(78 days)
No
The document explicitly states that there are "no changes to the technological characteristics of the cleared da Vinci Xi or X Surgical Systems" and describes them as "software-controlled, electro-mechanical systems" without mentioning AI or ML.
No
The device is described as an "Endoscopic Instrument Control System" intended to assist in the accurate control of surgical instruments during various surgical procedures. While it facilitates surgical interventions that can be therapeutic, the system itself is a tool for the surgeon, rather than directly applying a therapeutic effect to the patient.
No
The device is intended to assist in the accurate control of surgical instruments for performing various surgical procedures, not for diagnostic purposes.
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, in addition to software.
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 physicians in performing various surgical procedures by controlling endoscopic instruments. This involves direct manipulation of tissue within the body.
- Device Description: The device description further reinforces this by detailing a software-controlled, electro-mechanical system used in an operating room environment for minimally invasive surgery.
- Lack of IVD Characteristics: An In Vitro Diagnostic device is used to examine specimens (like blood, urine, or tissue) taken from the human body to provide information for diagnosis, monitoring, or screening. The provided information does not mention any analysis of biological specimens outside of the body.
The device is a surgical robot intended for use during surgical procedures, not for analyzing samples in vitro.
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" Indication 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: Gastrectomy. 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 softwarecontrolled, electro-mechanical systems designed for surgeons to perform minimally invasive surgery. The Model IS4000 and Model IS4200 Surgical Systems consist of a Surgeon Console, a Patient Side Cart (PSC), and a Vision Side Cart (VSC) and are used with an Endoscope, EndoWrist Instruments, and Accessories.
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
The system is indicated for adult and pediatric use.
Intended User / Care Setting
It is intended to be used by 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:
Published clinical data were provided to support use of the da Vinci Xi and X Surgical Systems (Models IS4000 and IS4200) in "Gastrectomy" procedures to demonstrate that the intended use of the devices is the same as the predicate devices. Sixteen (16) publications were identified for this procedure based on specific search criteria and filters. These publications included two (2) randomized controlled trials (1b), ten (10) systematic reviews/meta-analysis (2a), and four (4) database studies (2c) comparing da Vinci assisted procedures with laparoscopic and/or open cohorts.
Key Results:
The findings from the Gastrectomy publications show that da Vinci-assisted procedures as compared to laparoscopic procedures are associated with:
- Mortality: comparable mortality rates;
- Estimated Blood Loss (EBL): comparable or lower EBL volumes;
- Blood Transfusion: comparable blood transfusion rates;
- Lengths of Hospital Stay (LOS): comparable or shorter lengths of hospital stay;
- Intraoperative Complication Rates: comparable intraoperative complication rates;
- Postoperative Complication Rates: comparable postoperative complication rates;
- Conversion Rates: comparable conversion rates;
- Reoperation Rates: comparable reoperation rates;
- Readmission Rates: comparable readmission rates;
- Anastomotic Leak Rates: comparable anastomotic leak rates;
- Anastomotic Stenosis Rates: comparable anastomotic stenosis rates; and,
- Operative Time: comparable or longer operative times. However, this increase was not associated with an increase in the mortality or complication rates.
The findings from the Gastrectomy publications show that da Vinci-assisted procedures as compared to open procedures are associated with:
- Mortality: comparable mortality rates;
- Estimated Blood Loss (EBL): lower EBL volumes;
- Blood Transfusion: comparable blood transfusion rates;
- Lengths of Hospital Stay (LOS): comparable or shorter lengths of hospital stay;
- Intraoperative Complication Rates: comparable intraoperative complication rates;
- Postoperative Complication Rates: comparable postoperative complication rates;
- Reoperation Rates: comparable reoperation rates;
- Readmission Rates: comparable readmission rates;
- Anastomotic Stenosis Rates: comparable anastomotic stenosis rates; and,
- Operative Time: longer operative times. However, this increase was not associated with an increase in the mortality or complication rates.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
See "Summary of Performance Studies" for key metrics.
Predicate Device(s)
K131861, K152578, K153276, K161178, K170713, K171632, K171294, K172643, K173842, K173585
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.
