(34 days)
For use in aspirating subcutaneous fatty tissue including autologous fat collection.
Device function: 1. Contains port interfaces between: Canister to tubing & aspirator to canister. 2. Sterile tubing to connect the interfaces 3. Funnel to interface port to tubing. 4. Syringe to collect fat.
Device design: 1. Contents subjected to sterility
Material used: Plastic Canister, Syringe, silicone tubing
Physical properties: Plastic & Silicone
This document is a 510(k) premarket notification for the "LipiSystems AquaVage" sterile canister system, a device intended for aspirating subcutaneous fatty tissue, including autologous fat collection. It seeks to demonstrate substantial equivalence to a predicate device, the "LS Liposuction Aspirator" (K081593).
Regarding the device's acceptance criteria and studies, the provided text contains very limited information on performance evaluation beyond the claim of substantial equivalence to a predicate device.
Here's an attempt to structure the available information per your request:
1. Table of Acceptance Criteria and Reported Device Performance
The submission does not define specific acceptance criteria (e.g., in terms of sensitivity, specificity, accuracy, or specific physical performance metrics with numerical targets). Instead, it relies on demonstrating substantial equivalence to a predicate device.
| Acceptance Criterion (Implied) | Reported Device Performance |
|---|---|
| Safety | Demonstrated SE to predicate device. |
| Effectiveness | Demonstrated SE to predicate device. |
| Performance | Supported SE determination. Device performs "better than predicate due to addition of sterilized canister system." |
| Intended Use | For use in aspirating subcutaneous fatty tissue including autologous fat collection. |
| Patient Population | Patients who desire aesthetic body contouring and autologous fat collection. |
| Technological Characteristics | Same as predicate, except canister is sterilized. |
| Physical Properties | Plastic & Silicone (for components). |
2. Sample Size Used for the Test Set and Data Provenance
- Test Set Sample Size: Not specified.
- Data Provenance: The document states that the determination of substantial equivalence was based on "non-clinical data." No further details are provided regarding the origin (country, retrospective/prospective) of this data. Given the "non-clinical" description and the nature of the device (a sterile canister system for fluid collection), it's highly probable that this data pertains to bench testing, material compatibility, and sterilization validation, rather than clinical patient data.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
This information is not provided in the document. The substantial equivalence claim is based on "non-clinical data," implying that expert consensus or clinical ground truth as typically understood for diagnostic or image-based AI devices would not be applicable here.
4. Adjudication Method for the Test Set
This information is not provided. Given the nature of the device and the reliance on "non-clinical data," a formal adjudication method by experts for a test set (as would be seen in human-in-the-loop or standalone AI performance studies) is unlikely to have been performed or required for this type of submission.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done
No, a multi-reader multi-case (MRMC) comparative effectiveness study was not conducted or reported. This type of study is relevant for diagnostic or AI-assisted interpretation devices to assess the impact of AI on human reader performance. The LipiSystems AquaVage is a sterile canister system; therefore, an MRMC study would not be applicable.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
No, a standalone algorithm performance study was not conducted or reported. This device does not involve an algorithm or AI.
7. The Type of Ground Truth Used
The document mentions "non-clinical data" as the basis for substantial equivalence. For a sterile canister system, this would typically involve:
- Engineering/Performance Specifications: Verifying that the device meets physical dimensions, material properties, flow rates, vacuum integrity (if applicable), and connection compatibility.
- Sterilization Validation: Demonstrating that the sterilization process achieves the required sterility assurance level (SAL).
- Biocompatibility Testing: Ensuring materials are safe for patient contact.
These types of "ground truth" are established through standardized testing protocols against pre-defined engineering and regulatory standards, rather than expert consensus, pathology, or outcomes data in a clinical sense.
8. The Sample Size for the Training Set
This information is not applicable and not provided. The LipiSystems AquaVage is a physical medical device (sterile canister system), not a software or AI-driven device that requires training data.
9. How the Ground Truth for the Training Set Was Established
This information is not applicable and not provided 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.