(184 days)
The Medicamat B.U.S. Endotron® Ultrasonic Suction Unit is a classic ultrasonic scalpel, based on the principle of the breakdown and selective emulsification of tissue through cavitation. It utilizes the same fundamental principles as other ultrasonic surgical aspirators. The B.U.S. Endotron® is intended for use for general soft tissue removal in a variety of surgical applications, such as neurosurgery, hepatosurgery, general surgery, plastic and reconstructive surgery. The intended uses are the same as those for the predicate devices.
Endotron® units are for use by skilled physicians who use them in accordance with procedures and practices taught in special medical training.
The Medicamat B.U.S. Endotron® Ultrasonic Suction Unit is a classic ultrasonic scalpel, based on the principle of the breakdown and selective emulsification of tissue through cavitation. It utilizes the same fundamental principles as other ultrasonic surgical aspirators.
The provided documents are FDA 510(k) clearance letters for the "B.U.S. Endotron® Ultrasonic Suction Unit" and do not contain information about acceptance criteria or a study proving that the device meets such criteria. A 510(k) clearance evaluates substantial equivalence to existing devices, not necessarily performance against specific acceptance criteria.
The documents primarily state:
- The device, Medicamat B.U.S. Endotron®, is substantially equivalent to predicate devices.
- Its intended use is for general soft tissue removal in various surgical applications (neurosurgery, hepatosurgery, general surgery, plastic and reconstructive surgery), utilizing ultrasonic scalpel principles (tissue breakdown and selective emulsification through cavitation).
- It is for use by skilled physicians who use them in accordance with procedures and practices taught in special medical training.
Therefore, I cannot provide the requested information regarding acceptance criteria and a study proving the device meets them because this information is not present in the provided text.
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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three lines representing its body and wings. The eagle faces left and is enclosed within a circular border. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged around the upper half of the circle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
DEC 1 0 1997
Mr. Andrew S. Krulwich Medicamat S.A. C/O Wiley, Rein & Fielding 1776 K Street N.W. Washington, DC 20006
K972148 Re: Trade Name: B.U.S. Endotron Regulatory Class: II Product Code: LFL Dated: September 30, 1997 Received: September 30, 1997
Dear Mr. Krulwich:
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 requirements , as set forth in the Quality System Regulation (QS) 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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Page 2 - Mr. Krulwich
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.
Sincerely yours,
C. Celia McWilliams, Ph.D., M.D.
· 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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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three lines representing its body and wings. The eagle faces left and is enclosed within a circular border. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged around the upper half of the circle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
DEC 1 0 1997
Mr. Andrew S. Krulwich Medicamat S.A. C/O Wiley, Rein & Fielding 1776 K Street N.W. Washington, DC 20006
K972148 Re: Trade Name: B.U.S. Endotron Regulatory Class: II Product Code: LFL Dated: September 30, 1997 Received: September 30, 1997
Dear Mr. Krulwich:
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 requirements , as set forth in the Quality System Regulation (QS) 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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Page 2 - Mr. Krulwich
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.
Sincerely yours,
C. Celia McWilliams, Ph.D., M.D.
· 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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- The 510(k) is submitted by
Medicamat, S.A. 59, Avenue Augustin Dumont 92240 Malakoff FRANCE FDA Registration No. 9681310
2. Intended Use
The Medicamat B.U.S. Endotron® Ultrasonic Suction Unit is a classic ultrasonic scalpel, based on the principle of the breakdown and selective emulsification of tissue through cavitation. It utilizes the same fundamental principles as other ultrasonic surgical aspirators. The B.U.S. Endotron® is intended for use for general soft tissue removal in a variety of surgical applications, such as neurosurgery, hepatosurgery, general surgery, plastic and reconstructive The intended uses are the same as those for the surgery. predicate devices.
3. Indications for Use
(Per 21 CFR 801.109)
Endotron® units are for use by skilled physicians who use them in accordance with procedures and practices taught in special medical training. No specific use instructions are herein provided other than those included in th Manual (Document A-2). r reception Use
(Division Sign-Off)
Division of General Restorative Devices
510(k) Number
N/A