(202 days)
No
The summary explicitly states "There are no changes to the technological characteristics of the cleared da Vinci Xi Surgical System proposed in this submission." and there are no mentions of AI, DNN, or ML.
Yes.
The device is intended to assist in the accurate control of surgical instruments for various surgical procedures, which are therapeutic interventions.
No
The device is described as assisting in the control of surgical instruments for performing procedures, not for diagnostic purposes.
No
The device description explicitly states that the da Vinci Xi Surgical System is a "software-controlled, electromechanical system" and consists 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 in the control of surgical instruments for performing various surgical procedures on the human body. This is a therapeutic and surgical device, not a device used to examine specimens derived from the human body to provide information for diagnosis, monitoring, or compatibility testing.
- Device Description: The description details a software-controlled, electromechanical system consisting of a Surgeon Console, Patient Side Cart, and Vision Side Cart used with surgical instruments. This aligns with a surgical robot, not an IVD.
- Performance Studies: The performance studies focus on surgical outcomes like operative time, complications, blood transfusions, and length of stay, which are relevant to surgical procedures, not diagnostic testing.
- Lack of IVD Characteristics: There is no mention of analyzing biological specimens, detecting analytes, or providing diagnostic information.
Therefore, the Intuitive Surgical Endoscopic Instrument Control System (da Vinci Surgical System, Model IS4000) is a surgical device, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The Intuitive Surgical Endoscopic Instrument Control System, Model IS4000) 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, 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.
Product codes
NAY
Device Description
This 510(k) is for a labeling modification only, to include the following additional representative, specific procedures under the cleared "gynecologic laparoscopic surgical procedures" general indication for the da Vinci Xi Surgical System (K131861): Hysterectomy (Radical, Hysterectomy for Benign Disease 1), Salpingectomy, Oophorectomy, Lymphadenectomy, Myomectomy, Sacrocolpopexy, Endometriosis Resection, Adnexectomy, Omentectomy, Parametrectomy, Cyst Removal, and Lysis of Adhesions. 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, electromechanical 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.
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
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 7 evaluations in a total of 27 animals demonstrating use of da Vinci Xi Surgical System in the following procedures: Hysterectomy and Salpingectomy/Oophorectomy (Adnexectomy), Pyeloplasty, Nephrectomy, Nissen Fundoplication, Colectomy and Mitral Valve Repair. These data were previously submitted in support of clearance of the da Vinci Xi Surgical System and the da Vinci Xi Vessel Sealer (K131861 and K140189) 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 "gynecologic 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: Hysterectomy (Radical) Salpingectomy, Oophorectomy, Lymphadenectomy, Myomectomy and Sacrocolpopexy. Twenty-one (21) publications were identified for these umbrella procedures based on specific search criteria and filters. These publications included randomized controlled trials, meta-analyses, systematic reviews or Health Technology Assessments and comparative studies. A detailed summary of the published clinical data on these procedures is provided in Tables 1-3 below.
The findings from the Hysterectomy, Salpingectomy, Oophorectomy and Lymphadenectomy publications show that da Vinci-assisted procedures are associated with comparable or fewer complications and blood transfusions and a shorter length of hospital stay as compared to both open and laparoscopic surgical procedures. These 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 complication rates. Additionally, these publications report comparable operative times and comparable or lower conversion rates for da Vinci-assisted procedures as compared to laparoscopic procedures.
Outcomes reported in the Myomectomy publications demonstrate that da Vinci-assisted procedures are associated with comparable complication rates; comparable or lower blood transfusion rates (Two publications reported a higher transfusion rate in the da Vinci-assisted cohorts as compared to the laparoscopic groups. However, Barakat noted that the cases completed with the laparoscopic approach were less challenging than those completed with do Vinci assistance and Gargiulo noted that the majority of transfusions in the da Vinci-assisted procedures were planned pre-operatively.); and comparable or shorter length of hospital stays as compared to both open and laparoscopic surgical procedures. These 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 complication rates. Additionally, these publications report comparable conversion rates for da Vinci-assisted procedures as compared to laparoscopic procedures.
The data provided in the Sacrocolpopexy publications show that da Vinci-assisted procedures are associated with comparable or lower complication rates; comparable blood transfusion rates and comparable or shorter length of hospital stays as compared to both open and laparoscopic surgical procedures. These 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 complication rates. Additionally, these publications reported comparable conversion rates for da Vinci-assisted procedures as compared to laparoscopic procedures.
