The Lipogems System is a sterile medical device intended for the closed-loop processing of lipoaspirate tissue for the purpose of transferring autologous adipose tissue for aesthetic body contouring (lipofilling) in applications including plastic and reconstructive surgery, neurosurgery, gastrointestinal and affiliated organ surgery, urological surgery, general surgery, orthopedic surgery, qynecological surgery, thoracic surgery, and laparoscopic surgery. Only legally marketed accessory items. such as syringes, should be used with the system. If harvested fat is to be reimplanted. the harvested fat is only to be used without any additional manipulation.

Device Description

The Lipogems System is a pre-assembled device consisting of:

An ABS processing unit (Lipogems Processing Unit) containing 5 stainless steel spheres and . 2 stainless steel sieve filters;
. An input washing line connected to the 'blue' side the processing unit;
An access port for the loading of material to be processed with a Luer-lock connection and self-. occluding valve (blue side);
. A drain line connected to the gray side of the processing unit;
An access port for the discharge of processed material with a Luer-lock connection and selfoccluding valve (gray side);
. A bag for collecting waste material.

The Lipogems System Processing Unit is manufactured in two size variants with the same functional characteristics:
LGD 240: Lipogems Processing Unit with 240 cc capacity and standard exit sieve; LGD 60: Lipogems Processing Unit with 60 cc capacity and standard exit sieve;

The intrinsic characteristics of the Lipogems fat treatment can be summarized as follows:

. Minimal handling of adipose tissue (only via mechanical action);
Maintenance of the vascular-stromal niches; ●
. Reduction of fat clusters to allow injection with fine needles, up to 27G;
. Removal of impurities, such as oil residues and blood.

The result of processing with the Lipogens System is a homogeneous and micronized fraction of adjpose tissue, which allows a patient's subcutaneous fat to be processed for autologous reinjection within the operative procedure time.

There is no direct interaction of the device with the patient, although the adipose tissue that is processed in the device comes from the patient and is returned to the same patient after processing.

Interaction with other devices is necessary for operation of the Lipogems System, in particular, standard FDA cleared syringes are needed for the initial injection of adipose tissue into the processing unit, and for receiving the processed tissue upon completion of the processing steps.

The steps of operation of the Lipogems System are:

The Lipogems processing unit receives a constant gravity feed of physiological saline through the 1. upper port. After first filling the processing unit with saline, adipose tissue is injected into the processing unit, where it undergoes a first reduction treatment and micronization of lipidic cluster as it passes through the input sieve.
1. The processing unit is then shaken manually, causing the spheres contained within the processing unit to exert mechanical action on the tissue/saline emulsion and further reduce the lipidic clusters, preserving the vascular-stromal niches, while the continuous flow of saline eliminates oil and blood component residuals from the emulsion. The used saline is collected in the waste bag. Conducting the mechanical reduction while fully immersed in saline minimizes any traumatic action on the cells.
1. After completion of the shaking/washing step, the solution appears clear (at the top of the processing unit) and the lipoaspirate is yellow (at the bottom). The saline flow is then stopped and the device is inverted. A second adipose cluster reduction takes place by pushing the floating adipose clusters through the second sieve, pushing fluid from below with a svringe. The reduced clusters pass out of the (now) top of the unit into a collecting syringe.

AI/ML Overview

The provided text is a 510(k) summary for the Lipogems System, a medical device intended for processing lipoaspirate tissue. It does not describe a study proving the device meets specific acceptance criteria in terms of clinical or technical performance metrics beyond basic device functionality and safety. The document focuses on demonstrating substantial equivalence to a predicate device rather than presenting performance data from studies directly measuring the device's efficacy or outcomes.

Therefore, the following information cannot be extracted from the provided text: acceptance criteria related to device performance (e.g., accuracy, sensitivity, specificity, or outcome measures), a study proving the device meets such criteria, sample size for test sets or training sets, data provenance, number or qualifications of experts, adjudication methods, MRMC studies, standalone performance, or types of ground truth for performance evaluation of the device's intended use.

The document discusses "Performance data" in a section, but explicitly states: "The performance of the device is entirely controlled by the user and is not predetermined by the device itself." This indicates that the regulatory submission does not include studies for clinical performance or efficacy.

