(91 days)
Not Found
No
The device description and performance studies focus on mechanical filtration and tissue viability, with no mention of AI or ML algorithms for analysis, processing, or decision-making.
Yes
The device is used for aspirating, harvesting, filtering, and transferring autologous adipose tissue for aesthetic body contouring and re-implantation, indicating a therapeutic purpose.
No
The description states that the device is used for aspiration, harvesting, filtering, and transferring autologous adipose tissue for aesthetic body contouring. It does not mention any function related to diagnosing a condition or disease.
No
The device description clearly describes a physical medical device (syringe with filter) used for harvesting and filtering adipose tissue. There is no mention of software as a component or the primary function of the device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use of LipiVage® is for the aspiration, harvesting, filtering, and transferring of autologous adipose tissue for aesthetic body contouring. This is a surgical procedure involving the manipulation of tissue within the body, not the examination of samples in vitro (outside the body) to diagnose a condition.
- Device Description: The device description details a syringe with a filter designed to collect and process fat tissue for re-implantation. This aligns with a surgical tool, not a diagnostic test.
- Lack of Diagnostic Purpose: There is no mention of the device being used to analyze biological samples (like blood, urine, or tissue) to provide information about a patient's health status, disease, or condition.
- Focus on Tissue Handling: The entire description revolves around the physical handling and processing of adipose tissue for therapeutic purposes (body contouring).
IVD devices are specifically designed to perform tests on samples taken from the human body to provide information for diagnostic, monitoring, or screening purposes. LipiVage® does not fit this description.
N/A
Intended Use / Indications for Use
LipiVage® is used for aspiration, harvesting, filtering, and transferring of autologous adipose tissue for aesthetic body contouring. The system should be used with a legally marketed vacuum or aspirator apparatus as a source of suction. If harvested fat is to be re-implanted, the harvested fat is only to be used without any additional manipulation.
LipiVage® is intended for use in the following surgical specialties when aspiration of soft tissue is desired: plastic and reconstructive surgery, neurosurgery, gastrointestinal and affiliated organ surgery, general surgery, orthopedic surgery, gynecological surgery, thoracic surgery, and laparoscopic surgery.
Product codes (comma separated list FDA assigned to the subject device)
MUU
Device Description
LipiVage® is a 60cc hollow barrel harvesting syringe with plunger and an in-line polyester filter that is intended to receive, concentrate and filter autologous adipose tissue from lipoplasty procedures, for reimplantation of the extracted tissue back into the same patient at other anatomical locations in their body using a piston syringe and injection cannula. At one end of the LipiVage® harvesting syringe there is a male connector (nozzle) for fitting the female connector (hub) of a cannula for the harvesting of fat cells, while at the other end of the device there is a universal tubing connection to attach to a tubing set (not supplied by Genesis) that is connected to a controlled vacuum source, such as an aspirator or wall suction in the user facility. The LipiVage® harvesting syringe incorporates an in-line filter so there is no need to centrifuge, decant or expose fat cells to unnecessary handling. The device is for professional use only, made from medical grade polymers, single use, and provided sterile to the user.
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
professional use only
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)
Non-Clinical Performance Data: Genesis Biosystems has submitted LipiVage® and its packaging system for the appropriate biocompatibility testing per ISO 10993-1 and its applicable parts, sterilization per ISO 11137, accelerated aging per ASTM F1980, and performance testing per ISO 80369-1/-7. Adipose viability testing demonstrated that fat tissue viability was maintained. The subject device meets all internal Genesis Biosystems specification requirements to support substantial equivalence to the predicate device.
Clinical Performance Data: The performance and use of Suction Lipoplasty Systems classified under product code MUU and regulated within CFR 878.5040 has been well established in the clinical environment since the first such devices were cleared by the FDA. Therefore, there was no clinical testing required to support LipiVage®, as the indications for use is equivalent to the predicate device, which was not subjected to any clinical testing. The substantial equivalence of LipiVage® to the GID 700™ is supported by the non-clinical testing that was performed, along with other supporting documentation, and presented in this submission.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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.
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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
December 8, 2017
Genesis Biosystems, Incorporated % Mr. Stuart R. Goldman Senior Consultant, Regulatory Emergo Global Consulting, LLC 2500 Bee Cave Road, Building 1, Suite 300 Austin. Texas 78746
Re: K172714
Trade/Device Name: LipiVage® Regulation Number: 21 CFR 878.5040 Regulation Name: Suction Lipoplasty System Regulatory Class: Class II Product Code: MUU Dated: August 24, 2017 Received: September 8, 2017
Dear Mr. Goldman:
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
1
the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
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) K172714
Device Name LipiVage®
Indications for Use (Describe)
LipiVage® is used for aspiration, harvesting, filtering, and transferring of autologous adipose tissue for aesthetic body contouring. The system should be used with a legally marketed vacuum or aspirator apparatus as a source of suction. If harvested fat is to be re-implanted. the harvested fat is only to be used without any additional manipulation.
