(126 days)
No
The document describes a robotic surgical system controlled by a surgeon, with no mention of AI or ML in the device description, intended use, or performance studies. The system relies on direct surgeon input for control.
No.
The device is described as a surgical system intended to assist in the accurate control of laparoscopic instruments for manipulation of tissue, which is an interventional function, not a therapeutic one in itself.
No
The device is a surgical system intended for endoscopic manipulation of tissue during minimally invasive surgery and does not perform diagnostic functions.
No
The device description clearly outlines hardware components including a cockpit, manipulator arms, and a node, indicating it is a hardware-based surgical system with integrated software, not a software-only device.
Based on the provided information, the Senhance Surgical System is not an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use clearly describes a system for assisting in surgical procedures by controlling laparoscopic instruments for visualization and manipulation of tissue within the body. This is an in vivo application, not an in vitro (outside the body) diagnostic test.
- Device Description: The description details a surgical system with a cockpit, manipulator arms, and a node, all designed for performing surgery. There is no mention of components or functions related to analyzing samples of human origin (like blood, urine, tissue, etc.) for diagnostic purposes.
- Lack of IVD Characteristics: The information does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples.
- Providing diagnostic information about a patient's health status.
- Using reagents or assays.
- Measuring analytes.
The Senhance Surgical System is a surgical robot designed to assist surgeons in performing minimally invasive procedures. Its function is to facilitate the surgical process itself, not to provide diagnostic information based on in vitro analysis.
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. The Senhance Surgical System is intended for use in laparoscopic gynecological surgery, colorectal surgery, cholecystectomy, and inguinal hernia repair. 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 (comma separated list FDA assigned to the subject device)
NAY, GCJ
Device Description
The Senhance Surgical System is a console-based, multi-arm surgical system, which enables a surgeon to remotely control surgical instrumentation during minimally invasive surgery in the lower abdomen and pelvis. The capital equipment is comprised of three main sub-systems as follows:
- . Cockpit - The station where the surgeon inputs information through hand and eye movements to direct the motion of the arms in the surgical field.
- . Manipulator Arms - Independent mechanized support arms that interface with the endoscope and surgical instruments. The manipulator arms produce output movements based on the instructions from the surgeon at the cockpit. The system is configurable with up to three arms.
- Node A relay unit that connects the cockpit inputs to the manipulator arms in the system as configured, ● and converts and transmits the video signals to the 2D/3D monitor on the cockpit console.
The Senhance system includes a series of surgical instruments (Table 1), which are attached to the manipulator arms by way of corresponding adapters. All adapters and instruments are multi-use components that are steam sterilized by the end user before the first and each subsequent use. The instrument designs are adaptations of standard laparoscopic instruments that are commonly used in surgery. Each instrument type has a corresponding system adapter.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Lower abdomen and pelvis
Indicated Patient Age Range
adult
Intended User / Care Setting
trained physicians in an operating room environment
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Cholecystectomy Case Series
Two retrospective chart reviews were performed for 40 patients who underwent cholecystectomy procedures with the Senhance Robotic System. There were few intraoperative complications and two conversions to standard laparoscopy. No conversions to open technique, reoperations or readmissions related to the procedure were necessary.
- Sample Size: 40 patients (N=20 from Imperial College, N=20 from Hamburg University). Reference data: da Vinci System (N=1435), Laparoscopic arm from meta-analysis (N=921).
- Key Results:
- Non-serious complications (Clavien Dindo I-II): Senhance: 30% (Imperial College), 0% (Hamburg University). Reference da Vinci: 0-25%.
- Serious complications (Clavien Dindo III): Senhance: 0%. Reference da Vinci: 0-4%.
- Intra-op Adverse Events / Complications: Senhance: 5% (1 intraop bleeding) for Imperial College, 0% for Hamburg University. Reference da Vinci: 0-5%.
- Conversions to Laparoscopy: Senhance: 5% (1 case) for Imperial College, 5% (1 case) for Hamburg University. Reference da Vinci: 0-12.5%.
- Conversions to Open: Senhance: 0%. Reference da Vinci: unknown.
