Cystectorny (Radical). Sixty-one (61) publications were identified for these umbrella procedures based on specific search criteria and filters. These publications included
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prospective randomized controlled trials, meta-analyses, systematic reviews, Health Technology Assessments (HTAs), large database studies and comparative studies. A detailed summary of the published clinical data on these procedures is provided in Tables 1-4 below.
The findings from the Prostatectomy (Radical) publications show that da Vinci-assisted procedures are associated with comparable or lower mortality rates; comparable or lower blood transfusion rates and EBL volumes; comparable or shorter lengths of hospital stay; comparable or lower intraoperative and postoperative complication rates; comparable rates of positive surgical margins; comparable or higher potency and continence rates; and, comparable or shorter operative times as compared to both open and laparoscopic surgical procedures. Several publications also noted increased operative times in the da Vinci procedures as compared to open procedures. However, this increase did not correlate with an increase in the reported mortality or complication rates. Additionally, these publications report comparable or lower conversion rates for da Vinci-assisted procedures as compared to laparoscopic procedures. One publication reported a higher intraoperative complication rate for da Vinci-assisted procedures as compared to open procedures'; one publication reported a higher postoperative complication rate for da Vinci-assisted procedures as compared to laparoscopic procedures '; and one publication reported a higher surgical margin rate for da Vinci-assisted procedures as compared to laparoscopic procedures.3
Outcomes reported in the Nephrectomy (Partial) publications demonstrate that da Vinci-assisted procedures are associated with comparable or lower mortality rates; comparable or lower blood transfusion rates and EBL volumes; comparable or shorter lengths of hospital stay; comparable or lower intraoperative and postoperative complication rates; comparable rates of positive surgins; comparable or shorter warm ischemia times; and, comparable or shorter operative times as compared to both open and laparoscopic surgical procedures. Several publications also noted increased operative times in the da Vinci procedures as compared to open procedures. However, this increase did not correlate with an increase in the reported mortality or complication rates. Additionally, these publications report comparable or lower conversion rates for da Vinci-assisted procedures as compared to laparoscopic procedures. Two publications reported higher warm ischemia times for da Vinci-assisted procedures as compared to open procedures.4
ี With regards to the higher intraoperative complication rate, "Univariate analysis confirmed pre- and postoperative risk category, surgical technique and annual caseload to be significant contributors to intraoperative complication rate; however, only laparoscopic technique was significant on multivariate analysis [hazard ratio (HR) 2.45, 95% Cl 1.65-3.62, P < 0.001]."
´ The authors note, "We can say that once the learning curve is completed, LRP (laparoscopic radical prostatectorny) and RALP (robot-assisted radical prostatectomy) can be performed without a significations and with better results than RRP (retropubic radical prostatectomy)."
ី The PSM rate was higher for the robotic cohort, however, the rates were similar (22.5% R vs. 22.2% L), and there was no difference in <=pT2 rates or >=pT3 rates, and no difference in biochemical recurrence (OR 1.15, p=0.9).
" The robotic cohort had a WIT of 18.9 minutes. Hadjipavlou, et al (B10) states: "The strongest surgical risk factor for CKD is ischaemia time; current data supports safe warm ischaemia time to be less than 20 minutes and cold ischaemia time up to 2 hours". The WIT reported for the robotic cohort was within the safe WIT of < 20 minutes. "Our primary analysis showed that OPN had the shorter WIT compared with RAPN. However, the sensitivity analysis showed no significant difference. Furthermore, there was no difference between the two groups regarding postoperative eGFR decline. Although WIT is an important predictor of postoperative renal function, it certainly is not the only factor. In experienced hands and appropriate patient selection, the WIT of RAPN can be controlled to less than 20 minutes. So the marginal difference of WIT between RAPN and OPN may not have much clinical significance for patients with adequate renal reserve."
