(36 days)
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.
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.
This document describes a 510(k) submission for the SoundVASER Dissection System. A 510(k) submission is a premarket submission made to the FDA to demonstrate that the device to be marketed is at least as safe and effective, that is, substantially equivalent, to a legally marketed predicate device. This type of submission generally does not require clinical studies with acceptance criteria in the way a PMA (Premarket Approval) submission would.
Therefore, the provided document does not contain the information requested in your prompt regarding acceptance criteria and a study proving the device meets those criteria.
Instead, the document focuses on:
- Predicate Devices: Identifying existing devices with similar technical design and operation that have already been cleared by the FDA.
- Device Description: Explaining how the SoundVASER Dissection System works (ultrasonic surgical handpiece and dissection tips for cutting and coagulation of soft tissues).
- Intended Use: Stating the purpose of the device.
- Summary of Technological Characteristics: Arguing that the device is substantially equivalent to predicate devices based on design, operation, materials, sterilization, and intended use, thus creating no new safety or efficacy issues.
In summary, this document is a substantial equivalence claim, not a report of a study designed to meet specific performance acceptance criteria.
Therefore, I cannot populate the table or answer the specific questions about acceptance criteria, sample sizes, ground truth establishment, or clinical study outcomes because that information is not present in the provided text.
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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:_|< 99 3 d 6 f
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 November 10, 1999
Proprietary Name SoundVASER Dissection System
Common, Usual, or Classification Name Instrument, Ultrasonic Surgical
Classification
Class: Class II Panel: 21 CFR 878, General and Plastic Surgery Product Code: LFL
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Image /page/1/Picture/0 description: The image contains a sequence of handwritten alphanumeric characters. The sequence starts with the letter 'K', followed by the numbers '99386', and ends with the letter 'A'. The characters are written in a cursive style, with some connections between adjacent characters.
Predicate Devices
The SoundVASER Dissection System is similar in technical design and operation to other surgical systems that utilize ultrasonic frequency vibrating instruments for soft tissue cutting and coagulation that the FDA has determined to be substantially equivalent to pre-amendment devices as depicted below:
Ethicon Endo-Surgery, Cincinnati, OH USA
- Ultracision Harmonic Scalpel Handpiece, K990430, LFL ■
- Ultracision 5mm Instruments, K983316, LFL
- 체 Ultracision 5mm Laparosonic Hook Blades, K971302, LFL
- 트 Ultracision 5mm Hard Sheath LaparoSonic Blade, K962584, 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.
Intended 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.
Summary of Technological Characteristics
The SoundVASER Dissection 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 Dissection System is substantially equivalent to the predicate devices.
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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol that resembles an eagle or a bird in flight, composed of three curved lines.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
DEC 2 1 1999
William W. Cimino, Ph.D. President Sound Surgical Technologies LLC 1300 Plaza Court North, #203 Lafayette. Colorado 80026
Re: K993868
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.
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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
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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
N/A