(91 days)
LipiVage® 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 only to be used without any additional manipulation.
LipiVage® 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.
LipiVage® is a 60cc hollow barrel harvesting syringe with plunger and an in-line polyester filter that is intended to receive, concentrate and filter autologous adipose tissue from lipoplasty procedures, for reimplantation of the extracted tissue back into the same patient at other anatomical locations in their body using a piston syringe and injection cannula. At one end of the LipiVage® harvesting syringe there is a male connector (nozzle) for fitting the female connector (hub) of a cannula for the harvesting of fat cells, while at the other end of the device there is a universal tubing connection to attach to a tubing set (not supplied by Genesis) that is connected to a controlled vacuum source, such as an aspirator or wall suction in the user facility. The LipiVage® harvesting syringe incorporates an in-line filter so there is no need to centrifuge, decant or expose fat cells to unnecessary handling. The device is for professional use only, made from medical grade polymers, single use, and provided sterile to the user.
This document is a 510(k) premarket notification for a medical device called LipiVage®, a suction lipoplasty system. It is a submission to the FDA to demonstrate substantial equivalence to a legally marketed predicate device (GID 700™) rather than to prove device performance against specific acceptance criteria for AI/ML enabled devices.
Therefore, the requested information about acceptance criteria, study details (sample size, data provenance, expert involvement, ground truth, MRMC studies), and training set specifics for an AI/ML device is not applicable to this document. This submission focuses on comparing the LipiVage® to an existing device based on design, materials, and non-clinical performance testing.
Here's how the provided document relates to the general concepts of device acceptance:
1. Table of Acceptance Criteria and Reported Device Performance:
The document doesn't provide a typical "acceptance criteria" table with quantitative performance metrics (like accuracy, sensitivity, specificity) for a diagnostic AI/ML device. Instead, it presents a comparison table (Table 5-1 – Device Comparison: LipiVage® vs. GID 700™) that outlines points of substantial equivalence to a predicate device.
The "acceptance criteria" in this context are established by demonstrating that the LipiVage® device is equivalent in:
- Indications for Use: (Same for both devices)
- Fundamental Scientific Technology: (Closed loop system, user-supplied vacuum - Same for both)
- Device Materials: (Similar medical-grade polymers)
- Device Filter: (Similar woven fabric material with slightly different mesh opening - 180 µm for LipiVage® vs 200 µm for GID 700™, but deemed not to have significant difference in overall quality of harvested fat)
- Sterilization: (Yes, gamma radiation - Same)
- Single Patient Use: (Yes - Same)
- Implantable: (No - Same)
- Biocompatibility Testing: (Per ISO 10993-1 and its applicable parts - Same)
- Device Sterilization: (ISO 11137 - Same)
- Device Packaging and Shelf-Life: (Validated for LipiVage® per ASTM standards; not known for predicate but deemed acceptable)
- Device Performance Testing: (ISO 80369-1, -7, -20 for LipiVage®; general mentions for predicate)
- Animal Testing: (NA - Same)
- Clinical Testing: (NA - Same)
- Risk Analysis: (ISO 14971 for LipiVage®; not known for predicate but an appropriate analysis was done)
The reported "performance" for LipiVage® is that it "meets all internal Genesis Biosystems specification requirements to support substantial equivalence to the predicate device." Specifically, "Adipose viability testing demonstrated that fat tissue viability was maintained."
2. Sample size used for the test set and the data provenance:
- Not applicable (NA). This document describes a non-clinical device (lipoaspiration system), not an AI/ML diagnostic or prognostic tool that would require a test set of data. The testing is for material compatibility, sterilization, and basic mechanical function.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- NA. No ground truth establishment by experts is described as this is not an AI/ML device.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- NA. No adjudication method is described.
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:
- NA. No MRMC study was done, as this is not an AI-assisted diagnostic device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- NA. No standalone algorithm performance was assessed.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- NA. Ground truth as understood in the context of AI/ML evaluation is not relevant here. The "truth" for this device's performance is its ability to meet engineering specifications, maintain fat tissue viability, and be biocompatible, STERILE, and safe for its intended use, as demonstrated through laboratory testing outlined in section 5.9 "Non-Clinical Performance Data".
8. The sample size for the training set:
- NA. There is no training set mentioned or implied, as this is not an AI/ML device.
9. How the ground truth for the training set was established:
- NA. No training set, therefore no ground truth established for it.
In summary, this document exemplifies a 510(k) submission for a traditional medical device, focusing on demonstrating substantial equivalence to a predicate device through non-clinical testing rather than proving performance against specific quantitative criteria for an AI/ML product.
§ 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.