(211 days)
Intuitive Surgical da Vinci Si Surgical System (K171699)
No
The document describes a robotic surgical system with features like force feedback and eye tracking for control, but it does not mention or imply the use of AI or ML for decision-making, image analysis, or other functions. The focus is on remote manipulation and control by the surgeon.
No.
The device assists in surgical procedures by controlling instruments and providing visualization, but it does not directly treat a disease or condition in a therapeutic manner.
No
The device is described as a surgical system intended to assist in the accurate control of laparoscopic instruments for visualization and endoscopic manipulation of tissue. It performs actions such as grasping, cutting, suturing, and retraction, which are all surgical interventions, not diagnostic functions. While it provides visualization (endoscopic signal), this is for guiding surgical procedures, not for diagnosis.
No
The device description clearly outlines multiple hardware components including a surgeon console, manipulator arms, an Intelligent Surgical Unit (ISU), and instruments. It is a robotic surgical system, not a software-only device.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use of the Senhance Surgical System is to assist in the control of laparoscopic instruments for surgical procedures. It is used during surgery to manipulate tissue and visualize the surgical field.
- IVD Definition: In Vitro Diagnostics are devices used to examine specimens (like blood, urine, or tissue) outside the body to provide information for diagnosis, monitoring, or screening.
- Device Description: The description clearly outlines a robotic system used for performing surgery, not for analyzing samples in a lab.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples, reagents, or any of the typical components or processes associated with IVD devices.
The Senhance Surgical System is a surgical robotic system, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The Senhance® Surgical System is intended to assist in the accurate control of laparoscopic instruments for visualization and endoscopic manipulation of tissue including grasping, cutting, blunt and sharp dissection, approximation, ligation, electrocautery, suturing, mobilization, and retraction. The Senhance Surgical System is intended for use in general laparoscopic surgical procedures and laparoscopic gynecological surgery. The system is indicated for adult use. It is intended for use by trained physicians in an operating room environment in accordance with the instructions for use.
Product codes
NAY
Device Description
The Senhance Surgical System is a multi-arm, console-based robotic system that allows a surgical team to perform laparoscopic surgery in the abdomen and pelvis in a manner similar to a manual laparoscopic approach. Each robotic arm can hold either a laparoscopic surgical instrument or an endoscope to facilitate a surgeon remotely operating the instrument from the cockpit. The purpose of this submission is to seek clearance for modifications to the indications for use to expand the types of surgical procedures for which the Senhance Surgical System may be used.
The Senhance Surgical System consists of: a surgeon console (cockpit), which provides remote manipulators or handles to allow the surgeon to maneuver the surgical instruments and a video monitor to display the endoscopic signal; manipulator arms, which hold and maneuver the instruments and endoscope based on inputs from the surgeon; Intelligent Surgical Unit (ISU), which is the system communication hub, connecting the cockpit and manipulator arms; and instruments, which manipulate the tissue of interest.
In addition, force feedback provides an optional tactile sensory input to the surgeon control handles to give a sense of tissue elasticity. An eye tracking feature provides the surgeon an optional method to control the endoscope from the cockpit, rather than using the surgeon control handles. The ISU allows for three additional methods of camera control, in addition to the optional eye tracking method.
The Senhance instruments are similar in design and materials to traditional laparoscopic instrumentation.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Abdomen, pelvis
Indicated Patient Age Range
Adult use
Intended User / Care Setting
Trained physicians in an operating room environment
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
A retrospective chart review was performed for 34 patients who underwent Nissen fundoplication procedures with the Senhance system.
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Study Type: Clinical Data (Retrospective Chart Review)
Sample Size: 34 patients for Nissen fundoplication procedures with the Senhance system.
Key Results:
- There were no intraoperative complications and few postoperative complications and conversions to standard laparoscopy.
- No conversions to open technique were necessary.
- Operative times and complication rates were similar between the retrospective chart review with the Senhance system and the literature.
