(76 days)
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.
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.
This 510(k) is for a labeling modification only, to include the following additional representative, specific foregut procedures under the cleared "general laparoscopic surgical procedures" Indications for Use of the da Vinci Xi Surgical System, Model IS4000 (K131861) and the da Vinci X Surgical System, Model IS4200 (K171294): Heller Myotomy, Hiatal/Paraesophageal/Sliding Hernia Repair, Dor Fundoplication and Toupet Fundoplication. 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.
The document describes a 510(k) premarket notification for a labeling modification to the da Vinci Xi and X Surgical Systems (Models IS4000 and IS4200). The modification seeks to include additional "foregut" procedures (Heller Myotomy, Hiatal/Paraesophageal/Sliding Hernia Repair, Dor Fundoplication, and Toupet Fundoplication) under the already cleared "general laparoscopic surgical procedures" Indications for Use. The submission states that there are no changes to the technological characteristics of the device, implying that the device itself is not being changed, only its listed indications for use. Therefore, standard acceptance criteria for device performance (e.g., accuracy, precision, safety) in a new or modified device submission are not applicable here in the typical sense. Instead, the "acceptance criteria" are related to demonstrating substantial equivalence for the expanded indications.
The study that proves the device meets the "acceptance criteria" (i.e., demonstrating substantial equivalence for the new indications) is a clinical literature review comparing the da Vinci-assisted procedures to minimally invasive/laparoscopic procedures for the "foregut" procedures.
Here's the breakdown of the requested information based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
Given that this 510(k) is for a labeling modification only, with no technological changes to the device, the "acceptance criteria" are implicitly tied to demonstrating substantial equivalence for the expanded indications through clinical outcomes. The device performance is reported by comparing outcomes of da Vinci-assisted procedures to standard minimally invasive/laparoscopic procedures.
| Acceptance Criteria (Demonstration of Substantial Equivalence for New Indications via Clinical Outcomes) | Reported Device Performance (Comparison of da Vinci-assisted vs. Minimally Invasive/Laparoscopic) |
|---|---|
| For Heller Myotomy ("Umbrella Procedure #1"): Substantially equivalent rates for: | Heller Myotomy: Findings from publications demonstrate substantial equivalence based on: - Mortality Rates - Estimated Blood Loss (EBL) Volumes - Lengths of Hospital Stay (LOS) - Intraoperative Complication Rates - Post/Peri-Operative Complication Rates - Conversion Rates - Readmission Rates - Perforation Rates - Operative Times (See Table 1A for detailed study-specific data, e.g., Ali (2019): Robotic EBL Not Reported, Lap EBL Not Reported. Overall, across studies, these metrics were reported and determined to be comparable or equivalent.) |
| - Mortality Rates | |
| - Estimated Blood Loss (EBL) Volumes | |
| - Lengths of Hospital Stay (LOS) | |
| - Intraoperative Complication Rates | |
| - Post/Peri-Operative Complication Rates | |
| - Conversion Rates | |
| - Readmission Rates | |
| - Perforation Rates | |
| - Operative Times | |
| For Hiatal/Paraesophageal/Sliding Hernia Repair ("Umbrella Procedure #2"): Substantially equivalent rates for: | Hiatal/Paraesophageal/Sliding Hernia Repair: Findings from publications demonstrate substantial equivalence based on: - Mortality Rates - Estimated Blood Loss (EBL) Volumes - Blood Transfusion Rates - Lengths of Hospital Stay (LOS) - Intraoperative Complication Rates - Postoperative Complication Rates - Conversion Rates - Reoperation Rates - Readmission Rates - Operative Times (See Table 1B for detailed study-specific data, e.g., Gehrig (2013): Robotic Op Time 172±31 min, Lap Op Time 168±42 min. Overall, across studies, these metrics were reported and determined to be comparable or equivalent.) |
| - Mortality Rates | |
| - Estimated Blood Loss (EBL) Volumes | |
| - Blood Transfusion Rates | |
| - Lengths of Hospital Stay (LOS) | |
| - Intraoperative Complication Rates | |
| - Postoperative Complication Rates | |
| - Conversion Rates | |
| - Reoperation Rates | |
| - Readmission Rates | |
| - Operative Times |
2. Sample Size Used for the Test Set and the Data Provenance
- Sample Size (Test Set): The sample sizes vary by study within the literature review. For Heller Myotomy, the combined robotic cases across the 8 studies in Table 1A total 1043 patients. The combined laparoscopic cases total 5787 patients. For Hiatal/Paraesophageal/Sliding Hernia Repair, the combined robotic cases across the 7 studies in Table 1B total 1878 patients. The combined laparoscopic cases total 7085 patients.