What is described are non-clinical tests performed to ensure the device's safety, sterility, and biocompatibility, which are necessary for substantial equivalence:

1. Table of Acceptance Criteria and Reported Device Performance:

Since clinical or technical performance metrics for the device's intended use (processing lipoaspirate tissue for re-implantation) are not provided in the context of an acceptance criteria table, this table focuses on the non-clinical tests and their "performance."

Acceptance Criteria (Non-Clinical)	Reported Device Performance
Device Patency and Freedom from Leakage	100% testing of device patency and freedom from leakage carried out after manufacture
Sterility Assurance Level (SAL) via Sterilization Process Validation (ISO 11135-1)	SAL of 10^-6 (Note: text states 10^-9 in one place, and 10^-6 in the comparison table.)
5-year Shelf Life Validation (ASTM F1980)	Shelf life of five years established via accelerated aging
Biocompatibility (ISO 10993 series)	Biocompatible for materials in the fluid path (Cytotoxicity, Sensitization, Intracutaneous Reactivity, Acute Systemic Toxicity, LAL bacterial endotoxin test)
Pre-assembly Washing Process Validation	Validation performed on device spheres and sieves

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

For non-clinical tests (sterility, shelf-life, biocompatibility, patency/leakage), the sample sizes are not explicitly stated. These are typically performed on a representative number of devices or materials according to the respective standards.
Data provenance: Not applicable in the context of device performance related to its intended use as no clinical performance studies are presented. The non-clinical tests are conducted by the manufacturer as part of the device validation.

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

Not applicable, as no clinical performance or ground truth for diagnostic accuracy is being established in this document. The "ground truth" for non-clinical tests is defined by the standards and validated methodologies for those tests.

4. Adjudication method for the test set:

Not applicable, as no clinical performance or ground truth for diagnostic accuracy is being established.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done:

No, an MRMC comparative effectiveness study was not done. The document does not describe any clinical studies comparing the device's effectiveness.

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

This device is a mechanical processing system, not an algorithm. Therefore, "standalone performance" in the context of an algorithm is not applicable. The device's "performance" is described as user-controlled.

7. The type of ground truth used:

For the non-clinical tests, the "ground truth" is based on established scientific and regulatory standards (e.g., ISO, ASTM) for demonstrating sterility, biocompatibility, and physical integrity. There is no clinical or pathology-based ground truth related to the device's efficacy on tissue processing outcomes discussed.

8. The sample size for the training set:

Not applicable, as this is not an AI/algorithm-based device and no training set is mentioned or implied.

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

Not applicable.

Summary

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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

December 22, 2014

Lipogems International SpA % Mr. Roger Gray Donawa Lifescience Consulting Srl Piazza Albania 10 00153 Rome Italy

Re: K142682

Trade/Device Name: Lipogems System Regulation Number: 21 CFR 878.5040 Regulation Name: Suction lipoplasty system Regulatory Class: Class II Product Code: MUU Dated: September 24, 2014 Received: September 25, 2014

Dear Mr. Gray:

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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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 contact the Division of Industry and Consumer Education 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. 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 Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

Binita S. Ashar -S

Binita S. Ashar, M.D., M.B.A., F.A.C.S. Director Division of Surgical Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K142682

Device Name Lipogems System

Indications for Use (Describe)

The Lipogems System is a sterile medical device intended for the closed-loop processing of lipoaspirate tissue for the purpose of transferring autologous adipose tissue for aesthetic body contouring (lipofilling) in applications including plastic and reconstructive surgery, neurosurgery, gastrointestinal and affiliated organ surgery, general surgery, orthopedic surgery, gynecological surgery, thoracic surgery, and laparoscopic surgery. Only legally marketed accessory items, such as syringes, should be used with the system. If harvested fat is to be reimplanted, the is only to be used without any additional manipulation.

Type of Use (Select one or both, as applicable)

2 Prescription Use (Part 21 CFR 801 Subpart D)

Over-The-Counter Use (21 CFR 801 Subpart C)

PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.

