(511 days)
Not Found
No
The document explicitly states that this submission is for a labeling modification only and there are no changes to the technological characteristics of the cleared systems. There is no mention of AI or ML in the device description or intended use.
No
The device is described as assisting in surgical procedures by controlling instruments, not as directly providing therapy for a disease or condition.
No
The device is described as an instrument control system intended to assist in surgical procedures by controlling endoscopic instruments for tissue manipulation. It is not used for diagnosing medical conditions.
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.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly describes the system 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 designed for surgeons to perform minimally invasive surgery." It consists of components like a Surgeon Console, Patient Side Cart, and Vision Side Cart, used with instruments and accessories for surgical manipulation.
- Lack of IVD Characteristics: An IVD device is intended for use in vitro (outside the body) to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening. This device does not perform such analysis of specimens.
- Clinical Study Data: The performance studies focus on surgical outcomes and complications during procedures performed on patients, not on the analysis of biological samples.
Therefore, the Intuitive Surgical Endoscopic Instrument Control System (da Vinci Xi and X Surgical Systems) is a surgical robot system used for performing surgical procedures in vivo, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The Intuitive Surgical Endoscopic Instrument Control System (da Vinci Xi 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.
The Intuitive Surgical Endoscopic Instrument Control System (da Vinci X Surgical System Model 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 procedure under the cleared "general laparoscopic surgical procedures" and "general thoracoscopic surgical procedures and thoracoscopically-assisted cardiotomy procedures" Indications for Use of the da Vinci Xi Surgical System, Model IS4000 (K131861) and the da Vinci X Surgical System, Model IS4200 (K171294) and the associated labeling claims: Esophagectomy. There are no changes to the technological characteristics of the cleared da Vinci Xi or X Surgical Systems (Models IS400) 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
Endoscopic
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)
Clinical Study Data:
Seventeen (17) publications were identified for this procedure based on specific search criteria and filters used in three (3) search engines: PubMed, Scopus and Embase and two (2) separate searches. These publications included: one (1) prospective study (LOE 2b); five (5) database studies (LOE 2b/2c) and eleven (11) retrospective studies (LOE 3b) comparing da Vinci-assisted procedures with minimally invasive, laparoscopic and/or video-assisted cohorts.
The findings from the Esophagectomy publications demonstrate that do Vinci-assisted procedures as compared to minimally invasive, laparoscopic and/or video-assisted procedures are found to be substantially equivalent based on the following endpoints:
- Mortality Rates
- Estimated Blood Loss (EBL) Volumes
- Blood Transfusion Rates
- Lengths of Hospital Stay (LOS)
- Intraoperative Complication Rates
- Postoperative Complication Rates
- Conversion Rates
- Reoperation Rates
- Readmission Rates
- Anastomotic Leak Rates
- Operative Times
Learning Curve Publications:
A total of 17 publications that evaluated the learning curve associated with da Vinci-assisted esophagectomy procedures across different surgeons with varying levels of clinical and surgical expertise were also evaluated. These published reports identified a learning curve of 3 - 80 cases associated with da Vinci-assisted esophagectomy procedures.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
- Mortality Rates
- Estimated Blood Loss (EBL) Volumes
- Blood Transfusion Rates
- Lengths of Hospital Stay (LOS)
- Intraoperative Complication Rates
- Postoperative Complication Rates
- Conversion Rates
- Reoperation Rates
- Readmission Rates
- Anastomotic Leak Rates
- Operative Times
Predicate Device(s)
K131861, K152578, K153276, K161178, K170713, K171632, K171294, K172643, K173842, K173585, K182140, 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. Food & Drug Administration (FDA). The logo consists of two parts: a symbol on the left and the text on the right. The symbol is a stylized representation of a caduceus, a traditional symbol of medicine, with intertwined snakes and wings. To the right of the symbol is the text "FDA U.S. FOOD & DRUG ADMINISTRATION" in blue, with "FDA" in a larger font size than the rest of the text.
