The Lipogems System is a sterile medical device intended for the closed-loop processing of lipoaspirate tissue in medical procedures involving the harvesting, concentrating and transferring of autologous adipose tissue harvested with a legally marketed lipoplasty system. The device is intended for use in the following surgical specialties when the transfer of harvested adipose tissue is desired: orthopedic surgery, arthroscopic surgery, neurosurgery, gastrointestinal and affiliated organ surgery, urological surgery, general surgery, gynecological surgery, thoracic surgery, laparoscopic surgery, and plastic and reconstructive surgery when aesthetic body contouring is desired. Only legally marketed accessory items, such as syringes, should be used with the system. If harvested fat is to be transferred, 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 color-coded end cap of the processing unit; .
An access port for the loading of material to be processed with a Luer-lock connection and selfoccluding valve (color-coded end-cap);
. A drain line connected to the 'gray' end-cap of the processing unit;
An access port for the discharge of processed material with a Luer-lock connection and self-occluding valve (gray end-cap);
A bag for collecting waste material.

The Lipogems System Processing Unit is supplied sterile, for single use only, and 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;

AI/ML Overview

The provided document is a 510(k) premarket notification for the Lipogems System. It focuses on demonstrating substantial equivalence to a previously cleared predicate device (K161636 The Lipogems System), rather than presenting a study with specific acceptance criteria and performance data for a new device.

Therefore, the document does not contain the information requested in your prompt regarding acceptance criteria and a study proving those criteria are met.

Specifically, the following information is not available in the provided text:

A table of acceptance criteria and the reported device performance: This document is a comparison to a predicate device, not a performance study against predefined criteria.
Sample size used for the test set and the data provenance: No performance test set is described.
Number of experts used to establish the ground truth... and their qualifications: No ground truth establishment is described as there's no performance study.
Adjudication method for the test set: Not applicable as there's no performance test set.
If a multi reader multi case (MRMC) comparative effectiveness study was done... effect size: Not described. The device is a medical processing system, not one that involves human readers interpreting data.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable, as this is not an algorithm-based device.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable, as there's no performance study that would require ground truth.
The sample size for the training set: Not applicable, as this is not an AI/ML device that requires a training set.
How the ground truth for the training set was established: Not applicable.

The document primarily focuses on demonstrating that the current Lipogems System is substantially equivalent to its predicate device by having identical indications for use, technological characteristics (e.g., closed loop system concept, sterilization method, biocompatibility), and manufacturing processes. It notes "slight modifications in end cap and outer processing unit geometry" and the addition of "color-coded end caps," but asserts these do not raise new questions of safety and efficacy. Biocompatibility testing (Cytotoxicity, Intracutaneous Reactivity, Delayed Hypersensitivity, Acute Systemic Toxicity) was performed to confirm this.

Summary

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Image /page/0/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, stacked on top of each other.

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

May 18, 2017

Lipogems International S.p.A. % Scott Bruder, M.D., Ph.D. Principal, Bruder Consulting International, LLC 268 Glen Place Franklin Lakes, New Jersey 07417

Re: K171135

Trade/Device Name: Lipogems System Regulation Number: 21 CFR 878.5040 Regulation Name: Suction Lipoplasty System Regulatory Class: Class II Product Code: MUU Dated: April 14, 2017 Received: April 17, 2017

Dear Dr. Bruder:

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 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device

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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/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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,

David Krause -S

for 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)

K171135

Device Name The Lipogems System

Indications for Use (Describe)

The Lipogems System is a sterile medical device intended for the closed-loop processing of lipoaspirate tissue in medical procedures involving the harvesting, concentrating and transferring of autologous adipose tissue harvested with a legally marketed lipoplasty system. The device is intended for use in the following surgical specialties when the transfer of harvested adipose tissue is desired: orthroscopic surgery, neurosurgery, gastrontestinal and affiliated organ surgery, urological surgery, general surgery, thoracic surgery, laparoscopic surgery, and plastic and reconstructive surgery when aesthetic body contouring is desired. Only legally marketed accessory items, such as syringes, should be used with the system. If harvested fat is to be transferred, the harvested fat is only to be used without any additional manipulation.