FOR FDA USE ONLY

Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)

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510(k) Summary in accordance with 21 CFR 807.92(c)

Device Name:	The Lipogems System
Type of 510(k) submission:	Traditional
Date of Submission:	16 September 2014
Manufacturer:	Lipogems International S.p.A.Viale Bianca Maria 2420129 Milano (MI)Italy
510(k) Owner:	Lipogems International S.p.A.Viale Bianca Maria 2420129 Milano (MI)Italy
Phone:Fax:	+39 02 3707 2408/9+39 02 3707 2410
510(k) Submitter and Contact:	Mr Roger GrayVP Quality and RegulatoryDonawa Lifescience ConsultingPiazza Albania 1000153 RomeItalyPhone: +39 06 578 2665Fax: +30 06 574 3786Email: rgray@donawa.com
FDA Product Code:	MUU
FDA Regulation Number:	878.5040
FDA Classification Name:	System, Suction, Lipoplasty
Classification Panel:	General and Plastic Surgery
Common Name:	Lipoplasty System
FDA Classification:	Class II
FDA Identification:	A suction lipoplasty system is a device intended for aestheticbody 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 bottleand the safety trap), collection bottle, cannula, and connectingtube. The microbial filters, tubing, collection bottle, and cannulamust be capable of being changed between patients. Thepowered suction pump has a motor with a minimum of 1/3horsepower, a variable vacuum range from 0 to 29.9 inches ofmercury, vacuum control valves to regulate the vacuum withaccompanying vacuum gauges, a single or double rotary vane(with or without oil), a single or double diaphragm, a single ordouble piston, and a safety trap.

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Indications for Use/Intended Use:

Device Description:

The Lipogems System is a pre-assembled device consisting of:

An ABS processing unit (Lipogems Processing Unit) containing 5 stainless steel spheres and . 2 stainless steel sieve filters;
. An input washing line connected to the 'blue' side the processing unit;
An access port for the loading of material to be processed with a Luer-lock connection and self-. occluding valve (blue side);
. A drain line connected to the gray side of the processing unit;
An access port for the discharge of processed material with a Luer-lock connection and selfoccluding valve (gray side);
. A bag for collecting waste material.

The Lipogems System Processing Unit is manufactured in two size variants with the same functional characteristics:

LGD 240: Lipogems Processing Unit with 240 cc capacity and standard exit sieve; LGD 60: Lipogems Processing Unit with 60 cc capacity and standard exit sieve;

The intrinsic characteristics of the Lipogems fat treatment can be summarized as follows:

. Minimal handling of adipose tissue (only via mechanical action);
Maintenance of the vascular-stromal niches; ●
. Reduction of fat clusters to allow injection with fine needles, up to 27G;
. Removal of impurities, such as oil residues and blood.

There is no direct interaction of the device with the patient, although the adipose tissue that is processed in the device comes from the patient and is returned to the same patient after processing.

The steps of operation of the Lipogems System are:

The Lipogems processing unit receives a constant gravity feed of physiological saline through the 1. upper port. After first filling the processing unit with saline, adipose tissue is injected into the processing unit, where it undergoes a first reduction treatment and micronization of lipidic cluster as it passes through the input sieve.
1. The processing unit is then shaken manually, causing the spheres contained within the processing unit to exert mechanical action on the tissue/saline emulsion and further reduce the lipidic clusters, preserving the vascular-stromal niches, while the continuous flow of saline

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eliminates oil and blood component residuals from the emulsion. The used saline is collected in the waste bag. Conducting the mechanical reduction while fully immersed in saline minimizes any traumatic action on the cells.

1. After completion of the shaking/washing step, the solution appears clear (at the top of the processing unit) and the lipoaspirate is yellow (at the bottom). The saline flow is then stopped and the device is inverted. A second adipose cluster reduction takes place by pushing the floating adipose clusters through the second sieve, pushing fluid from below with a svringe. The reduced clusters pass out of the (now) top of the unit into a collecting syringe.
  The materials used in the manufacture of the device are in common usage for medical devices. Testing in accordance with the relevant standards in the ISO 10993 series has demonstrated device biocompatibility.

100 % testing of device patency and freedom from leakage is carried out after manufacture and before terminal sterilization by ethylene oxide gas, resulting in a sterility assurance level (SAL) of 10-9. The sterilization process has been validated in accordance with ISO 11135-1. The device is supplied for single use only.