0
Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
October 24, 2018
Intuitive Surgical, Inc % Cindy Domecus Principal, Domecus Consulting Services, LLC/ISI Chief Regulatory Advisor Domecus Consulting Services LLC 1171 Barroihet Drive Hillsborough, California 94010
Re: K182140
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: October 8, 2018 Received: October 10, 2018
Dear 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. 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 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
1
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/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.html; 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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm.
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/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).
Image /page/1/Picture/5 description: The image shows the closing of a letter with the word "Sincerely,". Below that is the name "Jennifer R. Stevenson-S3". The following line says "For Binita S. Ashar, M.D., M.B.A., F.A.C.S.". The last line says "Director".
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)
K182140
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)
K182140
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
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: | October 23, 2018 |
| II. SUBJECT DEVICE INFORMATION | |
| Device Trade Name: | da Vinci® Xi and X Surgical Systems, Model IS4000 and M |
| 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:
Intuitive Surgical da Vinci Xi and X Surgical Systems, Models IS4000 and Predicate Device: IS4200 (K131861, K152578, K153276, K161178, K170713, K171632, K171294 K172643, K173842, K173585) 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" Indication 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: Gastrectomy. 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 softwarecontrolled, electro-mechanical systems designed for surgeons to perform minimally invasive surgery. The Model IS4000 and Model IS4200 Surgical Systems consist of a Surgeon Console, a Patient Side Cart (PSC), and a Vision Side Cart (VSC) and are used with an Endoscope, EndoWrist Instruments, and Accessories.
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 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 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 Gastrectomy as a labeled use under the cleared "general laparoscopic surgical procedures" Indication for Use of the cleared predicate devices, do 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.
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 "Gastrectomy" procedures to demonstrate that the intended use of the devices is the same as the predicate devices. Sixteen (16) publications were identified for this procedure based on specific search criteria and filters. These publications included two (2) randomized controlled trials (1b), ten (10) systematic reviews/meta-analysis (2a), and four (4) database studies (2c) comparing da Vinci
6
assisted procedures with laparoscopic and/or open cohorts. A detailed summary of the published clinical data on this procedure is provided in Tables 1A and 1B below.
The findings from the Gastrectomy publications show that da Vinci-assisted procedures as compared to laparoscopic procedures are associated with:
- Mortality: comparable mortality rates;
- Estimated Blood Loss (EBL): comparable or lower2 EBL volumes;
- Blood Transfusion: comparable blood transfusion rates;
- Lengths of Hospital Stay (LOS): comparable or shorter² lengths of hospital stay;
- Intraoperative Complication Rates: comparable intraoperative complication rates; ●
- Postoperative Complication Rates: comparable postoperative complication rates;
- Conversion Rates: comparable conversion rates;
- Reoperation Rates: comparable reoperation rates;
- Readmission Rates: comparable readmission rates; 3
- Anastomotic Leak Rates: comparable anastomotic leak rates;
- Anastomotic Stenosis Rates: comparable anastomotic stenosis rates; and,
- Operative Time: comparable or longer operative times. However, this increase was not associated with an increase in the mortality or complication rates.
The findings from the Gastrectomy publications show that da Vinci-assisted procedures as compared to open procedures are associated with:
- Mortality: comparable mortality rates; ●
- Estimated Blood Loss (EBL): lower EBL4 volumes;
- Blood Transfusion: comparable blood transfusion rates;
- Lengths of Hospital Stay (LOS): comparable or shorter 1engths of hospital stay;
- Intraoperative Complication Rates: comparable intraoperative complication rates;
- . Postoperative Complication Rates: comparable postoperative complication rates;
- Reoperation Rates: comparable reoperation rates;
- Readmission Rates: comparable readmission rates; 6 ●
- Anastomotic Leak Rates: comparable anastomotic leak rates;
1Nine (9) publications reported EBL data. One (1) publication (Reference #9) reported comparable values between the da Vinci and laparoscopic cohorts; seven (7) publications reported lower EBL values for the da Vinci cohort as compared to the laparoscopic cohort (References #1, 3, 8, 10, 11, 13, 15); and, one (1) publication reported higher EBL values for the da Vinci cohort as compared to the laparoscopic cohort (Reference #6). The higher EBL value in the da Vinci cohort was not associated with increased blood transfusion, complication or mortality rates. EBL values are provided in Table 1A.
