(65 days)
No
The document describes a surgical aspirator system that uses ultrasonic energy, cavitation, irrigation, and aspiration to remove tissue. There is no mention of AI or ML in the intended use, device description, or performance studies. The focus is on the mechanical and fluid dynamics of the device.
Yes
Explanation: The device is indicated for use in various surgical procedures to fragment, emulsify, and aspirate soft and hard tissue. This directly aligns with the definition of a therapeutic device, which aims to treat or alleviate a medical condition.
No
The CUSA Clarity system is a surgical aspirator used for fragmentation, emulsification, and aspiration of tissue during surgical procedures, not for identifying or diagnosing medical conditions.
No
The device description explicitly details multiple hardware components including a console, handpieces, footswitch, surgical tips, irrigation flues, and a suction/irrigation system. It also mentions electrical safety and EMC testing, which are hardware-related.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the device is used for "fragmentation, emulsification and aspiration of soft and hard (e.g. bone) tissue" during surgical procedures. This is a direct surgical intervention on the patient's body.
- Device Description: The description details a system that physically interacts with tissue using ultrasonic energy, irrigation, and aspiration. This is a surgical tool, not a device used to examine specimens in vitro (outside the body).
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue samples, etc.) in vitro to provide diagnostic information. The device's function is to remove tissue during surgery.
Therefore, the CUSA® Clarity Ultrasonic Surgical Aspirator System is a surgical device, not an In Vitro Diagnostic device.
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
LFL, LBK
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
hepatic parenchyma, 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
Not Found
Summary of Performance Studies
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
- 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.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
N/A
0
Image /page/0/Picture/0 description: The image contains 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 consists of the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG" in blue, and then the word "ADMINISTRATION" in a smaller font size below.
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
1
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
2
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)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
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:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
FORM FDA 3881 (7/17)
Page 1 of 1
PSC Publishing Services (1011) 443-6700 BEF
3
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, 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 |
| 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,
4
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
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 |
5
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
6
- · 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.