A shelf life of five years has been established for the Lipogems System. This shelf life was established by exposing sterilized samples of the device to accelerated aging equivalent to five years real-time, in accordance with standard ASTM F1980.

ltem	Predicate device	Subject device	Similarity
Device name	GID 700 Tissue Canister	The Lipogems System	N/A
Device Manufacturer	GID Group Inc	Lipogems International SpA	N/A
510(k) Reference	K120902	Not yet assigned	N/A
FDA Product Code	MUU	MUU	Same
FDA Classification Name	System, Suction, Lipoplasty	System, Suction, Lipoplasty	Same
FDA Regulation Number	878.5040	878.5040	Same
Indications for Use /Intended Use	The GID 700 is used for aspiration,harvesting, filtering, and transferringof autologous adipose tissue foraesthetic body contouring. Thesystem should be used with alegally marketed vacuum oraspirator apparatus as a source ofsuction. If harvested fat is to bereimplanted, the harvested fat isonly to be used without anyadditional manipulation.The GID 700 is intended for use inthe following surgical specialtieswhen aspiration of soft tissue isdesired: plastic and reconstructivesurgery, neurosurgery,gastrointestinal and affiliated organsurgery, urological surgery, generalsurgery, orthopedic surgery,gynecological surgery, thoracicsurgery, and laparoscopic surgery.	The Lipogems System is a sterilemedical device intended for theclosed-loop processing oflipoaspirate tissue for the purpose oftransferring autologous adiposetissue for aesthetic body contouring(lipofilling) in applications includingplastic and reconstructive surgery,neurosurgery, gastrointestinal andaffiliated organ surgery, urologicalsurgery, general surgery, orthopedicsurgery, gynecological surgery,thoracic surgery, and laparoscopicsurgery. Only legally marketedaccessory items, such as syringes,should be used with the system. Ifharvested fat is to be reimplanted,the harvested fat is only to be usedwithout any additional manipulation.	Similar
Variations	One only: GID 700	Two: LGD 240, LGD 60	Different
System concept	Closed loop	Closed loop	Same
Construction	Preassembled	Preassembled	Same
Sterility	Supplied sterile for single use	Supplied sterile for single use	Same

Substantial equivalence:

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Item	Predicate device	Subject device	Similarity
Sterilization method	Electron beam radiation	Ethylene oxide	Different
Sterility Assurance Level	SAL = 10-6	SAL = 10-6	Same
Biocompatibility	Biocompatible	Biocompatible	Same
Source of Energy	User supplied vacuum	None required	Different
Mechanical operation	Manual stirring mechanismcomprising a propeller and a comb	Manual shaking of s/steel spheres	Different
Canister size	700 ml	240 or 60 ml	Different
Canister ports	Suction, vent, input, extraction	Saline feed, input, drainage,extraction	Similar
Tissue washing media	Lactated Ringers Solution	Physiological saline	Different
Mesh sizes	200 micron mesh to allowseparation of waste products fromadipose tissue - tissue does notpass through mesh	LGD 240 and LGD 60: 2000 micronmesh at inlet and 1000 micron meshat outlet - collected adipose tissuepasses though both meshes	Different
Unit testing	Implosion test	Leakage test	Different

The subject device and the predicate device share many identical or similar features and parameters. Differences exist in the following areas:

Size variations
Sterilization method
Source of energy ●
Mechanical operation ●
. Tissue washing media
Filtering .
Unit testing ●

The most significant difference relates to the user manual shaking of the processing unit of the subject device in order to achieve adipose tissue reduction, whereas the predicate devices utilizes a rotary stirring action of a propeller and comb.

Substantial Equivalence Conclusion:

Based on the information contained in this submission, it is concluded that the Lipogems System is substantially equivalent to the identified predicate device which is already in interstate commerce within the USA.

Performance data:

The performance of the device is entirely controlled by the user and is not predetermined by the device itself. The instructions for use advise the user to process the tissue by waving and shaking the unit vigorously for a few minutes to emulsify the content. The instructions continue by identifying that when the processing phase is complete, fat tissue will appear compact, light yellow in color, floating on the transparent liquid phase.

Nonclinical testing:

The following nonclinical tests have been performed on the relevant components of the Lipogems system:

Validation of the pre-assembly washing process carried out on the device spheres and sieves. ●
Biocompatibility testing of all materials in the fluid path, including: ●
- Cytoxicity (ISO 10993-5); o
- Sensitization (ISO 10993-10); O
- Intracutaneous Reactivity (ISO 10993-10); O
- Acute Systemic Toxicity (ISO 10993-11); O
- LAL bacterial endotoxin test. O

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. Validation of the sterilization process (ISO 11153-1)
- Testing to validate a 5 year shelf life, including:
  - o Peel strength;
  - o
. In-process patency and leakage testing of every 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.