(31 days)
The Lipogems System is a sterile medical device intended for the closed-loop processing of lipoaspirate tissue in medical procedures involving the harvesting, concentrating 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, general 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 Lipogems System is a pre-assembled device consisting of:
- . An ABS processing unit (Lipogems Processing Unit) containing 5 stainless steel spheres and 2 stainless steel sieve filters;
- An input washing line connected to the color-coded end cap of the processing unit; .
- An access port for the loading of material to be processed with a Luer-lock connection and selfoccluding valve (color-coded end-cap);
- . A drain line connected to the 'gray' end-cap of the processing unit;
- An access port for the discharge of processed material with a Luer-lock connection and self-occluding valve (gray end-cap);
- A bag for collecting waste material.
The Lipogems System Processing Unit is supplied sterile, for single use only, and manufactured in two size variants with the same functional characteristics:
- . LGD 240: Lipogems Processing Unit with 240 cc capacity and standard exit sieve;
- . LGD 60: Lipogems Processing Unit with 60 cc capacity and standard exit sieve;
The provided document is a 510(k) premarket notification for the Lipogems System. It focuses on demonstrating substantial equivalence to a previously cleared predicate device (K161636 The Lipogems System), rather than presenting a study with specific acceptance criteria and performance data for a new device.
Therefore, the document does not contain the information requested in your prompt regarding acceptance criteria and a study proving those criteria are met.
Specifically, the following information is not available in the provided text:
- A table of acceptance criteria and the reported device performance: This document is a comparison to a predicate device, not a performance study against predefined criteria.
- Sample size used for the test set and the data provenance: No performance test set is described.
- Number of experts used to establish the ground truth... and their qualifications: No ground truth establishment is described as there's no performance study.
- Adjudication method for the test set: Not applicable as there's no performance test set.
- If a multi reader multi case (MRMC) comparative effectiveness study was done... effect size: Not described. The device is a medical processing system, not one that involves human readers interpreting data.
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable, as this is not an algorithm-based device.
- The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable, as there's no performance study that would require ground truth.
- The sample size for the training set: Not applicable, as this is not an AI/ML device that requires a training set.
- How the ground truth for the training set was established: Not applicable.
The document primarily focuses on demonstrating that the current Lipogems System is substantially equivalent to its predicate device by having identical indications for use, technological characteristics (e.g., closed loop system concept, sterilization method, biocompatibility), and manufacturing processes. It notes "slight modifications in end cap and outer processing unit geometry" and the addition of "color-coded end caps," but asserts these do not raise new questions of safety and efficacy. Biocompatibility testing (Cytotoxicity, Intracutaneous Reactivity, Delayed Hypersensitivity, Acute Systemic Toxicity) was performed to confirm this.
§ 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.