(242 days)
The Allegro is indicated for use in the following surgical specialties when the fragmentation, emulsification and aspiration of soft tissue is desired.
-General Surgery
-Plastic and reconstructive Surgery
The Allegro is comprised of a power conditioner (110/120 volts AC), a microcomputer, a control panel, a signal generator, a BNC output, and a separate surgical handpiece. The power conditioner serves to buffer the system from commercial electrical discontinuities and provides a continuous electrical signal to Allegro's components. The microcomputer integrates Allegro's system components and provides a user-friendly control interface. The control panel provides for user input and system settings and displays. The signal generator creates electrical current in programmable waveforms (20-25 kHz). The BNC output connects the system to the surgical handpiece. The surgical handpiece contains the electromotive engine (piezoelectric ceramic stack), the infiltration/aspiration port, and the ultrasonic surgical probe. The electrical waveforms sent to the handpiece excite the motor stack and cause high-frequency, small amplitude motion of the ultrasonic surgical probe. Motion at the tip of the probe fragments local soft tissue, which is then aspirated through the probe.
This document is a 510(k) Summary for the CITEI Allegro Ultrasonic Soft Tissue Aspirator. It describes the device, its intended use, and argues for its substantial equivalence to predicate devices.
1. Table of Acceptance Criteria and Reported Device Performance:
The document does not explicitly state acceptance criteria in the form of performance metrics (e.g., accuracy, precision) for a diagnostic output. Instead, the "acceptance criteria" appear to be based on demonstrating comparability of key technical specifications and operational principles to legally marketed predicate devices. The "reported device performance" refers to these technical specifications.
| Acceptance Criteria (Implied by Predicate Device Comparison) | Reported Device Performance (Allegro Ultrasonic Soft Tissue Aspirator) |
|---|---|
| Electrical signal characteristics (amplitude, frequency) comparable to predicate devices. | Sinusoidal amplitude, 37-45 kHz (Note: the "Device Description" states 20-25 kHz, while non-clinical data states 37-45 kHz. There might be a discrepancy or different modes of operation. For this table, I'll use the non-clinical data which directly compares to predicate devices). |
| Motion at the probe tip comparable to predicate devices. | Motion at the probe tip ≥0 or ≤500 μm. Primarily vertical motion at 20-25 kHz. |
| Power consumption similar to predicate devices. | 0-100 watts. |
| Ultrasonic probe design and construction similar to predicate devices. | Titanium and/or stainless steel. |
2. Sample Size Used for the Test Set and Data Provenance:
No test set for evaluating the device's diagnostic or therapeutic efficacy is mentioned or implied. The data provided are non-clinical bench test data comparing the device's technical specifications to those of predicate devices. No patient or human subject data is used for this comparison. Therefore, information on sample size, country of origin, or retrospective/prospective nature is not applicable in this context.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications:
Not applicable. There was no test set requiring expert-established ground truth. The comparison is based on technical specifications and engineering design data.
4. Adjudication Method for the Test Set:
Not applicable. No test set requiring adjudication was performed.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, and its effect size:
No MRMC comparative effectiveness study was done. This document pertains to a medical device's technical specifications and substantial equivalence, not an AI or diagnostic imaging product requiring such a study.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done:
Not applicable. The Allegro Ultrasonic Soft Tissue Aspirator is a surgical instrument, not an algorithm or AI system.
7. The type of ground truth used:
Not applicable in the context of diagnostic performance. The "ground truth" for the non-clinical data is the measured technical specifications of the Allegro device, which are then compared to the known technical specifications of predicate devices to establish substantial equivalence.
8. The sample size for the training set:
Not applicable. This is a medical device, not a machine learning model, so there is no "training set."
9. How the ground truth for the training set was established:
Not applicable, as there is no training set for this device.
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NOV
6 1998
i
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 Instrumentation205 South West Street, Suite AVisalia, CA 93291 | |
|---|---|---|
| Contact Person: | Jeff Wheaton | (209) 625-9730(209) 695-3124 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 inGeneral and Plastic & Reconstructive Surgery. | |
| Device Description: | The Allegro is comprised of a power conditioner (110/120 voltsAC), a microcomputer, a control panel, a signal generator, a BNCoutput, and a separate surgical handpiece. The power conditionerserves to buffer the system from commercial electricaldiscontinuities and provides a continuous electrical signal toAllegro's components. The microcomputer integrates Allegro'ssystem components and provides a user-friendly control interface.The control panel provides for user input and system settings anddisplays. The signal generator creates electrical current inprogrammable waveforms (20-25 kHz). The BNC output connectsthe system to the surgical handpiece. The surgical handpiececontains the electromotive engine (piezoelectric ceramic stack), theinfiltration/aspiration port, and the ultrasonic surgical probe. Theelectrical waveforms sent to the handpiece excite the motor stackand cause high-frequency, small amplitude motion of theultrasonic surgical probe. Motion at the tip of the probe fragmentslocal 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 technicaldesign and operation to other surgical devices with irrigation,suction, and ultrasound which the FDA has determined to besubstantially equivalent to pre-amendment devices as depictedbelow: | |
| 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 (sinusoidalamplitude, 37-45 kHz) are comparable to the indicated predicatedevices. | |
| Motion at the probe tip (≥0 or ≤500 μm) is comparable to theindicated predicate devices. | ||
| The motion or amplitude of the working end of the device isprimarily in a vertical motion at the rate of 20-25 kHz. | ||
| Power consumption (0-100 watts) is similar to the indicatedpredicate devices. | ||
| Ultrasonic probe design and construction (titanium and/or stainlesssteel) is similar to the indicated predicate devices. | ||
| Conclusion: | The stated similarities between CITEI's Allegro Ultrasonic SoftTissue Aspirator and the indicated predicate devices motivate thedetermination 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 (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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Page 1 of 1
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.
'''
-General Surgery
-Plastic and reconstructive Surgery
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
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)
N/A