(28 days)
No
The document describes an ultrasonic surgical aspirator system and its accessories. There is no mention of AI or ML in the intended use, device description, or performance studies. The modifications described are related to the physical design of the tips for laparoscopic use and reduced friction.
No
The device is described as a surgical aspirator used for fragmenting, emulsifying, and aspirating tissues during various surgical procedures, which is an interventional function rather than therapeutic.
No
This device is used for tissue fragmentation, emulsification, and aspiration in surgical procedures, which are therapeutic functions, not diagnostic ones.
No
The device description explicitly states it is a "CUSA® Clarity 23kHz Laparoscopic Tip Packs" which are accessories intended for use with a "CUSA® Clarity Ultrasonic Surgical Aspirator System". This system is described as using ultrasonics, cavitation, irrigation, and aspiration to fragment and remove tissue, clearly indicating a hardware-based medical device. The testing performed also includes hardware-related tests like sterilization, biocompatibility, EMC, electrical safety, and mechanical performance.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly describes a surgical device used for fragmenting, emulsifying, and aspirating tissue during surgical procedures. This is a direct intervention on the patient's body.
- Device Description: The description details a surgical aspirator system that uses ultrasonics and cavitation to remove unwanted tissue. This is a therapeutic/surgical device, not a device used to examine specimens in vitro (outside the body) to provide diagnostic information.
- Lack of IVD Characteristics: The text does not mention any of the typical characteristics of an IVD, such as analyzing biological samples (blood, urine, tissue samples), providing diagnostic information, or being used in a laboratory setting for testing.
The device is a surgical tool used for tissue removal during various surgical procedures.
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 beingn 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 lapatic resection, lobectomy or trisegmentectony, 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 devices within the scope of this premarket notification are the CUSA® Clarity 23kHz Laparoscopic Tip Packs that are intended to be used with the 23 kHz Handpiece of the CUSA® Clarity Ultrasonic Surgical Aspirator System.
The CUSA® Clarity Ultrasonic Surgical Aspirator System is the newest device that was 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 Clarity), CUSA® Excel+ Ultrasonic Surgical Aspirator System (CUSA Excel+) and CUSA® NXT Ultrasonic Tissue Ablation System (CUSA NXT). 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 23kHz Laparoscopic Tip Packs have the same intended use and technological characteristics as the predicate CUSA Clarity and CUSA Excel+ systems, including the predicate tip pack accessories. The primary modification of the subject tips compared to the predicate devices is that they are longer, in order to provide an alternate tip design suited for laparoscopic surgery to the CUSA Clarity portfolio. CUSA Clarity is already indicated for laparoscopic surgery. The purpose of the subject tips is to continue to fill out the CUSA Clarity Tip portfolio to align with that of the legacy CUSA Excel+ system and meet user needs; the CUSA Excel+ system has a tip design very similar to the subject tips. Additionally, testing confirmed that the modifications reduce the frictional force between a trocar and the flue as compared to the predicate CUSA Excel+ Laparoscopic Tip, making the device easier to insert and retract from the trocar during surgical use.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Soft and hard (e.g. bone) tissue, brain and spinal tumors (meningiomas and gliomas), 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 (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 Laparoscopic Tip Packs. 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 requirements including those listed below:
- Tissue fragmentation rate
- Tip life with CEM
- Torque functionality during assembly
- Functionality within specification during environmental variations
- Mechanical and performance testing
- Trocar-Flue friction testing
- Thermal Effects and Capacitive Coupling per FDA guidance document
No clinical studies were required or performed as all conducted performance tests appropriately support a determination of substantial equivalence compared with the predicate devices.
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 Laparoscopic Tip Packs are substantially equivalent to the predicate devices.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
CUSA® Clarity Ultrasonic Surgical Aspirator System K200774, CUSA® Excel+ Ultrasonic Surgical Aspirator System K141668
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 shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health and 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.
