(241 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 the provided sections.
No
The device is described as assisting in the control of surgical instruments for various procedures, rather than directly applying a therapy itself.
No
The device is described as an "Endoscopic Instrument Control System" intended to "assist in the accurate control of Intuitive Surgical Endoscopic Instruments" for various surgical procedures, including "grasping, cutting, blunt and sharp dissection, approximation, ligation, electrocautery, suturing, and delivery and placement of microwave and cryogenic ablation probes and accessories." Its purpose is to facilitate minimally invasive surgery, not to diagnose a condition.
No
The device description explicitly states that the da Vinci Xi and X 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. These are hardware components, making it a hardware and software system, not software-only.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly describes a surgical system designed to assist in the control of endoscopic instruments for performing various surgical procedures on patients. This involves direct manipulation of tissue within the body.
- Device Description: The device is described as a software-controlled, electro-mechanical system consisting of a Surgeon Console, Patient Side Cart, and Vision Side Cart, used with instruments and accessories for minimally invasive surgery. This aligns with a surgical robot, not a device used for testing samples outside the body.
- Performance Studies: The performance studies involve pre-clinical animal studies and real-world evidence from a registry database comparing surgical outcomes (length of stay, complications, etc.) in patients undergoing surgical procedures. This is consistent with evaluating the performance of a surgical device, not an IVD.
- Key Metrics: The key metrics measured are related to surgical outcomes and complications, not diagnostic test performance metrics like sensitivity, specificity, PPV, or NPV, which are typical for IVDs.
IVD devices are used to examine specimens (like blood, urine, or tissue) taken from the human body to provide information for diagnosis, monitoring, or screening. This device does not perform such functions. It is a surgical system used during surgical procedures on the patient.
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 (comma separated list FDA assigned to the subject device)
NAY
Device Description
This 510(k) is for a labeling modification only, to include "Ventral Hernia Repair" (VHR) procedures under the cleared "general laparoscopic surgical procedures" Indication for Use of the da Vinci Xi Surgical System, Model IS4000 and the da Vinci X Surgical System, Model IS4200. There are no changes to the technological characteristics of the cleared da Vinci Xi or X Surgical Systems (Models IS4000 and IS4200) proposed in this submission. The da Vinci Xi and X Surgical Systems, Models IS4000 and IS4200, are software-controlled, electro-mechanical systems designed for surgeons to perform minimally invasive surgery. The Model IS4000 and Model IS4200 Surgical Systems consist of a Surgeon Console, a Patient Side Cart (PSC), and a Vision Side Cart (VSC) and are used with an Endoscope, EndoWrist Instruments, and Accessories.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
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
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).
Real World Evidence from the AHSQC Registry Database
Real world evidence (RWE) from the AHSQC registry database support use of the da Vinci Xi and X Surgical Systems (Models IS4000 and IS4200) in "Ventral Hernia Repair" (VHR) procedures that fall under the cleared "general laparoscopic surgical procedures" Indication for Use. The RWE provided included propensity matched comparative data from robotic-assisted, open and laparoscopic cohorts in noncomplex VHR procedures. Non-complex VHR procedures were defined as ventral (e.g., incisional, epigastric, umbilical) hernia repairs without myofascial release. Additionally, propensity matched comparative data from robotic-assisted and open cohorts and unmatched comparative data from robotic-assisted and laparoscopic cohorts in complex VHR procedures were also included. Complex VHR procedures were defined as incisional hernia repair plus myofascial release. Longer term endpoints beyond 30 days, such as ventral hernia repair recurrence and chronic pain were not assessed in this analysis, and thus no claims regarding these clinical outcomes data should be inferred. The results demonstrated the safety and effectiveness of robotic-assisted ventral hernia repair procedures.
Non-Complex VHR Procedures: Robotic-Assisted v. Open Surgery
Study type: Real World Evidence from AHSQC Registry Database, Propensity Score Matched.
Sample size: Robotic-Assisted Cohort (N=871), Open Cohort (N=871).
Key results:
- Length of Stay: comparable lengths of hospital stay were reported for both the robotic-assisted and open cohorts.
- Intraoperative Complications: comparable intraoperative complication rates were reported for both the robotic-assisted and open cohorts.
- Transfusions: comparable intraoperative blood transfusion rates were reported in both the robotic-assisted and open cohorts.
