(88 days)
No
The document mentions "image processing algorithms" but does not explicitly state or imply the use of AI or ML. The focus is on controlling instruments and processing video signals, which can be achieved with traditional algorithms.
Yes
The device performs endoscopic manipulation of tissue including grasping, cutting, blunt and sharp dissection, approximation, ligation, electrocautery, suturing, and mobilization, which directly address and treat medical conditions.
No
The Senhance Surgical System is intended to assist in the accurate control of laparoscopic instruments for visualization and endoscopic manipulation of tissue during surgical procedures. It is a surgical system designed for intervention and manipulation, not for diagnosis.
No
The device description explicitly mentions physical components like "articulating instruments," "coupler," and "articulating adapter" that attach to a "Senhance Manipulator Arm." While software is mentioned for controlling motion and image processing, the device is clearly a system with significant hardware components.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly describes a surgical system designed to assist in laparoscopic procedures by controlling instruments for visualization and manipulation of tissue within the body. This is a surgical device, not a diagnostic one.
- Device Description: The description focuses on the mechanical components and their function in assisting surgical procedures.
- Lack of Diagnostic Function: There is no mention of the device being used to examine specimens in vitro (outside the body) to obtain diagnostic information. While it uses image processing of the endoscope video signal, this is for guiding the surgical procedure, not for analyzing biological samples for diagnostic purposes.
- Performance Studies: The performance studies focus on aspects relevant to surgical devices, such as biocompatibility, reprocessing, bench testing of mechanical function, electrical safety, software validation, pre-clinical design validation in a simulated surgical environment, and usability testing for surgical tasks. There are no studies related to diagnostic accuracy, sensitivity, specificity, or other metrics typical of IVDs.
In summary, the Senhance Surgical System is a surgical device used for performing procedures on the patient, not a device used to diagnose conditions by testing samples from the patient.
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 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 (comma separated list FDA assigned to the subject device)
NAY
Device Description
The Senhance Articulating platform is intended as an addition to the suite of instruments and adapters previously cleared for use with the Senhance® Surgical System ("Senhance system"). These instruments add degrees of freedom near the instrument end effector to allow for additional range of motion for the surgeon when performing laparoscopic tissue manipulations. Two articulating instruments are being added to the suite of instruments –Bipolar Atraumatic Grasper and Needle Driver. The instruments are single use and provided sterile to the end user. The instruments connect to a coupler which in turn connects to the articulating adapter which attaches to the Senhance Manipulator Arm.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
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)
Biocompatibility Testing: The Senhance Articulating instruments are considered tissue contacting for a limited duration of less than 24 hours for contact with tissue or bone. The articulating instruments were assessed in accordance with the FDA Guidance for Industry and FDA Staff on Use of International Standard ISO 10993-1, "Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process", and ISO 10993-1 "Biological Evaluation of Medical Devices - Part 1: Evaluation and Testing Within a Risk Management Process". Testing demonstrated that the patient-contacting portions of the Senhance Articulating instruments are non-toxic, non-irritating, non-sensitizing, and nonpyrogenic and do not result in an unacceptable adverse biological response resulting from contact of the devices' materials with the body.
Reprocessing, Cleaning, and Sterilization: The reusable coupler has cleaning instructions that were validated based on the quidelines outlined in AAMI TIR30:2011. A steam sterilization validation 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" and the FDA recognized consensus standards ANSI/AAMI/ISO 17665-1:2006/(R)2013 and ANSI/AAMI/ISO 14937:2009/(R)2013. The coupler was validated to a Sterility Assurance Level of 10-6 using the half cycle testing validation method.
The articulating adapter is non-sterile capital equipment and is used with a sterile equipment drape. The drape remains intact throughout the procedure and thereby maintains a sterile barrier. A cleaning compatibility study confirmed that the agents used during cleaning/disinfection are compatible with the materials of construction and markings of the adapter.