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The data provided in the Nephrectomy (Radical) publications show that da Vinci-assisted procedures are associated with comparable or lower mortality rates; comparable or lower blood transfusion rates; comparable EBL volumes; comparable or shorter lengths of hospital stay; and, comparable or lower intraoperative and postoperative complication rates; and, comparable or shorter operative times as compared to both open and/or laparoscopic surgical procedures. Additionally, these publications report comparable operative times and conversion rates for da Vinci-assisted procedures as compared to laparoscopic procedures. One publication reported a higher blood transfusion rate for da Vinci-assisted procedures as compared to open and laparoscopic procedures ; one publication reported a longer length of stay and a higher "any" complication rate for da Vinci-assisted procedures as compared to laparoscopic procedures.6
The findings from the Cystectomy (Radical) publications show that da Vinci-assisted procedures are associated with comparable or lower mortality rates; comparable or lower blood transfusion rates and EBL volumes; comparable or shorter lengths of hospital stay; comparable or lower intraoperative and postoperative complication rates; comparable rates of positive surgical margins; and, comparable operative times as compared to both open and laparoscopic surgical procedures. Several publications also noted increased operative times in the da Vinci procedures as compared to open and laparoscopic procedures. However, this increase did not correlate with an increase in the reported mortality or complication rates. One publication reported conversion rates for da Vinci-assisted procedures as compared to laparoscopic procedures. One publication reported a higher post operative 90-day complication rate for da Vinci-assisted procedures as compared to open procedures. '
້ The authors state, "The higher transfusion rate of nephrectorny with RALS (robotic assisted laparoscopic surgery) may be related to the relative infrequency of use compared with RALS for the other 3 procedures and to the overall nephrectomy volume, which may reflect a learning curve effect." (Note: this publication reported results from four (4) procedures: 1) Nephrectomy; 2) Radical Prostatectomy; 3) Partial Nephrectomy; and, 4) Pyeloplasty).
6 The higher "any" complication rate for the robotic cohort was not associated with higher mortality or transfusion rates. 7 The higher 90 day "any" complication rate reported in Leow for the da Vinci cohort did not result in a higher 90 day mortality rate; the mortality rate for the da Vinci cohort was significantly lower.
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| TABLE 1: da Vinci vs. Open and da Vinci vs. Laparoscopic Prostatectomy (Radical) | |||
|---|---|---|---|
| ---------------------------------------------------------------------------------- | -- | -- | -- |
