(24 days)
Not Found
No
The device description focuses on the mechanical and electrical components (generator, piezoelectric crystals, titanium tip) and does not mention any software, algorithms, or data processing that would indicate AI/ML. The "Mentions AI, DNN, or ML" and "Mentions image processing" fields are explicitly marked as "Not Found".
Yes
The device is used to liquefy and aspirate soft tissues and fatty deposits for surgical and aesthetic purposes, which are therapeutic interventions.
No
The device description indicates its use for liquefaction and aspiration of tissues and fatty deposits, which are surgical procedures, not diagnostic ones.
No
The device description explicitly details hardware components such as a generator, handpiece with piezoelectric crystals, titanium tip, and an irrigation/aspiration unit.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use describes the device as being used for the "liquefaction and aspiration of soft tissues" and "localized subcutaneous fatty deposits" within the body during surgical procedures. This is a direct intervention on the patient's body.
- Device Description: The device description details a system that uses ultrasound energy to break down tissue and an irrigation/aspiration unit to remove it. This is a physical process performed on the patient.
- Lack of IVD Characteristics: IVD devices are used to examine specimens (like blood, urine, tissue samples) outside of the body to provide information about a person's health. The provided information does not mention any analysis of samples or diagnostic purposes.
Therefore, the LYSONIX 2000/3000 Systems are surgical devices used for tissue removal, not IVDs.
N/A
Intended Use / Indications for Use
LYSONIX 2000/3000 Systems are indicated for the liquefaction and aspiration of soft tissues in General Surgery, Plastic and Reconstructive Surgery and Gynecological Surgery Applications. It is also indicated for the liquefaction and aspiration of localized subcutaneous fatty deposits for the purposes of aesthetic body contouring.
Product codes
QPB, MUU
Device Description
LYSONIX 2000/3000 Ultrasonic Surgical System is comprised of a generator, which feeds a 22.5 kHz electrical signal to a piezoelectric crystals mounted in a hand-held handpiece; the crystals then vibrate at the same frequency. The titanium tip attached to the handpiece amplifies the vibration. An irrigation / aspiration unit is provided to introduce irrigation solution and remove fragmented material and waste liquids from the area.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
soft tissues, localized subcutaneous fatty deposits
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)
The Misonix Inc. LYSONIX 2000/3000 SYSTEMS have been designed and tested to pass the following Voluntary Standards:
UL 2601-1 Medical Electrical Equipment, Part 1: General Requirements for Safety
EN 60601-1 Medical Electrical Equipment, Part 1: General Requirements for Safety
EN 60601-1-2:1993 Electromagnetic Compatibility (LySonix 2000)
EN 60601-1-2:2001 Electromagnetic Compatibility (LySonix 3000)
FCC Part 18 EMC Requirements
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 878.5040 Suction lipoplasty system.
(a)
Identification. A suction lipoplasty system is a device intended for aesthetic body contouring. The device consists of a powered suction pump (containing a microbial filter on the exhaust and a microbial in-line filter in the connecting tubing between the collection bottle and the safety trap), collection bottle, cannula, and connecting tube. The microbial filters, tubing, collection bottle, and cannula must be capable of being changed between patients. The powered suction pump has a motor with a minimum of1/3 horsepower, a variable vacuum range from 0 to 29.9 inches of mercury, vacuum control valves to regulate the vacuum with accompanying vacuum gauges, a single or double rotary vane (with or without oil), a single or double diaphragm, a single or double piston, and a safety trap.(b)
Classification. Class II (special controls). Consensus standards and labeling restrictions.
0
Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
June 8, 2021
Misonix, Inc. Ronald Manna VP, Regulatory Affairs 1938 New Highway Farmingdale, New York 11735
Re: K041058
Trade/Device Name: Misonix Inc. Lysonix 2000/3000 Ultrasonic Surgical Aspirator Systems Regulation Number: 21 CFR 878.5040 Regulation Name: Suction lipoplasty system Regulatory Class: Class II Product Code: QPB
Dear Ronald Manna:
The Food and Drug Administration (FDA) is sending this letter to notify you of an administrative change related to your previous substantial equivalence (SE) determination letter dated May 17, 2004. Specifically, FDA is updating this SE Letter because FDA has created a new product code to better categorize your device technology.
Please note that the 510(k) submission was not re-reviewed. For questions regarding this letter please contact Cindy Chowdhury, OHT4: Office of Surgical and Infection Control Devices, 240-402-6647, Cindy.Chowdhury@fda.hhs.gov.