The single use articulating instruments are provided sterile to the end user via gamma irradiation. Gamma irradiation at a minimum dose of 25 kGy was validated per FDA recognized consensus standards ISO 11137-1:2006, ISO 11137-2:2013, and ISO 11137-3:2017 and demonstrated a Sterility Assurance Level of 10°. The packaging has been validated to maintain sterility for the stated shelf life of the device.
Bench Testing: Bench testing evaluated the performance of the Senhance Articulating instruments as well as compatibility of the Senhance Articulating platform when used with the Senhance Surgical System. The following tests confirmed that the articulating instruments perform as intended after tests of mechanical integrity under conditions of simulated use and that the Senhance system performs as intended when used with the subject Senhance Articulating platform:
- Cantilever Bending Reliability.
- Jaw Actuation Reliability
- Jaw Compensation
- Electrosurgical Unit (ESU) Compatibility
- Sterile Drape Reliability
Electrical Safety and Compatibility: The Senhance Articulating platform used in conjunction with the Senhance system comply with the current versions of IEC 60601-1 (Basic safety and essential performance), IEC 60601-1-2 (Electromagnetic disturbances), IEC 60601-2-18 (Endoscopic equipment interactions), and IEC 60601-2-2 (High frequency surgical equipment).
Software Verification and Validation Testing: Software verification and validation were successfully conducted on the latest Senhance software version that supports the Senhance Articulating platform. Documentation was provided as recommended in FDA's Guidance for Industry and FDA Staff "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices". The software is considered as a "major" level of concern.
Pre-Clinical Design Validation: Design validation of the Senhance Articulating platform was conducted to ensure that the devices perform as intended according to defined user needs and intended uses when used with the Senhance system in a simulated use environment. A singlecenter, un-blinded, observational, simulated use design validation evaluation of the Senhance system used in conjunction with Senhance Articulating platform was conducted with users who represented the intended primary user population. The design validation was conducted in a simulated patient model. All applicable user level requirements were assessed and found to be met.
Usability Testing: Modifications to the existing Senhance system Usability Engineering file were made based on the addition of the new articulating platform. A summative usability validation study was performed with final instructions for use and training materials. In a simulated use environment, the surgical teams were able to independently perform all critical tasks without use errors that would lead to harm. This study demonstrated that the overall residual risk of use errors with the Senhance Articulating platform have been mitigated to an acceptable level. The Senhance Articulating platform used in conjunction with the Senhance system can be used without use errors or problems that could result in serious harm.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
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 (K202166)
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 EndoWrist Instruments (K081137)
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 shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health and 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.
Asensus Surgical, Inc. Taylor Fisher Program Manager 1 TW Alexander Drive, Suite 160 Durham, North Carolina 27703
Re: K211325
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: April 30, 2021 Received: April 30, 2021
Dear Taylor Fisher:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for
1
devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely.
Mark Trumbore Ph.D. Acting Assistant Director THT4A1: Robotically-Assisted Surgical Devices Team DHT4A: Division of General Surgery Devices OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known)
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. 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) |
|---|---|
| ---------------------------------------------------------------------------------------------------------- | --------------------------------------------------------------------------------------------------------- |
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
3
510(k) Summary
[In accordance with 21CFR 807.92]
1. Submitter
Reference Device:
| 510(k) Sponsor: | Asensus Surgical, Inc. |
|---|---|
| Address: | 1 TW Alexander Drive, Suite 160 |
| Durham, NC 27703 USA | |
| Contact Person: | Taylor Fisher |
| Program Manager | |
| Contact Information: | Email: tfisher@asensus.com |
| Phone: +1 919.765.8400 | |
| Facsimile: +1 919.765.8459 | |
| Date Summary Prepared: | 7/12/2021 |
| 2. Device | |
| Proprietary (Trade) Name: | Senhance® Surgical System |
| Common Name: | System, Surgical, Computer Controlled Instrument |
| 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 |
| 3. Predicate and Reference Devices | |
| Predicate Device: | Senhance® Surgical System (K202166) |
Intuitive Surgical EndoWrist Instruments (K081137)
4
4. Device Description:
The Senhance Articulating platform is intended as an addition to the suite of instruments and adapters previously cleared for use with the Senhance® Surgical System ("Senhance system"). These instruments add degrees of freedom near the instrument end effector to allow for additional range of motion for the surgeon when performing laparoscopic tissue manipulations. Two articulating instruments are being added to the suite of instruments –Bipolar Atraumatic Grasper and Needle Driver. The instruments are single use and provided sterile to the end user. The instruments connect to a coupler which in turn connects to the articulating adapter which attaches to the Senhance Manipulator Arm.
