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  4. Consolidation of Devices That Process Autologous Human Cells, Tissues, and Cellular and Tissue-Based Devices at the Point of Care To Produce a Therapeutic Article
  1. Development & Approval Process (CBER)

Consolidation of Devices That Process Autologous Human Cells, Tissues, and Cellular and Tissue-Based Devices at the Point of Care To Produce a Therapeutic Article

On September 13, 2021, fat transfer devices with product code MUU that process adipose tissue for return to the body for the purpose of aesthetic body contouring were transferred from CDRH to CBER for regulation. This transfer is part of an effort to consolidate regulatory oversight responsibilities in CBER for devices that process autologous human cells, tissues, and cellular and tissue-based products (HCT/Ps) at the point of care to produce a therapeutic article.

As a result of this transfer, these devices were assigned new 510(k) numbers. Additionally, CBER created two new product codes under the existing suction lipoplasty system regulation (21 CFR 878.5040) to better distinguish between suction lipoplasty system technologies/functions:

QKL, Lipoaspirate processing system for aesthetic body contouring
Definition: Wash, filter, concentrate, and/or fragment autologous adipose tissue aspirated via liposuction for aesthetic body contouring without further manipulation.
Physical State: May include tubes, filter, sieve, canister, centrifuge, non-enzymatic wash solution. The system should be used with a legally-marketed vacuum or aspirator apparatus as a source of suction.  Should not use enzymatic digestion or cell selection.
Technical Method: Aspirated fat is washed, cleansed, rinsed, filtered, centrifuged, and/or fragmented without further manipulation such as cell selection or enzymatic digestion.
Target Area: Aesthetic body contouring of soft tissues.

QUB, Suction Lipoplasty System for Removal and Transfer
Definition: Removal and transfer/reimplantation of autologous adipose tissue without further manipulation for aesthetic body contouring.
Physical State: May include powered suction pump system, tubes, canisters, cannulas, syringes.
Technical Method: Removal and transfer/reimplantation of autologous adipose tissue without further manipulation for aesthetic body contouring.
Target Area: Aesthetic body contouring of soft tissues.

The transferred MUU devices were reassigned to these new product codes, and the new product codes will be used for new devices regulated by CBER that are intended to process adipose tissue for return to the body for the purpose of aesthetic body contouring. Suction lipoplasty systems regulated by CBER will no longer be assigned the MUU product code.

The transferred devices are listed in the table below with their corresponding new CBER 510(k) number and product code(s). The list of new CBER 510(k) numbers also include links to supporting documents (e.g., administrative letter, original clearance letter, indications for use, 510(k) summary, etc.). The 510(k) holders for the transferred devices were informed of their new CBER 510(k) numbers and new product codes via letter. Submissions, communications, and required reports for these devices should be directed to CBER.

Applicants citing any of the transferred devices below as a predicate(s) when submitting a new 510(k) premarket notification for a product intended to process adipose tissue for return to the body for the purpose of aesthetic body contouring should refer to the CBER 510(k) number listed below.

