da Vinci X Surgical System (IS4200); da Vinci Xi Surgical System (IS4000)
K240852 · Intuitive Surgical, Inc. · NAY · Jun 11, 2025 · Gastroenterology, Urology
Device Facts
Record ID
K240852
Device Name
da Vinci X Surgical System (IS4200); da Vinci Xi Surgical System (IS4000)
Applicant
Intuitive Surgical, Inc.
Product Code
NAY · Gastroenterology, Urology
Decision Date
Jun 11, 2025
Decision
SESE
Submission Type
Traditional
Regulation
21 CFR 876.1500
Device Class
Class 2
Attributes
Therapeutic, Real-World Evidence, Pediatric
Real-World Evidence
Submission
Device
Sponsor
RWD Sources
RWE Use Summary
Key Tags
K240852 · Jun 11, 2025
da Vinci X Surgical System (IS4200); da Vinci Xi Surgical System (IS4000)
Intuitive Surgical, Inc.
Premier Healthcare Database (PHD); Systematic literature review of published clinical outcomes
The sponsor used retrospective billing and procedure code data from the Premier Healthcare Database to identify 124 patients who underwent robotic-assisted tracheobronchoplasty (R-TBP). This was compared against a systematic literature review of 278 open tracheobronchoplasty (O-TBP) procedures to support the safety and effectiveness of the device for the new labeled indication.
Retrospective cohort; Billing records; Systematic literature review; Tracheobronchoplasty; Comparative effectiveness
Clinical Evidence
Study Design
Population
Comparator
Key Endpoints
Premier Healthcare Database (PHD) Analysis; Retrospective observational cohort study; Follow-up/Duration: 2013 to 2023; Study Period: 2013-2023
124 patients who underwent robotic-assisted tracheobronchoplasty (R-TBP); Sample Size: 124; Number of Sites: 6 hospitals in the USA
Open tracheobronchoplasty (O-TBP) data derived from systematic literature review (N=278)
Operative time, conversion rate, bleeding/transfusion rate, hospital length of stay, ICU length of stay, complication rates, mortality rate, 30-day readmission rate, 30-day reoperation rate
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, 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.
Device Story
The da Vinci Xi (IS4000) and X (IS4200) are software-controlled, electro-mechanical surgical systems. The system comprises a Surgeon Console, Patient Side Cart, and Vision Side Cart. Surgeons operate the system in an OR environment, using the console to control endoscopic instruments (e.g., dissectors, scissors, needle holders) and rigid endoscopes. The system translates surgeon hand movements into precise instrument motion, facilitating tissue manipulation, dissection, and suturing. The device provides high-definition visualization and ergonomic control, potentially reducing surgeon fatigue and improving precision in minimally invasive procedures. This submission adds tracheobronchoplasty for symptomatic, severe tracheobronchomalacia to the existing indications for use.
Clinical Evidence
No new bench or clinical testing was performed. Evidence consists of Real World Evidence (RWE) from the Premier Health Database (N=124 patients, 2013-2023) and a systematic literature review of open tracheobronchoplasty (O-TBP) (N=278 patients, 2000-2023). RWE demonstrated safety and effectiveness across nine outcomes, including operative time, conversion rate, bleeding, length of stay, and complication rates, showing performance comparable to or better than open procedures.
Technological Characteristics
Software-controlled, electro-mechanical system. Components: Surgeon Console, Patient Side Cart, Vision Side Cart. Accessories: EndoWrist instruments, rigid endoscopes. No changes to hardware, materials, or software architecture from predicate devices.
Indications for Use
Indicated for adult and pediatric patients undergoing urologic, general laparoscopic, gynecologic laparoscopic, general thoracoscopic, and thoracoscopically-assisted cardiotomy procedures, including tracheobronchoplasty for symptomatic, severe tracheobronchomalacia and coronary anastomosis via adjunctive mediastinotomy.
Regulatory Classification
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.
Special Controls
*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.
In combination with the general controls of the FD&C Act, the integrated operating table-electromechanical surgical system is subject to the following special controls:
1. (1) Premarket clinical performance testing, or a combination of premarket clinical performance testing and postmarket surveillance (in accordance with special control (2)), must include the following:
1. (i) Objective performance measures (e.g., rate and number of conversions to other surgical modalities, rate of device related adverse events (including tissue injury, hematoma, and increased blood loss), and their severity, cause, and outcomes) must be reported with relevant descriptive comparator performance measures.