²Eleven (11) publications reported LOS data. Three (3) publications (References #1, 9, 11) reported shorter LOS values for the da Vinci cohort; and, seven (7) publications reported comparable LOS values (References #5, 6, 10, 12, 13, 15) for the da Vinci and laparoscopic cohorts. One publication (Reference #4) reported comparable LOS values for the da Vinci, laparoscopic and open cohorts. LOS values are provided in Table 1A.
3 One (1) publication (Reference #4) reported comparable readmission rates for the da Vinci, laparoscopic and open cohorts. "Six (6) publications reported EBL data. All six (6) publications reported lower EBL values (References #2, 3 ,6, 7, 14, 15) for the da Vinci cohorts as compared to the open cohorts. EBL values are provided in Table 1A.
් Eight (8) publications reported LOS data. Five (5) publications (References #2, 6, 7, 14, 15) reported shorter LOS values for the da Vinci cohort as compared to the open cohort; and, two (2) publications reported comparable LOS values (References #5, 12) for the da Vinci and open cohorts. One publication (Reference #4) reported comparable LOS values across the da Vinci, laparoscopic and open cohorts. LOS values are provided in Table 1A.
رَ One (1) publication (Reference #4) reported comparable readmission rates for the da Vinci, laparoscopic and open cohorts.
7
- Anastomotic Stenosis Rates: comparable anastomotic stenosis rates; and,
- . Operative Time: longer operative times. However, this increase was not associated with an increase in the mortality or complication rates.
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 literature to support the safety and effectiveness for the new labeled use of Gastrectomy procedures under the "general laparoscopic surgical procedure" indications compared to the predicate devices. In addition, the subject devices have the same technological characteristics as the predicate devices. The da Vinci Xi and X Surgical Systems (Models IS4000 and IS4200) are substantially equivalent to the cleared predicate devices.
8
TABLE 1A: da Vinci vs. Open and da Vinci vs. Laparoscopic Gastrectomy Procedures
| Author | 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 (%) | Conversion Rate (%) | Author | Study Size (N) | Positive Surgical
Margin Rate (%) | Proximal resection
margin (cm) | Distal resection
margin (cm) | Lymph Node Yield (n) | Anastomotic
Leak Rate (%) | Anastomotic Stenosis
Rate (%) |
|--------------------|------------------------------------------|---------------------------------------|-----------------------------------------------|----------------------------------------|-------------------------------------|-----------------------|-------------------------------|------------------------------------------------------|----------------------|-----------------------------|--------------------|---------------------------------------------------|--------------------------------------|-----------------------------------------|------------------------------------------|----------------------------------------------------------------|------------------------------|----------------------------------|
