Senhance Ultrasonic System

K182421 · Transenterix, Inc. · NAY · Jan 11, 2019 · Gastroenterology, Urology

Device Facts

• Record ID: K182421
• Device Name: Senhance Ultrasonic System
• Applicant: Transenterix, Inc.
• Product Code: NAY · Gastroenterology, Urology
• Decision Date: Jan 11, 2019
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 876.1500
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Senhance Ultrasonic System and accessories are indicated for soft tissue surgical incisions when bleeding control and minimal thermal injury are important. The Senhance Ultrasonic Surgical System and accessories are indicated for use with the Senhance Surgical System.

Device Story

Senhance Ultrasonic System is an energized surgical instrument system for soft tissue incisions; used with Senhance Surgical System. Components: dissector, transducer, adapter, ultrasonic generator, footswitch. System converts electrical energy into torsional ultrasonic energy (35-37 kHz) to cut and coagulate tissue. Operated by surgeons in OR; robotic manipulation of laparoscopic instrument. Provides hemostasis with minimal thermal spread. Benefits: precise robotic control for soft tissue dissection; reduced thermal injury compared to traditional methods. Output: mechanical ultrasonic energy delivered to tissue via end effector. Healthcare providers use system to perform procedures like hysterectomy, cholecystectomy, and liver resection.

Clinical Evidence

No clinical data. Evidence consists of bench testing and a single-center, un-blinded, observational, simulated use design validation study. Four teams performed procedures (hysterectomy, salpingo-oophorectomy, cholecystectomy, liver resection) on a live porcine model. All pre-determined acceptance criteria met. Bench testing confirmed compatibility, force feedback, and tissue effects (burst pressure, lesion size) comparable to reference system.

Technological Characteristics

Robotic-manipulated laparoscopic instrument; torsional ultrasonic energy (35-37 kHz). Components: 12mm curved shear dissector, transducer, adapter, generator. Materials: biocompatible. Sterilization: EO (disposable dissector), steam (reusable components). Connectivity: standalone integration with Senhance Surgical System. Electrical safety: IEC 60601-1, 60601-1-2, 60601-2-2, 60601-2-18.

Indications for Use

Indicated for soft tissue surgical incisions requiring bleeding control and minimal thermal injury. For use with the Senhance Surgical System in surgical procedures.

Regulatory Classification

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.

Special Controls

*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.

Predicate Devices

• Intuitive Surgical 5mm Harmonic ACE Curved Shears (K112584)

Reference Devices

• BOWA Lotus Ultrasonic System 4 (K151101)
• Harmonic ACE manual laparoscopic instrument (K042777)

Submission Summary (Full Text)

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## 510(k) SUMMARY

[In accordance with 21CFR 807.92]

#### Submitter l.

| 510(k) Sponsor: | TransEnterix, Inc. |
|------------------------|-------------------------------------------------------------------------------------|
| Address: | 635 Davis Drive, Suite 300<br>Morrisville, NC 27713 |
| Contact Person: | Stephanie M. Fitts, PhD<br>Vice President, Clinical, Quality and Regulatory Affairs |
| Contact Information: | Email: [e-mail]<br>Phone: [phone]<br>Facsimile: 919.765.8459 |
| Date Summary Prepared: | 12/21/2018 |

#### II. Device

| Proprietary (Trade) Name: | Senhance™ Ultrasonic System |
|---------------------------------------|--------------------------------------------------------|
| Common Name: | System, Surgical, Computer Controlled Instrument |
| Classification: | Class II |
| Classification Advisory<br>Committee: | General and Plastic Surgery |
| Regulation Number: | 21 CFR 876.1500, Endoscope and Accessories |
| Product Codes: | NAY (System, Surgical, Computer Controlled Instrument) |

- Intuitive Surgical 5mm Harmonic ACE Curved Shears (K112584) lll. Predicate Device:
Reference Device

BOWA Lotus Ultrasonic System 4 (K151101)

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#### IV. Device Description:

The Senhance Ultrasonic System is an energized instrument system which delivers ultrasonic energy to the tissue of interest for soft tissue incisions. It is designed to be used with the Senhance Surgical System which precisely manipulates laparoscopically based instruments in surgery.

The Senhance Ultrasonic System is composed of five components:

- 1. The Dissector which interfaces with the tissue of interest
- 2. The Transducer which converts electrical energy into ultrasonic energy
- The Senhance Adapter which physically attaches the instrument to the Senhance Surgical 3. Robotic System manipulator arm
- The Ultrasonic Generator which controls the energy settings to be delivered to the tissue 4.
- 5. The Footswitch

The system components are presented in Figure 1 below:

Image /page/1/Figure/11 description: The image shows a diagram of a Senhance surgical system. The diagram labels five components of the system: the dissector, transducer, Senhance adapter, ultrasonic generator, and footswitch. The distal portion of the Senhance manipulator arm is also labeled. The numbers 1 through 5 are used to label the components.

