CUSA Clarity Ultrasonic Surgical Aspirator System

K182809 · Integra LifeSciences Corporation · LFL · Dec 7, 2018 · SU

Device Facts

• Record ID: K182809
• Device Name: CUSA Clarity Ultrasonic Surgical Aspirator System
• Applicant: Integra LifeSciences Corporation
• Product Code: LFL · SU
• Decision Date: Dec 7, 2018
• Decision: SESE
• Submission Type: Traditional
• Device Class: Class U
• Attributes: Therapeutic

Intended Use

The CUSA® Clarity Ultrasonic Surgical Aspirator System is indicated for use in surgical procedures where fragmentation, emulsification and aspiration of soft and hard (e.g. bone) tissue is desirable. The CUSA Clarity Ultrasonic Surgical Aspirator is indicated for use in: Neurosurgery, Plastic and Reconstructive Surgery, Orthopedic Surgery, Gynecological Surgery and Thoracic Surgery and the following specific uses: Gastrointestinal and Affiliated Organ Surgery - including removal of benign or malignant tumors or other unwanted tissue, including hepatic parenchyma, in open or laparoscopic procedures, hepatic resection, tumor resection, lobectomy or trisegmentectomy, or removal of tissue during liver allotransplantation and donor hepatectomy Urological Surgery- including removal of renal parenchyma during nephrectomy or partial nephrectomy General Surgery - including removal of benign or malignant tumors or other unwanted soft or hard tissue in open or minimally invasive general surgical procedures Laparoscopic Surgery - including removal of hepatic parenchyma in laparoscopic hepatic resection, lobectomy or trisegmentectomy, in laparoscopic donor hepatectomy or laparoscopic cholecystectomy or laparoscopic pancreatic jejunostomy, or pancreatectomy, or laparoscopic appendectomy, laparoscopic colon resection or laparoscopic partial gastrectomy

Device Story

CUSA Clarity is an ultrasonic surgical aspirator system used in OR settings by surgeons to selectively dissect tissue. System inputs include electrical power and user control via footswitch; system outputs include ultrasonic mechanical energy delivered through titanium tips to fragment/emulsify tissue, combined with irrigation and aspiration to remove debris. Device enables selective tissue removal while preserving vessels/ducts. Console manages power, aspiration, and irrigation. Subject submission adds 23 kHz handpiece and hard tissue (bone) capability to existing platform. Benefits include precise tissue removal and reduced trauma to surrounding structures.

Clinical Evidence

No clinical data. Substantial equivalence supported by bench testing, including sterilization, biocompatibility, software, electrical safety/EMC, tissue fragmentation rates, handpiece/tip life, torque functionality, operating frequency, and aspiration/irrigation flow.

Technological Characteristics

System comprises console, 23 kHz and 36 kHz titanium handpieces, footswitch, irrigation flues, and suction/irrigation manifold. Operates via ultrasonic mechanical energy (23/36 kHz) with irrigation and aspiration. MR Unsafe. Software-controlled console.

Indications for Use

Indicated for patients requiring fragmentation, emulsification, and aspiration of soft and hard (e.g., bone) tissue during neurosurgery, plastic/reconstructive, orthopedic, gynecological, thoracic, gastrointestinal, urological, general, and laparoscopic surgical procedures.

Predicate Devices

• CUSA Clarity Ultrasonic Surgical Aspirator System (K161882)
• CUSA Excel+ Ultrasonic Surgical Aspirator System (K141668)

Submission Summary (Full Text)

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December 7, 2018

Integra LifeSciences Corporation MaryBeth Carson Regulatory, Quality and Operations Associate 311 Enterprise Drive Plainsboro, New Jersey 08536

Re: K182809

Trade/Device Name: CUSA Clarity Ultrasonic Surgical Aspirator System Regulatory Class: Unclassified Product Code: LFL, LBK Dated: October 2, 2018 Received: October 3, 2018

Dear Marybeth Carson:

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 devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.html; good

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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 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 mediation-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

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### DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2020 See PRA Statement below.