- Median Operative Time: Senhance: 86.5 min (44-129) for Imperial College, 71.5 min (34-197) for Hamburg University. Reference da Vinci: 91.7 min (50-152).
- Conclusion: Comparison demonstrated that the Senhance System is as safe and effective as the predicate device for its intended use in cholecystectomy.
Inguinal Hernia Repair Surgery Data
A retrospective chart review was performed for 64 patients who underwent inguinal hernia repair procedures with the Senhance Robotic System. These patients underwent 76 transabdominal preperitoneal (TAPP) inguinal hernia repairs, including bilateral hernias and recurrent hernia after previous surgical repair. No significant intraoperative or postoperative complications were observed in the 64 patients. Two cases had to be converted to standard laparoscopic technique. No reoperations or readmissions related to the procedure were necessary.
- Sample Size: 64 patients (76 TAPP inguinal hernia repairs). Reference data: da Vinci System (N=652), Laparoscopic Cohort (N=3457).
- Key Results:
- Intraoperative Complications: Senhance: 0%. Reference da Vinci: 0.3%.
- Postoperative Complications: Senhance: 1.6%. Reference da Vinci: 2.3% (postop to discharge), 4.3% (post discharge to 30 days).
- Operative Time (Unilateral repair): Senhance: 44 ± 17.4 min. Reference da Vinci: 79.7 ± 31.7 min.
- All Complications: Senhance: 1.6%. Reference da Vinci: 6.9%.
- Conclusion: Operative times and complication rates were similar between the Senhance System retrospective chart review and the literature. The comparison demonstrated that the Senhance System is as safe and effective as the predicate device for its intended use in inguinal hernia repair.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
-
Cholecystectomy:
- Complication Non-serious (Clavien Dindo I-II): Senhance Imperial College - 30%, Senhance Hamburg University - 0%
- Serious Complication (Clavien Dindo III): Senhance Imperial College - 0%, Senhance Hamburg University - 0%
- Intra-op Adverse Events / Complications: Senhance Imperial College - 5%, Senhance Hamburg University - 0%
- Transfusions: Senhance Imperial College - 0%, Senhance Hamburg University - 0%
- Mortality: Senhance Imperial College - 0%, Senhance Hamburg University - 0%
- Conversion to Laparoscopy: Senhance Imperial College - 5%, Senhance Hamburg University - 5%
- Conversion to Open: Senhance Imperial College - 0%, Senhance Hamburg University - 0%
- Reoperation rates: Senhance Imperial College - 0%, Senhance Hamburg University - 0%
- Readmission rates: Senhance Imperial College - 15%, Senhance Hamburg University - 0%
-
Inguinal Hernia Repair Surgery:
- Intraoperative Complications: Senhance System - 0%
- Transfusions (Intraoperative): Senhance System - 0
- Transfusions (Perioperative): Senhance System - 0
- Postoperative Complications (Postop to discharge): Senhance System - 1.6%
- Postoperative Complications (Post discharge to 30 days): Senhance System - 0
- Readmission Rates: Senhance System - 0
- Reoperation Rates (Postop to discharge): Senhance System - 0
- Reoperation Rates (Post discharge to 30 days): Senhance System - 0
- Mortality: Senhance System - 0
- All Complications: Senhance System - 1.6%
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Senhance™ Surgical System (K171120)
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Intuitive Surgical da Vinci Xi Surgical System (K170713 and K172643)
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 876.1500 Endoscope and accessories.
