(45 days)
TransEnterix Senhance® Surgical System (K191482)
No
The summary describes a surgical instrument (Monopolar L-Hook Electrode) and adapter for a robotic surgical system, focusing on its physical characteristics, materials, and performance testing related to safety and effectiveness as an instrument. There is no mention of AI or ML capabilities in the instrument or its interaction with the robotic system in this summary.
Yes
The device is described as assisting in surgical procedures like grasping, cutting, and electrocautery, which are therapeutic interventions.
No
The device is described as assisting in the accurate control of laparoscopic instruments for visualization and endoscopic manipulation of tissue (e.g., grasping, cutting, suturing). This is a surgical tool, not a device for diagnosis.
No
The device description explicitly details physical hardware components (instrument, adapter, shaft, electrode, ceramic collar) and mentions mechanical verification, cleaning, sterilization, biocompatibility, and electrical safety testing, indicating it is a hardware device with potential software control as part of a larger system.
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 the control of laparoscopic instruments for direct manipulation of tissue within the body (grasping, cutting, suturing, etc.). This is an in vivo procedure.
- Device Description: The device is described as a surgical instrument (Monopolar L-Hook Electrode) used with a robotic system for surgical procedures.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens derived from the human body (blood, urine, tissue samples, etc.) to provide information for diagnosis, monitoring, or screening.
IVD devices are used to perform tests outside of the body on samples taken from the body. This device is used inside the body during surgery.
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 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 (comma separated list FDA assigned to the subject device)
NAY
Device Description
The Senhance® 3 mm Monopolar L-Hook Electrode instrument and adapter are intended as additions to the suite of monopolar hook instruments and adapters initially cleared for use with the TransEnterix Senhance Surgical System through K171120 (October 13, 2017) and then expanded through K191482 (July 11, 2019). The subject instrument and adapter are modifications of the predicate TransEnterix Senhance 5 mm Monopolar L-Hook Electrode instrument and adapter FDA cleared through K191482.
Like the predicate devices, the subject devices are multi-use surgical devices that are cleaned and steam sterilized by the end user before the first use and after each use. The subject and predicate instruments consist of a polymer coated stainless steel shaft with an electrode at the distal end and a ceramic collar between the two to provide monopolar insulation. In order to be used with the Senhance Surgical System, the typical manual laparoscopic handle at the proximal end of the instrument is removed and replaced by a connector that mates with an adapter. The adapter provides the mechanism which allows the instrument to interface with the robotic manipulator arm of the Senhance Surgical System. Each instrument is laser marked with a unique identification number that matches its corresponding 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 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 Monopolar L-Hook Electrode instrument and adapter was conducted in order to support substantial equivalence to the predicate devices and demonstrated that the technological differences between the subject devices and predicate devices do not raise any different questions of safety or effectiveness.
Performance testing included mechanical verification of cleaning effectiveness, biocompatibility evaluation, electrical safety, and electrosurgical unit (ESU) compatibility. Due to the similarity of the subject devices to the predicate devices, no other testing was necessary.
Biocompatibility testing: The Senhance Monopolar L-Hook Electrode instrument is categorized as tissue contacting for a limited duration of less than 24 hours for contact with tissue or bone. The instrument was assessed in accordance with the FDA Guidance for Industry and FDA Staff "Use of International Standard ISO 10993-1, Biological evaluation of medical devices – Part 1: Evaluation and testing within a risk management process issued on June 16, 2016, and International Standard ISO 10993-1, Biological evaluation of medical devices – Part 1: Evaluation and testing within a risk management process. Testing demonstrated that the patient-contacting portions of the Senhance Monopolar L-Hook Electrode instrument are non-toxic, non-irritating, and do not result in an unacceptable adverse biological response resulting from contact of the device's materials with the body.
Reprocessing, Cleaning, and Sterilization: The reusable Senhance Monopolar L-Hook Electrode instrument was tested for cleaning effectiveness to confirm the overall effectiveness of the prescribed cleaning procedures. The cleaning procedures and test protocols for the testing are consistent with the procedures and protocols utilized for the predicate instrument. The test results demonstrated that the cleaning procedures allows for the subject instrument to be effectively cleaned according to the processing instructions provided in the labeling.
Performance Testing: Testing evaluated the performance of the Senhance Monopolar L-Hook Electrode instrument as well as compatibility of the subject devices when used with the Senhance Surgical System. Mechanical verification testing confirmed that the subject devices perform as intended after tests of mechanical integrity under conditions of simulated use. Additionally, ESU compatibility testing demonstrated that all third-party ESUs that are compatible with the Senhance system are also compatible with the subject devices.
Electrical Safety and Compatibility: The monopolar hook instrument fulfilled all applicable requirements to demonstrate compliance with the current electrical safety standards, IEC 60601-2-2, 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, and IEC 60601-2-18, Medical Electrical Equipment - Part 2-18: Particular Requirements For The Basic Safety And Essential Performance Of Endoscopic Equipment.
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 (K191482)
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.
