(123 days)
No
The summary focuses on the mechanical and functional aspects of surgical instruments and adapters, with no mention of AI or ML capabilities. The performance studies described are standard engineering and validation tests for medical devices.
Yes
Explanation: The device is intended to assist in the manipulation of tissue for surgical procedures, including cutting, suturing, and electrocautery, which are therapeutic interventions.
No
The device description indicates it is a surgical system intended for endoscopic manipulation of tissue using laparoscopic instruments, not for diagnostic purposes.
No
The device description and performance studies clearly indicate the device includes physical instruments, adapters, and system components, not just software. Software validation is mentioned as one part of the overall testing, but it is not the sole component of the device.
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 describes a surgical system designed to assist in the control of laparoscopic instruments for manipulating tissue within the body during surgery. This is an in vivo (within a living organism) application, not an in vitro (outside the body, typically in a lab) diagnostic test.
- Device Description: The description focuses on surgical instruments and adapters used for physical manipulation of tissue.
- Lack of IVD Characteristics: There is no mention of analyzing samples (blood, tissue, etc.), detecting biomarkers, or providing diagnostic information based on laboratory tests.
Therefore, the Senhance Surgical System falls under the category of a surgical device, not an IVD.
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 laparoscopic gynecological surgery, colorectal surgery, cholecystectomy, and inguinal hernia repair. The system is indicated for adult use. It is intended for use by trained physicians in an operating room environment in accordance with the Instructions for Use.
Product codes
NAY
Device Description
The Senhance "Additional" surgical instruments and adapters are intended as additions to the predicate suite of instruments and adapters previously cleared for use with the TransEnterix Surgical System (Model Senhance™ - K171120 and K180163). All instruments and adapters are multi-use components that are steam sterilized by the end user before the first use and after each use. The instrument designs are adaptations of standard laparoscopic instruments that are commonly used in surgery. Each instrument type has a corresponding system adapter.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
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)
Bench Testing:
- Verification of Senhance System Force Feedback Response: Demonstrated that the Senhance system provides force feedback by measuring the forces presented to the device and conveying the force information proportionally to the user.
- Verification of Force Feedback Stability and Sensitivity: Demonstrated that the force feedback feature of the Senhance system properly dampens the haptic response signals from the Additional instruments to the cockpit handles.
- Verification of Senhance Manipulator Arm Fulcrum Feature: Demonstrated that the fulcrum feature of the Senhance system can be properly established for the Additional instruments.
- Verification of ESU Compatibility: Demonstrated that all third-party electrosurgical units (ESUs) that are compatible with the Senhance system are also compatible with the Additional instruments and adapters. Testing compared the rated voltage of the instruments with each ESU's manufacturer settings.
- Mechanical Verification Testing for Additional Instruments and Instrument Adapters: Demonstrated that the devices perform as intended when subjected to tests of mechanical integrity under conditions of simulated use. Cantilever Bending Reliability Testing Instrument Jaw Output Force Reliability Testing and Force to Jaw Failure Testing
- Clip Applier Ligation Performance: Demonstrated that the burst pressure of clips delivered by the Senhance Weck® Hem-o-lok Clip Applier when used with the Senhance system was not statistically different than the burst pressure of clips delivered by the legally marketed Teleflex Medical Hem-o-Lok® Clip Applier were not statistically different.
Biocompatibility:
- Biocompatibility evaluation and testing were performed to demonstrate that the patient-contacting portions of the subject Additional instruments: meet all applicable safety requirements related to material toxicity and biological responsiveness of limited contacting devices. do not result in an unacceptable adverse biological response resulting from contact of the devices' materials with the body. The results demonstrated that these components met the requirements of ISO 10993-1 with regard to Cytotoxicity, Sensitization, Irritation/Inflammatory Response (IR), Acute Systemic Toxicity, and Pyrogenicity.
Reprocessing, Cleaning, and Sterilization:
- Reprocessing/Cleaning: A cleaning effectiveness validation study was conducted consistent with the procedures and protocols utilized for the previously cleared instruments and adapters used with the Senhance system to confirm the overall effectiveness of the prescribed cleaning procedures. The test results demonstrated that the cleaning procedures for the Additional instruments and adapters allow them to be effectively cleaned according to the processing instructions provided in the labeling.
- Sterilization: A validation of the steam sterilization process was conducted to demonstrate a Sterility Assurance Level (SAL) of at least 10-6.
