(37 days)
No
The summary describes surgical instruments and an adapter for a robotic surgical system, focusing on mechanical, electrical, and biocompatibility testing. There is no mention of AI or ML in the intended use, device description, or performance studies.
Yes.
The device 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, and mobilization, for use in laparoscopic gynecological surgery, colorectal surgery, cholecystectomy, and inguinal hernia repair, which are all therapeutic interventions.
No
Explanation: The Senhance Surgical System and its associated instruments are described as assisting in the control of laparoscopic instruments for visualization and endoscopic manipulation of tissue (e.g., grasping, cutting, suturing). This is an interventional surgical device, not a diagnostic one, as it directly performs surgical tasks rather than providing diagnostic information about a patient's condition.
No
The device description explicitly states it is a "multi-use surgical device" and details performance testing related to mechanical verification, biocompatibility, electrical safety, and reprocessing, all of which are characteristic of hardware components, not software-only devices.
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 and instruments for manipulating tissue during surgery (in vivo), not for examining specimens outside the body (in vitro).
- Device Description: The description focuses on surgical instruments (monopolar electrodes and adapter) used in conjunction with a surgical system.
- Lack of IVD Characteristics: The text does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples (blood, urine, tissue samples, etc.)
- Detecting or measuring substances in samples
- Providing information for diagnosis, monitoring, or screening based on sample analysis
The device is a surgical tool used directly on the patient during a procedure.
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
NAY
Device Description
The Senhance™ 5 mm Monopolar L-Hook Electrode instruments and adapter are intended as additions to the suite of monopolar hook instruments and adapters previously cleared for use with the TransEnterix Senhance™ Surgical System. Three monopolar electrodes and one monopolar electrode adapter are being added. The instruments and adapter are modifications of the predicate TransEnterix® Senhance™ 5 mm Monopolar L-Hook Electrode instruments and adapters FDA cleared through K181517 (October 9, 2018). 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.
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)
Performance testing of the Senhance Monopolar L-Hook Electrode instruments and adapter was conducted to support substantial equivalence to the predicate devices and demonstrated that the technological differences between the subject monopolar hook instruments and adapter and the 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 instruments are categorized as tissue contacting for a limited duration of less than 24 hours for contact with tissue or bone. The instruments were 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 instruments are non-toxic, non-irritating, and do not result in an unacceptable adverse biological response resulting from contact of the devices' materials with the body.
Reprocessing, Cleaning, and Sterilization: The reusable Senhance Monopolar L-Hook Electrode instruments were 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 previously cleared monopolar hooks used with the Senhance Surgical System. The test results demonstrated that the cleaning procedures for the subject instruments allow them 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 instruments 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 and that the Senhance system performs as intended when used with the subject devices. 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 instruments fulfilled all applicable requirements to demonstrate that the instruments are compliant with the current electrical safety standard, 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)
TransEnterix Senhance™ Surgical System (K181517)
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 with the full name of the agency 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 written out in a smaller font next to it.
July 11, 2019
TransEnterix Inc. Kaitlyn Alexander Senior Regulatory Affairs Specialist 635 Davis Drive, Suite 300 Morrisville, North Carolina 27560
Re: K191482
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: June 3. 2019 Received: June 4, 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.
1
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 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 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.
Dr. Long Chen Assistant Director DHT4A: Division of General Surgery Devices OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation and Ouality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K191482
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) | ☐ |
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
Senhance™ 5 mm Monopolar Hook Instruments 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: | 7/10/2019 |
| 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 (K181517) |
4
4. Device Description:
The Senhance™ 5 mm Monopolar L-Hook Electrode instruments and adapter are intended as additions to the suite of monopolar hook instruments and adapters previously cleared for use with the TransEnterix Senhance™ Surgical System. Three monopolar electrodes and one monopolar electrode adapter are being added. The instruments and adapter are modifications of the predicate TransEnterix® Senhance™ 5 mm Monopolar L-Hook Electrode instruments and adapters FDA cleared through K181517 (October 9, 2018). 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.
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 inquinal 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 instruments and adapter have the same intended use/ indications for use as previously cleared for the Senhance system through K181517. 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 instruments are very similar to the predicate devices cleared through K181517, with differences in manufacturer, instrument length, and materials of construction. 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 instruments and adapter was conducted to support substantial equivalence to the predicate devices and demonstrated that the technological differences between the subject monopolar hook instruments and adapter and the 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.
5
K191482
Biocompatibility testing: The Senhance Monopolar L-Hook Electrode instruments are categorized as tissue contacting for a limited duration of less than 24 hours for contact with tissue or bone. The instruments were 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 instruments are non-toxic, non-irritating, and do not result in an unacceptable adverse biological response resulting from contact of the devices' materials with the body.
Reprocessing, Cleaning, and Sterilization: The reusable Senhance Monopolar L-Hook Electrode instruments were 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 previously cleared monopolar hooks used with the Senhance Surgical System. The test results demonstrated that the cleaning procedures for the subject instruments allow them 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 instruments 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 and that the Senhance system performs as intended when used with the subject devices. 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 instruments fulfilled all applicable requirements to demonstrate that the instruments are compliant with the current electrical safety standard, 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 5 mm Monopolar L-Hook Electrode instruments and adapter, as summarized herein, demonstrate that the devices are as safe and effective and perform similarly to the predicate devices cleared through K181517. The intended use/ indications for use for the subject devices are identical to those cleared for the Senhance Surgical System under K181517. The subject instruments 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.