The Intuitive Surgical Endoscopic Instrument Control System, Model 184000) 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 laparosopic 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 Surgical System, Model 184200) 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 laparosopic 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 Description

This 510(k) is for a labeling modification only, to include the following additional representative, specific procedures under the cleared "general laparoscopic surgical procedures" Indication for Use of the da Vinci Xi Surgical System, Model IS4000 (K131861) and the da Vinci X Surgical System, Model IS4200 (K171294): Pancreatectomy (partial, distal, segmental), Pancreaticoduodenectomy (Whipple Procedure), Splenectomy and Cholecystectomy. 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.

AI/ML Overview

The provided text describes a 510(k) premarket notification for a labeling modification of the da Vinci Xi and X Surgical Systems, Models IS4000 and IS4200. This modification adds specific representative procedures (Pancreatectomy, Pancreaticoduodenectomy, Splenectomy, and Cholecystectomy) under the existing "general laparoscopic surgical procedures" indication for use.

Crucially, the submission states that there are no changes to the technological characteristics of the device. Therefore, the "device" in question (the da Vinci surgical system itself) is already cleared, and the performance data presented is to establish substantial equivalence for the expanded indications for use, not to prove the fundamental performance of the surgical robot. The acceptance criteria and "device performance" in this context refer to the clinical outcomes of procedures performed using the da Vinci system compared to traditional open or laparoscopic methods, demonstrating that the new indications are safe and effective.

Here's an analysis of the provided information:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are not explicitly stated as numerical targets in the document. Instead, the study aims to demonstrate that da Vinci Xi/X-assisted procedures for the newly added indications are comparable or superior to existing open or laparoscopic surgical procedures across a range of clinical outcomes.

The "reported device performance" is derived from the clinical literature review for the "umbrella procedures" (Pancreatectomy and Pancreaticoduodenectomy), which are considered representative of the more complex/higher-risk operations. The less complex/lower-risk "covered procedures" (Splenectomy and Cholecystectomy) were supported by inference from the umbrella procedures.

Below is a summary of the findings, which implicitly serve as the "acceptance criteria" and "reported performance" through comparative equivalence:

Performance Metric	Da Vinci-assisted vs. Open/Laparoscopic Pancreatectomy (Umbrella Procedure #1)	Da Vinci-assisted vs. Open/Laparoscopic Pancreaticoduodenectomy (Umbrella Procedure #2)
Mortality	Comparable mortality rates.	Comparable mortality rates.
Estimated Blood Loss (EBL) / Transfusion Rates	Comparable or lower blood transfusion rates and/or EBL volumes.	Comparable EBL volumes.
Length of Hospital Stay	Comparable or shorter length of hospital stay as compared to laparoscopy and open surgery.	Comparable length of hospital stay as compared to laparoscopy and comparable or shorter length of hospital stay as compared to open surgery.
Complication Rates	Comparable or lower complication rates.	Comparable or lower complication rates.
Spleen Preservation Rates	Higher or comparable spleen preservation rates. (Specific to pancreatectomy)	Not applicable / Not reported in the context of this procedure.
Gastric Emptying Rates	Lower or comparable delayed gastric emptying rates.	Lower or comparable delayed gastric emptying rates.
Reoperation Rates	Comparable reoperation rates.	Comparable reoperation rates.
Readmission Rates	Comparable or higher readmission rates.	Not explicitly summarized as "comparable or higher" but individual studies show variations (e.g., Orti-Rodriguez not reported, Zhang not reported). Needs closer interpretation of Tables 2A/2B.
Pancreatic Fistula Rates	Comparable pancreatic fistula rates as compared to both open and laparoscopic surgical procedures.	Comparable pancreatic fistula rates as compared to both open and laparoscopic surgical procedures.
Operative Time	Increased operative times were associated with da Vinci procedures as compared to open and laparoscopic procedures. (Not associated with increased mortality/complications).	Increased operative times were associated with da Vinci procedures as compared to open and laparoscopic procedures. (Not associated with increased mortality/complications).
Conversion Rates	Comparable or lower conversion rates reported for da Vinci-assisted procedures as compared to laparoscopic procedures.	Comparable or lower conversion rates for da Vinci-assisted procedures as compared to laparoscopic procedures.