Electrical Safety and Compatibility:
- Electrical Safety and Electromagnetic Compatibility Testing: The Additional electrosurgical instruments fulfilled all applicable requirements to demonstrate that the instruments are compliant with the current electrical safety standard, IEC 60601-2-2:2017, Medical electrical equipment Part 2-2: Particular requirements for the basic safety and essential performance of high frequency surgical equipment and high frequency surgical accessories.
Software:
- Software: Software testing was conducted to demonstrate that the Senhance system software continues to reliably operate as designed with the addition of the new instruments and adapters.
Design Validation:
- Design Validation: Design Validation was conducted to ensure that the subject Additional instruments and adapters perform as intended according to defined user needs and intended uses, and to support substantial equivalence to the predicate devices cleared under K171120. The design validation was conducted in a porcine model, which was used to simulate key human anatomy. This validation used production-equivalent instruments and adapters in a simulated use environment.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
TransEnterix® Senhance™ Surgical System (K171120), TransEnterix® Senhance™ Surgical System Indication Expansion (K180163)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 876.1500 Endoscope and accessories.
(a)
Identification. An endoscope and accessories is a device used to provide access, illumination, and allow observation or manipulation of body cavities, hollow organs, and canals. The device consists of various rigid or flexible instruments that are inserted into body spaces and may include an optical system for conveying an image to the user's eye and their accessories may assist in gaining access or increase the versatility and augment the capabilities of the devices. Examples of devices that are within this generic type of device include cleaning accessories for endoscopes, photographic accessories for endoscopes, nonpowered anoscopes, binolcular attachments for endoscopes, pocket battery boxes, flexible or rigid choledochoscopes, colonoscopes, diagnostic cystoscopes, cystourethroscopes, enteroscopes, esophagogastroduodenoscopes, rigid esophagoscopes, fiberoptic illuminators for endoscopes, incandescent endoscope lamps, biliary pancreatoscopes, proctoscopes, resectoscopes, nephroscopes, sigmoidoscopes, ureteroscopes, urethroscopes, endomagnetic retrievers, cytology brushes for endoscopes, and lubricating jelly for transurethral surgical instruments. This section does not apply to endoscopes that have specialized uses in other medical specialty areas and that are covered by classification regulations in other parts of the device classification regulations.(b)
Classification —(1)Class II (special controls). The device, when it is an endoscope disinfectant basin, which consists solely of a container that holds disinfectant and endoscopes and accessories; an endoscopic magnetic retriever intended for single use; sterile scissors for cystoscope intended for single use; a disposable, non-powered endoscopic grasping/cutting instrument intended for single use; a diagnostic incandescent light source; a fiberoptic photographic light source; a routine fiberoptic light source; an endoscopic sponge carrier; a xenon arc endoscope light source; an endoscope transformer; an LED light source; or a gastroenterology-urology endoscopic guidewire, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 876.9.(2) Class I for the photographic accessories for endoscope, miscellaneous bulb adapter for endoscope, binocular attachment for endoscope, eyepiece attachment for prescription lens, teaching attachment, inflation bulb, measuring device for panendoscope, photographic equipment for physiologic function monitor, special lens instrument for endoscope, smoke removal tube, rechargeable battery box, pocket battery box, bite block for endoscope, and cleaning brush for endoscope. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807of this chapter, subject to the limitations in § 876.9.
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 followed by the full name of the agency, "U.S. Food & Drug Administration," on the right. The FDA part of the logo is in blue, with the acronym in a solid blue square and the agency's name in a lighter shade of blue.