Table 1: da Vinci vs. Open and da Vinci vs. Laparoscopic Hysterectomy (Radical), Salpingectomy, Oophorectomy, Lymphadenectomy. Data from 7 publications: Gaia (2010), Reza (2010), O'Sullivan (2011), O'Neill (2012), Ran (2015), Geetha (2012), Shazly (2015). Key metrics include Operative Time (minutes), Transfusions (%), Length of Stay (days), and Complications (%).
Table 2: da Vinci vs. Open and da Vinci vs. Laparoscopic Myomectomy. Data from 10 publications: Pundir (2013), Barakat (2011), Bedient (2009), Gargiulo (2012), Nezhat (2008), Hsaio (2013), Pluchino (2013), Gobern (2013), Gocmen (2013), Behera (2011). Key metrics include Operative Time (minutes), Transfusions (%), EBL (mL), Length of Stay (days), and Complications (%).
Table 3: da Vinci vs. Open and da Vinci vs. Laparoscopic Sacrocolpopexy. Data from 4 publications: Serati (2014), Paraiso (2011), Anger (2014), Flack (2015). Key metrics include Operative Time (minutes), Transfusions (%), Length of Stay (days), and Complications (%).
Covered Procedures:
The published data on the above cited umbrella procedures were used to support clearance of the following covered procedures: Endometriosis Resection, Adnexectomy, Omentectomy, Lysis of Adhesions, Cyst Removal and Parametrectomy.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Operative Time (minutes), Transfusions (%), Length of Stay (days), Complications (%), EBL (mL).
Predicate Device(s)
K131861, K081137, K123463, K090993
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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
Image /page/0/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol that resembles an eagle or a stylized human profile.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
March 30, 2016
Intuitive Surgical, Inc. % Ms. Cindy Domecus Chief Regulatory Advisor, Intuitive Surgical Domecus Consulting Services, LLC 1171 Barroilhet Drive Hillsborough, California 94010
Re: K152578
Trade/Device Name: da Vinci Surgical System, Model IS4000 Regulation Number: 21 CFR 876.1500 Regulation Name: Endoscope And Accessories Regulatory Class: Class II Product Code: NAY Dated: March 21, 2016 Received: March 23, 2016
Dear Ms. Cindy 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 (reporting of medical device
1
related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in 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 -A
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
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
510(k) Number (if known) K152578
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, 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.
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)
Form Approved: OMB No. 0910-0120
Expiration Date: January 31, 2017
See PRA Statement below
CONTINUE ON A SEPARATE PAGE IF NEEDED.
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*DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW."
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
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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: | March 29, 2016 |
| 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) 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 "gynecologic laparoscopic surgical procedures" general indication for the da Vinci Xi Surgical System (K131861): Hysterectomy (Radical, Hysterectomy for Benign Disease 1), Salpingectomy, Oophorectomy, Lymphadenectomy, Myomectomy, Sacrocolpopexy, Endometriosis Resection, Adnexectomy, Omentectomy, Parametrectomy, Cyst Removal, and Lysis of Adhesions. 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, electromechanical 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
4 "Hysterectomy" was previously cleared as a representative, specific procedure for the da Vinci Xi Surgical System under K131861.
4
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.
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 7 evaluations in a total of 27 animals demonstrating use of da Vinci Xi Surgical System in the following procedures: Hysterectomy and Salpingectomy/Oophorectomy (Adnexectomy), Pyeloplasty, Nephrectomy, Nissen Fundoplication, Colectomy and Mitral Valve Repair. These data were previously submitted in support of clearance of the da Vinci Xi Surgical System and the da Vinci Xi Vessel Sealer (K131861 and K140189) 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 "gynecologic 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: Hysterectomy (Radical) Salpingectomy, Oophorectomy, Lymphadenectomy, Myomectomy and Sacrocolpopexy. Twenty-one (21) publications were identified for these umbrella procedures based on specific search criteria and filters. These publications included randomized controlled trials, meta-analyses, systematic reviews or Health Technology Assessments and comparative studies. A detailed summary of the published clinical data on these procedures is provided in Tables 1-3 below.
The findings from the Hysterectomy, Salpingectomy, Oophorectomy and Lymphadenectomy publications show that dd Vinci-assisted procedures are associated with comparable or fewer complications and blood transfusions and a shorter length of hospital stay as compared to both open and laparoscopic surgical procedures. These 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 complication rates. Additionally, these publications report comparable operative times and comparable or lower conversion rates for da Vinci-assisted procedures as compared to laparoscopic procedures.
