The CUSA Clarity Ultrasonic 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:

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

Neurosurgery - including removal of primary and secondary main and spinal tumors, including but not limited to meningiomas and gliomas

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 (CUSA Clarity) is an ultrasonically vibrating surgical device which, in combination with irrigation and aspiration, fragments, emulsifies and removes unwanted tissue. It allows 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 provide 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.

AI/ML Overview

Here's an analysis of the provided text, focusing on the acceptance criteria and the study used to prove the device meets these criteria:

Device: CUSA Clarity Ultrasonic Surgical Aspirator System
510(k) Number: K200774

This submission appears to be an update to an existing device (CUSA Clarity K182809), specifically an expansion of its neurosurgical indications for use, rather than a new device entirely. Therefore, the "acceptance criteria" and "study" described are primarily focused on supporting this updated indication for neurosurgery.

1. Table of Acceptance Criteria and Reported Device Performance

The FDA clearance for this device, based on the provided text, is a substantial equivalence determination. This means the device is being compared to a predicate device (CUSA Clarity Ultrasonic Surgical Aspirator; K182809) rather than requiring specific performance targets independent of a predicate. The "acceptance criteria" revolve around demonstrating the new indications for use are safe and effective, and that the device's technological characteristics remain the same.

Acceptance Criteria Category	Reported Device Performance
New Neurosurgery Indications Safety and Effectiveness	The device can be safely and effectively used in neurosurgery, including removal of primary and secondary malignant and benign brain and spinal tumors (e.g., meningiomas and gliomas). The literature showed CUSA to be useful for the resection of tumors ranging from soft to firm consistencies, with benefits including enhanced tissue selectivity, preservation of healthy tissue, and more efficient debulking and resection.
Technological Equivalence to Predicate	The technological characteristics of the device are the same compared to the predicate device.
General Indications Equivalence to Predicate	No changes to the general Indications for Use compared to the predicate, confirming continued equivalence.

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

Test Set (Clinical Data): 72 peer-reviewed articles discussing neurosurgical cases.
Number of Cases: Approximately 1,706 cases reported across these 72 articles.
Data Provenance: Retrospective, derived from published peer-reviewed clinical literature. The country of origin is not specified but would be global as it's from peer-reviewed literature.

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

This section is not applicable in the traditional sense for this submission. The "ground truth" for this substantial equivalence determination is established by the existing body of peer-reviewed clinical literature. The "experts" are the authors and peer reviewers of the 72 articles themselves, who conducted the studies and produced the reported outcomes. Their qualifications would vary widely but generally include neurosurgeons, neurologists, and other medical professionals involved in the care and study of neurosurgical patients. The submission does not describe an independent panel of experts reviewing cases specifically for this 510(k) alongside the device.

4. Adjudication method for the test set

None in the context of an independent adjudication process for this 510(k) submission. The clinical data comes from already published and peer-reviewed articles, implying that any internal adjudication or consensus methods used by the authors of those individual studies would have occurred prior to publication.

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

Not applicable. This device is an ultrasonic surgical aspirator, not an AI-powered diagnostic or interpretive device. Therefore, an MRMC study comparing human readers with and without AI assistance is not relevant to its function or clearance.

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

Not applicable. This is a surgical tool, not a standalone diagnostic algorithm.

7. The type of ground truth used

The ground truth is established by clinical outcomes data reported in peer-reviewed medical literature. This includes observations on the safety and effectiveness of the CUSA device in various neurosurgical procedures, tumor debulking, tissue selectivity, and patient outcomes over approximately 40 years of use.

8. The sample size for the training set

Not applicable. This device is not an AI/ML algorithm that requires a training set. The clinical literature serves as the justification for the expanded indications.

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

Not applicable. See point 8.