2. Sample Size Used for the Test Set and Data Provenance

Sample Size for Clinical Studies (Test Set):
- Pancreatectomy (Umbrella Procedure #1): Eleven (11) publications were identified. The sample sizes within these publications varied significantly. For example, in Table 1A, individual study cohorts ranged from 22 to 3743 patients for da Vinci, laparoscopic, and open procedures. The largest single cohort for da Vinci was 258 (Zureikat, 2017) and for open was 3743 (Zureikat, 2017).
- Pancreaticoduodenectomy (Umbrella Procedure #2): Eight (8) publications were identified. Individual study cohorts ranged from 102 to 3743 patients. The largest single cohort for da Vinci was 476 (Pedziwiatr, 2017) and for open was 3743 (Zureikat, 2017).
- Covered Procedures (Splenectomy and Cholecystectomy): No specific clinical studies were provided for these procedures; their clearance was supported by the data from the umbrella procedures.
Data Provenance: The data are derived from published clinical literature, including:
- Prospective randomized controlled trials
- Meta-analyses
- Systematic reviews
- Large database comparative studies
The specific countries of origin are not specified, but peer-reviewed medical literature typically encompasses international data. The studies are retrospective and prospective, depending on the nature of the individual publications included in the literature review.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

This is not applicable in the traditional sense for this submission. The "ground truth" for the clinical effectiveness and safety of the da Vinci system for these procedures is established by the peer-reviewed published clinical literature, which is generated by numerous clinical researchers and practicing surgeons. The FDA review process itself involves experts (e.g., "Director, Division of Surgical Devices, Office of Device Evaluation") who evaluate the scientific rigor and conclusions of the submitted literature review.

4. Adjudication Method for the Test Set

Not directly applicable in the terms of human reader adjudication of images. The "adjudication" in this context is the consensus reached through the scientific and statistical analysis presented in the peer-reviewed meta-analyses, systematic reviews, and comparative studies. The FDA then adjudicates the strength of this evidence for the purpose of granting substantial equivalence.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done

No, an MRMC comparative effectiveness study was not done. The submission relies on a literature review comparing clinical outcomes of different surgical approaches (da Vinci, laparoscopic, open).

6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was Done

This question is not applicable. The da Vinci Surgical System is a human-in-the-loop device; it is controlled by a surgeon. The "performance" being evaluated is the outcome of surgical procedures when performed using the da Vinci system (with a human surgeon operating it), compared to other surgical methods. This is not an AI algorithm performing a task autonomously.

7. The Type of Ground Truth Used

The "ground truth" for the clinical performance claims is based on patient outcomes data reported in published clinical trials and studies. These outcomes include:

Mortality rates
Estimated blood loss
Length of hospital stay
Postoperative complication rates
Spleen preservation rates (for pancreatectomy)
Gastric emptying rates
Reoperation rates
Readmission rates
Pancreatic fistula rates
Operative time
Conversion rates
R0/R1 resection rates
Lymph node yield

8. The Sample Size for the Training Set

No explicit "training set" for an AI algorithm is mentioned as this device is not presented as an AI-driven autonomous system in this submission. The performance data is for the surgical system itself. The publications reviewed in the submission can be considered the evidence base that informs the regulatory decision, rather than a training set for an AI model.

9. How the Ground Truth for the Training Set Was Established

As no training set for an AI algorithm is mentioned, this question is not applicable. The clinical "ground truth" for the effectiveness of the surgical system is established through the standard methodologies of clinical research (e.g., prospective trials, retrospective analyses, meta-analyses) that generated the published literature.

Summary

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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo is in blue and includes the letters "FDA" followed by the words "U.S. Food & Drug Administration."