5
Outcomes reported in the Myomectomy publications demonstrate that da Vinci-assisted procedures are associated with comparable complication rates; comparable or lower blood transfusion rates (Two publications reported a higher transfusion rate in the da Vinci-assisted cohorts as compared to the laparoscopic groups. However, Barakat noted that the cases completed with the laparoscopic approach were less challenging than those completed with do Vinci assistance and Gargiulo noted that the majority of transfusions in the da Vinci-assisted procedures were planned pre-operatively.); and comparable or shorter length of hospital stays as compared to both open and laparoscopic surgical procedures. These 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 complication rates. Additionally, these publications report comparable conversion rates for da Vinci-assisted procedures as compared to laparoscopic procedures.
The data provided in the Sacrocolpopexy publications show that da Vinci-assisted procedures are associated with comparable or lower complication rates; comparable blood transfusion rates and comparable or shorter length of hospital stays as compared to both open and laparoscopic surgical procedures. These 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 complication rates. Additionally, these publications reported comparable conversion rates for da Vinci-assisted procedures as compared to laparoscopic procedures.
| Oophorectomy, Lymphadenectomy | |||||
|---|---|---|---|---|---|
| Publications | Operative Time | ||||
| (minutes) | Transfusions | ||||
| (%) | Length of Stay | ||||
| (days) | Complications | ||||
| (%) | |||||
| 1. Gaia (2010) | da Vinci | 207 – 219 | 1.7 - 2.6 | 1.2 - 1.4 | 2.0 - 3.8 |
| (Simple Total) | Open | 130 | 7.2 | 3.9 | 14.5 |
| Lap | 209 | 5.0 | 1.9 | 3.8 | |
| 2a. Reza (2010) | da Vinci | 177 - 283 | 0 - 5 | 1.0-2.3 | 7.1 - 8.3 |
| (Simple Total) | Open | 79 - 146.5 | 1.5 - 15 | 3.2 - 5.3 | 27.0 |
| Lap | 171.1 - 255 | 2.5 - 10 | 1.2 - 2.0 | 13.0 | |
| 2b. Reza (2010) | da Vinci | 144 - 290 | 0 - 7.5 | 1.0-3.7 | 13.9 - 30.4 |
| (Radical) | Open | 114 - 247.8 | 8.2 - 35.7 | 3.2 - 5.6 | 19.4 |
| Lap | 132 - 220.4 | 0 | 2.3 - 2.4 | 30.2 | |
| 3. O'Sullivan (2011) | da Vinci | 173 - 231 | 6 | 1.5 - 1.9 | 18 |
| (Simple Total, Radical) | Open | 181 | 27 | 4.4 | 36 |
| Lap | 161 | 10 | 1.9 | 26 | |
| 4a. O'Neill (2012) | da Vinci | 242 | 5 | 3.7 | 21 |
| (Simple Total) | Open | 79 - 187.9 | 0 - 42.9 | 3.0 - 10.8 | 13.2 - 33.0 |
| Lap | 82.9 - 287.0 | 0 - 16 | 1.2 - 7.7 | 2.5 - 21.9 | |
| 4b. O'Neill (2012) | da Vinci | 202 | 4 | 1.7 | 11 |
| (Radical) | Open | 114 - 283 | 8.2 - 42.5 | 2.8 - 9.5 | 4.7 - 70.8 |
| Lap | 132 - 300 | 0 | 2.2 - 8.0 | 23.5 - 85.7 | |
| 5. Ran (2015) | da Vinci | 96.7 - 331.8 | 1.0-3.8 | 1.0 - 7.9 | 8.4 - 13.2 |
| (Simple Total) | Open | 79 - 187.9 | 10.0 | 4.0 - 10.8 | 35.6 |
| Lap | 80 - 287 | 1.7 | 1.2 - 8.1 | 13.2 | |
| 6. Geetha (2012) | da Vinci | 253.6 | 2.1 | 3.1 | 3.9~ |
| (Radical) | Open | 219.7 | 25.2 | 8.4 | 18.2~ |
| Lap | 259.7 | 5.3 | 5.6 | 6.6~ | |
| 7. Shazly (2015) | da Vinci | 144 - 383 | 3.4 - 4.0 | 1.7 - 13.5 | 17.1 - 22.4 |
| (Radical) | Open | 114 - 302.9 | 17.3 | 4.0 - 16.9 | 16.8 |
| Lap | 132 - 364.2 | 6.6 | 2.0 - 10.0 | 20.2 |
TABLE 1: da Vinci vs. Open and da Vinci vs. Laparoscopic Hysterectomy (Radical), Salpingectomy,
6
| Publications | | Operative Time
(minutes) | Transfusions
(%) | EBL
(mL) | Length of Stay
(days) | Complications
(%) |
