BK220668 · Alma Lasers, Inc. · QKL · Jun 12, 2023 · General, Plastic Surgery
Device Facts
Record ID
BK220668
Device Name
VorFat System
Applicant
Alma Lasers, Inc.
Product Code
QKL · General, Plastic Surgery
Decision Date
Jun 12, 2023
Decision
SESE
Regulation
21 CFR 878.5040
Device Class
Class 2
Attributes
Therapeutic
Indications for Use
The VorFat System is 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 for aesthetic body contouring 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. Only legally marketed accessory items, such as syringes, should be used with the system. Any fat concentrated with this system is to be transferred back to the patient without any additional manipulation.
Device Story
Closed-loop system for processing lipoaspirate; includes canister with filter and vortex mixer. Input: lipoaspirate harvested via legally marketed lipoplasty system. Operation: tissue enters collection canister; vortex mixer applies mechanical action to reduce fat cluster sizes; process preserves cell viability and tissue micro-architecture. Output: micronized fraction of adipose tissue transferred to syringes for autologous re-injection. Used in clinical/surgical settings by physicians. Benefits: provides homogenous, micronized adipose tissue for autologous transfer within operative procedure time.
Clinical Evidence
Bench testing only. Evaluated tissue cluster size (mm²), cell viability, and red blood cell content. Results demonstrated suitable characteristics for intended use and equivalence to predicate.
Technological Characteristics
Closed-loop system; 100mL canister filter; vortex mixer with sterile cover sleeve. Mechanical processing principle; no non-manual energy used for fragmentation. Canister is sterile (SAL 10^-6); mixer is multi-use with single-use sterile cover.
Indications for Use
Indicated for patients undergoing surgical procedures requiring autologous adipose tissue transfer for aesthetic body contouring across various specialties including orthopedic, arthroscopic, neurosurgery, gastrointestinal, urological, general, gynecological, thoracic, laparoscopic, and plastic/reconstructive surgery.
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.
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# 510(k) Summary
## I. SUBMITTER
Owner/Submitter: Alma Lasers, Inc.
485 Half Day Rd Suite # 100
Buffalo Grove, Illinois, 60089Phone: 224-377-2019Contact Person: Jessica Rivera-MontejoDate Prepared: May 5, 2023
## II. DEVICE
Name of Device: VorFat System
Common or Usual Name: Lipoaspirate Washing System For Aesthetic Body Contouring
Classification Name: Suction Lipoplasty System
Regulation Number: 21 CFR 878.5040
Regulatory Class: Class II
Product Code: QKL
Classification Panel: General and Plastic Surgery
## III. PREDICATE DEVICE
Primary: The Lipogems System, K171135 / BK220712
## IV. DEVICE DESCRIPTION
The canister with filter (fat canister) of the VorFat System is a closed loop tissue collection system that includes a vacuum port, collection port, tissue port and lid. The canister with filter was previously cleared in K092482. It is used with legally marketed lipoplasty systems to separate, filter, and microfragment adipose tissue for re-injection. As the tissue is harvested from the patient, it enters the collection canister via the collection port in the canister lid. The vacuum port is connected to the standard waste canister, which is connected between the device and the legally marketed lipoplasty system. During harvest, waste is filtered out to the waste canister. After harvest, the collection canister is secured in the adapter attached to the mixer. The mixer applies a mechanical action to the tissue in the collection canister that allows for reduction of the fat cluster sizes. This gentle processing diminishes tissue damage, thereby preserving the cell viability and tissue micro-architecture of the adipose tissue. The product is a micronized fraction of fatty tissue that can be transferred to syringes via the tissue port for autologous fat re-injection. The canister filter is offered in a 100mL size.
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The subject device VorFat System includes a canister, vortex mixer with canister adapter, and sterile cover for the mixer. The mechanical action of the Subject Device mixer produces a micronized fraction of the adipose tissue, and this technological characteristic is comparable to the predicate device K171135/BK220712. There is no additional non-manual energy delivered to aid in fragmentation of the adipose tissue.
## V. INDICATION FOR USE
The VorFat System is 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 for aesthetic body contouring is desired:
- orthopedic surgery,
- arthroscopic surgery,
- neurosurgery,
- gastrointestinal and affiliated organ surgery,
- urological surgery,
- general surgery,
- gynecological surgery,
- thoracic surgery,
- laparoscopic surgery,
- plastic and reconstructive surgery
Only legally marketed accessory items, such as syringes, should be used with the system. Any fat concentrated with this system is to be transferred back to the patient without any additional manipulation.
