(60 days)
Not Found
No
The document explicitly states "Mentions AI, DNN, or ML: Not Found" and the description focuses on mechanical components and software reliability without mentioning AI/ML functionalities.
No
Explanation: The device is intended to assist in surgical procedures by controlling laparoscopic instruments for visualization and manipulation of tissue, which are actions performed by the surgeon, not therapeutic actions by the device itself. It is a surgical aid, not a device that directly treats a disease or condition.
No
The Senhance Surgical System is intended to assist in the control of laparoscopic instruments for manipulation of tissue during surgical procedures, not for diagnosing conditions.
No
The device description explicitly states it is an "Articulating platform" and includes "Articulating Adapter and two (2) Articulating Couplers," which are hardware components. The performance studies also include bench testing and reprocessing/cleaning/sterilization, which are relevant to hardware.
Based on the provided information, the Senhance® Surgical System is not an In Vitro Diagnostic (IVD) 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 during surgical procedures. This is an in-vivo (within a living organism) application, not an in-vitro (outside of a living organism) diagnostic test.
- Device Description: The description focuses on the mechanical components (adapters, couplers, instruments) used for surgical manipulation.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue samples, etc.), detecting specific analytes, or providing diagnostic information based on laboratory testing.
- Performance Studies: The performance studies described are related to the mechanical reliability, reprocessing, electrical safety, software operation, and usability of the surgical system, not the accuracy or performance of a diagnostic test.
In summary, the Senhance® Surgical System is a surgical tool designed to assist physicians in performing laparoscopic procedures, not a device used for diagnosing diseases or conditions by testing samples outside the body.
N/A
Intended Use / Indications for Use
The Senhance® Surgical System is intended to assist in the accurate control of laparoscopic instruments for visualization and endoscopic manipulation of tissue including grasping, cutting, blunt and sharp dissection, approximation, ligation, electrocautery, suturing, mobilization and retraction. The Senhance Surgical System is intended for use in general laparoscopic surgical procedures and laparoscopic gynecological surgery. The system is indicated for adult use. It is intended for use by trained physicians in an operating room environment in accordance with the Instructions for Use.
Product codes (comma separated list FDA assigned to the subject device)
NAY
Device Description
The Senhance Articulating platform (internally named Articulating Be4) is intended as an addition to the suite of adapters, couplers and instruments previously cleared for use with the Senhance Surgical System ("Senhance System") most recently cleared under K212054 which is being used as the predicate. This submission requests clearance for one (1) new Articulating Adapter and two (2) Articulating Couplers to be used with the existing articulating instruments. A representative image of the assembled adapter and coupler are shown in Figure 1.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Abdomen and pelvis
Indicated Patient Age Range
Adult Patients
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)
Bench Testing: Bench testing evaluated the performance of the Senhance Articulating instruments as well as compatibility of the Senahance Articulating platform when used with 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. Sterile Drape Reliability Cantilever Bending Reliability Jaw Actuation Reliability Coupler Use Life.
Reprocessing/Cleaning: A cleaning effectiveness validation study was conducted consistent with the procedures and protocols utilized for the previously cleared coupler used with the Senhance Surgical System to confirm the overall effectiveness of the prescribed cleaning procedures. The test results demonstrated that the cleaning procedures for the modified articulating couplers allow them to be effectively cleaned according to the processing instructions provided in the labeling.
Sterilization: A validation of the steam sterilization process for the modified articulating couplers was conducted to demonstrate a Sterility Assurance Level (SAL) of at least 10^-6.
Electrical Safety Testing: The Senhance Articulating platform used in conjunction with the Senhance system comply with 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: Software testing was conducted to demonstrate that the Senhance system software continues to reliably operate as designed with the addition of the new adapter and couplers.
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 single-center, 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: 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.
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.
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.
Not Found
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). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA acronym with the full name of the agency on the right. The FDA part of the logo is in blue, with the acronym in a square and the full name written out to the right of the square.
May 27, 2022
Asensus Surgical, Inc. Casey Hinckley Regulatory Affairs Manager 1 TW Alexander Drive, Suite 160 Durham. North Carolina 27703
Re: K220889
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: May 2, 2022 Received: May 3, 2022
Dear Casey Hinckley:
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
1
801): medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device (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 Assistant Director DHT4A: Division of General Surgery Devices OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
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 and retraction. The Senhance Surgical System is intended for use in general laparoscopic surgical procedures and laparoscopic gynecological surgery. The system is indicated for adult use. It is intended for use by trained physicians in an operating room environment in accordance with the Instructions for Use.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| ☑ Prescription Use (Part 21 CFR 801 Subpart D) | ☐ Over-The-Counter Use (21 CFR 801 Subpart C) |
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3
Special 510(k) SUMMARY
Senhance® Articulating Platform
for use with the Senhance Surgical System
[In accordance with 21CFR 807.92]
| 510(k) Sponsor: | Asensus Surgical, Inc. |
|---|---|
| Address: | 1 TW Alexander Drive, Suite 160 |
| Durham, NC 27703 | |
| Contact Person: | Casey Hinckley |
| Regulatory Affairs Manager | |
| Contact Information: | Email: chinckley@asensus.com |
| Phone: 801.310.5491 | |
| Date Summary Prepared: | 3/22/2022 |
| Proprietary (Trade) Name: | Asensus Surgical® Senhance® Surgical System |
| Common Name: | 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 (K212054) |
CONFIDENTIAL
4
Device Description:
The Senhance Articulating platform (internally named Articulating Be4) is intended as an addition to the suite of adapters, couplers and instruments previously cleared for use with the Senhance Surgical System ("Senhance System") most recently cleared under K212054 which is being used as the predicate. This submission requests clearance for one (1) new Articulating Adapter and two (2) Articulating Couplers to be used with the existing articulating instruments. A representative image of the assembled adapter and coupler are shown in Figure 1.
