(86 days)
The HydraSolve™ Lipoplasty System is intended to be used for liquefaction and aspiration of localized subcutaneous fatty deposits for the purpose of aesthetic body contouring. Adipose tissue harvested with the HydraSolve™ Lipoplasty System may be used for autologous transfer following the method provided in the manual.
The Andrew Technologies HydraSolve "" Lipoplasty System is a liposuction system used to perform body contouring. It is designed to perform selective tissue extraction through a cannula that utilizes pressurized, heated, and pulsed saline solution to suction. Adipose tissue aspirated with the HydraSolve™ Lipoplasty System can be harvested for subsequent autologous transfer.
The device includes the HydraSolve™ Console which contains within its durable case: a user interface, controller, power supply, and Phaser™ energy transfer systems (both heat and pressure). The system also includes a tumescent infusion component which is compatible with commercial off-the-shelf (COTS) turnescent cannulae and tubing. The device also includes the Sterile Treatment Kit consisting of a pumping mechanism, heat exchanger and tubing and a reusable limited-use handpiece with integral cannula. The device interfaces with COTS waste canisters and suction tubing.
Acceptance Criteria and Study for HydraSolve™ Lipoplasty System (K130152)
This document details the acceptance criteria and the study performed to demonstrate the safety and effectiveness of the HydraSolve™ Lipoplasty System for an expanded indication (autologous fat transfer).
1. Table of Acceptance Criteria and Reported Device Performance
Given the nature of the submission (510(k) for an extended indication and substantial equivalence based on non-clinical data), specific quantitative acceptance criteria in terms of performance metrics (like sensitivity, specificity, etc.) are not explicitly stated in the provided text. Instead, the acceptance is based on demonstrating substantial equivalence to predicate devices and proving the safety and effectiveness for the new indication through non-clinical testing.
The "reported device performance" in this context refers to the outcomes of the non-clinical tests that supported the substantial equivalence and the expanded indication.
| Acceptance Criterion (Implicit) | Reported Device Performance |
|---|---|
| Substantial Equivalence to Predicate Devices (K121218 & K121005) | The subject device (HydraSolve™ Lipoplasty System with AFT Indication) is substantially equivalent in major components, technological characteristics, user population, and intended use to the predicate HydraSolve™ Lipoplasty System (K121218). The new indication for autologous fat transfer (AFT) makes it substantially equivalent to the Harvest AdiPrep (K121005) in terms of tissue processing and implantation technique. The only difference is the expanded Indications for Use statement. |
| Safety and Effectiveness for Autologous Fat Transfer | Non-clinical testing demonstrated: |
- Adepted aspirate cell viability
- Fat graft survivability
- Fat graft quality |
Note: The FDA's 510(k) clearance (K130152) confirms that based on the provided information, the device is substantially equivalent to the predicate devices and may be marketed. This implicitly means the acceptance criteria for market clearance under the 510(k) pathway were met.
Details of the Study
The provided text describes a non-clinical study to demonstrate safety and effectiveness, especially for the expanded indication of autologous fat transfer.
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Type of Study: Non-clinical testing. The submission explicitly states: "Clinical testing was not necessary."
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Purpose: To demonstrate the safety and effectiveness of the HydraSolve™ Lipoplasty System for its intended use, particularly with the addition of autologous fat transfer. This was done to establish substantial equivalence to predicate devices.
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Test Set: Not specified. Non-clinical studies (e.g., in-vitro or animal studies) typically involve a different kind of "sample size" than human clinical trials. The document does not provide details on the number of samples (e.g., tissue samples, animals) used for the cell viability, survivability, and quality tests.
- Data Provenance: Not specified (e.g., country of origin, whether retrospective or prospective). Given it's a non-clinical study, "country of origin" might refer to where the lab work was conducted, which is not mentioned. The data would be prospective in the sense that the tests were specifically conducted for this submission.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
- Not applicable. As this was a non-clinical study involving laboratory and bench testing (cell viability, fat graft survivability, and quality), there was no "ground truth" established by human experts in the way it would be for diagnostic imaging or clinical assessment. The "truth" would be based on scientific measurements and established protocols for evaluating these biological parameters.
4. Adjudication Method for the Test Set
- Not applicable. There was no human expert adjudication of test results in the manner described (e.g., 2+1, 3+1). The outcomes of the non-clinical tests would typically be objectively measured and analyzed according to scientific standards.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
- No. An MRMC comparative effectiveness study was not done. The submission explicitly states "Clinical testing was not necessary," and the study described is non-clinical. Therefore, there is no information on human reader improvement with or without AI assistance.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Study Was Done
- Not applicable. This device is a medical device (a liposuction system), not an AI or algorithm-based diagnostic tool. Therefore, the concept of a "standalone algorithm-only performance" study does not apply. The device's performance is tied to its mechanical and biological effects, not an algorithm's classification or detection capabilities.
7. The Type of Ground Truth Used
- Type of Ground Truth: The "ground truth" in this context refers to established scientific measurements and biological parameters for evaluating aspirated adipocyte cell viability, fat graft survivability, and fat graft quality. This would involve specific laboratory assays, histological assessments, or other quantifiable biological markers considered standard in the field for assessing the health and integrity of adipose tissue for autologous transfer.
8. The Sample Size for the Training Set
- Not applicable. This is a medical device, not an AI/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 medical 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.