(76 days)
No
The submission explicitly states that there are no changes to the technological characteristics of the cleared systems and the description focuses on software-controlled, electro-mechanical systems for surgical assistance. There is no mention of AI or ML.
Yes.
The device is intended to assist in various surgical procedures, which are therapeutic interventions.
No
The device is described as an "Endoscopic Instrument Control System" intended to "assist in the accurate control of Intuitive Surgical Endoscopic Instruments" for surgical procedures, not for diagnosis.
No
The device description explicitly states that the da Vinci Xi and X Surgical Systems are "software-controlled, electro-mechanical systems" and consist of hardware components like a Surgeon Console, Patient Side Cart, and Vision Side Cart. This indicates it is not a software-only device.
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 is a therapeutic and surgical device, not a diagnostic one.
- Device Description: The description details a software-controlled, electro-mechanical system used for minimally invasive surgery, consisting of a console, patient cart, and vision cart, used with instruments and accessories. This aligns with a surgical robot, not an IVD.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens (blood, tissue, etc.) in vitro (outside the body) to provide diagnostic information. The device is used in vivo (inside the body) during surgery.
Therefore, the Intuitive Surgical Endoscopic Instrument Control System (da Vinci X and Xi Surgical Systems) is a surgical device, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications 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.
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.
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 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.
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
Intended User / Care Setting
trained physicians in an operating room environment
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Clinical Study Data:
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 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
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, K171632, K171294, K172643, K173842, K173585, K182140, K183086, K081137, K123463, K090993
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.
Not Found
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 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
1
statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
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
2
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."
3
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."
4
510(k) Summary (21 CFR § 807.92(c)) K202834
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, Inc.
Telephone: 650.343.4813
Fax: 650.343.7822
Email: 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.
5
V. INDICATIONS FOR USE
The Intuitive Surgical Endoscopic Instrument Control System (da Vinci Surgical System, Models: IS4000 and IS4200) is intended to assist in the accurate control of Intuitive Surgical Endoscopic Instruments including rigid endoscopes, blunt and sharp endoscopic dissectors, scalpels, forceps/pick-ups, needle holders, endoscopic retractors, electrocautery and accessories for endoscopic manipulation of tissue, including grasping, cutting, blunt and sharp dissection, approximation, ligation, electrocautery, suturing, and delivery and placement of microwave and cryogenic ablation probes and accessories, during urologic surgical procedures, general laparoscopic surgical procedures, gynecologic laparoscopic surgical procedures, general thoracoscopic surgical procedures and thoracoscopically-assisted cardiotomy procedures. The system can also be employed with adjunctive mediastinotomy to perform coronary anastomosis during cardiac revascularization. The system is indicated for adult and pediatric use. It is intended to be used by trained physicians in an operating room environment in accordance with the representative, specific procedures set forth in the Professional Instructions for Use.
Precaution for Representative Uses
The demonstration of safety and effectiveness for the representative specific procedures did not include evaluation of outcomes related to the treatment of cancer (overall survival, disease-free survival, local recurrence) or treatment of the patient's underlying disease/condition. Device usage in all surgical procedures should be guided by the clinical judgment of an adequately trained surgeon.
VI. COMPARISON OF INTENDED USE, INDICATIONS FOR USE AND TECHNOLOGICAL CHARACTERISTICS WITH THE PREDICATE DEVICE
There are no changes to the technological characteristics for the subject devices compared to the cleared predicate devices, da Vinci Xi Surgical System, Model IS4000 (K131861) and the da Vinci X Surgical System, Model IS4200 (K171294). This 510(k) is for a labeling modification to include 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
6
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 44 | ||||||||||
| Lap 40 | Median: 183.5 | ||||||||||
| Median: 157 | Not Reported | Median: 1 | |||||||||
| Median: 1 | 0 | ||||||||||
| 15 | Not Reported | 0 | |||||||||
| 0 | Not Reported | ||||||||||
| 2.5 | 2.3 | ||||||||||
| 7.5 | 0 | ||||||||||
| 5 | 0 | ||||||||||
| 2.5 | |||||||||||
| 2. Kim (2018) | Robotic 37 | ||||||||||
| Lap 35 | 158 | ||||||||||
| 157 | 41 | ||||||||||
| 56 | 2.02 | ||||||||||
| 2.17 | Not Reported | 0 | |||||||||
| 0 | 0 | ||||||||||
| 0 | 0 | ||||||||||
| 8.6 | 2.7 | ||||||||||
| 11.4 | |||||||||||
| 3. Maseo (2010) | Robotic 102 | ||||||||||
| Lap 150 | $202.9 \pm 97.0$ | ||||||||||
| $183.7 \pm 79.8$ | Not Reported | 0 | |||||||||
| 11 | |||||||||||
| 4. Milone (2019) | Robotic 338 | ||||||||||
| Lap 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 | 0 | |||||||||
| 3.0 | 3.0 | ||||||||||
| 12.2 | |||||||||||
| 5. Perry (2014) | Robotic 56 | ||||||||||
| Lap 19 | $133 \pm 29$ | ||||||||||
| $121 \pm 22$ | 25 | ||||||||||
| 50 | Median: 1 | ||||||||||
| Median: 2 | Not Reported | 0 | |||||||||
| 0 | Not Reported | 0 | |||||||||
| 0 | 0 | ||||||||||
| 15.8 | |||||||||||
| 6. Sanchez (2012) | Robotic 13 | ||||||||||
| Lap 18 | $79 \pm 20$ | ||||||||||
| $76 \pm 13$ | Not Reported | 0 | |||||||||
| 5.5 | Not Reported | 0 | |||||||||
| 0 | 0 | ||||||||||
| 5.5 | |||||||||||
| 7. Shaligram (2011) | Robotic 149 | ||||||||||
| Lap 2116 | Not Reported | 2.42 | |||||||||
| 2.70 | Not Reported | 4.02 | |||||||||
| 5.19 | 0 | ||||||||||
| 0.14 | Not Reported | 2.84 | |||||||||
| 1.41 | Not Reported | Not Reported | |||||||||
| 8. Villamere (2014) | Robotic 314 | ||||||||||
| Lap 3135 | Not Reported | 2.26 | |||||||||
| 2.78 | Not Reported | 1.27 | |||||||||
| 1.02 | 0 | ||||||||||
| 0 | Not Reported | 0.66 | |||||||||
| 1.5 | 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
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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