- The comparison of the Senhance Nissen fundoplication surgery clinical data with the findings from the Nissen Fundoplications demonstrated that the Senhance system is as safe and effective as the predicate for this clinical use based on the following endpoints:
- Length of Hospital Stay
- Intraoperative Complication Rates
- Estimated Blood Loss (EBL) Volumes and Blood Transfusion Rates
- Conversion Rates
- Readmission Rates
- Reoperation Rates
- Mortality Rates
- Postoperative Complication Rates
- Operative Times
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Senhance® Surgical System (K200049)
Reference Device(s)
Intuitive Surgical da Vinci Si Surgical System (K171699)
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 876.1500 Endoscope and accessories.
(a)
Identification. An endoscope and accessories is a device used to provide access, illumination, and allow observation or manipulation of body cavities, hollow organs, and canals. The device consists of various rigid or flexible instruments that are inserted into body spaces and may include an optical system for conveying an image to the user's eye and their accessories may assist in gaining access or increase the versatility and augment the capabilities of the devices. Examples of devices that are within this generic type of device include cleaning accessories for endoscopes, photographic accessories for endoscopes, nonpowered anoscopes, binolcular attachments for endoscopes, pocket battery boxes, flexible or rigid choledochoscopes, colonoscopes, diagnostic cystoscopes, cystourethroscopes, enteroscopes, esophagogastroduodenoscopes, rigid esophagoscopes, fiberoptic illuminators for endoscopes, incandescent endoscope lamps, biliary pancreatoscopes, proctoscopes, resectoscopes, nephroscopes, sigmoidoscopes, ureteroscopes, urethroscopes, endomagnetic retrievers, cytology brushes for endoscopes, and lubricating jelly for transurethral surgical instruments. This section does not apply to endoscopes that have specialized uses in other medical specialty areas and that are covered by classification regulations in other parts of the device classification regulations.(b)
Classification —(1)Class II (special controls). The device, when it is an endoscope disinfectant basin, which consists solely of a container that holds disinfectant and endoscopes and accessories; an endoscopic magnetic retriever intended for single use; sterile scissors for cystoscope intended for single use; a disposable, non-powered endoscopic grasping/cutting instrument intended for single use; a diagnostic incandescent light source; a fiberoptic photographic light source; a routine fiberoptic light source; an endoscopic sponge carrier; a xenon arc endoscope light source; an endoscope transformer; an LED light source; or a gastroenterology-urology endoscopic guidewire, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 876.9.(2) Class I for the photographic accessories for endoscope, miscellaneous bulb adapter for endoscope, binocular attachment for endoscope, eyepiece attachment for prescription lens, teaching attachment, inflation bulb, measuring device for panendoscope, photographic equipment for physiologic function monitor, special lens instrument for endoscope, smoke removal tube, rechargeable battery box, pocket battery box, bite block for endoscope, and cleaning brush for endoscope. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807of this chapter, subject to the limitations in § 876.9.
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March 3, 2021
TransEnterix, Inc. Kaitlyn Alexander Regulatory Affairs Manager 635 Davis Drive, Suite 300 Morrisville, North Carolina 27560
Re: K202166
Trade/Device Name: Senhance Surgical System Regulation Number: 21 CFR 876.1500 Regulation Name: Endoscope and accessories Regulatory Class: Class II Product Code: NAY
Dear Kaitlyn Alexander:
The Food and Drug Administration (FDA) is sending this letter to notify you of an administrative change related to your previous substantial equivalence (SE) determination letter dated March 2, 2021. Specifically, FDA is updating this SE Letter because a valid digital signature with FDA watermark was not included on the SE letter as an administrative correction.
Please note that the 510(k) submission was not re-reviewed. For questions regarding this letter please contact Je Hi An, Ph.D. OHT4: Office of Surgical and Infection Control Devices, 240-402-0018, jehi.an@fda.hhs.gov.
