(182 days)
Intuitive Surgical da Vinci Si Surgical System IS3000 (K081137)
No
The document does not mention AI, ML, or related terms, and the description of the system's functionality focuses on direct surgeon control and mechanical manipulation.
No
The device aids surgeons in operating but does not directly provide therapy. It is an instrument control system, not a treatment in itself.
No
Explanation: The device is described as a surgical system intended to assist in the accurate control of laparoscopic instruments for manipulation of tissue during surgery. Its primary function is to perform surgical procedures, not to diagnose medical conditions.
No
The device description clearly outlines hardware components including a cockpit, manipulator arms, and a node, which are integral to the system's function. The performance studies also include testing on hardware aspects like mechanical performance, electrical safety, and biocompatibility of instruments.
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 states that the system is for assisting in the control of laparoscopic instruments for visualization and manipulation of tissue within the body during surgery. 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. These components are designed for performing surgical procedures, not for analyzing samples like blood, urine, or tissue in a laboratory setting.
- Lack of IVD Characteristics: The description does not mention any components or functions related to:
- Analyzing biological samples.
- Detecting or measuring substances in samples.
- Providing diagnostic information based on sample analysis.
The device is a surgical robot designed to assist surgeons in performing minimally invasive procedures. While it uses visualization (endoscopic signal), this is for guiding the surgical instruments during the procedure, not for diagnostic purposes based on analyzing a sample.
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 in laparoscopic colorectal surgery 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 (comma separated list FDA assigned to the subject device)
NAY
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 which 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.
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 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
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
- Biocompatibility testing: Conducted on all patient contacting instruments, in accordance with FDA Guidance and ISO 10993-1. Included Cytotoxicity, Sensitization, Irritation/Inflammatory Response (IR), Acute Systemic toxicity, and Pyrogenicity tests. Instruments are tissue contacting for less than 24 hours.
- Cleaning, Disinfection (Reprocessing) and Sterilization: Capital equipment validated through cleaning effectiveness, cleaning compatibility and low-level disinfection testing, based on AAMI TIR12:2010, ANSI/AAMI TIR30:2011, and ANSI/AAMI ST58:2013. Reusable instruments and adapters underwent cleaning effectiveness study based on AAMI TIR12:2010 and ANSI/AAMI TIR30:2011. Steam sterilization study conducted per FDA's Guidance for Industry and FDA Staff "Reprocessing Medical Devices in Health Care Settings: Validation Methods and Labeling" and ANSI/AAMI/ISO 17665-1:2006/(R)2013 and ANSI/AAMI/ISO 14937:2009/(R)2013.
- Electrical safety and electromagnetic compatibility (EMC): Complies with IEC 60601-1:2012, IEC 60601-1-2:2014, IEC 60601-2-2 2009/COR1:2014, and IEC 60601-2-18:2009.
- Software Verification and Validation Testing: Documentation 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." Software considered "major" level of concern.
- Bench testing: Evaluated mechanical performance including Instruments Dynamic Cantilever Testing, Instruments Jaw Grasping Reliability and Force to Jaw Failure, Shears Reliability, Video Signal Verification, System Latency, Robotic arm and surgical instrument motion accuracy, Video Signal Latency, Force Feedback, Eye Sensing (ISO 15004-2:2007 and IEC 62471:2006), Transit and Packing Testing, Drape Compatibility, Endoscope Compatibility, and ESU Compatibility.
- Human Factors/Usability Engineering Testing: Full summative human factors (usability) testing per FDA Guidance "Applying Human Factors and Usability Engineering to Medical Devices" issued on February 3, 2016. Sample size: Sixteen (16) teams of 3 users (one surgeon, one surgical assistant and one nurse). Setting: porcine wet lab environment. Key Results: All study endpoints confirmed that the Senhance system can be used by surgeons, surgical assistants, and nurses in an operating room environment without patterns of preventable use errors that may cause harm when the system is in use during laparoscopic surgery.
- Animal Testing: Pre-clinical Design Validation: Single-center, un-blinded, observational, simulated use study. Sample size: Four (4) teams of trained subjects (one surgeon and one surgical assistant per team). Setting: live porcine model. Procedures: serosal bladder incision with repair, oophorectomy, total laparoscopic hysterectomy, gastric serosal incision with repair, cholecystectomy, and nephrectomy. Key Results: All surgical procedures were successfully completed, and all essential user requirements were assessed and found to be met by the system.
