(152 days)
No
The document explicitly states "There are no changes to the technological characteristics of the cleared da Vinci Xi or X Surgical Systems (Models IS4000 and IS4200) proposed in this submission." and there is no mention of AI or ML in the description or performance studies.
Yes
The device is intended to assist in various surgical procedures, including cutting, grasping, ligating, and suturing tissue, and delivering therapeutic probes for ablation, which are all therapeutic actions.
No
Explanation: The device is described as an "Endoscopic Instrument Control System" intended to "assist in the accurate control of Intuitive Surgical Endoscopic Instruments" for surgical procedures, including tissue manipulation, cutting, and suturing. It is a surgical system designed for intervention, not for diagnosing conditions or diseases.
No
The device description explicitly states that the da Vinci Xi and X Surgical Systems are "software-controlled, electro-mechanical systems" and consist of hardware components like a Surgeon Console, Patient Side Cart, and Vision Side Cart. This indicates it is not a software-only medical device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use/Indications for Use: The intended use clearly describes the device as assisting in the control of surgical instruments for performing various surgical procedures on patients. This involves direct interaction with the patient's body during surgery.
- Device Description: The device is described as a software-controlled, electro-mechanical system used by surgeons in an operating room environment to perform minimally invasive surgery. It consists of a console, patient cart, and vision cart, and is used with instruments and an endoscope.
- IVD Definition: An In Vitro Diagnostic device is defined as a medical device that is used to perform tests on samples taken from the human body, such as blood, urine, or tissue, to provide information about a person's health.
This device does not perform tests on samples taken from the body. It is a surgical tool used on the body during a procedure.
N/A
Intended Use / Indications for Use
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 endoscopic dissectors, scissors, 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.
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.
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 "general laparoscopic surgical procedures" Indication for Use of the da Vinci Xi Surgical System, Model IS4000 (K131861) and the da Vinci X Surgical System, Model IS4200 (K171294): Pancreatectomy (partial, distal, segmental), Pancreaticoduodenectomy (Whipple Procedure), Splenectomy and Cholecystectomy. There are no changes to the technological characteristics of the cleared da Vinci Xi or X Surgical Systems (Models IS4000 and IS4200) proposed in this submission. The da Vinci Xi and X Surgical Systems, Models IS4000 and IS4200, are software-controlled, electro-mechanical systems designed for surgeons to perform minimally invasive surgery. The Model IS4000 and Model IS4200 Surgical Systems consist of a Surgeon Console, a Patient Side Cart (PSC), and a Vision Side Cart (VSC) and are used with an Endoscope, EndoWrist Instruments, and Accessories.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
urologic, general laparoscopic, gynecologic laparoscopic, general thoracoscopic, thoracoscopically-assisted cardiotomy, mediastinotomy (for coronary anastomosis), Pancreatectomy (partial, distal, segmental), Pancreaticoduodenectomy (Whipple Procedure), Splenectomy, Cholecystectomy.
Indicated Patient Age Range
adult and pediatric use
Intended User / Care Setting
trained physicians in an operating room environment
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Pre-Clinical Animal Study Data:
Animal performance data were provided in this premarket notification, including the results from seven (7) evaluations in a total of 27 animals demonstrating use of da Vinci Xi Surgical System (Model IS4000) in the following procedures: Nephrectomy, Pyeloplasty, Hysterectomy and Salpingectomy/Oophorectomy/, Nissen Fundoplication, Colectomy, Mitral Valve Repair and Splenectomy. These data were previously submitted in support of clearance of the da Vinci Xi Surgical System, Model IS4000 (K131861), the da Vinci Xi Vessel Sealer (K140189/S001) and the da Vinci Xi (Model IS4000) 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); urologic surgical procedures general indication (K161178); and, general laparoscopic surgical procedures general indication (K170713 and K171632). These data also support inclusion of the subject representative, specific procedures.