Sincerely,
Digitally
Je An -S signed by
Je An -S
Je Hi An, Ph.D. Assistant Director DHT4A: Division of General Surgery Devices OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
1
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March 2, 2021
TransEnterix, Inc. Kaitlyn Alexander Regulatory Affairs Manager 635 Davis Drive, Suite 300 Morrisville, North Carolina 27560
Re: K202166
Trade/Device Name: Senhance Surgical System Regulation Number: 21 CFR 876.1500 Regulation Name: Endoscope And Accessories Regulatory Class: Class II Product Code: NAY Dated: February 5, 2021 Received: February 5, 2021
Dear Kaitlyn Alexander:
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.
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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 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 mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely.
Je Hi An, Ph.D. Assistant Director DHT4A: Division of General Surgery Devices OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation and Ouality Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known)
K202166
Device Name TransEnterix® Senhance® Surgical System
Indications for Use (Describe)
The Senhance® Surgical System is intended to assist in the accurate control of laparoscopic instruments for visualization and endoscopic manipulation of tissue including grasping, cutting, blunt and sharp dissection, approximation, ligation, electrocautery, suturing, mobilization, and retraction. The Senhance Surgical System is intended for use in general laparoscopic surgical procedures and laparoscopic gynecological surgery. The system is indicated for adult use. It is intended for use by trained physicians in an operating room environment in accordance with the 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) |
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510(K) SUMMARY
[In accordance with 21CFR 807.92]
1. Submitter 510(k) Sponsor: TransEnterix, Inc. 635 Davis Drive, Suite 300 Address: Morrisville, NC 27560 Contact Person: Kaitlyn Alexander Regulatory Affairs Manager Contact Information: Email: kalexander@transenterix.com Phone: 919-765-8400 x8505 Facsimile: 919.765.8459 Date Summary Prepared: 3/1/2021 2. Device Proprietary (Trade) Name: Senhance® Surgical System Common Name: System, Surgical, Computer Controlled Instrument Classification: Class II Classification Advisory General and Plastic Surgery Committee: Regulation Number: 21 CFR 876.1500, Endoscope and Accessories Product Codes: NAY (System, Surgical, Computer Controlled Instrument) 3. Predicate and Reference Devices Senhance® Surgical System (K200049) Predicate Device: Reference Device: Intuitive Surgical da Vinci Si Surgical System (K171699)
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4. Device Description:
The Senhance Surgical System is a multi-arm, console-based robotic system that allows a surgical team to perform laparoscopic surgery in the abdomen and pelvis in a manner similar to a manual laparoscopic approach. Each robotic arm can hold either a laparoscopic surgical instrument or an endoscope to facilitate a surgeon remotely operating the instrument from the cockpit. The purpose of this submission is to seek clearance for modifications to the indications for use to expand the types of surgical procedures for which the Senhance Surgical System may be used.
In this submission, the indications for use have been expanded to cover laparoscopic general surgical procedures. The new indications for use statement does not create a new intended use for the system.
5. Intended Use/ Indications for Use:
The Senhance Surqical System is intended to assist in the accurate control of laparoscopic instruments for visualization and endoscopic manipulation of tissue including grasping, cutting, blunt and sharp dissection, approximation, ligation, electrocautery, suturing, mobilization, and retraction. The Senhance Surgical System is intended for use in general laparoscopic surgical procedures and laparoscopic gynecological surgery. The system is indicated for adult use. It is intended for use by trained physicians in an operating room environment in accordance with the instructions for use.
6. Summary of Technological Characteristics:
The subject device has the same technological characteristics as the predicate device, the Senhance Surgical System (K200049). There are no changes to the technological characteristics of the cleared Senhance Surqical System. Both the subject and predicate devices involve robotically assisted tele-operation as the primary technological principle. It is based on the accurate translation of user inputs to robotically assisted outputs. It involves the use of endoscopic instrumentation for manipulation of tissue and vessels in the insufflated body cavity.
The Senhance Surgical System consists of: a surgeon console (cockpit), which provides remote manipulators or handles to allow the surgeon to maneuver the surgical instruments and a video monitor to display the endoscopic signal; manipulator arms, which hold and maneuver the instruments and endoscope based on inputs from the surgeon; Intelligent Surgical Unit (ISU), which is the system communication hub, connecting the cockpit and manipulator arms; and instruments, which manipulate the tissue of interest.