## VI. COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE PREDICATE DEVICE
The VorFat System is substantially equivalent in terms of indications for use, technological characteristics, and performance characteristics to the predicate device. Tissue collection, separation and filtering for autologous reinjection is the technological principle for the predicate device. The VorFat System is substantially equivalent to the predicate device in terms of mechanical processing to produce a micronized fraction of tissue for autologous transfer using syringes.
The following Table provides a comparison and evidence of substantial equivalence of the subject device with the predicate device:
| Characteristic | Primary Predicate K171135 / BK220712 | Subject Device | Comparison |
| --- | --- | --- | --- |
| Device Name | The Lipogems System | VorFat System | N/A |
| Product Code | MUU / QKL | QKL | Same |
| Regulation | 21 CFR 878.5040 | 21 CFR 878.5040 | Same |
| Intended Use | Mechanical processing, filtering and transferring of autologous adipose tissue | Mechanical processing, filtering, and transferring of autologous adipose tissue | Same |
| Indications for Use | The Lipogems System is a sterile medical device intended for the closed-loop processing of lipoaspirate | The VorFat System is intended for the closed-loop processing of lipoaspirate tissue in medical | Same |
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| Characteristic | Primary Predicate K171135 / BK220712 | Subject Device | Comparison |
| --- | --- | --- | --- |
| | 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. | 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 for aesthetic body contouring 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. Only legally marketed accessory items, such as syringes, should be used with the system. Any fat concentrated with this system is to be transferred back to the patient without any additional manipulation. | |
| Prescription Use | Yes | Yes | Same |
| Design Features | The fat canister filter works with an aspiration system to separate, mechanically process, and filter adipose tissue for autologous reinjection. | The fat canister filter works with an aspiration system to separate, mechanically process, and filter adipose tissue for autologous reinjection. The fat canister is provided in the manufacturer's original packaging with original labeling. | Same |
| Operational Principle | Fat is aspirated into a syringe, and transferred to the Lipogems System device, where under constant gravity the fat is mixed with saline and undergoes micronization of the lipidic clusters through a sieve. The unit is shaken while the saline flows through, thus removing oil and blood residuals, and further reducing the clusters. This processing diminishes tissue disaggregation, thus preserving the cell and tissue micro-architecture of the adipose tissue. Finally, the concentrated adipose tissue clusters are passed out of the device into a collecting syringe for transferring back to the patient. | The VorFat System is a closed loop tissue collection system that includes a canister filter (fat canister) and vortex mixer, used with a legally marketed lipoplasty system to separate, filter, and microfragment adipose tissue for autologous reinjection. The canister is connected to a rapid stirrer/vortex mixer. The mechanical mixing action diminishes tissue disaggregation, thus preserving the cell and tissue micro-architecture of the adipose tissue. The result of processing with the VorFat System is a homogenous and micronized fraction of adipose tissue, which allows a patient's subcutaneous fat to be processed for autologous reinjection within the operative procedure time. | Substantially equivalent |
| Sterility | Canister: Sterile, SAL 10^{-6} Mixer: Shaken by hand by user | Canister: Sterile, SAL 10^{-6}, purchased from third party, previously cleared Mixer: Non-sterile (covered with sterile sleeve during use) | Same |
| Single Use? | Canister: Single Use | Canister: Single Use Mixer: Multi-use Cover sleeve: Single Use | Same |
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## VII. PERFORMANCE DATA
The following performance data were provided in support of the substantial equivalence determination.
### Bench Testing/Assessment
The following evaluations were performed for the VorFat System configuration to demonstrate substantial equivalence:
- Tissue Cluster Size Analysis (Adipose Aggregate/Cluster Size in mm²)
- Cell Viability
- Red Blood Cell Content
Both the subject and predicate devices had suitable characteristics for their indication for use.
## VIII. CONCLUSIONS
Based on the information contained within this submission, Alma Lasers, Inc. believes that the VorFat 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.
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Head to the search page and work through a few of these AI/ML fuzzy searches to build intuition: perivascular fat on CT · aortic valve calcification opportunistic screening on noncontrast CT · breast cancer prediction on digital pathology slides · autism detection · gestational age prediction · a hearing aid that can also detect a pulse · foundation model based analysis of ECG · large language models · penetration test. Watch how the relevance scores, intended use, and AI Performance tables tell you when results stop being meaningful.