5. 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 qynecological 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.
Comparison with Predicate Device Intended Use/ Indications for Use:
The Senhance Articulating platform has the identical intended use and indications for use as predicate Senhance Surgical System (K202166).
6. Summary of Technological Characteristics:
The substantial equivalence comparison below shows that the subject Senhance Articulating platform is very similar to the predicate Senhance Surgical System. Many of the subject device's technological characteristics and principles of operation are identical or similar to those of the predicate. Furthermore, a comparison of the subject articulating instruments to a reference device (Intuitive Surgical EndoWrist Instruments, K081137) shows that both the subject and reference devices have similarities in their dimensions and design. Any differences in technological characteristics between the subject and predicate devices have been addressed through a comprehensive set of testing using established test methods and do not raise any different questions of safety and effectiveness.
| Characteristic | Subject Device | Predicate Device |
|---|---|---|
| Name | Senhance Articulating Platform for use | |
| with the Senhance Surgical System | Senhance Surgical System | |
| K202166 | ||
| Capital | ||
| Equipment | The subject Senhance system is | |
| comprised of three main components: | ||
| cockpit, manipulator arms, and ISU. | The subject Senhance system is | |
| comprised of three main components: | ||
| cockpit, manipulator arms, and ISU. | ||
| Characteristic | Subject Device | Predicate Device |
| Cockpit – positioned outside the sterile | ||
| field, is where the surgeon inputs | ||
| information through hand and eye | ||
| movements to direct the motion of the | ||
| manipulator arms in the surgical field. | ||
| The surgeon manipulates two cockpit | ||
| handles to transmit position and jaw | ||
| actuation movements to the manipulator | ||
| arms. | Cockpit - positioned outside the sterile | |
| field, is where the surgeon inputs | ||
| information through hand and eye | ||
| movements to direct the motion of the | ||
| manipulator arms in the surgical field. | ||
| The surgeon manipulates two cockpit | ||
| handles to transmit position and jaw | ||
| actuation movements to the manipulator | ||
| arms. | ||
| Manipulator Arms - the independent, | ||
| mechanical support arms that interface | ||
| with the endoscope and surgical | ||
| instruments. The manipulator arms | ||
| produce output movements based on the | ||
| input movement from the surgeon at the | ||
| cockpit. The Senhance system is | ||
| configurable with up to three manipulator | ||
| arms. Each manipulator arm has a total | ||
| of six joints: three joints that allow the | ||
| surgical team to grossly position each | ||
| manipulator arm above the operating | ||
| table and three joints for positioning of | ||
| the instrument interface. | ||
| The connector in the center of the | ||
| instrument interface has been removed | ||
| and a connection port was added to | ||
| power the new articulating motorized | ||
| adapter while maintaining the sterile field. | Manipulator Arms - the independent, | |
| mechanical support arms that interface | ||
| with the endoscope and surgical | ||
| instruments. The manipulator arms | ||
| produce output movements based on the | ||
| input movement from the surgeon at the | ||
| cockpit. The Senhance system is | ||
| configurable with up to three manipulator | ||
| arms. Each manipulator arm has a total | ||
| of six joints: three joints that allow the | ||
| surgical team to grossly position each | ||