- Data Provenance: The data provenance is from published clinical literature. The document states that "Fifteen (15) publications were identified...used in three (3) databases: PubMed, Scopus and Embase." These studies would encompass various countries and healthcare systems depending on the authors' affiliations. The study types include two (2) systematic reviews/meta-analyses, one (1) prospective study, two (2) database studies, and ten (10) retrospective studies.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts
The ground truth for the test set (the clinical outcomes reported in the literature) was established by the physicians and researchers who conducted the original studies. The document does not specify the number or specific qualifications of these original researchers, but it can be inferred that they are medical professionals and researchers in the field of surgery, as their work was published in peer-reviewed journals and structured as systematic reviews, prospective, database, and retrospective studies.
4. Adjudication Method for the Test Set
The document does not describe a formal adjudication method for the test set in the context of the 510(k) submission. Instead, the "adjudication" of the clinical data comes from:
- The peer-review process of the scientific journals where the original 15 papers were published.
- The methodology of systematic reviews and meta-analyses included, which involve rigorous evaluation of study quality and results.
- The FDA's own review of these publications to determine if they support substantial equivalence.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, If So, What Was the Effect Size of How Much Human Readers Improve with AI vs Without AI Assistance
No. An MRMC comparative effectiveness study was not done. This submission is for a surgical system and its indications, not an AI-powered diagnostic or interpretive tool that would typically involve human "readers" or AI assistance in interpretation. The comparison is between different surgical approaches (da Vinci-assisted vs. conventional laparoscopic), not between human performance with and without AI.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
Given that the device is a surgical system (the da Vinci Xi and X Surgical Systems), which involves a human surgeon operating the robot, a "standalone algorithm only" performance study is not applicable or relevant to this device. This device is inherently "human-in-the-loop."
7. The Type of Ground Truth Used
The ground truth used is clinical outcomes data reported in published medical literature. These outcomes include objective measures such as mortality rates, estimated blood loss, length of hospital stay, complication rates (intraoperative and postoperative), conversion rates, readmission rates, perforation rates, reoperation rates, and operative times. This data is the direct result of actual surgical procedures.
8. The Sample Size for the Training Set
Not applicable. The submission describes a labeling modification for an existing surgical system. As there are no changes to the technological characteristics of the device and no new algorithm is being deployed, there is no "training set" in the context of machine learning or AI algorithms. The system's "training" for surgeons occurs through professional instruction and practice, not through a data-driven training set in the AI sense.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as there is no training set in the AI/ML context. If interpreted metaphorically, the "ground truth" for training surgeons on how to use the da Vinci system is established through medical education, surgical training programs, professional instructions for use, and clinical experience, guided by established surgical best practices and outcomes. However, this is not a ground truth for a machine learning training set as typically inquired.
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Image /page/0/Picture/0 description: The image contains the logos of the Department of Health and Human Services and the Food and Drug Administration (FDA). The Department of Health and Human Services logo is on the left, and the FDA logo is on the right. The FDA logo includes the letters "FDA" in a blue square, followed by the words "U.S. Food & Drug Administration" in blue text.
December 10, 2020
Intuitive Surgical, Inc. % Cindy Domecus Principal, Domecus Consulting Services, LLC/ISI Chief Regulatory Advisor Domecus Consulting Services LLC 1171 Barroilhet Drive Hillsborough. California 94010
Re: K202834
Trade/Device Name: da Vinci Xi Surgical System (IS4000), da Vinci X Surgical System (IS4200) Regulation Number: 21 CFR 876.1500 Regulation Name: Endoscope And Accessories Regulatory Class: Class II Product Code: NAY Dated: September 24, 2020 Received: September 25, 2020
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
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statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Je Hi An. Ph.D. Assistant Director DHT4A: Division of General Surgery Devices OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known)
K202834
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."
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Indications for Use
510(k) Number (if known)
K202834
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."