Image /page/4/Picture/3 description: The image shows a blue articulating instrument. The instrument has a white articulating instrument adapter and an articulating instrument coupler. The instrument is long and cylindrical, with a black cable attached to the back.
Figure 1, Senhance Articulating Platform
Intended Use/ Indications for Use:
The Senhance® Surgical System is intended to assist in the accurate control of laparoscopic instruments for visualization and endoscopic manipulation of tissue including grasping, cutting, blunt and sharp dissection, approximation, ligation, electrocautery, suturing, mobilization and retraction. The Senhance Surgical System is intended for use in general laparoscopic surgical procedures and laparoscopic gynecological surgery. The system is indicated for adult use. It is intended for use by trained physicians in an operating room environment in accordance with the Instructions for Use.
Comparison with Predicate Device Intended Use/ Indications for Use:
The Senhance Articulating platforms proposed adapter and couplers have the same intended use/ indications for use as previously cleared Senhance system under K212054. There are no differences in how the Senhance Articulating platform manipulates the instruments that alter the Senhance system's therapeutic effect or raise different questions of safety or effectiveness.
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 devices' technological characteristics and principles of operation are identical or very similar to those of the predicate. Any differences in technological characteristics between the subject and predicate devices have been
Senhance® Articulating Platform Special 510(k) Asensus Surgical, Inc.
37
5
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 | Modified Senhance Articulating | |
| Platform for use with the Senhance | ||
| Surgical System | Senhance Articulating Platform for | |
| use with the Senhance Surgical | ||
| System | ||
| K212054 | ||
| Classification/ | ||
| Product Code | Class II, NAY (System, Surgical, | |
| Computer Controlled Instrument) | Class II, NAY (System, Surgical, | |
| Computer Controlled Instrument) | ||
| Intended Use/ | ||
| Indications for | ||
| Use | The Senhance® Surgical System is | |
| intended to assist in the accurate | ||
| control of laparoscopic instruments | ||
| for visualization and endoscopic | ||
| manipulation of tissue including | ||
| grasping, cutting, blunt and sharp | ||
| dissection, approximation, ligation, | ||
| electrocautery, suturing, | ||
| mobilization and retraction. The | ||
| Senhance Surgical System is | ||
| intended for use in general | ||
| laparoscopic surgical procedures | ||
| and laparoscopic gynecological | ||
| surgery. The system is indicated for | ||
| adult use. It is intended for use by | ||
| trained physicians in an operating | ||
| room environment in accordance | ||
| with the Instructions for Use. | The Senhance® Surgical System is | |
| intended to assist in the accurate | ||
| control of laparoscopic instruments | ||
| for visualization and endoscopic | ||
| manipulation of tissue including | ||
| grasping, cutting, blunt and sharp | ||
| dissection, approximation, ligation, | ||
| electrocautery, suturing, | ||
| mobilization and retraction. The | ||
| Senhance Surgical System is | ||
| intended for use in general | ||
| laparoscopic surgical procedures | ||
| and laparoscopic gynecological | ||
| surgery. The system is indicated for | ||
| adult use. It is intended for use by | ||
| trained physicians in an operating | ||
| room environment in accordance | ||
| with the Instructions for Use. | ||
| Target | ||
| Population | Adult Patients | Adult Patients |
| Anatomical | ||
| Areas | ||
| of Use | Abdomen and pelvis | Abdomen and pelvis |
| Software | ||
| Version | Senhance Software Version 2.7.1.52 | Senhance Software Version |
| 2.6.0.282 |
| Table 1, Substantial Equivalence Comparison | |
|---|---|
6
| Characteristic | Subject Device | Predicate Device |
|---|---|---|
| Articulating | ||
| Instrument | ||
| Adapter | Motorized articulating adapter that | |
| attaches to the manipulator arm | ||
| and drives articulation (or "tilt") and | ||
| rotation of the instrument tip | ||
| ("roll"), while jaw actuation | ||
| continues to be driven by actuation | ||
| of the trolley pin in the adapter like | ||
| the predicate. The articulating | ||
| adapter is covered by a sterile, | ||
| disposable drape before each use | ||
| like the Senhance capital | ||
| equipment. The adapter has a | ||
| pocket compartment and latch for | ||
| attaching the articulating | ||
| instrument couplers. | Motorized articulating adapter that | |
| attaches to the manipulator arm and | ||
| drives articulation (or "tilt") and | ||
| rotation of the instrument tip | ||
| ("roll"), while jaw actuation | ||
| continues to be driven by actuation | ||
| of the trolley pin in the adapter like | ||
| the predicate. The articulating | ||
| adapter is covered by a sterile, | ||
| disposable drape before each use | ||
| like the Senhance capital | ||
| equipment. | ||
| Articulating | ||
| Instrument | ||
| Couplers | Reusable instrument specific | |
| articulating couplers that connect | ||
| the articulating instruments to the | ||
| articulating adapter. | Reusable articulating coupler that | |
