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.
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.
The provided FDA 510(k) summary for the Misonix Inc. LYSONIX 2000/3000 Ultrasonic Surgical Aspirator Systems focuses on demonstrating substantial equivalence to predicate devices rather than providing specific acceptance criteria and performance data from a clinical study.
Therefore, much of the requested information regarding acceptance criteria, specific device performance metrics, sample sizes, ground truth establishment, expert involvement, and MRMC studies is not available in the provided document. The 510(k) process for this device relies on proving that the new device is as safe and effective as existing legally marketed devices, often through comparison of design, materials, and operating parameters, and adherence to voluntary standards.
Here's an attempt to answer what can be extracted from the document, along with explanations for what is not available due to the nature of the submission:
1. Table of Acceptance Criteria and Reported Device Performance
This information is not explicitly stated as acceptance criteria for specific performance metrics in the provided document. The submission focuses on demonstrating substantial equivalence to predicate devices and adherence to voluntary safety standards.
- Acceptance Criteria (Implied/General): The device is substantially equivalent to legally marketed predicate devices regarding design, materials, operating parameters, and intended use. It also meets voluntary safety and EMC standards.
- Reported Device Performance:
- Intended Use: Liquefaction and aspiration of soft tissues in General Surgery, Plastic and Reconstructive Surgery, and Gynecological Surgery Applications. Also indicated for the liquefaction and aspiration of localized subcutaneous fatty deposits for aesthetic body contouring.
- Operating Parameters: Generates a 22.5 kHz electrical signal, piezoelectric crystals vibrate at the same frequency, and a titanium tip amplifies the vibration. Irrigation/aspiration unit provided.
- Safety/EMC: Designed and tested to pass UL 2601-1, EN 60601-1, EN 60601-1-2 (for LySonix 2000/3000), and FCC Part 18 EMC Requirements.
2. Sample size used for the test set and the data provenance
- Sample Size: Not applicable/not provided. The submission does not describe a clinical "test set" in the context of performance metrics that would require a defined sample size (e.g., number of patients, images, or cases). Instead, it relies on comparison to predicate devices and adherence to engineering standards.
- Data Provenance: The document does not describe specific clinical data provenances (e.g., country of origin, retrospective/prospective) because it's not a clinical efficacy study involving patient data endpoints.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Not applicable/not provided. Ground truth establishment by experts for a test set is not part of this 510(k) submission, as it's not a study evaluating diagnostic or treatment outcomes against a gold standard in a clinical population.
4. Adjudication method for the test set
- Not applicable/not provided. Adjudication methods are relevant for studies comparing interpretations or outcomes, which is not the focus of this 510(k) submission.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
- No. This device is an ultrasonic surgical aspirator, not an AI-powered diagnostic or assistive tool. Therefore, an MRMC study related to human readers and AI assistance is not relevant and was not conducted.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable. This device is a surgical instrument and does not feature algorithms that would perform "standalone" operations without human interaction in a diagnostic or interpretive sense. The document explicitly states: "This device does not contain software."
7. The type of ground truth used
- Not applicable/not provided for clinical outcomes. The "ground truth" in this context refers to the established safety and effectiveness of the predicate devices and the adherence of the new device to recognized voluntary safety and electromagnetic compatibility (EMC) standards. There is no mention of pathology, outcomes data, or expert consensus being used to establish ground truth for performance metrics of the device itself beyond its design and intended function as a surgical tool.
8. The sample size for the training set
- Not applicable/not provided. There is no "training set" in the context of an algorithm or machine learning for this type of device submission.
9. How the ground truth for the training set was established
- Not applicable/not provided. As there is no training set mentioned, this question is not relevant.
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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
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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.
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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
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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
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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 UltrasonicSurgical Aspirator Systems |
|---|---|
| Common/Usual Name: | Ultrasonic Surgical SystemUltrasonic 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.
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K04/058
P2/2
| 5. | Intended Use: | LYSONIX 2000/3000 System is indicatedfor the liquefaction and aspiration of softtissues in General Surgery, Plastic andReconstructive Surgery and GynecologicalSurgery Applications. It is also indicated forthe liquefaction and aspiration of localizedsubcutaneous fatty deposits for the purposesof aesthetic body contouring. |
|---|---|---|
| 6. | Comparison to Predicate Device | LYSONIX 2000/3000 Systems is similar indesign, material and operating parameters tothe SoundVaser Ultrasonic Aspirator. TheSound Vaser is an Ultrasonic AspiratorSystem that features Pulsed OutputTechnology. It has an Ultrasonic LipoplastyIndication for Use as well. In addition,LYSONIX 2000/3000 Systems aresubstantially equivalent to the MentorContour Genesis System in terms of Theoryof Operation, Indications and OperatingSpecifications with the exception that theMentor Contour Genesis System (K004005)does not incorporate Pulsed OutputTechnology. |
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
§ 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.