Clinical Study Data:
Published clinical data support use of the da Vinci Xi and X Surgical Systems (Models IS400) 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 Pancreatectomy and Pancreaticoduodenectomy (Whipple Procedure) (referred to as the "umbrella" procedures). The published data on these "umbrella" procedures were deemed sufficient to cover the less complex/lower risk procedures (referred to as "covered" procedures), so published clinical data on the covered procedures were not provided.
Umbrella Procedure #1: Pancreatectomy
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.
Findings:
- Mortality: comparable mortality rates;
- Estimated Blood Loss and/or Transfusion Rates: comparable or lower blood transfusion rates and/or EBL volumes;
- Lengths of Hospital Stay: comparable or shorter length of hospital stay as compared to laparoscopy and open surgery;
- Complication Rates: comparable or lower complication rates;
- Spleen Preservation Rates: higher or comparable spleen preservation rates;
- Gastric Emptying Rates: lower or comparable delayed gastric emptying rates;
- Reoperation Rates: comparable reoperation rates;
- Readmission Rates: comparable or higher readmission rates; and
- Pancreatic Fistula Rates: comparable pancreatic fistula 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.
- Conversion Rates: comparable or lower conversion rates were reported for da Vinci-assisted procedures as compared to laparoscopic procedures.
Umbrella Procedure #2: Pancreaticoduodenectomy
Eight (8) publications were identified for this umbrella procedure based on specific search criteria and filters. These publications included meta-analyses, systematic reviews and a large database comparative study.
Findings:
- Mortality: comparable mortality rates;
- Estimated Blood Loss Volume2: comparable EBL volumes;
- Lengths of Hospital Stay: comparable length of hospital stay as compared to laparoscopy and comparable or shorter length of hospital stay as compared to open surgery;
- Complication Rates: comparable or lower complication rates;
- Gastric Emptying Rates: lower or comparable delayed gastric emptying rates;
- Reoperation Rates: comparable reoperation rates; and,
- Pancreatic Fistula Rates: comparable pancreatic fistula 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.
- Conversion Rates: comparable or lower conversion rates for da Vinci-assisted procedures were reported as compared to laparoscopic procedures.
Covered Procedures:
The published data on the above cited Pancreatectomy and Pancreaticoduodenectomy (Whipple Procedure) umbrella procedures were used to support clearance of the following covered procedures: Splenectomy and Cholecystectomy.
Conclusion:
Based on the information provided in this premarket notification, the inclusion of the following additional representative, specific procedures under the da Vinci Xi and X Surgical Systems (Models IS4000 and IS4200) "general laparoscopic surgical procedure" Indication for Use is substantially equivalent to the predicate devices: Pancreatectomy (partial, distal, segmental), Pancreaticoduodenectomy (Whipple Procedure), Splenectomy and Cholecystectomy.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
K131861, K152578, K153276, K161178, K170713, K171294
Reference Device(s)
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.
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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo is in blue and includes the letters "FDA" followed by the words "U.S. Food & Drug Administration."
January 31, 2018
Intuitive Surgical, Inc. % Ms. Cindy Domecus Domecus Consulting Services LLC 1171 Barroilhet Drive Hillsborough, California 94010
Re: K172643
Trade/Device Name: da Vinci Xi Surgical System, da Vinci X Surgical System; Model IS4000 and Model IS4200 Regulation Number: 21 CFR 876.1500 Regulation Name: Endoscope and Accessories Regulatory Class: Class II Product Code: NAY Dated: January 29, 2018 Received: January 31, 2018
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 device-related adverse events) (21 CFR 803); good
1
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.
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.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely, Jennifer R. Stevenson -S3 For Binita S. Ashar, M.D., M.B.A., F.A.C.S.
