The subject device is used in conjunction with the Lipomatic Handpiece. The Lipomatic Handpiece is a motorized pneumatic handle with interchangeable canulae. The Lipomatic handpiece can be used with readily available air sources at the hospital or clinic.

The EVA sp6 is an aspiration system that can be used with the Lipomatic handpiece for the purposes of aesthetic body contouring.

The EVA sp6 can be in continuous operation or can be controlled by a foot pedal. The device has two modes; infiltration and aspiration. Syringes are used for infiltration.

The EVA sp6 has wheels to allow it to move around the clinical or hospital as needed.

The list of accessories include:

Pedal .
. Hospital Grade Power Cord and Plug
Replacement Fuses .
Tubing (5 kits) .
Twisted Pipe of 5 meter with one connector .
Aspiration Jars (2 jars) .

AI/ML Overview

The request is to describe the acceptance criteria and the study that proves the device meets those criteria based on the provided text.

Based on the provided FDA 510(k) submission summary for the "Euromi EVA sp6 Lipoplasty Suction System" (K101413), here's the information regarding acceptance criteria and supporting studies:

A table of acceptance criteria and the reported device performance

Characteristic	Acceptance Criteria (Specification)	Reported Device Performance
Electrical	110-120 V	110-120 V (Implied by specification. No test result explicitly states the measured voltage, but passing electrical safety testing implies conformity.)
Power	250 W	250 W (Implied by specification. No test result explicitly states the measured power, but passing electrical safety testing implies conformity.)
Noise Level	57 dB	57 dB
Weight	10 Kg	10 Kg
Final Vacuum (mb relative)	-850	-850

Note: The document lists "Specification" which functions as the acceptance criteria for these characteristics. The "Reported Device Performance" is implied to meet these specifications as the device passed non-clinical testing.

Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)

The text indicates that non-clinical testing was performed on the subject device. For electrical safety, EMC, FCC Part 15, and accuracy testing, typically a sample size of one or a small number of devices is used to demonstrate compliance. The exact sample size is not specified in the document. The data provenance is also not specified, but given it's for an EU manufacturer (Euromi SA in Belgium) seeking US FDA clearance, the testing would generally follow internationally recognized standards (like IEC) and potentially be conducted by accredited labs. It is a prospective test in the sense that the device was specifically tested for these parameters.

Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience)

Not applicable. This device is a lipoplasty suction system, not an AI or diagnostic imaging device that requires expert-established ground truth for performance evaluation in the context of the provided document. The performance data relates to engineering specifications and safety standards.

Adjudication method (e.g., 2+1, 3+1, none) for the test set

Not applicable. As above, this is about engineering performance and safety testing, not diagnostic accuracy requiring adjudication among experts.

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. A MRMC comparative effectiveness study was not performed. This device is a medical instrument (lipoplasty suction system), not an AI diagnostic tool.

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

Not applicable. This is not an AI algorithm. The performance evaluation was for the standalone physical device. The device was subjected to standalone non-clinical testing for electrical safety, EMC, FCC Part 15, and accuracy.

The type of ground truth used (expert consensus, pathology, outcomes data, etc)

For the non-clinical performance data (electrical, power, noise, weight, vacuum), the "ground truth" is established by engineering specifications and measurements against recognized standards. For example, electrical safety is measured against IEC 60601-1. The vacuum level is a direct measurement.

The sample size for the training set

Not applicable. This is not an AI/machine learning device. There is no training set mentioned or implied.

How the ground truth for the training set was established

Not applicable. There is no training set for this device.

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.

Euromi Sa Curtis Raymond Sr Regulatory & Quality Consultant 80 Shelton Technology Center Shelton, Connecticut 06484

June 9, 2021

Re: K101413

Trade/Device Name: Euromi Eva Sp6 Regulation Number: 21 CFR 878.5040 Regulation Name: Suction lipoplasty system Regulatory Class: Class II Product Code: QPB

Dear Curtis Raymond:

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 December 16, 2010. 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 logo for the U.S. Department of Health & Human Services. The logo consists of a circular arrangement of text that reads "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA". Inside the circle is a stylized symbol that resembles a bird or a wing-like shape, composed of several curved lines. The overall design is simple and conveys a sense of official government branding.

Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room W-066-0609 Silver Spring, MD 20993-0002

DEC 16 2010

Euromi SA % Orchid Design Mr. Curtis Raymond 80 Shelton Technology Center Shelton, Connecticut 06484

Re: K101413

· Trade/Device Name: Euromi EVA sp6 Lipoplasty Suction System Regulation Number: 21 CFR 878.5040 Regulation Name: Suction lipoplasty system Regulatory Class: II Product Code: MUU Dated: October 18, 2010 Received: October 20, 2010

Dear Mr. Raymond:

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 general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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

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Page 2 - Mr. Curtis Raymond

CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to .

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

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) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely vours.

Fon Pithan

Mark N. Melkerson Director Division of Surgical, Orthopedic and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known):

Device Name: Euromi EVA sp6 Lipoplasty Suction System

Indications For Use:

The device is intended to be used for 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)

Page 1 of 1

Daniel Kruce for Mxm

(Division Sign-Off) Division of Surgical, Orthopedic, and Restorative Devices

.510(k) Number K101413

Page 12

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K101413
page 1/1

510 (k) Summary

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

December 1. 2010

DFC 1 6 2010

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

This 510(k) is being submitted by Orchid Design on behalf of Euromi SA.

Sponsor / Manufacturer: Euromi S.A. Zoning Industriel de Lambermont Rue des Ormes 151 B-4800 Verviers - BELGIUM

Regulatory Contact / Consultant: Curtis Ravmond Orchid Design 80 Shelton Technology Center - Shelton, CT 06484 Tel: (203) 922-0105 - Fax: (203) 922-0130 Email: joseph.azary@orchid-orthopedics.com

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

Device Trade or Proprietary Name:

The device trade names are:

Euromi EVA sp6 Lipoplasty Suction System

Common, Usual, or Classification Name:

Lipoplasty Suction System .
Liposuction Suction System ●

Classification: Class II, 21 CFR 878.5040, MUU

Predicate Device [21 CFR 807.92(a)(3)] Byron Medical, PSI-Tec Liposuction, K981215 Byron Medical, PSI-Tec Infiltration Pump, K040149

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

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The EVA sp6 is an aspiration system that can be used with the Lipomatic handpiece for the purposes of aesthetic body contouring.

The EVA sp6 can be in continuous operation or can be controlled by a foot pedal. The device has two modes; infiltration and aspiration. Syringes are used for infiltration.

The EVA sp6 has wheels to allow it to move around the clinical or hospital as needed.

The list of accessories include:

Pedal .
. Hospital Grade Power Cord and Plug
Replacement Fuses .
Tubing (5 kits) .
Twisted Pipe of 5 meter with one connector .
Aspiration Jars (2 jars) .

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

This device is intended to be used for aesthetic body contouring.

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

The device relies on an external source of compressed air for operation.

The EVA sp6 does not make direct contact with the patient. The device is connected to the Lipomatic Handpieces / Cannulas that were cleared under K010311.

The device has the same technological characteristics as the predicate device including electrical power, use with sterile cannulas, indications for use, and aspiration and infiltration modes.

The main difference between the subject device and predicate device is that the devices are specific to the cannulas from each manufacturer.

Performance Data [21 CFR 807.92(b)(1) and (2)]

The subject device has been subjected to non-clinical testing including biocompatibility testing, electrical safety, EMC testing, FCC Part 15, and accuracy testing. The subject device has been tested and passed electrical safety and EMC requirements utilizing IEC 60601-1, 60601-1-2, and FCC Part 15.

Characteristic	Specification
Electrical	110-120 V
Power	250 W
Noise Level	57 dB
Weight	10 Kg
Final Vacuum(mb relative)	-850

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page 3/3

Clinical studies were not performed with regards to this device. However, this device has been used internationally and published studies were included in the 510(k).

Clinical data was not required to demonstrate substantial equivalence.

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

The conclusions drawn from the nonclinical tests as well as the comparison to the predicate device demonstrate that the changes are minor and conclude that the subject devices are 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.