2. (ii) The data must demonstrate the performance of the device for providing accurate and precise control of attached surgical instruments in range of clinical conditions relevant to the device's intended use.
3. (iii) The test dataset must include data collected from a patient population representative of the intended patient population under anticipated conditions of use.
2. (2) Data obtained from postmarket surveillance must demonstrate, in consideration of the premarket data obtained in accordance with special control (1), that the device performs in accordance with special control (1), unless FDA determines, based on the totality of the premarket data, that data from postmarket surveillance is not required to demonstrate that the device performs as intended. Such postmarket surveillance must be conducted per a protocol determined appropriate by FDA to demonstrate that the device performs as intended (in consideration of the premarket data obtained in accordance with special control (1)), and must include initiation, enrollment, and reporting requirements to ensure timely periodic updates to FDA on post-market surveillance progress and outcomes.
3. (3) Animal performance testing must evaluate the extent of port site trauma due to repositioning of table during surgical procedures when utilizing robotic minimally invasive and laparoscopic approaches
4. (4) The device manufacturer must develop, and update as necessary, a device-specific use training program that ensures proper device setup/use/shutdown, accurate control of instruments to perform the intended surgical procedures, troubleshooting and handling during unexpected events or emergencies, and safe practices to mitigate use error.
5. (5) The device manufacturer may only distribute the device to facilities that implement and maintain the device-specific use training program and ensure that users of the device have completed the device-specific use training program.
(6) Human factors assessment must demonstrate that the user can correctly use the device system across all intended use environments with the provided instructions and training materials, including patient access during normal operating conditions and emergency situations, and effects arising from the integrated nature of the operating table and robotic surgical arms.
(7) Labeling must include:
(i) A detailed summary of clinical performance testing conducted with the device, including study population, results, adverse events, and comparisons to any comparator groups identified;
(ii) A statement in the labeling that the 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 the patient's underlying disease or condition, unless FDA determines that it can be removed or modified based on clinical performance data submitted to FDA;
(iii) Identification of compatible devices;
(iv) The list of surgical procedures for which the device has been determined to be safe with clinical justification;
(v) Reprocessing instructions for reusable components;
(vi) A shelf life for any sterile components;
(vii) A description of the device-specific use training program;
(viii) A statement that the device is only for distribution to facilities that implement and maintain the device-specific use training program and ensure that users of the device have completed the device-specific use training program; and
(ix) A summary of any completed postmarket surveillance data collected as required by special control (2), including updated labeling to accurately reflect outcomes observed in postmarket surveillance.
(8) Non-clinical performance testing must demonstrate that the device performs as intended under anticipated conditions of use and must include:
(i) Device motion accuracy and repeatability;
(ii) System testing;
(iii) Instrument reliability;
(iv) Crosstalk;
(v) Table motion control;
(vi) Thermal effects on tissue;
(vii) User-device interface performance;
(viii) Workspace access testing; and
(ix) Performance testing with compatible devices.
(9) Software verification, validation, and hazard analysis must be performed.
(10) Electromagnetic compatibility and electrical, thermal, and mechanical safety testing must be performed.
(11) Performance data must demonstrate the sterility of all patient-contacting device components.
(12) Performance data must support the shelf life of the device components provided sterile by demonstrating continued sterility and package integrity over the labeled shelf life.
(13) Performance data must validate the reprocessing instructions for the reusable components of the device.
(14) Performance data must demonstrate that all patient-contacting components of the device are biocompatible.
(15) Performance data must demonstrate that all patient-contacting components of the device are non-pyrogenic.
(16) The device manufacturer must submit a report to the FDA annually on the anniversary of initial marketing authorization for the device, until such time as FDA may terminate such reporting, which comprises the following information:
(i) Cumulative summary, by year, of complaints and adverse events since date of initial marketing authorization; and
(ii) Identification and rationale for changes made to the device, labeling, or device specific use training program, which did not require submission of a premarket notification during the reporting period.
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FDA U.S. FOOD & DRUG ADMINISTRATION
June 11, 2025
Intuitive Surgical, Inc.
Mike Yramategui
Fellow Regulatory Engineer
1020 Kifer Road
Sunnyvale, California 94086
Re: K240852
Trade/Device Name: da Vinci X Surgical System (IS4200); da Vinci Xi Surgical System (IS4000)
Regulation Number: 21 CFR 876.1500
Regulation Name: Endoscope And Accessories
Regulatory Class: Class II
Product Code: NAY
Dated: June 10, 2025
Received: June 10, 2025
Dear Mike Yramategui:
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 (the 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 available 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.