Director Division of Surgical Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known)
Device Name
da Vinci Surgical System, Model IS4000, and EndoWrist Instruments and Accessories
Indications for Use (Describe)
The Intuitive Surgical Endoscopic Instrument Control System, Model 184000) is intended to assist in the accurate control of Intuitive Surgical Endoscopic Instruments including rigid endoscopes, blunt and sharp endoscopic dissectors, scissors, 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) | ☐ |
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
*DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW *
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
3
Indications for Use
510(k) Number (if known)
Device Name
da Vinci Surgical System, Model IS4200, and EndoWrist Instruments and Accessories
Indications for Use (Describe)
The Intuitive Surgical Endoscopic Instrument Control System (da Vinci Surgical System, Model 184200) 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 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) |
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
*DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW *
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
4
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 16, 2018
II. SUBJECT DEVICE INFORMATION
| Device Trade Name: | da Vinci® Xi and X 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:
Predicate Device: Intuitive Surgical da Vinci Xi and X Surgical Systems, Models IS4000 and IS4200 (K131861, K152578, K153276, K161178, K170713, K171294) Intuitive Surgical da Vinci Si 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 "general laparoscopic surgical procedures" Indication for Use of the da Vinci Xi Surgical System, Model IS4000 (K131861) and the da Vinci X Surgical System, Model IS4200 (K171294): Pancreatectomy (partial, distal, segmental), Pancreaticoduodenectomy (Whipple Procedure), Splenectomy and Cholecystectomy. There are no changes to the technological characteristics of the cleared da Vinci Xi or X Surgical Systems (Models IS4000 and IS4200) proposed in this submission. The da Vinci Xi and X Surgical Systems, Models IS4000 and IS4200, are software-controlled, 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.
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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 do 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 27 animals demonstrating use of da Vinci Xi Surgical System (Model IS4000) in the following procedures: Nephrectomy, Pyeloplasty, Hysterectomy and Salpingectomy/Oophorectomy/, Nissen Fundoplication, Colectomy, Mitral Valve Repair and Splenectomy. These data were previously submitted in support of clearance of the da Vinci Xi Surgical System, Model IS4000 (K131861), the da Vinci Xi Vessel Sealer (K140189/S001) and the da Vinci Xi (Model IS4000) 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); urologic surgical procedures general indication (K161178); and, general laparoscopic surgical procedures general indication (K170713 and K171632). These data also support inclusion of the subject representative, specific procedures.
6
Clinical Study Data
Published clinical data support use of the da Vinci Xi and X Surgical Systems (Models IS400) 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 Pancreatectomy and Pancreaticoduodenectomy (Whipple Procedure) (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: Pancreatectomy
Published clinical data were provided for the umbrella procedure "Pancreatectomy". 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 Pancreatectomy publications show that da Vinci-assisted procedures as compared to open and laparoscopic procedures are associated with:
- Mortality: comparable mortality rates;
- Estimated Blood Loss and/or Transfusion Rates: comparable or lower blood transfusion rates and/or EBL volumes;
- Lengths of Hospital Stay: comparable or shorter length of hospital stay as compared to laparoscopy and open surgery;
- . Complication Rates: comparable or lower complication rates;
- Spleen Preservation Rates: higher or comparable spleen preservation rates;
- Gastric Emptying Rates: lower or comparable delayed gastric emptying rates;
- Reoperation Rates: comparable reoperation rates;
- Readmission Rates: comparable or higher readmission rates; and
- . Pancreatic Fistula Rates: comparable pancreatic fistula 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.
- Conversion Rates: comparable or lower conversion rates were reported for da Vinci-assisted procedures as compared to laparoscopic procedures.
7
Umbrella Procedure #2: Pancreaticoduodenectomy
Published clinical data were provided for the umbrella procedure "Pancreaticoduodenectomy". Eight (8) publications were identified for this umbrella procedure based on specific search criteria and filters. These publications included meta-analyses, systematic reviews and a large database comparative study. A detailed summary of the published clinical data on this procedure is provided in Tables 2A and 2B below.
The findings from the Pancreaticoduodenectomy publications show that da Vinci-assisted procedures as compared to open and laparoscopic procedures are associated with:
- Mortality: comparable mortality rates;
- Estimated Blood Loss Volume2: comparable EBL volumes;
- Lengths of Hospital Stay: comparable length of hospital stay as compared to laparoscopy and ● comparable or shorter length of hospital stay as compared to open surgery;
- Complication Rates: comparable or lower complication rates;
- Gastric Emptying Rates: lower or comparable delayed gastric emptying rates;
- Reoperation Rates: comparable reoperation rates; and,
- Pancreatic Fistula Rates: comparable pancreatic fistula 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.