(a)
Identification. An endoscope and accessories is a device used to provide access, illumination, and allow observation or manipulation of body cavities, hollow organs, and canals. The device consists of various rigid or flexible instruments that are inserted into body spaces and may include an optical system for conveying an image to the user's eye and their accessories may assist in gaining access or increase the versatility and augment the capabilities of the devices. Examples of devices that are within this generic type of device include cleaning accessories for endoscopes, photographic accessories for endoscopes, nonpowered anoscopes, binolcular attachments for endoscopes, pocket battery boxes, flexible or rigid choledochoscopes, colonoscopes, diagnostic cystoscopes, cystourethroscopes, enteroscopes, esophagogastroduodenoscopes, rigid esophagoscopes, fiberoptic illuminators for endoscopes, incandescent endoscope lamps, biliary pancreatoscopes, proctoscopes, resectoscopes, nephroscopes, sigmoidoscopes, ureteroscopes, urethroscopes, endomagnetic retrievers, cytology brushes for endoscopes, and lubricating jelly for transurethral surgical instruments. This section does not apply to endoscopes that have specialized uses in other medical specialty areas and that are covered by classification regulations in other parts of the device classification regulations.(b)
Classification —(1)Class II (special controls). The device, when it is an endoscope disinfectant basin, which consists solely of a container that holds disinfectant and endoscopes and accessories; an endoscopic magnetic retriever intended for single use; sterile scissors for cystoscope intended for single use; a disposable, non-powered endoscopic grasping/cutting instrument intended for single use; a diagnostic incandescent light source; a fiberoptic photographic light source; a routine fiberoptic light source; an endoscopic sponge carrier; a xenon arc endoscope light source; an endoscope transformer; an LED light source; or a gastroenterology-urology endoscopic guidewire, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 876.9.(2) Class I for the photographic accessories for endoscope, miscellaneous bulb adapter for endoscope, binocular attachment for endoscope, eyepiece attachment for prescription lens, teaching attachment, inflation bulb, measuring device for panendoscope, photographic equipment for physiologic function monitor, special lens instrument for endoscope, smoke removal tube, rechargeable battery box, pocket battery box, bite block for endoscope, and cleaning brush for endoscope. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807of this chapter, subject to the limitations in § 876.9.
0
Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
May 25, 2018
TransEnterix, Inc. Stephanie Fitts VP, Clinical, Quality and Regulatory Affairs, Chief Compliance Officer 635 Davis Drive, Suite 300 Morrisville, North Carolina 27560
Re: K180163
Trade/Device Name: TransEnterix Senhance Surgical System Regulation Number: 21 CFR 876.1500 Regulation Name: Endoscope and Accessories Regulatory Class: Class II Product Code: NAY, GCJ Dated: April 23, 2018 Received: April 24, 2018
Dear Stephanie Fitts:
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, 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 manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820);
1
Page 2 - Stephanie Fitts
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 medical devices and radiation-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 -S 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
2
Indications for Use
510(k) Number (if known) K180163
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. The Senhance Surgical System is intended for use in laparoscopic gynecological surgery, colorectal surgery, cholecystectomy, and inguinal hernia repair. 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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3
510(k) SUMMARY
K180163
| [In accordance with 21 CFR 807.92] | |
|---|---|
| 510(k) Sponsor: | |
| Address: | TransEnterix, Inc. |
| 635 Davis Drive, Suite 300 | |
| Morrisville, NC 27560 | |
| Contact Person: | Stephanie Fitts, Ph.D. |
| Vice President, RA/QA, and Clinical | |
| Contact Information: | Email: sfitts@transenterix.com |
| Phone: 919.765.8400 | |
| Facsimile: 919.765.8549 | |
| Date Summary Prepared: | May 14, 2018 |
| Proprietary (Trade) Name: | TransEnterix® Senhance™ Surgical System |
| Common Name: | Endoscopic Instrument Control System |
| Endoscopic Instruments and Accessories | |
| Classification: | Class II |
| Classification Advisory | |
| Committee: | General and Plastic Surgery |
| Regulation Number: | 21 CFR 876.1500, Endoscope and Accessories |
| Product Codes: | NAY (System, Surgical, Computer Controlled Instrument) |
| Predicate Device: | Senhance™ Surgical System (K171120) |
| Reference Devices: | Intuitive Surgical da Vinci Xi Surgical System (K170713 and |
| K172643) |
I. Device Description
The Senhance Surgical System is a console-based, multi-arm surgical system, which enables a surgeon to remotely control surgical instrumentation during minimally invasive surgery in the lower abdomen and pelvis. The capital equipment is comprised of three main sub-systems as follows:
- . Cockpit - The station where the surgeon inputs information through hand and eye movements to direct the motion of the arms in the surgical field.