- Clinical Data:
- Gynecological Laparoscopic Surgery Data: Prospective non-randomized clinical trial, 150 patients. Indications included ovarian cyst removal (39%), cancer prophylaxis (2%), uterine fibroids (3%), benign or early stage uterine and adnexal cancer (43%) and advanced uterine/adnexal cancer (13%). Comparison with eight peer-reviewed research publications (over 8000 operations) using the predicate device. Key Results: Comparison of procedural endpoints (length of hospital stay, intraoperative complications, estimated blood loss, post-operative complications, readmission rates, reoperation rates, mortality, operative time, and conversion rates) demonstrated that the Senhance system is as safe and effective as the predicate device for its intended use.
- Colorectal Laparoscopic Surgery Data: Retrospective chart review (real world evidence), 45 patients. Indications included colorectal cancer (66%), endoscopically unresectable adenoma (4.4%), complicated inflammatory bowel disease (18%) and diverticular disease (11%). Comparison with 11 peer-reviewed research publications (over 5000 operations) using the predicate device. Key Results: Comparison of procedural endpoints (length of hospital stay, conversion rates, intraoperative complications, estimated blood loss, adverse events / all complications, anastomotic leak rate, readmission rates, reoperation rates, mortality, operative time, and surgical margins) demonstrated that the Senhance system is as safe and effective as the predicate device for its intended use.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
- Gynecological Laparoscopic Surgery Data (N=150):
- Conversion to Lap: 10 total, 5 (3.3%) for Total Hysterectomy, 5 (3.3%) for Total Hysterectomy plus adjacent structures.
- Intra-op Adverse Events / Complications: 2 for Total Hysterectomy.
- Serious Complication (Clavien Dindo III): 8 for Total Hysterectomy.
- Estimated Blood Loss (mL):
§ 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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October 13, 2017 TransEnterix, Inc. Stephanie Fitts, Ph.D. VP, Clinical, Quality and Regulatory Affairs, Chief Compliance Officer 635 Davis Drive, Suite 300 Morrisville. North Carolina 27560
Re: K171120
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: September 15, 2017 Received: September 15, 2017
Dear Dr. 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 practice, 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 (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education (DICE) at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education (DICE) at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
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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) K171120
Device Name 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 in laparoscopic colorectal surgery 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] Submitter -510(k) Submitter: TransEnterix, Inc. Address: 635 Davis Drive, Suite 300 Morrisville, NC 27560 Contact Person: Stephanie M. Fitts. PhD Vice President, RA/QA, Clinical and Compliance Contact Information: Email: sfitts@transenterix.com Phone: 919.765.8400 Facsimile: 919.765.8549 Date Summary Prepared: October 13, 2017 II. Device Senhance™ Surgical System Name of Device: Common or Usual Name: Endoscopic Instrument Control System Endoscopic Instruments and Accessories Classification Name: Endoscope and Accessories (21 CFR 876.1500) Requlatory Class: ll Product Code: NAY (System, Surgical, Computer Controlled Instrument) Intuitive Surgical da Vinci Si Surgical System IS3000 III. Predicate Device (K081137) This predicate has not been subject to a design-related recall Stryker (MAKO) RIO Robotic Arm Assisted System Reference Devices (K093425) Stryker Surgical Instruments (K150127) GIMMI GmbH Surgical Instruments (K012660) Bissinger GmbH POWERGRIP Coagulation Forceps (K033177 and K970968)
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IV. 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 which 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.
Figure 1, below, is a graphical depiction of the main Senhance system components.
Image /page/4/Figure/6 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, while the node is used to control the arms. The cockpit is where the surgeon sits and controls the system.
Figure 1. Senhance System
The following are the device safety features:
- Manipulator Arm Brakes ●
- . Indicator Lights
- Audible Alerts ●
- . Trocar Fulcrum
- Hierarchv 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 .