TransEnterix Senhance® Surgical System (K181517)
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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November 22, 2019
TransEnterix, Inc. Kaitlyn Alexander Senior Regulatory Affairs Specialist 635 Davis Drive, Suite 300 Morrisville, North Carolina 27560
Re: K192877
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: October 7, 2019 Received: October 8, 2019
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/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
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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 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 (OS) 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 mediation-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,
Jitendra Virani Acting 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
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Indications for Use
510(k) Number (if known)
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. 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) |
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510(k) Summary
Senhance® 3 mm Monopolar Hook Instrument and Adapter
[In accordance with 21CFR 807.92]
1. Submitter
| 510(k) Sponsor: | TransEnterix, Inc. |
|---|---|
| Address: | 635 Davis Drive, Suite 300 |
| Morrisville, NC 27560 | |
| Contact Person: | Kaitlyn Alexander |
| Senior Regulatory Affairs Specialist | |
| Contact Information: | Email: kalexander@transenterix.com |
| Phone: 919-765-8400 x8505 | |
| Facsimile: 919.765.8459 | |
| Date Summary Prepared: | 10/4/2019 |
| 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 Device | |
| Predicate Device: | TransEnterix Senhance® Surgical System (K191482) |
| Reference Device: | TransEnterix Senhance® Surgical System (K181517) |
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4. Device Description:
The Senhance® 3 mm Monopolar L-Hook Electrode instrument and adapter are intended as additions to the suite of monopolar hook instruments and adapters initially cleared for use with the TransEnterix Senhance Surgical System through K171120 (October 13, 2017) and then expanded through K191482 (July 11, 2019). The subject instrument and adapter are modifications of the predicate TransEnterix Senhance 5 mm Monopolar L-Hook Electrode instrument and adapter FDA cleared through K191482.
Like the predicate devices, the subject devices are multi-use surgical devices that are cleaned and steam sterilized by the end user before the first use and after each use. The subject and predicate instruments consist of a polymer coated stainless steel shaft with an electrode at the distal end and a ceramic collar between the two to provide monopolar insulation. In order to be used with the Senhance Surgical System, the typical manual laparoscopic handle at the proximal end of the instrument is removed and replaced by a connector that mates with an adapter. The adapter provides the mechanism which allows the instrument to interface with the robotic manipulator arm of the Senhance Surgical System. Each instrument is laser marked with a unique identification number that matches its corresponding adapter.
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 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.
Comparison with Predicate Device Intended Use/ Indications for Use:
The Senhance Monopolar L-Hook Electrode instrument and adapter have the same intended use/ indications for use as previously cleared for the Senhance system through K180163 (May 25, 2018). There are no differences in how the subject devices are used that alter the Senhance system's therapeutic effect or raise different questions of safety or effectiveness.
6. Technological Characteristics:
The Senhance Monopolar L-Hook Electrode instrument is very similar to the predicate devices cleared through K191482, with differences only in instrument diameter, length, materials of construction, and voltage ratings. The subject adapter is equivalent to the predicate monopolar hook adapter in overall design characteristics. The only differences for the new adapter are RFID programming and the content of the laser marking.
Performance Data:
Performance testing of the Senhance Monopolar L-Hook Electrode instrument and adapter was conducted in order to support substantial equivalence to the predicate devices and
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demonstrated that the technological differences between the subject devices and predicate devices do not raise any different questions of safety or effectiveness.
Performance testing included mechanical verification of cleaning effectiveness, biocompatibility evaluation, electrical safety, and electrosurgical unit (ESU) compatibility. Due to the similarity of the subject devices to the predicate devices, no other testing was necessary.
The following performance testing was conducted for the devices in this submission.
Biocompatibility testing: The Senhance Monopolar L-Hook Electrode instrument is categorized as tissue contacting for a limited duration of less than 24 hours for contact with tissue or bone. The instrument was assessed in accordance with the FDA Guidance for Industry and FDA Staff "Use of International Standard ISO 10993-1, Biological evaluation of medical devices – Part 1: Evaluation and testing within a risk management process issued on June 16, 2016, and International Standard ISO 10993-1, Biological evaluation of medical devices – Part 1: Evaluation and testing within a risk management process. Testing demonstrated that the patient-contacting portions of the Senhance Monopolar L-Hook Electrode instrument are non-toxic, non-irritating, and do not result in an unacceptable adverse biological response resulting from contact of the device's materials with the body.
Reprocessing, Cleaning, and Sterilization: The reusable Senhance Monopolar L-Hook Electrode instrument was tested for cleaning effectiveness to confirm the overall effectiveness of the prescribed cleaning procedures. The cleaning procedures and test protocols for the testing are consistent with the procedures and protocols utilized for the predicate instrument. The test results demonstrated that the cleaning procedures allows for the subject instrument to be effectively cleaned according to the processing instructions provided in the labeling.
Performance Testing: Testing evaluated the performance of the Senhance Monopolar L-Hook Electrode instrument as well as compatibility of the subject devices when used with the Senhance Surgical System. Mechanical verification testing confirmed that the subject devices perform as intended after tests of mechanical integrity under conditions of simulated use. Additionally, ESU compatibility testing demonstrated that all third-party ESUs that are compatible with the Senhance system are also compatible with the subject devices.
Electrical Safety and Compatibility: The monopolar hook instrument fulfilled all applicable requirements to demonstrate compliance with the current electrical safety standards, IEC 60601-2-2, 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, and IEC 60601-2-18, Medical Electrical Equipment - Part 2-18: Particular Requirements For The Basic Safety And Essential Performance Of Endoscopic Equipment.
7. Conclusions/ Substantial Equivalence:
The data acquired from the performance testing of the Senhance 3 mm Monopolar L-Hook Electrode instrument and adapter, as summarized herein, demonstrate that the devices are as safe and effective and perform similarly to the predicate devices cleared through K191482. The intended use/ indications for use for the subject devices are identical to those for the cleared
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Senhance Surgical System. The subject instrument and adapter 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.
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