|----------------------|-----------------|-----------------------------|---------------------|-----------------|--------------------------|----------------------|
| 8. Pundir (2013) | da Vinci | 181 – 231.4 | 0 – 5 | 100 – 370 | 0.5 – 1.5 | 0 – 11.1 |
| | Open | 92.5 – 161.7 | 6.4 – 14.3 | NA^^ | 3.0 – 3.6 | 0.3 – 13.0 |
| | Lap | 115 – 203 | 0 – 0.9 | 85.3 – 420 | 1.0 – 3.0 | 0.9 – 2.5 |
| 9. Barakat (2011)* | da Vinci | | 2.2 | 100 | | |
| | Lap | | 0 | 150 | | |
| 10. Bedient (2009)* | da Vinci | | 4.8 | 100 | | |
| | Lap | | 5.0 | 250 | | |
| 11. Gargiulo (2012)* | da Vinci | | 5.7 | 112.2 | | |
| | Lap | | 0.9 | 85.3 | | |
| 12. Nezhat (2008)* | da Vinci | | 0 | 370 | | |
| | Lap | | 0 | 420 | | |
| 13. Hsaio (2013)* | da Vinci | | 20 | 175 | | |
| | Lap | | 14 | 200 | | |
| 14. Pluchino (2013)* | da Vinci | | 0 | 125.8 | | |
| | Lap | | 4.6 | 222.1 | | |
| 15. Gobern (2013)* | da Vinci | | 6 | 100 | | |
| | Lap | | 12 | 100 | | |
| 16. Gocmen (2013)* | da Vinci | | Not
Reported^ | 101.33 | | |
| | Lap | | | 119.78 | | |
| 17. Behera (2011)* | da Vinci | | 0 | Not
Reported | | |
| | Lap | | 0 | Reported | | |
TABLE 2: da Vinci vs. Open and da Vinci vs. Laparoscopic Myomectomy
TABLE 3: da Vinci vs. Open and da Vinci vs. Laparoscopic Sacrocolpopexy
| Publications | | Operative Time
(minutes) | Transfusions
(%) | Length of Stay
(days) | Complications
(%) |
|--------------------|-----------------|-----------------------------|---------------------|--------------------------|----------------------|
| 18. Serati (2014) | da Vinci | 265 | 0.9 | 1.5 | 17.1 |
| | Open | 212 | da Vinci | 265 | Not Reported | 43 hours | Not Reported** |
| | Lap | 199 | Not Reported | 34 hours | |
| 20. Anger (2014) | da Vinci | 202.8 | Not Reported | Not Reported | 15 |
| | Lap | 178.4 | Not Reported | Not Reported | 26 |
| 21. Flack (2015) | da Vinci | Not Reported | Not Reported | 1.0 | 8.0 |
| | Lap | Not Reported | Not Reported | 2.0 | 7.0 |
^Rates reported are for "Infectious" complications; Non-infectious complication rates were 7.8%, 19.4% and 18.3% for the da Vinci-assisted, open and lap cohorts, respectively.
*Transfusion and/or EBL (estimated blood loss) data only were provided for this publication.
**Not Reported but publication states that there were no differences in intraoperative complications. ^Transfusion rates not reported.
^^EBL volumes not provided. Author states "Pooled results showed that the mean EBL was significantly lower in the RLM group compared with the AM group."
Covered Procedures
The published data on the above cited umbrella procedures were used to support clearance of the following covered procedures: Endometriosis Resection, Adnexectomy, Omentectomy, Lysis of Adhesions, Cyst Removal and Parametrectomy.
7
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 "gynecologic laparoscopic surgical procedure" general indication is substantially equivalent to the predicate devices: Hysterectomy (Radical, Hysterectomy for Benign Disease2), Salpingectomy, Oophorectomy, Lymphadenectomy, Myomectomy, Sacrocolpopexy, Endometriosis Resection, Adnexectomy, Omentectomy, Parametrectomy, Cyst Removal, and Lysis of Adhesions.
The demonstration of safety and effectiveness was based on evaluation of the device as a surgical tool and did not include evaluation of outcomes related to treatment of cancer (overall survival, disease-free survival, local recurrence).
2 "Hysterectomy" was previously cleared as a representative, specific procedure for the do Vinci Xi Surgical System under K131861.