| Publications | Sample Size(N) | Operative Time(minutes) | Transfusions (%)or EBL (ml) | Length of Stay(days) | PostOp Complications(%) | ||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| A1. Pan (2014) | da Vinci | 798 | 220.0 - 330.0 | 0.94 - 16.88% | 1.4 / 5.8* | ||||||||
| Open | 1571 | 151.0 - 289.0 | 1.99 - 65.0% | Not Reported | 2.6 / 12.2* | ||||||||
| A2. Trinh (2013) | da Vinci | 11,889 | 1.95% | 12.86%** | 0.36 / 8.20 | ||||||||
| Open | 7389 | Not Reported | 7.74% | 39.56% | 0.99 / 11.14 | ||||||||
| A3. Davis (2013) | da Vinci | 27,348 | 264.0 | 2.3% | 2.2 | 10.6 | |||||||
| Open | 30,124 | 204.0 | 11.5% | 3.4 | 15.8 | ||||||||
| A4. Pilecki (2013) | da Vinci | 4,374 | 212.3 | 1.87% | 5.62 | ||||||||
| Open | 1,097 | 174.0 | 17.68% | Not Reported | 23.2 | ||||||||
| A5. Ellimoottil(2014) | da Vinci | 5,503 | 2.2% | 19.4%^ | 2.1 / 16.6 | ||||||||
| Open | 3,605 | Not Reported | 11.2% | 46.3%^ | 3.5 / 21.6 | ||||||||
| A6. Asimakopoulos(2011) | da Vinci | 64 | Not Reported | 0% | Not Reported | 8 | |||||||
| Lap | 64 | 5% | 15 | ||||||||||
| A7. Porpiglia(2012) | da Vinci | 60 | 147.6 | 202.0 ml | 4.6 | 16.6 | |||||||
| Lap | 60 | 138.1 | 234.1 ml | 4.8 | 11.6 | ||||||||
| A8. Robertson(2013) | da Vinci | 6,768 | 225 | 3.5% | Not Reported | 0.5 - 3.9** | |||||||
| Lap | 4,952 | 239 | 5.0% | 0.8 - 7.2** | |||||||||
| A9. Novara (2012) | da Vinci | 2,446/977 | 153.0 - 330.0 | 0 - 13.33% | 1.9 | 1.89 - 41.67 | |||||||
| Open | 2,843 | 127.0 - 289.0 | 1.67 - 80.65% | 5.5 - 17.0 | 0.97 - 83.87 | ||||||||
| Lap | 903 | 159.5 - 267.0 | 0 - 48.57% | 2.6 - 16.4 | 7.06 - 74.29 | ||||||||
| A10. Tewari (2012) | da Vinci | 62,389 | 1.8% | 1.4 | 7.8 | ||||||||
| Open | 167,184 | Not Reported | 16.5% | 3.1 | 17.9 | ||||||||
| Lap | 57,303 | 4.7% | 2.1 | 11.1 | |||||||||
| A11. DeCarlo(2014) | da Vinci | 4,044 | 187.91 | 4.66% | 5.87 | 18.52 | |||||||
| Open | 7,047 | 179.03 | 19.93% | 7.87 | 23.2 | ||||||||
| Lap | 2,841 | 236.54 | 6.3% | 9.02 | 13.42 | ||||||||
| A12. Moran (2013) | da Vinci | 1,581 | 160 - 341 | 0 - 20.0% | 1.0-8.0 | 2.13 - 22.86 | |||||||
| Open | 1,365 | 127.2 - 330 | 0-90.0% | 1.3 - 17.0 | 4.79 - 40.0 | ||||||||
| Lap | 2,166 | 160.0 - 264.0 | 0-9.8% | 1.76 - 6.1 | 6.34 - 9.02 | ||||||||
| A13. Yu (2012) | da Vinci | 11,506 | 1.6% | 1.7 | 8.4 | ||||||||
| Open | 9,694 | Not Reported | 5.2% | 2.4 | 10.1 | ||||||||
| Lap | 611 | ≤ 1.8% | 2.0 | 14.5 | |||||||||
| A14. Laird (2015) | da Vinci | 424 | 0% | 2.5 | 10.3 | ||||||||
| Open | 558 | Not Reported | 2.7% | 4.7 | 8.8 | ||||||||
| Lap | 1181 | 0.4% | 2.9 | 14.6 | |||||||||
| A15. Gandaglia(2014) | da Vinci | 3476 | Not Reported | 1.9% | 1 | 22.2 | |||||||
| Open | 2439 | 8.9% | 2 | 23.8 | |||||||||
| A16. Hyams(2013) | da Vinci | 1499 | Not Reported | 1.7 | Not Reported | ||||||||
| Open | 2565 | 1.9 | |||||||||||
| A17. Kim (2013) | da Vinci | 20,424 | Not Reported | 1 | 8.2 | ||||||||
| Open | 9413 | 2 | 11.3 | ||||||||||
