(184 days)
Not Found
Not Found
No
The description focuses on the physical principles of ultrasonic tissue breakdown and suction, with no mention of AI, ML, or related concepts like image processing or data-driven algorithms.
Yes
The device is used for surgical applications involving soft tissue removal, which is a therapeutic intervention.
No
Explanation: The device is described as an "ultrasonic scalpel" and is "intended for use for general soft tissue removal in a variety of surgical applications." This indicates it is a surgical tool for treatment, not for diagnosis.
No
The device description explicitly states it is an "Ultrasonic Suction Unit" and an "ultrasonic scalpel," which are hardware devices.
Based on the provided information, the Medicamat B.U.S. Endotron® Ultrasonic Suction Unit is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states it's for "general soft tissue removal in a variety of surgical applications." This describes a surgical device used on the patient's body during a procedure.
- Device Description: The description reinforces this by calling it an "ultrasonic scalpel" and describing its function in breaking down and emulsifying tissue.
- Lack of IVD Characteristics: IVD devices are used to examine specimens (like blood, urine, tissue samples) outside the body to provide information about a patient's health. The provided text does not mention any such use or interaction with patient specimens.
Therefore, the Medicamat B.U.S. Endotron® is a surgical device, not an in vitro diagnostic device.
N/A
Intended Use / Indications for 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 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. No specific use instructions are herein provided other than those included in th Manual (Document A-2). r reception Use
Product codes (comma separated list FDA assigned to the subject device)
LFL
Device Description
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
skilled physicians
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Not Found
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
N/A
0
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.
1
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
2
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.
3
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
4
- 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