(142 days)
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 and Thoracic Surgery and the following specific uses:
Neurosurgery - including removal of primary 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, 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
Gynecological Surgery - including removal of dysplastic genital epithelial tissue including vulvar and vaginal intraepithelial neoplasia, removal of condyloma, debulking of metastatic uterine, ovarian, fallopian tube or primary peritoneal carcinoma, and open or laparoscopic excision of tissue and adhesions associated with endometriosis
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. The CUSA Clarity may also be optionally used with the CUSA Electrosurgical Modules which provide optional electrosurgical capability.
The information provided describes a 510(k) premarket notification for the CUSA® Clarity Ultrasonic Surgical Aspirator System, primarily focusing on a modification to its Indications for Use to include more specific gynecological surgery indications. The submission claims substantial equivalence to a predicate device (K182809) and did not involve any design or technological changes to the device itself. Therefore, the "acceptance criteria" and "device performance" in the traditional sense of a new or modified device's functional characteristics are not directly presented as a series of quantitative benchmarks met by a specific study on the device's technical performance. Instead, the "acceptance criteria" here refer to demonstrating that the expanded indications for use for gynecological surgery are safe and effective, supported by existing literature and showing no new safety or effectiveness concerns compared to the predicate device.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Implied for Expanded Indications) | Reported Device Performance (Based on Literature Review) |
|---|---|
| For Dysplastic Genital/Perianal Epithelial Tissue (e.g., VIN, Condyloma): | CUSA was used to treat 272 patients with dysplasia or condyloma. Successful achievement of desired treatment outcomes was reported, and no significant postoperative complications or scarring were noted in the clinical literature for condyloma cases. |
| For Debulking Metastatic Uterine, Ovarian, Fallopian Tube, or Primary Peritoneal Carcinoma: | The provided articles demonstrated the safe and effective use of CUSA in debulking ovarian cancer, as well as metastases from endometrial cancer, tubal adenocarcinoma, and peritoneal tumors for 630 patients requiring debulking procedures. Articles reported both increased and decreased procedure durations when CUSA was used. One article noted risk of DIC (Disseminated Intravascular Coagulation), but no other studies found such a risk in a CUSA population of 1,465 patients. |
| For Excision of Tissue and Adhesions Associated with Endometriosis: | In cases where endometrial tissue was removed (18 patients), CUSA effectively removed the endometrial tissue while preserving vessels and nerves. |
| Overall Safety and Effectiveness for Gynecological Applications: | The literature review, encompassing 1,465 patients across 54 articles, concluded that CUSA is safe and effective in these gynecological applications, demonstrating substantial equivalence to the predicate device. |
2. Sample size used for the test set and the data provenance
The "test set" in this context refers to the body of clinical evidence reviewed to support the expanded indications.
- Sample Size: 1,465 patients. This total is comprised of:
- 272 patients for dysplasia or condyloma.
- 630 patients for debulking procedures (cancers).
- 18 patients for endometriosis.
- The remaining patients likely fall into categories not specifically broken down or represent overlaps in articles.
- Data Provenance: The data was derived from an "analysis of peer-reviewed articles." This indicates a retrospective review of published clinical literature. The country of origin of the data is not specified but would likely span various international institutions given the nature of peer-reviewed publications over an extended period.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable in the typical sense. This was a literature review, not a study where experts established ground truth for a novel dataset. The "ground truth" is implicitly established by the reported outcomes in the published clinical studies themselves, which are conducted by various medical professionals (surgeons, pathologists, etc.) in their respective fields. The submission does not specify an independent panel of experts reviewing the collected literature to establish a "ground truth" for the purpose of this 510(k).
4. Adjudication method for the test set
Not applicable. There was no explicit adjudication method for a test set as this was a review of existing peer-reviewed literature. The outcomes reported in the individual studies within the literature served as the evidence.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
Not applicable. The device is an ultrasonic surgical aspirator system, not an AI or imaging diagnostic device that involves human "readers" interpreting output. This submission focuses on the safety and effectiveness of the existing device for expanded (gynecological) indications.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. The CUSA Clarity is a surgical instrument used by a surgeon, not a standalone algorithm.
7. The type of ground truth used
The "ground truth"-like evidence used was outcomes data and reported effectiveness/safety from published clinical studies. This includes:
- Achievement of desired treatment outcomes (e.g., successful removal of tissue).
- Reported presence or absence of postoperative complications.
- Preservation of vessels and nerves.
- Comparison of procedure durations.
8. The sample size for the training set
Not applicable. This was a 510(k) submission for an existing device with expanded indications, not an AI/algorithm development where a training set would be used. The "evidence" supporting the expanded indications comes from published literature.
9. How the ground truth for the training set was established
Not applicable. As above, there was no training set for an algorithm.
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July 11, 2024
Integra LifeSciences Corporation Karen Monaghan Senior Regulatory Affairs Specialist 1100 Campus Rd Princeton Princeton, New Jersey 08540
K240493 Re:
Trade/Device Name: CUSA® Clarity Ultrasonic Surgical Aspirator System Regulatory Class: Unclassified Product Code: LFL, LBK Dated: February 16, 2024 Received: May 13, 2024
Dear Karen Monaghan:
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 (the 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 available 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.
Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
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Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).