January 31, 2018

Intuitive Surgical, Inc. % Ms. Cindy Domecus Domecus Consulting Services LLC 1171 Barroilhet Drive Hillsborough, California 94010

Re: K172643

Trade/Device Name: da Vinci Xi Surgical System, da Vinci X Surgical System; Model IS4000 and Model IS4200 Regulation Number: 21 CFR 876.1500 Regulation Name: Endoscope and Accessories Regulatory Class: Class II Product Code: NAY Dated: January 29, 2018 Received: January 31, 2018

Dear Ms. Domecus:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing 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); good

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manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely, Jennifer R. Stevenson -S3 For Binita S. Ashar, M.D., M.B.A., F.A.C.S.

Director Division of Surgical Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known)

K172643

Device Name

da Vinci Surgical System, Model IS4000, and EndoWrist Instruments and Accessories

Indications for Use (Describe)

Type of Use (Select one or both, as applicable)
Prescription Use (Part 21 CFR 801 Subpart D)	☑
Over-The-Counter Use (21 CFR 801 Subpart C)	☐

CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

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Indications for Use

510(k) Number (if known)

K172643

Device Name

da Vinci Surgical System, Model IS4200, and EndoWrist Instruments and Accessories

Indications for Use (Describe)

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

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 RoadSunnyvale, CA 94086
Contact:	Cindy Domecus, R.A.C. (US & EU)Principal, Domecus Consulting Services LLCChief Regulatory Advisor to Intuitive SurgicalTelephone: 650.343.4813Fax: 650.343.7822Email: domecusconsulting@comcast.net

Date Summary Prepared: January 16, 2018

II. SUBJECT DEVICE INFORMATION

Device Trade Name:	da Vinci® Xi and X Surgical Systems, Model IS4000 and Model IS4200
Common Name:	System, Surgical, Computer Controlled Instrument
Classification Name:	Endoscope and Accessories (21 CFR §876.1500)
Regulatory Class:	II
Product Code:	NAY
Submission Type:	Traditional 510(k)

III. PREDICATE DEVICE INFORMATION:

Predicate Device: Intuitive Surgical da Vinci Xi and X Surgical Systems, Models IS4000 and IS4200 (K131861, K152578, K153276, K161178, K170713, K171294) Intuitive Surgical da Vinci Si Surgical System, Model IS3000 (K081137, K123463, K090993)

IV. DEVICE DESCRIPTION:

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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 was based on evaluation of the device as a surgical tool and did not include evaluation of outcomes related to the treatment of cancer (overall survival, disease-free survival, local recurrence) or treatment of the patient's underlying disease/condition. Device usage in all surgical procedures should be guided by the clinical judgment of an adequately trained surgeon.

VI. COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE PREDICATE DEVICE

There are no changes to the technological characteristics of the cleared do Vinci Xi or X Surgical Systems (IS4000 and IS4200) proposed in this submission.

VII. PERFORMANCE DATA

Pre-Clinical Animal Study Data

Animal performance data were provided in this premarket notification, including the results from seven (7) evaluations in a total of 27 animals demonstrating use of da Vinci Xi Surgical System (Model IS4000) in the following procedures: Nephrectomy, Pyeloplasty, Hysterectomy and Salpingectomy/Oophorectomy/, Nissen Fundoplication, Colectomy, Mitral Valve Repair and Splenectomy. These data were previously submitted in support of clearance of the da Vinci Xi Surgical System, Model IS4000 (K131861), the da Vinci Xi Vessel Sealer (K140189/S001) and the da Vinci Xi (Model IS4000) labeling modification to add specific procedures under the gynecologic laparoscopic surgical procedures general indication (K152578); general thoracoscopic surgical procedures and thoracoscopically-assisted cardiotomy procedures indication (K153276); urologic surgical procedures general indication (K161178); and, general laparoscopic surgical procedures general indication (K170713 and K171632). These data also support inclusion of the subject representative, specific procedures.

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Clinical Study Data

Published clinical data support use of the da Vinci Xi and X Surgical Systems (Models IS400) in the subject representative, specific 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 of Pancreatectomy and Pancreaticoduodenectomy (Whipple Procedure) (referred to as the "umbrella" procedures). The published data on 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 were not provided.

