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 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, 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.

AI/ML Overview

The provided text is a 510(k) summary for the CUSA Clarity Ultrasonic Surgical Aspirator System. It details an FDA clearance for expanding the device's indications to include hard tissue (bone) and adding a 23 kHz handpiece and related accessories.

Based on the information provided, here's a description of the acceptance criteria and study that proves the device meets them:

1. A table of acceptance criteria and the reported device performance:

The document summarizes performance testing but does not explicitly present acceptance criteria in a formal table with pass/fail results. Instead, it lists categories of testing and a general statement of success.

Acceptance Criteria Category	Reported Device Performance
Sterilization, cleaning, shipping and stability	"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."
Biocompatibility	"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."
Software testing	"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."
Electrical Safety and EMC (Electromagnetic Compatibility)	"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."
Bench Testing (e.g., Tissue Fragmentation Rate, Handpiece and Tip Life, Torque functionality during assembly, 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."

2. Sample size used for the test set and the data provenance:

The document does not specify the sample sizes used for any of the performance tests. It also does not mention data provenance (e.g., country of origin, retrospective or prospective) as the studies were non-clinical bench tests.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

This information is not applicable as the studies were non-clinical performance (bench) tests, not human-in-the-loop studies requiring expert ground truth establishment.

4. Adjudication method for the test set:

This information is not applicable as the studies were non-clinical performance (bench) tests, not human-in-the-loop studies.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:

No MRMC comparative effectiveness study was done. The submission explicitly states: "No clinical studies were performed or required as all conducted performance tests appropriately support a determination of substantial equivalence compared with the predicate devices." This device is a surgical aspirator, not an AI-assisted diagnostic tool for human readers.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:

The device itself is a surgical tool, not an algorithm. The performance tests ("standalone" in the sense of device-only operation) were bench tests to verify system requirements, such as tissue fragmentation rate, handpiece life, and electrical safety.

7. The type of ground truth used:

For the non-clinical performance tests, the "ground truth" would be defined by the predefined technical specifications and standards (e.g., acceptable fragmentation rates, lifespan expectations, safety limits). The document does not explicitly state the specific ground truth metrics but implies they were based on established engineering and regulatory standards for medical device performance.

8. The sample size for the training set:

This information is not applicable. The CUSA Clarity Ultrasonic Surgical Aspirator System is a physical medical device, not a machine learning model that requires training data.

9. How the ground truth for the training set was established:

This information is not applicable as the device is not a machine learning model.

Summary

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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 (DICE@fda.hhs.gov) or phone (1-800-638-2041 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 is indicated for use in:

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

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

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 DrivePlainsboro, 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 AspiratorSystem
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 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.

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

Indicationsfor Use	The CUSA® Clarity Ultrasonic Surgical Aspirator System is indicated for usein surgical procedures where fragmentation, emulsification and aspiration ofsoft 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 ormalignant tumors or other unwanted tissue, including hepatic parenchyma, inopen or laparoscopic procedures, hepatic resection, tumor resection, lobectomyor trisegmentectomy, or removal of tissue during liver allotransplantation anddonor hepatectomy
	Urological Surgery- including removal of renal parenchyma duringnephrectomy or partial nephrectomy
	General Surgery - including removal of benign or malignant tumors or otherunwanted soft or hard tissue in open or minimally invasive general surgicalprocedures
	Laparoscopic Surgery - including removal of hepatic parenchyma inlaparoscopic hepatic resection, lobectomy or trisegmentectomy, in laparoscopicdonor 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.

Regulation Number and Section

N/A