- Conversion Rates: comparable or lower conversion rates for da Vinci-assisted procedures were reported as compared to laparoscopic procedures.
Covered Procedures
The published data on the above cited Pancreatectomy and Pancreaticoduodenectomy (Whipple Procedure) umbrella procedures were used to support clearance of the following covered procedures: Splenectomy and Cholecystectomy.
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 and X Surgical Systems (Models IS4000 and IS4200) "general laparoscopic surgical procedure" Indication for Use is substantially equivalent to the predicate devices: Pancreatectomy (partial, distal, segmental), Pancreaticoduodenectomy (Whipple Procedure), Splenectomy and Cholecystectomy.
1 One publication (Orti-Rodriguez, et al) reported a higher EBL volume, a longer length of stay and a higher pancreatic fistula rate for the da Vinci cohort as compared to the laparoscopic cohort. These outcomes were not associated with increased complication or mortality rates.
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TABLE 1A: da Vinci vs. Open and da Vinci vs. Laparoscopic Pancreatectomy
| Publications | Sample Size (N) | Operative Time (minutes) | Estimated Blood Loss “EBL” (ml) | Length of Stay (days) | PostOp Complications (%) | Mortality Rate (%) | Transfusion Rate (%) | Reoperation Rate (%) | Readmission Rate (%) | |
|---|---|---|---|---|---|---|---|---|---|---|
| 1. Adam | ||||||||||
| (2015) | da Vinci | 61 | Not Reported | Not Reported | 8 | Not Reported | 0 | Not Reported | Not Reported | Suppressed 12.9% |
| Lap | 474 | 6 | suppressed | 11 | ||||||
| Open | 1198 | 9 | 2 | 9 | ||||||
| 2. Chen S | ||||||||||
| (2017) | da Vinci | 50 | 160 | 50 | 15.6 | 46 | 0 | 0 | 4 | 2 |
| Open | 50 | 193 | 200 | 21.7 | 60 | 0 | 10 | 8 | 2 | |
| 3. Chen Y | ||||||||||
| (2013) | da Vinci | 67 / 45 | range (293 - 719) | range (150 - 372) | range (3.8 - 16.4) | Not Reported | Not Reported | Not Reported | Not Reported | Not Reported |
| Lap | 137 | range (224 - 372) | range (150 - 667) | range (6.4 - 7.3) | ||||||
| Open | 45 | range (234 - 420) | range (210 - 858) | range (7.7 - 24.3) | ||||||
| 4. Gavrilidis | ||||||||||
| (2016) | da Vinci | 246 | range (213 - 349) | Not Reported | range (5 - 11.6) | 16 | 0.4 | Not Reported | Not Reported | 5.6 - 36.7 |
| Lap | 391 | range (174 - 372) | range (6.0 - 14.7) | 17 | 0.3 | 0 - 23.4 | ||||
| 5. Huang | ||||||||||
| (2016) | da Vinci | 238 | range (293 - 349) | Not Reported | range (6.1 - 8.9) | Not Reported | 0 | 13.9 | Not Reported | Not Reported |
| Lap | 929 | range (250 - 372) | range (6.0 - 19.2) | 0 | 11.4 | |||||
| 6. Konstantinidis | ||||||||||
| (2017) | da Vinci | 115 | Not Reported | Not Reported | Not Reported | Not Reported | Not Reported | Not Reported | Not Reported | Not Reported |
| Lap | 365 | |||||||||
| Open | 558 | |||||||||
| 7. Wright | ||||||||||
| (2016) | da Vinci | 195 | 230 | 172 | 8 | 18 | 0 | Not Reported | Not Reported | Not Reported |
| Lap | 349 | 249 | 281 | 7 | 17 | da Vinci | 200 | 243 | Not Reported | |
| Lap | 694 | 205 | 5 | 36 | 1 | 5 | 3 | 14 | ||
| Open | 921 | 222 | 7 | 45 | 1.5 | 21 | 5 | 18 | ||
| 9. Zhang | ||||||||||
| (2013) | da Vinci | 22 | range (298 - 432) | range (275 - 279) | range (4 - 14.6) | 17.6 - 20* | 0 | Not Reported | 0 | Not Reported |
| Open | 32 | range (234 - 286.5) | range (681 - 858.3) | range (8 - 22.1) | 18.2 - 50* | 0 | 2 | |||