Umbrella Procedures

Umbrella Procedure #1: Pancreatectomy

Published clinical data were provided for the umbrella procedure "Pancreatectomy". Eleven (11) publications were identified for this umbrella procedure based on specific search criteria and filters. These publications included a prospective randomized controlled trial, meta-analyses, systematic reviews and large database comparative studies. A detailed summary of the published clinical data on this procedure is provided in Tables 1A and 1B below.

The findings from the Pancreatectomy publications show that da Vinci-assisted procedures as compared to open and laparoscopic procedures are associated with:

Mortality: comparable mortality rates;
Estimated Blood Loss and/or Transfusion Rates: comparable or lower blood transfusion rates and/or EBL volumes;
Lengths of Hospital Stay: comparable or shorter length of hospital stay as compared to laparoscopy and open surgery;
. Complication Rates: comparable or lower complication rates;
Spleen Preservation Rates: higher or comparable spleen preservation rates;
Gastric Emptying Rates: lower or comparable delayed gastric emptying rates;
Reoperation Rates: comparable reoperation rates;
Readmission Rates: comparable or higher readmission rates; and
. Pancreatic Fistula Rates: comparable pancreatic fistula rates as compared to both open and laparoscopic surgical procedures.
. Operative Time: Increased operative times were associated with da Vinci procedures as compared to open and laparoscopic procedures. However, this increase was not associated with an increase in the mortality or complication rates.
Conversion Rates: comparable or lower conversion rates were reported for da Vinci-assisted procedures as compared to laparoscopic procedures.

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Umbrella Procedure #2: Pancreaticoduodenectomy

Published clinical data were provided for the umbrella procedure "Pancreaticoduodenectomy". Eight (8) publications were identified for this umbrella procedure based on specific search criteria and filters. These publications included meta-analyses, systematic reviews and a large database comparative study. A detailed summary of the published clinical data on this procedure is provided in Tables 2A and 2B below.

The findings from the Pancreaticoduodenectomy publications show that da Vinci-assisted procedures as compared to open and laparoscopic procedures are associated with:

Mortality: comparable mortality rates;
Estimated Blood Loss Volume2: comparable EBL volumes;
Lengths of Hospital Stay: comparable length of hospital stay as compared to laparoscopy and ● comparable or shorter length of hospital stay as compared to open surgery;
Complication Rates: comparable or lower complication rates;
Gastric Emptying Rates: lower or comparable delayed gastric emptying rates;
Reoperation Rates: comparable reoperation rates; and,
Pancreatic Fistula Rates: comparable pancreatic fistula rates as compared to both open and laparoscopic surgical procedures.
Operative Time: Increased operative times were associated with da Vinci procedures as compared to open and laparoscopic procedures. However, this increase was not associated with an increase in the mortality or complication rates.
Conversion Rates: comparable or lower conversion rates for da Vinci-assisted procedures were reported as compared to laparoscopic procedures.

Covered Procedures

The published data on the above cited Pancreatectomy and Pancreaticoduodenectomy (Whipple Procedure) umbrella procedures were used to support clearance of the following covered procedures: Splenectomy and Cholecystectomy.

VIII. CONCLUSION

Based on the information provided in this premarket notification, the inclusion of the following additional representative, specific procedures under the da Vinci Xi and X Surgical Systems (Models IS4000 and IS4200) "general laparoscopic surgical procedure" Indication for Use is substantially equivalent to the predicate devices: Pancreatectomy (partial, distal, segmental), Pancreaticoduodenectomy (Whipple Procedure), Splenectomy and Cholecystectomy.

1 One publication (Orti-Rodriguez, et al) reported a higher EBL volume, a longer length of stay and a higher pancreatic fistula rate for the da Vinci cohort as compared to the laparoscopic cohort. These outcomes were not associated with increased complication or mortality rates.

