(126 days)
No
The submission is for a labeling modification only, and explicitly states 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 performance studies.
Yes.
The device is intended to assist in surgical procedures like grasping, cutting, dissection, and suturing, which are therapeutic interventions.
No
The device description and intended use clearly state that this is a surgical system designed to assist surgeons in performing minimally invasive surgery by controlling endoscopic instruments for manipulation of tissue (e.g., grasping, cutting, suturing). It does not mention any diagnostic functions.
No
The device description explicitly states that the system consists of a Surgeon Console, a Patient Side Cart (PSC), and a Vision Side Cart (VSC), which are hardware components. While the system is software-controlled, it is not solely software.
Based on the provided text, the Intuitive Surgical Endoscopic Instrument Control System (Models IS4000 and IS4200) is not an In Vitro Diagnostic (IVD) device.
Here's why:
- Intended Use: The intended use clearly describes the system's function as assisting in the control of surgical instruments for manipulating tissue during surgical procedures. This is an in vivo (within a living organism) application, not an in vitro (outside of a living organism) diagnostic test.
- Device Description: The description details a software-controlled, electro-mechanical system used in an operating room environment for performing minimally invasive surgery. This aligns with a surgical device, not a diagnostic device that analyzes samples.
- Performance Studies: The performance studies focus on surgical outcomes like complication rates, operative time, and hospital stay, which are relevant to surgical procedures, not diagnostic accuracy.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.) or providing diagnostic information based on such analysis.
Therefore, the device is a surgical system intended for use in vivo during surgical procedures, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The Intuitive Surgical® da Vinci® Xi Endoscopic Instrument Control System (da Vinci Xi System, Model IS4000) and Endoscopic Instruments and Accessories 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 laparoscopic surgical procedures, general thoracoscopical 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® da Vinci® X Endoscopic Instrument Control System (da Vinci X System, Model IS4200) and Endoscopic Instruments and Accessories 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): Gastric Bypass (Roux-en-Y) and Gastric Sleeve. 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
urologic, general laparoscopic, gynecologic laparoscopic, general thoracoscopic, thoracoscopically-assisted cardiotomy, coronary
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:
Six (6) evaluations in a total of 24 animals demonstrating use of da Vinci Xi Surgical System in the following procedures: Hysterectomy and Salpingectomy/Oophorectomy (Adnexectomy), Pyeloplasty, Nephrectomy, Nissen Fundoplication, Colectomy and Mitral Valve Repair. These data were initially submitted in support of clearance of the da Vinci Xi Surgical System (K131861) and were subsequently submitted in support of clearance the da Vinci Xi and X labeling modification to add specific procedures under the gynecologic laparoscopic surgical procedures Indications for Use (K152578); general thoracoscopic surgical procedures and thoracoscopically-assisted cardiotomy procedures Indications for Use (K153276); urologic surgical procedures Indications for Use (K161178); and, general laparoscopic surgical procedures Indications for Use (K170713 and K171632). These data also support inclusion of the subject representative, specific procedures.
Clinical Study Data:
Published clinical data provided for the umbrella procedure "Gastric Bypass (Roux-en-Y)". Ten (10) publications were identified, including two (2) non-randomized, controlled, prospective studies (LOE 2b) and 8 retrospective cohort studies (LOE 3b) comparing da Vinci-assisted procedures with laparoscopic and/or open cohorts.
Key results for da Vinci-assisted procedures compared to open procedures:
- Mortality: comparable mortality rates
- Lengths of Hospital Stay: shorter lengths of hospital stay
- Intraoperative Complication Rates: comparable intraoperative complication rates
- Postoperative Complication Rates: comparable or lower postoperative complication rates
- Anastomotic Leak Rate: comparable anastomotic leak rates
- Anastomotic Stricture Rate: comparable anastomotic stricture rates
- Reoperation Rate: comparable or lower reoperation rates
- Operative Time: Increased.