In addition, force feedback provides an optional tactile sensory input to the surgeon control handles to give a sense of tissue elasticity. An eye tracking feature provides the surgeon an optional method to control the endoscope from the cockpit, rather than using the surgeon control handles. The ISU allows for three additional methods of camera control, in addition to the optional eye tracking method.
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The Senhance instruments are similar in design and materials to traditional laparoscopic instrumentation.
Since there are no technological differences between the subject and predicate devices, no different questions of safety or effectiveness have been raised.
7. Clinical Data:
To demonstrate that the subject device is safe and effective for the expanded indications for use, the company has collected real-world evidence on the Senhance Surgical System for the general surgery reconstructive upper abdominal umbrella procedure, Nissen fundoplication. These data demonstrate favorable performance and safety results for the proposed indications.
Nissen Fundoplication Case Series
A retrospective chart review was performed for 34 patients who underwent Nissen fundoplication procedures with the Senhance system. There were no intraoperative complications and few postoperative complications and conversions to standard laparoscopy. No conversions to open technique were necessary.
Data from the Nissen fundoplication case series using the Senhance system were compared with the results from six (6) publications describing the clinical outcomes for two (2) alternative surgical techniques: laparoscopic and robotically assisted surgery (specifically performed by the reference device). The publications were selected based on specific search criteria used in two (2) search engines (PubMed and Medline) by multiple independent reviewers.
The selected publications included: one (1) prospective trial; three (3) randomized clinical trials; and three (3) non-blinded clinical evaluations. The search terms, inclusion/exclusion criteria, and the flowchart depicting the results from these searches are provided in Figure 1, below. Tables 1 and 2, below, provide the retrospective real-world clinical evidence for the subject device along with a detailed summary of the published clinical data on this procedure for the two (2) alternative surgical techniques.
Operative times and complication rates were similar between the retrospective chart review with the Senhance system and the literature. Overall, the comparison of the Senhance Nissen fundoplication surgery clinical data with the findings from the Nissen Fundoplications demonstrated that the Senhance system is as safe and effective as the predicate for this clinical use based on the following endpoints:
- Length of Hospital Stay
- . Intraoperative Complication Rates
- . Estimated Blood Loss (EBL) Volumes and Blood Transfusion Rates
- Conversion Rates
- Readmission Rates
- Reoperation Rates
- Mortality Rates ●
- . Postoperative Complication Rates
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- Operative Times ●
Thus, the representative procedures for the subject Senhance Surgical System are outlined in the table below.
| Umbrella Procedures | Covered Procedures |
|---|---|
| Gynecological Procedures | |
| Laparoscopic radical/total hysterectomy, cyst | |
| removal, salpingectomy, oophorectomy | Benign/ simple total laparoscopic |
| hysterectomy, lymphadenectomy, | |
| endometriosis resection, adnexectomy, | |
| omentectomy, parametrectomy, lysis of | |
| adhesions | |
| Myomectomy | Myomectomy |
| General Surgery Procedures | |
| Low Anterior Resection Total Mesorectal | |
| Excision (LAR/TME), Colectomy (Right, Left, | |
| Total) | Colectomy (Transverse, Hemi & |
| Sigmoidectomy), Small Bowel Resection, | |
| Rectopexy, Abdominoperineal Resection | |
| (APR), Appendectomy | |
| Cholecystectomy, Inguinal Hernia Repair (Uni | |
| and bilateral) | Cholecystectomy, Inguinal Hernia Repair (Uni |
| and bilateral) | |
| Nissen Fundoplication | Hiatal hernia repair, Paraesophageal hernia |
| repair, Sleeve Gastrectomy |
Table 3 - Umbrella and Covered Procedures
PRECAUTION: Clinical data for the representative specific labeled uses was based on evaluation of the device as a surgical tool that assists in the accurate control and performance of coordinated surgical tasks in the form of specific surgical procedures. Therefore, safety and effectiveness considerations were limited to validating the indications for use and do not imply that any outcomes related to surgeon training, skill or proficiency were considered. Outcomes related to the treatment of cancer (i.e., local recurrence, disease-free survival, overall survival), or any specific treatment for underlying disease or patient condition were not evaluated.
