(91 days)
The Fibra Sonics Ultrasonic Surgical Aspirator System has been designed or use in the The Flora Somes Offication and aspiration of soft tissues as used in the following surgical areas:
NEUROSURGERY
For the ablation and aspiration of various intracranial and spinal cord soft tissue tumors, which may include but are not necessarily limited to the following:
Astrocytoma Pituitary adeonoma Acoustic neuroma Meningioma Glioma Brain stem tumors Spinal cord tumors.
GASTROENTEROLOGY
Various Gastroenterological and General surgery procedures along the GI tract , which may include, but are not necessarily limited to the following:
Hepatic resection Liver trauma Hepatic cysts Colon cancer Rectal Tumor Bowel tumor Retropertioneal turnor
ORTHOPEDICS
Various orthopedic procedures which may include, but are not necessarily limited to the following:
Discectomy
Fibra Sonics Ultrasonic Surgical Aspirator Model 1000
I am sorry, but the provided text is a 510(k) premarket notification letter from the FDA to Fibra-Sonics, Incorporated regarding their Ultrasonic Surgical Aspirator System Model 1000. It confirms that the device is substantially equivalent to legally marketed predicate devices and outlines the general regulatory requirements.
This document does not contain information about acceptance criteria, device performance studies, sample sizes, ground truth establishment, or any details typically found in a study report proving a device meets acceptance criteria.
Therefore, I cannot extract the requested information as it is not present in the provided text.
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DEC | 4 1998
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Mr. Robert Brohm Director of Quality Systems and Regulatory Affairs Fibra-Sonics, Incorporated 5312 North Elston Avenue Chicago, Illinois 60630
K983199 Re: Trade Name: Fibrasonics Ultrasonic Surgical Aspirator System Model 1000 Regulatory Class: II Product Code: LFL Dated: September 11, 1998 Received: September 14, 1998
Dear Mr. Brohm:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). 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 (Premarket Approval), 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 895. A substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (OS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic (QS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
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This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed 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 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4595. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html",
Sincerely yours,
Celia M. Witten, Ph.D., M.D. Director Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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510 (k) Number K983199
Device Name: Fibra Sonics Ultrasonic Surgical Aspirator Model 1000
Indications For Use:
The Fibra Sonics Ultrasonic Surgical Aspirator System has been designed or use in the The Flora Somes Offication and aspiration of soft tissues as used in the following surgical areas:
NEUROSURGERY
For the ablation and aspiration of various intracranial and spinal cord soft tissue tumors, which may include but are not necessarily limited to the following:
Astrocytoma Pituitary adeonoma Acoustic neuroma Meningioma Glioma Brain stem tumors Spinal cord tumors.
Indications for use continued on next page.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
bcoolefo
(Division Sign-Off)
Division of General Restorative Devices
510(k) Number K983199
Image /page/2/Picture/15 description: The image shows the words "Prescription Use" and the phrase "(Per 21 CFR 801.109)" in a bold, sans-serif font. There is a large check mark to the right of the text. The text is left-aligned and the check mark is slightly offset to the right.
or
Over-The-Counter Use (Optional Format 1-2-96)
response Indicafor use statement.doc
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510 (k) Number K983199
Device Name: Fibra Sonics Ultrasonic Surgical Aspirator Model 1000
Indications For Use Statement Continued:
GASTROENTEROLOGY
Various Gastroenterological and General surgery procedures along the GI tract , which may include, but are not necessarily limited to the following:
Hepatic resection Liver trauma Hepatic cysts Colon cancer Rectal Tumor Bowel tumor Retropertioneal turnor
ORTHOPEDICS
Various orthopedic procedures which may include, but are not necessarily limited to the following:
Discectomy
bessett
on Sign-Off
Prescription Use
(Per 21 CFR 801.109)
N/A