U.S. Food & Drug Administration
10903 New Hampshire Avenue
Silver Spring, MD 20993
www.fda.gov
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K240852 - Mike Yramategui
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Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reporting-combination-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 Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rule"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance/unique-device-identification-system-udi-system.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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-devices/medical-device-safety/medical-device-reporting-mdr-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/medical-devices/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-devices/device-advice-comprehensive-regulatory-
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K240852 - Mike Yramategui
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assistance/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,
Mark
Trumbore -S
Digitally signed by Mark Trumbore -S
Date: 2025.06.11 14:40:48
-04'00"
Mark Trumbore 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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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
Indications for Use
Form Approved: OMB No. 0910-0120
Expiration Date: 07/31/2026
See PRA Statement below.
Submission Number (if known)
K240852
Device Name
da Vinci X Surgical System (IS4200);
da Vinci Xi Surgical System (IS4000)
Indications for Use (Describe)
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, 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.
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
K240852
Page 1 of 8
# 510(k) Summary (21 CFR § 807.92(c))
## I. SUBMITTER INFORMATION
Submitter: Intuitive Surgical, Inc.
1266 Kifer Road
Sunnyvale, CA 94086
Contact: Mike Yramategui
Fellow Regulatory Engineer
Mike.Yramategui@intusurg.com
408-594-4207
Date Summary Prepared: June 10, 2025
## 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, K202834, K211784, K223080, K231224)
## IV. DEVICE DESCRIPTION:
This 510(k) is for a labeling modification only, to include “tracheobronchoplasty for symptomatic, severe tracheobronchomalacia” as an additional representative, specific procedure under the previously cleared “General Thoracoscopic Surgical Procedures and Thoracoscopically-Assisted Cardiotomy Procedures” Indications for Use for the da Vinci Xi Surgical System, Model IS4000 (K131861) and the da Vinci X Surgical System, Model IS4200 (K171294).
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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510(k) Summary
K240852
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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, 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.
# 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 "tracheobronchoplasty for symptomatic, severe tracheobronchomalacia" as an additional representative, specific procedure under the previously cleared "General Thoracoscopic Surgical Procedures and Thoracoscopically-Assisted Cardiotomy 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. Real world evidence (RWE) from the Premier Health Database 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.
# Real World Evidence (RWE) from the Premier Health Database (PHD)
Real world evidence (RWE) from the Premier Health Database (PHD) support use of the da Vinci Xi and X Surgical Systems (Models IS4000 and IS4200) in "tracheobronchoplasty procedures" that fall under the cleared "General Thoracoscopic Surgical Procedures and Thoracoscopically-Assisted Cardiotomy Procedures" Indications for Use. Using robotic ICD/HCPCS procedure codes, robotic billing records, or a combination of both, 124 patients were identified in PHD that underwent tracheobronchoplasty procedures at 6 hospitals in the USA from 2013 to 2023.
Comparative open tracheobronchoplasty (O-TBP) data were derived from a systematic literature review. Three online databases (Embase, Scopus, and PubMed) were searched and all relevant citations were assessed against pre-defined inclusion and exclusion criteria. The key search filters applied to these publications included: 1) performance of open TBP procedures; 2) articles published between January 1,
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510(k) Summary
K240852
Page 3 of 8
2000 through December 31, 2023; and 3) inclusion of outcomes of interest (i.e., complications, operative time, length of stay, etc.). Three (3) publications met these criteria and were included in the analysis.¹ These publications reported on approximately 278 O-TBP procedures in patients with tracheobronchomalacia at the Massachusetts General Hospital (MGH) and the Beth Israel Deaconess Medical Center (BIDMC) from 2000 to 2023.
The results in Tables 1 – 4 demonstrated the safety and effectiveness of robotic-assisted tracheobronchoplasty surgical procedures. The findings from this analysis demonstrate that da Vinci-assisted procedures as compared to open procedures are substantially equivalent based on the following nine (9) outcomes of interest:
1. Operative Time
2. Conversion Rate
3. Bleeding/Transfusion Rate
4. Hospital Length of Stay
5. ICU Length of Stay
6. Complication rates
7. Mortality Rate
8. 30-Day Readmission Rate
9. 30-Day Reoperation Rate
## Surgeon Experience Prior to First R-TBP Procedure
Nine (9) surgeons performing R-TBP procedures were identified in the Premier Healthcare Database between 2013 and Q1 2023. The dates that the first R-TBP procedure were performed are summarized in Table 5 for each anonymous surgeon identifier. Based on the available data from the Premier Healthcare Database, surgeons had performed the following thoracic procedures from 2016 onward²:
- 1 – 790 robotic-assisted thoracic procedures prior to their first R-TBP procedure.
