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.

AI/ML Overview

The provided document is a 510(k) premarket notification for a medical device (Micro-France Liposuction Cannulas). It does not contain the acceptance criteria or a study proving the device meets those criteria in the way typically seen for AI/ML-based diagnostic devices.

The document is primarily concerned with establishing "substantial equivalence" to a predicate device, a regulatory pathway that focuses on comparing a new device to a legally marketed one, rather than demonstrating de novo performance against specific clinical endpoints with detailed statistical studies.

Therefore, most of the requested information cannot be extracted from this document.

Here's an assessment based on the available information:

No information on acceptance criteria or performance study results is provided. The 510(k) process for this device relies on demonstrating similarity to a predicate, not on a new performance study with acceptance criteria.

However, I can extract information related to the device itself and the regulatory context:

Device Information:

Device Name: Micro-France Liposuction Cannulas
Intended Use: Aesthetic body contouring and general tissue aspiration.
Device Description: Consist of a hollow stainless steel tube with one or more distal openings and a handle with a suction line connector.
Predicate Devices: Byron Medical (K981172) and Wells Johnson Co. (K832520)

Regarding your specific questions:

A table of acceptance criteria and the reported device performance: Not applicable. This document does not describe acceptance criteria for a performance study nor does it report device performance against such criteria. The "performance" demonstrated here is primarily through substantial equivalence to predicate devices, implying similar safety and effectiveness.
Sample sized used for the test set and the data provenance: Not applicable. No test set or clinical study data is mentioned for this 510(k) submission.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. No ground truth establishment for a test set is discussed.
Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable. No test set adjudication is discussed.
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: Not applicable. This is not an AI/ML device, and no MRMC study is mentioned.
If a standalone (i.e. algorithm only without human-in-the loop performance) was done: Not applicable. This is not an AI/ML device.
The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not applicable. No ground truth for device performance is discussed beyond the regulatory assertion of substantial equivalence.
The sample size for the training set: Not applicable. This is not an AI/ML device, and no training set is mentioned.
How the ground truth for the training set was established: Not applicable. This is not an AI/ML device, and no training set is mentioned.

Summary

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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

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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 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.

Regulation Number and Section

§ 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.