(60 days)
Not Found
No
The summary describes a surgical aspirator system and its accessories, focusing on mechanical and ultrasonic tissue fragmentation. There is no mention of AI, ML, or any computational analysis of data for decision-making or control.
No
The device is used for surgical procedures to fragment, emulsify, and aspirate tissue, which is an interventional/surgical function rather than therapeutic.
No
The device is described as an "Ultrasonic Surgical Aspirator System" used for fragmentation, emulsification, and aspiration of tissue, and its stated purpose is for use in surgical procedures. It does not perform diagnostic functions.
No
The device description explicitly states it is a "Tip Pack" intended to be used with a "Handpiece" of an "Ultrasonic Surgical Aspirator System." This clearly indicates a physical, hardware component, not a software-only device.
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 tissue. This is a physical process performed on tissue in vivo (within the living body).
- Lack of IVD Characteristics: An IVD device is used to examine specimens derived from the human body (like blood, urine, tissue samples) in vitro (outside the body) to provide information for diagnosis, monitoring, or screening. The provided text does not mention any such use or analysis of specimens.
The device is a surgical tool used for tissue removal during surgery, not for diagnostic testing of samples.
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: 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
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 CUSA® Clarity 23kHz Single-Sided Bone Tip Pack that is 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. All CUSA systems are surgical aspirators that use ultrasonics and cavitation 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 Single-Sided Bone Tip Pack has the same intended use and technological characteristics as the predicate CUSA Clarity system, including all predicate tip pack accessories. A bone tip is currently cleared with the predicate CUSA Clarity system (CUSA Clarity 23 kHz Bone Tip). The primary modification of the CUSA Clarity 23 kHz Single-Sided Bone Tip Pack when compared to the currently cleared CUSA Clarity bone tip is that the subject device has a limited abrasive fragmentation surface at the distal end of the tip when compared to the existing bone tip.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
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 and/or predicate testing adoptions were performed to ensure the safety and efficacy of the CUSA Clarity 23 kHz Single-Sided Bone Tip Pack as well as substantial equivalence with the predicate device. The testing and adoptions included, but were not limited to: - Sterilization, shipping and stability per FDA Guidance documents and recognized standards - Biocompatibility per FDA Guidance documents and recognized standards - EMC and Electrical Safety per FDA Guidance documents and recognized standards - Bench testing to verify requirements including those listed below: - Tissue fragmentation rate - Tip life - Torque functionality during assembly - Functionality within specification during environmental variations - Mechanical and performance testing. No clinical studies were performed or required 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 Single-Sided Bone Tip Pack is substantially equivalent to the predicate device.
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 System K200774
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 contains two logos. The logo on the left is the Department of Health & Human Services logo. The logo on the right is the FDA logo, which stands for U.S. Food & Drug Administration. The FDA logo is in blue.
August 22, 2022
Integra Lifesciences Corporation Alexandra Wells Senior Regulatory Specialist 1100 Campus Road Princeton, New Jersey 08540
Re: K221835
Trade/Device Name: CUSA Clarity Ultrasonic Surgical Aspirator System Regulatory Class: Unclassified Product Code: LFL, LBK Dated: June 22, 2022 Received: June 23, 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 |
Form Approved: OMB No. 0910-0120 Expiration Date: 0&/30/2023 See PRA Statemen! below.
51D(k) Number (if known)
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:
Plastic and Reconstructive surgery, Orthopedic Surgery, Gynecological Surgery and the following specific uses:
Neurosurgery - including removal of poimary and secondary malignant 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, lobectory or trisegmentectomy, or removal of tissue during liver allotransplantation and donor hepatectomy
Urological surgery- including removal of renal parenchyma during nephrectomy or partial nephrectory
General Surgery - including removal of beingn or malignant turnors 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 trisegmentectory, 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)
2 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 1986.
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 as pect 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 (6/20)
Page of
PSC Patfishing Services (300) 44)-4149 EP
3
Integra LifeSciences Corporation - Traditional 510(k) CUSA® Clarity 23 kHz Single-Sided Bone Tip Packs
SECTION 5 - 510(K) SUMMARY
4
Integra LifeSciences Corporation - Traditional 510(k) CUSA® Clarity 23 kHz Single-Sided Bone Tip
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 21, 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 |
5
Integra LifeSciences Corporation - Traditional 510(k) CUSA® Clarity 23 kHz Single-Sided Bone Tip
807.92(a)(4) - Device description
The device within the scope of this premarket notification is the CUSA® Clarity 23kHz Single-Sided Bone Tip Pack that is 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. All CUSA systems are surgical aspirators that use ultrasonics and cavitation 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 Single-Sided Bone Tip Pack has the same intended use and technological characteristics as the predicate CUSA Clarity system, including all predicate tip pack accessories. A bone tip is currently cleared with the predicate CUSA Clarity system (CUSA Clarity 23 kHz Bone Tip). The primary modification of the CUSA Clarity 23 kHz Single-Sided Bone Tip Pack when compared to the currently cleared CUSA Clarity bone tip is that the subject device has a limited abrasive fragmentation surface at the distal end of the tip when compared to the existing bone tip.
807.92(a)(5) - Intended use of the device
6
Integra LifeSciences Corporation – Traditional 510(k) CUSA® Clarity 23 kHz Single-Sided Bone Tip
| 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. | |
| Indications for | |
| Use | 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 | |
| 807.92(a)(6) Summary of the technological characteristics of the device compared to the | |
| predicate | |
| The CUSA Clarity 23 kHz Single-Sided Bone Tip Pack has the same technological | |
| characteristics compared to the predicate device. The main purpose of this submission is to | |
| continue the effort to fill out the CUSA Clarity tip portfolio to align with the legacy CUSA | |
| systems. The device is maintaining the same underlying technology and intended use of previous | |
| CUSA systems. Thus, the features and technology of the CUSA Clarity 23 kHz Single-Sided | |
| Bone Tip Pack are not new for a CUSA device and benefit from longstanding safety and/or | |
| efficacy. |
7
Integra LifeSciences Corporation – Traditional 510(k) CUSA® Clarity 23 kHz Single-Sided Bone Tip
807.92(b)(1-2) – Nonclinical and clinical tests submitted
8
Integra LifeSciences Corporation - Traditional 510(k) CUSA® Clarity 23 kHz Single-Sided Bone Tip
Non-clinical testing and/or predicate testing adoptions were performed to ensure the safety and efficacy of the CUSA Clarity 23 kHz Single-Sided Bone Tip Pack as well as substantial equivalence with the predicate device. The testing and adoptions included, but were not limited to:
- Sterilization, shipping and stability per FDA Guidance documents and recognized standards
- Biocompatibility per FDA Guidance documents and recognized standards ●
- EMC and Electrical Safety per FDA Guidance documents and recognized standards ●
- Bench testing to verify requirements including those listed below: ●
- Tissue fragmentation rate O
- Tip life O
- Torque functionality during assembly O
- Functionality within specification during environmental variations O
- Mechanical and performance testing O
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 Single-Sided Bone Tip Pack is substantially equivalent to the predicate device.