| A18. Lundstrom(2016)## | da Vinci | 7256 | Not Reported | 0.07, 0.08, 0.06 | |||||||||
| Open | 9787 | 0.01, 0.02, 0 | |||||||||||
| A19. Monn(2016) | da Vinci | 9248 | 210 | 1 | |||||||||
| Open | 3206 | 162 | Not Reported | 2 | Not Reported | ||||||||
| A20. Pearce (2016) | da Vinci | 73,131 | 11.6%~ | ||||||||||
| Open | 23,804 | Not Reported | 39.0%~ | Not Reported | |||||||||
| A21. Seo (2016) | da Vinci | 15,766 | 32 - 341 | 0 - 20.0 | 1 – 9 | ||||||||
| Open | 16,628 | 74 – 289 | 1.7 - 90 | 1 - 17 | Not Reported | ||||||||
| A22. Yaxley (2016) | da Vinci | 157 | 202.03 | 0.6 | 1.55 | 3.8 | |||||||
| Open | 151 | 234.34 | 4.0 | 3.27 | 9.3 | ||||||||
| A23. Huang(2016) | da Vinci | 4114 | 145.5 - 280.8 | 0 – 7.6 | 2.2 - 6.4 | 3.6 - 21.0 | |||||||
| Lap | 5064 | 118.1 - 283.2 | 0 - 25.1 | 2.2 - 6.6 | 6.0 - 42.6 | ||||||||
| A24. Weiner(2015) | da Vinci | 82,338 | |||||||||||
| Lap | 5077 | Not Reported | |||||||||||
| A25. Anderson(2012) | da Vinci | 12,588 | 1.7 (vs. O), 1.9 (vs. L) | ||||||||||
| Open | 8968 | Not Reported | 2.5 | Not Reported | |||||||||
| Lap | 547 | 1.8 | |||||||||||
| A26. Basto (2016) | da Vinci | 233 | 0% | 1.4 | |||||||||
| Open | 882 | Not Reported | 6% | 3.6 | Not Reported | ||||||||
| Lap | Lap | 233 | 233 | 15% | 15% | 4.8 | 4.8 | ||||||
| A27. Stolzenburg | da Vinci | 2495 | 2.6% | 4.6 | |||||||||
| (2016) | Open | 14,741 | Not Reported | 12.4% | Not Reported | 5.4 | |||||||
| Lap | 2831 | 3.8% | 3.9 |
{8}------------------------------------------------
| Publications | Sample Size(N) | Operative Time(minutes) | Transfusions (%)or EBL (ml) | Length of Stay(days) | PostOp Complications(%) | |
|---|---|---|---|---|---|---|
| A28. Sugihara(2014)^^ | da Vinci | 2126 | 322 | Auto: 12.2% Homo: 0.7% | 11 | 0.8 |
| Open | 7202 | 268 | Auto: 82.6% Homo: 7.3% | 14 | 5.3 | |
| Lap | 2483 | 329 | Auto: 41.8% Homo: 2.3% | 11 | 3.9 | |
| A29. Wen (2014) | da Vinci | 61,656 | Not Reported | Not Reported | Odds Ratio 0.4# | Not Reported |
| Open | 111,361 | Not Reported |
*Complication rates reported for: Bladder Neck Dissection / Inguinal Hernia; ^Percentage of cases with prolonged length of stay > 2 days reported; **Range includes complications reported for Clavin I – IV; ^^Sugihara reports anesthesia time and postoperative complications. "Wen, et al reports odds ratio only; * Rates reported for abdominal wall defects, wound dehiscence surgery and peritoneal drainage. ; " Percentage of patients with LOS of 2 or more days
|--|
| Publications | Sample Size (N) | Operative Time (minutes) | Transfusions (%) or EBL (ml) | Length of Stay (days) | PostOp Complications (%) | |
|---|---|---|---|---|---|---|
| B1. Aboumarzouk(2012) | da Vinci | 313 | 152.17 – 233 | 122.4 – 368 ml | 2.51 – 6.2 | 0 – 33.3 |
| Lap | 404 | 117.5 – 226.05 | 136.7 – 580 ml | 2.2 – 5.3 | 0 – 33.3 | |
| B2. Choi (2015) | da Vinci | 1,152 | 140 – 376 | 93.3 – 368 ml | 2 – 6.2 | 10.91 – 37.03*2.67 – 11.11** |
