K Number
K190180
Device Name
CUSA Clarity Ultrasonic Surgical Aspirator System
Date Cleared
2019-04-01

(59 days)

Product Code
Regulation Number
N/A
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
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 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.
More Information

Not Found

No
The summary describes a surgical aspirator system with an electrosurgery accessory for coagulation. There is no mention of AI or ML in the intended use, device description, or performance studies. The device's function is based on ultrasonic aspiration and electrosurgical coagulation, not data-driven algorithms.

No
The device is used for surgical procedures involving tissue fragmentation, emulsification, and aspiration, as well as electrosurgical coagulation, which are actions performed during, not for the purpose of, therapy.

No

The device is an ultrasonic surgical aspirator system used for fragmentation, emulsification, and aspiration of tissue during surgical procedures, not for diagnosing conditions.

No

The device description explicitly states it is an "optional CUSA® Electrosurgery Module (CEM) accessory" consisting of a "nosecone, cable and plug which are molded together and packaged as one unit." This describes physical hardware components, not software.

Based on the provided information, this device is not an IVD (In Vitro Diagnostic).

Here's why:

  • Intended Use: The intended use clearly describes a surgical device used for fragmentation, emulsification, and aspiration of tissue during surgical procedures. This is a therapeutic and surgical function, not a diagnostic one performed on samples outside the body.
  • Device Description: The description details a surgical aspirator system and an accessory for electrosurgical coagulation. This aligns with surgical tools, not diagnostic tests.
  • Lack of IVD Characteristics: There is no mention of analyzing samples (blood, tissue, etc.) in vitro (outside the body) to provide diagnostic information about a patient's condition. The device is used directly on tissue in vivo during surgery.

Therefore, the CUSA® Clarity Ultrasonic Surgical Aspirator System and its CEM accessory are surgical devices, not In Vitro Diagnostics.

N/A

Intended Use / Indications for 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

Product codes (comma separated list FDA assigned to the subject device)

LFL, LBK

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.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

hepatic parenchyma, kidney (renal parenchyma)

Indicated Patient Age Range

Not Found

Intended User / Care Setting

Not Found

Description of the training set, sample size, data source, and annotation protocol

Not Found

Description of the test set, sample size, data source, and annotation protocol

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: 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.

Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)

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: 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.

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Not Found

Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.

K141668, K182809

Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).

Not Found

N/A

0

Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

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

1

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

2

K190180

Page 1 of 1

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug AdministrationForm Approved: OMB No. 0910-0120
Expiration Date: 06/30/2020
See PRA Statement below.
Indications for Use
510(k) Number (if known)To Be Determined
Device NameCUSA® 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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DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

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FORM FDA 3881 (7/17)Page 1 of 1PSC 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
NameIntegra LifeSciences Corporation
Address311 Enterprise Drive Plainsboro, NJ 08536 USA
Phone Number1-609-275-0500
Establishment Registration Number9004007
Name of Contact PersonAlexandra Wells
Date PreparedJanuary 31, 2019
807.92(a)(2) – Name of device
Trade or Propriety NameCUSA® Clarity Ultrasonic Surgical Aspirator System
Common or Usual NameUltrasonic Surgical Aspirator
Classification NameInstrument, Ultrasonic Surgical
Classification PanelGeneral and Plastic Surgery
RegulationUnclassified
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

4

807.92(a)(4) - 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.

5

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 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
Indications forUrological surgery- including removal of renal parenchyma during
nephrectomy or partial nephrectomy
UseGeneral Surgery - including removal of benign or malignant tumors or
other unwanted soft 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

6

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.