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510(k) Summary (21 CFR § 807.92(c)) K202834
I. SUBMITTER INFORMATION
| Submitter: | Intuitive Surgical, Inc.1266 Kifer RoadSunnyvale, CA 94086 |
|---|---|
| Contact: | Cindy Domecus, R.A.C. (US & EU)Principal, Domecus Consulting Services LLCChief Regulatory Advisor to Intuitive Surgical, Inc.Telephone: 650.343.4813Fax: 650.343.7822Email: domecusconsulting@comcast.net |
| Date Summary Prepared: | December 7, 2020 |
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 Devices: Intuitive Surgical da Vinci Xi and X Surgical Systems, Models IS4000 and IS4200 (K131861, K152578, K153276, K161178, K170713, K171632, K171294 K172643, K173842, K173585, K182140, K183086) 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 foregut procedures under the cleared "general laparoscopic surgical procedures" Indications for Use of the da Vinci Xi Surgical System, Model IS4000 (K131861) and the da Vinci X Surgical System, Model IS4200 (K171294): Heller Myotomy, Hiatal/Paraesophageal/Sliding Hernia Repair, Dor Fundoplication and Toupet Fundoplication. There are no changes to the technological characteristics of the cleared da Vinci Xi or X Surgical Systems (Models IS4000 and IS4200) proposed in this submission. The da Vinci Xi and X Surgical Systems, Models IS4000 and IS4200, are software-controlled, electro-mechanical systems designed for surgeons to perform minimally invasive surgery. The Model IS4000 and Model IS4200 Surgical Systems consist of a Surgeon Console, a Patient Side Cart (PSC), and a Vision Side Cart (VSC) and are used with an Endoscope, EndoWrist Instruments, and Accessories.
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V. INDICATIONS FOR USE
The Intuitive Surgical Endoscopic Instrument Control System (da Vinci Surgical System, Models: IS4000 and IS4200) is intended to assist in the accurate control of Intuitive Surgical Endoscopic Instruments including rigid endoscopes, blunt and sharp endoscopic dissectors, scalpels, forceps/pick-ups, needle holders, endoscopic retractors, electrocautery and accessories for endoscopic manipulation of tissue, including grasping, cutting, blunt and sharp dissection, approximation, ligation, electrocautery, suturing, and delivery and placement of microwave and cryogenic ablation probes and accessories, during urologic surgical procedures, general laparoscopic surgical procedures, gynecologic laparoscopic surgical procedures, general thoracoscopic surgical procedures and thoracoscopically-assisted cardiotomy procedures. The system can also be employed with adjunctive mediastinotomy to perform coronary anastomosis during cardiac revascularization. The system is indicated for adult and pediatric use. It is intended to be used by trained physicians in an operating room environment in accordance with the representative, specific procedures set forth in the Professional Instructions for Use.
Precaution for Representative Uses
The demonstration of safety and effectiveness for the representative specific procedures 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 representative, specific "foregut" procedures as labeled uses under the cleared "general laparoscopic surgical procedures" Indications for Use of the cleared predicate devices, da Vinci Xi Surgical System, Model IS4000 and the da Vinci X Surgical System, Model IS4200. The subject devices differ from the predicate devices by this modification to the labeling. Results of clinical data from the 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 the subject representative, specific foregut procedures that fall under the cleared "general laparoscopic surgical procedures" Indication for Use. Clinical data were not provided for all of the representative, specific procedures. Instead, clinical data were provided only for the most complex/highest risk representative, specific procedures: Heller Myotomy and Hiatal/Paraesophageal/Sliding Hernia Repair (referred to as "umbrella" procedures). The published data for these "umbrella" procedures were deemed sufficient to cover the less complex/lower risk
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procedures (referred to as "covered" procedures), so published clinical data on the covered procedures of "Dor Fundoplication" and "Toupet Fundoplication" were not provided.
Fifteen (15) publications were identified for the two (2) umbrella procedures based on specific search criteria and filters used in three (3) databases: PubMed, Scopus and Embase. The search terms, inclusion/exclusion criteria and a flowchart depicting the results from these searches is provided in Figure A. These publications included: two (2) systematic reviews/meta-analyses (LOE 2a); one (1) prospective study (LOE 2b); two (2) database studies (LOE 2c) and ten (10) retrospective studies (LOE 3b) comparing da Vinci-assisted procedures with minimally invasive/ laparoscopic cohorts. Detailed summaries of the published clinical data on these procedures are provided in Tables 1A and 1B.
