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 device within the scope of this premarket notification is the optional CUSA® Electrosurgery Module (CEM) accessory that is intended to be used with the 23 kHz components of the CUSA® Clarity Ultrasonic Surgical Aspirator System. The CUSA® Clarity Ultrasonic Surgical Aspirator System is the newest device added to the Integra Lifesciences Corporation family of tissue ablation products. There are three (3) systems currently marketed in the United States: CUSA® Clarity Ultrasonic Surgical Aspirator System, CUSA® Excel+ Ultrasonic Surgical Aspirator System and CUSA® NXT Ultrasonic Tissue Ablation System. Of these currently marketed products, a CEM accessory is offered with the CUSA® Excel+ Ultrasonic Surgical Aspirator System that allows for coagulation capabilities at the surgical site. The CEM accessory that is offered with the CUSA® Clarity is nearly identical to its predecessor, modified for use with the CUSA® Clarity system. The CEM accessory will allow the surgeon to apply immediate electrosurgical coagulation to bleeding tissue at the surgical site, with the same handpiece assembly that is removing unwanted tissue. The CEM accessory consists of a nosecone, cable and plug which are molded together and packaged as one unit.

AI/ML Overview

The provided document is a 510(k) summary for the CUSA® Clarity Ultrasonic Surgical Aspirator System with the optional Electrosurgery Module (CEM) accessory. It describes the device, its intended use, and argues for its substantial equivalence to previously cleared predicate devices.

Based on the document, here's an analysis of the acceptance criteria and study information:

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

The document does not present a formal table of quantitative acceptance criteria directly tied to specific performance metrics for the CEM accessory. Instead, it describes categories of non-clinical tests conducted to ensure safety and efficacy, and states that these tests were "successful."

Acceptance Criteria Category (Implicit)	Reported Device Performance (Summary)
Sterilization	Successful per FDA guidance and recognized standards
Shipping and Stability	Successful per FDA guidance and recognized standards
Biocompatibility	Successful per FDA guidance and recognized standards
EMC and Electrical Safety	Successful per FDA guidance and recognized standards
Bench Testing (General Device Requirements)	Successful, "all 13 protocols within the 4 testing categories... met product specifications and design inputs."
- Handpiece and Tip Life with CEM	Functionality verified
- Functionality within environmental variations	Functionality verified
Mechanical and Performance Testing	Functionality verified
Thermal Effects and Capacitive Coupling	Functionality verified per FDA guidance document

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

The document does not explicitly state sample sizes for individual tests. It broadly mentions "non-clinical testing" and refers to "all 13 protocols within the 4 testing categories." This indicates various tests were performed, likely on multiple units or components, but specific numbers are not provided. The data provenance is implied to be from Integra LifeSciences Corporation's internal testing labs, likely in the USA given the company address, but no specific country of origin is mentioned for the data. All testing appears to be prospective as it was conducted specifically to support this 510(k) submission.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience)

This information is not applicable and therefore not provided. The study conducted was non-clinical (bench, mechanical, electrical, etc.) and did not involve human experts establishing ground truth in a clinical sense.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

This information is not applicable. Adjudication methods are typically used in clinical studies, particularly when establishing ground truth from multiple human readers/experts. The testing described is non-clinical.

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 device is an ultrasonic surgical aspirator with an electrosurgery module, not an AI-based diagnostic or assistive technology.

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

This is not an AI algorithm, so the concept of standalone algorithm performance is not applicable. The device's performance was evaluated through non-clinical bench testing.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

For the non-clinical tests, the "ground truth" would be defined by engineering specifications, recognized standards (e.g., for biocompatibility, EMC, electrical safety), and predefined functional requirements (e.g., handpiece life, functionality under environmental variations, thermal effects). These are objective, measurable criteria established through engineering principles and regulatory standards rather than subjective expert consensus, pathology, or outcomes data.

8. The sample size for the training set

This information is not applicable. As this is not an AI/machine learning device, there is no concept of a "training set."

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

This information is not applicable, as there is no training set mentioned in the context of this device.

