(31 days)
Not Found
No
The device description and intended use focus on a mechanical system for processing adipose tissue and do not mention any computational or data-driven components indicative of AI/ML.
No
The device is described as a "sterile medical device intended for the closed-loop processing of lipoaspirate tissue" and is used in a variety of surgical specialties for "harvesting, concentrating and transferring of autologous adipose tissue." It does not directly provide therapy but rather processes tissue for use in therapeutic procedures.
No
The Lipogems System is described as a sterile medical device intended for the processing of lipoaspirate tissue (harvesting, concentrating, and transferring) for use in various surgical specialties. Its function is to process tissue, not to diagnose conditions.
No
The device description explicitly lists multiple physical components made of ABS and stainless steel, indicating it is a hardware-based medical device for processing tissue.
Based on the provided information, the Lipogems System is not an In Vitro Diagnostic (IVD) device.
Here's why:
- Intended Use: The intended use clearly states that the device is for the "closed-loop processing of lipoaspirate tissue in medical procedures involving the harvesting, concentrating and transferring of autologous adipose tissue". This describes a process performed on the patient's tissue for therapeutic or reconstructive purposes, not for diagnostic testing of the tissue or patient sample.
- Device Description: The device description details a system for processing tissue (containing spheres and filters), not for analyzing biological samples to provide diagnostic information.
- Lack of Diagnostic Elements: There is no mention of the device being used to analyze blood, urine, tissue samples, or any other biological material to determine the presence of a disease, condition, or to provide diagnostic information.
- Focus on Tissue Processing and Transfer: The entire description revolves around the physical processing and transfer of adipose tissue.
IVD devices are specifically designed to perform tests on samples taken from the human body to provide information for the diagnosis, monitoring, or treatment of diseases or conditions. The Lipogems System does not fit this definition. It is a device used in surgical procedures for tissue manipulation and transfer.
N/A
Intended Use / Indications for 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.
Product codes
MUU
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;
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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)
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.
0
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
1
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
2
Indications for Use
510(k) Number (if known)
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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3
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 24 | |
| 20129 Milano (MI) Italy | |
| Phone: +39 02 3707 2408/9 | |
| Fax: +39 02 3707 2410 | |
| 510(k) Submitter and Contact: | Scott Bruder, MD, PhD |
| Principal | |
| Bruder Consulting International, LLC | |
| 268 Glen Place | |
| Franklin Lakes, NJ 07417 | |
| Phone: 201.874.9701 | |
| Email: 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; .
4
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 |
5
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 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. | 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. | 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)
6
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.