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- RFID surgical instrument ●
- Power loss stoppage ●
The Senhance system includes a series of surgical instruments (Table 1), which are attached to the manipulator arms by way of corresponding 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 Grasper | Mixter Dissector |
| Kocher Grasper | Needle Holder, Left |
| Allis Grasper | Needle Holder, Right |
| Strong Grasper | Fundus Grasper |
| MONOPOLAR INSTRUMENTS | |
| Maryland Dissector | Curved Metzenbaum Scissors Short Tip |
| Curved Metzenbaum Scissors | L-Hook Electrode |
| BIPOLAR INSTRUMENTS | |
| Large Grasping Forceps | Maryland Dissector |
| Curved Scissors |
| TABLE 1. Senhance Surgical Instruments | |
|---|---|
V. 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 in laparoscopic colorectal surgery 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.
VI. Summary of Technological Characteristics:
Robotically-assisted tele-operation is the primary technological principle for both the subject and predicate devices. It is based on the accurate translation of user input to a robotically assisted output, It involves the use of endoscopic instrumentation for manipulation of tissues and vessels in the insufflated body cavity. At a high level, the subject and predicate devices are based on the following same technological elements: surgeon console which provides remote manipulators or handles to allow the surgeon to maneuver the surqical instruments and a video monitor for the endoscopic signal, manipulator arms which hold the instruments and endoscope based on inputs from the surgeon, and instruments which manipulate the tissue of interest.
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The eye sensing feature provides the surgeon an optional alternate method to control the endoscope other than using their hands. This feature is similar to the Class II exempt device, the Tobii CEve System Augmentative and Alternative Communication Devices with ISO 15004-2: 2007-02-15 and IEC 62471: 2006-07. Force feedback provides an optional tactile sensory input to the surgeon control handles to give a sense of tissue elasticity. This feature is similar to that of the reference device Stryker (MAKO) RIO Robotic Arm Assisted System (K093425).
The Senhance Surgical System differs from the predicate in the instrumentation. The predicate utilizes wristed instruments with an additional degree of freedom. The Senhance instruments are similar in design and materials to traditional laparoscopic instrumentation. The instrument reference devices listed (Stryker Surgical Instruments (K150127), GIMMI GmbH Surgical Instruments (K012660), and Bissinger GmbH POWERGRIP Coagulation Forceps (K033177 and K970968)) all have instrument designs and materials which have a long history of safe clinical use.
Table 2 lists the differences between the subject device and the predicate device features.
| Feature | Senhance | Predicate |
|---|---|---|
| Surgeon Console | Open Cockpit design | Head-in cockpit |
| Surgeon Controls | Laparoscopic style grip and motion | Three-finger grip with open surgery motion |
| Instrument | Dual surgeon inputs for manipulator arm | Dual surgeon inputs for manipulator arm |
| Activation | motion (fingers in handles plus clutch | |
| pedal) | motion (forehead sensor plus finger grip | |
| activation) | ||
| Endoscope Control | Hand or optional Infrared Eye sensor | Clutch pedal selection and hand control |
| Force Feedback | Yes | No |
| Surgeon Display | Active instruments shown | Similar |
| Robotic Arms | Three separate carts with one arm each | |
| Manual brake and wheels | ||
| Exceeding Force Stop -arms stop when | ||
| excessive force is detected | ||
| Emergency Stop button | One cart with 3-4 arms | |
| Powered brake and wheels | ||
| Arms stop after collision when joints are | ||
| moved from original position | ||
| Similar | ||
| Surgical | ||
| Instruments | Fulcrum set by force sensor | |
| Straight stick standard laparoscopy | Fulcrum set by remote center function using | |
| potentiometers | ||
| Wristed instruments | ||
| Third Party | Reusable instruments | Reusable instruments |
| Endoscope | ||
| Adapters | Yes | No |
| Drapes | Third party sterile equipment covers | Same |
TABLE 2. Differences between Senhance and Predicate, da Vinci Si (K081137)
To establish the substantial equivalence (SE) with the predicate device and address the above listed differences, the subject device was tested in preclinical, usability, and in-vivo testing as summarized in Section VII of this document.
Table 3 lists some of the Senhance technological features along with a reference device which includes a similar feature.
