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, gastrointestinal and affiliated organ surgery, urological 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 'blue' end-cap the processing unit;
An access port for the loading of material to be processed with a Luer-lock connection and self-occluding valve (blue 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

This document is a 510(k) premarket notification for the Lipogems System. It focuses on demonstrating substantial equivalence to a previously cleared device (K142682, also the Lipogems System) and a reference device (Ranfac FATS Procedure Pack, K150156). The document explicitly states that "The subject device is identical in every way to the predicate device previously cleared," and later, "The Subject and Predicate device are identical in every material and functional way, as there has been no change to the device materials, design, manufacturing, sterilization, packaging or any other feature since its prior clearance under K142682."

Therefore, the submission does not present new acceptance criteria or a new study to prove the device meets new criteria. Instead, it relies on the previous clearance and asserts that the current device is the same. The only change mentioned is a "revised language of the IFU and other labelling."

Given this, I cannot provide a table of acceptance criteria and reported device performance from this document, nor details about a new study, sample sizes, experts, adjudication methods, or MRMC studies. This information would have been part of the original K142682 submission.

However, I can extract information relevant to the current submission's claims of equivalence:

Device Name: Lipogems System
510(k) Number: K161636
Predicate Device: K142682 The Lipogems System, Lipogems International, S.p.A.
Reference Device: K150156 Ranfac FATS Procedure Pack, Ranfac Corporation

The submission emphasizes that the current Lipogems System is identical to the predicate device K142682. The comparison table with the reference device, Ranfac FATS Procedure Pack, highlights similarities across various aspects.

Below are the details that can be extracted or inferred from this specific document, primarily regarding the assertion of equivalence rather than new performance data:

Table of Acceptance Criteria and Reported Device Performance: This document does not provide a new table of acceptance criteria or performance data for the K161636 submission because it claims the device is identical to a previously cleared predicate. Performance was presumably established during the K142682 submission process. The table provided in the document focuses on comparing the subject device (K161636 Lipogems System) to its predicate (K142682 Lipogems System) and a reference device (Ranfac FATS Procedure Pack) to establish substantial equivalence based on device characteristics and indications for use, rather than new performance metrics.

Implicit Acceptance Criterion (for Equivalence): The device (K161636) should be identical in material, functional aspects, design, manufacturing, sterilization, and packaging to the predicate device (K142682) and have similar technological characteristics and indications for use to the predicate and reference devices.

Characteristic	Predicate Device (K142682)	Subject Device (K161636)	Reference Device (K150156)	Similarity
Device Name	The Lipogems System	The Lipogems System	Ranfac Fat Aspiration Transfer Syringe (FATS) Procedure Pack	Identical to predicate, different from reference
Device Manufacturer	Lipogems International SpA	Lipogems International SpA	Ranfac Corporation	Identical to predicate, different from reference
510(k) Reference	K142682	K161636	K150156	N/A (unique to each submission)
FDA Product Code	MUU	MUU	MUU	Identical
FDA Classification Name	System, Suction, Lipoplasty	System, Suction, Lipoplasty	System, Suction, Lipoplasty	Identical
FDA Regulation Number	878.5040	878.5040	878.5040	Identical
System concept	Closed loop	Closed loop	Closed Loop	Identical
Device Size Variations	Two: LGD 60, LGD 240	Two: LGD 60, LGD 240	None	Identical to predicate, different from reference
Fill Volumes	Up to 30 or 120 ml of fat	Up to 30 or 120 ml of fat	5ml to 25ml of fat	Identical to predicate, different from reference
Construction	Preassembled	Preassembled	Preassembled	Identical
Sterility	Supplied sterile for single use	Supplied sterile for single use	Supplied sterile for single use	Identical
Sterilization method	Ethylene oxide Gas	Ethylene oxide Gas	Ethylene oxide Gas	Identical
Sterility Assurance Level (SAL)	SAL = 10-6	SAL = 10-6	SAL = 10-6	Identical to predicate
Biocompatibility	Biocompatible	Biocompatible	Biocompatible	Identical
Indications for Use / Intended Use	Similar (for processing and transfer of autologous adipose tissue in various surgical specialties)	Similar (expanded list of surgical specialties, but core function is processing and transferring autologous adipose tissue)	Similar (for harvesting, concentrating, and transferring autologous adipose tissue in various surgical specialties)	Similar (The subject device's Indications for Use language is slightly different/expanded compared to its own predicate, but still asserts overall similarity, especially compared to the Ranfac reference device for the core function of processing and transferring autologous adipose tissue.)

Sample size used for the test set and the data provenance: Not applicable to this filing. This submission relies on substantial equivalence to a previously cleared device (K142632) that is stated to be "identical in every way." Any performance testing data would have been part of the original K142632 filing.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. This document does not describe a new study requiring expert ground truth establishment for performance testing.
Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable. This document does not describe a new study or test set requiring adjudication.
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. The Lipogems System is a physical medical device for processing adipose tissue, not an AI or imaging diagnostic device.
If a standalone (i.e. algorithm only without human-in-the loop performance) was done: Not applicable. The Lipogems System is a physical medical device.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable to this filing. As this is a substantial equivalence claim for an identical device, new performance data and corresponding ground truth are not presented.
The sample size for the training set: Not applicable. This is not an AI/machine learning device.
How the ground truth for the training set was established: Not applicable. This is not an AI/machine learning device.