July 15, 2022
Integra LifeSciences Corporation Alexandra Wells Senior Regulatory Specialist 1100 Campus Rd Princeton, New Jersey 08540
Re: K221763
Trade/Device Name: CUSA Clarity Ultrasonic Surgical Aspirator System Regulatory Class: Unclassified Product Code: LFL, LBK Dated: June 16, 2022 Received: June 17, 2022
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,
for
Long Chen, Ph.D. Assistant Director DHT4A: Division of General Surgery Devices OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
2
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
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 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 beingn 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 lapatic resection, lobectomy or trisegmentectony, 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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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 | 1100 Campus Rd, NJ 08540 USA |
| Phone Number | 1-609-903-6300 |
| Establishment Registration Number | 9004007 |
| Name of Contact Person | Alexandra Wells |
| Date Prepared | June 15, 2022 |
| 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 System K200774 | |
| CUSA® Excel+ Ultrasonic Surgical Aspirator System K141668 |
4
807.92(a)(4) - Device description
The devices within the scope of this premarket notification are the CUSA® Clarity 23kHz Laparoscopic Tip Packs that are intended to be used with the 23 kHz Handpiece of the CUSA® Clarity Ultrasonic Surgical Aspirator System.
The CUSA® Clarity Ultrasonic Surgical Aspirator System is the newest device that was 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 Clarity), CUSA® Excel+ Ultrasonic Surgical Aspirator System (CUSA Excel+) and CUSA® NXT Ultrasonic Tissue Ablation System (CUSA NXT). 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 23kHz Laparoscopic Tip Packs have the same intended use and technological characteristics as the predicate CUSA Clarity and CUSA Excel+ systems, including the predicate tip pack accessories. The primary modification of the subject tips compared to the predicate devices is that they are longer, in order to provide an alternate tip design suited for laparoscopic surgery to the CUSA Clarity portfolio. CUSA Clarity is already indicated for laparoscopic surgery. The purpose of the subject tips is to continue to fill out the CUSA Clarity Tip portfolio to align with that of the legacy CUSA Excel+ system and meet user needs; the CUSA Excel+ system has a tip design very similar to the subject tips. Additionally, testing confirmed that the modifications reduce the frictional force between a trocar and the flue as compared to the predicate CUSA Excel+ Laparoscopic Tip, making the device easier to insert and retract from the trocar during surgical use.
807.92(a)(5) - Intended use of the device
5
| | 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 |
|--|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | Indications for
Use |
| | 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 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 CUSA Clarity 23 kHz Laparoscopic Tip Packs have the same technological characteristics compared to the predicate device. The primary modification of the CUSA Clarity 23 kHz Laparoscopic Tip Packs compared to the predicate devices is that they are longer, in order to provide an alternate tip design suited for laparoscopic surgery to the CUSA Clarity portfolio. CUSA Clarity is already indicated for laparoscopic surgery. The purpose of the CUSA Clarity 23 kHz Laparoscopic Tip Packs is to continue to fill out the CUSA Clarity tip portfolio to align with that of the legacy CUSA Excel+ system and meet user needs.
The device is maintaining the same underlying technology and intended use of previous CUSA systems. Thus, the majority of the features and technology of the CUSA Clarity 23 kHz Laparoscopic Tip Packs are not new for a CUSA device and benefit from longstanding safety and/or efficacy.
807.92(b)(1-2) – Nonclinical and clinical tests submitted
7
K221763
Non-clinical testing was performed to ensure the safety and efficacy of the CUSA Clarity 23 kHz Laparoscopic Tip Packs. 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 requirements including those listed below: .
- Tissue fragmentation rate o
- o Tip life with CEM
- o Torque functionality during assembly
- Functionality within specification during environmental variations o
- o Mechanical and performance testing
- Trocar-Flue friction testing
- Thermal Effects and Capacitive Coupling per FDA guidance document
No clinical studies were required or performed 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 Laparoscopic Tip Packs are substantially equivalent to the predicate devices.