da Vinci X Surgical System (IS4200), da Vinci Xi Surgical System (IS4000)

K223080 · Intuitive Surgical, Inc. · NAY · Nov 22, 2022 · Gastroenterology, Urology

Device Facts

• Record ID: K223080
• 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: Nov 22, 2022
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 876.1500
• Device Class: Class 2
• Attributes: Therapeutic, Pediatric

Intended 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. Itis 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

Computer-controlled, electro-mechanical surgical system; assists surgeons in performing minimally invasive surgery. Components: Surgeon Console, Patient Side Cart (PSC), Vision Side Cart (VSC). Inputs: Surgeon hand/foot movements at console; real-time endoscopic video. Transformation: System translates surgeon inputs into precise, scaled movements of EndoWrist instruments and endoscopes. Output: Real-time visualization and robotic-assisted tissue manipulation (grasping, cutting, dissection, suturing). Used in operating rooms by trained physicians. Enhances surgical precision and control; facilitates complex procedures like duodenal switch bariatric surgeries. Clinical decision-making remains with the surgeon; system provides the platform for execution.

Clinical Evidence

Retrospective real-world evidence (RWE) study using Premier Health Database (2016-2020). Compared 314 propensity-matched robotic-assisted vs. 314 laparoscopic duodenal switch bariatric procedures. Primary endpoints: operative time, length of stay, conversion rates, transfusion rates, intraoperative complications, 30-day post-operative complications, readmission, reoperation, and mortality. Results showed safety and effectiveness; robotic-assisted procedures were substantially equivalent to laparoscopic procedures across all metrics.

Technological Characteristics

Software-controlled, electro-mechanical system. Comprises Surgeon Console, Patient Side Cart, and Vision Side Cart. Uses proprietary EndoWrist instruments and rigid endoscopes. No changes to hardware, materials, or energy sources from predicate. System is networked for clinical use; sterilization via standard hospital protocols for reusable instruments.

Indications for Use

Indicated for adult and pediatric patients undergoing urologic, general laparoscopic, gynecologic laparoscopic, general thoracoscopic, and thoracoscopically-assisted cardiotomy procedures, including coronary anastomosis via adjunctive mediastinotomy. Includes bariatric procedures: Biliopancreatic Diversion-Duodenal-Switch (BPD-DS), Single Anastomosis-Duodeno Ileal Bypass with Sleeve (SADI-S), One Anastomosis Duodenal Switch (OADS), and Transit Bipartition (TB).

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.

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)
• Intuitive Surgical da Vinci Si Surgical System, Model IS3000 (K081137, K123463, K090993)

Submission Summary (Full Text)

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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the symbol of the Department of Health & Human Services on the left and the FDA acronym along with the full name of the agency on the right. The FDA part of the logo is in blue, with the acronym in a square and the full name written out next to it. The full name reads "U.S. Food & Drug Administration".

November 22, 2022

Intuitive Surgical, Inc Connor McCarty Senior Regulatory Engineer 1266 Kifer Road Sunnyvale, California 94086

Re: K223080

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: September 30, 2022 Received: September 30, 2022

Dear Connor McCarty:

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 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

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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 ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely.

Digitally signed by Mark Mark Trumbore -S Trumbore -S Date: 2022.11.22
13:42:23 -05'00'

Mark Trumbore 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) K223080

#### 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. Itis 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) | |
|--------------------------------------------------------------------------------|-------------------------------------------------------------------------------|
| <div> <span> Prescription Use (Part 21 CFR 801 Subpart D) </span> </div> | <div> <span> Over-The-Counter Use (21 CFR 801 Subpart C) </span> </div> |

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# Indications for Use

510(k) Number (if known) K223080

#### 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. Itis 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)

| <span style="font-family: DejaVu Sans, sans-serif">☑</span> Prescription Use (Part 21 CFR 801 Subpart D) | <span style="font-family: DejaVu Sans, sans-serif">☐</span> 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))

#### I. SUBMITTER INFORMATION

| Submitter: | Intuitive Surgical, Inc. |
|--------------------------------|--------------------------------------------------------------------|
| | 1266 Kifer Road |
| | Sunnyvale, CA 94086 |
| Contact: | Connor McCarty |
| | Senior Regulatory Engineer |
| | [e-mail] |
| | 805.798.4205 |
| Date Summary Prepared: | September 30, 2022 |
| 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 |

### 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) |
| | Intuitive Surgical da Vinci Si Surgical System, Model IS3000 (K081137, |
| | K123463, K090993) |

### IV. DEVICE DESCRIPTION:

Submission Type:

This 510(k) is for a labeling modification only, to include the following additional representative, specific "duodenal switch bariatric surgical 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):

- 1. Biliopancreatic Diversion-Duodenal-Switch/BPD-DS,
- 2. Single Anastomosis-Duodeno Ileal Bypass with Sleeve/SADI-S,

Traditional 510(k)

- 3. One Anastomosis Duodenal Switch/OADS, and
- 4. Transit Bipartition/TB.