March 31, 2020
Intuitive Surgical, Inc Mark Johnson Senior Vice President, Regulatory Affairs 1266 Kifer Road Sunnyvale, California 94086
Re: K183086
Trade/Device Name: da Vinci Xi Surgical System, da Vinci X Surgical System Regulation Number: 21 CFR 876.1500 Regulation Name: Endoscope and Accessories Regulatory Class: Class II Product Code: NAY Dated: January 27, 2020 Received: January 28, 2020
Dear Mark Johnson:
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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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
1
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) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; 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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). 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 (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Long Chen, Ph.D. Assistant Director DHT4A: Division of General Surgery Devices OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known)
K183086
Device Name
Intuitive Surgical® da Vinci® Xi Endoscopic Instrument Control System
(da Vinci Xi System, Model IS4000) and Endoscopic Instruments and Accessories
Indications for Use (Describe)
The Intuitive Surgical Endoscopic Instrument Control System (da Vinci Xi 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.
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
Intuitive Surgical® da Vinci® X Endoscopic Instrument Control System (da Vinci X System, Model IS4200) and Endoscopic Instruments and Accessories
Indications for Use (Describe)
The Intuitive Surgical Endoscopic Instrument Control System (da Vinci X Surgical System Model 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.
| 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
K183086
510(k) Summary (21 CFR § 807.92(c))
I. SUBMITTER INFORMATION
| Submitter: | Intuitive Surgical, Inc.
1266 Kifer Road
Sunnyvale, CA 94086 |
|--------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact: | Mark Johnson
Senior Vice President, Regulatory Affairs & Program Management Office
Intuitive Surgical, Inc.
Telephone: 650-523-8027
Email: Mark.Johnson@intusurg.com |
| Date Summary Prepared: | March 24, 2020 |
| II. SUBJECT DEVICE INFORMATION | |
| Device Trade Name: | da Vinci® Xi and X Surgical Systems, Model IS4000 and Model IS4200 |
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: 11 Product Code: NAY Submission Type: Traditional 510(k)
III. PREDICATE DEVICE INFORMATION:
| Predicate Devices: | Intuitive Surgical da Vinci Xi and X Surgical Systems, Models IS4000 and
IS4200 (K131861, K152578, K153276, K161178, K170713, K171632, K171294
K172643, K173842, K173585 and K182140) |
|---------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 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 procedure under the cleared "general laparoscopic surgical procedures" and "general thoracoscopic surgical procedures and thoracoscopically-assisted cardiotomy procedures" Indications for Use of the da Vinci Xi Surgical System, Model IS4000 (K131861) and the da Vinci X Surgical System, Model IS4200 (K171294) and the associated labeling claims: Esophagectomy. There are no changes to the technological characteristics of the cleared da Vinci Xi or X Surgical Systems (Models IS400) 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.
5
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 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 INTENDED USE, INDICATIONS FOR USE AND TECHNOLOGICAL CHARACTERISTICS WITH THE PREDICATE DEVICE
There are no changes to the technological characteristics for the subject devices compared to the cleared predicate devices, da Vinci Xi Surgical System, Model IS4000 (K131861) and the da Vinci X Surgical System, Model IS4200 (K171294). This 510(k) is for a labeling modification to include Esophagectomy as a labeled use under the cleared "general laparoscopic surgical procedures" and "general thoracoscopic surgical procedures and thoracoscopically-assisted cardiotomy procedures" Indications for Use of the cleared predicate devices, da Vinci Xi Surgical System, Model IS4000 and the da Vinci X Surgical System, Model IS4200. The subject devices differ from the predicate devices by this modification to the labeling. Results of clinical data from literature demonstrated that the subject devices have the same intended use as the predicate devices.
VII. PERFORMANCE DATA
There were no technological changes to the subject devices, thus no bench testing, electromagnetic compatibility testing, sterilization testing or biocompatibility testing was required.
6
Clinical Study Data
Published clinical data were provided to support use of the da Vinci Xi and X Surgical Systems (Models IS4000 and IS4200) in "Esophagectomy" procedures to demonstrate that the intended use of the devices is the same as the predicate devices. Seventeen (17) publications were identified for this procedure based on specific search criteria and filters used in three (3) search engines: PubMed, Scopus and Embase and two (2) separate searches. The search terms, inclusion criteria and the flowcharts depicting the results from these searches are provided in Figures A and B. These publications included: one (1) prospective study (LOE 2b); five (5) database studies (LOE 2b/2c) and eleven (11) retrospective studies (LOE 3b) comparing da Vinci-assisted procedures with minimally invasive, laparoscopic and/or video-assisted cohorts. A detailed summary of the published clinical data on this procedure is provided in Tables 1A and 1B below.
