(242 days)
Not Found
No
The device description focuses on standard electrical and mechanical components for ultrasonic tissue fragmentation and aspiration, with no mention of AI/ML terms or functionalities.
No
The device's description and intended use focus on the fragmentation, emulsification, and aspiration of soft tissue during surgery, which describes a surgical tool rather than a therapeutic device.
No
The device is described as a surgical tool used for fragmentation, emulsification, and aspiration of soft tissue, indicating its therapeutic rather than diagnostic function.
No
The device description explicitly lists multiple hardware components including a power conditioner, microcomputer, control panel, signal generator, BNC output, and a separate surgical handpiece containing an electromotive engine and ultrasonic surgical probe.
No, the Allegro device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices intended for use in vitro for the examination of specimens, including blood and tissue samples, derived from the human body, solely or principally for the purpose of providing information concerning a physiological or pathological state, or concerning a congenital abnormality, or to determine the safety and compatibility with potential recipients, or to monitor therapeutic measures.
- Allegro's Intended Use: The Allegro is intended for the fragmentation, emulsification and aspiration of soft tissue during surgery. This is a direct surgical intervention on the patient's body, not an examination of a specimen outside the body.
- Device Description: The description details a surgical handpiece with an ultrasonic probe that physically interacts with tissue. This is consistent with a surgical device, not a diagnostic one.
The Allegro is a surgical device used for tissue removal during procedures.
N/A
Intended Use / Indications for Use
Facilitates fragmentation and emulsification of soft tissues in General and Plastic & Reconstructive Surgery.
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
Product codes (comma separated list FDA assigned to the subject device)
79LFL
Device Description
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
soft tissues
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.
Mentor Ultrasound Assisted Tissue Removal System (K970471), Valleylab CUSA® System (K910696), SMEI Sculpture (K971609), Ultra-Safe (K962525)
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
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 Instrumentation
205 South West Street, Suite A
Visalia, 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 in
General and Plastic & Reconstructive Surgery. | |
| Device Description: | 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. | |
| Sterility Information: | This product is not supplied sterile. | |
| Predicate Devices: | The Allegro Ultrasonic Soft Tissue Aspirator is similar in technical
design and operation to other surgical devices with irrigation,
suction, and ultrasound which the FDA has determined to be
substantially equivalent to pre-amendment devices as depicted
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
amplitude, 37-45 kHz) are comparable to the indicated predicate
devices. | |
| | Motion at the probe tip (≥0 or ≤500 μm) is comparable to the
indicated predicate devices. | |
| | The motion or amplitude of the working end of the device is
primarily in a vertical motion at the rate of 20-25 kHz. | |
| | Power consumption (0-100 watts) is similar to the indicated
predicate devices. | |
| | Ultrasonic probe design and construction (titanium and/or stainless
steel) is similar to the indicated predicate devices. | |
| Conclusion: | The stated similarities between CITEI's Allegro Ultrasonic Soft
Tissue Aspirator and the indicated predicate devices motivate the
determination that these devices are substantially equivalent. | |
1
.
. .
2
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.
3
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
4
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)