X Prescription Use (Part 21 CFR 801 Subpart D)

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

CONTINUE ON A SEPARATE PAGE IF NEEDED.

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Image /page/3/Picture/0 description: The image shows the logo for Lipogems. The logo consists of a geometric shape on the left, followed by the word "LIPOGEMS" in capital letters. The geometric shape is a dark gray octagon with gray circles at each vertex and at the center of each side, connected by lines. The letters "LIPO" are in dark gray, while the letters "GEMS" are in light gray, with the "O" and "G" overlapping.

510(k) Summary

Device Name:	The Lipogems System
Type of 510(k) submission:	Traditional
Date of Submission:	May 3, 2017
510(k) Owner & Manufacturer:	Lipogems International S.p.A.Viale Bianca Maria 2420129 Milano (MI) ItalyPhone: +39 02 3707 2408/9Fax: +39 02 3707 2410
510(k) Submitter and Contact:	Scott Bruder, MD, PhDPrincipalBruder Consulting International, LLC268 Glen PlaceFranklin Lakes, NJ 07417Phone: 201.874.9701Email: scottbruder@me.com
FDA Product Code:	MUU
FDA Regulation Number:	21 CFR 878.5040
FDA Classification Name:	System, Suction, Lipoplasty
Classification Panel:	General and Plastic Surgery
Common Name:	Lipoplasty System
FDA Classification:	Class II
Predicate Device:	K161636 The Lipogems System

Indications for Use / Intended Use:

The Lipogems System is a sterile medical device intended for the closed-loop processing of lipoaspirate tissue in medical procedures involving the harvesting, concentrating and transferring of autologous adipose tissue harvested with a legally marketed lipoplasty system. The device is intended for use in the following surgical specialties when the transfer of harvested adjoose tissue is desired; orthopedic surgery. neurosurgery, gastrointestinal and affiliated organ surgery, general surgery, general surgery, gynecological surgery, thoracic surgery, laparoscopic surgery, and plastic and reconstructive surgery when aesthetic body contouring is desired. Only legally marketed accessory items, such as syringes, should be used with the system. If harvested fat is to be transferred, 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 color-coded end cap of the processing unit; .

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Image /page/4/Picture/1 description: The image shows the logo for Lipogems. The logo consists of a geometric shape on the left, followed by the word "LIPOGEMS" in bold, sans-serif font. The geometric shape is a dark octagon with gray circles connected to each vertex. The letters "LIPO" are in black, while "GEMS" are in gray, with the "O" overlapping the "G".

An access port for the loading of material to be processed with a Luer-lock connection and selfoccluding valve (color-coded end-cap);
. A drain line connected to the 'gray' end-cap of the processing unit;
An access port for the discharge of processed material with a Luer-lock connection and self-occluding valve (gray end-cap);
A bag for collecting waste material.

The Lipogems System Processing Unit is supplied sterile, for single use only, and 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 following Table provides a comparison and evidence of substantial equivalence of the subject device with the predicate device:

Predicate device comparison table
Item	Predicate device (Lipogems)	Subject device (Lipogems)	Similarity
Device name	The Lipogems System	The Lipogems System	Identical
Device Manufacturer	Lipogems International SpA	Lipogems International SpA	Identical
510(k) Reference	K161636	Not yet assigned	N/A
Clearance Date:	November 4, 2016	Not yet assigned	N/A
FDA Product Code	MUU	MUU	Identical
FDA Classification Name	System, Suction, Lipoplasty	System, Suction, Lipoplasty	Identical
FDA Regulation Number	878.5040	878.5040	Identical
System concept	Closed loop	Closed loop	Identical
Device Size Variations	Two: LGD 60, LGD 240	Two: LGD 60, LGD 240	Identical
Fill Volumes	Up to 30 or 120 ml of fat	Up to 30 or 120 ml of fat	Identical
Construction	Preassembled	Preassembled	Identical
Sterility	Supplied sterile for single use	Supplied sterile for single use	Identical
Sterilization method	Ethylene oxide Gas	Ethylene oxide Gas	Identical
Sterility Assurance Level	SAL = 10-6	SAL = 10-6	Identical
Biocompatibility	Biocompatible	Biocompatible	Identical