- 0 – 337 VATS thoracic procedures prior to their first R-TBP procedure.
- 0 – 119 Open thoracic procedures prior to their first R-TBP procedure.
This real-world evidence demonstrates the safe and effective use of the da Vinci Xi/X systems in R-TBP procedures across a range of surgeons with varying surgical experience across robotic-assisted, VATS and open thoracic surgical procedures.
¹ 1. Buitrago, D. H., A. Majid, D. E. Alape, J. L. Wilson, M. Parikh, M. S. Kent and S. P. Gangadharan (2018). "Single-Center Experience of Tracheobronchoplasty for Tracheobronchomalacia: Perioperative Outcomes." Ann Thorac Surg 106(3): 909-915.
2. Digesu, C. S., D. Ospina-Delgado, J. Ascanio, A. Majid, M. S. Parikh, S. P. Gangadharan and J. L. Wilson (2022). "Obese Patients Undergoing Tracheobronchoplasty Have Excellent Outcomes." Ann Thorac Surg 114(3): 926-932.
3. Wright, C. D., et al. (2005). "Tracheoplasty for expiratory collapse of central airways." Ann Thorac Surg 80(1): 259-266
² No R-TBP procedures were identified in the Premier Healthcare Database from 2013 through 2015; thoracic experience for this assessment was evaluated from 2016 onward.
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510(k) Summary
K240852
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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 RWE to support the safety and effectiveness for the new labeled use of "tracheobronchoplasty" surgical procedures under the "General Thoracoscopic Surgical Procedures and Thoracoscopically-Assisted Cardiotomy Procedures" Indications for Use as compared to the predicate devices. In addition, the subject devices have the same technological characteristics as the predicate devices. Tracheobronchoplasty procedures can be completed using the da Vinci Xi or X Surgical Systems without introducing any new or different issues of safety or effectiveness as compared to the representative, specific General Thoracoscopic Surgical Procedures and Thoracoscopically-Assisted Cardiotomy surgical procedures previously cleared for the Xi and X systems. The addition of Tracheobronchoplasty as a representative, specific procedure does not represent a change or modification in the device that could significantly affect the safety or effectiveness of the device. Therefore, use of the da Vinci Xi and X Surgical Systems (Models IS4000 and IS4200) in Tracheobronchoplasty procedures are substantially equivalent to the cleared predicate devices.
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510(k) Summary
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# Robotic and Open Tracheobronchoplasty Outcomes Data
Table 1. Demographics
| Variables | Surgeon 898779703
R-TBP from PHD
N=96 | All Other Surgeons
R-TBP from PHD
N=28 | Combined Surgeons
R-TBP from PHD
N=124 | O-TBP from SLR
N=278 |
| --- | --- | --- | --- | --- |
| Age in Years | 66.2 (9.8) | 63.5 (12.3) | 65.6 (10.4) | 57.4 (8.8) |
| Male Sex | 34 (35.4) | 9 (32.1) | 43/124 (34.7) | 94/278 (33.8) |
| Race | | | | |
| White | 76 (79.2) | 20 (71.4) | 96/124 (77.4) | 240/264 (90.9) |
| Black or African American | 3 (3.1) | 1 (3.6) | 4/124 (3.2) | Not Reported |
| Others | 1 (1.0) | 3 (10.7) | 4/124 (3.2) | Not Reported |
| Unknown | 16 (16.7) | 4 (14.3) | 20/124 (16.1) | Not Reported |
*Unless otherwise specified, count variables are reported as Event N/Total N (Percent) and continuous variables are reported as Mean (Standard Deviation).