- . Manipulator Arms - Independent mechanized support arms that interface with the endoscope and surgical instruments. The manipulator arms produce output movements based on the instructions from the surgeon at the cockpit. The system is configurable with up to three arms.
- Node A relay unit that connects the cockpit inputs to the manipulator arms in the system as configured, ● and converts and transmits the video signals to the 2D/3D monitor on the cockpit console.
4
The figure below is a graphical depiction of the main Senhance system components.
Image /page/4/Picture/1 description: The image shows a robotic surgery system. The system includes manipulator arms, a node, and a cockpit. The manipulator arms are used to perform the surgery, the node is used to control the arms, and the cockpit is where the surgeon sits to control the system.
Senhance System
The following are the device safety features:
- Manipulator Arm Brakes ●
- . Indicator Lights
- Audible Alerts ●
- . Trocar Fulcrum
- Hierarchy of Control ●
- Exceeding Force
- Multiple inputs required at cockpit to initiate motion
- . Emergency Stop
- Surgeon presence
- Eye tracking lost gaze stop ●
- . Jog mode velocity restriction
- RFID surgical instrument ●
- Power loss stoppage ●
5
The Senhance system includes a series of surgical instruments (Table 1), which are attached to the manipulator arms by way of corresponding adapters. All adapters and instruments are multi-use components that are steam sterilized by the end user before the first and each subsequent use. The instrument designs are adaptations of standard laparoscopic instruments that are commonly used in surgery. Each instrument type has a corresponding system adapter.
| PASSIVE INSTRUMENTS | |
|---|---|
| Johan Grasping Forceps | Mixter |
| Kocher | Needle Holder, Left |
| Allis Atraumatic Grasper | Needle Holder, Right |
| Strong Grasper | Fundus/ Universal Grasping Forceps |
| MONOPOLAR INSTRUMENTS | |
| Maryland Dissector | Metzenbaum Short Tip |
| Metzenbaum Curved | L-Hook |
| BIPOLAR INSTRUMENTS | |
| Large Grasping Forceps | Maryland Dissector |
| Curved Scissors |
Table 1. Senhance Surgical Instruments
II. 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 laparoscopic gynecological surgery, cholecystectomy, and inguinal hernia repair. 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.
III. Summary of Technological Characteristics
This 510(k) is for a labeling modification only, to include inguinal hernia repair and cholecystectomy procedures under the cleared list of procedures for the Senhance Surgical System. There are no changes to the technological characteristics of the cleared Senhance Surgical System proposed in this submission. The comparison of the subject device technological characteristics to the predicate device is provided in Table 2 below.
6
| Feature | Senhance (Subject Device,
K180163) | Senhance (Predicate
Device, K171120) | da Vinci Xi
(Reference Devices,
K170713 & K172543) |
|--------------------------------------|------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------|
| Surgeon Console
Surgeon Controls | Open Cockpit design
Laparoscopic style grip and
motion | Open Cockpit design
Laparoscopic style grip
and motion | Head-in cockpit
Three-finger grip with
open surgery motion |
| Instrument
Activation | Dual surgeon inputs for
manipulator arm motion
(fingers in handles plus
clutch pedal) | Dual surgeon inputs for
manipulator arm motion
(fingers in handles plus
clutch pedal) | Dual surgeon inputs
for manipulator arm
motion (forehead
sensor plus finger grip
activation) |
| Endoscope
Control | Hand or optional Infrared
Eye sensor | Hand or optional Infrared
Eye sensor | Clutch pedal selection
and hand control |
| Force Feedback | Yes | Yes | No |
| Surgeon Display | Active instruments shown | Active instruments shown | Similar |
| Robotic Arms | Three separate carts with
one arm each | Three separate carts with
one arm each | One cart with 4 arms |
| | Manual brake and wheels | Manual brake and wheels | Powered brake and
wheels |
| | Exceeding Force Stop –
arms stop when excessive
force is detected | Exceeding Force Stop –
arms stop when excessive
force is detected | Arms stop after
collision when joints
are moved from
original position |
| | Emergency Stop button | Emergency Stop button | Similar |
| Surgical
Instruments | Fulcrum set by force sensor | Fulcrum set by force
sensor | Fulcrum set by remote
center function using
potentiometers |
| | Straight stick standard
laparoscopy | Straight stick standard
laparoscopy | Wristed instruments |
| | Reusable instruments | Reusable instruments | Reusable instruments |
| Third Party
Endoscope
Adapters | Yes | Yes | No |
| Drapes | Third party sterile
equipment covers | Third party sterile
equipment covers | Same |
The subject Senhance System has undergone software revision since the predicate Senhance System was cleared in K171120 to add the following 3 non-end user related features:
- Software Compatibility Check Feature: This feature queries and retrieves all software component ● version levels for TransEnterix-created binary files. The gathered binary files are compared against expected versions, and if any discrepancies are found during the check, the system displays a version incompatibility error message on the cockpit monitor. The check is performed at system startup and any time an arm is newly connected to an active system.