Key results for da Vinci-assisted procedures compared to laparoscopic procedures:
- Mortality: comparable mortality rates
- Estimated Blood Loss: comparable EBL volumes
- Lengths of Hospital Stay: comparable or shorter lengths of hospital stay
- Intraoperative Complication Rates: comparable intraoperative complication rates
- Postoperative Complication Rates: comparable or lower postoperative complication rates
- Anastomotic Leak Rate: comparable anastomotic leak rates when comparing hand-sewn gastrojejunal anastomoses in both cohorts; comparable or lower anastomotic leak rates when comparing stapled laparoscopic gastrojejunal anastomoses with hand-sewn robotic-assisted gastrojejunal anastomoses.
- Anastomotic Stricture Rate: comparable anastomotic stricture rates when comparing hand-sewn gastrojejunal anastomoses in both cohorts; comparable or lower anastomotic stricture rates when comparing stapled laparoscopic gastrojejunal anastomoses with hand-sewn robotic-assisted gastrojejunal anastomoses.
- Reoperation Rate: comparable or lower reoperation rates
- Readmission Rate: comparable readmission rates
- Operative Time: comparable or shorter operative times (N = 3 publications); Increased operative times (N = 7 publications), not associated with increased mortality or complication rates.
- Conversion Rates: comparable or lower conversion rates.
The published data on the Gastric Bypass (Roux-en-Y) umbrella procedure were used to support clearance of Gastric Sleeve procedures.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
See Table 1A details for: Operation Time (minutes), EBL (ml), Length of Stay (days), Conversion Rate (%), Intraop Comp Rate, Postop Comp Rate, Mortality (in-hospital or 30 days), Anastomotic Leak Rate (%), Anastomotic Stricture Rate (%), Reoperation Rate (%), Readmission Rate (%).
Predicate Device(s)
K131861, K152578, K153276, K161178, K170713, K171632, 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 contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services USA seal. To the right of the seal is the FDA logo, with the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG" in blue, and the word "ADMINISTRATION" in a smaller font size below.
April 23, 2018
Intuitive Surgical. Inc % Cindy Domecus Principal, Domecus Consulting Services, LLC ISI Chief Regulatory Advisor 1171 Barroilhet Drive Hillsborough, California 94010
Re: K173842
Trade/Device Name: da Vinci Xi Surgical System (Model IS4000), and da Vinci X Surgical System (Model IS4200) Regulation Number: 21 CFR 876.1500 Regulation Name: Endoscope and accessories Regulatory Class: Class II Product Code: NAY Dated: April 4, 2018 Received: April 5, 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. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing, 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 entiled, "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 For Binita S. Ashar, M.D., M.B.A., F.A.C.S. Director Division of Surgical Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K173842
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 Model IS4000) 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 laparoscopic surgical procedures, general thoracoscopical 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.
| Concession Concession of Children Company of Children | . |
|---|---|
| Collection Colline College of Children Company | ------------------ |
| 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) K173842
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 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: | April 12, 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) |
II. SUBJECT DEVICE INFORMATION
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) 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): Gastric Bypass (Roux-en-Y) and Gastric Sleeve. 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.
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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 da Vinci Xi or X Surgical Systems (IS4000 and IS4200) proposed in this submission.
VII. PERFORMANCE DATA
Pre-Clinical Animal Study Data
This premarket notification is supported by animal study data including the results from six (6) evaluations in a total of 24 animals demonstrating use of da Vinci Xi Surgical System in the following procedures: Hysterectomy and Salpingectomy/Oophorectomy (Adnexectomy), Pyeloplasty, Nephrectomy, Nissen Fundoplication, Colectomy and Mitral Valve Repair. These data were initially submitted in support of clearance of the da Vinci Xi Surgical System (K131861) and were subsequently submitted in support of clearance the da Vinci Xi and X labeling modification to add specific procedures under the gynecologic laparoscopic surgical procedures Indications for Use (K152578); general thoracoscopic surgical procedures and thoracoscopically-assisted cardiotomy procedures Indications for Use (K153276); urologic surgical procedures Indications for Use (K161178); and, general laparoscopic surgical procedures Indications for Use (K170713 and K171632). These data also support inclusion of the subject representative, specific procedures.
