The Lipogems System

{0}------------------------------------------------ Image /page/0/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 border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, stacked on top of each other, creating a sense of depth and unity. 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 {1}------------------------------------------------ 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 {2}------------------------------------------------ # 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) This section applies only to requirements of the Paperwork Reduction Act of 1995. ### *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.* The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to: > Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov "An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number." {3}------------------------------------------------ # 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.<br>Viale Bianca Maria 24<br>20129 Milano (MI)<br>Italy | | 510(k) Owner: | Lipogems International S.p.A.<br>Viale Bianca Maria 24<br>20129 Milano (MI)<br>Italy | | Phone:<br>Fax: | +39 02 3707 2408/9<br>+39 02 3707 2410 | | 510(k) Submitter and Contact: | Mr Roger Gray<br>VP Quality and Regulatory<br>Donawa Lifescience Consulting<br>Piazza Albania 10<br>00153 Rome<br>Italy<br><br>Phone: +39 06 578 2665<br>Fax: +30 06 574 3786<br>Email: 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 aesthetic<br>body contouring. The device consists of a powered suction pump<br>(containing a microbial filter on the exhaust and a microbial in-<br>line filter in the connecting tubing between the collection bottle<br>and the safety trap), collection bottle, cannula, and connecting<br>tube. The microbial filters, tubing, collection bottle, and cannula<br>must be capable of being changed between patients. The<br>powered suction pump has a motor with a minimum of 1/3<br>horsepower, a variable vacuum range from 0 to 29.9 inches of<br>mercury, vacuum control valves to regulate the vacuum with<br>accompanying vacuum gauges, a single or double rotary vane<br>(with or without oil), a single or double diaphragm, a single or<br>double piston, and a safety trap. | {4}------------------------------------------------ # Indications for Use/Intended Use: 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. - 2. 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 {5}------------------------------------------------ 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. - 3. 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 /<br>Intended Use | The GID 700 is used for aspiration,<br>harvesting, filtering, and transferring<br>of autologous adipose tissue for<br>aesthetic body contouring. The<br>system should be used with a<br>legally marketed vacuum or<br>aspirator apparatus as a source of<br>suction. If harvested fat is to be<br>reimplanted, the harvested fat is<br>only to be used without any<br>additional manipulation.<br>The GID 700 is intended for use in<br>the following surgical specialties<br>when aspiration of soft tissue is<br>desired: plastic and reconstructive<br>surgery, neurosurgery,<br>gastrointestinal and affiliated organ<br>surgery, urological surgery, general<br>surgery, orthopedic surgery,<br>gynecological surgery, thoracic<br>surgery, and laparoscopic surgery. | The Lipogems System is a sterile<br>medical device intended for the<br>closed-loop processing of<br>lipoaspirate tissue for the purpose of<br>transferring autologous adipose<br>tissue for aesthetic body contouring<br>(lipofilling) in applications including<br>plastic and reconstructive surgery,<br>neurosurgery, gastrointestinal and<br>affiliated organ surgery, urological<br>surgery, general surgery, orthopedic<br>surgery, gynecological surgery,<br>thoracic surgery, and laparoscopic<br>surgery. Only legally marketed<br>accessory items, such as syringes,<br>should be used with the system. If<br>harvested fat is to be reimplanted,<br>the harvested fat is only to be used<br>without 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: {6}------------------------------------------------ | 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 mechanism<br>comprising 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,<br>extraction | Similar | | Tissue washing media | Lactated Ringers Solution | Physiological saline | Different | | Mesh sizes | 200 micron mesh to allow<br>separation of waste products from<br>adipose tissue - tissue does not<br>pass through mesh | LGD 240 and LGD 60: 2000 micron<br>mesh at inlet and 1000 micron mesh<br>at outlet - collected adipose tissue<br>passes 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 {7}------------------------------------------------ - . 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.