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Image /page/5/Picture/1 description: The image shows the logo for Lipogems. The logo consists of a geometric shape on the left, resembling a molecule or cell structure, followed by the word "LIPOGEMS" in capital letters. The letters "LIPO" are in a darker shade, while "GEMS" are in a lighter shade of gray, creating a visual contrast.

Predicate device comparison table

Item	Predicate device (Lipogems)	Subject device (Lipogems)	Similarity
Indications for Use /Intended Use	The Lipogems System is a sterilemedical device intended for theclosed-loop processing of lipoaspiratetissue in medical procedures involvingthe harvesting, concentrating andtransferring of autologous adiposetissue harvested with a legallymarketed lipoplasty system. Thedevice is intended for use in thefollowing surgical specialties when thetransfer of harvested adipose tissue isdesired: orthopedic surgery,arthroscopic surgery, neurosurgery,gastrointestinal and affiliated organsurgery, urological surgery, generalsurgery, gynecological surgery,thoracic surgery, laparoscopicsurgery, and plastic andreconstructive surgery when aestheticbody contouring is desired. Onlylegally marketed accessory items,such as syringes, should be used withthe system. If harvested fat is to betransferred, the harvested fat is only tobe used without any additionalmanipulation.	The Lipogems System is a sterilemedical device intended for theclosed-loop processing of lipoaspiratetissue in medical procedures involvingthe harvesting, concentrating andtransferring of autologous adiposetissue harvested with a legallymarketed lipoplasty system. Thedevice is intended for use in thefollowing surgical specialties when thetransfer of harvested adipose tissue isdesired: orthopedic surgery,arthroscopic surgery, neurosurgery,gastrointestinal and affiliated organsurgery, urological surgery, generalsurgery, gynecological surgery,thoracic surgery, laparoscopicsurgery, and plastic andreconstructive surgery when aestheticbody contouring is desired. Onlylegally marketed accessory items,such as syringes, should be used withthe system. If harvested fat is to betransferred, the harvested fat is only tobe used without any additionalmanipulation.	Identical

Summary of technological Characteristics:

The subject device is identical to the predicate device in regards to:

. Indications/Intended Use
Size variations
Sterilization method ●
. Packaging
Manufacturing
Mechanical operation
. Tissue washing media
Filtering
Unit testing
. Fundamental scientific technology

Differences exist between the Subject and Predicate Device with regards to the addition of color-coded end caps in the Subject Device, and labeling changes to clarify the Instructions for Use. There have also been slight modifications in end cap and outer processing unit geometry. None of these modifications raise new questions of safety and efficacy.

Summary of Nonclinical testing:

Biocompatibility testing according to ISO 10993 was performed to confirm that the proposed modifications do not raise new questions of safety and/or efficacy. This included:

Cytotoxicity (ISO 10993-5) •
. Intracutaneous Reactivity* (ISO 10993-10)
Delayed Hypersensitivity (ISO 10993-10)
Acute Systemic Toxicity (ISO 10993-11)

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K171135, pg. 4 of 4

Image /page/6/Picture/1 description: The image shows the logo for "LIPOGEMS". The logo consists of a geometric shape on the left, resembling a molecule or network, followed by the company name in a combination of dark and light gray letters. The "O" and "G" in "LIPOGEMS" are intertwined, creating a unique visual element.

Substantial Equivalence Conclusion:

Based on the information contained within this submission, Lipogems International S.p.A. believes that the Lipogems System is substantially equivalent to the identified predicate device and does not introduce any new or significantly modified risks, and no new questions of safety and efficacy.

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.