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Clinical Study Data
Published clinical data support use of the da Vinci Xi and X Surgical Systems (Models IS4000 and IS4200) 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 procedure of Gastric Bypass (Roux-en-Y) (referred to as the "umbrella" procedure). The published data on this "umbrella" procedure were deemed sufficient to cover the less complex/lower risk procedure (referred to as a "covered" procedure), so published clinical data on the covered procedure were not provided.
Umbrella Procedure
Published clinical data were provided for the umbrella procedure "Gastric Bypass (Roux-en-Y)". Ten (10) publications were identified for this umbrella procedure based on specific search criteria and filters. These publications included two (2) non-randomized, controlled, prospective studies (LOE 2b) and 8 retrospective cohort studies (LOE 3b) comparing da Vinci-assisted procedures with laparoscopic and/or open cohorts. A detailed summary of the published clinical data on this procedure is provided in Table 1A below.
The findings from the Gastric Bypass publications show that da Vinci-assisted procedures as compared to open procedures are associated with:
- Mortality: comparable mortality rates;
- Lengths of Hospital Stay: shorter lengths of hospital stay; ●
- Intraoperative Complication Rates: comparable intraoperative complication rates;
- Postoperative Complication Rates: comparable or lower postoperative complication rates;
- Anastomotic Leak Rate: comparable anastomotic leak rates;
- Anastomotic Stricture Rate: comparable anastomotic stricture rates;
- Reoperation Rate: comparable or lower reoperation rates1; and,
- . Operative Time: Increased operative times were associated with da Vinci procedures. However, this increase was not associated with an increase in the mortality or complication rates.
The findings from the Gastric Bypass publications show that do Vinci-assisted procedures as compared to laparoscopic procedures are associated with:
- Mortality: comparable mortality rates;
- Estimated Blood Loss: comparable EBL volumes;
- Lengths of Hospital Stay: comparable or shorter lengths of hospital stay';
- Intraoperative Complication Rates: comparable intraoperative complication rates;
1 No publications comparing da Vinci-assisted and open procedures reported readmission rates.
2 One (1) publication (Benizri, et al) reported a longer length of stay, a higher reoperation rate and a higher 30-90 day anastomotic stricture rate for the robotic cohort. These outcomes were not associated with increased intraoperative, overall postoperative complication or mortality rates.
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- Postoperative Complication Rates: comparable or lower postoperative complication rates;
- Anastomotic Leak Rate:
- o Comparable anastomotic leak rates when comparing hand-sewn gastrojejunal anastomoses in both cohorts;
- Comparable or lower anastomotic leak rates when comparing stapled laparoscopic o gastrojejunal anastomoses with hand-sewn robotic-assisted gastrojejunal anastomoses.
- Anastomotic Stricture Rate: 2; ●
- o Comparable anastomotic stricture rates when comparing hand-sewn gastrojejunal anastomoses in both cohorts;
- Comparable or lower anastomotic stricture rates when comparing stapled laparoscopic o gastrojejunal anastomoses with hand-sewn robotic-assisted gastrojejunal anastomoses.
- . Reoperation Rate: comparable or lower reoperation rates ;
- Readmission Rate: comparable readmission rates; and,
- Operative Time: comparable or shorter operative times (N = 3 publications). Increased operative times were associated with da Vinci procedures as compared laparoscopic procedures (N = 7 publications). 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.
Covered Procedure
The published data on the Gastric Bypass (Roux-en-Y) umbrella procedure were used to support clearance of Gastric Sleeve procedures .
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: Gastric Bypass (Roux-en-Y) and Gastric Sleeve.