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TABLE 1A: da Vinci vs. Open and da Vinci vs. Laparoscopic Pancreatectomy

Publications		Sample Size (N)	Operative Time (minutes)	Estimated Blood Loss “EBL” (ml)	Length of Stay (days)	PostOp Complications (%)	Mortality Rate (%)	Transfusion Rate (%)	Reoperation Rate (%)	Readmission Rate (%)
1. Adam(2015)	da Vinci	61	Not Reported	Not Reported	8	Not Reported	0	Not Reported	Not Reported	Suppressed 12.9%
	Lap	474			6		suppressed			11
	Open	1198			9		2			9
2. Chen S(2017)	da Vinci	50	160	50	15.6	46	0	0	4	2
	Open	50	193	200	21.7	60	0	10	8	2
3. Chen Y(2013)	da Vinci	67 / 45	range (293 - 719)	range (150 - 372)	range (3.8 - 16.4)	Not Reported	Not Reported	Not Reported	Not Reported	Not Reported
	Lap	137	range (224 - 372)	range (150 - 667)	range (6.4 - 7.3)
	Open	45	range (234 - 420)	range (210 - 858)	range (7.7 - 24.3)
4. Gavrilidis(2016)	da Vinci	246	range (213 - 349)	Not Reported	range (5 - 11.6)	16	0.4	Not Reported	Not Reported	5.6 - 36.7
	Lap	391	range (174 - 372)		range (6.0 - 14.7)	17	0.3			0 - 23.4
5. Huang(2016)	da Vinci	238	range (293 - 349)	Not Reported	range (6.1 - 8.9)	Not Reported	0	13.9	Not Reported	Not Reported
	Lap	929	range (250 - 372)		range (6.0 - 19.2)		0	11.4
6. Konstantinidis(2017)	da Vinci	115	Not Reported	Not Reported	Not Reported	Not Reported	Not Reported	Not Reported	Not Reported	Not Reported
	Lap	365
	Open	558
7. Wright(2016)	da Vinci	195	230	172	8	18	0	Not Reported	Not Reported	Not Reported
	Lap	349	249	281	7	17	<1
8. Xourafas(2017)	da Vinci	200	243	Not Reported	5	37	0.5
	Lap	694	205		5	36	1	5	3	14
	Open	921	222		7	45	1.5	21	5	18
9. Zhang(2013)	da Vinci	22	range (298 - 432)	range (275 - 279)	range (4 - 14.6)	17.6 - 20*	0	Not Reported	0	Not Reported
	Open	32	range (234 - 286.5)	range (681 - 858.3)	range (8 - 22.1)	18.2 - 50*	0		2
10. Zhou(2016)	da Vinci	211	range (150 - 372)	range (100 - 375)	range (3.8 - 11.6)	43.6	1.4	8.3	Not Reported	Not Reported
	Lap	357	range (193 - 295)	range (262 - 667)	range (5 - 14.7)	52.4	2.0	11.1
11. Zureikat(2017)	da Vinci	258	Not Reported	Not Reported	Not Reported	Not Reported	Not Reported	Not Reported	Not Reported	Not Reported
	Lap	684
	Open	3743

*Authors reported on "Overall Complication Rate"

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TABLE 1B: da Vinci vs. Open and da Vinci vs. Laparoscopic Pancreatectomy