8. Conclusions:
The clinical analysis of the subject Senhance Surgical System demonstrates that the device is as safe and effective for the additional surgical procedures as the predicate, Senhance Surgical System (K200049).
The subject Senhance Surgical System has the same intended use as the predicate and its expanded indications for use do not affect the safety or effectiveness of the device. In addition, the subject device has the same technological characteristics and principles of operation as the predicate device. Performance data of the device in these new procedures indicate there is no new issue of safety or effectiveness. Thus, the subject Senhance Surgical System is substantially equivalent to the predicate device.
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Image /page/8/Figure/1 description: This image shows a flow diagram outlining a study selection process. The process begins with the identification of records through database searches, with 35 records from PubMed and Medline, and 24 additional records from other sources. After removing duplicates, there are 23 records, which are then screened, resulting in 23 records screened and 9 records excluded. The diagram continues with full-text articles assessed for eligibility (n=14), full-text articles excluded with reasons (n=8), studies included in qualitative synthesis (n=6), and studies included in quantitative synthesis (meta-analysis) (n=6).
Figure 1 – Search Criteria and Flowchart for Nissen Fundoplication Literature Search
PubMed and Medline Search Terms: Robotic AND laparoscopic "Nissen fundoplication".
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| Senhance System | Traditional Laparoscopic Approach | |||||||
|---|---|---|---|---|---|---|---|---|
| Cohort 1 | Cohort 2 | Draaisma WA, et al. 2006 ¹ | Melvin WS, et al. 2002 ² | Nakadi IE, et al. 2006 ³ | Morino M, et al. 2006 4 | Muller-Stich BP, et al. 2007 5 | Heemskerk J et al. 2007 6 | |
| General Information | ||||||||
| Country of Origin | Germany | Netherlands | Netherlands | USA | Belgium | Italy | Germany | Netherlands |
| Number of cases (n) | 18 | 16 | 25 | 20 | 11 | 25 | 20 | 11 |
| Clinical Outcomes | ||||||||
| Length of Hospital Stay (days) Mean (range) | 5 (3-6) | 2 (1-4) | 3^ (1-13) | 1 (1-2) | 4.1 (Range not reported) | 2.9 (2-6) | 3.3 (Range not reported) | 4 (Range not reported) |
| Intraoperative Complications | 0 | 0 | 7 (28%) | 0 | Not Reported | 0 | 2 (10%) | 0 |
| Transfusion Rate/Estimated Blood Loss (mL) | 0 * | 14 (Range 0-50) | 45 (Range 0-200) | Not Reported | Not Reported | Not Reported | Not Reported | 0 |
| Conversion Rate | 2 (11%) † | 4 (25%) † | 2 (8%) | 0 | 0 | 0 | 0 | 0 |
| Readmission Rates | 0 | 2 (13%) | 0 | 0 | 0 | 0 | 0 | Not Reported |
| Reoperation Rates | 1 (6%) | 0 | 0 | 1 (5%) | 0 | Not Reported | 0 | 1 (9%) |
| Mortality | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Post-Operative Complications | 5 (14.7%) for N=34 | 0 | 3 (11%) | 0 | 4 (36%) | 0 | 4 (20%) | 2 (18%) |
| Operative Time Mean (range) | 111.5 (68-194) for N=34 | 95^ (60-210) | 97.1 (45-168) | 96 (Range not reported) | 91.1 (72-106) | 102 (75-152) | 173 (Range not reported) |
Table 1 – Comparison of Clinical Endooints for Senhance and Traditional Laproach for Nissen Fundoplication
*Only reported for 16 of 18 patients.
^Median Reported
T Senhance cases completed using hybrid technique of robotically-assisted and traditional laparoscopy.