Summary

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

November 4, 2016

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: K161636

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 27, 2016 Received: September 30, 2016

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 (reporting of medical devicerelated 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.

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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

Binita S. Ashar, M.D., M.B.A., F.A.C.S. for 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) K161636

Device Name Lipogems System

Indications for Use (Describe)

X Prescription Use (Part 21 CFR 801 Subpart D)

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

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510(k) Summary

Device Name:	The Lipogems System
510(k) Submission:	K161636
Date of Submission:	June 11, 2016
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 Requlation 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:Reference Device:	K142682 The Lipogems System, Lipogems International, S.p.A.K150156 Ranfac FATS Procedure Pack, Ranfac Corporation

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 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 subject device is identical in every way to the predicate device previously cleared, and described in K142682, also submitted by Lipogems International, S.p.A.

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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' end-cap the processing unit;
An access port for the loading of material to be processed with a Luer-lock connection and self-● occluding valve (blue 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; ●

Item	Reference device(Ranfac)	Predicate device(Lipogems)	Subject device(Lipogems)	Similarity
Device name	Ranfac Fat AspirationTransfer Syringe (FATS)Procedure Pack	The Lipogems System	The Lipogems System	Identicaltopredicate
DeviceManufacturer	Ranfac Corporation	Lipogems InternationalSpA	Lipogems InternationalSpA	Identicaltopredicate
510(k) Reference	K150156	K142682	K161636	N/A
FDA ProductCode	MUU	MUU	MUU	Identical
FDA ClassificationName	System, Suction,Lipoplasty	System, Suction,Lipoplasty	System, Suction,Lipoplasty	Identical
FDA RegulationNumber	878.5040	878.5040	878.5040	Identical
System concept	Closed Loop	Closed loop	Closed loop	Identical
Device SizeVariations	None	Two: LGD 60, LGD 240	Two: LGD 60, LGD 240	Identicaltopredicate
Fill Volumes	5ml to 25ml of fat	Up to 30 or 120 ml of fat	Up to 30 or 120 ml of fat	Identicaltopredicate;Differentfromreference
Construction	Preassembled	Preassembled	Preassembled	Identical
Sterility	Supplied sterile for singleuse	Supplied sterile for singleuse	Supplied sterile for singleuse	Identical
Sterilizationmethod	Ethylene oxide Gas	Ethylene oxide Gas	Ethylene oxide Gas	Identical
Sterility AssuranceLevel	SAL = 10-6	SAL = 10-6	SAL = 10-6	Identicaltopredicate

Predicate and Reference device comparison table

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Predicate and Reference device comparison table
Item	Reference device(Ranfac)	Predicate device(Lipogems)	Subject device(Lipogems)	Similarity
Biocompatibility	Biocompatible	Biocompatible	Biocompatible	Identical
Indications for Use/ Intended Use	The Ranfac FATSProcedure Pack is used inmedical proceduresinvolving the harvestingand transferring ofautologous adipose tissue.The FATS Procedure Packis for concentratingadipose tissue harvestedwith a legally marketedlipoplasty system. Thedevice is intended for usein the following surgicalspecialties when theconcentration of harvestedadipose is desired:Neurosurgery,gastrointestinal surgery,urological surgery, plastic& reconstructive surgery,general surgery, orthopedicsurgery, gynecologicalsurgery, thoracic surgery,laparoscopic surgery,arthroscopic surgery.	The Lipogems System is asterile medical deviceintended for the closed-loop processing oflipoaspirate tissue for thepurpose of transferringautologous adipose tissuefor aesthetic bodycontouring (lipofilling) inapplications includingplastic and reconstructivesurgery, neurosurgery,gastrointestinal andaffiliated organ surgery,urological surgery, generalsurgery, orthopedicsurgery, gynecologicalsurgery, thoracic surgery,and laparoscopic surgery.Only legally marketedaccessory items, such assyringes, should be usedwith the system. Ifharvested fat is to bereimplanted, the harvestedfat is only to be usedwithout any additionalmanipulation.	The Lipogems System is asterile medical deviceintended for the closed-loop processing oflipoaspirate tissue inmedical proceduresinvolving the harvesting,concentrating andtransferring of autologousadipose tissue harvestedwith a legally marketedlipoplasty system. Thedevice is intended for usein the following surgicalspecialties when thetransfer of harvestedadipose tissue is desired:orthopedic surgery,arthroscopic surgery,neurosurgery,gastrointestinal andaffiliated organ surgery,urological surgery, generalsurgery, gynecologicalsurgery, thoracic surgery,laparoscopic surgery, andplastic and reconstructivesurgery when aestheticbody contouring is desired.Only legally marketedaccessory items, such assyringes, should be usedwith the system. Ifharvested fat is to betransferred, the harvestedfat is only to be usedwithout any additionalmanipulation.	Similar

Substantial Equivalence Discussion:

The Subject and Predicate device are identical in every material and functional way, as there has been no change to the device materials, design, manufacturing, sterilization, packaging or any other feature since its prior clearance under K142682.

The subject device of this submission is indicated for concentration and transfer of autologous adipose tissue. The minimally manipulated nature of such tissue in the subject device, and the reference device, is reiterated in the IFUs and form the basis of 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 devices already cleared, and that the revised language of the IFU and other labelling in this submission is appropriate.

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.