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TABLE 3. Senhance Features and Reference Devices with Similar Feature.
| Senhance Feature | Reference Device with Similar Feature or Standard Used to Test
Safety of the Given Feature |
|---------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------|
| Handle to Instrument Movement,
Straight shaft design and standard
end effectors | Stryker Surgical Instruments (K150127)
GIMMI GmbH Surgical Instruments (K012660) |
| Standard port placement and size | Bissinger GmbH POWERGRIP Coagulation Forceps (K033177 and
K970968) |
| Haptic force feedback to handles | Stryker (MAKO) RIO Robotic Arm Assisted System (K093425) |
| Eye sensing camera control | Radiation safety testing per ISO 15004-2: 2007-02-15 and IEC 62471:
2006-07 |
The compatibility of the features listed in the above table was established as a part of usability testing and during the design validation process.
VII. Performance Data
The following performance testing of the Senhance Surgical System was conducted to support substantial equivalence to the predicate device.
Biocompatibility testing: The biocompatibility evaluation for the Senhance Surgical System was conducted on all patient contacting instruments in accordance with the FDA Guidance for Industry and FDA Staff "Use of International Standard ISO 10993-1 , Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process" issued on June 16, 2016 , and International Standard ISO 10993-1 "Biological Evaluation of Medical Devices - Part 1: Evaluation and Testing Within a Risk Management Process," as recognized by FDA. The battery of testing included the following tests:
- · Cytotoxicity
- Sensitization ●
- Irritation/Inflammatory Response (IR) ●
- Acute Systemic toxicity
- . Pyrogenicity
The instruments are considered tissue contacting for a limited duration of less than 24 hours for contact with tissue or bone.
Cleaning, Disinfection (Reprocessing) and Sterilization: The capital equipment was validated through cleaning effectiveness, cleaning compatibility and low level disinfection testing. Cleaning effectiveness and low-level disinfection studies were conducted on non-draped areas of the Senhance manipulator arm. These studies were based on the quidelines outlined in AAMI TIR12:2010, ANSI/AAMI TIR30:2011, and ANSI/AAMI ST58:2013. The reusable instruments and adapters were the subject of a cleaning effectiveness study based on the guidelines outlined in AAMI TIR12:2010 and ANSI/AAMI TIR30:2011. A steam sterilization study was conducted in accordance with the FDA's Guidance for Industry and FDA Staff "Reprocessing Medical Devices in Health Care Settings: Validation Methods and Labeling" issued on: March 17, 2015 and the FDA recognized consensus standards ANSI/AAMI/ISO 17665-1:2006/(R)2013 and ANSI/AAMI/ISO 14937:2009/(R)2013.
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Electrical safety and electromagnetic compatibility (EMC): Electrical safety and EMC testing were conducted on the Senhance Surgical System. The system complies with the IEC 60601-1:2012 standard for basic safety and essential performance of medical equipment and IEC 60601-1-2:2014 collateral standard for EMC. High frequency electrical safety requirements were evaluated per IEC 60601-2-2 2009/COR1:2014 and applicable safety requirements for the endoscopic equipment were evaluated per IEC 60601-2-18:2009.
Software Verification and Validation Testing: Software verification and validation testing were conducted and 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." The software for this device was considered as a "maior" level of concern.
Bench testing: Bench testing evaluated the mechanical performance of the system and included the following:
- Instruments Dynamic Cantilever Testing .
- Instruments Jaw Grasping Reliability and Force to Jaw Failure ●
- Shears Reliability
- Video Signal Verification ●
- System Latency
- Robotic arm and surgical instrument motion accuracy
- Video Signal Latency
- Force Feedback
- Eye Sensing [ISO 15004-2:2007 Ophthalmic Instruments - Fundamental Requirements and Test Methods Part 2: Light Hazards Protection and IEC 62471:2006 Photobiological safety of lamps and lamp systems]
- Transit and Packing Testing
- Drape Compatibility
- Endoscope Compatibility
- ESU Compatibility
Human Factors/ Usability Enqineering Testing: The Senhance Surgical System underwent full summative human factors (usability) testing. The study was conducted in accordance with the FDA Guidance for Industry and FDA Staff "Applying Human Factors and Usability Engineering to Medical Devices" issued on February 3, 2016. In this study, realistic team-based scenarios were evaluated. Sixteen (16) teams of 3 users were evaluated in performing use tasks in a porcine wet lab environment which was simulated to reflect the actual intended conditions of use. The teams, which consisted of one surgeon, one surgical assistant and one nurse, were training program intended for use at market introduction which includes individual and team based training exercises. After a training decay period of between overnight and seven days, the team was evaluated by an independent usability investigator while performing surqical tasks in a porcine model. All study endpoints confirmed that the Senhance system can be used by surgeons, surgical assistants, and nurses in an operating room environment without patterns of preventable use errors that may cause harm when the system is in use during laparoscopic surgery.