- Postoperative Complications through 30 days: comparable postoperative complications through 30 days follow up were reported for both the robotic-assisted and open cohorts.
- Readmission Rates through 30 days: comparable readmission rates through 30 days follow up were reported for both the robotic-assisted and open cohorts.
- Re-encounter Rates through 30 days: a lower clinic re-encounter rate through 30 days follow up was reported for the robotic-assisted cohort (29%) as compared to the open cohort (41%). Comparable emergency room re-encounter rates through 30 days follow up were reported for both the roboticassisted and open cohorts.
- Reoperation Rates through 30 days: comparable reoperation rates were reported for both the robotic-assisted and open cohorts.
- Recurrence Rates through 30 days: comparable surgeon reported recurrence rates were reported for both the robotic-assisted and open cohorts through the 30-day postoperative period.
- Mortality through 30 days: comparable mortality rates were reported in both the robotic-assisted and open cohorts through the 30-day postoperative period.
- Operative Time: longer operative times were reported for the robotic-assisted cohort as compared to the open cohort.
Non-Complex VHR Procedures: Robotic-Assisted v. Laparoscopic Surgery
Study type: Real World Evidence from AHSQC Registry Database, Propensity Score Matched.
Sample size: Robotic-Assisted Cohort (N=615), Laparoscopic Cohort (N=615).
Key results:
- Length of Stay: a shorter length of hospital stay was reported for the robotic-assisted cohort (2 days ± 7) as compared to the laparoscopic cohort (4 days ± 13).
- Intraoperative Complications: comparable intraoperative complication rates were reported for both the robotic-assisted and laparoscopic cohorts.
- Transfusions: comparable intraoperative blood transfusion rates were reported in both the robotic-assisted and laparoscopic cohorts.
- Conversion Rate: a comparable conversion rate was reported for the robotic-assisted cohort as compared to the laparoscopic cohort.
- Postoperative Complications through 30 days: comparable postoperative complications through 30 days follow up were reported for both the robotic-assisted and laparoscopic cohorts.
- Readmission Rates through 30 days: comparable readmission rates through 30 days follow up were reported for both the robotic-assisted and laparoscopic cohorts.
- Re-encounter Rates through 30 days: comparable clinic and emergency room re-encounter rates through 30 days follow up were reported for the robotic-assisted cohort as compared to the laparoscopic cohort.
- Reoperation Rates through 30 days: comparable reoperation rates were reported for both the robotic-assisted and laparoscopic cohorts.
- Recurrence Rates through 30 days: comparable surgeon reported recurrence rates were reported for both the robotic-assisted and laparoscopic cohorts through the 30-day postoperative period.
- Mortality through 30 days: comparable mortality rates were reported in both the robotic-assisted and laparoscopic cohorts through the 30-day postoperative period.
- Operative Time: longer operative times were reported for the robotic-assisted cohort as compared to the laparoscopic cohort.
Complex VHR Procedures: Robotic-Assisted v. Open Surgery
Study type: Real World Evidence from AHSQC Registry Database, Propensity Score Matched.
Sample size: Robotic-Assisted Cohort (N=297), Open Cohort (N=297).
Key results:
- Length of Stay: a shorter length of hospital stay was reported in the robotic-assisted cohort (2 days ± 3) as compared to the open cohort (5 days ± 7).
- Intraoperative Complications: comparable intraoperative complication rates were reported for both the robotic-assisted and open cohorts.
- Transfusions: comparable intraoperative blood transfusion rates were reported in both the robotic-assisted and open cohorts.
- Postoperative Complications through 30 days: comparable postoperative complication rates through 30 days follow up were reported for both the robotic-assisted cohort and open cohort.
- Readmission Rates through 30 days: comparable readmission rates through 30 days follow up were reported for both the robotic-assisted and open cohorts.
- Re-encounter Rates through 30 days: a lower clinic re-encounter rate through 30 days follow up was reported for the robotic-assisted cohort (16%) as compared to the open cohort (27%). Comparable emergency room re-encounter rates through 30 days follow up were reported for both the roboticassisted and open cohorts.
- Reoperation Rates through 30 days: comparable reoperation rates were reported for both the robotic-assisted cohort and open cohorts.