Publications	Sample Size (N)	Spleen Preservation Rate (%)	R0 Resection Rate (%)	R1 Resection Rate (%)	Lymph Node Yield (n)	Delayed Gastric Emptying Rate (%)	Pancreatic Fistula Rate (%)	Conversion Rate (%)
1. Adam (2015)	da Vinci 61Lap 474Open 1198	Not Reported	Not Reported	Not Reported	121213	Not Reported	Not Reported	suppressed 14.823NA
2. Chen S (2017)	da Vinci 50Open 50	Not Reported	Not Reported	Not Reported	Not Reported	A (12), B (6), C (6)A (22), B (8), C (4)	4454	Not Reported
3. Chen Y (2013)	da Vinci 67 / 45Lap 137Open 45	81.148.813.6	988382	Not Reported	Not Reported	Not Reported	30.236.631.1	Not Reported
4. Gavrilidis (2016)	da Vinci 246Lap 391	Not Reported	10098	02	Not Reported	Not Reported	24.324.0	920
5. Huang (2016)	da Vinci 238Lap 929	35.427.7	Not Reported	Not Reported	Not Reported	Not Reported	29.931.3	8.923.0
6. Konstantinidis (2017)	da Vinci 115Lap 365Open 558	Not Reported	Not Reported	Not Reported	Not Reported	Not Reported	Not Reported	11.321.9NA
7. Wright (2016)	da Vinci 195Lap 349	Not Reported	Not Reported	Not Reported	Not Reported	Not Reported	Not Reported	1019
8. Xourafas (2017)	da Vinci 200Lap 694Open 921	8910	Not Reported	Not Reported	Not Reported	135	211817	816NA
9. Zhang (2013)	da Vinci 22Open 32	Not Reported	Not Reported	Not Reported	Not Reported	Not Reported	4.525.0	0 - 12NA
10. Zhou (2016)	da Vinci 211Lap 357	53.627.8	10092.6	Not Reported	range (5 - 19)range (5 - 15.2)	Not Reported	25.824.7	16.123.0
11. Zureikat (2017)	da Vinci 258Lap 684Open 3743	Not Reported	Not Reported	Not Reported	Not Reported	Not Reported	Not Reported	1018.2NA

*Authors provided combined data for pancreatectomy and pancreaticoduodenectomy procedures.

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	TABLE 2A: da Vinci vs. Open and da Vinci vs. Laparoscopic Pancreaticoduodenectomy
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Publications	Sample Size (N)	Operative Time (minutes)	Estimated Blood Loss "EBL" (ml)	Length of Stay (days)	PostOp Complications (%)	Mortality Rate (%)	Transfusion Rate (%)	Reoperation Rate (%)	Readmission Rate (%)
1. de Rooij (2016)	da Vinci 160	Not Reported	Not Reported	Not Reported	Not Reported	2.5	Not Reported	Not Reported	Not Reported
	Lap 641					3.0
	Open 1123					3.7
2. Lei P (2014)	da Vinci 102	range (444 - 719)	range (154 - 485)	range (13 - 16.4)	43.14**	Not Reported	Not Reported	Not Reported	Not Reported
	Lap 107	range (338 - 657)	range (195 - 448)	range (8 - 48)	57.01**
	Open 144 / 285	range (265 - 559)	range (210 - 1510)	range (12.4 - 43)	54.9 / 65.3**
3. Orti-Rodriguez (2012)	da Vinci 109	394.77	319.06	15.31	16.5	3	Not Reported	Not Reported	Not Reported
	Lap 192	388.8	178.7	9.9	35.9	2.7
4. Pedziwiatr (2017)	da Vinci 476	range (400 - 718)	range (100 - 775)	range (7.4 - 20.0)	37.7	Not Reported	Not Reported	Not Reported	Not Reported
	Lap 229	range (361 - 513)	range (260 - 492.4)	range (6.0 - 10.0)	59.5
	Open 1162 / 319	range (300 - 559)	range (210 - 867)	range (8.0 - 25.8)	31.9 / 80.0
5. Peng (2016)	da Vinci 245	range (410 - 718.8)	range (100 - 650)	range (13 - 20)	35	2.9	Not Reported	7.3	Not Reported
	Open 435	range (264.9 - 559)	range (210 - 840)	range (14.6 - 25.8)	45	2.8		13.0
6. Shin (2016)	da Vinci 160	range (340 - 492)	range (100 - 500)	range (7 - 20)	37.1	Not Reported	Not Reported	Not Reported	Not Reported
	Lap 450	range (342 - 551)	range (195 - 609)	range (6 - 25)	40.8
	Open 294 / 718	range (264 - 410)	range (293 - 1032)	range (8 - 26)	47.7 / 50.9
7. Zhang (2013)	da Vinci 115	range (444 - 718.8)	range (153.75 - 537)	range (7 - 16.38)	25 - 36.4*	0 - 4.5	Not Reported	6.5	Not Reported
	Open 171	range (364 - 559)	range (210 - 840)	range (13.26 - 24.25)	23.2 - 75*	0 - 12.5		18.6
8. Zureikat (2017)	da Vinci 258	Not Reported	Not Reported	Not Reported	Not Reported	Not Reported	Not Reported	Not Reported	Not Reported
	Lap 684
	Open 3743

*Authors reported on "Overall Complication Rate"; **Authors reported both intraoperative complication rates.