| Lap | 1,088 | 156 – 293 | 100 – 400 ml | 2 – 6.9 | 6.67 – 30.56*0 – 15.56** | |
| B3. Froghi (2013) | da Vinci | 101 | 153.2 – 242 | 139.2 – 355.7 ml | 2.8 – 6.2 | 8.53 – 18.52 |
| Lap | 155 | 117.5 – 256 | 146.3 – 456.3 ml | 2.95 – 5.3 | 0 – 20.34 | |
| B4. Mir (2011) | da Vinci | 477 | 188 | Not Reported | 2.6 | Not Reported |
| Lap | 2,220 | 200 | Not Reported | 3.2 | Not Reported | |
| Open | 2,745 | 193 | Not Reported | 5.9 | Not Reported | |
| B5. Zhang (2013) | da Vinci | 425 | 151.17 – 233 | 122.40 – 323.00 ml | 2.51 – 6.20 | 0 – 22.22 |
| Lap | 341 | 117.50 – 226.50 | 146.30 – 387.50 ml | 2.71 – 6.80 | 0 – 31.11 | |
| B6. Zhang (2014) | da Vinci | 705 | 152 – 376 | 100 – 368 ml | 2 – 6.2 | 0.78 – 26.63*2.67 – 7.75** |
| Lap | 835 | 117.5 – 361 | 150 – 400 ml | 2 – 14 | 2.54 – 30.56*1.33 – 11.76** | |
| B7. Wu (2014) | da Vinci | 757 | 168 – 231.8 | 3.81 – 7.91% | 2.5 – 6.2 | 9.52 – 40.66 |
| Open | 2661 | 123 – 238.8 | 4.7 – 10.61% | 4.5 – 18 | 13.79 – 54.21 | |
| B8. Ghani (2014)^ | da Vinci | 9095 | Not Reported | 5.8% | 12.4% | 22.1 |
| Lap | 3508 | Not Reported | 7.1% | 17.6% | 24.9 | |
| Open | 25,461 | Not Reported | 10.6% | 34.8% | 30.5 | |
| B9. Kates (2015) | da Vinci | 1078 | Not Reported | 2.51 | Not Reported | |
| Lap | 282 | Not Reported | 3.0 | Not Reported | ||
| B10. Hadjipavlou(2016) | da Vinci | 83 | 179 | 272 mL | 16.0 | |
| Lap | 192 | 159 | 322 mL | Not Reported | 16.3 | |
| Open | 412 | 126 | 335 mL | Not Reported | 18.5 | |
| B11. Leow (2016) | da Vinci | 2671 | 108 – 376 | 88 – 490 ml | 2.51 – 10.9 | 0 – 30.8 |
| Lap | 2238 | 111 – 361 | 61 – 626 ml | 2.0 – 14.0 | 4.8 – 27.8 | |
| B12. Xia (2016) | da Vinci | 1216 | 122.3 – 263.0 | 0 – 14.5% / 57.5-322ml | 1.51 – 9.67 | 0 – 25.5 |
| Open | 2335 | 123.0 – 288.7 | 0 – 37.8% / 183.33-653.6ml | 2.47 – 18.0 | 0 – 30.1 |
*Minor complications; **Major complications; ^Ghani reports prolonged length of stay.
TABLE 3: da Vinci vs. Open and da Vinci vs. Laparoscopic Nephrectomy (Radical)
| Publications | SampleSize (N) | Operative Time(minutes) | Transfusions(%) | Length of Stay(days) | PostOp Complications(%) |
|---|---|---|---|---|---|
| C1. Yu (2012) | da Vinci327 | Not Reported | 23.5 | 5.2 | 29.9 |
| Lap2,601 | 7.4 | 4.2 | 33.8 | ||
| Open11,287 | 14.1 | 5.9 | 37.4 | ||
| C2. Yang (2014) | da Vinci7,787 | Not Reported | Not Reported | 3.0, IQR* 2-4 | 11.0 |
| Lap16,525 | 3.0, IQR* 2-5 | 12.0 | |||
| C3. Kates (2015) | da Vinci376 | Not Reported | Not Reported | 3.52 | 4.0^ |
| Lap1,098 | 4.0 | 4.0^ | |||
| C4. Boger (2010) | da Vinci13 | 168.0 | Not Reported | 2.0 | 15.4 |
| Lap46 | 171.0 | 2.0 | 2.2 | ||
| C5. Weinberg(2016) | da Vinci5,849 | Not Reported | 4.5 | 2.12 | 27.8 |
| Lap18,329 | 4.7 | 2.04 | 26.4 | ||
| Open100,284 | 7.1 | 3.89 | 35.3 | ||
| C6. Park (2012) | da Vinci20 | Not Reported | Not Reported | 6 | Not Reported |
| Lap20 | 7.4 | ||||
| Open20 | 8 |
*IQR = Interquartile Range; ^Readmission rates provided in study publication.