| 10. Zhou | ||||||||||
| (2016) | da Vinci | 211 | range (150 - 372) | range (100 - 375) | range (3.8 - 11.6) | 43.6 | 1.4 | 8.3 | Not Reported | Not Reported |
| Lap | 357 | range (193 - 295) | range (262 - 667) | range (5 - 14.7) | 52.4 | 2.0 | 11.1 | |||
| 11. Zureikat | ||||||||||
| (2017) | da Vinci | 258 | Not Reported | Not Reported | Not Reported | Not Reported | Not Reported | Not Reported | Not Reported | Not Reported |
| Lap | 684 | |||||||||
| Open | 3743 |
*Authors reported on "Overall Complication Rate"
9
TABLE 1B: da Vinci vs. Open and da Vinci vs. Laparoscopic Pancreatectomy
| Publications | Sample Size (N) | Spleen Preservation Rate (%) | R0 Resection Rate (%) | R1 Resection Rate (%) | Lymph Node Yield (n) | Delayed Gastric Emptying Rate (%) | Pancreatic Fistula Rate (%) | Conversion Rate (%) |
|---|---|---|---|---|---|---|---|---|
| 1. Adam (2015) | da Vinci 61 | |||||||
| Lap 474 | ||||||||
| Open 1198 | Not Reported | Not Reported | Not Reported | 12 | ||||
| 12 | ||||||||
| 13 | Not Reported | Not Reported | suppressed 14.8 | |||||
| 23 | ||||||||
| NA | ||||||||
| 2. Chen S (2017) | da Vinci 50 | |||||||
| Open 50 | Not Reported | Not Reported | Not Reported | Not Reported | A (12), B (6), C (6) | |||
| A (22), B (8), C (4) | 44 | |||||||
| 54 | Not Reported | |||||||
| 3. Chen Y (2013) | da Vinci 67 / 45 | |||||||
| Lap 137 | ||||||||
| Open 45 | 81.1 | |||||||
| 48.8 | ||||||||
| 13.6 | 98 | |||||||
| 83 | ||||||||
| 82 | Not Reported | Not Reported | Not Reported | 30.2 | ||||
| 36.6 | ||||||||
| 31.1 | Not Reported | |||||||
| 4. Gavrilidis (2016) | da Vinci 246 | |||||||
| Lap 391 | Not Reported | 100 | ||||||
| 98 | 0 | |||||||
| 2 | Not Reported | Not Reported | 24.3 | |||||
| 24.0 | 9 | |||||||
| 20 | ||||||||
| 5. Huang (2016) | da Vinci 238 | |||||||
| Lap 929 | 35.4 | |||||||
| 27.7 | Not Reported | Not Reported | Not Reported | Not Reported | 29.9 | |||
| 31.3 | 8.9 | |||||||
| 23.0 | ||||||||
| 6. Konstantinidis (2017) | da Vinci 115 | |||||||
| Lap 365 | ||||||||
| Open 558 | Not Reported | Not Reported | Not Reported | Not Reported | Not Reported | Not Reported | 11.3 | |
| 21.9 | ||||||||
| NA | ||||||||
| 7. Wright (2016) | da Vinci 195 | |||||||
| Lap 349 | Not Reported | Not Reported | Not Reported | Not Reported | Not Reported | Not Reported | 10 | |
| 19 | ||||||||
| 8. Xourafas (2017) | da Vinci 200 | |||||||
| Lap 694 | ||||||||
| Open 921 | 8 | |||||||
| 9 | ||||||||
| 10 | Not Reported | Not Reported | Not Reported | 1 | ||||
| 3 | ||||||||
| 5 | 21 | |||||||
| 18 | ||||||||
| 17 | 8 | |||||||
| 16 | ||||||||
| NA | ||||||||
| 9. Zhang (2013) | da Vinci 22 | |||||||
| Open 32 | Not Reported | Not Reported | Not Reported | Not Reported | Not Reported | 4.5 | ||
| 25.0 | 0 - 12 | |||||||
| NA | ||||||||
| 10. Zhou (2016) | da Vinci 211 | |||||||
| Lap 357 | 53.6 | |||||||
| 27.8 | 100 | |||||||
| 92.6 | Not Reported | range (5 - 19) | ||||||
| range (5 - 15.2) | Not Reported | 25.8 | ||||||
| 24.7 | 16.1 | |||||||
| 23.0 | ||||||||
| 11. Zureikat (2017) | da Vinci 258 | |||||||
| Lap 684 | ||||||||
| Open 3743 | Not Reported | Not Reported | Not Reported | Not Reported | Not Reported | Not Reported | 10 | |
| 18.2 | ||||||||
| NA |
*Authors provided combined data for pancreatectomy and pancreaticoduodenectomy procedures.