Summary

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April 1, 2019

Integra LifeSciences Corporation Alexandra Wells Regulatory Affairs Specialist 311 Enterprise Drive Plainsboro, New Jersey 08536

Re: K190180

Trade/Device Name: CUSA Clarity Ultrasonic Surgical Aspirator System Regulatory Class: Unclassified Product Code: LFL. LBK Dated: January 31, 2019 Received: February 1. 2019

Dear Alexandra Wells:

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

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https://www.fda.gov/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.html: 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 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 (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

Image /page/1/Picture/5 description: The image shows a digital signature. The signature is for Long H. Chen -S. The date of the signature is 2019.04.01. The time of the signature is 15:50:48 -04'00'.

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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K190180

Page 1 of 1

	DEPARTMENT OF HEALTH AND HUMAN SERVICES
	Food and Drug Administration	Form Approved: OMB No. 0910-0120Expiration Date: 06/30/2020See PRA Statement below.
	Indications for Use
510(k) Number (if known)	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)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

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FORM FDA 3881 (7/17)	Page 1 of 1	PSC Publishing Services (101)-443-6780
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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 Plainsboro, NJ 08536 USA
Phone Number	1-609-275-0500
Establishment Registration Number	9004007
Name of Contact Person	Alexandra Wells
Date Prepared	January 31, 2019
807.92(a)(2) – Name of device
Trade or Propriety Name	CUSA® Clarity Ultrasonic Surgical Aspirator System
Common or Usual Name	Ultrasonic Surgical Aspirator
Classification Name	Instrument, Ultrasonic Surgical
Classification Panel	General and Plastic Surgery
Regulation	Unclassified
Product Code(s)	LFL, LBK
807.92(a)(3) - Legally marketed device(s) to which equivalence is claimed
CUSA® Excel+ Ultrasonic Surgical Aspirator System K141668
CUSA® Clarity Ultrasonic Surgical Aspirator System K182809

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807.92(a)(4) - Device description

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807.92(a)(5) - Intended use of the device
	The CUSA® Clarity Ultrasonic Surgical Aspirator System is indicated
	for use in surgical procedures where fragmentation, emulsification andaspiration 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 specificuses:
	Gastrointestinal and Affiliated Organ Surgery – including removal ofbenign or malignant tumors or other unwanted tissue, including hepaticparenchyma, in open or laparoscopic procedures, hepatic resection,tumor resection, lobectomy or trisegmentectomy, or removal of tissueduring liver allotransplantation and donor hepatectomy
Indications for	Urological surgery- including removal of renal parenchyma duringnephrectomy or partial nephrectomy
Use	General Surgery - including removal of benign or malignant tumors orother unwanted soft tissue in open or minimally invasive generalsurgical procedures
	Laparoscopic Surgery - including removal of hepatic parenchyma inlaparoscopic hepatic resection, lobectomy or trisegmentectomy, inlaparoscopic donor hepatectomy or laparoscopic cholecystectomy orlaparoscopic pancreatic jejunostomy, or pancreatectomy, or laparoscopicappendectomy, laparoscopic colon resection or laparoscopic partialgastrectomy

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807.92(a)(6) Summary of the technological characteristics of the device compared to the predicate

The CEM accessory offered with the CUSA Clarity has the same technological characteristics compared to the predicate device. The main purpose of the CEM accessory is to align CUSA Clarity with CUSA Excel in its ability to provide electrosurgical coagulation to bleeding tissue at the surgical site. The device is maintaining the same underlying technology and intended use of previous CEM accessory used with CUSA Excel. Thus, the majority of the features and technology of the CEM accessory are not new for a CUSA device and benefit longstanding safety and/or efficacy.

807.92(b)(1-2) – Nonclinical and clinical tests submitted

Non-clinical testing was performed to ensure the safety and efficacy of the CUSA Clarity 23 kHz CEM Nosecone accessory. Testing included, but was not limited to:

Sterilization, Shipping and Stability testing per FDA guidance documents and ● recognized standards
Biocompatibility testing per FDA guidance documents and recognized standards ●
EMC and Electrical Safety testing per FDA guidance documents and recognized . standards
Bench testing to verify device requirements, including those listed below ●
- o Handpiece and Tip Life with CEM
- Functionality within specification during environmental variations
- Mechanical and Performance Testing ●
- Thermal Effects and Capacitive Coupling per FDA guidance document ●

Testing was determined successful for all 13 protocols within the 4 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 23 kHz CEM Nosecone accessory 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 non-clinical and clinical data

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

Regulation Number and Section

N/A