1 Draaisma WA, Ruuda JP, Schefter RCH, et al.Randard laparoscopic versus robot-asisted laparoscopic Nissen fundoplication for gastooesophageal refluxdisease. Br J Surg 2006; 93: 1351-1359.
2 Melvin WS, Needleman BJ, Krause KR, et al. Computer-enhanced vs. standard laparoscopic antireflux surgency, 1Gastroinest Surg 2002; 611; 11–15.
1 Nakad IE, Melot C, Closset , et al. Eraluation of da Vinci Nissen fundoplication. World JSurg 2006; 30(6): 1050-1054.
4 Morino M. Pellegrino L. Giacone C, et al. Randomized clinical trial of robot-assisted versus laparosopic Nissen fundoplication.Br.J Surg 2006; 93: 558
5 Muller-Stich BP, Reiter MA, Wente MN, et al. Robot-assisted versus conventional laparescopic fundomied ontrolled trial. Surg Endosc 2007; 21: 1800-1805.
ී Heemskek , yan Gemert WG, Greve JW, Robot-asisted versus conventional laparosopic Nissen fundopication: a comparative retrospective study on costs and time consumption. Surg Laparosc Endosc Percutan Tech. 2007 Feb;17(1):1-4. doi: 10.1097/01.sle.0000213756.76761.b7. PMD: 17318044.
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| Senhance System | Robotically Assisted Surgical Approach | |||||||
|---|---|---|---|---|---|---|---|---|
| Cohort 1 | Cohort 2 | Draaisma WA, et al. 2006 | Melvin WS, et al. 2002 | Nakadi IE, et al. 2006 | Morino M, et al. 2006 | Muller-Stich BP, et al. 2007 | Heemskerk J, et al. 2007 | |
| General Information | ||||||||
| Country of Origin | Germany | Netherlands | Netherlands | USA | Belgium | Italy | Germany | Netherlands |
| Number of cases (n) | 18 | 16 | 25 | 20 | 9 | 25 | 20 | 11 |
| Clinical Outcomes | ||||||||
| Length of Hospital Stay | ||||||||
| (days) | ||||||||
| Mean (range) | 5 (3-6) | 2 (1-4) | 3^ (2-6) | 1 (1-2) | 4.4 (Range | |||
| not reported) | 3.0 (2-7) | 2.9 (0.4-1.7) | 4 (Range not | |||||
| reported) | ||||||||
| Intraoperative Complications | 0 | 0 | 4 (16%) | 0 | Not Reported | 0 | 1 (5%) | 0 |
| Transfusion Rate/Estimated | ||||||||
| Blood Loss (EBL) (mL) | 0 * | 14 (Range 0- |
- | 20 (Range 0-
-
| Not Reported | Not Reported | Not Reported | Not Reported | 0 |
| Conversion Rate | 2 (11%) + | 4 (25%) + | 0 ** | 0 | 1 (11%) | 1 (4%) | 0 | 0 |
| Readmission Rates | 0 | 2 (13%) | 0 | 0 | 0 | 0 | 0 | Not Reported |
| Reoperation Rates | 1 (6%) | 0 | 0 | 0 | 0 | Not Reported | 0 | 0 |
| Mortality | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Post-Operative
Complications | 5 (14.7%) for N=34 | 0 | 0 | 3 (33%) | 0 | 5 (25%) | 4 (36%) | |
| Operative Time
Mean (range) | 111.5 (68-194) for N=34 | 120^ (80-180) | 140.9 (88-
271) | 137 (Range
not reported) | 131.3 (90-
162) | 88 (60-150) | 220 (Range
not reported) | |
Table 2 – Comparison of Clinical Endpoints for Senhance and Robotically Assisted Surgical Approach for Nissen Fundoplication
*Only reported for 16 of 18 patients.
^Median Reported
† Senhance cases completed using hybrid technique of robotically-assisted and traditional laparoscopy.
** Note that this paper states that all robot-assisted procedures were completed by laparoscopy, however, there were no unplanned conversions.