- R&D Mode: This function was added to allow the system to enable or disable specific features to facilitate . unrestricted continued software development of the system. The R&D Mode feature will only be enabled once a "development config" file is placed on a component of the system. This file can only be placed on a component through physically deconstructing the component and interacting with the PCs internal to the
7
device, or through the Node's service port which is only accessible by authorized and trained personnel using a password protected interface.
- . Service function for Automated Instrument Calibration: Instrument calibration is a time-consuming task that is normally performed by Field Service to calibrate the jaw open and close ranges for designated "grasping" surgical instruments. This feature automates that process to save time during a field service visit.
The subject device is substantially similar in technological characteristics to the predicate Senhance device. When used for the additional laparoscopic surgeries proposed, the substantial equivalence has been demonstrated through the clinical data, summary of which is included in this document.
The bench, usability, pre-clinical and in-vivo data provided for Senhance device under K171120 are applicable to the subject device since in terms of technology and intended use the remains similar to the predicate cleared under K171120. These data along with additional clinical data presented under the subject submission demonstrate the subject device is substantially equivalent to the predicate device. Moreover, the clinical data provided for subject device for laparoscopic inguinal hernia and cholecystectomy procedures had similar outcomes when compared with the reference device, da Vinci Xi Surgical System, and standard laparoscopic technique.
IV. Software Verification and Validation
The subject Senhance System has undergone software revision to add the following 3 non-end user related features: Software Compatibility Check Feature, R&D Mode, and Service function for Automated Instrument Calibration. These features are described above in Section III.
Software verification and validation testing were conducted for the architecture including regression testing and integration for the revised code. Documentation was provided as recommended by FDA's Guidance for Industry and FDA Staff, "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices" including re-presentation of unchanged specifications and test reports submitted with the predicate device submission K171120. The software for this device was considered as a "major" level of concern.
V. Clinical Data
In supplement to the previously submitted clinical data in K171120, the company has collected data on the Senhance Robotic System for cholecystectory and inguinal hernia procedures as part of three studies. In sum, data has been collected on 76 inguinal hernia repair procedures and 40 cholecystectomy procedures with the Senhance Robotic System. These data demonstrate results that support substantial equivalence to the predicates for the proposed indications.
Cholecystectomy Case Series
Two retrospective chart reviews were performed for 40 patients who underwent cholecystectomy procedures with the Senhance Robotic System. There were few intraoperative complications and two conversions to standard laparoscopy. No conversions to open technique, reoperations or readmissions related to the procedure were necessary.