October 9, 2018
TransEnterix, Inc. Kaitlyn Alexander Regulatory Affairs Specialist 635 Davis Drive, Suite 300 Morrisville, North Carolina 27560
Re: K181517
Trade/Device Name: TransEnterix Senhance Surgical System Regulation Number: 21 CFR 876.1500 Regulation Name: Endoscope and Accessories Regulatory Class: Class II Product Code: NAY Dated: September 4, 2018 Received: September 6, 2018
Dear Kaitlyn Alexander:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/ofdocs/ofpmn.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/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.html; 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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely. Jennifer R. Stevenson -S
For Binita S. Ashar, M.D., M.B.A., F.A.C.S. Director Division of Surgical Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K181517
Device Name
TransEnterix® Senhance™ Surgical System
Indications for Use (Describe)
The Senhance Surgical System is intended to assist in the accurate control of laparoscopic instruments for visualization and endoscopic manipulation of tissue including grasping, cutting, blunt and sharp dissection, approximation, ligation, electrocautery, suturing, mobilization and retraction. The Senhance Surgical System is intended for use in laparoscopic gynecological surgery, colorectal surgery, cholecystectomy, and inguinal hernia repair. The system is indicated for adult use. It is intended for use by trained physicians in an operating room environment in accordance with the Instructions for Use.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| ☑ Prescription Use (Part 21 CFR 801 Subpart D) | ☐ Over-The-Counter Use (21 CFR 801 Subpart C) |
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
Additional Senhance Surgical Instruments and Adapters
[In accordance with 21CFR 807.92]
| 510(k) Sponsor: | TransEnterix, Inc. |
|---|---|
| Address: | 635 Davis Drive, Suite 300 |
| Morrisville, NC 27713 | |
| Contact Person: | Kaitlyn Alexander |
| Regulatory Affairs Specialist | |
| Contact Information: | Email: kalexander@transenterix.com |
| Phone: 919.765.8400 ext. 8505 | |
| Facsimile: 919.765.8459 | |
| Date Summary Prepared: | 10/5/2018 |
| Proprietary (Trade) Name: | TransEnterix® 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 Devices: | TransEnterix® Senhance™ Surgical System (K171120) |
| TransEnterix® Senhance™ Surgical System Indication Expansion | |
| (K180163) |
4
Device Description:
The Senhance "Additional" surgical instruments and adapters are intended as additions to the predicate suite of instruments and adapters previously cleared for use with the TransEnterix Surgical System (Model Senhance™ - K171120 and K180163). All instruments and adapters are multi-use components that are steam sterilized by the end user before the first use and after each 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 End Effector | Diameter/Length (mm) | Monopolar End Effector | Diameter/Length (mm) | Bipolar End Effector | Diameter/Length (mm) |
|---|---|---|---|---|---|
| Atraumatic Single Action Grasper Cobra Grasper DeBakey Grasper Needle Holder Straight | 3/ 280 | Monopolar Maryland Dissector Monopolar Metzenbaum Scissors | 3/ 280 | None | None |
| Johan Grasper 15 mm Tip Kocher Grasper Allis Grasper Strong Grasper Mixter Dissector Needle Holder Left Needle Holder Right Fundus Grasper | 5/ 240 | Monopolar Maryland Dissector Monopolar Metzenbaum Scissors 18 mm Tip Monopolar Metzenbaum Scissors 15 mm Tip | 5/ 240 | Bipolar Large Grasping Forceps Bipolar Maryland Dissector Bipolar Curved Scissors Bipolar Shaft | 5/ 250 |
| Babcock Forceps Weck® Hem-o-lok® ML Clip Applier | 5/ 240 | ||||
| 5/ 310 | |||||
| 5/ 410 | None | None | Bipolar Curved Grasping Forceps | 5/ 250 | |
| 5/ 310 |
Additional Senhance Surgical Instruments
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 laparoscopic gynecological surgery, colorectal surgery,
5
cholecystectomy, and inguinal hernia repair. The system is indicated for adult use. It is intended for use by trained physicians in an operating room environment in accordance with the Instructions for Use.
Comparison with Predicate Device Intended Use/ Indications for Use:
The Additional surgical instruments and adapters have the same intended use/ indications for use as previously cleared for the Senhance system under K180163, which expanded the original clearance under K171120 to include cholecystectomy and inguinal hernia repair. There are no differences in how the Additional devices are used that alter the Senhance system's therapeutic effect or raise different questions of safety or effectiveness.
Technological Characteristics:
The Additional instruments and adapters are very similar to the predicate devices cleared under K171120, with some differences in length, diameter, end effector types, and voltage ratings.
Performance Data:
Performance testing of the Additional instruments and adapters was conducted to support substantial equivalence to the predicate device and demonstrated that the technological differences between the Additional instruments and adapters and the predicate devices did not raise any different questions of safety or effectiveness.
Testing and evaluation included mechanical verification, biocompatibility evaluation, validation of cleaning, reprocessing, and sterilization, electrical safety and electromagnetic compatibility, electrosurgical unit compatibility, software validation, and design validation.