LipiVage® is intended for use in the following surgical specialties when aspiration of soft tissue is desired: plastic and reconstructive surgery, neurosurgery, gastrointestinal and affiliated organ surgery, general surgery, orthopedic surgery, gynecological surgery, thoracic surgery, and laparoscopic surgery.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| ------------------------------------------------- | -- |
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
LipiVage®
к 172714
Submission Sponsor 5.1
Genesis Biosystems, Inc.
1500 Eagle Court
Lewisville, TX 75057
Phone Number: 972.315.7888
Contact: Jim Lafferty
Email: JLafferty@genesisbiosystems.com>
5.2 Submission Correspondent
Emergo Global Consulting, LLC
2500 Bee Cave Road, Bldg. 1, Suite 300
Austin, TX 78746
Office Phone: 512.327.9997
Contact: Stuart R. Goldman, Senior Consultant, RA/QA
Email: project.management@emergogroup.com
5.3 Date Prepared
August 24, 2017
Device Identification 5.4
Trade/Proprietary Name: LipiVage® Common/Usual Name: Harvesting syringe Classification Name: Suction lipoplasty system Regulation Number: MUU Product Code: 878.5040 Device Class: Class II Classification Panel: General & Plastic Surgery
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Legally Marketed Predicate Device 5.5
GID 700™ (K120902)
5.6 Device Description
LipiVage® is a 60cc hollow barrel harvesting syringe with plunger and an in-line polyester filter that is intended to receive, concentrate and filter autologous adipose tissue from lipoplasty procedures, for reimplantation of the extracted tissue back into the same patient at other anatomical locations in their body using a piston syringe and injection cannula. At one end of the LipiVage® harvesting syringe there is a male connector (nozzle) for fitting the female connector (hub) of a cannula for the harvesting of fat cells, while at the other end of the device there is a universal tubing connection to attach to a tubing set (not supplied by Genesis) that is connected to a controlled vacuum source, such as an aspirator or wall suction in the user facility. The LipiVage® harvesting syringe incorporates an in-line filter so there is no need to centrifuge, decant or expose fat cells to unnecessary handling. The device is for professional use only, made from medical grade polymers, single use, and provided sterile to the user.
5.7 Indication for Use
LipiVage® is used for aspiration, harvesting, filtering, and transferring of autologous adipose tissue for aesthetic body contouring. The system should be used with a legally marketed vacuum or aspirator apparatus as a source of suction. If harvested fat is to be re-implanted, the harvested fat is only to be used without any additional manipulation.
LipiVage® is intended for use in the following surgical specialties when aspiration of soft tissue is desired: plastic and reconstructive surgery, neurosurgery, gastrointestinal and affiliated organ surgery, urological surgery, general surgery, orthopedic surgery, gynecological surgery, and laparoscopic surgery.
5.8 Substantial Equivalence Discussion
Genesis Biosystems has chosen the GID 700™ harvesting canister system as the predicate device for its LipiVage® harvesting syringe. The GID 700™ was cleared by the FDA under K120902. The following table compares the subject device to the predicate device with respect to their indications for use, technology and performance testing, thus demonstrating the basis for determination of substantial equivalence between these devices.
| Regulatory Information | |||
|---|---|---|---|
| Device Name | LipiVage® | GID 700™ | Similarities/Differences |
| Manufacturer | Genesis Biosystems | Gid Group | NA |
| 510(k) | Pending | K120902 | NA |
| Product Code | MUU | MUU | Same |
| Regulation | §878.5040 | §872.5040 | Same |
| Class | II | II | Same |
| Indications for Use | LipiVage® is used for aspiration, harvesting, filtering, and transferring of autologous adipose tissue for aesthetic body contouring. The system should be used with a legally marketed vacuum or aspirator apparatus as a source of suction. If harvested fat is to be re-implanted, the harvested fat is only to be used without any additional manipulation. |
The LipiVage® is intended for use in the following surgical specialties when aspiration of soft tissue is desired: plastic and reconstructive surgery, neurosurgery, gastrointestinal and affiliated organ surgery, urological surgery, general surgery, orthopedic surgery, gynecological surgery, thoracic surgery, and laparoscopic surgery. | The GID 700™ is used for aspiration, harvesting, filtering, and transferring of autologous adipose tissue for aesthetic body contouring. The system should be used with a legally marketed vacuum or aspirator apparatus as a source of suction. If harvested fat is to be re-implanted, the harvested fat is only to be used without any additional manipulation.