Summary

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June 23, 2020

Integra LifeSciences Corporation Alexandra Wells Regulatory Affairs Specialist 1100 Campus Rd Princeton, New Jersey 08540

Re: K200774

Trade/Device Name: CUSA Clarity Ultrasonic Surgical Aspirator System Regulatory Class: Unclassified Product Code: LFL, LBK Dated: March 24, 2020 Received: March 25, 2020

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/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 medical devices and radiation-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,

Adam Pierce, Ph.D. Assistant Director DHT5A: Division of Neurosurgical, Neurointerventional and Neurodiagnostic Devices OHT5: Office of Neurological and Physical Medicine Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K200774

Device Name

CUSA Clarity Ultrasonic Surgical Aspirator System

Indications for Use (Describe)

The CUSA Clarity Ultrasonic 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:

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

Neurosurgery - including removal of primary and secondary main and spinal tumors, including but not limited to meningiomas and gliomas

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)

X 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	1100 Campus Rd Princeton, NJ 08540 USA
Phone Number	609-936-2311
Establishment RegistrationNumber	9004007
Name of Contact Person	Alexandra Wells
Date Prepared	June 23, 2020
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 Clarity Ultrasonic Surgical Aspirator; K182809
807.92(a)(4) – Device description
used for assembly/disassembly and reprocessing.
807.92(a)(5) – Intended use of the device
Indications for Use	The Indications for Use for the CUSA® Clarity UltrasonicSurgical Aspirator System are listed below. When compared tothe predicate, the Indications for Use statement for neurosurgeryhas been modified to include specific indications in addition tothe previously cleared general indication. There have been noother changes to the Indications for Use when compared to thepredicate.
	The CUSA® Clarity Ultrasonic Surgical AspiratorSystem is indicated for use in surgical procedures wherefragmentation, emulsification and aspiration of soft andhard (e.g. bone) tissue is desirable.
	The CUSA Clarity Ultrasonic Surgical Aspirator isindicated for use in:
	Plastic and Reconstructive surgery, Orthopedic Surgery,Gynecological Surgery and Thoracic Surgery and thefollowing specific uses:
	Neurosurgery - including removal of primary andsecondary malignant and benign brain and spinal tumors,including but not limited to meningiomas and gliomas
	Gastrointestinal and Affiliated Organ Surgery – includingremoval of benign or malignant tumors or other unwantedtissue, including hepatic parenchyma, in open orlaparoscopic procedures, hepatic resection, tumorresection, lobectomy or trisegmentectomy, or removal of
tissue during liver allotransplantation and donorhepatectomy
Urological surgery- including removal of renalparenchyma during nephrectomy or partial nephrectomy
General Surgery – including removal of benign ormalignant tumors or other unwanted soft or hard tissue inopen or minimally invasive general surgical procedures
Laparoscopic Surgery - including removal of hepaticparenchyma in laparoscopic hepatic resection, lobectomyor trisegmentectomy, in laparoscopic donor hepatectomyor laparoscopic cholecystectomy or laparoscopicpancreatic jejunostomy, or pancreatectomy, orlaparoscopic appendectomy, laparoscopic colon resectionor laparoscopic partial gastrectomy

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

The technological characteristics of the device are the same compared to the predicate device.

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

No non-clinical testing was required as the design itself was not modified.

The clinical evidence used to support the revision to the neurosurgical indication for use is provided from peer-reviewed clinical literature. An analysis of peer-reviewed articles on the use of CUSA in neurosurgical procedures presents clinical evidence to support the indications for use of CUSA in neurosurgery.

72 articles discuss neurosurgical cases in which CUSA was used (reported on approximately 1,706 cases), including the debulking and resection of brain stem tumors, spinal tumors, and brain tumors of a variety of types. Overall, the literature demonstrated that CUSA can be safely

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and effectively used in neurosurgery. The literature showed CUSA to be useful for the resection of tumors ranging from soft to firm consistencies. The benefits described by the authors include enhanced tissue selectivity, preservation of healthy tissue, and more efficient debulking and resection. CUSA has been utilized in neurosurgical applications for over 40 years; and the literature shows CUSA to be safe and effective in neurosurgery including removal of primary and secondary malignant and benign brain and spinal tumors, including but not limited to meningiomas and gliomas.

807.92(b)(3) – Conclusions drawn from non-clinical and clinical data

The information from the peer-reviewed clinical literature supports the proposed changes from general to specific indication in neurosurgery and the subject device is substantially equivalent to the predicate device.

Regulation Number and Section

N/A