(57 days)
The VASERlipo System is intended for the fragmentation of subcutaneous fatty tissues for aesthetic body contouring.
The VentX console is intended for the suction of fluids and tissue during surgical procedures. The VentX console is designed to operate with the VASERlipo System or as a stand-alone system.
The VASERlipo System is intended for the fragmentation, emulsification of subcutaneous fatty tissue for the purpose of aesthetic body contouring.
The VASERlipo System is also indicated for use in the following surgical specialties for the fragmentation, emulsification and aspiration of soft tissues:
- · Neurosurgery
- · Gastrointestinal and affiliated organ surgery
- · Urological surgery
- · Plastic and reconstructive surgery
- · General surgery
- · Orthopedic surgery
- · Gynecological surgery
- · Thoracic surgery and
- · Laparoscopic surgery
The VASERlipo System is an ultrasonic surgical system that fragments, emulsifies, and aspirates soft tissues.
The VASERlipo System is comprised of two components: the VASER Ultrasonic Amplifier and the VentX Infiltration and Aspiration Console. Both components are designed to operate independently, and may be sold or used separately/together, or as a system.
The Amplifier uses an ultrasonic surgical handpiece and probe to fragment and emulsify the soft tissue. The Console uses sterile tubing, a handle, and cannula to infiltrate the tissue with fluids and aspirate the fluids/soft tissue.
This document is a 510(k) premarket notification for the VASERlipo System, establishing its substantial equivalence to a predicate device. As such, it does not contain a typical "study" proving the device meets performance-based acceptance criteria for efficacy in the same way a new drug or novel medical device might. Instead, the "study" here is the non-clinical testing demonstrating compliance with electrical safety standards and functional specifications that show its substantial equivalence to the predicate.
Here's the information broken down:
1. Table of Acceptance Criteria and Reported Device Performance:
The acceptance criteria are implicitly defined by the predicate device's characteristics and relevant electrical safety standards. The "performance" is demonstrating that the new device meets these, primarily through non-clinical testing.
| Acceptance Criteria Category | Specific Criteria (from predicate/standards) | Reported Device Performance |
|---|---|---|
| Intended Use | Identical to predicate: fragmentation & emulsification of subcutaneous fatty tissues for aesthetic body contouring | Identical to predicate |
| Operating Frequency | 36kHz Nominal (from predicate) | 36kHz Nominal |
| Infiltration Rates | 50-550 ml/min (from predicate) | 50-550 ml/min |
| Suction Vacuum (max) | 20 inHg at 5,000 ft (from predicate) | 20 inHg at 5,000 ft |
| Cannula Diameter | 2.4-4.6 mm (from predicate) | 1-6 mm |
| Cannula Length | 17-34 cm (from predicate) | 7-40 cm |
| Electrical Safety | Compliance with IEC 60601-1:2005/AM1:2012 | Compliant |
| Suction Equipment Safety | Compliance with ISO 10079-1:2015 | Compliant |
| Cannula Deformation Resistance | $20°±5°$ and straightening without shaft exhibiting fractures, sharp edges, or loss of suction performance | Demonstrated compliance |
Important Note: The cannula dimensions (diameter and length) are presented in the document as slightly different between the subject and predicate devices. However, the document concludes "The technological characteristics of the VASERlipo System are substantially equivalent to those of the predicate device" and "shares the same indications for use, design features, and functional features". This implies these differences were deemed not to raise new questions of safety or effectiveness.
2. Sample Size Used for the Test Set and Data Provenance:
This document describes non-clinical testing of the device itself, not a clinical study involving human or animal subjects. Therefore, the concept of a "sample size for a test set" in the traditional sense of a clinical trial (e.g., number of patients) is not applicable. The provenance of the data is from internal laboratory testing conducted by Solta Medical Inc.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of those Experts:
Not applicable. The "ground truth" for non-clinical device testing largely involves engineering specifications, electrical safety standards, and functional parameters. This is established through standard engineering and regulatory practices, not by expert consensus in a clinical context.
4. Adjudication Method for the Test Set:
Not applicable. This document pertains to non-clinical testing and substantial equivalence determination, not a clinical trial requiring adjudication of outcomes.
5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
Not applicable. The VASERlipo System is a surgical device, not an AI/imaging diagnostic tool that would typically involve human readers or MRMC studies.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done:
Not applicable. The VASERlipo System is a physical surgical device, not an algorithm.
7. The Type of Ground Truth Used:
The ground truth used for this 510(k) submission is primarily engineering specifications, functional parameters established by the predicate device, and compliance with recognized national and international electrical and medical device safety standards (e.g., IEC 60601-1, ISO 10079-1).
8. The Sample Size for the Training Set:
Not applicable. This is a physical medical device, not a machine learning algorithm that requires a "training set."
9. How the Ground Truth for the Training Set was Established:
Not applicable, as there is no training set for this type of device.
§ 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.