The device is indicated for use to filter and wash aspirated, harvested 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 to be used without any additional manipulation.
Device Story
System processes harvested autologous adipose tissue for aesthetic body contouring; utilizes vacuum/aspirator apparatus for suction. Three-step process: harvesting, washing/filtering, concentrating/transferring. Components include chamber, concentration tray, basket, auraclens, and spatula. Used in clinical settings by healthcare providers to prepare fat for re-implantation without additional manipulation. Benefits include standardized washing/filtering of lipoaspirate.
Clinical Evidence
Bench testing only. Performance data includes biocompatibility, shelf life, and transit testing to demonstrate substantial equivalence to the predicate device.
Technological Characteristics
Components: chamber, concentration tray, basket, auraclens, spatula. Principle: mechanical filtration/washing of adipose tissue. Energy source: external vacuum/aspirator. Sterilization: identical to predicate. Shelf life: 2 years.
Indications for Use
Indicated for filtering and washing harvested autologous adipose tissue for aesthetic body contouring. Contraindications are identical to the predicate device.
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.
REVOLVE ENVI 600 Advanced Adipose System (BK220721)
Submission Summary (Full Text)
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## 510(k) Summary
This 510(k) Summary is being submitted in accordance with the requirements of 21 CFR 807.92.
Applicant: Tiger Aesthetics Medical, LLC
9630 S 54th Street Franklin,
WI 53132
Contact: Chet Jones
Regulatory Affairs Manager
888-665-5005
Chesterj@tigerbios.com
Alternate Contact: Jo Huang
Regulatory Affairs Senior Director
(b) (4)
joh@tigerbios.com
## Device identification
Common Name: Suction Lipoplasty System
Device Name: Lipoaspirate Washing System for Aesthetic Body Contouring
Proprietary Name: Viality™ Lipoaspirate Wash System for Aesthetic Body
Contouring Product Code: QKL
Classification: Class II
## Predicate device
Primary predicate: AuraClens™ Suction Lipoplasty System (A 123 + AuraClens)
Predicate 510(k): BK190433
Reference Predicate: REVOLVE ENVI 600 Advanced Adipose System
Predicate 510(k): BK220721
## Equivalence
The product code, common name, indications, operational principle, sterilization method, shelf life, key technological characteristics, and contraindications are identical to those of
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the predicate device. Slight differences in materials and design are shown to have no impact on the safety and effectiveness of the device.
### **Intended use / indications for use**
The device is indicated for use to filter and wash aspirated, harvested 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 to be used without any additional manipulation.
The indications for use are identical to those of the predicate device and no new indications are proposed.
### **Device description and technological characteristics**
The subject and predicate devices utilize fundamentally the same technology and scientific principles. The processing steps are the same, e.g., a three-step lipoplasty system for 1) harvesting, 2) washing/filtering, 3) concentrating/transferring adipose tissue. They are both intended to be used with a legally marketed vacuum or aspirator apparatus as a means of suction. No new modes of action are introduced.
The subject device has the same technological characteristics (consisting of the following primary components: chamber, concentration tray, basket, auraclens, and spatula), design concept, and process steps as the predicate device.
### **Sterilization and shelf life**
The subject device uses the same sterilization method and sterility assurance level as the predicate device. The labeled shelf life of two (2) years is supported by equivalent packaging configuration and stability evaluation and does not raise new questions of safety or effectiveness.
### **Contraindications**
The contraindications for use are identical to those of the predicate device. No new contraindications are introduced.
### **Performance data**
Performance testing, including bench testing, biocompatibility, shelf life, and transit testing, demonstrate the substantial equivalence of the subject device to the predicate device.
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## Conclusion
The Viality™ Lipoaspirate Wash System for Aesthetic Body Contouring (Viality-1400) is substantially equivalent to the predicate device.
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