10
| TABLE 2A: da Vinci vs. Open and da Vinci vs. Laparoscopic Pancreaticoduodenectomy | |
|---|---|
| -- | ----------------------------------------------------------------------------------- |
| Publications | Sample Size (N) | Operative Time (minutes) | Estimated Blood Loss "EBL" (ml) | Length of Stay (days) | PostOp Complications (%) | Mortality Rate (%) | Transfusion Rate (%) | Reoperation Rate (%) | Readmission Rate (%) |
|---|---|---|---|---|---|---|---|---|---|
| 1. de Rooij (2016) | da Vinci 160 | Not Reported | Not Reported | Not Reported | Not Reported | 2.5 | Not Reported | Not Reported | Not Reported |
| Lap 641 | 3.0 | ||||||||
| Open 1123 | 3.7 | ||||||||
| 2. Lei P (2014) | da Vinci 102 | range (444 - 719) | range (154 - 485) | range (13 - 16.4) | 43.14** | Not Reported | Not Reported | Not Reported | Not Reported |
| Lap 107 | range (338 - 657) | range (195 - 448) | range (8 - 48) | 57.01** | |||||
| Open 144 / 285 | range (265 - 559) | range (210 - 1510) | range (12.4 - 43) | 54.9 / 65.3** | |||||
| 3. Orti-Rodriguez (2012) | da Vinci 109 | 394.77 | 319.06 | 15.31 | 16.5 | 3 | Not Reported | Not Reported | Not Reported |
| Lap 192 | 388.8 | 178.7 | 9.9 | 35.9 | 2.7 | ||||
| 4. Pedziwiatr (2017) | da Vinci 476 | range (400 - 718) | range (100 - 775) | range (7.4 - 20.0) | 37.7 | Not Reported | Not Reported | Not Reported | Not Reported |
| Lap 229 | range (361 - 513) | range (260 - 492.4) | range (6.0 - 10.0) | 59.5 | |||||
| Open 1162 / 319 | range (300 - 559) | range (210 - 867) | range (8.0 - 25.8) | 31.9 / 80.0 | |||||
| 5. Peng (2016) | da Vinci 245 | range (410 - 718.8) | range (100 - 650) | range (13 - 20) | 35 | 2.9 | Not Reported | 7.3 | Not Reported |
| Open 435 | range (264.9 - 559) | range (210 - 840) | range (14.6 - 25.8) | 45 | 2.8 | 13.0 | |||
| 6. Shin (2016) | da Vinci 160 | range (340 - 492) | range (100 - 500) | range (7 - 20) | 37.1 | Not Reported | Not Reported | Not Reported | Not Reported |
| Lap 450 | range (342 - 551) | range (195 - 609) | range (6 - 25) | 40.8 | |||||
| Open 294 / 718 | range (264 - 410) | range (293 - 1032) | range (8 - 26) | 47.7 / 50.9 | |||||
| 7. Zhang (2013) | da Vinci 115 | range (444 - 718.8) | range (153.75 - 537) | range (7 - 16.38) | 25 - 36.4* | 0 - 4.5 | Not Reported | 6.5 | Not Reported |
| Open 171 | range (364 - 559) | range (210 - 840) | range (13.26 - 24.25) | 23.2 - 75* | 0 - 12.5 | 18.6 | |||
| 8. Zureikat (2017) | da Vinci 258 | Not Reported | Not Reported | Not Reported | Not Reported | Not Reported | Not Reported | Not Reported | Not Reported |
| Lap 684 | |||||||||
| Open 3743 |
*Authors reported on "Overall Complication Rate"; **Authors reported both intraoperative complication rates.
