(386 days)
The intelliFat Disposable Adipose Tissue Harvesting and Transfer or BOD Kit is a sterile medical device intended for the closed-loop processing of lipoaspirate tissue in medical procedures involving the harvesting, and transferring of autologous adipose tissue harvested with a legally marketed lipoplasty system. The device is intended for use in the following surgical specialties when the transfer of harvested adipose tissue is desired: orthopedic surgery, arthroscopic surgery, neurosurgery, gastrointestinal and affiliated organ surgery, urological surgery, gynecological surgery, thoracic surgery, laparoscopic surgery, and plastic and reconstructive surgery when aesthetic body contouring is desired. Only legally marketed accessory items, such as syringes, should be used with the system. If harvested fat is to be transferred, the harvested fat is only to be used without any additional manipulation.
The intelliFat Disposable Adipose Tissue Harvesting and intelliFat BOD Kits are sterile single-use, disposable suction lipoplasty systems that are intended for closed-loop processing of lipoaspirate tissue in various medical procedures involving harvesting autologous adipose tissue. These kits contain stand-alone components that are assembled by the physician user. Primary components include: cannulae, filters, resizer, luer adapters, and syringe caps. The intelliFat Kits accommodate minimal handling of adipose tissue. These devices may be used in combination with FDA-cleared device such as syringes.
The provided text is a 510(k) premarket notification for a medical device called the "intelliFat Disposable Adipose Tissue Harvesting and Transfer Kit" (and "intelliFat BOD Kit"). This document focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than proving the device meets specific acceptance criteria through a clinical study.
Therefore, the document does not contain the information requested in your prompt regarding acceptance criteria and a study proving device performance in a clinical setting.
Specifically:
- No table of acceptance criteria and reported device performance is provided. The document is a regulatory filing for substantial equivalence, not a performance report.
- No sample size for a test set or data provenance is mentioned for proving clinical performance. The "nonclinical testing" section describes lab-based tests (biocompatibility, sterilization, packaging, nucleated cell viability), not clinical or performance outcome studies.
- No information about experts used for ground truth, adjudication methods, or MRMC studies is present. These are typically relevant for AI/imaging device evaluations, which this device is not.
- No standalone (algorithm-only) performance is discussed as this is a physical medical device, not an AI algorithm.
- No type of ground truth is specified for clinical performance, as no clinical performance study demonstrating efficacy is detailed.
- No training set sample size or ground truth establishment for a training set is mentioned. This information would be relevant for machine learning models, which this device is not.
The document explicitly states: "Clinical testing was not required to support a substantial equivalence determination for the intelliFat Kits." This means the FDA cleared the device based on its similarity in intended use and technological characteristics to existing devices, and not on new clinical performance data from the manufacturer.
§ 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.