| manipulator arm above the operating | ||
| table and three joints for positioning of | ||
| the instrument interface. | ||
| ISU - the communication hub that | ||
| connects the cockpit inputs to the | ||
| manipulator arms. The Smart Node | ||
| contains a high-performance PC that | ||
| enables the surgeon to command | ||
| endoscopic motion using software | ||
| features that apply image processing | ||
| algorithms to the endoscope video signal. | ISU - the communication hub that | |
| connects the cockpit inputs to the | ||
| manipulator arms. The Smart Node | ||
| contains a high-performance PC that | ||
| enables the surgeon to command | ||
| endoscopic motion using software | ||
| features that apply image processing | ||
| algorithms to the endoscope video signal. | ||
| Surgeon Controls | Touchpad, keyboard, clutch pedal, | |
| handles, eye tracker. | ||
| The trigger/tilt button on the cockpit | ||
| handle is used to activate articulation of | ||
| the instrument. The instrument is | ||
| articulated by rotating the handles about | ||
| the yaw axis. | Touchpad, keyboard, clutch pedal, | |
| handles, eye tracker | ||
| Software | ||
| Architecture | Four software subsystems: LTM, ARM, | |
| RHMI, SNIP | Four software subsystems: LTM, ARM, | |
| RHMI, SNIP | ||
| Software Version | Senhance Software Version 2.5.3.14 | Senhance Software Version 2.5.0.22 |
| Characteristic | Subject Device | Predicate Device |
| Instrument | ||
| Adapters | A new motorized articulating adapter that | |
| attaches to the manipulator arm and | ||
| drives articulation (or "tilt") and rotation of | ||
| the instrument tip ("roll"). Jaw actuation is | ||
| the same as the predicate. The | ||
| articulating adapter is covered by a | ||
| sterile, disposable drape before each use | ||
| like the Senhance capital equipment. |
A new reusable articulating coupler that
connects the articulating instruments to
the articulating adapter.
The articulating adapter is uniquely
matched to the articulating instruments.
The adapter has an embedded RFID tag
which is used by the manipulator arm to
identify which adapter is attached to the
instrument interface. This allows the icon
representing the instrument type to be
displayed to the surgeon on the functions
area of the cockpit monitor. | Five (5) different types of reusable
instrument adapters that connect to the
Senhance Surgical Instruments and
attach to the manipulator arm(s): passive
(non-energized), monopolar, bipolar,
ultrasonic, and endoscope.
Each adapter is uniquely matched to
each instrument or endoscope. Each
adapter has an embedded RFID tag
which is used by the manipulator arm to
identify which adapter is attached to the
instrument interface. This allows the icon
representing the instrument type or
endoscope to be displayed to the
surgeon on the functions area of the
cockpit monitor. |
| Equipment
Drapes | Single use, sterile equipment drapes
cover the manipulator arm and
instrument interface. The drapes are
classified as Class 2, 510(k)-exempt
devices under product code PUI.
A new single use, sterile, articulating
adapter drape pack is provided to cover
and connect the instrument interface and
articulating adapter during use. The
drapes are classified as Class 2, 510(k)-
exempt devices under product code PUI. | Single use, sterile equipment drapes
cover the manipulator arm and
instrument interface. The drapes are
classified as Class 2, 510(k)-exempt
devices under product code PUI. |
| Surgical
Instruments | Two new single use, sterile, laparoscopic
articulating instruments with an
articulating design at the distal tip that
simulates the human wrist. The
articulating instruments can bend up to
65 degrees when fully articulated.