11
TABLE 2B: da Vinci vs. Open and da Vinci vs. Laparoscopic Pancreaticoduodenectomy
| Publications | Sample Size (N) | Spleen Preservation Rate (%) | R0 Resection Rate (%) | R1 Resection Rate (%) | Lymph Node Yield (n) | Delayed Gastric Emptying Rate (%) | Pancreatic Fistula Rate (%) | Conversion Rate (%) |
|---|---|---|---|---|---|---|---|---|
| 1. de Rooij | ||||||||
| (2016) | da Vinci 160 | |||||||
| Lap 641 | ||||||||
| Open 1123 | Not Reported | Not Reported | Not Reported | Not Reported | Not Reported | 7.6 | 8 | |
| 12.7 | 7 | |||||||
| 18.4 | NA | |||||||
| 2. Lei P | ||||||||
| (2014) | da Vinci 102 | |||||||
| Lap 107 | ||||||||
| Open 144 / 285 | Not Reported | Not Reported | Not Reported | Not Reported | 4.3 | 20.6 | Not Reported | |
| 13.1 | 23.4 | |||||||
| 7.4 / 13.7 | 19.4 / 17.5 | |||||||
| 3. Orti-Rodriguez | ||||||||
| (2012) | da Vinci 109 | |||||||
| Lap 192 | Not Reported | Not Reported | Not Reported | Not Reported | Not Reported | 30 | 12 | |
| 14.5 | 8.3 | |||||||
| 4. Pedziwiatr | ||||||||
| (2017) | da Vinci 476 | |||||||
| Lap 229 | ||||||||
| Open 1162 / 319 | Not Reported | Not Reported | 35.5 | range (15 - 37) | 23.7 | 20.2 | Not Reported | |
| 20.7 | range (8.7 - 23) | 8.7 | 15.7 | |||||
| 29.5 / 23.0 | range (9.6 - 36) | 20.1 / 17.2 | 12.7 / 17.6 | |||||
| 5. Peng | ||||||||
| (2016) | da Vinci 245 | |||||||
| Open 435 | Not Reported | 93.1 | Not Reported | range (10.0 - 16.8) | 6.8 | 17.9 | 7.3 | |
| 81.5 | range (10.0 - 12.5) | 14.1 | 21.4 | NA | ||||
| 6. Shin | ||||||||
| (2016) | da Vinci 160 | |||||||
| Lap 450 | ||||||||
| Open 294 / 718 | Not Reported | Not Reported | 13.4 | range (10 - 15) | 8.8 | 18.5 | 7.5 | |
| 21.6 | range (8.7 - 23.4) | 9.6 | 29.8 | 7.8 | ||||
| 22.8 / 22.1 | range (9.6 - 25.0) | 15.6 / 14.2 | 21.6 / 23.0 | NA | ||||
| 7. Zhang | ||||||||
| (2013) | da Vinci 115 | |||||||
| Open 171 | Not Reported | Not Reported | 3.1 | Not Reported | Not Reported | 14.4 | Not Reported | |
| 14.8 | 22.0 | |||||||
| 8. Zureikat | ||||||||
| (2017) | da Vinci 258 | |||||||
| Lap 684 | ||||||||
| Open 3743 | Not Reported | Not Reported | Not Reported | Not Reported | Not Reported | Not Reported | 14.8 | |
| 31.9 | ||||||||
| NA |