Former CDRH 510(k) Number Applicant Device Name Decision Date New CBER 510(k) Number New Product Code(s)
K072587 CYTORI THERAPEUTICS INC. CYTORI AFT SYSTEM 12/10/2007 BK220684 QKL, QUB
K081848 LIPOSE CORP. LIPOSE FAT TRANSFER SYSTEM 12/4/2008 BK220685 QKL
K083455 MEDI-KHAN USA INC LIPOKIT WITH DISPOSABLE 50CC AFT SYRINGE MODEL ZLK-100 5/18/2009 BK220686 QKL, QUB
K092284 MEDICAL DEVICE RESOURCE CORP. LIPISYSTEMS AQUAVAGE MODELS AV2000 AND AV1200 9/1/2009 BK220687 QKL
K092482 SHIPPERT MEDICAL TECHNOLOGIES CORP. TISSU TRANS FILTRON MODELS 3-TT-FILTRON 2000-500 12/4/2009 BK220688 QKL
K092923 CYTORI THERAPEUTICS INC. CYTORI PUREGRAFT 250/PURE SYSTEM 1/6/2010 BK220689 QKL
K100114 BIOMET INC. FAT CONCENTRATION SYSTEM 9/29/2010 BK220690 QKL
K101713 HUMAN MED AG LIPCOLLECTOR II 6/29/2010 BK220691 QKL
K102117 SHIPPERT MEDICAL TECHNOLOGIES CORP. TISSU TRANS FILTRON SYRINGE FILL 8/6/2010 BK220692 QKL
K113255 CYTORI THERAPEUTICS INC. PUREGRAFT 850/PURE SYSTEM 3/7/2012 BK220693 QKL
K120328 SOUND SURGICAL TECHNOLOGIES LLC. ORIGINS LIPOHARVESTING SYSTEM 9/17/2012 BK220694 QKL
K120902 THE GID GROUP INC. GID 700 8/15/2012 BK220695 QKL
K121005 HARVEST TECHNOLOGIES CORP. ADIPREP ADIPOSE TRANSFER SYSTEM 9/21/2012 BK220696 QKL, QUB
K121703 MEDI-KHAN USA INC LIPOKIT WITH DISPOSABLE 50CC AFT SYRINGE 12/7/2012 BK220697 QKL, QUB
K130152 ANDREW TECHNOLOGIES LLC HYDRASOLVE LIPOPLASTY SYSTEM 4/18/2013 BK220698 QKL, QUB
K132815 CYTORI THERAPEUTICS INC. PUREGRAFT 50 SYSTEM 1/24/2014 BK220699 QKL
K141591 INGENERON INC. SMARTGRAFT 30 SYSTEM 9/24/2014 BK220700 QKL
K141713 INGENERON INC. SMARTGRAFT 200 SYSTEM 10/28/2014 BK220701 QKL
K142073 THIEBAUD SAS ST'RIM 4/29/2015 BK220702 QUB
K142682 Lipogems International SpA The Lipogems System 12/22/2014 BK220703 QKL
K150156 Ranfac Corp Ranfac Fat Aspiration Transfer Syringe (FATS) Procedure Pack
Ranfac Fat Aspiration Transfer Syringe (FATS) Containment Vessel
10/19/2015 BK220704 QKL
K150779 MICROAIRE SURGICAL INSTRUMENTS LLC LipoFilter - Hospital Pack
LipoFilter - Clinic Pack
5/22/2015 BK220705 QKL
K161372 MIAMI FAT SUPPLY The Red Head Collection Device
The Jordy Connection System
2/24/2017 BK220706 QKL
K161636 Lipogems International SpA Lipogems System 11/4/2016 BK220707 QKL
K162932 RANFAC CORP. Ranfac Fat Aspiration Cannula 1/19/2017 BK220708 QUB
K163647 LifeCell Corporation Revolve Envi 600 Advanced Adipose System 8/25/2017 BK220709 QKL
K170449 Millennium Medical Technologies Inc. Autoclavable Suction Jar with Luer Lock extension - 250 500 1000 2000 and 3000 ml
Autoclavable Suction Jar without Luer Lock extension - 1500 and 2500 ml
Sterile 1500 and 2500 Lids with Conical patient connection 6-10 and overflow protection
3/31/2017 BK220711 QKL
K171135 Lipogems International SpA Lipogems System 5/18/2017 BK220712 QKL
K171242 Alma Lasers Inc. Alma LipoFlow System 7/14/2017 BK220713 QKL
K172714 Genesis Biosystems Inc. LipiVage 12/8/2017 BK220714 QKL
K172717 BSL Co. Automatic Tissue Processing Unit 5/25/2018 BK220715 QKL
K182732 Jointechlabs, Inc. Jtl-250-01 11/18/2019 BK220716 QKL
K190278 AuraGen Aesthetics LLC AuraGen 123 Suction Lipoplasty System (A123) 5/3/2019 BK220717 QKL
K190386 Stemics S.A.S. KTA Adipose Treatment Kit 10/10/2019 BK220718 QKL, QUB
K191564 Emcyte Corporation Progenikine Concentrating Sytem 25 M System 11/7/2019 BK220719 QKL
K193363 Puregraft LLC Dermapose Refresh 4/14/2020 BK220720 QKL
K193539 LifeCell Corporation REVOLVE ENVI 600 Advanced Adipose System 5/28/2020 BK220721 QKL
K202443 BSL Co., Ltd Smart Kit Basic, Smart Kit Pro 3/11/2021 BK220722 QKL
K203800 Syntr Health Technologies, Inc. Syntrfuge System 7/2/2021 BK220723 QKL
K210528 Millennium Medical Technologies Inc (DBA Cellmyx) IntelliFat Disposable Adipose Tissue Harvesting and Transfer Kit, IntelliFat Body On Demand (BOD) Kit 3/16/2022 BK220726 QKL, QUB

Submissions for these devices should be sent to CBER's document control room in accordance with the CBER Regulatory Submissions - Electronic and Paper website.

For additional information regarding this transfer, please contact CBER Office of Communication, Outreach and Development (OCOD):

Division of Communication and Consumer Affairs
Office of Communication, Outreach and Development
Center for Biologics Evaluation and Research
Food and Drug Administration
10903 New Hampshire Ave WO71-3103
Silver Spring, MD 20993-0002
ocod@fda.hhs.gov
(800) 835-4709
(240) 402-8010

Suction lipoplasty devices solely intended to remove fat for discard for the purpose of body contouring remain under CDRH regulation and have been assigned a new product code, QPB. Submissions, communications, and required reports for QPB devices should continue to be directed to CDRH.

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