| connects the articulating | ||
| instruments to the articulating | ||
| adapter. | ||
| Equipment | ||
| Drapes | Single use, sterile, articulating | |
| adapter drape pack is provided to | ||
| cover the articulating adapter | ||
| during use. The pack includes an | ||
| instrument interface drape with a | ||
| right-angle USB Type-C cable | ||
| connector, an articulating adapter | ||
| drape with an integrated USB Type- | ||
| C cable and a tear-away portion to | ||
| further ensure the preservation of | ||
| the sterile barrier. | ||
| The drapes are manufactured by | ||
| DAS Medical and are classified as | ||
| Class 2, 510(k)-exempt devices | ||
| under product code PUI. | Single use, sterile, articulating | |
| adapter drape pack is provided to | ||
| cover the instrument interface and | ||
| articulating adapter during use. The | ||
| pack includes an instrument | ||
| interface drape with a right-angle | ||
| USB Type-C cable connector and an | ||
| articulating adapter drape with an | ||
| integrated USB Type-C cable. The | ||
| drapes are manufactured by DAS | ||
| Medical and are classified as Class 2, | ||
| 510(k)-exempt devices under | ||
| product code PUI. | ||
| Characteristic | Subject Device | Predicate Device |
| Articulating | ||
| Instruments | Single use, sterile, laparoscopic articulating instruments with an articulating design at the distal tip that simulates the human wrist. The 5mm x 310mm articulating instruments include a bipolar grasper and needle driver. | Single use, sterile, laparoscopic articulating instruments with an articulating design at the distal tip that simulates the human wrist. The 5mm x 310mm articulating instruments include a bipolar grasper and needle driver. |
| Biocompatibility | The instruments are made from biocompatible metals and plastics with a long history of safe use and demonstrated to be non-toxic, non-irritating, non-sensitizing, and non-pyrogenic. | The instruments are made from biocompatible metals and plastics with a long history of safe use and demonstrated to be non-toxic, non-irritating, non-sensitizing, and non-pyrogenic. |
7
Performance Data:
The following performance testing of the Senhance Articulating platform was conducted to demonstrate substantial equivalence of the device to the predicate.
Bench Testing:
| Test | Summary |
|---|---|
| Bench Testing | Bench testing evaluated the performance of the Senhance Articulating instruments as well as compatibility of the Senahance Articulating platform when used with 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. Sterile Drape Reliability Cantilever Bending Reliability Jaw Actuation Reliability Coupler Use Life |
Reprocessing, Cleaning, and Sterilization:
| Test | Summary |
|---|---|
| Reprocessing/ Cleaning | A cleaning effectiveness validation study was conducted consistent with the |
| procedures and protocols utilized for the previously cleared coupler used | |
| with the Senhance Surgical System to confirm the overall effectiveness of the | |
| prescribed cleaning procedures. The test results demonstrated that the | |
| cleaning procedures for the modified articulating couplers allow them to be |
Asensus Surgical, Inc. Senhance® Articulating Platform Special 510(k)
8
| | effectively cleaned according to the processing instructions provided in the
labeling. |
|---------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Sterilization | A validation of the steam sterilization process for the modified articulating
couplers was conducted to demonstrate a Sterility Assurance Level (SAL) of
at least $10^{-6}$ . |
Electrical Safety and Compatibility:
| Test | Summary |
|---|---|
| Electrical Safety Testing | The Senhance Articulating platform used in conjunction with the Senhance |
| system comply with 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:
| Test | Summary |
|---|---|
| Software | Software testing was conducted to demonstrate that the Senhance system |
| software continues to reliably operate as designed with the addition of the | |
| new adapter and couplers. |
Design Validation:
| Test | Summary |
|---|---|
| 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 single-center, 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:
| Test | Summary |
|---|---|
| Usability Testing | 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 |
Asensus Surgical, Inc. Senhance® Articulating Platform Special 510(k)
9
| risk of use errors with the Senhance Articulating platform have been mitigated to an acceptable level. | |
|---|---|
| -------------------------------------------------------------------------------------------------------- | -- |
Conclusions/ Substantial Equivalence:
The data acquired from the performance testing and software testing of the Senhance Articulating platforms adapter and couplers, as summarized herein, demonstrate that the devices are as safe and effective and perform similarly to the predicate devices cleared under K212054. The intended use/ indications for use for the subject devices are identical to those cleared under K212054. The Senhance Articulating platforms adapter and couplers do not raise any new issues of safety or effectiveness when compared to the predicate devices, thus, they are substantially equivalent to the predicate devices.