(90 days)
Not Found
No
The device description focuses on ultrasonic mechanical energy, irrigation, and aspiration for tissue fragmentation and removal. There is no mention of AI or ML in the device description, intended use, or performance studies.
Yes
The device aids in various surgical procedures by fragmenting, emulsifying, and aspirating tissue, including the removal of tumors and other unwanted tissue, which is a therapeutic intervention.
No.
This device description indicates it is a surgical tool used for fragmentation, emulsification, and aspiration of tissue during various surgical procedures, not for diagnostic purposes.
No
The device description explicitly lists multiple hardware components including a console, handpieces, footswitch, surgical tips, irrigation flues, and a suction/irrigation system.
Based on the provided information, the CUSA Clarity Ultrasonic System is not an In Vitro Diagnostic (IVD) device.
Here's why:
- Intended Use: The intended use clearly describes a surgical device used for the fragmentation, emulsification, and aspiration of tissue during surgical procedures. This is an active intervention on the patient's body.
- Device Description: The device description details a system that uses ultrasonic energy, irrigation, and aspiration to physically remove tissue. This is a surgical tool, not a device used to examine specimens outside the body for diagnostic purposes.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue samples, etc.) in vitro (outside the body) to provide diagnostic information. The device's function is to remove tissue in vivo (within the body).
In summary, the CUSA Clarity is a surgical device used for tissue removal during various surgical procedures, which falls under the category of a surgical instrument or system, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
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
Product codes (comma separated list FDA assigned to the subject device)
LFL, LBK
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
main and spinal tumors, hepatic parenchyma, renal parenchyma, soft or hard tissue
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
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 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.
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.
CUSA Clarity Ultrasonic Surgical Aspirator; 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). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo is a blue square with the letters "FDA" in white, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue.
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
1
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
2
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
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)
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 Registration | |
| Number | 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 Ultrasonic |
| Surgical Aspirator System are listed below. When compared to | |
| the predicate, the Indications for Use statement for neurosurgery | |
| has been modified to include specific indications in addition to | |
| the previously cleared general indication. There have been no | |
| other changes to the Indications for Use when compared to the | |
| predicate. | |
| 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: | |
| Plastic and Reconstructive surgery, Orthopedic Surgery, | |
| Gynecological Surgery and Thoracic Surgery and the | |
| following specific uses: | |
| Neurosurgery - including removal of primary and | |
| secondary malignant and benign brain 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 |
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
4
5
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
6
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.