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.

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.

AI/ML Overview

The provided document is a 510(k) summary for the SoundVASER System, which focuses on demonstrating substantial equivalence to predicate devices rather than proving performance against specific acceptance criteria through a detailed study. Therefore, much of the requested information regarding acceptance criteria, study design, and ground truth is not present in this document.

Here's an analysis based on the information available in the provided text:

Acceptance Criteria and Study Details

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria	Reported Device Performance
Not specified	Not specified

Explanation: This 510(k) summary does not define specific performance acceptance criteria for the SoundVASER System. The focus of the submission is to demonstrate "substantial equivalence" to existing predicate devices, implying that if it is equivalent, it implicitly meets the safety and effectiveness standards of those devices. No quantitative performance metrics are provided.

2. Sample Size for Test Set and Data Provenance

Sample Size for Test Set: Not applicable. No specific test set or study data is presented for performance evaluation.
Data Provenance: Not applicable. No study data is provided.

3. Number of Experts and Qualifications for Establishing Ground Truth (Test Set)

Number of Experts: Not applicable. No test set requiring expert ground truth is mentioned.
Qualifications of Experts: Not applicable.

4. Adjudication Method for Test Set

Adjudication Method: Not applicable. No test set or expert evaluation requiring adjudication is mentioned.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

MRMC Study Done?: No. This document does not describe an MRMC study.
Effect Size: Not applicable.

6. Standalone Performance Study (Algorithm Only)

Standalone Study Done?: No. The SoundVASER System is a surgical instrument, not an AI algorithm. Its performance is related to its mechanical and ultrasonic properties, not an algorithm's standalone accuracy.

7. Type of Ground Truth Used

Type of Ground Truth: Not applicable. The document does not describe a study involving ground truth. The substantial equivalence argument relies on the inherent characteristics of the device and its similarity to already-approved devices, rather than a comparison to a "ground truth" derived from patient data or expert consensus.

8. Sample Size for Training Set

Sample Size for Training Set: Not applicable. The SoundVASER System is a physical medical device, not an AI model that requires a training set.

9. How Ground Truth for Training Set Was Established

How Established: Not applicable.

Summary from the Document:

The 510(k) summary for the SoundVASER System primarily aims to demonstrate substantial equivalence to predicate devices (Valleylab Inc., CUSA Excel Ultrasonic Surgical Aspirator System and CUSA Lap Accessory). It achieves this by highlighting:

Similar Technical Design and Operation: The device is described as an ultrasonic generator, surgical handpiece with a probe, and a suction/irrigation subsystem, similar to existing devices.
Similar Intended Use: Fragmentation, emulsification, and aspiration of soft tissue in various surgical specialties (Neurosurgery, Gastrointestinal, Urological, Plastic/Reconstructive, General, Orthopedic, Gynecological, Thoracic, and Laparoscopic Surgery).
Similar Technological Characteristics: Design, operation, materials, methods of sterilization, and intended use are stated to be similar, leading to the conclusion that "no new safety or efficacy issues are created."

Conclusion:

This 510(k) submission is a regulatory document focused on proving equivalence rather than a detailed scientific study with defined acceptance criteria and performance metrics. It does not contain the information required to populate the requested table or answer most of the detailed questions about study design, sample sizes, expert involvement, or ground truth.

Summary

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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

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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

Intended Use

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.

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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.

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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,

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

Regulation Number and Section

N/A