| 1. Pan 2017 | Robotic 102
Lap 61 | 153.11
151.97 | 41.27
83.69 | 3.75
5.36 | Not Reported | | 4.9
19.7 | 0
0 | Not Reported | 0
0 | 1. Pan 2017 | Robotic
102
Lap
61 | Not Reported | | | 36.06
30.03 | 0
3.3 | Not Reported |
| 2. Wang 2016 | Robotic 151
Open 145 | 242.7
192.4 | 94.2
152.8 | 5.7
6.4 | 0.66
0.69 | Not Reported | 9.3
10.3 | 0
0 | Not Reported | | 2. Wang 2016 | Robotic
151
Open
145 | Not Reported | $5.3 \pm 1.5$ | $5.5 \pm 1.7$ | 30.1
29.1 | 2.6
2.1 | Not Reported |
| 3. Eom 2016* | Robotic 53
Lap 541
Open 2654 | 268.4
227.3
200.4 | 74.2
137.7
272.4 | | Not Reported | | | | | | 3. Eom 2016* | Robotic
53
Lap
541
Open
2654 | Not Reported | Not Reported | | Not Reported | Not Reported | Not Reported |
| 4. Glenn 20156 | Robotic 223
Lap 789
Open 8585 | Not Reported | | 12.2
12.1
13.0 | Not Reported | | 33.6***
27.8***
31.7*** | 4.9
1.9
2.6 | Not Reported | | 4. Glenn 20156 | Robotic
223
Lap
789
Open
8585 | Not Reported | Not Reported | | Not Reported | Not Reported | Not Reported |
| 5. Greenleaf 20176 | Robotic 223
Lap 1487
Open 4717 | Not Reported | | 8
8
9 | Not Reported | | | Not Available1,2
Not Reported
Not Available1,2 | Not Reported | 7.6
19
N/A | 5. Greenleaf 20176 | Robotic
223
Lap
1487
Open
4717 | 5.8
10.9
14.6 | Not Reported | Not Reported | 129/223 (57.8%)**
791/1487 (53.2%)**
2352/4717 (49.9%)** | Not Reported | Not Reported |
| 6. Parisi 2017 | Robotic 151
Lap 151
Open 302 | 365.44
220.37
198.67 | 117.91
95.93
127.26 | 8.85
9.07
12.68 | 2.6/8.6**
4.6/8.6**
3.0/6.3** | 1.3
2.0
1.7 | 17.9
11.9
19.5 | 0
0
0 | 1.3
3.3
3.6 | 4.6
5.3
N/A | 6. Parisi 2017 | Robotic
151
Lap
151
Open
302 | 2.0
4.0
5.0 | Not Reported | Not Reported | 27.78
24.58
25.82 | 2.6
2.6
3.6 | 0.7
0.7
0.3 |
| 7. Caruso 2017 | Robotic 689
Open 5434 | 226 - 415.9
126.7 - 331.8 | 30.3 - 208.2
78.8 - 564.6 | 5.1 - 11.3
6.4 - 16.5 | Not Reported | | 12.77
11.94 | 0.44
0.64 | Not Reported | 1.4
N/A | 7. Caruso 2017 | Robotic
689
Open
5434 | Not Reported | Not Reported | Not Reported | 22 - 41.1
25.2 - 43.3 | 3.0
1.6 | Not Reported |
| 8. Chen 2017 | Robotic 1830
Lap 4123 | 202.1 - 439
166.7 - 361 | 30.3 - 176.6
34 - 212.5 | 5.1 - 14
5.9 - 15 | Not Reported | | 10.60
10.11 | 0.84
0.52 | 1.9
1.11 | 0.57
0.73 | 8. Chen 2017 | Robotic
1830
Lap
4123 | Not Reported | 2.6 - 5.9
2.9 - 5.7 | 4 - 7.4
3.8 - 7.7 | 23.1 - 47.2
20 - 46.5 | Not Reported | Not Reported |
| 9. Chuan 2015 | Robotic 551
Lap 1245 | 226 - 361
176 - 345 | 30.3 - 130.48
44.7 - 131.3 | 5.1 - 12.1
6.5 - 17.3 | Not Reported | | 12.70
13.01 | | Not Reported | | 9. Chuan 2015 | Robotic
551
Lap
1245 | Not Reported | 3.8 - 5.6
3.68 - 5.7 | 7.3 - 12.4
6.21 - 11.6 | 32.8 - 44.3
32.6 - 43.2 | 2.55
2.68 | Not Reported |
| 10. Duan 2017 | Robotic 993
Lap 2510 | 202 - 439
170.7 - 345 | 30.3 - 131.3
44.7 - 173.45 | 5.1 - 12.1
6.5 - 17.3 | Not Reported | | 12.22
12.68 | | Not Reported | | 10. Duan 2017 | Robotic
993
Lap
2510 | Not Reported | Not Reported | Not Reported | 25 - 44.3
