CUSA Clarity Ultrasonic Surgical Aspirator System

K230427 · Integra LifeSciences Corporation · LFL · Jul 11, 2023 · SU

Device Facts

• Record ID: K230427
• Device Name: CUSA Clarity Ultrasonic Surgical Aspirator System
• Applicant: Integra LifeSciences Corporation
• Product Code: LFL · SU
• Decision Date: Jul 11, 2023
• Decision: SESE
• Submission Type: Traditional
• Device Class: Class U
• Attributes: Therapeutic

Intended 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

Device Story

CUSA Clarity Ultrasonic Surgical Aspirator System uses ultrasonic energy to fragment, emulsify, and aspirate soft and hard tissue. The subject device is an expanded Electrosurgery Module (CEM) nosecone accessory. It allows the CUSA handpiece to connect to additional electrosurgical generators (Medtronic FT10, FX8; Erbe VIO 300D, VIO 3; Medtronic Force FX) to provide simultaneous electrosurgical coagulation of bleeding tissue during aspiration. Used in OR settings by surgeons; the device enables dual-function tissue removal and hemostasis. Benefits include improved surgical efficiency and control over bleeding at the surgical site.

Clinical Evidence

No clinical studies were performed or required. Substantial equivalence is supported by non-clinical bench testing, including sterilization, shipping, stability, biocompatibility, EMC, electrical safety, handpiece/tip life, and mechanical performance testing.

Technological Characteristics

Ultrasonic surgical aspirator with CEM nosecone accessory. Operates at 23 kHz. Materials and design are consistent with predicate. Connectivity expanded to include multiple third-party electrosurgical generators. Testing performed per FDA guidance and recognized standards for biocompatibility, EMC, and electrical safety.

Indications for Use

Indicated for patients requiring fragmentation, emulsification, and aspiration of soft and hard (e.g., bone) tissue during surgical procedures, including neurosurgery, gastrointestinal, urological, general, and laparoscopic surgeries.

Predicate Devices

• CUSA® Clarity Ultrasonic Surgical Aspirator System (K190180)

Reference Devices

• Medtronic FT10 (K191601)
• Medtronic FX8 (K181389)
• Erbe VIO 300D (K083452)
• Erbe VIO 3 (K190823)
• Medtronic Force FX (K143161)

Submission Summary (Full Text)

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July 11, 2023

Integra Lifesciences Corporation Alexandra Wells Senior Regulatory Specialist 1100 Campus Rd Princeton, New Jersey 08540

Re: K230427

Trade/Device Name: CUSA Clarity Ultrasonic Surgical Aspirator System Regulatory Class: Unclassified Product Code: LFL, LBK Dated: June 22, 2023 Received: June 22, 2023

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

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devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see 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 mediation-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 ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely.

Digitally signed by Mark Mark Trumbore -S Trumbore -S Date: 2023.07.11 15:15:07 -04'00'

Mark Trumbore, 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

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| DEPARTMENT OF HEALTH AND HUMAN SERVICES<br>Food and Drug Administration | Form Approved: OMB No. 0910-0120<br>Expiration Date: 06/30/2023<br>See PRA Statement below. |
|-------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 510(k) Number (if known) | 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: |
| | 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 |
| Type of Use (Select one or both, as applicable) | <label><input checked="checked" type="checkbox"/> Prescription Use (Part 21 CFR 801 Subpart D)</label> <label><input type="checkbox"/> Over-The-Counter Use (21 CFR 801 Subpart C)</label> |

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#### K230427

Integra LifeSciences Corporation - Traditional 510(k) CUSA® Clarity 23 kHz Expanded CEM Nosecone Accessory

## 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 Road, NJ 08540 USA |
| Phone Number | 1-609-903-6300 |
| Establishment Registration Number | 9004007 |
| Name of Contact Person | Alexandra Wells |
| Date Prepared | February 13, 2023 |
| | 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 K190180 | |
| | 807.92(a)(4) - Device description |

The device within the scope of this premarket notification is the optional CUSA® Electrosurgery Module (CEM) accessory that is intended to be used with the 23 kHz components of the CUSA® Clarity Ultrasonic Surgical Aspirator System.

