The subject device is intended to be used for the removal of soft tissue and fluid from the body during general surgical procedures including suction lipoplasty for aesthetic body contouring.

Device Description

The subject device consists of:

Lipomatic Control Unit
Tubing
Key for the Lipomatic Control Unit
Oil
Silicone Pipe
Lipomatic Cannulas
Handle with a pneumatic motor
Collection Container
Pedal

The handpiece is a motorized pneumatic handle with interchangeable cannulas. The motor is linear and not rotary. The subject device uses external air sources. Therefore, the user chooses the air source and filtration system from readily available sources within a hospital or clinical environment. The Lipomatic does not include an aspirator or compressor.

The subject device includes either stainless steel or Teflon coated cannulas (based on customer order) that vary in length between 150mm-350mm and vary in diameter between 2.5mm-4.5mm.

The subject device has a built in safety feature which stops the device in the event hard tissue is encountered.

AI/ML Overview

The provided text is a 510(k) summary for the Euromi S.A. Lipomatic Liposuction Device. This document does not include acceptance criteria for device performance in the way a medical AI/CADe device would. Instead, it focuses on the device's substantial equivalence to predicate devices, its intended use, technological characteristics, and safety features for FDA clearance as a surgical tool.

Therefore, many of the requested categories related to medical AI/CADe device studies (e.g., sample sizes for test/training sets, expert ground truth adjudication, MRMC studies) are not applicable to this type of device and submission.

However, I can extract information relevant to the device's performance claims and the "study" mentioned for its international usage:

1. Table of Acceptance Criteria and Reported Device Performance

Criterion/Claim (Implicit)	Reported Device Performance (from text)
Safety Profile (absence of adverse events)	"High success rate and no adverse events" in a clinical study by Dr. Angelo Rebelo.
Effectiveness (satisfactory results)	"High success rate" in a clinical study by Dr. Angelo Rebelo. "Clinical usage has found the subject device to produce satisfactory results".
Compliance with Biocompatibility Standards	"Components that make contact with the patient are composed of materials that meet biocompatibility requirements as found in ISO 10993."
Built-in Safety Feature Functionality	"The subject device has a built in security feature which stops the device when hard tissue is encountered."
Compliance with Quality Standards	"The subject device is compliant to European Medical Device Directives and is manufactured by an ISO 9000 certified facilities."

2. Sample size used for the test set and the data provenance

Sample Size: The text states, "A clinical study by Dr. Angelo Rebelo documented the use of the Lipomatic for more than 1600 liposuction/liposculpture procedures."
Data Provenance: The study was conducted based on "international" usage, without specifying a particular country. It is a retrospective summary of accumulated clinical experience.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

The text mentions a "clinical study by Dr. Angelo Rebelo." It does not specify if other experts were involved in establishing "ground truth," nor does it detail Dr. Rebelo's specific qualifications beyond being a doctor who performed procedures. For a surgical device, the "ground truth" often refers to the clinical outcomes and safety observed during actual procedures by the operating physician.

4. Adjudication method for the test set

Not applicable in the context of this device and study. The study appears to be a review of clinical outcomes by a single physician based on their own procedures.

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 was not an MRMC comparative effectiveness study. This device is not an AI/CADe system for diagnosis or interpretation but a surgical tool.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

No, this is not an algorithm, but a physical medical device (liposuction system). Performance is inherently linked to human operation.

7. The type of ground truth used

The "ground truth" was based on clinical outcomes and observed safety from real-world surgical procedures ("success rate and no adverse events").

8. The sample size for the training set

Not applicable. This is not a machine learning device with a distinct training set. The 1600+ procedures represent accumulated clinical experience, not a "training set" in the AI sense.

9. How the ground truth for the training set was established

Not applicable, as there is no training set in the AI sense. The clinical outcomes were observed and documented by Dr. Angelo Rebelo during the reported procedures.

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). 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

Euromi Sa Joseph Azary P.O. Box 2156 Huntington, Connecticut 06484

Re: K010311

Trade/Device Name: Lipomatic; Lipomatic Liposuction Device Regulation Number: 21 CFR 878.5040 Regulation Name: Suction lipoplasty system Regulatory Class: Class II Product Code: QPB

Dear Joseph Azary:

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 June 29, 2001. 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 is a black and white emblem for the Department of Health & Human Services - USA. The emblem features a stylized eagle head with three curved lines representing the feathers. The eagle head is positioned within a circular border, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is written around the border of the circle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUN 2 9 2001

Euromi S.A. c/o Mr. Joseph M. Azary Azary Technologies, LLC P.O. Box 2156 Huntington, Connecticut 06484

Re: K010311

Trade/Device Name: Euromi S.A. Lipomatic Liposuction Device Regulation Number: 878.5040 Regulatory Class: II Product Code: MUU Dated: May 4, 2001 Received: May 9, 2001

Dear Mr. Azary:

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 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). 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 requirements, 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. Joseph M. Azary

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) 594-4659. 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" (21CFR 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/dsma/dsmamain.html".