26 - 43.2 | Not Reported | Not Reported |
| 11. Hu 2016 | Robotic 1096
Lap 2484 | 178 - 439
137.6 - 319.8 | 47 - 171.3
87.1 - 152.8 | 4.5 - 11
5.7 - 13.2 | Not Reported | | UK
UK | 0.26
0.60 | Not Reported | 1.91
1.30 | 11. Hu 2016 | Robotic
1096
Lap
2484 | Not Reported | UK
UK | UK
UK | 25.3 - 44
20.7 - 40 | Not Reported | Not Reported |
| 12. Kostakis 2017 | Robotic 85
Lap 1281
Open 11194 | Not Reported | | 9.6
8 - 16.9
11.5 - 24 | Not Reported | | 10.71
7.99
5.83 | 3.45
3.06
5.35 | 3.45
5.98
4.04 | 0 - 18.2
0 - 27.7
N/A | 12. Kostakis 2017 | Robotic
85
Lap
1281
Open
11194 | 0
4.63
8.07 | Not Reported | Not Reported | Not Reported | 0-3.4
0-5.6
0-5.8 | 0
2.4 - 5.6
0 - 1.4 |
| 13. Wang 2017 | Robotic 1134
Lap 2610 | 202.1 - 415.9
173.5 - 362.2 | 30.3 - 214.2
44.7 - 212.5 | 4.5 - 12.1
4.3 - 17.3 | Not Reported | | 11.7
10.7 | | Not Reported | | 13. Wang 2017 | Robotic
1134
Lap
2610 | Not Reported | range (3.8 - 5.8)
range (3.68 - 5.7) | range (5.1 - 12.4)
range (5.6 - 11.6) | 25 - 44.3
26 - 43.2 | 2.4
2.3 | 0.50
1.20 |
| 14. Yang 2017 | Robotic 606
Open 5364 | Not Available1,3 | Not Available1,4 | Not Available1,5 | Not Reported | | 12.71
12.08 | | Not Reported | | 14. Yang 2017 | Robotic
606
Open
5364 | Not Reported | Not Available1,2
Not Available1,2 | Not Available1,3
Not Available1,3 | Not Available1,4
Not Available1,4 | 3.0
1.6 | Not Reported |
| 15. Zong 2014 | Robotic 520/997
Lap 2207
Open 5260 | 202 - 344
134 - 235
126.7 - 222 | 30.3 - 197.6
39.5 - 173.45
78.8 - 386.1 | 5.1 - 10.5
6.2 - 11.9
6.7 - 13.4 | Not Reported | | 11.54
12.01
11.50 | 0.50 - 0.58
0.32
0.67 | Not Reported | | 15. Zong 2014 | Robotic
520/997
Lap
2207
Open
5260 | Not Reported | Not Reported | Not Reported | 25 - 42.8
26 - 42.7
31.7 - 43.3 | 2.7
1.6
2.3 | Not Reported |
| 16. Guerra 2018 | Robotic 570
Lap 1456 | 206.4 - 439.0
167.1 - 361.0 | Not Reported | 6.75 - 10.5
6.7 - 13.0 | Not Reported | | | Not Reported | Not Reported | | 16. Guerra 2018 | Robotic
570
Lap
1456 | Not Reported | Not Reported | Not Reported | Not Available1,5
Not Available1,5 | Not Reported | Not Reported |
*Data reported for "total" gastrectorny proced sinilar results for "listal" gastrectory procedures; ** Intra-op and post-op reported; *** M-hopital overal complication rate. ¹Absolute rates/means not available; ²OR 1.07 [0.42, 2.75]; ³WMD 129.74 [-178.31, -81.16]; ³WMD -2.39 [-2.92] -1.87]
"The years 2010, 2011 and 202 overlap the two (2) databases used in the Glenn and Greenleaf publications. As such, the eported results.
9
TABLE 1B: da Vinci vs. Open and da Vinci vs. Laparoscopic Gastrectomy Procedures
*Data reported for "total" gastrectory procedures her results for "distal" gastrectomy procedures, ** V reported for cases with > 15 UV
¹Absolute rates/means not available; ׳WMD 0.10 [-0.43, 0.64]; ³WMD 0.52 [-0.76, 1.79); 'WMD -1.36 [-3.69, 0.97]; ³MD 2.92 [0.32, 5.53]
"The years 2010, 2011 and 2012 verləp between the Glenn and Greenleaf publications. As such, there is a possibility of data overlap in the eported results.