(136 days)
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Not Found
No
The device description lists standard components of a suction lipoplasty system and there are no mentions of AI, ML, or related concepts in the provided text.
No
The device is intended for aesthetic body contouring, which is not a therapeutic purpose. Therapeutic devices are typically used to treat or cure diseases or medical conditions.
No
Explanation: The "Intended Use / Indications for Use" states the system is "intended for use in aesthetic body contouring," which is a treatment or procedure, not a diagnostic purpose.
No
The device description explicitly lists multiple hardware components (Aspiration Pump, Aspiration Cannulas, Sterile Tubing Set, Microbial Filter, Collection Canisters, and Canister Liners), indicating it is a hardware-based system, not software-only.
Based on the provided information, the LySonix Suction Lipoplasty System is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is "aesthetic body contouring," which is a surgical procedure performed on the body, not a diagnostic test performed on samples taken from the body.
- Device Description: The components listed (Aspiration Pump, Cannulas, Tubing, Filters, Canisters) are all related to the physical process of suctioning fat from the body. They are not designed to analyze biological samples.
- Lack of IVD Characteristics: The description does not mention any components or processes related to analyzing blood, urine, tissue, or other biological specimens for diagnostic purposes.
IVD devices are specifically designed to examine specimens derived from the human body to provide information for the diagnosis, prevention, monitoring, treatment, or alleviation of disease or injury. The LySonix system's function is purely procedural for body contouring.
N/A
Intended Use / Indications for Use
The LySonix Suction Lipoplasty System is intended for use in aesthetic body contouring.
Product codes
OPB, MUU
Device Description
The LySonix Suction Lipoplasty System consists of an Aspiration Pump, Aspiration Cannulas, Sterile Tubing Set, Microbial Filter, Collection Canisters, and Canister Liners.
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
Not Found
Indicated Patient Age Range
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Intended User / Care Setting
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Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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Predicate Device(s)
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Reference Device(s)
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Predetermined Change Control Plan (PCCP) - All Relevant Information
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§ 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
June 8, 2021
Image /page/0/Picture/1 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health and Human Services seal on the left and the FDA acronym along with the full name of the agency on the right. The FDA part of the logo is in blue, with the acronym in a square and the full name written out to the right of it.
Lysonix, Inc. Ronald Lagerquist Regulatory Affairs Manager 1170 Mark Ave. Carpinteria, California 93013
Re: K980771
Trade/Device Name: Lysonix Suction Lipoplasty System Regulation Number: 21 CFR 878.5040 Regulation Name: Suction lipoplasty system Regulatory Class: Class II Product Code: OPB
Dear Ronald Lagerquist:
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 July 13, 1998. 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 contains the text 'Public Health Service'. The text is black and appears to be a title or heading. The background is white and there are no other objects in the image.
Image /page/1/Picture/2 description: The image shows the logo for the Department of Health & Human Services USA. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" arranged around the top half of the circle. Inside the circle is a stylized image of three human profiles facing to the right, with the profiles overlapping each other.
JUL 1 3 1998
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Mr. Ronald F. Lagerquist Regulatory Affairs Manager Lysonix, Inc. 1170 Mark Avenue Carpinteria. California 93013
K980771 Re: Trade Name: Lysonix Suction Lipoplasty System Regulatory Class: II Product Code: MUU Dated: May 19, 1998 Received: May 22, 1998
Dear Mr. Lagerquist:
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 (QS) 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.
2
Page 2 - Mr. Lagerquist
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.
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
3
INDICATIONS FOR USE
Applicant:
LySonix, Inc.
510(k) Number:
1980771
Device Name:
.
. ··
LySonix Suction Lipoplasty System
Indications For Use:
The LySonix Suction Lipoplasty System is intended for use in aesthetic body contouring.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH Office of Device Evaluation (ODE)
| (Division Sign-Off) | |
|---|---|
| Division of General Restorative Devices | |
| 510(k) Number | K980771 |
| Prescription Use
| Per 21 CFR 801.109 | OR | Over-the-Counter |
|---|---|---|
| ---------------------------------------- | ------------------------------------------ | ------------------ |
4
TUL 1 3 1998
510(k) SUMMARY
This 510(k) summary is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR § 807.92
| Submitted by: | Ronald F. Lagerquist
Regulatory Affairs Manager |
|---------------|----------------------------------------------------|
| | LySonix Inc. |
| | 1170 Mark Avenue |
| | Carpinteria, CA 93013 |
Telephone: (805) 684-0409 (805) 684-0170 FAX:
February 25, 1998 Date Prepared:
Device Name:
Proprietary Name: LySonix Suction Lipoplasty System
Common Name: Suction Lipoplasty System
Indication for Use:
The LySonix Suction Lipoplasty System is intended for use in aesthetic body contouring.
Device Description:
The LySonix Suction Lipoplasty System consists of an Aspiration Pump, Aspiration Cannulas, Sterile Tubing Set, Microbial Filter, Collection Canisters, and Canister Liners.
Substantial Equivalence:
The LySonix Suction Lipoplasty System is substantially equivalent to suction lipoplasty systems described in 21 CFR § 878.5040. The components of the LySonix Suction Lipoplasty System have been found to be substantially equivalent in previously submitted LySonix Inc. 510(k) notifications.