(88 days)
Not Found
No
The description details a mechanical device using ultrasonic vibration for tissue fragmentation and removal, with no mention of AI/ML terms or functionalities.
Yes
The device is described as aiding in the fragmentation, emulsification, and removal of soft tissue in General and Plastic & Reconstructive Surgery, which is a therapeutic function.
No
The device description clearly states its purpose is for "fragmentation, emulsification and removal of soft tissue," which are surgical procedures, not diagnostic ones. It converts electrical energy into mechanical motion to fragment tissues.
No
The device description clearly outlines hardware components including a generator, console, surgical handpiece, piezoceramic crystals, and a tip, indicating it is not a software-only device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is "Aids in the fragmentation, emulsification and removal of soft tissue in General and Plastic & Reconstructive Surgery." This describes a surgical procedure performed directly on a patient's body, not a test performed on a sample taken from the body (which is the definition of an in vitro diagnostic).
- Device Description: The description details a surgical system that uses ultrasonic energy to break down tissue and a vacuum to remove it. This is consistent with a surgical device, not an IVD.
- Lack of IVD Characteristics: The description does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples (blood, urine, tissue samples, etc.)
- Detecting or measuring substances in samples
- Providing diagnostic information based on sample analysis
Therefore, the VIBRA-SURGE ™ System VS2120 is a surgical device, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
Aids in the fragmentation, emulsification and removal of soft tissue in General and Plastic & Reconstructive Surgery
Aids in The Removal of Soft Tissue in General Surgery and Plastic and Reconstructive Surgery
Product codes
LFL
Device Description
The VIBRA-SURGE ™ System VS2120 is comprised of a generator, operating at one of several possible standard line voltages, contained in a console which feeds a 20-22 kHz electrical signal to a surgical handpiece containing piezoceramic crystals. These crystals convert the electrical energy into mechanical motion. This mechanical motion has the same frequency of 20-22 kHz. Fragmentation of unwanted tissues occurs at the end of the tip which is hollow allowing the use of a vacuum source to remove these fragments.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
soft tissue
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
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)
MedSonic Incorporated Alliger Ultrasonic Surgical System Model AUSS-1, Valleylab CUSA® 200 Series Ultrasonic Surgical Aspirator, Sharplan ULTRA Ultrasonic Surgical Aspirator
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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 circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" arranged around it. Inside the circle is a stylized image of an eagle with three lines representing its wings and head.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Mr. Robert Soloff President Sonics & Materials Inc ................ Kenosia Avenue Danbury, Connecticut 06810
JUL 25 1997
Re: K971533
Trade Name: VIBRA-SURGE™ System Model VS2120 Ultrasonic Surgical Instrument Regulatory Class: Unclassified Product Code: LFL Dated: April 23, 1997 Received: April 28, 1997
Dear Mr. Soloff:
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 reguiation (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
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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.
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
2
JUL 2 5 1997
6971533
510(k) Summary - Sonics and Materials, Inc. VIBRA~SURGE™ System Model VS2120
This summary of safety and effectiveness is submitted in accordance with the requirements of 21 CFR 807 92
| Submitter: | Sonics & Materials, Inc.
Kenosia Avenue
Danbury, CT 06810
(203)744-4400 |
|---------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Alan Broadwin (914) 833-2649 |
| Date Prepared: | 4/23/97 |
| Trade or Proprietary Name: | VIBRA-SURGE ™ System VS2120 |
| Common, Usual or Classification Name: | Instrument, Ultrasonic Surgical |
| Predicate Devices: | MedSonic Incorporated Alliger Ultrasonic Surgical
System Model AUSS-1; Valleylab CUSA® 200
Series Ultrasonic Surgical Aspirator; Sharplan
ULTRA Ultrasonic Surgical Aspirator. |
| Device Description: | The VIBRA-SURGE ™ System VS2120 is comprised
of a generator, operating at one of several possible
standard line voltages, contained in a console which
feeds a 20-22 kHz electrical signal to a surgical
handpiece containing piezoceramic crystals. These
crystals convert the electrical energy into mechanical
motion. This mechanical motion has the same
frequency of 20-22 kHz. Fragmentation of
unwanted tissues occurs at the end of the tip which
is hollow allowing the use of a vacuum source to
remove these fragments. |
| Intended Use: | Aids in the fragmentation, emulsification and removal of soft
tissue in General and Plastic & Reconstructive Surgery |
| Technological Characteristics. | The VIBRA-SURGE ™ System VS2120 is similar in
design, material and operating parameters to the
predicate devices indicated above. Consequently no
new safety or efficacy issues exist and this device
was determined to be substantially equivalent. |
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510(k) Number (if known):
Device Name:
Indications For Use:
Aids in The Removal of Soft Tissue in General Surgery and Plastic and Reconstructive Surgery
Sonics & Materials VIBRA~SURGE™ System Model VS2120
Initial Submission K971533
Ultrasonic Surgical Instrument __
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use (Per 21 CFR 801.109)
(Division)Sign-O
Division of Gene
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(Division)Sign-Off)
Division of General Restorative Devices, K971533
510(k) Number