(84 days)
The A123 is used for aspiration, harvesting, filtering and transferring of 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 A123 is intended for use in the following surgical specialties when aspiration of soft tissue is desired: plastic and reconstructive surgery, neurosurgery, gastrointestinal and affiliated organ surgery, urological surgery, general surgery, orthopedic surgery, gynecological surgery, thoracic surgery, and laparoscopic surgery.
The A123 is a suction lipoplasty system designed to be used in the operating room in conjunction with, and attached to, a user-provided liposuction cannula, a vacuum source, and a waste canister. The A123 allows the surgeon to conveniently and accurately harvest, wash, filter, concentrate, and transfer autologous adipose tissue for reinjection into the same patient for body contouring in cosmetic and reconstructive surgery applications during the same procedure in which autologous adipose tissue is collected. The system is a sterile, disposable unit for single patient use.
The A123 consists of the following components:
- Collection chamber
- Collection mesh basket
- Concentration chamber with fluid-absorbing pads
- AuraClens™ powder packets
- Outlet tube and drain valve with tube clamp
- Mixing spatula
The A123 is to be used together with FDA-cleared devices (such as a lipoplasty device [Product Code MUU, Requlation Number 21 CFR 878.50401, liposuction cannula, high vacuum tubing, waste container, syringes [e.g. 60 cc Toomev-tip svringes, Luer-Lock, Product Code KYZ1, and roomtemperature, sterile 0.9% normal saline solution, all provided by the user.
The provided text describes the 510(k) summary for the AuraGen 123™ Suction Lipoplasty System (A123). This device is a Class II medical device used for aspirating, harvesting, filtering, and transferring autologous adipose tissue for aesthetic body contouring. The summary details bench testing conducted to demonstrate substantial equivalence to a predicate device.
Here's an analysis of the acceptance criteria and study information, based on the provided text:
1. A table of acceptance criteria and the reported device performance:
The document mentions that "The A123 meets the acceptance criteria for all tests," but it does not provide a table detailing the specific acceptance criteria for each test nor the quantitative reported device performance values. It lists the bench tests performed but not the specific thresholds for "meeting" the criteria.
| Bench Test | Acceptance Criteria (Not Explicitly Stated in Document) | Reported Device Performance (Not Explicitly Stated in Document) |
|---|---|---|
| Cell Viability | (e.g., Minimum percentage of viable cells) | "Found to be biocompatible" |
| Fat Volume | (e.g., Minimum recovered fat volume, consistency across trials) | "Volume of the fat layer was measured" |
| Fat Concentration | (e.g., Minimum fat concentration in processed tissue) | "Fat concentration was calculated" |
| Time-to-Graft (TTG) | (e.g., Maximum allowed processing time) | "Time from the start of the washing step to the end of the transfer/extraction step was measured" |
| Device Usability | (e.g., Meets predefined usability objectives, no critical errors) | "Usability of the device was evaluated" |
| Canister implosion | (e.g., Withstands specified vacuum pressure without implosion) | "A123 units were tested for medical vacuum suction canister implosion test requirements" |
| Tubing collapse | (e.g., Withstands specified vacuum pressure without collapse) | "A123 units were tested for medical vacuum suction canister tubing collapse test requirements" |
| System leak | (e.g., Meets leakage specifications) | "A123 units were tested for vacuum seal to determine leakage" |
| Tubing tensile strength (pull-off force) | (e.g., Withstands specified pull-off force) | "A123 units were tested to measure the tensile strength (pull-off force)" |
| Biocompatibility | (e.g., No cytotoxic, irritation, or sensitization effects) | "The test articles were found to be biocompatible" |
| Sterility | (e.g., Sterile per ISO 11137) | "Both met the sterility requirements per ISO 11137" |
2. Sample size used for the test set and the data provenance:
The document mentions "A123 units were tested" for various bench tests, but it does not specify the sample size (number of units) used for each test.
The data provenance is not explicitly stated in terms of country of origin. The study appears to be retrospective in the sense that it's bench testing on manufactured units, rather than a prospective clinical trial.
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 to this type of submission. The ground truth for bench testing of a lipoplasty system involves quantifiable physical measurements and material properties, rather than expert interpretation of medical images or conditions.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
This is not applicable. Adjudication methods are typically used in studies involving subjective human interpretation (e.g., reading medical images) to resolve discrepancies. For bench testing, the results are typically objective measurements.
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:
This is not applicable. This submission is for a medical device used for tissue processing, not an AI-assisted diagnostic tool that supports human readers/interpreters.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
This is not applicable. The device is a physical system, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
The "ground truth" for this device's performance evaluation is based on objective, quantitative measurements obtained through standardized bench testing methods (e.g., centrifugation for fat volume, time measurement for TTG, force measurement for tensile strength, and established ISO standards for sterility, biocompatibility, implosion, collapse, and leak tests).
8. The sample size for the training set:
This is not applicable. The device is a physical product and not an AI algorithm that requires a training set.
9. How the ground truth for the training set was established:
This is not applicable. As stated above, the device is not an AI algorithm.
§ 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.