(29 days)
No
The summary describes a surgical system and new instruments, focusing on mechanical, electrical, and software verification. There is no mention of AI or ML capabilities in the intended use, device description, or performance studies.
Yes
The device, described as the Senhance Surgical System, is intended to assist in various surgical manipulations and procedures, which are forms of therapy. It directly performs actions on tissue for diagnostic or therapeutic purposes, fitting the definition of a therapeutic device.
No
The device is described as assisting in the control of laparoscopic instruments for manipulation of tissue during surgery, which is a therapeutic function, not a diagnostic one.
No
The device description explicitly mentions physical instruments (bipolar surgical instruments and adapters) and discusses hardware-related testing such as mechanical verification, electrical safety, and reprocessing. While software is mentioned, it is in the context of ensuring compatibility with the existing system, not as the sole component of the device.
Based on the provided text, 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 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 (in glass, or outside the body) diagnostic test.
- Device Description: The device is described as surgical instruments and adapters used with a surgical system. This aligns with surgical tools, not diagnostic tests performed on samples.
- Lack of Diagnostic Elements: There is no mention of analyzing biological samples (blood, urine, tissue, etc.) or providing diagnostic information about a patient's condition. The focus is entirely on facilitating surgical procedures.
Therefore, the Senhance Surgical System and its associated instruments are surgical devices, not IVDs.
N/A
National:
Intended Use / Indications for Use
The Senhance Surgical System is intended to assist in the accurate control of laparoscopic instruments for visualization and endoscopic manipulation of tissue including grasping, cutting, blunt and sharp dissection, approximation, ligation, electrocautery, suturing, mobilization. The Senhance Surgical System is intended for use in laparoscopic gynecological surgery, colorectal surgery, cholecystectorny, and inguinal hernia repair. The system is indicated for adult use. It is intended for use by trained physicians in an operating room environment in accordance with the instructions for use.
Product codes (comma separated list FDA assigned to the subject device)
NAY
Device Description
The Senhance 3 mm bipolar surgical instruments and adapters are additions to the suite of bipolar instruments and adapters previously cleared for use with the Senhance Surgical System (K181517). The instrument designs are adaptations of standard laparoscopic instruments that are commonly used in surgery. Each instrument type has a corresponding system adapter. All instruments and adapters are multi-use devices that are steam sterilized by the end user before the first use and after each use. The Senhance 3 mm bipolar instruments include:
- . Bipolar Maryland Dissector – diameter 3 mm / length 280 mm
- . Bipolar Grasping Forceps - diameter 3 mm / length 280 mm
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 use.
Intended User / Care Setting
trained physicians in an operating room environment
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Performance testing of the Senhance 3 mm bipolar instruments and adapters was conducted to support substantial equivalence to the predicate device and demonstrated that the technological differences between the 3 mm bipolar instruments and adapters and the predicate devices did not raise any different questions of safety or effectiveness.
Testing and evaluation included mechanical verification of cleaning and sterilization, electrical safety, electrosurgical unit compatibility, software verification, and design validation.
The 3 mm bipolar devices are cleaned and sterilized in the same way as the predicate devices. Due to the similarity of the subject devices to the predicate devices, no other testing was necessary.
Bench Testing:
- Mechanical Verification Testing for 3 mm Bipolar Instruments and Adapter: 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 Jaw Force to Failure Testing Bipolar Jaw Spreading Force
- Verification of ESU Compatibility: Demonstrated that all third-party electrosurgical units (ESUs) that are compatible with the Senhance Surgical System are also compatible with the 3 mm bipolar instruments and adapters. Testing compared the rated voltage of the instruments with each ESU's manufacturer settings.
Reprocessing, Cleaning, and Sterilization:
- Reprocessing/ Cleaning: A cleaning effectiveness validation study was conducted consistent with the procedures and protocols utilized for the previously cleared adapters 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 3 mm bipolar adapters 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 3 mm bipolar adapters was conducted to demonstrate a Sterility Assurance Level (SAL) of at least 10^-6.
Electrical Safety and Compatibility:
- Electrical Safety Testing: The 3 mm bipolar instruments and adapters 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 3 mm bipolar 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 K181517. 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): 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.
TransEnterix® Senhance™ Surgical System (K181517)
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.
Bissinger Powergrip Bipolar Coagulation Forceps (K033177), TransEnterix® Senhance™ Surgical System (K171120)
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.
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Image /page/0/Picture/0 description: The image contains the logos of the Department of Health & Human Services and the Food and Drug Administration (FDA). The Department of Health & Human Services logo is on the left, and the FDA logo is on the right. The FDA logo includes the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.
