The CUSA Excel 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, including Neurosurgery, Plastic and Reconstructive Surgery, General Surgery, Orthopedic Surgery, Gynecological Surgery, Thoracic Surgery, Laparoscopic Surgery and Thoracoscopic Surgery.
The CUSA Excel Ultrasonic Surgical Aspirator System (CUSA) 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 Excel System consists of a console which provides control and power functions, a surgical handpiece which provides ultrasonic mechanical energy, a titanium handpiece tip and flexible irrigation flue, and a suction/irrigation system (manifold tubing and cooling water canister). A tip has been added to the CUSA Excel system to enable it to abrade bone. Testing was completed to demonstrate that the tip will abrade bone. The tip is manufactured from the same materials as in the other CUSA Excel tips.
The provided text is a 510(k) summary for the Radionics CUSA Excel Ultrasonic Surgical Aspirator System with Bone Tip. This document describes the device, its intended use, and its substantial equivalence to predicate devices. However, it does not contain any information about acceptance criteria, device performance metrics (such as accuracy, sensitivity, specificity), sample sizes for test sets or training sets, expert qualifications, adjudication methods, or results from comparative effectiveness studies.
The text simply states: "Testing was completed to demonstrate that the tip will abrade bone." This is a general statement and does not provide quantified performance data or details of a study that would establish specific acceptance criteria.
Therefore, I cannot fulfill the request to provide the detailed information required for the table and all the numbered points because the provided document does not contain this type of performance study data.
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Attachment VI: Summary of Safety and Effectiveness Information [510(k) Summary]
AUG 2 2 2005
Radionics, a division of Tyco Healthcare LP SUBMITTER: 22 Terry Ave. Burlington, MA 01803 Tel .: (781) 272-1233 Fax: (781) 238-0645 Contact: Kevin J. O'Connell Regulatory Affairs Manager Radionics CUSA Excel Ultrasonic Surgical Aspirator System with PROPRIETARY NAME: Bone Tip Ultrasonic Aspirator COMMON OR USUAL NAME: Unclassified CLASSIFICATION CODE: CUSA Excel Ultrasonic Surgical aspirator System, K981262. PREDICATE DEVICES: Cavitron Ultasonic Surgical Aspirator CUSA System Model NS-100, K801623. Synergetics Sonotome Ultrasonic Aspirator Tips, K020220. The CUSA Excel Ultrasonic Surgical Aspirator System is indicated INTENDED USE: for use in surgical procedures where fragmentation, emulsification and aspiration of soft and hard (e.g.: bone) tissue is desirable, including Neurosurgery, Plastic and Reconstructive Surgery, General Surgery, Orthopedic Surgery, Gynecological Surgery, Thoracic Surgery, Laparoscopic Surgery and Thoracoscopic Surgery. The CUSA Excel Ultrasonic Surgical Aspirator System (CUSA) is DESCRIPTION: 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 Excel System consists of a console which provides control and power functions, a surgical handpiece which provides ultrasonic mechanical energy, a titanium handpiece tip and flexible irrigation flue, and a suction/irrigation system (manifold tubing and cooling water canister). A tip has been added to the CUSA Excel system to enable it to abrade bone. Testing was completed to demonstrate that the tip will abrade bone. The tip is manufactured from the same materials as in the other CUSA Excel tips.
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Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized eagle with three lines forming its body and wings. The eagle is enclosed within a circle of text that reads "U.S. Department of Health and Human Services, USA".
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
AUG 2 2 2005
Mr. Kevin J. O'Connell Regulatory Affairs Manager Radionics, a division of Tyco Healthcare LP 22 Terry Avenue Burlington, Massachusetts 01803
Re: K051947
Trade/Device Name: Radionics CUSA Excel Ultrasonic Surgical Aspirator System with Bone Tip Regulation Number: 21 CFR 878.4400 Regulation Name: Electrosurgical cutting and coagulation device and accessories Regulatory Class: II Product Code: LFL Dated: July 15, 2005 Received: July 18, 2005
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.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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); 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
This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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 (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely vours.
Barbara Buell
Mark N. Melkerson Acting Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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K 051947
Indications for Use
510(k) Number (if known): K051947
Device Name: Radionics CUSA Excel Ultrasonic Surgical Aspirator System with Bone Tip
Indications For use: The CUSA Excel Ultrasonic Surgical Aspirator System is indicated from and in surgical procedures where fragmentation, emulsification and aspiration of soft lor use in Surgrour procession is desirable, including Neurosurgery, Plastic and and franc (C.g.. bono) (Code is Costingery, 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)
barbare Bouchers for mixim
Divisio and Neurol
510(k) Number K051947
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