Table 2. Patient Comorbidities
| Variables | Surgeon 898779703
R-TBP from PHD
N=96 | All Other Surgeons
R-TBP from PHD
N=28 | Combined Surgeons
R-TBP from PHD
N=124 | O-TBP from SLR |
| --- | --- | --- | --- | --- |
| CCI, Cancer Included | 1.6 (1.2) | 1.4 (0.9) | 1.5 (1.1) | 3/103 (0.6) |
| Obesity | 27 (28.1) | 16 (57.1) | 43/124 (34.7) | 130/264 (49.2) |
| Smoking History Ever | 48 (50.0) | 6 (21.4) | 54/124 (43.5) | 144/278 (51.8) |
| COPD | 28 (29.2) | 4 (14.3) | 32/124 (25.8) | 103/278 (37.1) |
| Asthma | 67 (69.8) | 18 (64.3) | 85/124 (68.5) | 133/264 (50.4) |
| GERD | 73 (76.0) | 18 (64.3) | 91/124 (73.4) | 143/264 (54.2) |
| Obstructive Sleep Apnea | 44 (45.8) | 16 (57.1) | 60/124 (48.4) | 100/264 (37.9) |
| Hypertension | 42 (43.8) | 17 (60.7) | 59/124 (47.6) | 112/264 (42.4) |
| Diabetes | 23 (24.0) | 5 (17.9) | 28/124 (22.6) | 59/264 (22.3) |
| Congestive Heart Failure | 6 (6.3) | 2 (7.1) | 8/124 (6.5) | 23/264 (8.7) |
| Cerebrovascular Disease | 1 (1.0) | 0 (0.0) | 1/124 (0.8) | Not Reported |
| Pre-operative Tracheostomy | 0 (0.0) | 0 (0.0) | 0/124 (0.0) | 19/161 (11.8) |
*Unless otherwise specified, count variables are reported as Event N/Total N (Percent) and continuous variables are reported as Mean (Standard Deviation).
{9}
510(k) Summary
K240852
Table 3. Safety Outcomes
| Variables | Surgeon 898779703 R-TBP from PHD N=96 | All Other Surgeons R-TBP from PHD N=28 | Combined Surgeons R-TBP from PHD N=124 | O-TBP from SLR |
| --- | --- | --- | --- | --- |
| Respiratory Failure | 4 (4.2) [1.3, 10.6] | 5 (17.9) [7.4, 36.1] | 9/124 (7.3) [3.7, 13.4] | 28/161 (17.4) [12.3, 24.0] |
| Mechanical Ventilation with Intubation | 0 (0.0) [0.0, 4.6] | 0 (0.0) [0.0, 14.3] | 0/124 (0.0) [0, 3.6] | 49/278 (17.6) [13.6, 22.6] |
| Prolonged Air Leak | 3 (3.1) [0.7, 9.2] | 0 (0.0) [0.0, 14.3] | 3/124 (2.4) [0.5, 7.2] | 1/161 (0.6) [0, 3.8] |
| Pneumothorax with Chest Tube | 7 (7.3) [3.3, 14.5] | 1 (3.6) [0.0, 19.2] | 8/124 (6.5) [3.1, 12.4] | 6/264 (2.3) [0.9, 5.0] |
| Pleural Effusion | 2 (2.1) [0.1, 7.7] | 0 (0.0) [0.0, 14.3] | 2/124 (1.6) [0.1, 6.1] | 8/264 (3.0) [1.4, 6.0] |
| Chest Tube After Surgery | 4 (4.2) [1.3, 10.6] | 0 (0.0) [0.0, 14.3] | 4/124 (3.2) [1.0, 8.3] | Not Reported |
| Hemothorax | 1 (1.0) [0.0, 6.2] | 0 (0.0) [0.0, 14.3] | 1/124 (0.8) [0, 4.9] | Not Reported |
| Intraoperative Bleeding** | 0 (0.0) [0.0, 4.6] | 0 (0.0) [0.0, 14.3] | 0/124 (0.0) [0, 3.6] | N = 161 200 (111.1) [182.8, 217.2] |
| Postprocedural Bleeding | 1 (1.0) [0.0, 6.2] | 0 (0.0) [0.0, 14.3] | 1/124 (0.8) [0, 4.9] | 3/264 (1.1) [0.2, 3.4] |
| Venous Thromboembolism | 0 (0.0) [0.0, 4.6] | 0 (0.0) [0.0, 14.3] | 0/124 (0.0) [0, 3.6] | 7/264 (2.7) [1.2, 5.5] |
| Surgical Site Infection | 0 (0.0) [0.0, 4.6] | 0 (0.0) [0.0, 14.3] | 0/124 (0.0) [0, 3.6] | 9/264 (3.4) [1.7, 6.4] |
| Bronchitis | 4 (4.2) [1.3, 10.6] | 1 (3.6) [0.0, 19.2] | 5/124 (4.0) [1.5, 9.3] | 5/264 (1.9) [0.7, 4.5] |