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 the representative, specific "duodenal switch bariatric surgical procedures" as a labeled use 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 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 "duodenal switch bariatric surgical procedures" that fall under the cleared "general laparoscopic surgical procedures" Indication for Use. Real-world data (RWD) were not provided for all of the representative, specific procedures. Instead, RWD were provided only for the most complex/highest risk representative, duodenal switch bariatric surgical procedures (referred to as the "umbrella" procedures). The RWE for these "umbrella" procedures (i.e.,

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Billopancreatic Diversion-Duodenal-Switch/BPD-DS, Single Anastomosis-Duodeno Ileal Bypass with Sleeve/SADI-S, and, One Anastomosis Duodenal Switch/OADS) were deemed sufficient to cover the less complex/lower risk procedure of "Transit Bipartition" (referred to as "covered" procedure), so RWD on the noted covered procedure was not provided.

Using ICD-10 and CPT codes, 1,878 patients, including 377 robotic-assisted and 1501 laparoscopic, were identified in PHD that underwent primary DS Bariatric surgical procedures for an obesity indication at 73 hospitals in the USA from 2016 to 2020. After propensity score matching, 314 patients were evaluated in each cohort. Table 1 includes a summary of the unmatched and propensity matched comparative data from the robotic-assisted and laparoscopic duodenal switch bariatric surgical procedure cohorts. Outcomes were assessed through 30 days. The results demonstrated the safety and effectiveness of robotic-assisted duodenal switch bariatric surgical procedures. The findings from this analysis demonstrate that da Vinci-assisted procedures as compared to laparoscopic procedures are substantially equivalent based on the following nine (9) outcomes of interest:

- 1. Operative Times
- 2. Lengths of Hospital Stay (LOS)
- 3. Conversion Rates
- 4. Transfusion Rates
- 5. Intraoperative Complication Rates
- 6. 30 Day Post-operative Complication Rates
- 7. 30 Day Readmission Rates
- 8. 30 Day Reoperation Rates
- 9. 30 Day Mortality Rates

# VIII. CONCLUSION

The do 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 the representative, specific duodenal switch surgical procedures of: Billopancreatic Diversion-Duodenal-Switch/BPD-DS, Single Anastomosis-Duodeno Ileal Bypass with Sleeve/SADI-S, One Anastomosis Duodenal Switch/OADS, and Transit Bipartition 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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#### K223080

| | | Unmatched | | | PS Matched | | |
|----|----------------------------------------------------|-------------------|-------------------|---------|-------------------|-------------------|---------|
| | Outcomes | L | R | p-value | L | R | p-value |
| 1. | Operative Time (min),<br>median (IQR) | 180<br>(150, 240) | 284<br>(240, 345) | <.001 | 210<br>(165, 270) | 270<br>(240, 330) | <.001¶ |
| | 2. Length of Hospital Stay<br>(days), median (IQR) | 2 (1, 3) | 2 (1, 3) | 0.518 | 2 (1, 3) | 2 (1, 3) | 0.372§§ |
| 3. | Conversion to Open<br>Surgery, n (%) | 5 (0.3) | 0 (0.0) | 0.590 | 1 (0.3) | 0 (0.0) | 1.000§§ |
| 4. | Transfusion Rate, n (%) | 9 (0.6) | 4 (1.1) | 0.308 | 3 (1.0) | 3 (1.0) | 1.000 |
| 5. | Intraoperative<br>Complication Rate, n (%) | 2 (0.1) | 1 (0.3) | 0.490 | 1 (0.3) | 1 (0.3) | 1.000 |
| 6. | 30 Day Post-Operative<br>Complication Rate, n (%) | 309 (20.6) | 86 (22.8) | 0.343 | 85 (27.1) | 67 (21.3) | 0.094 |
| 7. | 30 Day Readmission | 84 (5.6) | 14 (3.7) | 0.142 | 28 (8.9) | 10 (3.2) | 0.003 |
| 8. | 30 Day Reoperation | 30 (2.0) | 7 (1.9) | 0.859 | 14 (4.5) | 5 (1.6) | 0.036 |
| 9. | 30 Day Mortality | 2 (0.1) | 0 (0.0) | 1.000 | 1 (0.3) | 0 (0.0) | 1.000 |

# TABLE 1: Unmatched and Propensity Score Matched da Vinci and Laparosocopic Duodenal Switch Bariatric Surgical Procedures

§§ No adjustment to the p-value according to the step-down approach described in section 5.2.1. We started with the p-value for OR time first and then LOS, p-value of LOS greater that the significance level was observed therefore the adjustment method stopped.