Sincerely yours,

fo Murk M. Mellemson

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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FDA 510(k) Premarket Notification Euromi S.A. - Lipomatic Liposuction Device

010311 5 10(k) Number (if known):

Device Name: Euromi S.A. Lipomatic liposuction device

Indications For Use:

The subject device is intended to be used for the removal of soft tissue and fluid from the body during general surgical procedures including suction lipoplasty for aesthetic body contouring.

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH Office of Device Evaluation (ODE)

X Prescription Use (Per 21 CFR 801.109)

Over-The-Counter Use __

for Mark N Milkers

(Division Sign-Off)

Division of General, Restorative

nd Neurological Devices

510(k) Number -

(Optional Format 1-2-96)

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FDA 510(k) Premarket Notification Euromi S.A. - Lipomatic Liposuction Device

K010311

510 (k) Summary

[as required by 21 CFR 807.92]

Date Prepared [21 CFR 807.92(a)(1)]

January 30, 2001

Submitter's Information [21 CFR 807.92(a)(1)|

Euromi C/o Joseph Azary Azary Technologies LLC P.O. Box 2156 Huntington, CT. 06484

Trade Name, Common Name, Classification [21 CFR 807.92(a)(2)]

The device trade names are:

. Lipomatic
Lipomatic liposuction device .

Predicate Device [21 CFR 807.92(a)(3)]

The predicate device is the MicroAire Power Aspiration Device PAD System, which received clearance on 12/10/98 under 510k number K981922 and the Bryon Medical Accelerator Reciprocating Cannula, which received clearance on 8/4/00 under 510k number K001803.

Description of the Device [21 CFR 807.92(a)(4)]

The subject device consists of:

Lipomatic Control Unit .
Tubing .
. Key for the Lipomatic Control Unit
Oil .
. Silicone Pipe
Lipomatic Cannulas .
Handle with a pneumatic motor .
Collection Container ●
. Pedal

The handpiece is a motorized pneumatic handle with interchangeable cannulas. The motor is linear and not rotary. Detailed description of the device can be found in the attached instruction manual. The subject device uses external air sources. Therefore, the user chooses the air source and filtration system from readily available sources within a hospital or clinical environment. The Lipomatic does not include an aspirator or compressor.

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FDA 510(k) Premarket Notification Euromi S.A. - Lipomatic Liposuction Device

The subject device includes either stainless steel or Teflon coated cannulas (based on customer order) that vary in length between 150mm-350mm and vary in diameter between 2.5mm-4.5mm.

The subject device has a built in safety feature which stops the device in the event hard tissue is encountered.

Intended Use [21 CFR 807.92(a)(5)]

The subject device is intended to be used for the removal of soft tissue and fluid from the body during general surgical procedures including suction lipoplasty for aesthetic body contouring.

Technological Characteristics [21 CFR 807.92(a)(6)]

The subject device is equivalent to the predicate device, Microaire PAD system, based on the indications for use ond similar technological characteristics. The subject device requires less force and has built-in safety features to alert the user that hard tissue has been encountered.

Performance Data [21 CFR 807.92(b)(1)]

The subject device has been used internationally for several years with positive results. A clinical study by Dr. Angelo Rebelo documented the use of the Lipomatic for more than 1600 liposuction/liposculpture procedures with a high success rate and no adverse events.

The components that make contact with the patient are composed of materials that meet biocompatibility requirements as found in ISO 10993.

The subject device has a built in security feature which stops the device when hard tissue is encountered. The subject device is compliant to European Medical Device Directives and is manufactured by an ISO 9000 certified facilities.

Conclusion [21 CFR 807.92(b)(3){

The subject device has identical indications for use and similar technological characteristics as the predicate device. The subject device is composed of materials that have passed biocompatibility testing and can be sterilized using commonly accepted methods. Lastly, clinical usage has found the subject device to produce satisfactory results and function safely as a medical device.

We conclude that the subject device is as safe and effective as the predicate device.

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.