(79 days)
Not Found
No
The description focuses on the mechanical and electrical components of an ultrasonic surgical aspirator and does not mention any AI or ML capabilities. The "Mentions AI, DNN, or ML" section is explicitly marked as "Not Found".
Yes
The device is used in surgical specialties for fragmentation, emulsification, and aspiration of soft tissue, which are actions performed to treat or manage a disease or condition.
No
The device description and intended use indicate that the SoundVASER System is a surgical tool used for fragmentation, emulsification, and aspiration of soft tissue during surgery. It describes a mechanism of action related to physical tissue removal, not diagnostic assessment or interpretation.
No
The device description explicitly lists hardware components such as an ultrasonic generator, handpiece, probe, and suction/irrigation subsystem, 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 clearly states that the SoundVASER System is used for the fragmentation, emulsification, and aspiration of soft tissue during surgical procedures. This is an in vivo application, meaning it is used directly on living tissue within the body.
- Device Description: The description details a surgical system with an ultrasonic generator, handpiece, probe, and suction/irrigation subsystem. These components are designed for physical interaction with tissue during surgery.
- Lack of IVD Characteristics: An IVD device is used to examine specimens (like blood, urine, tissue samples) outside of the body to provide information about a person's health. The SoundVASER System does not perform this function.
Therefore, the SoundVASER System is a surgical device, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The SoundVASER System is indicated for use in the following surgical specialties when the fragmentation, emulsification, and aspiration of soft tissue is desired: Neurosurgery, Gastrointestinal and Affiliated Organ Surgery, Urological Surgery, Plastic and Reconstructive Surgery, General Surgery, Orthopedic Surgery, Gynecological Surgery, Thoracic Surgery, and Laparoscopic Surgery.
Product codes (comma separated list FDA assigned to the subject device)
LFL
Device Description
The SoundVASER System is comprised of an ultrasonic generator (110/120 and 220/240 VAC, 50 & 60 Hz), an ultrasonic surgical handpiece with an ultrasonic surgical probe, and a suction/irrigation subsystem. The ultrasonic surgical handpiece converts electrical energy supplied by the ultrasonic generator into vibratory motion. The vibratory motion is applied to the ultrasonic surgical probe that is attached to the ultrasonic surgical handpiece. The vibratory motion at the tip of the ultrasonic surgical probe fragments and emulsifies contacted soft tissues. The suction/irrigation subsystem is used to remove the fragmented tissues. The suction and irrigation functions may be performed simultaneously or independently.
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): 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.
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
Sound Surgical Technologies LLC - Creating the Perfect Wave >
1300 Plaza Court North, Suite 203, Lafayette, CO 80026 fax 303.926.8615 tel 303.926.8608 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.
991791 The assigned 510(k) number is:
Submitter
Sound Surgical Technologies LLC 1300 Plaza Court North, #203 Lafayette, Colorado 80026
Contact Person William W. Cimino, Ph.D.
303-926-8608 (TEL) 303-926-8615 (FAX)
Date Prepared May 24, 1999
Proprietary Name SoundVASER System
Common, Usual, or Classification Name Instrument, Ultrasonic Surgical
Classification
Class: Class II Panel: 21 CFR 878, General and Plastic Surgery Product Code: LFL
1
Predicate Devices
The SoundVASER System is similar in technical design and operation to other surgical systems with ultrasonic vibration, irrigation, and suction that the FDA has determined to be substantially equivalent to pre-amendment devices as depicted below:
- Valleylab Inc., CUSA Excel Ultrasonic Surgical Aspirator System -(K981262) and CUSA Lap Accessory (K921251)
Device Description
The SoundVASER System is comprised of an ultrasonic generator (110/120 and 220/240 VAC, 50 & 60 Hz), an ultrasonic surgical handpiece with an ultrasonic surgical probe, and a suction/irrigation subsystem. The ultrasonic surgical handpiece converts electrical energy supplied by the ultrasonic generator into vibratory motion. The vibratory motion is applied to the ultrasonic surgical probe that is attached to the ultrasonic surgical handpiece. The vibratory motion at the tip of the ultrasonic surgical probe fragments and emulsifies contacted soft tissues. The suction/irrigation subsystem is used to remove the fragmented tissues. The suction and irrigation functions may be performed simultaneously or independently.
Intended Use
The SoundVASER System is indicated for use in the following surgical specialties when the fragmentation, emulsification, and aspiration of soft tissue is desired: Neurosurgery, Gastrointestinal and Affiliated Organ Surgery, Urological Surgery, Plastic and Reconstructive Surgery, General Surgery, Orthopedic Surgery, Gynecological Surgery, Thoracic Surgery, and Laparoscopic Surgery.
Summary of Technological Characteristics
The SoundVASER System is similar with regard to design, operation, materials, methods of sterilization, and intended use to the predicate devices indicated above. Therefore, no new safety or efficacy issues are created and the SoundVASER System is substantially equivalent to the predicate devices.
2
Image /page/2/Picture/1 description: The image is a black and white seal for the Department of Health & Human Services - USA. The seal is circular with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is a stylized image of a bird-like figure with three curved lines representing its wings or body.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
AUG 12 1999
William W. Cimino, Ph.D. President Sound Surgical Technologies LLC 1300 Plaza Court North. Suite 203 Lafavette. Colorado 80026
Re: K991791 Trade Name: Sound Vaser System Regulatory Class: II Product Code: LFL Dated: May 24, 1999 Received: May 26, 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 (OS) 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,
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 (if known):
ber (if known): K 991791
Device Name: SoundVASER System
Indications for Use:
The SoundVaser System is indicated for use in the following surgical specialties when the fragmentation, emulsification, and aspiration of soft tissue is desired
- Neurosurgery -
- Gastrointestinal and Affiliated Organ Surgery -
- Urological Surgery -
- -Plastic and Reconstructive Surgery
- General Surgery -
- Orthopedic Surgery -
- Gynecological Surgery -
- Thoracic Surgery -
- Laparoscopic Surgery -
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
signature
(Division Sign-Off)
Division of General Restorative Devices
510(k) Number. K99179/
Prescription Use لل (per 2.1 CFR 801 109) (Optional Format 1-2-96) OR
Over-The-Counter Use