Due to the similarity of the subject devices to the predicate devices, new usability and clinical testing were not necessary.
The testing conducted for the devices in this submission is summarized below:
Bench Testing:
| Test | Summary |
|---|---|
| Verification of Senhance | |
| System Force Feedback | |
| Response | Demonstrated that the Senhance system provides force feedback by |
| measuring the forces presented to the device and conveying the force | |
| information proportionally to the user. | |
| Verification of Force Feedback | |
| Stability and Sensitivity | Demonstrated that the force feedback feature of the Senhance system |
| properly dampens the haptic response signals from the Additional instruments | |
| to the cockpit handles. | |
| Verification of Senhance | |
| Manipulator Arm Fulcrum | |
| Feature | Demonstrated that the fulcrum feature of the Senhance system can be |
| properly established for the Additional instruments. |
6
| Test | Summary |
|---|---|
| Verification of ESU | |
| Compatibility | Demonstrated that all third-party electrosurgical units (ESUs) that are |
| compatible with the Senhance system are also compatible with the Additional | |
| instruments and adapters. Testing compared the rated voltage of the | |
| instruments with each ESU's manufacturer settings. | |
| Mechanical Verification | |
| Testing for Additional | |
| Instruments and Instrument | |
| Adapters | Demonstrated that the devices perform as intended when subjected to tests of |
| mechanical integrity under conditions of simulated use. | |
| Cantilever Bending Reliability Testing Instrument Jaw Output Force Reliability Testing and Force to Jaw | |
| Failure Testing | |
| Clip Applier Ligation | |
| Performance | Demonstrated that the burst pressure of clips delivered by the Senhance |
| Weck® Hem-o-lok Clip Applier when used with the Senhance system was not | |
| statistically different than the burst pressure of clips delivered by the legally | |
| marketed Teleflex Medical Hem-o-Lok® Clip Applier were not statistically | |
| different. |
Biocompatibility:
| Test | Summary |
|---|---|
| Biocompatibility | Biocompatibility evaluation and testing were performed to demonstrate that |
| the patient-contacting portions of the subject Additional instruments: | |
| meet all applicable safety requirements related to material toxicity and | |
| biological responsiveness of limited contacting devices. do not result in an unacceptable adverse biological response resulting | |
| from contact of the devices' materials with the body. The results demonstrated that these components met the requirements of ISO | |
| 10993-1 with regard to Cytotoxicity, Sensitization, Irritation/Inflammatory | |
| Response (IR), Acute Systemic Toxicity, and Pyrogenicity. |
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 instruments and | |
| adapters used with the Senhance system to confirm the overall effectiveness of | |
| the prescribed cleaning procedures. The test results demonstrated that the | |
| cleaning procedures for the Additional instruments and adapters allow them to | |
| be effectively cleaned according to the processing instructions provided in the | |
| labeling. | |
| Sterilization | A validation of the steam sterilization process was conducted to demonstrate a |
| Sterility Assurance Level (SAL) of at least 10-6. |
7
Electrical Safety and Compatibility:
| Test | Summary |
|---|---|
| Electrical Safety and | |
| Electromagnetic | |
| Compatibility Testing | The Additional electrosurgical instruments fulfilled all applicable requirements |
| to demonstrate that the instruments are compliant with the current electrical | |
| safety standard, IEC 60601-2-2:2017, Medical electrical equipment Part 2-2: | |
| Particular requirements for the basic safety and essential performance of high | |
| frequency surgical equipment and high frequency surgical accessories. |
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 | |
| instruments and adapters. |
Design Validation:
| Test | Summary |
|---|---|
| Design Validation | Design Validation was conducted to ensure that the subject Additional |
| instruments and adapters perform as intended according to defined user needs | |
| and intended uses, and to support substantial equivalence to the predicate | |
| devices cleared under K171120. The design validation was conducted in a | |
| porcine model, which was used to simulate key human anatomy. This validation | |
| used production-equivalent instruments and adapters in a simulated use | |
| environment, |
Conclusions/ Substantial Equivalence:
The data acquired from the performance testing and software testing of the TransEnterix® Additional Senhance™ Surgical Instruments and Adapters, as summarized herein, demonstrate that the devices are as safe and effective and perform similarly to the predicate devices cleared under K171120. The intended use/ indications for use for the subject devices are identical to those cleared under K180163. The Additional instruments and adapters 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.