Bipolar Atraumatic Grasper,
Articulating - 5mm diameter x
310mm shaft length Needle Driver, Articulating - 5mm
diameter x 310mm shaft length | A suite of reusable, laparoscopic
Senhance Surgical Instruments available
in a variety of sizes (diameters and
lengths), end effector designs, and
energy (passive, monopolar, bipolar,
ultrasonic) including:
Bipolar Large Grasping Forceps -
5mm diameter x 310mm shaft length Needle Holder Left/Right - 5mm
diameter x 310mm shaft length |
| Biocompatibility | The instruments are made from
biocompatible metals and plastics with a
long history of safe use and
demonstrated to be non-toxic, non- | The instruments are made from
biocompatible metals and plastics with a
long history of safe use and
demonstrated to be non-toxic, non- |
| Characteristic | Subject Device | Predicate Device |
| | irritating, non-sensitizing, and non-pyrogenic. | irritating, non-sensitizing, and non-pyrogenic. |
| Instruments
Rated Voltage | 5mm Bipolar Articulating Instrument @ 250 Vpeak | 5mm Bipolar Instruments @ 500 Vpeak |
| Compatible
Electrosurgical
Units (ESUs) | Compatible third-party ESUs include: Erbe VIO® 300 D Covidien ForceTriad™ Covidien/Valleylab Force FX™ CONMED System 5000™ The ESU connects directly to the articulating instrument using a bipolar ESU accessory cable, rather than to the adapter like with the predicate. The ESU is operated in the usual manner by the ESU's foot pedal positioned near the surgeon at the cockpit. There is no communication between the Senhance system and any ESU. | Compatible third-party ESUs include: Erbe VIO® 300 D Covidien ForceTriad™ Covidien/Valleylab Force FX™ CONMED System 5000™ ESUs connect to the adapters through monopolar or bipolar cables and provide energy directly to the instruments. The ESU is operated in the usual manner by the ESU's foot pedal positioned near the surgeon at the cockpit. There is no communication between the Senhance system and any ESU. |
Table 1. Substantial Equivalence Comparison
5
6
7
| Table 2. Reference Device Comparison | |||||
|---|---|---|---|---|---|
| -- | -- | -------------------------------------- | -- | -- | -- |
| Characteristic | Subject Device | Reference Device |
|---|---|---|
| Name | Senhance Articulating Instruments | Intuitive Surgical EndoWrist Instruments |
| for use with da Vinci Si Surgical System/ | ||
| IS3000 (K081137) | ||
| Instrument | ||
| Classification | Single Use Disposable (Gamma | |
| Sterilization) | Reusable, programmed with a maximum | |
| number of surgical procedures. They | ||
| must be cleaned, and steam sterilized by | ||
| the end user between uses. | ||
| Articulated | ||
| Instrument Types | ||
| and Dimensions | Two laparoscopic articulating instruments | |
| with an articulating design at the distal tip | ||
| that simulates the human wrist: | ||
| Bipolar Atraumatic Grasper, | ||
| Articulating - 5mm diameter x | ||
| 310mm shaft length Needle Driver, Articulating - 5mm | ||
| diameter x 310mm shaft length | A variety of articulating instruments | |
| consisting of graspers, dissectors, | ||
| needle drivers, scissors, monopolar | ||
| energy, bipolar energy, and clip appliers. | ||
| The EndoWrist instruments have an | ||
| articulating design at the distal tip that | ||
| simulates the human wrist and include: | ||
| Bipolar grasper – 8mm diameter x | ||
| ~310mm shaft length) Need driver – 8mm diameter x | ||
| ~310mm shaft length | ||
| Degrees of | ||
| Articulation | 0 degrees (straight) to 65 degrees (fully | |
| articulated) | 0 degrees (straight) to 90 degrees (fully | |
| articulated) |
8
7. Performance Data:
The following performance testing of the Senhance Articulating platform was conducted to demonstrate substantial equivalence of the device to the predicate.
Biocompatibility Testing: The Senhance Articulating instruments are considered tissue contacting for a limited duration of less than 24 hours for contact with tissue or bone. The articulating instruments were assessed in accordance with the FDA Guidance for Industry and FDA Staff on Use of International Standard ISO 10993-1, "Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process", and ISO 10993-1 "Biological Evaluation of Medical Devices - Part 1: Evaluation and Testing Within a Risk Management Process". Testing demonstrated that the patient-contacting portions of the Senhance Articulating instruments are non-toxic, non-irritating, non-sensitizing, and nonpyrogenic and do not result in an unacceptable adverse biological response resulting from contact of the devices' materials with the body.