{11}------------------------------------------------

TABLE 2B: da Vinci vs. Open and da Vinci vs. Laparoscopic Pancreaticoduodenectomy

Publications	Sample Size (N)	Spleen Preservation Rate (%)	R0 Resection Rate (%)	R1 Resection Rate (%)	Lymph Node Yield (n)	Delayed Gastric Emptying Rate (%)	Pancreatic Fistula Rate (%)	Conversion Rate (%)
1. de Rooij(2016)	da Vinci 160Lap 641Open 1123	Not Reported	Not Reported	Not Reported	Not Reported	Not Reported	7.6	8
							12.7	7
							18.4	NA
2. Lei P(2014)	da Vinci 102Lap 107Open 144 / 285	Not Reported	Not Reported	Not Reported	Not Reported	4.3	20.6	Not Reported
						13.1	23.4
						7.4 / 13.7	19.4 / 17.5
3. Orti-Rodriguez(2012)	da Vinci 109Lap 192	Not Reported	Not Reported	Not Reported	Not Reported	Not Reported	30	12
							14.5	8.3
4. Pedziwiatr(2017)	da Vinci 476Lap 229Open 1162 / 319	Not Reported	Not Reported	35.5	range (15 - 37)	23.7	20.2	Not Reported
				20.7	range (8.7 - 23)	8.7	15.7
				29.5 / 23.0	range (9.6 - 36)	20.1 / 17.2	12.7 / 17.6
5. Peng(2016)	da Vinci 245Open 435	Not Reported	93.1	Not Reported	range (10.0 - 16.8)	6.8	17.9	7.3
			81.5		range (10.0 - 12.5)	14.1	21.4	NA
6. Shin(2016)	da Vinci 160Lap 450Open 294 / 718	Not Reported	Not Reported	13.4	range (10 - 15)	8.8	18.5	7.5
				21.6	range (8.7 - 23.4)	9.6	29.8	7.8
				22.8 / 22.1	range (9.6 - 25.0)	15.6 / 14.2	21.6 / 23.0	NA
7. Zhang(2013)	da Vinci 115Open 171	Not Reported	Not Reported	3.1	Not Reported	Not Reported	14.4	Not Reported
				14.8			22.0
8. Zureikat(2017)	da Vinci 258Lap 684Open 3743	Not Reported	Not Reported	Not Reported	Not Reported	Not Reported	Not Reported	14.8
								31.9
								NA

Regulation Number and Section

§ 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.

Indications for Use

510(k) Number (if known)

Device Name

Indications for Use (Describe)

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Indications for Use

Device Name

Indications for Use (Describe)

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510(k) Summary (21 CFR § 807.92(c))

I. SUBMITTER INFORMATION

II. SUBJECT DEVICE INFORMATION

III. PREDICATE DEVICE INFORMATION:

IV. DEVICE DESCRIPTION:

V. INDICATIONS FOR USE

Precaution for Representative Uses

VI. COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE PREDICATE DEVICE

VII. PERFORMANCE DATA

Pre-Clinical Animal Study Data

Clinical Study Data

Umbrella Procedures

Umbrella Procedure #1: Pancreatectomy

Umbrella Procedure #2: Pancreaticoduodenectomy

Covered Procedures

VIII. CONCLUSION

TABLE 1A: da Vinci vs. Open and da Vinci vs. Laparoscopic Pancreatectomy

TABLE 1B: da Vinci vs. Open and da Vinci vs. Laparoscopic Pancreatectomy

TABLE 2B: da Vinci vs. Open and da Vinci vs. Laparoscopic Pancreaticoduodenectomy

§ 876.1500 Endoscope and accessories.

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