Figure 1: The Senhance Ultrasonic System Components

#### > Intended Use/ Indications for Use:

The Senhance Ultrasonic System and accessories are indicated for soft tissue surgical incisions when bleeding control and minimal thermal injury are important. The Senhance Ultrasonic Surgical System and accessories are indicated for use with the Senhance Surgical System.

# Comparison with Predicate Device Intended Use/ Indications for Use:

The Senhance Ultrasonic System has the same intended use as the predicate Intuitive Surgical 5mm Harmonic ACE Curved Shears as cleared in K112584. The da Vinci Harmonic ACE Curved Shears are intended for soft tissue incisions when bleeding control and minimal thermal injury are desired. It is designed to be used in conjunction with the da Vinci Surgical Systems (Models IS1200, IS2000 and IS3000) and a compatible Ethicon Endo-Surgery Generator and Handpiece. Thus the intended use (soft tissue incisions when bleeding control and minimal thermal injury are important/desired) is the

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same and both systems reference the larger robotically assisted surgical device system with which they are intended to be used.

#### VI. Summary of Technological Characteristics:

The Senhance™ Ultrasonic System has the same basic technological characteristics as the predicate Intuitive Surgical 5mm Harmonic ACE curved Shears cleared under K112584. Both systems robotically manipulate a variant of a standard manual laparoscopic instrument that delivers ultrasonic energy to the tissue of interest. The Intuitive Surgical predicate adapted the Harmonic ACE manual laparoscopic instrument (K042777) and the Senhance Ultrasonic System is an adaptation of the BOWA Lotus manual laparoscopic system cleared under K151101.

The Senhance Ultrasonic system includes some technological characteristics that differ from the predicate device. The end effector design is different (12mm shear versus 14mm shear for the predicate) and there are different materials of construction. The wavelength of the ultrasonic energy differs between the systems as well as its mode (torsional for Senhance versus linear for Harmonic ACE). See the table below for a description of the technological differences among the subject, predicate and reference device systems.

| | Subject Device<br>Senhance<br>Ultrasonic System | Predicate Device<br>Intuitive Surgical 5mm<br>Harmonic ACE Curved<br>Shears (K112584) | Reference Device<br>BOWA Lotus Ultrasonic<br>System 4 (K151101) |
|--------------------------------------------|------------------------------------------------------------|---------------------------------------------------------------------------------------|-----------------------------------------------------------------|
| Manipulation<br>Method | Robotic | Robotic | Manual |
| Method of<br>Activation | Footswitch - not<br>integrated to robotic<br>system | Footpedal - integrated to<br>robotic system | Footswitch or handpiece<br>buttons |
| End Effector<br>Design | 12mm Curved Shear | 14mm Curved Shear | 12mm Curved Shear |
| End Effector<br>packaging and<br>Sterility | Single Use<br>Disposable (EO<br>Sterilization) SAL<br>10-6 | Single Use Disposable (EO<br>Sterilization) SAL 10-6 | Single Use Disposable<br>(EO Sterilization) SAL 10-6 |
| End Effector<br>Dimensions | Shaft Diameter:<br>5.5mm<br>Shaft Length: 349mm | Shaft Diameter: 5.5mm<br>Shaft Length: 360mm | Shaft Diameter: 5.5mm<br>Shaft Length: 340mm |
| Ultrasonic Mode | Torsional | Linear | Torsional |
| Ultrasonic<br>Wavelength | 35 to 37 kHz | 55.5 kHz | 35 to 37 kHz |
| Generator | Rebranded Lotus<br>Series 4 generator | Ethicon Harmonic ACE<br>generator | Lotus Series 4 generator |

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Performance testing demonstrated that the technological differences between the Senhance System and the predicate device did not raise any different questions of safety or effectiveness. The end effectors are both made of biocompatible materials that are either effectively provided sterile to the end user or can be effectively cleaned and sterilized by the end user. Both systems effectively create soft tissue incisions with effective hemostasis and minimal thermal damage to adjacent tissues.

#### VII. Performance Data

The following performance testing of the Senhance Ultrasonic System was conducted to support the substantial equivalence of the device.

Biocompatibility testing: The biocompatibility evaluation for the Senhance Ultrasonic System relied on testing for the manual reference device and newly performed testing. All patient contacting devices 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," as recognized by FDA. The dissector and transducer are considered tissue contacting for a limited duration of less than 24 hours for contact with tissue or bone.

Cleaning, Disinfection (Reprocessing) and Sterilization: The reusable transducer and adapter have cleaning instructions that have been validated based on the guidelines outlined in AAMI TIR12:2010 and ANSI/AAMI TIR30:2011. A steam sterilization study was conducted in accordance with the FDA's Guidance for Industry and FDA Staff "Reprocessing Medical Devices in Health Care Settings: Validation Methods and Labeling" issued on: March 17, 2015 and the FDA recognized consensus standards ANSI/AAMI/ISO 17665-1:2006/(R) 2013 and ANSI/AAMI/ISO 14937:2009/(R)2013. Both items were validated to a Sterlity Assurance Level of 10° using the Half Cycle Testing validation method.