| Pneumonia | 1 (1.0) [0.0, 6.2] | 1 (3.6) [0.0, 19.2] | 2/124 (1.6) [0.1, 6.1] | 39/278 (14.0) [10.4, 18.6] |
| Atrial Arrhythmia | 4 (4.2) [1.3, 10.6] | 0 (0.0) [0.0, 14.3] | 4/124 (3.2) [1.0, 8.3] | 17/264 (6.4) [4.0, 10.1] |
| Acute Renal Failure | 1 (1.0) [0.0, 6.2] | 2 (7.1) [0.9, 23.7] | 3/124 (2.4) [0.5, 7.2] | 30/264 (11.4) [8.0, 15.8] |
| Injury to Adjacent Organs | 0 (0.0) [0.0, 4.6] | 1 (3.6) [0.0, 19.2] | 1/124 (0.8) [0, 4.9] | Not Reported |
| Mortality, N (%) | 0 (0.0) [0.0, 4.6] | 0 (0.0) [0.0, 14.3] | 0/124 (0.0) [0, 3.6] | 2/278 (0.7) [0, 2.8] |
| 30-Day Readmission | 7 (7.3) [3.3, 14.5] | 4 (14.3) [5.1, 32.1] | 11/124 (8.9) [4.9, 15.3] | 19/161 (11.8) [7.6, 17.8] |
| 30-Day Reoperation | 1 (1.0) [0.0, 6.2] | 1 (3.6) [0.0, 19.2] | 2/124 (1.6) [0.1, 6.1] | 4/161 (2.5) [0.8, 6.4] |
*Unless otherwise specified, count variables are reported as Event N/Total N (Percent) [Lower 95% CI, Upper 95% CI] and continuous variables are reported as Mean (Standard Deviation) [Lower 95% CI, Upper 95% CI]. 95% confidence intervals are calculated for continuous outcomes and 95% Agresti-Coull confidence intervals are calculated for categorical outcomes.
**All identified O-TBP papers reported intraoperative bleeding as mL blood loss. The data used for the R-TBP cohort does not report mL blood loss, and so ICD-9/10 codes and CPT codes were used to identify whether or not blood loss was reported during the procedure.
{10}
510(k) Summary
K240852
Table 4. Effectiveness Outcomes
| Variables | Surgeon 898779703 R-TBP from PHD N=96 | All Other Surgeons R-TBP from PHD N=28 | Combined Surgeons R-TBP from PHD N=124 | O-TBP from SLR |
| --- | --- | --- | --- | --- |
| Surgical Time in Minutes | 325.0 (53.8) [314.1, 335.9] | 343.4 (83.0) [311.2, 375.6] | 329.1 (61.7) [318.2, 340.1] | N = 264 388.2 (60.2) [381.0, 395.5] |
| Hospital Length of Stay in Days | 4.1 (3.2) [3.5, 4.8] | 5.1 (5.8) [2.9, 7.4] | 4.4 (3.9) [3.7, 5.1] | N = 175 8.1 (3.7) [7.5, 8.6] |
| ICU Length of Stay in Days | 1.7 (1.8) [1.4, 2.1] | 1.9 (3.5) [0.6, 3.3] | 1.8 (2.3) [1.4, 2.2] | N = 264 3.7 (1.2) [3.6, 3.9] |
| Conversion to Open Surgery | 0 (0.0) [0.0, 4.6] | 1 (3.6) [0.0, 19.2] | 1 (0.8) [0, 4.9] | Not Applicable |
| Discharge Disposition** | | | | |
| Home or Self Care | 71 (74.0) [64.3, 81.7] | 16 (57.1) [39.1, 73.5] | 87/124 (70.2) [61.6, 77.5] | 60/161 (37.3) [30.2, 45.0] |
| Home with Assistance | 24 (25.0) [17.4, 34.6] | 11 (39.2) [23.5, 57.6] | 35/124 (28.2) [21.0, 36.7] | 50/161 (31.1) [24.4, 38.6] |
| Rehabilitation Facility | 1 (1.0) [0.0, 6.2] | 1 (3.6) [0.0, 19.2] | 2/124 (1.6) [0.1, 6.1] | 49/161 (30.4) [23.8, 37.9] |
*Unless otherwise specified, count variables are reported as Event N/Total N (Percent) [Lower 95% CI, Upper 95% CI] and continuous variables are reported as Mean (Standard Deviation) [Lower 95% CI, Upper 95% CI]. 95% confidence intervals are calculated for continuous outcomes and 95% Agresti-Coull confidence intervals are calculated for categorical outcomes.