- Recurrence Rates through 30 days: comparable surgeon reported recurrence rates were reported for both the robotic-assisted and open cohorts through the 30-day postoperative period.
- Mortality through 30 days: comparable mortality rates were reported in both the robotic-assisted and open cohorts through the 30-day postoperative period.
- Operative Time: longer operative times were reported for the robotic-assisted cohort as compared to the open cohort.
Complex VHR Procedures: Robotic-Assisted v. Laparoscopic Surgery
Study type: Real World Evidence from AHSQC Registry Database (Unmatched) and review of published literature.
Sample size: Robotic-Assisted Cohort (N=305), AHSQC Laparoscopic Cohort (N=27), Published Literature Laparoscopic Cohort (N=3-53).
Key results: Clinical analysis of the da Vinci Surgical Systems in robotically-assisted complex ventral hernia repair procedures raises no new issues of safety or effectiveness for the proposed labeling modification and therefore is substantially equivalent.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
K131861, K152578, K153276, K161178, K170713, K171294, K171632
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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 contains the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health and Human Services logo on the left, and the FDA acronym along with the full name of the agency on the right. The FDA part of the logo is in blue, with the acronym in a square and the full name written out to the right of it. The full name reads "U.S. Food & Drug Administration".
July 19, 2018
Intuitive Surgical, Inc. % Ms. Cindy Domecus Principal, Domecus Consulting Services, LLC/ISI Chief Regulatory Advisor Domecus Consulting Services LLC 1171 Barroilhet Drive Hillsborough, California 94010
Re: K173585
Trade/Device Name: da Vinci Xi Surgical System (Model IS4000), 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: June 18, 2018 Received: June 19, 2018
Dear Ms. Domecus:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing, 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); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm.
For 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 -23
For Binita S. Ashar, M.D., M.B.A., F.A.C.S. Director Division of Surgical Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known)
K173585
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)
K173585
Device Name
Intuitive Surgical® da Vinci® X Endoscopic Instrument Control System (da Vinci X System, Model IS4200) and Endoscopic Instruments and Accessories
(da Vinci X System, Model IS4200) and Endoscopic Instruments and Access
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: | July 19, 2018 |
| II. SUBJECT DEVICE INFORMATION | |
| Device Trade Name: | da Vinci® Xi and X Surgical Systems, Model IS4000 and Model IS4200 |
| Common Name: | System, Surgical, Computer Controlled Instrument |
| Classification Name: | Endoscope and Accessories (21 CFR §876.1500) |
| Regulatory Class: | II |
| Product Code: | NAY |
| Submission Type: | Traditional 510(k) |
III. PREDICATE DEVICE INFORMATION:
Predicate Device: Intuitive Surgical da Vinci Xi and X Surgical Systems, Models IS4000 and IS4200 (K131861, K152578, K153276, K161178, K170713, K171294, K171632) 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 "Ventral Hernia Repair" (VHR) procedures under the cleared "general laparoscopic surgical procedures" Indication for Use of the da Vinci Xi Surgical System, Model IS4000 and the da Vinci X Surgical System, Model IS4200. There are no changes to the technological characteristics of the cleared da Vinci Xi or X Surgical Systems (Models IS4000 and IS4200) proposed in this submission. The da Vinci Xi and X Surgical Systems, Models IS4000 and IS4200, are software-controlled, electro-mechanical systems designed for surgeons to perform minimally invasive surgery. The Model IS4000 and Model IS4200 Surgical Systems consist of a Surgeon Console, a Patient Side Cart (PSC), and a Vision Side Cart (VSC) and are used with an Endoscope, EndoWrist Instruments, and Accessories.
5
V. INDICATIONS FOR USE
da Vinci Xi Surgical System
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, 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 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.
da Vinci X Surgical System
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.
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.
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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).
Real World Evidence from the AHSQC Registry Database
Real world evidence (RWE) from the AHSQC registry database support use of the da Vinci Xi and X Surgical Systems (Models IS4000 and IS4200) in "Ventral Hernia Repair" (VHR) procedures that fall under the cleared "general laparoscopic surgical procedures" Indication for Use. The RWE provided included propensity matched comparative data from robotic-assisted, open and laparoscopic cohorts in noncomplex VHR procedures. Non-complex VHR procedures were defined as ventral (e.g., incisional, epigastric, umbilical) hernia repairs without myofascial release. Additionally, propensity matched comparative data from robotic-assisted and open cohorts and unmatched comparative data from robotic-assisted and laparoscopic cohorts in complex VHR procedures were also included. Complex VHR procedures were defined as incisional hernia repair plus myofascial release. Longer term endpoints beyond 30 days, such as ventral hernia repair recurrence and chronic pain were not assessed in this analysis, and thus no claims regarding these clinical outcomes data should be inferred. The results demonstrated the safety and effectiveness of robotic-assisted ventral hernia repair procedures.
