(78 days)
Not Found
No
The device description is purely mechanical, and there are no mentions of AI, ML, or related concepts in the provided text.
No
Explanation: A therapeutic device is used to treat a disease or condition. Liposuction cannulas are indicated for aesthetic body contouring and general tissue aspiration, which are not necessarily treatments for a disease but rather cosmetic or general medical procedures.
No
The Intended Use / Indications for Use section states the cannulas are "indicated for aesthetic body contouring and general tissue aspiration," which are therapeutic or surgical procedures, not diagnostic ones. There is no mention of the device being used to identify or analyze a condition.
No
The device description explicitly states it is a hollow stainless steel tube with a handle and connector, indicating it is a physical hardware device, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is "aesthetic body contouring and general tissue aspiration." This describes a surgical procedure performed on a living patient, not a test performed on a sample in vitro (outside the body).
- Device Description: The description of a "hollow stainless steel tube with one or more distal openings and a handle with a suction line connector" is consistent with a surgical instrument used for aspiration, not a device for analyzing biological samples.
- Lack of IVD Characteristics: The information does not mention any components or functions related to analyzing biological samples (like reagents, detection methods, or measurement of analytes).
IVD devices are specifically designed to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening. This device's purpose is to remove tissue from the body for aesthetic or general aspiration purposes, not for diagnostic testing of that tissue.
N/A
Intended Use / Indications for Use
Liposuction cannulas are indicated for aesthetic body contouring and general tissue aspiration.
Product codes
OPB,MUU
Device Description
Micro-France liposuction cannulas consist of a hollow stainless steel tube with one or more distal openings and a handle with a suction line connector.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
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
Not Found
Key Metrics
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.
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Image /page/0/Picture/0 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 & Human Services logo on the left and the FDA logo on the right. The FDA logo features the letters 'FDA' in a blue square, followed by the words 'U.S. FOOD & DRUG ADMINISTRATION' in blue text.
Xomed, Inc. Martin Sargent Senior Regulatory Affairs Specialist 6743 Southpoint Dr. North Jacksonville, Florida 32216-0980
June 8, 2021
Re: K992282
Trade/Device Name: Micro-France Liposuction Cannulas Regulation Number: 21 CFR 878.5040 Regulation Name: Suction lipoplasty system Regulatory Class: Class II Product Code: OPB
Dear Martin Sargent:
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 September 23, 1999. 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 stylized eagle or bird symbol, with three curved lines representing the bird's body and wings. The logo is encircled by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a circular arrangement.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
SEP 2 3 1999
Mr. Martin D. Sargent Senior Regulatory Affairs Specialist Xomed, Inc. 6743 Southpoint Drive North Jacksonville, Florida 32216
Re: K992282
Trade Name: Micro-France Liposuction Cannulas Regulatory Class: II Product Code: MUU Dated: July 6, 1999 Received: July 7, 1999
Dear Mr. Sargent:
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.
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Page 2 - Mr. Martin D. Sargent
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,
to Dellef
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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992212 510(k) Number (if known): Device Name: J Micro - France Liposuction Cannolas Indications for Use:
Liposuction cannulas are indicated for aesthetic body contouring and general tissue aspiration.
(Please do not write below this line - continue on another page if needed) Concurrence of CDRH, Office of Device Evaluation (ODE) Sign-Off) (Division (Division Sign-Off)
Division of General Restorative Devices 1992282 510(k) Number Prescription Use _ Or Over-the-Counter Use _ (Per 21 CFR 801.109) (Optional Format 1-2-96)
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510(k) Summary
长992282
1.0 Date Prepared July 6, 1999
2.0 Submitter (Contact)
Martin D. Sargent Xomed Surgical Products Jacksonville, FL (904) 279-7586
3.0 Device Name
| Proprietary Name: | Micro-France liposuction cannula |
|---|---|
| Common Name: | Liposuction cannulas |
| Classification Name: | Suction lipoplasty accessories |
5.0 Device Classification
Suction lipoplasty accessories: Procode MUU Class II 21 CFR 878.5040
6.0 Device Description
Micro-France liposuction cannulas consist of a hollow stainless steel tube with one or more distal openings and a handle with a suction line connector.
7.0 Intended Use
Liposuction cannulas are indicated for aesthetic body contouring and general tissue aspiration.
8.0 Substantial Equivalence
The Micro-France liposuction cannulas are substantially equivalent to devices marketed by Byron Medical (K981172) and Wells Johnson Co. (K832520) in their intended use, materials, and overall design.