Animal Testing: Pre-clinical Design Validation: A single-center, un-blinded, observational, simulated use study of the Senhance System was conducted with representative users. Four (4) teams of trained subjects (one surqeon and one surgical assistant per team) performed surgical tasks on a live porcine model. The teams performed serosal bladder incision with repair, oophorectomy, total laparoscopic hysterectomy, gastric serosal incision with repair, cholecystectomy, and nephrectomy.
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The procedures were non-survival. The surgical teams performed tasks representing major user needs which included: Patient and Trocar Placement, Initial Endoscope and Instrument, Initial Endoscope and Instrument Insertion, Cockpit Setup, Communication, Laparoscopic Procedure, Feature-specific Laparoscopic Tasks, Instrument Removal and Detachment, Incision Site Evaluation, and Emergency Access. The surgical tasks from the Senhance system's indications for use were performed according to the demands of the specific surgical procedure. All surgical procedures were successfully completed, and all essential user requirements were assessed and found to be met by the system.
Clinical Data: The gynecological laparoscopic surqery data were from a prospective non-randomized clinical trial for 150 patients undergoing surgery with the Senhance system. The colorectal laparoscopic surgery data were from a retrospective chart review (referred to as real world evidence or RWE) of 45 patient's medical records of colorectal surgery.
The Gynecological Laparoscopic Surgery Data
The gynecological study enrolled 150 subjects with surgical indications that included ovarian cyst removal (39%), cancer prophylaxis (2%), uterine fibroids (3%), benign or early stage uterine and adnexal cancer (43%) and advanced uterine/adnexal cancer (13%). The majority (57%) of patients reported a previous abdominal/pelvic surgery with 33% specifically reporting a previous gynecological surgery. The patients enrolled had an average Body Mass Index (BMI) of 24.4 kg/m². Ten conversions to manual laparoscopy were reported and all were included as intraoperative complications in the results. Two conversions were associated with serious adverse events at the time of surgery: one patient converted to laparoscopy for bladder perforation requiring repair and one patient who developed subcutaneous emphysema due to the anesthetic technique. Neither of the events was device related according to the investigator's assessment. The remaining conversions were due to patient anatomy or surgeon preference. No blood transfusions or other complications were reported in the intra-operative timeframe. Post-operatively an additional six serious adverse events (4%) were reported including one wound dehiscence, two infections, one suspected pleurisy requiring hospitalization, and one rapid onset anemia. One patient returned to the operating room after pathology confirmed a cancer diagnosis was included conservatively as an adverse event, but was not a true re-operation. None of these serious adverse events was considered device related according to the investigators.
Data were extrapolated from two umbrella procedures: total laparoscopic radical hysterectorny and myomectomy. This allowed labeling for representative specific covered gynecological procedures (listed in Table 4) without the need to provide clinical data for the covered procedures.
| Representative Procedures | |
|---|---|
| Umbrella Procedures | Covered 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 |
TABLE 4. Umbrella and Covered Procedures for Laparoscopic Gynecology
The data from the gynecology procedures are shown below in Table 5.
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| | Mono/Bilateral
salpingo-
oophorectomy,
cyst removal | Myomectomy | Total
Hysterectomy | Total Hysterectomy
plus adjacent
structures (radical) |
|---------------------------------------------------|--------------------------------------------------------------|-------------|-----------------------|-------------------------------------------------------------|
| Number of pts | 62 | 4 | 64 | 20 |
| Complication Non-serious
(Clavien Dindo I-II)* | 16 | 0 | 14 | 15 |
| Serious Complication
(Clavien Dindo III)* | 0 | 0 | 8 | 0 |
| Estimated Blood Loss
(mL) |