{9}------------------------------------------------
| Publications | Study Size(N) | Operative Time(minutes) | Transfusions(%)or EBL (ml) | Length of Stay(days) | PostOp Complications(%) | |
|---|---|---|---|---|---|---|
| D1. Ishii (2014) | da Vinci | 461 | 252 - 455 | 2-40 | Not Reported | 25.0 - 66.34 |
| Open | 287 | 211 - 393 | 19 - 50 | 25.0 - 61.54 | ||
| D2. Li (2013) | da Vinci | 364 | 252 - 606 | 2 - 52.63 | 4.4 - 40.2 | 33.33 - 66 |
| Open | 598 | 210-420 | 24 - 71.43 | 5.3 - 37.0 | 50 - 73.33 | |
| D3. Novarra | da Vinci | 565/ 62 | 308 - 638 | 4.17 - 57.14 | 8.0 - 40.2 | 15.38 - 83.33 |
| (2015) | Open | 943 | 259 - 507 | 24.0 - 86.96 | 8.0 - 37.0 | 16.67 - 78.57 |
| Lap | 78 | 316-419 | 25.9 - 70.0 | 9.4 - 16 | 55.0 - 81.0 | |
| D4. Tang (2014) | da Vinci | 382 | 252 - 638 | 0-53.85 | 5.0 - 40.2 | 15.38 - 66.0 |
| Open | 510 | 211.2 - 507 | 30.30 - 86.96 | 6.0 - 27.0 | 16.67 - 85.00 | |
| D5. Xia (2015) | da Vinci | 787 | 285.5 - 606 | 4.0 - 52.53 | 5.5 - 28.9 | 40.96 - 66 |
| Open | 992 | 222 - 500.6 | 24.0 - 80.95 | 8 - 27.1 | 58.65 - 73.33 | |
| D6. Bochner | da Vinci | 60 | 456 | 516 ml | 8.0 | 62.0 |
| (2014) | Open | 58 | 329 | 676 ml | 8.0 | 66.0 |
| D7. Messer (2014) | da Vinci | 20 | 300 | 40% / 400 ml | 6.0 | 25.0 |
| Open | 20 | 285.5 | 50% / 800 ml | 6.0 | 25.0 | |
| D8. Fonseka | da Vinci | 728 | 252 - 638 | 212 – 422 ml | 5.1 - 40.2 | 28.0 |
| (2015) | Lap | 276 | 300 - 419 | 331 - 653 ml | 9.13 - 16.1 | 72.1 |
| Open | 1100 | 211 - 507 | 398 - 1790 ml | 6-37.0 | 47.2 | |
| D9. Khan (2015) | da Vinci | 20 | 389 | 585 ml | 11.96 | 55 |
| Lap | 19 | 301 | 460 ml | 9.7 | 26 | |
| Open | 20 | 293 | 808 ml | 14.4 | 70 | |
| D10. Bagi (2016) | da Vinci | 348 | Not Reported | 8 - 15.5 | Not Reported | |
| Open | 1509 | 9 - 32 | ||||
| D11. Hu (2016) | da Vinci | 439 | Not Reported | RR 0.97 (0.96 - 0.98) | 10.1 | Not Reported |
| Open | 7308 | |||||
| D12. Leow (2014) | da Vinci | 2667 | 386 | Not Reported | 10.2 | Any 90d: 59.7 |
| Open | 40,980 | 338 | 11.8 | |||
| D13.Mantulewicz | da Vinci | 2397 | Not Reported | |||
| (2016) | Open | 9639 | ||||
| D14. Monn (2014) | da Vinci | 3733 | Not Reported | 7 | Any in-hospital: 33.2 | |
| Open | 25,986 | 8 |
TABLE 4: da Vinci vs. Open and da Vinci vs. Laparoscopic Cystectomy (Radical)
Covered Procedures
The published data on the above cited umbrella procedures were used to support clearance of the following covered procedures: Cystectomy (Partial), Donor Nephrectomy, Cyst Removal, Ureteral Implantation, Lysis of Adhesions and Lymphadenectomy.
VIII. CONCLUSION
Based on the information provided in this premarket notification, the inclusion of the following additional representative, specific procedures under the da Vinci Xi Surgical System "urologic surgical procedure" general indication is substantially equivalent to the predicate devices: Prostatectomy (Radical), Nephrectomy (Partial, Radical), and Cystectomy (Radical, Partial), Donor Nephrectomy, Cyst Removal, Ureteral Implantation, Lysis of Adhesions and Lymphadenectomy.
§ 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.