The purpose of this submission is to modify the CEM nosecone accessory currently offered with CUSA Clarity to allow for connection with additional electrosurgical generators, to continue to

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provide electrosurgical capabilities to the user. The additional electrosurgical generators that the modified CEM Nosecone may be used with include the Medtronic FT10 (K191601), Medtronic FX8 (K181389), Erbe VIO 300D (K083452), and Erbe VIO 3 (K190823). Compatibility with the Medtronic Force FX (K143161) will be maintained as well.

The CUSA Clarity 23kHz Expanded CEM Nosecone has the same intended use and technological characteristics as the predicate CUSA Clarity 23 kHz CEM Nosecone (K190180). The subject CEM nosecone will continue to allow the surgeon to apply immediate electrosurgical coagulation to bleeding tissue at the surgical site, with the same handpiece assembly that is removing unwanted tissue.

807.92(a)(5) - Intended use of the device

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| Indications for Use | The CUSA Clarity Ultrasonic Surgical Aspirator System is indicated for<br>use in surgical procedures where fragmentation, emulsification and<br>aspiration of soft and hard (e.g. bone) tissue is desirable. |
|---------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | The CUSA Clarity Ultrasonic Surgical Aspirator is indicated for use in:<br>Plastic and Reconstructive surgery, Orthopedic Surgery, Gynecological<br>Surgery and Thoracic Surgery and the following specific uses: |
| | Neurosurgery – including removal of primary and secondary malignant<br>and benign brain and spinal tumors, including but not limited to<br>meningiomas and gliomas |
| | Gastrointestinal and Affiliated Organ Surgery – including removal of<br>benign or malignant tumors or other unwanted tissue, including hepatic<br>parenchyma, in open or laparoscopic procedures, hepatic resection,<br>tumor resection, lobectomy or trisegmentectomy, or removal of tissue<br>during liver allotransplantation and donor hepatectomy |
| | Urological surgery- including removal of renal parenchyma during<br>nephrectomy or partial nephrectomy |
| | General Surgery – including removal of benign or malignant tumors or<br>other unwanted soft or hard tissue in open or minimally invasive general<br>surgical procedures |
| | Laparoscopic Surgery – including removal of hepatic parenchyma in<br>laparoscopic hepatic resection, lobectomy or trisegmentectomy, in<br>laparoscopic donor hepatectomy or laparoscopic cholecystectomy or<br>laparoscopic pancreatic jejunostomy, or pancreatectomy, or laparoscopic<br>appendectomy, laparoscopic colon resection or laparoscopic partial |

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#### gastrectomy

# 807.92(a)(6) Summary of the technological characteristics of the device compared to the predicate

The subject CEM nosecone offered with the CUSA Clarity has the same technological characteristics compared to the predicate device. The main purpose of the modified device is to provide the same electrosurgical coagulation abilities when used with additional electrosurgical generators. The device is maintaining the same underlying technology and intended use of previous CUSA devices. Thus, the majority of the features and technology of the CEM nosecone 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

Non-clinical testing and/or predicate device testing adoptions were performed to ensure the safety and efficacy of the CUSA Clarity system. This included, but was 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 system requirements, including those listed below: .
- Handpiece and Tip Life with CEM
- Functionality within specification during environmental variations ●
- Mechanical and Performance Testing o
- Thermal Effects and Capacitive Coupling per FDA guidance document ●

Testing was determined successful 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 23 kHz Expanded CEM Nosecone support a determination of substantial equivalence when compared with the predicate device.

No clinical studies were performed or required as all conducted performance tests appropriately support a determination of substantial equivalence compared with the predicate device.

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## 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 Expanded CEM Nosecone is substantially equivalent to the predicate device.