(36 days)
Not Found
No
The description focuses on the mechanical action of ultrasonic vibration for cutting and coagulation, with no mention of AI/ML terms or functionalities.
Yes
The device is indicated for use in cutting and coagulation of soft tissues, including bleeding control. These are therapeutic actions aimed at treating or alleviating a medical condition.
No
The device is described as a surgical system used for cutting and coagulation of soft tissues, which are therapeutic actions, not diagnostic ones.
No
The device description explicitly states it is comprised of an ultrasonic surgical handpiece and associated dissection tips, which are hardware components.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for "cutting and coagulation of soft tissues" during surgical procedures. This is a direct intervention on the patient's body.
- Device Description: The device works by using ultrasonic vibrations to physically cut and coagulate tissue. This is a surgical tool, not a device that analyzes samples from the body (like blood, urine, or tissue) to provide diagnostic information.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples, providing diagnostic results, or being used in a laboratory setting.
IVD devices are used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device operates directly on the patient's tissue for surgical purposes.
N/A
Intended Use / Indications for Use
The SoundVASER Dissection System (dissection tips and handpiece for The SoundVaser System) is indicated for use in when cutting and coagulation of soft tissues is desired, including bleeding control with minimal thermal damage.
The SoundVASER Dissection System (Dissection Tips and Handpiece for The SoundVaser System) is indicated for use in when cutting and coagulation of soft tissues is desired, including bleeding control with minimal thermal injury.
Product codes
LFL
Device Description
The SoundVASER Dissection System is comprised of an ultrasonic surgical handpiece and associated dissection tips. The ultrasonic surgical handpiece converts electrical energy supplied by the SoundVASER ultrasonic generator into vibratory motion. The vibratory motion is applied to the dissection tip that is attached to the ultrasonic surgical handpiece. The vibratory motion at the tip cuts and coagulates contacted soft tissues.
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
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)
K990430, K983316, K971302, K962584
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
N/A
0
Sound Surgical Technologies LLC Creating the Perfect Wave >>
1300 Plaza Court North, Suite 203, Lafayette, CO 80026 tel 303.926.8608 fax 303.926.8615 SSTmail@soundsurgical.com
510(k) Summary
This summary of safety and effectiveness information is submitted in accordance with the requirements of 21 CFR 807.92.
The assigned 510(k) number is:_| Trade Name: SoundVASER Dissection System Regulatory Class: II Product Code: LFL Dated: November 12, 1999 · Received: November 15, 1999
Dear Dr. Cimino:
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 (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 - William W. Cimino, Ph.D.
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,
Stupt Rlwork
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
510(k) Number (if known): 4993 d 6 d
Device Name: The SoundVASER Dissection System (Dissection Tips and Handpiece for The SoundVASER System)
Indications for Use:
The SoundVASER Dissection System (Dissection Tips and Handpiece for The SoundVaser System) is indicated for use in when cutting and coagulation of soft tissues is desired, including bleeding control with minimal thermal injury.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Stupt Chrode
(Division Sigh-Off) Division of General Restorative Devices K993868 510(k) Number _
Prescription Use (per 2.1 CFR 801.109) (Optional Format 1-2-96)
OR
Over-The-Counter Use