Umbrella Procedure #1: Heller Myotomy
The findings from the Heller Myotomy publications demonstrate that da Vinci-assisted procedures as compared to minimally invasive/laparoscopic procedures are found to be substantially equivalent based on the following endpoints:
- Mortality Rates
- Estimated Blood Loss (EBL) Volumes
- Lengths of Hospital Stay (LOS)
- Intraoperative Complication Rates
- Post/Peri-Operative Complication Rates
- Conversion Rates
- Readmission Rates
- Perforation Rates
- . Operative Times
Umbrella Procedure #2: Hiatal/Paraesophageal/Sliding Hernia Repair
The findings from the Hiatal/Paraesophageal/Sliding Hernia Repair publications demonstrate that da Vinci-assisted procedures as compared to minimally invasive/laparoscopic procedures are found to be substantially equivalent based on the following endpoints:
- Mortality Rates
- Estimated Blood Loss (EBL) Volumes
- Blood Transfusion Rates
- Lengths of Hospital Stay (LOS)
- Intraoperative Complication Rates
- Postoperative Complication Rates
- Conversion Rates
- Reoperation Rates
- Readmission Rates
- Operative Times
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VIII. CONCLUSION
The da Vinci Xi and X Surgical Systems (models IS4000 and IS4200) have the same intended use as the predicate devices, as demonstrated by the clinical data from the literature to support the safety and effectiveness for the new labeled use of representative, specific "foregut" procedures under the "general laparoscopic surgical procedure" Indications for Use as compared to the predicate devices. In addition, the subject devices have the same technological characteristics as the predicate devices. Therefore, the da Vinci Xi and X Surgical Systems (Models IS4000 and IS4200) are substantially equivalent to the cleared predicate devices.
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510(k) Summary - Page 5 of 6
TABLE 1A: da Vinci vs. Minimally Invasive/Laparoscopic Heller Myotomy Procedures
| Author/Year | Study Size (N) | Operation Time (minutes) | EBL (ml) | Length of Stay (days) | Intraop Comp Rate (%) | Post/Peri-Op Comp Rate (%) | Mortality (in-hospital - 30 days, %) | Reoperation Rate (%) | Readmission Rate (%) | Conversion Rate (%) | Perforation (%) |
|---|---|---|---|---|---|---|---|---|---|---|---|
| 1. Ali (2019) | Robotic 44Lap 40 | Median: 183.5Median: 157 | Not Reported | Median: 1Median: 1 | 015 | Not Reported | 00 | Not Reported2.5 | 2.37.5 | 05 | 02.5 |
| 2. Kim (2018) | Robotic 37Lap 35 | 158157 | 4156 | 2.022.17 | Not Reported | 00 | 00 | 08.6 | 2.711.4 | ||
| 3. Maseo (2010) | Robotic 102Lap 150 | $202.9 \pm 97.0$$183.7 \pm 79.8$ | Not Reported | 011 | |||||||
| 4. Milone (2019) | Robotic 338Lap 2287 | $164.9 \pm 74.7$$159.9 \pm 70.2$ | $36.4 \pm 13.6$$45.8 \pm 11.6$ | $2.3 \pm 0.5$$2.4 \pm 0.2$ | Not Reported | 03.0 | 3.012.2 | ||||
| 5. Perry (2014) | Robotic 56Lap 19 | $133 \pm 29$$121 \pm 22$ | 2550 | Median: 1Median: 2 | Not Reported | 00 | Not Reported | 00 | 015.8 | ||
| 6. Sanchez (2012) | Robotic 13Lap 18 | $79 \pm 20$$76 \pm 13$ | Not Reported | 05.5 | Not Reported | 00 | 05.5 | ||||
| 7. Shaligram (2011) | Robotic 149Lap 2116 | Not Reported | 2.422.70 | Not Reported | 4.025.19 | 00.14 | Not Reported | 2.841.41 | Not Reported | Not Reported | |
| 8. Villamere (2014) | Robotic 314Lap 3135 | Not Reported | 2.262.78 | Not Reported | 1.271.02 | 00 | Not Reported | 0.661.5 | Not Reported | Not Reported |