Non-Complex VHR Procedures: Robotic-Assisted v. Open Surgery
Table 1 summarizes the results of the RWE that compared the results of non-complex robotic-assisted and open VHR procedures. The RWE included information comparing the use of the da Vinci System in non-complex Ventral Hernia Repair procedures with open surgery in the following key measures:
- Length of Stay: comparable lengths of hospital stay were reported for both the robotic-assisted and open cohorts.
- Intraoperative Complications: comparable intraoperative complication rates were reported for both the robotic-assisted and open cohorts.
- Transfusions: comparable intraoperative blood transfusion rates were reported in both the robotic-assisted and open cohorts.
- Postoperative Complications through 30 days: comparable postoperative complications through 30 days follow up were reported for both the robotic-assisted and open cohorts.
- Readmission Rates through 30 days: comparable readmission rates through 30 days follow up were reported for both the robotic-assisted and open cohorts.
- Re-encounter Rates through 30 days: a lower clinic re-encounter rate through 30 days follow up was reported for the robotic-assisted cohort (29%) as compared to the open cohort (41%). Comparable emergency room re-encounter rates through 30 days follow up were reported for both the roboticassisted and open cohorts.
- Reoperation Rates through 30 days: comparable reoperation rates were reported for both the robotic-assisted and open cohorts.
- Recurrence Rates through 30 days: comparable surgeon reported recurrence rates were reported for both the robotic-assisted and open cohorts through the 30-day postoperative period.
- Mortality through 30 days: comparable mortality rates were reported in both the robotic-assisted and open cohorts through the 30-day postoperative period.
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- Operative Time: longer operative times were reported for the robotic-assisted cohort as compared to the open cohort1.
| TABLE 1: Propensity Score Matched da Vinci and Open Non-Complex Ventral Hernia Repair (without | ||||||||
|---|---|---|---|---|---|---|---|---|
| myofascial release)^ |
| Outcome | Robotic-Assisted Cohort (N=871) | Open Cohort (N=871) |
|---|---|---|
| Patient Demographics | ||
| Mean age, y (± SD) | 56 ± 14 | 55 ± 14 |
| Female Gender, n (%) | 399 (46) | 361 (41) |
| Male Gender, n (%) | 472 (54) | 510 (59) |
| Mean BMI, kg/ m2 (± SD) | 33 ± 7 | 32 ± 7 |
| Length of Stay (days), mean ± SD | 2 ± 7 | 2 ± 14 |
| Intraoperative Complications, n (%) | 11 (1) | 5 (1) |
| Transfusions, n (%) | ||
| Intraoperative | 1 (4 The longer operative time for the robotic-assisted cohort was not associated with increases in the complication, readmission, reoperation or mortality rates. |
8
- Conversion Rate: a comparable conversion rate was reported for the robotic-assisted cohort as compared to the laparoscopic cohort.
- Postoperative Complications through 30 days: comparable postoperative complications through 30 days follow up were reported for both the robotic-assisted and laparoscopic cohorts.
- Readmission Rates through 30 days: comparable readmission rates through 30 days follow up were reported for both the robotic-assisted and laparoscopic cohorts.
- Re-encounter Rates through 30 days: comparable clinic and emergency room re-encounter rates through 30 days follow up were reported for the robotic-assisted cohort as compared to the laparoscopic cohort.
- Reoperation Rates through 30 days: comparable reoperation rates were reported for both the robotic-assisted and laparoscopic cohorts.
- Recurrence Rates through 30 days: comparable surgeon reported recurrence rates were reported for both the robotic-assisted and laparoscopic cohorts through the 30-day postoperative period.
- Mortality through 30 days: comparable mortality rates were reported in both the robotic-assisted and laparoscopic cohorts through the 30-day postoperative period.