Indications for Use 510(k) Number (if known)

K182809 To Be Determined

Device Name CUSA® Clarity Ultrasonic Surgical Aspirator System

Indications for Use (Describe)

The CUSA® Clarity Ultrasonic Surgical Aspirator System is indicated for use in surgical procedures where fragmentation, emulsification and aspiration of soft and hard (e.g. bone) tissue is desirable.

The CUSA Clarity Ultrasonic Surgical Aspirator is indicated for use in:

Neurosurgery, Plastic and Reconstructive Surgery, Orthopedic Surgery, Gynecological Surgery and Thoracic Surgery and the following specific uses:

Gastrointestinal and Affiliated Organ Surgery - including removal of benign or malignant tumors or other unwanted tissue, including hepatic parenchyma, in open or laparoscopic procedures, hepatic resection, tumor resection, lobectomy or trisegmentectomy, or removal of tissue during liver allotransplantation and donor hepatectomy

Urological Surgery- including removal of renal parenchyma during nephrectomy or partial nephrectomy

General Surgery - including removal of benign or malignant tumors or other unwanted soft or hard tissue in open or minimally invasive general surgical procedures

Laparoscopic Surgery - including removal of hepatic parenchyma in laparoscopic hepatic resection, lobectomy or trisegmentectomy, in laparoscopic donor hepatectomy or laparoscopic cholecystectomy or laparoscopic pancreatic jejunostomy, or pancreatectomy, or laparoscopic appendectomy, laparoscopic colon resection or laparoscopic partial gastrectomy

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

A summary of 510(k) safety and effectiveness information in accordance with the requirements of 21 CFR 807.92

| 807.92(a)(1)- Submitter Information | |
|------------------------------------------------------------------------------|-------------------------------------------------------|
| Name | Integra LifeSciences Corporation |
| Address | 311 Enterprise Drive<br>Plainsboro, New Jersey 08536 |
| Telephone Number | 609-275-0500 |
| Establishment Registration Number | 9004007 |
| Contact Person | MaryBeth Carson |
| Date Summary Prepared | October 2, 2018 |
| 807.92(a)(2)- Name of Device | |
| Trade or Proprietary Name | CUSA® Clarity Ultrasonic Surgical Aspirator<br>System |
| Common or Usual Name | Ultrasonic Surgical Aspirator |
| Classification Name | Instrument, Ultrasonic Surgical |
| Classification Panel | General and Plastic Surgery |
| Device Class | Unclassified |
| Product Code(s) | LFL, LBK |
| 807.92(a)(3)- Legally Marketed Devices to Which Submitter Claims Equivalence | |
| CUSA® Clarity Ultrasonic Surgical Aspirator System K161882 | |
| CUSA® Excel+ Ultrasonic Surgical Aspirator System K141668 | |
| 807.92(a)(4)- Device Description | |

The CUSA® Clarity Ultrasonic Surgical Aspirator System was originally cleared October 14, 2016 (K161882). The purpose of this submission is to obtain FDA clearance for expanding the current CUSA Clarity indication for use statement to add a hard tissue indication (bone) and to add a 23 kHz handpiece and related accessories for use with the previously cleared CUSA Clarity system. The submission includes a bone tip that facilitates the removal of hard tissue, and additional tips intended for the removal of soft tissue.

The CUSA Clarity system shares the same intended use and principle of operation as previous CUSA systems. All CUSA systems are surgical aspirators that use ultrasonics and cavitation,

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in combination with irrigation and aspiration, to fragment, emulsify and remove unwanted tissue. It allows for the selective dissection of target tissue while preserving vessels, ducts, and other delicate structures.

The CUSA Clarity consists of a console that provides power and control of the ultrasonic, aspiration and irrigation functions, two surgical handpieces that provides ultrasonic mechanical energy (23 kHz and 36 kHz), a footswitch to allow user control over the ultrasonics, titanium surgical tips (variety of models), irrigation flues, suction/irrigation system (manifold tubing and vacuum canister) and accessories used for assembly/disassembly and reprocessing. The CUSA Clarity system, including the 23 kHz components that are the subject of this submission, will be labelled MR Unsafe.