TABLE 1B: da Vinci vs. Minimally Invasive/Laparoscopic Hiatal/Paraesophageal/Sliding Hernia Repair Procedures
| Author/Year | Study Size (N) | Operation Time (minutes) | EBL (ml) | Length of Stay (days) | Intraop Comp Rate (%) | Postop Comp Rate (%) | Mortality (in-hospital - 30 days, %) | Reoperation Rate (%) | Readmission Rate (%) | Conversion Rate (%) | |
|---|---|---|---|---|---|---|---|---|---|---|---|
| 1. Gehrig (2013) | Robotic | 12 | $172 \pm 31$ | $33 \pm 85$ | $7.8 \pm 3.9$ | 8.3 | 8.3 | 0 | 8.3 | Not Reported | 0 |
| Lap | 17 | $168 \pm 42$ | $24 \pm 42$ | $6.5 \pm 1.6$ | 5.9 | 11.8 | 0 | 0 | Reported | 5.9 | |
| 2. Gerull (2020) | Robotic | 830 | $174.1 \pm 63$ | $27.3 \pm 5.9$ | $1.8 \pm 0.6$ | Not Reported | 0 | 0.2 | Not Reported | 0 | |
| Lap | 1024 | $187.3 \pm 65$ | $89.3 \pm 27.8$ | $2.9 \pm 1.4$ | 0.5 | 0.8 | Reported | 7.0 | |||
| 3. Hosein (2020) | Robotic | 835 | Not Reported | $3.44 \pm 5.01$ | Not Reported | 2 | 0.1 | Not Reported | |||
| Lap | 6774 | Not Reported | $3.9 \pm 5.22$ | Reported | 3.7 | 0.4 | |||||
| 4. Howell (2020) | Robotic | 44 | Not Reported | Median: 2.0 | Not Reported | 13.6 | 0 | 0 | 4.6 | 0 | |
| Lap | 84 | Not Reported | Median: 1.0 | Reported | 11.9 | 0 | 2.4 | 8.3 | 0 | ||
| 5. O'Connor (2020) | Robotic | 114 | 179 | Not Reported | 2.3 | Not Reported | |||||
| Lap | 279 | 175 | Reported | 3.3 | Not Reported | ||||||
| 6. Soliman (2019) | Robotic | 142 | 186.5 | 1.4^ | $1.3 \pm 1.8$ | Not Reported | 6.3 | 0 | 1.4 | 3.50 | 0.7 |
| Lap | 151 | 158.0 | 2.0^ | $1.8 \pm 1.5$ | Reported | 19.2 | 0 | 2.0 | 4.00 | 0 | |
| 7. Tolboom (2016) | Robotic | 45 | 120 | Not Reported | Median: 1.0 | 15.56 | Not Reported | 0 | 8.89 | ICU: 0 | 2.2 |
| Lap | 30 | 95 | Reported | Median: 4.0 | 13.3 | Reported | 0 | 13.33 | ICU: 6.67 | 16.7 |
^Post-operative blood transfusion rates reported
{9}------------------------------------------------
FIGURE A: Search Criteria & Flowchart for Identification of Heller Myotomy, Hiatal/Paraesophageal/Sliding Hernia Repair Publications
Image /page/9/Figure/2 description: This image shows a flow diagram of the process used to identify publications related to robotic Heller Myotomy and Hiatal/Paraesophageal/Sliding Hernia. The process starts with 859 publications from PubMed, Scopus, and Embase searches, and after removing duplicates, 587 publications remain. After applying inclusion and exclusion criteria, 15 publications were identified that met the criteria. The exclusion criteria included not being in English, reporting on a pediatric population, and not providing quantitative results.
PubMed Search Terms: robot, robot assist, robotically assist, da vinci, intuitive surgical, robot surgery, achalasia, achalasias, heller myotomy, cardiomyotomy, foregut, hiatal hernia, paraesophageal hernia, hernia, paraesophageal, siding hernia Scopus Search Terms: davinci, robotic surgecal, robotic assist, robot surgery, robotic assist, achalasia, achalasias, esophageal achalasia, heller myotomy, foregut, hiatal hernia, paraesophageal hernia, paraesophageal, sliding hernia
Embase Search Terms: da vinci, davinci, intuitive surgical, endalasia, esophagus achalasia, heller myotomy, foregut, hiatal hernia, paraesophageal hernia, hernia, paraoesophageal, sliding hernia
§ 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.