The findings from the Esophagectomy publications demonstrate that do Vinci-assisted procedures as compared to minimally invasive, laparoscopic and/or video-assisted procedures are found to be substantially equivalent based on the following endpoints:
- Mortality Rates
- Estimated Blood Loss (EBL) Volumes
- Blood Transfusion Rates
- Lengths of Hospital Stay (LOS)
- Intraoperative Complication Rates
- Postoperative Complication Rates
- Conversion Rates
- Reoperation Rates
- Readmission Rates
- Anastomotic Leak Rates
- Operative Times
Anastomotic Leak Rate Subgroup Analysis
In the da Vinci-assisted group, the handsewn sutured cohort had an ALR of 14.73% and the stapled cohort had an ALR of 9.24% (difference of 5.49%). In the MIE group, the handsewn sutured cohort had an ALR of 8.72% and the stapled cohort had an ALR of 9.86% (difference 1.14%). Importantly, the vast majority of the sutured anastomoses for both cohorts were performed in an open manner in the neck. Although the handsewn sutures cohort of the da Vinci group (14.73%) had the highest leak rates amongst the 4 groups compared, this number still appears to be within the reported range (roughly 5-15%) for ALR for esophagectomy procedures. While taking into consideration these published data showing potentially less risk of anastomotic leak with a stapled anastomosis during robotic-assisted esophagectomy, ultimately the appropriate location and technique for the anastomosis should be based on clinical assessment of patient factors as well as the experience and training of the surgeon.
Learning Curve Publications
A total of 17 publications that evaluated the learning curve associated with da Vinci-assisted esophagectomy procedures across different surgeons with varying levels of clinical and surgical expertise were also evaluated. These published reports identified a learning curve of 3 - 80 cases
7
associated with da Vinci-assisted esophagectomy procedures. This information is reflected in the following statement included in the device labeling:
"The da Vinci Xi or X Surgical System should only be used in esophagectomy procedures performed by experienced foregut and/or thoracic surgeons who have credentials and privileges to perform such procedures at their institution. Additionally, Intuitive recommends experience with the da Vinci Xi or X Surgical Systems in less complex procedures (e.g., thymectomy, Nissen Fundoplication) prior to use of the system in esophagectomy procedures. Published literature indicates that the learning curve associated with stabilization of operative time of da Vinciassisted esophagectomy procedures can range from 3-80 cases. Intuitive encourages the use of a proctor or preceptor during use of the device in early esophagectomy procedures."
VIII. CONCLUSION
The da Vinci Xi and X Surgical Systems (models IS4000 and IS4200) have the same intended use as the predicate devices, as demonstrated by the clinical data from the literature to support the safety and effectiveness for the new labeled use of Esophagectomy procedures under the "general laparoscopic surgical procedure" and "general thoracoscopic surgical procedures and thoracoscopically-assisted cardiotomy procedures" indications as compared to the predicate devices. In addition, the subject devices have the same technological characteristics as the predicate devices. Therefore, the da Vinci Xi and X Surgical Systems (Models IS4000 and IS4200) are substantially equivalent to the cleared predicate devices.