8
TABLE 1A: da Vinci vs. Open and da Vinci vs. Laparoscopic Gastric Bypass (Roux-en-Y)
| Author | Study Size (N) | Operation Time (minutes) | EBL (ml) | Length of Stay (days) | Conversion Rate (%) | Intraop Comp Rate | Postop Comp Rate | Mortality (in-hospital or 30 days) | Anastomotic Leak Rate (%) | Anastomotic Stricture Rate (%) | Reoperation Rate (%) | Readmission Rate (%) |
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 1. Ahmad 2015 | Robotic 172 | 155.0 | 11.6 | 2.4 | 0.0% | 0.0% | 0.0% | 0.0% | 0.0% | 0.0% | 0 | NR |
| Lap 173 | 135.3 | 13.4 | 2.5 | 0.0% | 0.0% | 0.0% | 0.0% | 0.0% | 0.0% | 0 | ||
| 2. Ayloo 2016 | Robotic 61 | 213.1 | 24 | 2.8 | 3.3% | 3.3 | 9.8%, 1.6%a | 0.0% | 0%f | NR | 1.6 | NR |
| Lap 46 | 234.0 | 20.2 | 2.5 | 0.0% | 0.0% | 15.2%, 0%a | 0.0% | 2.2%f | 2.2 | |||
| 3. Benizri 2013 | Robotic 100 | 130 | NR | 9.3 | 3.0% | 21.0%b | 24.0%i | 1% | 3 | 7%g | 9 | NR |
| Lap 100 | 147 | NR | 6.7 | 1.0% | 16.0%b | 21.0%i | 0% | 0 | 0g | 1 | ||
| 4. Myers 2013 | Robotic 100 | 144 | NR | 1.55 | 0.0% | NR | 11.0% | 0.0% | 1.0% | 6.0% | 2.0 | 3.0 |
| Lap 100 | 87 | NR | 2.17 | 0.0% | 15.0% | 0.0% | 1.0% | 2.0% | 1.0 | 8.0 | ||
| 5. Smeenk 2016 | Robotic 100 | 67 | NR | 2 | 0.0% | NR | 5%, 17%c | 0.0% | 0.0% | 0.0% | 3.0 | NR |
| Lap 100 | 31 | NR | 2 | 0.0% | 5%, 13%c | 0.0% | 0.0% | 1.0% | 1.0 | |||
| 6. Stefanidis 2017 | Robotic 125 | 213 | 49 | 1.7 | 0.0% | 0.0% | 12.0% | 0.0% | 0 | 0.8%h | 0.8 | 5.6 |
| Lap 121 | 155 | 56 | 2.1 | 0.8% | 0.0% | 20.0% | 0.0% | 0 | 2.4%h | 6.6 | 8.2 | |
| 7. Wood 2014 | Robotic 100 | 182.29 | NR | 3.15 | NR | NR | 22%, 37%d | 0.0% | 0.0% | 9% | 0.0 | 8.0 |
| Lap 100 | 158.91 | NR | 2.77 | NR | NR | 19%, 30%d | 0.0% | 0.0% | 7% | 0.0 | 7.0 | |
| 8. Buchs 2016 | Robotic 65 | 244 | NR | 6 | 3.1% | 1.5% | 13.8% | 0.0% | 0.0% | 0.0% | 3.1 | |
| Lap 54 | 238 | NR | 16 | 13.0% | 3.7% | 27.8% | 1.9% | 3.7% | 0.0% | 13.0 | NR | |
| Open 95 | 217 | NR | 14 | NA | 1.1% | 27.4% | 1.1% | 4.2% | 1.1% | 36.8 | ||
| 9. Buchs 2014 | Robotic 388 | 245.0 | NR | 6.2 | 0.8% | 0.8% | 11.6% | 0.3% | 0.3% | NR | 1.0 | NR |
| Lap 389 | 215.8 | NR | 10.4 | 4.9% | 1.5% | 16.7% | 0.3% | 3.6% | NR | 3.3 | NR | |
| 10. Hagen 2012 | Robotic 143 | 293 | NR | 7.4 | 1.4% | NR | 16.1% | 0.0% | 0.0% | 0.0% | 0.7 | |
| Lap 323 | 206 | NR | 11.0 | 5.0% | NR | 18.0% | 0.0% | 4.0% | 6.8% | 4.0 | NR | |
| Open 524 | NR | NR | 10.9 | N/A | NR | 12.4% | 0.6% | 1.9% | 1.1% | 1.9 |
Authors reported perioperative and long-term rates, respectively. a.
b. Authors reported "intraoperative difficulties".
Authors reported 30 day and overall rates, respectively. c.
Authors reported surgical and all complications, respectively. d.
NR = Not Reported e.
ギ Authors reported GI leak
Authors reported 30 – 90-day stricture rate g.
h. 1 year timepoint reported
i. 30-day rates reported