The disposable dissector is provided sterile to the end user via ethylene oxide sterilant in a fixed rigid chamber (FDA Established Category A). Sterility validation established the Sterility Assurance Level of 106 per EN ISO 11135-1:2014 with EO and ECH residuals meeting the acceptance criteria per EN ISO 10993-7:2008.

Bench Testing: Bench testing included system integrations of the Ultrasonic System with the Surgical System as well as tests to determine any effects of the instrument to the ultrasonic energy delivered. The following tests confirmed compatibility of the systems and that the ultrasonic energy delivery to tissue is comparable to that provided by the reference system.

- Cantilever bend stiffness characterization
- Force Feedback Response Linearity, Sensitivity and Stability ●
- Fulcrum Accuracy
- . Jaw output force verification
- Mechanical reliability of the dissector ●
- . Thermal spread characterization of end effector and adjacent tissue
- Tissue effects vessel sealing burst pressure comparison ●
- Tissue effects lesion size comparison on soft tissues ●

As both the reference and predicate have demonstrated safe and effective use for soft tissue dissections, the subject device has demonstrated equivalence with the predicate.

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Electrical Safety and Compatibility: The Senhance Ultrasonic System components as well as the Senhance Surgical System comply with current versions of IEC 60601-1 (Basic safety and essential performance), IEC 60601-1-2 (Electromagnetic disturbances), and IEC 60601-2-2 (High frequency surgical equipment). Previous testing and analysis demonstrate electrical safety and electromagnetic compatibility of the Senhance Ultrasonic system in the operating room environment. Although the system does not contain an endoscopic vision system, the effects of the energy delivered on the vision system in use concurrently with the system was evaluated using IEC 60601-2-18 (Endoscopic Equipment). The testing verified that the devices when used concurrently do not cause interference in the vision system signal.

Software Verification and Validation Testing: Software verification were conducted on both the Senhance Surgical System software modification which supported the extension to incorporate the Senhance Ultrasonic System components and also the Senhance Ultrasonic Generator. Documentation was provided as recommended by FDA's Guidance for Industry and FDA Staff "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices". The software was considered as a "major" level of concern

Pre-Clinical Design Validation: Design Validation of the Senhance Ultrasonic system was conducted to ensure that the system conforms to defined user needs and intended uses in a simulated use environment. A single-center, un-blinded, observational, simulated use design validation evaluation of the Senhance System was conducted with users who represented the intended primary user population.

Four (4) teams of trained subjects (one surgeon and one surgical assistant per team) performed surgical tasks and procedures on a live porcine model, which most closely represents the human anatomy for the given procedures were non-survival and did not include any animal endpoints. Users were divided into two surgical specialties: gynecological and general surgery. Two gynecological teams each performed a bilateral salpingo-oophorectomy, and a hysterectomy. Two general surqical teams each performed a cholecystectomy, dissection of short gastric vessels and a liver wedge resection. All pre-determined acceptance criteria were met.

#### Conclusions VIII.

The Senhance™ Ultrasonic System has the same intended use as the predicate device. There are technological differences between the subject device and the predicate device, but these raise no different questions of safety or effectiveness. Further, the device is an adaptation of the BOWA Lotus manual laparoscopic system cleared under K151101. The performance testing supported the safety and functionality of the device and demonstrate the device is substantially equivalent to the predicate device.

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# Indications for Use

510(k) Number (if known) K182121

Device Name Senhance Ultrasonic System

Indications for Use (Describe)

The Senhance Ultrasonic System and accessories are indicated for soft tissue surgical incisions when bleeding control and minimal thermal injury are important. The Senhance Ultrasonic System are indicated for use with the Senhance Surgical System.

| Type of Use (Select one or both, as applicable) | |
|-------------------------------------------------------------------------------|------------------------------------------------------------------------------|
| <div> <span> </span> Prescription Use (Part 21 CFR 801 Subpart D) </div> | <div> <span> </span> Over-The-Counter Use (21 CFR 801 Subpart C) </div> |

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January 11, 2019

TransEnterix, Inc. Stephanie Fitts VP, Clinical, Quality and Regulatory Affairs 635 Davis Drive, Suite 300 Morrisville, North Carolina 27650

Re: K182421

Trade/Device Name: Senhance Ultrasonic System Regulation Number: 21 CFR 876.1500 Regulation Name: Endoscope and Accessories Regulatory Class: Class II Product Code: NAY Dated: November 30, 2018 Received: December 4, 2018

Dear Stephanie Fitts:

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/cfpmr/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

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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 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 ([e-mail]) or phone [phone] 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