- Operative Time: longer operative times were reported for the robotic-assisted cohort as compared to the laparoscopic cohort2.
TABLE 2: Propensity Score Matched da Vinci and Laparoscopic Non-Complex Ventral Hernia Repair (without myofascial release)^
| Outcome | Robotic-Assisted Cohort (N=615) | Laparoscopic Cohort (N=615) |
|---|---|---|
| Patient Demographics | ||
| Mean age, y (± SD) | 55 ± 14 | 56 ± 14 |
| Female Gender, n (%) | 305 (50) | 284 (46) |
| Male Gender, n (%) | 310 (50) | 331 (54) |
| Mean BMI, kg/ m² (± SD) | 33 ± 7 | 33 ± 8 |
| Length of Stay (days), mean ± SD | 2 ± 7 | 4 ± 13 |
| Intraoperative Complications, n (%) | 6 (1) | 8 (1) |
| Transfusions, n (%) | ||
| Intraoperative | 1 (2 The longer operative time for the robotic-assisted cohort was not associated with increases in the complication, readmission, reoperation or mortality rates. |
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^ Includes data from the AHSQC registry for procedures that occurred between July 7, 2013 and January 1, 2017. The total number of non-complex VHR procedures in the registry during this time period was 873 and 1,961 for the robotic-assisted and laparoscopic cohorts, respectively. The total number in the propensity matched cohorts is 615 as noted in the column header of the above table.
Complex VHR Procedures: Robotic-Assisted v. Open Surgery
Table 3 summarizes the results of the RWE that compared the results of complex robotic-assisted and open VHR procedures. The RWE included information comparing the use of the da Vinci System in complex Ventral Hernia Repair procedures with open surgery in the following key measures:
- Length of Stay: a shorter length of hospital stay was reported in the robotic-assisted cohort (2 days ± 3) as compared to the open cohort (5 days ± 7).
- Intraoperative Complications: comparable intraoperative complication rates were reported for both the robotic-assisted and open cohorts.
- Transfusions: comparable intraoperative blood transfusion rates were reported in both the robotic-assisted and open cohorts.
- Postoperative Complications through 30 days: comparable postoperative complication rates through 30 days follow up were reported for both the robotic-assisted cohort and open cohort.
- Readmission Rates through 30 days: comparable readmission rates through 30 days follow up were reported for both the robotic-assisted and open cohorts.
- Re-encounter Rates through 30 days: a lower clinic re-encounter rate through 30 days follow up was reported for the robotic-assisted cohort (16%) as compared to the open cohort (27%). Comparable emergency room re-encounter rates through 30 days follow up were reported for both the roboticassisted and open cohorts.
- Reoperation Rates through 30 days: comparable reoperation rates were reported for both the robotic-assisted cohort and open cohorts.
- Recurrence Rates through 30 days: comparable surgeon reported recurrence rates were reported for both the robotic-assisted and open cohorts through the 30-day postoperative period.
- Mortality through 30 days: comparable mortality rates were reported in both the robotic-assisted and open cohorts through the 30-day postoperative period.
- Operative Time: longer operative times were reported for the robotic-assisted cohort as compared to the open cohort3.
TABLE 3: Propensity Score Matched da Vinci and Open Complex Ventral Hernia Repair (with myofascial release)^
| Outcome | Robotic-Assisted Cohort (N=297) | Open Cohort (N=297) |
|---|---|---|
| Patient Demographics | ||
| Mean age, y (± SD) | 57 ± 13 | 57 ± 13 |
| Female Gender, n (%) | 169 (57) | 159 (54) |
| Male Gender, n (%) | 128 (43) | 138 (46) |
| Mean BMI, kg/ m² (± SD) | 33 ± 7 | 33 ± 7 |
| Length of Stay (days), mean ± SD | 2 ± 3 | 5 ± 7 |
| Intraoperative Complications, n (%) | 7 (2) | 9 (3) |
3 The longer operative time for the robotic-assisted cohort was not associated with increases in the intraoperative complication, readmission, recurrence or mortality rates.
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| Outcome | Robotic-Assisted Cohort (N=297) | Open Cohort (N=297) |
|---|---|---|
| Transfusions, n (%) | ||
| Intraoperative | 0 (0) | 0 (0) |
| Postoperative | 0 (0) | 1 ( |