**For the R-TBP cohort discharge disposition, "Home with Assistance" includes the categories "Home Health Organization" (n = 34, 27.4%) and "Skilled Nursing Facility" (n = 1, 0.8%).
{11}
510(k) Summary
K240852
TABLE 5: Thoracic Surgical Procedure Experience Prior to First R-TBP Procedure
| De-Identified Surgeon ID** | Date of First R-TBP | RAS TBP Procedures performed in the Study | Number of Thoracic Procedures* BEFORE first R-TBP | | |
| --- | --- | --- | --- | --- | --- |
| | | | RAS | VATS | Open |
| 2156970 | 2/10/2023 | 1 | 131 | 337 | 119 |
| 6084487 | 9/15/2020 | 1 | 1 | 3 | 0 |
| 11945750 | 7/13/2022 | 1 | 790 | 14 | 5 |
| 26035138 | 2/18/2020 | 7 | 93 | 9 | 1 |
| 27087862 | 1/26/2022 | 8 | 699 | 167 | 36 |
| 27218818 | 6/13/2017 | 8 | 15 | 21 | 2 |
| 86160552 | 3/25/2022 | 1 | 34 | 0 | 0 |
| 119279619 | 11/1/2022 | 1 | 12 | 0 | 1 |
| 898779703 | 9/12/2016 | 96 | 74 | 19 | 5 |
| Grand Total = | | | 1,849 | 570 | 169 |
* Thoracic procedures identified using ICD-10 PCS codes from the Healthcare Cost Utilization Project CCSR category RES008 (Lung, pleura, or diaphragm resection).
** Surgeons who performed their first TBP earlier in the range of available data had less available information to ascertain thoracic surgery experience.
Two short videos show you everything — or skip straight to the written tutorial if you'd rather read. You can reopen this any time from the Tutorial button in the top bar.
Part 1 — Search, results, and everyday workflows 16 min
Part 2 — Embeddings: the galaxy map 3 min
1. Search: exact and fuzzy
Type a phrase like "coronary artery calcification" into the search box. You get two kinds of results. Exact results match the literal phrase — prefix searches work ("coronary artery calcificati") but suffix searches do not. Fuzzy results match on the meaning and intent of your phrase rather than the exact words, and are sorted by relevance score. Hover over the Exact or Fuzzy badge on any row to see exactly why it matched.
Use the checkboxes above the results to narrow: SaMD keeps only software-only devices, AI / ML keeps only devices with AI.
Exact vs. fuzzy search: what's the difference?
Exact matches on the literal phrase (prefix search works, suffix does not). Fuzzy matches on the meaning and intent of the phrase rather than the exact words. Hover over the badge on any row to see why it matched.
You search "coronary artery calcification" and want only software devices with AI. What two filters do you apply?
Narrow by SaMD (software-only devices), then narrow by AI/ML (devices with AI).
2. The results table
Scroll right in the results table. The intended use is extracted for you — no need to open the PDF. The device story gives a high-level snapshot of what the device does and how it's used. The AI Performance sub-table shows each output name, acceptance criteria, observed values, and development/test dataset descriptions — the same format Innolitics uses for regulatory strategy outputs, and the fastest high-level fingerprint of an AI device. It is AI-generated but has been very reliable in practice.
Where do you find a device's intended use without opening the PDF?
Scroll right in the search results table. The intended use column is extracted for you; no need to dig into the 510(k) summary PDF.
What does the AI Performance sub-table show, and why is it useful?
Output name, acceptance criteria, observed values, development dataset description, and test dataset description. It's the same format we use for regulatory strategy output and Fast 510(k) input, and the fastest high-level fingerprint of an AI device. AI-generated but reliable in practice.
3. Judging fuzzy relevance
Fuzzy results trail off in relevance as you scroll. Use three signals to decide how far down to go: the fuzzy badge explanations, the intended use column, and whether your target output (e.g., Cobb angle) still appears in the AI Performance sub-table. Once it stops appearing, you're past the relevant zone. A top hit with a low score (~0.4) and a stretched explanation is a hint the closest predicates are far away — the project may be headed for De Novo. Note the fuzzy search is a pattern match: it doesn't handle negation ("not") well, and hardware devices can appear — filter by SaMD/AI ML to cut them.
