(141 days)
The Sound Surgical VASER 2.1 is intended for the fragmentation and emulsification of subcutaneous fatty tissues for aesthetic body contouring.
The Sound Surgical VentX 2.1 is intended for the suction or aspiration of fluids and tissue during surgical procedures. The VentX 2.1 is designed to operate with the Sound Surgical VASER 2.1 or as a stand-alone system.
The Sound Surgical VASER 2.1 Lipo System is intended for the fragmentation, emulsification and aspiration of subcutaneous fatty tissue for the purpose of aesthetic body contouring.
The Sound Surgical VASER 2.1 Lipo 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
- Gynecological surgery:
- Thoracic surgery; and
- Laparoscopic surgery.
The Sound Surgical Technologies LLC (Sound) VASER 2.1 Lipo System (VASER 2.1) is an ultrasonic surgical system that fragments, emulsifies, and aspirates soft tissues.
The Sound VASER 2.1 is comprised of two (2) primary components: (1) the Sound VASER 2.1 Ultrasonic Amplifier; and (2) the VentX 2.1 Infiltration and Aspiration Console. Both the Sound VASER 2.1 Ultrasonic Amplifier and the Sound VentX 2.1 Infiltration and Aspiration Console are designed to operate independently, and may be sold or used separately, or together, as a system.
The VASER 2.1 Amplifier utilizes an ultrasonic surgical VASER Handpiece and Probe to fragment and emulsify the soft tissue. The VentX 2.1 Console utilizes sterile infiltration tubing, a handle and cannulae to infiltrate the tissue with fluids, and sterile suction tubing, a handle and cannulae to aspirate fluids and soft tissue.
This document describes the regulatory approval (510(k) clearance) for the "Sound Surgical Technologies LLC VASER 2.1 Lipo System." The approval is based on its substantial equivalence to a predicate device (Sound VASER System, K022051), rather than a study proving the device meets acceptance criteria in the sense of a clinical trial demonstrating efficacy against specific endpoints.
The performance testing detailed in the document focuses on compliance with recognized standards for medical device safety, sterility, biocompatibility, software, electrical safety, and electromagnetic compatibility. It does not present specific acceptance criteria with numerical targets for clinical performance or statistically derived device performance metrics.
Here's a breakdown of the information requested, based on the provided text, acknowledging that much of it is not applicable in the context of a 510(k) summary focused on substantial equivalence and compliance with general safety and performance standards:
1. A table of acceptance criteria and the reported device performance
Since this is a 510(k) submission based on substantial equivalence and compliance with established standards, explicit "acceptance criteria" for clinical performance (e.g., specific percentages for fragmentation, emulsification, or aspiration effectiveness) are not provided in the document. Instead, the "acceptance criteria" are implied by adherence to the cited industry standards. The "reported device performance" is a statement of compliance with these standards and the device's predetermined specifications.
| Category | Acceptance Criteria (Implied by Compliance) | Reported Device Performance |
|---|---|---|
| Sterilization (User) | Compliance with ISO 17665-1: 2006 (Moist Heat Sterilization) for Handpiece, Probes, Handle, and Cannulae. | "The sterilization of the Handpiece ... will be validated prior to commercial distribution in accordance with ISO 17665-1: 2006." (No results for this. It's a commitment.) |
| Sterilization (Provided) | Compliance with ISO 11137-1: 2006 and ISO 11137-2: 2006 (Radiation Sterilization) for Infiltration and Suction Tubing. | "Test results indicate that the Sound VASER 2.1 complies with the Standards." |
| Shelf-Life | Compliance with ISO 11607-1: 2006 and ISO 11607-2: 2006 (Packaging for Terminally Sterilized Medical Devices) for a two-year shelf life of Infiltration and Suction Tubing. | "Test results indicate that the Sound VASER 2.1 complies with the Standards." |
| Biocompatibility | Compliance with ISO 10993-1: 2003 (Biological Evaluation of Medical Devices) for patient-contact materials (Handpiece, Probes, Tubing, Handle, Cannulae). | "Test results and analyses indicate that the VASER Handpiece and Probes, and VentX Infiltration and Suction Tubing, Handle and Cannulae materials comply in accordance with ISO 10993-1: 2003." |
| Software Testing | Compliance with FDA guidance documents: "The content of premarket submissions for software contained in medical devices, 11 May 05" and "General principles of software validation; Final guidance for industry and FDA staff, 11 Jan 02." Software designed and developed according to a robust software development process, rigorously verified and validated. | "Test results indicate that the Sound VASER 2.1 complies with its predetermined specification." (Software has a "MODERATE level of concern") |
| Electrical Safety | Compliance with IEC 60601-1:1988, UL 60601-1: 2006, IEC 60601-1-1: 2000, and IEC 60601-1-8: 2006. | "Test results indicate that the Sound VASER 2.1 complies with the Standards." |
| Electromagnetic Compatibility (EMC) | Compliance with IEC 60601-1-2: 2007. | "Test results indicate that the Sound VASER 2.1 complies with the Standard." |
| Performance Testing - Bench | Compliance with "predetermined specifications" as detailed in Section 11 (not provided in this excerpt). | "Test results indicate that the Sound VASER 2.1 complies with its predetermined specification." (This refers to functional bench testing to ensure the device operates as designed, but no specific performance metrics like power output, fragmentation efficiency, etc., are given in this summary.) |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
This information is not provided in the document. The testing described (sterilization, shelf-life, biocompatibility, software, electrical safety, EMC, and bench performance) are laboratory and engineering tests, not clinical studies involving patient data or test sets in the typical sense for an AI/diagnostic device.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
This information is not applicable/provided. The 510(k) summary does not describe any clinical studies where expert-established ground truth would be relevant. The "ground truth" for the various performance tests is defined by the technical standards (e.g., a sterile product tested to ISO 11137 standards, or an electrical safety test to IEC 60601-1).
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not applicable/provided. Adjudication methods are typically relevant for clinical studies or image interpretation studies, which are not detailed here.
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
A multi-reader multi-case (MRMC) comparative effectiveness study was not done or at least not described in this 510(k) summary. This type of study is relevant for AI-powered diagnostic or assistive devices, which this VASER 2.1 Lipo System is not. This is a surgical device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This information is not applicable/provided. The device described is a physical surgical system, not an algorithm, and its performance inherently involves a human operator (surgeon).
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The concept of "ground truth" in the context of this 510(k) submission refers to the established requirements and methods defined by the relevant international and national standards (e.g., ISO, IEC, UL, FDA guidance for software). For example, the ground truth for electrical safety is defined by the limits and test procedures in IEC 60601-1. For sterilization, it's achieving a specified sterility assurance level (SAL) as validated against ISO 11137.
8. The sample size for the training set
This information is not applicable/provided. As this is a physical medical device, not an AI or machine learning algorithm, there is no "training set."
9. How the ground truth for the training set was established
This information is not applicable/provided for the same reason as point 8.
§ 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.