8
K183086
BLE 1A: da Vinci vs. Minimally Invasive/Laparoscopic/Video-Assisted Esophagectomy ("MIE") Procedures
| Author/Year | Study Size (N) | Operation Time (minutes) | EBL (ml) | Length of Stay (days) | Transfusion Rate (%) | Intraop Comp Rate (%) | Postop Comp Rate (%) | Mortality (in-hospital - 30 days, %) | Reoperation Rate (%) | Readmission Rate (%) | Conversion Rate (%) |
|---|---|---|---|---|---|---|---|---|---|---|---|
| 1. Weksler 2017* | Robotic 569 | Not Reported | Not Reported | Not Reported | Not Reported | Not Reported | 5.6 | Not Reported | 7.0 | Not Reported | Not Reported |
| 2. Yerokun 2016* | Robotic 170 | Not Reported | Not Reported | 10^ | Not Reported | Not Reported | 3.7 | Not Reported | 5.9 | Not Reported | Not Reported |
| MIE 170 | Not Reported | Not Reported | 10^ | Not Reported | Not Reported | 2.7 | Not Reported | 8.8 | Not Reported | Not Reported | |
| 3. Diez del Val 2015 | Robotic 34 | Not Reported | Not Reported | 17.4 | Not Reported | Not Reported | 41.18 | 8.8 | 2.9 | Not Reported | 8.8 |
| MIE 17 | Not Reported | Not Reported | 25.9 | Not Reported | Not Reported | 64.71 | 17.6 | 17.6 | Not Reported | 11.8 | |
| 4. Suda 2012 | Robotic 16 | 692.5^ | 144.5 | 22 | Not Reported | Not Reported | 0 | Not Reported | Not Reported | Not Reported | Not Reported |
| MIE 20 | 649.5^ | 139 | 35.5 | Not Reported | Not Reported | 0 | Not Reported | Not Reported | Not Reported | Not Reported | |
| 5. Chao 2018 | Robotic 39 | 149.33 | 83.33 | 16.36 | 15.4 | Not Reported | 20.5 | 0^^ | 12.8 | 10.3 | 0 |
| MIE 67 | 156.05 | 120.75 | 17.82 | 9.0 | Not Reported | 34.3 | 4.5^^ | 14.9 | 16.9 | 0 | |
| 6. Park 2016 | Robotic 62 | 490.3 ± 84.0 | 462.9 ± 493.9 | Not Reported | Not Reported | Not Reported | Not Reported | 1.6 | Not Reported | Not Reported | 1.6 |
| MIE 43 | 458.4 ± 111.9 | 466.8 ± 333.0 | Not Reported | Not Reported | Not Reported | Not Reported | 0 | Not Reported | Not Reported | 2.3 | |
| 7. Weksler 2012 | Robotic 11 | 439 ± 70 | 200 ± 150 | 8.7 ± 3.4 | Not Reported | Not Reported | 36.4 | 0.0 | Not Reported | Not Reported | 0 |
| MIE 26 | 483.8 ± 76.5 | 226 ± 372 | 10.0 ± 7.7 | Not Reported | Not Reported | 38.5 | 7.7 | Not Reported | Not Reported | 3.85 | |
| 8. Deng 2018 | Robotic 79 | 353 | 96.3 | 14.3 | 0 | Not Reported | 28.8** | 3.8^^ | Not Reported | Not Reported | 0 |
| MIE 72 | 274 | 127.5 | 12.7 | 0 | Not Reported | 23.1** | 3.8^^ | Not Reported | Not Reported | 0 | |
| 9. He 2018 | Robotic 27 | 349 ± 45 | 119 ± 72 | 13.8 ± 2.0 | Not Reported | Not Reported | 37^* | 0 | Not Reported | Not Reported | Not Reported |
| MIE 27 | 285 ± 66 | 158 ± 82 | 12.8 ± 2.7 | Not Reported | Not Reported | 33.3^* | 3.7 | Not Reported | Not Reported | Not Reported | |
| 10. Motoyama 2019 | Robotic 21 | 634.0 | 492 | Not Reported | Not Reported | Not Reported | Not Reported | Not Reported | Not Reported | Not Reported | Not Reported |
| MIE 38 | 598.5 | 385 | Not Reported | Not Reported | Not Reported | Not Reported | Not Reported | Not Reported | Not Reported | Not Reported | |
| 11. Zhang 2019 | Robotic 76 | 303.5 | 200 | 9.0 | Not Reported | Not Reported | 31.6^* | 0 | Not Reported | Not Reported | 2.6 |
| MIE 108 | 277.2 | 200 | 9.0 | Not Reported | Not Reported | 33.3^* | 0 | Not Reported | Not Reported | 0 | |
| 12. Tagkalos 2019 | Robotic 50 | 388 | 339 | 12.0 | Not Reported | Not Reported | Not Reported | 5.0^^ | Not Reported | Not Reported | Not Reported |
