ALLEGRO ULTRASONIC SOFT TISSUE ASPIRATOR

K980895 · California Institute of Tissue Eng. & Instrumenti · LFL · Nov 6, 1998 · SU

Device Facts

• Record ID: K980895
• Device Name: ALLEGRO ULTRASONIC SOFT TISSUE ASPIRATOR
• Applicant: California Institute of Tissue Eng. & Instrumenti
• Product Code: LFL · SU
• Decision Date: Nov 6, 1998
• Decision: SESE
• Submission Type: Traditional
• Device Class: Class U
• Attributes: Therapeutic

Intended Use

Facilitates fragmentation and emulsification of soft tissues in General and Plastic & Reconstructive Surgery.

Device Story

Allegro Ultrasonic Soft Tissue Aspirator is a surgical device for soft tissue fragmentation, emulsification, and aspiration. System components include a power conditioner, microcomputer, control panel, signal generator, and surgical handpiece. The microcomputer integrates system components and provides a user interface for settings. The signal generator produces programmable electrical waveforms (20-25 kHz) sent to the handpiece. The handpiece contains a piezoelectric ceramic stack that converts electrical energy into high-frequency, small-amplitude mechanical motion of an ultrasonic probe. The probe tip fragments local soft tissue, which is then aspirated through the probe. Used in clinical surgical settings by physicians. The device assists in tissue removal, potentially benefiting patients by facilitating precise soft tissue management during general and plastic/reconstructive procedures.

Clinical Evidence

Bench testing only. No clinical data provided. Performance was validated through comparative bench testing of electrical signal generation, probe tip motion, and power consumption against predicate devices.

Technological Characteristics

System includes power conditioner, microcomputer, signal generator, and piezoelectric handpiece. Probe constructed of titanium and/or stainless steel. Operates at 20-25 kHz frequency. Power consumption 0-100 watts. Not supplied sterile.

Indications for Use

Indicated for use in general surgery and plastic & reconstructive surgery when fragmentation, emulsification, and aspiration of soft tissue is desired.

Predicate Devices

• Mentor Ultrasound Assisted Tissue Removal System (K970471)
• Valleylab CUSA® System (K910696)
• SMEI Sculpture (K971609)
• Ultra-Safe (K962525)

Submission Summary (Full Text)

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NOV

6 1998

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## 510(K) Summary of Safety and Effectiveness for CITEI's Allegro Ultrasonic Soft Tissue Aspirator

This summary of safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR § 807.92

| Submitter: | California Institute of Tissue Engineering and Instrumentation<br>205 South West Street, Suite A<br>Visalia, CA 93291 | |
|------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------|
| Contact Person: | Jeff Wheaton | [phone]<br>[phone] Fax |
| Date Prepared: | Friday 30 January 1998 | |
| Proprietary Name: | Allegro Ultrasonic Soft Tissue Aspirator | |
| Classification Name: | Ultrasonic Surgical Instrument | |
| Device Classification: | Class II | |
| Device Product Code: | 79LFL | |
| Intended Use: | Facilitates fragmentation and emulsification of soft tissues in<br>General and Plastic & Reconstructive Surgery. | |
| Device Description: | The Allegro is comprised of a power conditioner (110/120 volts<br>AC), a microcomputer, a control panel, a signal generator, a BNC<br>output, and a separate surgical handpiece. The power conditioner<br>serves to buffer the system from commercial electrical<br>discontinuities and provides a continuous electrical signal to<br>Allegro's components. The microcomputer integrates Allegro's<br>system components and provides a user-friendly control interface.<br>The control panel provides for user input and system settings and<br>displays. The signal generator creates electrical current in<br>programmable waveforms (20-25 kHz). The BNC output connects<br>the system to the surgical handpiece. The surgical handpiece<br>contains the electromotive engine (piezoelectric ceramic stack), the<br>infiltration/aspiration port, and the ultrasonic surgical probe. The<br>electrical waveforms sent to the handpiece excite the motor stack<br>and cause high-frequency, small amplitude motion of the<br>ultrasonic surgical probe. Motion at the tip of the probe fragments<br>local soft tissue, which is then aspirated through the probe. | |
| Sterility Information: | This product is not supplied sterile. | |
| Predicate Devices: | The Allegro Ultrasonic Soft Tissue Aspirator is similar in technical<br>design and operation to other surgical devices with irrigation,<br>suction, and ultrasound which the FDA has determined to be<br>substantially equivalent to pre-amendment devices as depicted<br>below: | |
| | Mentor Ultrasound Assisted Tissue Removal System (K970471) | |
| | Valleylab CUSA® System (K910696) | |
| | SMEI Sculpture (K971609) | |
| | Ultra-Safe (K962525) | |
| Non-Clinical Data: | Electrical signals generated by CITEI's device (sinusoidal<br>amplitude, 37-45 kHz) are comparable to the indicated predicate<br>devices. | |
| | Motion at the probe tip (≥0 or ≤500 μm) is comparable to the<br>indicated predicate devices. | |
| | The motion or amplitude of the working end of the device is<br>primarily in a vertical motion at the rate of 20-25 kHz. | |
| | Power consumption (0-100 watts) is similar to the indicated<br>predicate devices. | |
| | Ultrasonic probe design and construction (titanium and/or stainless<br>steel) is similar to the indicated predicate devices. | |
| Conclusion: | The stated similarities between CITEI's Allegro Ultrasonic Soft<br>Tissue Aspirator and the indicated predicate devices motivate the<br>determination that these devices are substantially equivalent. | |

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Image /page/2/Picture/2 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo consists of a stylized caduceus symbol, which is a staff with two snakes coiled around it, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged in a circular pattern around the symbol. The caduceus is depicted with three lines forming the staff and the snakes are represented by curved lines.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

NOV 6 1998

Mr. Jeff Wheaton Project Manager California Institute of Tissue Engineering and Instrumentation 205 South West Street, Suite A Visalia, California 93291

Re: K980895 Trade Name: Allegro Ultrasonic Soft Tissue Aspirator Regulatory Class: II Product Code: LFL Dated: August 05, 1998 Received: August 11, 1998

Dear Mr. Wheaton:

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 (OS) 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.

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.

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Page 2 - Mr. Jeff Wheaton

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 [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. 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 [phone] or [phone] 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): ____________________________________________________________________________________________________________________________________________________

ALLEGRO SOFT TISSUE ASPIRATOR Device Name:

Indications For Use:

The Allegro is indicated for use in the following surgical specialties when the fragmentation, emulsification and aspiration of soft tissue is desired.

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-General Surgery

-Plastic and reconstructive Surgery

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Concurrence of CDRH, Office of Device Evaluation (ODE)

*Proleps*

(Division Sign-Off)
Division of General Restorative Devices K980895
510(k) Number

Prescription Use
(Per 21 CFR 801.109)

OR

Over-The-Counter Use

iri

(Optional Format 1-2-96)