Lipogems System

K161636 · Lipogems International Spa · MUU · Nov 4, 2016 · General, Plastic Surgery

Device Facts

• Record ID: K161636
• Device Name: Lipogems System
• Applicant: Lipogems International Spa
• Product Code: MUU · General, Plastic Surgery
• Decision Date: Nov 4, 2016
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.5040
• Device Class: Class 2
• Attributes: Therapeutic

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 Story

Lipogems System is a sterile, single-use, closed-loop device for processing lipoaspirate tissue. Input: lipoaspirate tissue harvested via legally marketed lipoplasty system. Processing: tissue passes through an ABS unit containing five stainless steel spheres and two stainless steel sieve filters to concentrate and wash the adipose tissue. Output: processed autologous adipose tissue ready for transfer. Used in various surgical specialties (orthopedic, neurosurgery, plastic, etc.) by physicians. The device facilitates minimal manipulation of fat for autologous transfer. Benefits include providing a standardized, closed-loop method for preparing adipose tissue for clinical use without additional manipulation.

Clinical Evidence

No clinical data provided. Substantial equivalence is based on identical design, materials, and functional characteristics to the predicate device (K142682).

Technological Characteristics

ABS processing unit; 5 stainless steel spheres; 2 stainless steel sieve filters; Luer-lock connections; self-occluding valves. Available in 60cc and 240cc capacities. Sterilized via ethylene oxide gas (SAL 10^-6). Single-use, closed-loop system.

Indications for Use

Indicated for patients undergoing surgical procedures requiring the transfer of autologous adipose tissue, including orthopedic, arthroscopic, neurosurgical, gastrointestinal, urological, general, gynecological, thoracic, laparoscopic, and plastic/reconstructive surgeries. Contraindicated for use with non-legally marketed accessories or if additional manipulation of harvested fat is required.

Regulatory Classification

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 of 1/3 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.

Special Controls

*Classification.* Class II (special controls). Consensus standards and labeling restrictions.

Predicate Devices

• The Lipogems System (K142682)

Reference Devices

• Ranfac FATS Procedure Pack (K150156)

Submission Summary (Full Text)

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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 [phone] or [phone] 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 [phone] or [phone] 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)

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.

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.<br>Viale Bianca Maria 24<br>20129 Milano (MI) Italy<br>Phone: [phone]<br>Fax: [phone] |
| 510(k) Submitter and Contact: | Scott Bruder, MD, PhD<br>Principal<br>Bruder Consulting International, LLC<br>268 Glen Place<br>Franklin Lakes, NJ 07417<br>Phone: [phone]<br>Email: [e-mail] |
| 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:<br>Reference Device: | K142682 The Lipogems System, Lipogems International, S.p.A.<br>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<br>(Ranfac) | Predicate device<br>(Lipogems) | Subject device<br>(Lipogems) | Similarity |
|------------------------------|--------------------------------------------------------------------|------------------------------------|------------------------------------|-----------------------------------------------------------------|
| Device name | Ranfac Fat Aspiration<br>Transfer Syringe (FATS)<br>Procedure Pack | The Lipogems System | The Lipogems System | Identical<br>to<br>predicate |
| Device<br>Manufacturer | Ranfac Corporation | Lipogems International<br>SpA | Lipogems International<br>SpA | Identical<br>to<br>predicate |
| 510(k) Reference | K150156 | K142682 | K161636 | N/A |
| FDA Product<br>Code | MUU | MUU | MUU | Identical |
| FDA Classification<br>Name | System, Suction,<br>Lipoplasty | System, Suction,<br>Lipoplasty | System, Suction,<br>Lipoplasty | Identical |
| FDA Regulation<br>Number | 878.5040 | 878.5040 | 878.5040 | Identical |
| System concept | Closed Loop | Closed loop | Closed loop | Identical |
| Device Size<br>Variations | None | Two: LGD 60, LGD 240 | Two: LGD 60, LGD 240 | Identical<br>to<br>predicate |
| Fill Volumes | 5ml to 25ml of fat | Up to 30 or 120 ml of fat | Up to 30 or 120 ml of fat | Identical<br>to<br>predicate;<br>Different<br>from<br>reference |
| Construction | Preassembled | Preassembled | Preassembled | Identical |
| Sterility | Supplied sterile for single<br>use | Supplied sterile for single<br>use | Supplied sterile for single<br>use | Identical |
| Sterilization<br>method | Ethylene oxide Gas | Ethylene oxide Gas | Ethylene oxide Gas | Identical |
| Sterility Assurance<br>Level | SAL = 10-6 | SAL = 10-6 | SAL = 10-6 | Identical<br>to<br>predicate |

#### Predicate and Reference device comparison table

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| Predicate and Reference device comparison table | | | | |
|-------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------|
| Item | Reference device<br>(Ranfac) | Predicate device<br>(Lipogems) | Subject device<br>(Lipogems) | Similarity |
| Biocompatibility | Biocompatible | Biocompatible | Biocompatible | Identical |
| Indications for Use<br>/ Intended Use | The Ranfac FATS<br>Procedure Pack is used in<br>medical procedures<br>involving the harvesting<br>and transferring of<br>autologous adipose tissue.<br>The FATS Procedure Pack<br>is for concentrating<br>adipose tissue harvested<br>with a legally marketed<br>lipoplasty system. The<br>device is intended for use<br>in the following surgical<br>specialties when the<br>concentration of harvested<br>adipose is desired:<br>Neurosurgery,<br>gastrointestinal surgery,<br>urological surgery, plastic<br>& reconstructive surgery,<br>general surgery, orthopedic<br>surgery, gynecological<br>surgery, thoracic surgery,<br>laparoscopic surgery,<br>arthroscopic surgery. | The Lipogems System is a<br>sterile medical device<br>intended for the closed-<br>loop processing of<br>lipoaspirate tissue for the<br>purpose of transferring<br>autologous adipose tissue<br>for aesthetic body<br>contouring (lipofilling) in<br>applications including<br>plastic and reconstructive<br>surgery, neurosurgery,<br>gastrointestinal and<br>affiliated organ surgery,<br>urological surgery, general<br>surgery, orthopedic<br>surgery, gynecological<br>surgery, thoracic surgery,<br>and laparoscopic surgery.<br>Only legally marketed<br>accessory items, such as<br>syringes, should be used<br>with the system. If<br>harvested fat is to be<br>reimplanted, the harvested<br>fat is only to be used<br>without any additional<br>manipulation. | The Lipogems System is a<br>sterile medical device<br>intended for the closed-<br>loop processing of<br>lipoaspirate tissue in<br>medical procedures<br>involving the harvesting,<br>concentrating and<br>transferring of autologous<br>adipose tissue harvested<br>with a legally marketed<br>lipoplasty system. The<br>device is intended for use<br>in the following surgical<br>specialties when the<br>transfer of harvested<br>adipose tissue is desired:<br>orthopedic surgery,<br>arthroscopic surgery,<br>neurosurgery,<br>gastrointestinal and<br>affiliated organ surgery,<br>urological surgery, general<br>surgery, gynecological<br>surgery, thoracic surgery,<br>laparoscopic surgery, and<br>plastic and reconstructive<br>surgery when aesthetic<br>body contouring is desired.<br>Only legally marketed<br>accessory items, such as<br>syringes, should be used<br>with the system. If<br>harvested fat is to be<br>transferred, the harvested<br>fat is only to be used<br>without any additional<br>manipulation. | 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.