Sincerely,
Cindy Chowdhury -S
Cindy Chowdhury, Ph.D., M.B.A. Assistant Director DHT4B: Division of Infection Control and Plastic Surgery Devices OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
1
Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol that resembles an eagle or bird in flight. The symbol is composed of three curved lines that form the wings and body of the bird.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAY 1 7 2004
Mr. Ronald R. Manna Vice President Regulatory Affairs Misonix, Inc. 1938 New Highway Farmingdale, New York 11735
Re: K041058
Trade/Device Name: Misonix Inc. LYSONIX 2000/3000 Ultrasonic Surgical Aspirator System Regulation Number: 21 CFR 878.5040 Regulation Name: Suction lipoplasty system Regulatory Class: II Product Code: MUU Dated: April 15, 2004 Received: April 23, 2004
Dear Mr. Manna:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate 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) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The gencral 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 (PMA), 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 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electromic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
2
Page 2 - Mr. Ronald R. Manna
This letter will allow you to begin marketing your device as described in your Section 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), please contact the Office of Compliance at (301) 594-4659. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely yours,
Miriam C. Provost
(d Celia M. Witten, Ph.D., M.D. Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
3
K04/1058
Exhibit C Indications for Use Statement
Device Name: Misonix Inc. L YSONIX 2000/3000 Ultrasonic Surgical Aspirator System
L YSONIX 2000/3000 Systems are indicated for the liquefaction and aspiration of soft tissues in General Surgery, Plastic and Reconstructive Surgery and Gynecological Surgery Applications. It is also indicated for the liquefaction and aspiration of localized subcutaneous fatty deposits for the purposes of aesthetic body contouring.
Prescription Use
(Part 21 CFR 801 Subpart D)
✓
AND/OR
Over-The-Counter Use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Miriam C. Provost
Page 1 of
(Division Division of General, Restorative. and Neurological Devices
510(k) Number K641058
4
MAY 1 7 2004
K04/058
P.1/2
510(k) SUMMARY - Misonix Inc. LYSONIX 2000/3000Ultrasonic Exhibit E Aspirator Systems
This summary of safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21CFR 807.92.
】. Submitter's Identification
| Submitter's Name: | MISONIX INCORPORATED |
|---|---|
| Address: | 1938 New Highway, Farmingdale, NY 11735 |
| Telephone Number: | 516-694-9555 |
| Contact Person: | Ronald R. Manna |
| Date Prepared: | April 1, 2004 |
2. Name of Device
| Proprietary Name: | Misonix Inc. LYSONIX 2000/3000 Ultrasonic
Surgical Aspirator Systems |
|----------------------|-------------------------------------------------------------------------|
| Common/Usual Name: | Ultrasonic Surgical System
Ultrasonic Surgical Aspirator |
| Classification Name: | Instrument, Ultrasonic Surgical |
3. Predicate Device Information
Mentor Contour Genesis Ultrasound Assisted Predicate Devices Tissue Removal System K004005 SoundVaser System, Sound Surgical Technologies Inc. K022051 LYSONIX 2000/3000 Ultrasonic Surgical System 4. Device Description is comprised of a generator, which feeds a 22.5 kHz electrical signal to a piezoelectric crystals mounted in a hand-held handpiece; the crystals then vibrate at the same frequency. The titanium tip attached to the handpiece amplifies the vibration. An irrigation / aspiration unit is provided to introduce irrigation solution and remove fragmented material and waste liquids from the area.
5
K04/058
P2/2
| 5. | Intended Use: | LYSONIX 2000/3000 System is indicated
for the liquefaction and aspiration of soft
tissues in General Surgery, Plastic and
Reconstructive Surgery and Gynecological
Surgery Applications. It is also indicated for
the liquefaction and aspiration of localized
subcutaneous fatty deposits for the purposes
of aesthetic body contouring. |
|----|--------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 6. | Comparison to Predicate Device | LYSONIX 2000/3000 Systems is similar in
design, material and operating parameters to
the SoundVaser Ultrasonic Aspirator. The
Sound Vaser is an Ultrasonic Aspirator
System that features Pulsed Output
Technology. It has an Ultrasonic Lipoplasty
Indication for Use as well. In addition,
LYSONIX 2000/3000 Systems are
substantially equivalent to the Mentor
Contour Genesis System in terms of Theory
of Operation, Indications and Operating
Specifications with the exception that the
Mentor Contour Genesis System (K004005)
does not incorporate Pulsed Output
Technology. |
7. Safety and Performance Data
The Misonix Inc. LYSONIX 2000/3000 SYSTEMS have been designed and tested to pass the following Voluntary Standards:
UL 2601-1 Medical Electrical Equipment, Part 1: General Requirements for Safety EN 60601-1 Medical Electrical Equipment, Part 1: General Requirements for Safety EN 60601-1-2:1993 Electromagnetic Compatibility (LySonix 2000) EN 60601-1-2:2001 Electromagnetic Compatibility (LySonix 3000) FCC Part 18 EMC Requirements
- This device docs not contain software. 7. Software Validation
- Validation reports are contained in Exhibit J. 8. Sterilization Validations