The GID 700™ is intended for use in the following surgical specialties when aspiration of soft tissue is desired: plastic and reconstructive surgery, neurosurgery, gastrointestinal and affiliated organ surgery, urological surgery, general surgery, orthopedic surgery, gynecological surgery, thoracic surgery, and laparoscopic surgery. | Same |
| Prescription use | Yes | Yes | Same |
| Fundamental Scientific Technology | | | |
| System Concept | Closed loop | Closed loop | Same |
| Source of Energy | User supplied vacuum. | User supplied vacuum. | Same |
| Device Size
(fill volume) | Syringe: 60 cc | Canister: 700 ml | The differences in the size of the subject and predicate devices are a function of their overall differences in design geometries (syringe vs. canister), and not considered to have any significant difference in the overall quality of the |
| | | | harvested fat. |
| Device Materials | Syringe: Molded, polycarbonate
- Plunger Tip: Polyolefin
- O-Rings: Silicone | Canister: Polymer (unknown) | The subject and predicate
device are made of similar
medical grade polymer
materials. |
| Device Filter | Image: Estene Polyester thread | Image: Similar woven fabric material | The subject device uses
Estene® Polyester thread
(natural color) for its woven
filter fabric with a calculated
mesh opening of 180 μm,
while the predicate device
uses a similar woven fabric
material with a reported
mesh opening of 200 μm. |
| | Estene® Polyester thread (natural
color) woven filter fabric with a
calculated mesh opening of
180 μm | Similar woven fabric material
with a reported mesh opening
of 200 µm | |
| Provided Sterile | Yes (gamma radiation) | Yes (gamma radiation) | Same |
| Single Patient
Use | Yes | Yes | Same |
| Implantable | No | No | Same |
| | | Relevant Testing Performed | |
| Biocompatibility
Testing | Per ISO 10993-1: - Part 5 Cytotoxicity
- Part 10 Intracutaneous
Reactivity - Part 10 Irritation-Sensitization
- Part 11 Systemic Toxicity
- Part 11 Pyrogenicity | ISO 10993-1 | Same |
| Device
Sterilization | ISO 11137-1,-2 | ISO 11137 | Same |
| Device Packaging
and Shelf-Life | ASTM F1980
ASTM F1140-07
ASTM F1929-15 | Not known. | Device packaging and shelf
have been validated for the
subject device in accordance
with the referenced
ASTM standards. |
| Device
Performance
Testing | ISO 80369-1
ISO 80369-7
ISO 80369-20 | Implosion
Tubing Connection
Tensile Strength
Mechanical Plugging | |
| Animal Testing | NA | NA | Same |
| Clinical Testing | NA | NA | Same |
| Risk Analysis | ISO 14971 | Not Known. | An appropriate Risk Analysis |
| | | | has been performed on the |
| | | | subject device. |
Table 5-1 – Device Comparison: LipiVage® vs. GID 700™
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Non-Clinical Performance Data 5.9
Genesis Biosystems has submitted LipiVage® and its packaging system for the appropriate biocompatibility testing per ISO 10993-1 and its applicable parts, sterilization per ISO 11137, accelerated aging per ASTM F1980, and performance testing per ISO 80369-1/-7. Adipose viability testing demonstrated that fat tissue viability was maintained. The subject device meets all internal Genesis Biosystems specification requirements to support substantial equivalence to the predicate device.
5.10 Clinical Performance Data
The performance and use of Suction Lipoplasty Systems classified under product code MUU and regulated within CFR 878.5040 has been well established in the clinical environment since the first such devices were cleared by the FDA. Therefore, there was no clinical testing required to support LipiVage®, as the indications for use is equivalent to the predicate device, which was not subjected to any clinical testing. The substantial equivalence of LipiVage® to the GID 700™ is supported by the non-clinical testing that was performed, along with other supporting documentation, and presented in this submission.
5.11 Statement of Substantial Equivalence
By definition, a device is substantially equivalent to a predicate device has the same intended use and the same technological characteristics as the previously cleared device, or has the same intended use and different technological characteristics, but it can be demonstrated that the new device is substantially equivalent to the predicate device, and that the new device does not raise any questions regarding its safety and effectiveness when compared to the predicate device.
LipiVage® has the same intended use and indications for use as the predicate device. The conclusions drawn from the data included in this submission, demonstrate that LipiVage® is as safe, as effective, and are substantially equivalent to the predicate device in intended use, indications for use, technological characteristics, mode of operation, mechanical performance, materials, biocompatibility and is therefore substantially equivalent to the GID 700™.