Reprocessing, Cleaning, and Sterilization: The reusable coupler has cleaning instructions that were validated based on the quidelines outlined in AAMI TIR30:2011. A steam sterilization validation 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" and the FDA recognized consensus standards ANSI/AAMI/ISO 17665-1:2006/(R)2013 and ANSI/AAMI/ISO 14937:2009/(R)2013. The coupler was validated to a Sterility Assurance Level of 10-6 using the half cycle testing validation method.
The articulating adapter is non-sterile capital equipment and is used with a sterile equipment drape. The drape remains intact throughout the procedure and thereby maintains a sterile barrier. A cleaning compatibility study confirmed that the agents used during cleaning/disinfection are compatible with the materials of construction and markings of the adapter.
The single use articulating instruments are provided sterile to the end user via gamma irradiation. Gamma irradiation at a minimum dose of 25 kGy was validated per FDA recognized consensus standards ISO 11137-1:2006, ISO 11137-2:2013, and ISO 11137-3:2017 and demonstrated a Sterility Assurance Level of 10°. The packaging has been validated to maintain sterility for the stated shelf life of the device.
Bench Testing: Bench testing evaluated the performance of the Senhance Articulating instruments as well as compatibility of the Senhance Articulating platform when used with the Senhance Surgical System. The following tests confirmed that the articulating instruments perform as intended after tests of mechanical integrity under conditions of simulated use and that the Senhance system performs as intended when used with the subject Senhance Articulating platform:
- Cantilever Bending Reliability .
- . Jaw Actuation Reliability
9
- . Jaw Compensation
- . Electrosurgical Unit (ESU) Compatibility
- Sterile Drape Reliability
Electrical Safety and Compatibility: The Senhance Articulating platform used in conjunction with the Senhance system comply with the current versions of IEC 60601-1 (Basic safety and essential performance), IEC 60601-1-2 (Electromagnetic disturbances), IEC 60601-2-18 (Endoscopic equipment interactions), and IEC 60601-2-2 (High frequency surgical equipment).
Software Verification and Validation Testing: Software verification and validation were successfully conducted on the latest Senhance software version that supports the Senhance Articulating platform. Documentation was provided as recommended in FDA's Guidance for Industry and FDA Staff "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices". The software is considered as a "major" level of concern.
Pre-Clinical Design Validation: Design validation of the Senhance Articulating platform was conducted to ensure that the devices perform as intended according to defined user needs and intended uses when used with the Senhance system in a simulated use environment. A singlecenter, un-blinded, observational, simulated use design validation evaluation of the Senhance system used in conjunction with Senhance Articulating platform was conducted with users who represented the intended primary user population. The design validation was conducted in a simulated patient model. All applicable user level requirements were assessed and found to be met.
Usability Testing: Modifications to the existing Senhance system Usability Engineering file were made based on the addition of the new articulating platform. A summative usability validation study was performed with final instructions for use and training materials. In a simulated use environment, the surgical teams were able to independently perform all critical tasks without use errors that would lead to harm. This study demonstrated that the overall residual risk of use errors with the Senhance Articulating platform have been mitigated to an acceptable level. The Senhance Articulating platform used in conjunction with the Senhance system can be used without use errors or problems that could result in serious harm.
Conclusions
The Senhance Articulating platform used with the Senhance Surgical System is as safe and effective as the predicate Senhance Surgical System (K202166). The subject device has the same intended use/ indications for use and either identical or very similar technological characteristics and principles of operation as the predicate device. Any differences in technological characteristics between the subject and predicate devices have been addressed through a comprehensive set of testing using established test methods and do not raise any new or different questions of safety or effectiveness. Thus, the equivalence assessment and testing results support a determination of substantial equivalence to the predicate in terms of safety, efficacy, and performance.