# 807.92(a)(5)- Intended Use of Device

| Indications<br>for Use | The CUSA® Clarity Ultrasonic Surgical Aspirator System is indicated for use<br>in surgical procedures where fragmentation, emulsification and aspiration of<br>soft and hard (e.g. bone) tissue is desirable. |
|------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | The CUSA Clarity Ultrasonic Surgical Aspirator is indicated for use in: |
| | Neurosurgery, Plastic and Reconstructive Surgery, Orthopedic Surgery,<br>Gynecological Surgery and Thoracic Surgery and the following specific uses: |
| | Gastrointestinal and Affiliated Organ Surgery – including removal of benign or<br>malignant tumors or other unwanted tissue, including hepatic parenchyma, in<br>open or laparoscopic procedures, hepatic resection, tumor resection, lobectomy<br>or trisegmentectomy, or removal of tissue during liver allotransplantation and<br>donor hepatectomy |
| | Urological Surgery- including removal of renal parenchyma during<br>nephrectomy or partial nephrectomy |
| | General Surgery - including removal of benign or malignant tumors or other<br>unwanted soft or hard tissue in open or minimally invasive general surgical<br>procedures |
| | Laparoscopic Surgery - including removal of hepatic parenchyma in<br>laparoscopic hepatic resection, lobectomy or trisegmentectomy, in laparoscopic<br>donor hepatectomy or laparoscopic cholecystectomy or laparoscopic pancreatic |

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jejunostomy, or pancreatectomy, or laparoscopic appendectomy, laparoscopic colon resection or laparoscopic partial gastrectomy

# 807.92(a)(6)- Summary of Technological Characteristics Compared to the Predicate

The CUSA Clarity system with the 23 kHz components has the same technological characteristics compared to the predicate devices. All CUSA devices utilize ultrasonic mechanical action to fragment unwanted tissue while simultaneously providing irrigation and aspiration. The purpose of this submission is to add in 23 kHz components to be used with the previously cleared CUSA Clarity system and expand the current CUSA Clarity indications. The result is a CUSA Clarity system that will match the functionality and indications offered by the CUSA Excel+, which has a hard tissue indication and is cleared with both 23 kHz and 36 kHz handpieces. The same underlying technology and intended use of previous CUSA devices is maintained with the addition of the CUSA Clarity 23 kHz components, as the functionality is carried over from the predicate devices with minor design improvements that generally focus on improving ease of use. Thus, the majority of the features and technology of the CUSA Clarity are not new for a CUSA device and benefit longstanding safety and/or efficacy.

# 807.92(b)(1-2)- Non-clinical and clinical tests submitted

Performance testing was executed to demonstrate substantial equivalence with the predicate devices. Testing included but was not limited to:

- . Sterilization, cleaning, shipping and stability testing per FDA guidance documents and recognized standards
- . Biocompatibility testing per FDA guidance documents and recognized standards
- . Software testing per FDA guidance document and recognized standards
- . Electrical Safety and EMC testing per FDA recognized standards
- . Bench testing to verify system requirements, including those listed below
- · Tissue Fragmentation Rate
- Handpiece and Tip Life
- Torque functionality during assembly

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- · Operating frequency
- · Functionality within specification during environmental variations
- Aspiration and Irrigation flow

Testing was determined successful for all 42 protocols within the 5 testing categories above and supports the conclusion that all product specifications and design inputs have been met. Integra LifeSciences therefore believes verification testing results for the CUSA Clarity system with the 23 kHz components support a determination of substantial equivalence when compared with the predicate devices.

No clinical studies were performed or required as all conducted performance tests appropriately support a determination of substantial equivalence compared with the predicate devices.

807.92(b)(3)- Conclusions drawn from the nonclinical and clinical tests

The results of the non-clinical testing indicate that the intended use of the device, fundamental scientific technology and performance of the CUSA Clarity system with 23 kHz components are substantially equivalent to the predicate devices.