How do you judge how far down fuzzy search results to go?
Use the relevancy signals: the fuzzy badge explanations, the intended use column, and whether the target output (e.g., Cobb angle) still appears in the AI Performance sub-table. Once it stops appearing, results are trailing off in relevancy.
4. Device detail page: chat and citations
Click a device name to open its detail page: device facts on the left, a chat window on the right. Ask something like "Describe the training data". The answer carries little citation bubbles — click one to jump to the highlighted passage in the source PDF, so you can verify every AI answer against the document. There's also a Download PDF button for sharing.
How do you verify an AI chat answer on the device detail page?
Click the citation bubbles to jump to the relevant highlight in the source document.
Reading rule for every project: how many summaries do you read in full?
At least the three most relevant 510(k) or De Novo summaries, in full. After that, use targeted chat questions to confirm your memory quickly. The tool supports this professional habit — it doesn't replace it.
5. Side-by-side comparison
Select multiple rows in the results table (aim for under ~10), then open the PDF Viewer tab. Ask one question — it goes to all selected devices in parallel, each with citations. This is the fastest way to compare and contrast devices: training data, PCCP scope, how they handled adding new scanners, and so on.
What does the side-by-side PDF viewer mode do?
Select multiple devices, open the PDF viewer tab, and ask one question (e.g., "Describe the training data"). It queries all selected devices simultaneously with citations, so you can compare and contrast quickly.
6. Collections
With rows selected, go to the Collections tab and create a labeled collection (e.g., "Cobb Angle Project"). Reload that selection any time — before a client call, pull up the collection and ask questions across all of its devices at once.
How do you save a set of selected devices for later use?
Select the rows, go to the Collections tab, and create a labeled collection (e.g., "Cobb Angle Project"). You can reload the selection anytime and carry it into the PDF viewer and other tabs that support selections.
7. Product codes and the regulations tree
Click a product code in the results to jump to it in the regulations tree — identification text, sibling product codes, and devices you can open in a PDF viewer on the right. Click a regulation number to see its identification, special controls, and related product codes. You can also search by product code or regulation number at the top of the tree. Always read the special controls if any exist for your device — it broadens your search and sharpens pre-kickoff research.
What can you do from the regulations tree view?
Browse product codes and regulation numbers, read the identification text and special controls, browse sibling product codes, open device PDFs on the right, and search by product code or regulation number at the top of the tree.
8. Chart view
Click Show Chart and segment by regulation number (or product code) to see which regulations dominate your result set. Clicking a regulation takes you into the regulations tree. Great for spotting that most matches are, say, hardware laparoscopic devices — a cue to go back and filter.
How do you see which regulations dominate a search result set?
Click "Show Chart" and segment by Regulation Number. Clicking a regulation takes you to the regulations tree.
9. The predicate graph
Open the Predicates tab for a family-tree view of predicate relationships. Click a node to trace its parents and children; selections from search carry over pre-selected. Commonly predicated devices are worth reading — a lot of people predicated them for a reason. The visual lineage is also handy on client calls, e.g. to show how a predicate family evolved and justify why your predicate still holds.
In the predicate graph, why are commonly predicated devices worth reading?
A lot of people predicated them for a reason. Clicking a node traces parents and children, and selections from search carry over pre-selected.
10. Embeddings: the galaxy map
The Embeddings tab plots every matching document in a 2-D "galaxy map" where semantically similar devices cluster together. Hover or click clusters to explore, and let AI label the clusters for you. Embeddings beat product codes for grouping: two devices can carry different product codes (LLZ vs. QIH) yet do the same thing — the embedding captures the meaning of the intended use and device story. This is also exactly how retrieval-augmented generation (RAG) works under the hood, and it makes a great visual on client calls.
Try it yourself
Head to the search page and work through a few of these AI/ML fuzzy searches to build intuition: perivascular fat on CT · aortic valve calcification opportunistic screening on noncontrast CT · breast cancer prediction on digital pathology slides · autism detection · gestational age prediction · a hearing aid that can also detect a pulse · foundation model based analysis of ECG · large language models · penetration test. Watch how the relevance scores, intended use, and AI Performance tables tell you when results stop being meaningful.