December 6, 2018
TransEnterix, Inc. Michele Jans Sr. Manager, Regulatory Affairs 635 Davis Drive, Suite 300 Morrisville, North Carolina 27560
Re: K183098
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: November 6, 2018 Received: November 7, 2018
Dear Michele Jans:
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/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,
Long H. Chen Digitally signed by Long
H. Chen -S Date: 2018.12.06 12:49:08 -5 -05'00' 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
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Indications for Use
510(k) Number (if known) K183098
Device Name TransEnterix® SenhanceTM Surgical System
Indications for Use (Describe)
The Senhance Surgical System is intended to assist in the accurate control of laparoscopic instruments for visualization and endoscopic manipulation of tissue including grasping, cutting, blunt and sharp dissection, approximation, ligation, electrocautery, suturing, mobilization. The Senhance Surgical System is intended for use in laparoscopic gynecological surgery, colorectal surgery, cholecystectorny, and inguinal hernia repair. The system is indicated for adult use. It is intended for use by trained physicians in an operating room environment in accordance with the instructions for use.
Type of Use (Select one or both, as applicable)
Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
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510(k) SUMMARY
Senhance 3 mm Bipolar 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: | Michele Jans |
| Sr. Manager, Regulatory Affairs | |
| Contact Information: | Email: mjans@transenterix.com |
| Phone: 919.765.8420 | |
| Facsimile: 919.765.8459 | |
| Date Summary Prepared: | 12/5/2018 |
| 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 (K181517) |
| Reference Devices | Bissinger Powergrip Bipolar Coagulation Forceps (K033177) |
| TransEnterix® Senhance™ Surgical System (K171120) |
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Device Description:
The Senhance 3 mm bipolar surgical instruments and adapters are additions to the suite of bipolar instruments and adapters previously cleared for use with the Senhance Surgical System (K181517). The instrument designs are adaptations of standard laparoscopic instruments that are commonly used in surgery. Each instrument type has a corresponding system adapter. All instruments and adapters are multi-use devices that are steam sterilized by the end user before the first use and after each use. The Senhance 3 mm bipolar instruments include:
- . Bipolar Maryland Dissector – diameter 3 mm / length 280 mm
- . Bipolar Grasping Forceps - diameter 3 mm / length 280 mm
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, cholecystectorny, 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 Senhance 3 mm bipolar instruments and adapters have the same intended use/ indications for use as previously cleared for the Senhance system under K181517. There are no differences in how the 3mm bipolar devices are used that alter the Senhance system's therapeutic effect or raise different questions of safety or effectiveness.
Technological Characteristics:
The Senhance 3 mm bipolar instruments and adapters are very similar to the predicate devices cleared under K181517, with differences in diameter, length, and voltage ratings. The patient contacting instruments are made of the same biocompatible materials as the Reference devices.
Performance Data:
Performance testing of the Senhance 3 mm bipolar instruments and adapters was conducted to support substantial equivalence to the predicate device and demonstrated that the technological differences between the 3 mm bipolar instruments and adapters and the predicate devices did not raise any different questions of safety or effectiveness.
Testing and evaluation included mechanical verification of cleaning and sterilization, electrical safety, electrosurgical unit compatibility, software verification, and design validation.
The 3 mm bipolar devices are cleaned and sterilized in the same way as the predicate devices. Due to the similarity of the subject devices to the predicate devices, no other testing was necessary.
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The testing conducted for the devices in this submission is summarized below:
Bench Testing:
| Test | Summary |
|---|---|
| Mechanical Verification | |
| Testing for 3 mm Bipolar | |
| Instruments and Adapter | 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 Jaw Force to | |
| Failure Testing Bipolar Jaw Spreading Force | |
| Verification of ESU | |
| Compatibility | Demonstrated that all third-party electrosurgical units (ESUs) that are |
| compatible with the Senhance Surgical System are also compatible with the 3 | |
| mm bipolar instruments and adapters. Testing compared the rated voltage of | |
| the instruments with each ESU's manufacturer settings. |
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 adapters 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 3 mm bipolar adapters 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 3 mm bipolar adapters |
| was conducted to demonstrate a Sterility Assurance Level (SAL) of at least $10^{-6}$ . |
Electrical Safety and Compatibility:
| Test | Summary |
|---|---|
| Electrical Safety Testing | The 3 mm bipolar instruments and adapters 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. |
6
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 3 mm bipolar |
| 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 K181517. 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 Senhance 3 mm bipolar instruments and adapters, as summarized herein, demonstrate that the devices are as safe and effective and perform similarly to the predicate devices cleared under K181517. The intended use/ indications for use for the subject devices are identical to those cleared under K181517. The Senhance 3 mm bipolar 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.