8
| | Senhance -
Imperial
College
N=20 | Senhance -
Hamburg
University
N=20 | Reference
da Vinci
System
N=1435 | Laparoscopic
arm from
meta-analysis
(Huang et al)*
N=921 |
|-----------------------------------------------------------------------|-------------------------------------------|---------------------------------------------|-------------------------------------------|----------------------------------------------------------------------|
| Complication Non-serious
(Clavien Dindo I-II) (n, %)
or % range | 6, 30% | 0 | 0-25% | Not Reported |
| Serious Complication
(Clavien Dindo III) (%) | 0 | 0 | 0-4% | 0-10% |
| Estimated Blood Loss (mL) | Minimal | Not Reported | Not Reported | 12-14 mL |
| Intra-op Adverse Events /
Complications (n, %) or %
range | 1 (intraop
bleeding),
5% | 0 | 0-5% | 0-33.3% |
| Transfusions (%) | 0 | 0 | 0-2% | 0 |
| Mortality (%) | 0 | 0 | 0-0.5% | 0 |
| Conversion to Laparoscopy
(n, %) or % range | 1,5% | 1,5% | 0-12.5% | N/A |
| Conversion to Open (n, %)
or % range | 0 | 0 | unknown | 0-15.7% |
| Reoperation rates (n, %) or
% range | 0 | 0 | 0-4% | Not Reported |
| Readmission rates (n, %) | 3, 15% | 0 | 0-4% | 0-4.3% |
| Median Operative Time in
min (range) | 86.5 (44-129) | 71.5 (34-197) | 91.7 (50-152) | 115.3 (65-141) |
| Hospital Length of Stay
(days) | 0 (1 pt
remained
overnight) | 2** | 1-5 | 2.2 (range 1.0-
5.1) |
Table 3. Cholecystectomy Data - Senhance, Predicate Robotic and Laparoscopic
- Reference da Vinci data compiled from 19 papers obtained from structured PubMed literature search years 2000-2018
- Huang et al. Robotic cholecystectory versus conventional laparoscopic cholecystectomy: A metaanalysis. Surgery. 2017 Mar;161(3):628-636. doi: 10.1016/j.surg.2016.08.061
** 2-day hospital stay per protocol
For the data provided under the heading entitled "Reference da Vinci System" and a PubMed search was conducted using specific Medical Subject Heading (MeSH) terms for the years 2000-2018 which vielded 61 robotic papers of interest. A pre-determined excision criteria was used to filter the final set of 19 per-reviewed research publications describing the clinical outcomes for more than 1400 cholecystectomy robotically assisted surgery operations.
A meta-analysis publication (Huang et al) was used for the laparoscopic comparison. This publication summarized 13 trials for the outcomes of interest and reported on over 900 cholecystectomies performed by manual laparoscopic technique.
When comparing results from the Senhance System and the literature, all outcomes measures demonstrated comparable results. Overall, the comparison of the provided cholecystectomy surgery clinical data with the published literature data from other surgical techniques demonstrated that the Senhance System is as safe and effective as the predicate device for its intended use.
9
Inguinal Hernia Repair Surgery Data
A retrospective chart review was performed for 64 patients who underwent inguinal hernia repair procedures with the Senhance Robotic System. These patients underwent 76 transabdominal preperitoneal (TAPP) inguinal hernia repairs, including bilateral hernias and recurrent hernia after previous surgical repair. No significant intraoperative or postoperative complications were observed in the 64 patients. Two cases had to be converted to standard laparoscopic technique. No reoperations or readmissions related to the procedure were necessary.
