(39 days)
The CUSA Shear Tip, an accessory of the CUSA EXcel Ultrasonic Surgical Aspirator System, is indicated for use in surgical procedures where fragmentation, emulsification and aspiration of soft tissue is desirable, including Neurosurgery, Gastrointestinal and affiliated organ surgery, Urological surgery, Plastic and Reconstructive surgery, General surgery, Orthopedic surgery, Gynecological surgery, Thoracic surgery, Laparoscopic surgery and Thoracoscopic surgery.
The CUSA Shear Tip is an additional tip that is used with CUSA EXcel system to fragment fibrous tissue. The distal end of the CUSA Shear Tip has a series of opposing angled lands, instead of a flat surface. This pattern promotes refracted longitudinal waves propagating in greatly different directions at the interface to coupled tissue. No changes to the console, handpiece or suction/irrigation system were needed.
The provided text outlines a 510(k) summary for the CUSA Shear Tip, an accessory to an ultrasonic surgical aspirator system. However, it does not contain the specific details required to answer your request regarding acceptance criteria and a study proving the device meets those criteria.
The document states: "Performance testing has been completed to demonstrate that the CUSA Shear Tip can better fragment fibrous tissue." This is a general statement and lacks all the specific information you've asked for.
Therefore, I cannot provide a table of acceptance criteria and reported device performance or any other details about sample sizes, ground truth, expert qualifications, adjudication methods, or MRMC studies, as none of that information is present in the provided text.
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Ko90864
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CUSA Shear Tip, an accessory of the CUSA EXcel Ultrasonic Surgical Aspirator System 510(k) Summary
Submitter's Name and Address:
Integra Radionics 22 Terry Avenue Burlington, MA 01803 781-565-1227 (Telephone) 781-238-0645 (Fax)
Contact Person and Telephone Number:
MAY - 8 2009
Kevin J. O'Connell Director Regulatory Affairs Integra Radionics, Inc. Tel.: (781) 565-1227
Date Summary was Prepared: May 7, 2009.
Name of the Device:
Trade Name: CUSA Shear Tip
Common Name: Ultrasonic Surgical Aspirator
Classification Name: Instrument, Ultrasonic Surgical Product Code: LFL
Classification Panel: General and Plastic Surgery
Substantial Equivalence:
The CUSA Shear Tip, an accessory of the CUSA EXcel Ultrasonic Surgical Aspirator System, is indicated for use in surgical procedures where fragmentation, emulsification and aspiration of soft tissue is desirable, including Neurosurgery, Gastrointestinal and affiliated organ surgery, Urological surgery, Plastic and Reconstructive surgery, General surgery, Orthopedic surgery, Gynecological surgery, Thoracic surgery, Laparoscopic surgery and Thoracoscopic surgery. Such functions are within the indications of use for the predicate devices. The technological characteristics are similar to those found in the following predicate devices: CUSA EXCEL Ultrasonic Surgical Aspirator System via 510(k) K981262 on July, 6, 1998; CUSA EXCEL Ultrasonic Surgical Aspirator System with Bone Tip cleared via 510(k) K051947 on August 22, 2005 and CUSA Selector NXT Ultrasonic Tissue Ablation System cleared via 510(k) K081459 on August 13, 2008.
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Ko90864
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The CUSA Shear Tip is an additional tip that is used with CUSA EXcel system to fragment fibrous tissue. The distal end of the CUSA Shear Tip has a series of opposing angled lands, instead of a flat surface. This pattern promotes refracted longitudinal waves propagating in greatly different directions at the interface to coupled tissue. No changes to the console, handpiece or suction/irrigation system were needed.
Performance testing has been completed to demonstrate that the CUSA Shear Tip can better fragment fibrous tissue.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS) of the United States. The seal features an eagle with its wings spread, symbolizing the federal government. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle.
MAY - 8 2009
ood and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Public Health Service
Integra Radionics, Inc % Mr. Kevin J O'Connell Director Regulatory Affairs 22 Terry Avenue Burlington, Massachusetts 01803
Re: K090864
Trade/Device Name: CUSA Shear Tip, An Accessory of The CUSA Excel Ultrasonic Surgical Aspirator System
Regulation Number: 21 CFR 878.4400
Regulation Name: Electrosurgical cutting and coagulation device and accessories Regulatory Class: II Product Code: LFL Dated: May 4, 2009 Received: May 5, 2009
Dear Mr. O'Connell:
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. 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 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 (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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Page 2 - Mr. Kevin J O'Connell
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please contact the CDRH/Office of Surveillance and Biometrics/Division of Postmarket Surveillance at (240) 276-3464. For more information regarding the reporting of adverse events, please go to http://www.fda.gov/cdrh/mdr/.
You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Daniel Knane
Mark N. Melkerson Division of Surgical, Orthopedic and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use Statement
510(k) Number (if known):
Device Name: CUSA Shear Tip, an accessory of the CUSA EXcel Ultrasonic Surgical Aspirator System
Indications For Use:
The CUSA Shear Tip, an accessory of the CUSA EXcel Ultrasonic Surgical Aspirator System, is indicated for use in surgical procedures where fragmentation, emulsification and aspiration of soft tissue is desirable, including Neurosurgery, Gastrointestinal and affiliated organ surgery, Urological surgery, Plastic and Reconstructive surgery, General surgery, Orthopedic surgery, Gynecological surgery, Thoracic surgery, Laparoscopic surgery and Thoracoscopic surgery.
PRESCRIPTION USE __ × (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use_ (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
David Krone for MXM
(Division Sign-Off) Division of Surgical, Orthopedic, and Restorative Devices
510(k) Number K090864
N/A