| MIE 50 | 321 | 343 | 12.5 | Not Reported | Not Reported | Not Reported | 2.5^^ | Not Reported | Not Reported | Not Reported | |
| 13. Harbison 2019 | Robotic 100 | 445 | Not Reported | 10 | 10.0 | Not Reported | 31.0^* | 3.0 | 17.0 | 18.0 | 11.0 |
| MIE 625 | 418 | Not Reported | 12 | 9.76 | Not Reported | 39.2^* | 2.2 | 16.3 | 11.7 | 8.48 | |
| 14. Meredith 2019 | Robotic 144 | 409 | 155 | 9 | Not Reported | Not Reported | 23.6 | 1.4 | Not Reported | Not Reported | 0 |
| MIE1 158 | 231-299 | 189-242 | 9-10 | Not Reported | Not Reported | 29.5-49.2 | 2.1-3.2 | Not Reported | Not Reported | 7.4-12.7 | |
| 15. Washington 2019 | Robotic 18 | 168 | Not Reported | 9.9 | Not Reported | Not Reported | 5.6** | 0 | Not Reported | Not Reported | Not Reported |
| MIE 18 | 164 | Not Reported | 9.8 | Not Reported | Not Reported | 11.2** | 5.6 | Not Reported | Not Reported | Not Reported | |
| 16. Chen 2019 | Robotic 68 | 187.2 | 118.9 | 17.1 | Not Reported | Not Reported | Not Reported | 0 | 0 | Not Reported | Not Reported |
| MIE 74 | 193.4 | 116.5 | 15.2 | Not Reported | Not Reported | Not Reported | 0 | 0 | Not Reported | Not Reported | |
| 17. Yang 2019 | Robotic 271 | 244.5 | 210.7 | 11.0 | Not Reported | Not Reported | 45.0 | 0^^ | 1.5 | Not Reported | 0.7 |
| MIE 271 | 276.0 | 209.6 | 11.0 | Not Reported | Not Reported | 37.3 | 0.7^^ | 3.3 | Not Reported | 5.9 | |
| ^Medians reported, *Major complications, ^ Overall complications, ^^ 90-day mortality rate |
90
y
*The years 2010 2011 and 2012 overlap between the two (2) databases used in the Weksler and Yer
he years 2010, 2011 and 2012 overlap between the Welsler and Yerokun publications. As such, there is a possibility of data overlap in the reported results
Publication reported on two (2) MIE cohorts: "TL – thoracoscopic" and "TH – transhiatal
9
K183086
| Author/Year | Study Size (N) | Positive Surgical Margin
Rate (%) | RO Resection
Rate (%) | Lymph Node Yield (n) | Anastomotic Leak Rate (%) |
|----------------------|------------------------|--------------------------------------|--------------------------|--------------------------------|---------------------------|
| 1. Weksler 2017* | Robotic
MIE
569 | Not Reported | 95.1 | 16.0 | Not Reported |
| 2. Yerokun 2016* | Robotic
MIE
170 | 6.5
4.1 | 94.6
93.5
95.9 | 16.0
median 16
median 16 | Not Reported |
| 3. Diez del Val 2015 | Robotic
MIE
34 | Not Reported | | 20.9
24.4 | 20.6
29.4 |
| 4. Suda 2012 | Robotic
MIE
16 | 12.5
10.0 | 87.5
90 | 37.5
39 | 37.5
10.0 |
| 5. Chao 2018 | Robotic
MIE
39 | 0
2.9 | 94.9
88.1 | 29
28 | 12.8
9.0 |
| 6. Park 2016 | Robotic
MIE
62 | Not Reported | 98
98 | 37.3
28.7 | 8.1
2.3 |
| 7. Weksler 2012 | Robotic
MIE
11 | 0
0 | 100
100 | $23 \pm 10$
$23 \pm 10$ | 9.1
15.4 |
| 8. Deng 2018 | Robotic
MIE
79 | 0
0 | 100
100 | 21.5
17.3 | 7.6
5.6 |
| 9. He 2018 | Robotic
MIE
27 | Not Reported | Not Reported | $20 \pm 7$
$19 \pm 5$ | 11.11
3.70 |
| 10. Motoyama 2019 | Robotic
MIE
21 | Not Reported | | 52
59 | 4.8
7.9 |
| 11. Zhang 2019 | Robotic
MIE
76 | Not Reported | 100
99.1 | 19.7
20.3 | 9.2
5.6 |
| 12. Tagkalos 2019 | Robotic
MIE
50 | Not Reported | 95
97.5 | 27
23 | 12.0
18.0 |
| 13. Harbison 2019 | Robotic
MIE
100 | | 6.0
6.7 | | 14.0
15.4 |
| 14. Meredith 2019 | Robotic
MIE1
144 | Not Reported | 100
60-93.5% | 20
9 | 2.8