| Outcome | Senhance System | Reference da Vinci | Laparoscopic Cohort |
|---|---|---|---|
| N=64^ | System N=652** | N=3457* | |
| Patient Demographics | |||
| Mean age, (y ± SD or range) | 54.5 ± 16.3 | 55.8 ± 15.6 | 34.91 - 62.3 |
| Female, n (%) or % range | 10 (15.6%) | 64 (9.8%) | 0 - 6.1% |
| Mean BMI, kg/m2 (± SD) or range | 25.9 ± 3.1 | 27.3 ± 5.1 | 22.4 - 26.8 |
| Length of Stay | |||
| Inpatient (days, mean ± SD or range) | 1.04 ± 0.2 days† | 3.01 ± 4.65 (n=52) | 0.8 - 5 days |
| Outpatient (hours) | n/a | 7.16 ± 3.01 | |
| Intraoperative Complications, n (%) or | 0 (0%) | 2 (0.3%) | 0 - 8% |
| % range | |||
| Transfusions, n (%) | |||
| Intraoperative | 0 | 0 | Not Reported |
| Perioperative | 0 | 2 (0.3%) | |
| Postoperative Complications, n (%) or | 0-36% | ||
| % range | 1 (1.6%) | 15 (2.3%) | (reported as total time |
| Postop to discharge | 0 | 28 (4.3%) | period) |
| Post discharge to 30 days | |||
| Readmission Rates, n (%) | 0 | 23 (3.5%) | Not Reported |
| Reoperation Rates, n (%) or % range | 0-2.5% | ||
| Postop to discharge | 0 | 3 (0.5%) | (reported as total time |
| Post discharge to 30 days | 0 | 0 | period) |
| Mortality, n | 0 | 0 | 0 |
| Operative Time, min, avg ± SD/range | |||
| Unilateral repair | 44 ± 17.4 | 79.7 ± 31.7 | 32.6 - 110 |
| Bilateral repair | 79 ± 23.7 | ||
| All Complications, n (%) or % range | 1 (1.6%) | 45 (6.9%) | 7.9 – 8.7% |
| Table 4. Inguinal Hernia Repair Surgery - Senhance, Reference da Vinci System and Laparoscopic |
|---|
^ All performed via TAPP method
TOne patient in each group was hospitalized for 2 days. All other patients were admitted for 1 day.
- Data from eleven (11) publications referenced in Bittner, et al., "Update of guidelines on laparoscopic (TAPP) and endoscopic (TEP) treatment of inguinal hernia (International Endohernia Society", Chapter 4: "TEP versus TAPP: which is better?" Surg Endosc 29:289-321 (2015).
** Data from 510(k) summary K170713
Data from the inguinal hernia repair case series using the Senhance system were compared with the results from over 650 robotic surgeries using the reference da Vinci system and over 3400 inguinal hernia repair operations performed using standard laparoscopic technique.
Operative times and complication rates were similar between the Senhance System retrospective chart review and the literature. Longer term endpoints such as inguinal hernia repair recurrence and chronic pain were not assessed
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in this study, and thus no claims regarding these outcomes data should be inferred. Overall, the comparison of the provided inguinal hernia repair surgery clinical data with the published literature data demonstrated that the Senhance System is as safe and effective as the predicate device for its intended use.
Clinical data were not provided for all of the representative, specific procedures. Instead, clinical data were provided for the most complex/highest risk representative, specific procedures of Total Radical Hysterectorny, and Low Anterior Resection Total Mesorectal Excision (referred to as the "umbrella" procedures). The data on these "umbrella" procedures were extrapolated to cover the less complex/lower risk procedures (referred to as "covered" procedures) so published clinical data on the covered procedures were not provided. Clinical data were provided for Myomectomy, Cholecystectomy, and Inguinal Hernia Repair yet these data did not act as umbrella procedures to cover any other procedure. Thus, the Representative Procedures for the Senhance System are outlined in Table 5 below.
| Representative Procedures | ||
|---|---|---|
| Surgical Specialties | ||
| /Procedures | Umbrella Procedures | Covered Procedures |
| Laparoscopic 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 | ||
| Laparoscopic Colorectal | ||
| 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 | ||
| Specific Laparoscopic | ||
| Procedures | Cholecystectomy | |
| Inguinal Hernia Repair (Uni and | ||
| bilateral) |
Table 5. 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.
VI. Conclusions
The clinical analysis of the TransEnterix Senhance System, as summarized herein, demonstrates that the device is as safe and effective for the two additional umbrella procedures as the predicate Senhance System cleared in K171120.
The Senhance System has the same intended use and its expanded indications for cholecystectomy and inguinal hernia repair do not affect the safety or effectiveness of the device compared to predicate device. In addition, the Senhance System has identical technological characteristics and principles of operation as the predicate device.
TransEnterix, Inc.
Senhance Surgical System
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Analysis and clinical performance of the device in these new procedures indicate that no new issues of safety or effectiveness have been raised for the expanded claim. Thus, the Senhance System is substantially equivalent.