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 Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatoryinformation/postmarketing-safety-reporting-combination-products); 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 Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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-devicereporting-mdr-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/medical-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-devices/device-advicecomprehensive-regulatory-assistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@tda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerelv.
Reginald K. Avery -S
for Jason R. Roberts, Ph.D. Assistant Director DHT3B: Division of Reproductive, Gynecology and Urology Devices OHT3: Office of Gastrorenal, ObGyn, General Hospital, and Urology Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
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Indications for Use
Form Approved: OMB No. 0910-0120 Expiration Date: 07/31/2026 See PRA Statement below.
Submission 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 and Thoracic Surgery and the following specific uses:
Neurosurgery - including removal of primary 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, 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
Gynecological Surgery - including removal of dysplastic genital epithelial tissue including vulvar and vaginal intraepithelial neoplasia, removal of condyloma, debulking of metastatic uterine, ovarian, fallopian tube or primary peritoneal carcinoma, and open or laparoscopic excision of tissue and adhesions associated with endometriosis
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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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 | +353-87-710-5565 |
| Name of Contact Person | Karen Monaghan |
| Date Prepared | 10-July-2024 |
| 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 | None |
| Classification Panel | General and Plastic Surgery |
| Regulation | Unclassified |
| Product Code(s) | LFL (Instrument, Ultrasonic Surgical), LBK (NeurosurgicalUltrasonic Instruments) |
| 807.92(a)(3) – Legally marketed device(s) to which equivalence is claimed |
CUSA Clarity Ultrasonic Surgical Aspirator: K182809
The predicate K182809 has not been subject to a design-related recall.
807.92(a)(4) - 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. The CUSA Clarity may also be optionally used with the CUSA Electrosurgical Modules which provide
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| optional electrosurgical capability.807.92(a)(5) – Intended use of the device | |
|---|---|
| Indications for Use | The Indications for Use for the CUSA® Clarity UltrasonicSurgical Aspirator System are listed below. When compared tothe predicate, the Indications for Use Statement forgynecological surgery has been modified to include specificindications in addition to the previously cleared generalindication. There have been no other changes to the Indicationsfor Use when compared to the predicate.The CUSA® Clarity Ultrasonic Surgical Aspirator Systemis indicated for use in surgical procedures wherefragmentation, emulsification and aspiration of soft andhard (e.g. bone) tissue is desirable.The CUSA Clarity Ultrasonic Surgical Aspirator isindicated for use in:Plastic and Reconstructive surgery, Orthopedic Surgery,and Thoracic Surgery and the following specific uses:Neurosurgery – including removal of primary andsecondary malignant and benign brain and spinal tumors,including but not limited to meningiomas and gliomasGastrointestinal and Affiliated Organ Surgery – includingremoval of benign or malignant tumors or other unwantedtissue, including hepatic parenchyma, in open orlaparoscopic procedures, hepatic resection, tumorresection, lobectomy or trisegmentectomy, or removal oftissue during liver allotransplantation and donorhepatectomy |
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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 laparoscopic cholecystectomy or or laparoscopic or pancreatic jejunostomy, or or pancreatectomy, or laparoscopic appendectomy, laparoscopic colon resection or laparoscopic partial gastrectomy Gynecological Surgery - including removal of dysplastic genital or perianal epithelial tissue including vulvar and vaginal intraepithelial neoplasia, removal of condyloma, debulking of metastatic uterine, ovarian, fallopian tube or primary peritoneal carcinoma, and open or laparoscopic excision of tissue and adhesions associated with
807.92(a)(6) Summary of the technological characteristics of the device compared to the predicate
endometriosis
The technological characteristics of the device are the same compared to the predicate device. There are no technological or design changes in the subject device compared to the predicate device. The change included in this submission is an addition of the specific gynecological surgery indication.
807.92(b) (1-2) – Nonclinical and clinical tests submitted
No non-clinical testing was provided as the subject device design was not modified from the predicate device.
The labeling is developed in accordance with the FDA guidance, "Product Labeling for
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Certain Ultrasonic Surgical Aspirator Devices."
An analysis of peer-reviewed articles on the use of CUSA in Gynecological Surgeries was provided as clinical evidence to support the revision to the indications for use of CUSA in Gynecological surgery (1,465 patients in 54 articles published between 1988 and 2023).
Specifically, in the literature, CUSA was used to treat 272 patients with dysplasia or condyloma, 630 patients requiring debulking procedures, and 18 patients with endometriosis. CUSA was able to perform the procedures effectively with desired treatment outcomes.
Likewise, in condyloma cases, CUSA was successful in achieving desired treatment outcomes. In the clinical literature, use of CUSA also did not result in significant postoperative complications or scarring.
The provided articles demonstrated the safe and effective use of CUSA in debulking ovarian cancer, as well as metastases from endometrial cancer, tubal adenocarcinoma, and peritoneal tumors. Articles reported both increased and decreased procedure durations when CUSA was used. One article noted risk of DIC (Disseminated Intravascular Coagulation); however, no other studies found such a risk of DIC in a CUSA population of 1,465 patients.
In cases where endometrial tissue was removed, CUSA effectively removed the endometrial tissue while preserving vessels and nerves.
807.92(b)(3) – Conclusions drawn from non-clinical and clinical data
The information from the peer reviewed clinical literature supports that the subject device is as safe and effective as the predicate device and supports a determination of substantial equivalence.
N/A