5.2 |
| 15. Washington 2019 | Robotic
MIE
18 | Not Reported | 94.4
94.4 | 14.28
13.9 | 5.6
5.6 |
| 16. Chen 2019 | Robotic
MIE
68 | Not Reported | 100
100 | 25.4
24.7 | 8.8
2.7 |
| 17. Yang 2019 | Robotic
MIE
271 | Not Reported | 94.1
93.7 | 20.3
19.2 | 11.8
14.4 |
TABLE 1B: da Vinci vs. Minimally Invasive/Laparoscopic/Video-Assisted Esophagectomy ("MIE") Procedures
The vers 2010, 2011 and 2012 – 1 = 1 = 1 = 1 = 1 = 1 = 1 = 1 = 1 = 1 = 1 = 1 = 1 = 1 =
1 Publication reported on two (2) MIE cohorts: "TL - thoracoscopic/laparoscopic" and "TH - transhiatal"
10
Image /page/10/Figure/2 description: This image shows a flow chart of the process used to identify publications related to da Vinci-assisted esophagectomy. The process starts with 823 publications and ends with 9 publications that meet the inclusion and exclusion criteria. The inclusion criteria include publication date between 1/1/2010 & 9/5/2018, LOE ≤ 3b, and study is an RCT, Meta Analysis / Systematic Review, independent database, or comparative study reporting on robotic-assisted, minimally invasive, laparoscopic, and/or video-assisted surgery. The exclusion criteria include not in English, paper reports on a pediatric population, publication is an HTA that was not published in a peer reviewed journal, alternate technique/approach, no stratified analysis by study arm, esophagectomy data mixed with other procedures, original research study does not provide quantitative results or a review paper does not provide a meta/summary analysis, original research publication includes a redundant patient population and similar conclusions, and study is a review paper that only includes redundant publications and similar conclusions.
FIGURE A: Search Criteria and Flowchart for Literature Search Conducted in January 2019
Robotic Esophagectomy Publications from January 2019 PubMed and Scopus Searches
Figure A and the below search terms are associated with the identification of references 1 through 9 listed in Tables 1A and 1B.
PubMed Search Terms: robotic, robot assist, robotically assist, da vinci, davinci, intuitive surgical, robot surgery, esophagectomy, esophageal
Scopus Search Terms: davinci, robotic surgery, intuitive surgical, robot surgery, esophagectomy, esophageal
11
FIGURE B: Search Criteria and Flowchart for Literature Search Conducted in December 2019
Image /page/11/Figure/3 description: This image shows a flow chart of the process used to identify relevant publications for a study on robotic-assisted esophagectomy. The process starts with 2810 publications from PubMed, Scopus, and Embase searches, and after removing duplicates, 370 publications remain. After applying inclusion and exclusion criteria, 15 publications were identified as relevant for the study. The exclusion criteria included not being in English, reporting on a pediatric population, and not providing quantitative results.
Figure B and the below search terms are associated with the identification of references 3 – 17 listed in Tables 1A and 1B.
PubMed Search Terms: robotic, robot assist, robotically assist, da vinci, davinci, intuitive surgical, robot surgery, esophagectomy, esophageal, esophagus
Scopus Search Terms: davinci, robotic surgical, robotic assist, robot surgery, robotic assist, esophaged, esophagus Embase Search Terms: da vinci, intuitive surgical, endowrist, esophagectomy, esophagus