(94 days)
The Lipogems System is a sterile medical device intended for the closed-loop processing of lipoaspirate tissue for the purpose of transferring autologous adipose tissue for aesthetic body contouring (lipofilling) in applications including plastic and reconstructive surgery, neurosurgery, gastrointestinal and affiliated organ surgery, urological surgery, general surgery, orthopedic surgery, qynecological surgery, thoracic surgery, and laparoscopic surgery. Only legally marketed accessory items. such as syringes, should be used with the system. If harvested fat is to be reimplanted. 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 'blue' side the processing unit;
- An access port for the loading of material to be processed with a Luer-lock connection and self-. occluding valve (blue side);
- . A drain line connected to the gray side of the processing unit;
- An access port for the discharge of processed material with a Luer-lock connection and selfoccluding valve (gray side);
- . A bag for collecting waste material.
The Lipogems System Processing Unit is 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 intrinsic characteristics of the Lipogems fat treatment can be summarized as follows:
- . Minimal handling of adipose tissue (only via mechanical action);
- Maintenance of the vascular-stromal niches; ●
- . Reduction of fat clusters to allow injection with fine needles, up to 27G;
- . Removal of impurities, such as oil residues and blood.
The result of processing with the Lipogens System is a homogeneous and micronized fraction of adjpose tissue, which allows a patient's subcutaneous fat to be processed for autologous reinjection within the operative procedure time.
There is no direct interaction of the device with the patient, although the adipose tissue that is processed in the device comes from the patient and is returned to the same patient after processing.
Interaction with other devices is necessary for operation of the Lipogems System, in particular, standard FDA cleared syringes are needed for the initial injection of adipose tissue into the processing unit, and for receiving the processed tissue upon completion of the processing steps.
The steps of operation of the Lipogems System are:
- The Lipogems processing unit receives a constant gravity feed of physiological saline through the 1. upper port. After first filling the processing unit with saline, adipose tissue is injected into the processing unit, where it undergoes a first reduction treatment and micronization of lipidic cluster as it passes through the input sieve.
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- The processing unit is then shaken manually, causing the spheres contained within the processing unit to exert mechanical action on the tissue/saline emulsion and further reduce the lipidic clusters, preserving the vascular-stromal niches, while the continuous flow of saline eliminates oil and blood component residuals from the emulsion. The used saline is collected in the waste bag. Conducting the mechanical reduction while fully immersed in saline minimizes any traumatic action on the cells.
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- After completion of the shaking/washing step, the solution appears clear (at the top of the processing unit) and the lipoaspirate is yellow (at the bottom). The saline flow is then stopped and the device is inverted. A second adipose cluster reduction takes place by pushing the floating adipose clusters through the second sieve, pushing fluid from below with a svringe. The reduced clusters pass out of the (now) top of the unit into a collecting syringe.
The provided text is a 510(k) summary for the Lipogems System, a medical device intended for processing lipoaspirate tissue. It does not describe a study proving the device meets specific acceptance criteria in terms of clinical or technical performance metrics beyond basic device functionality and safety. The document focuses on demonstrating substantial equivalence to a predicate device rather than presenting performance data from studies directly measuring the device's efficacy or outcomes.
Therefore, the following information cannot be extracted from the provided text: acceptance criteria related to device performance (e.g., accuracy, sensitivity, specificity, or outcome measures), a study proving the device meets such criteria, sample size for test sets or training sets, data provenance, number or qualifications of experts, adjudication methods, MRMC studies, standalone performance, or types of ground truth for performance evaluation of the device's intended use.
The document discusses "Performance data" in a section, but explicitly states: "The performance of the device is entirely controlled by the user and is not predetermined by the device itself." This indicates that the regulatory submission does not include studies for clinical performance or efficacy.
What is described are non-clinical tests performed to ensure the device's safety, sterility, and biocompatibility, which are necessary for substantial equivalence:
1. Table of Acceptance Criteria and Reported Device Performance:
Since clinical or technical performance metrics for the device's intended use (processing lipoaspirate tissue for re-implantation) are not provided in the context of an acceptance criteria table, this table focuses on the non-clinical tests and their "performance."
| Acceptance Criteria (Non-Clinical) | Reported Device Performance |
|---|---|
| Device Patency and Freedom from Leakage | 100% testing of device patency and freedom from leakage carried out after manufacture |
| Sterility Assurance Level (SAL) via Sterilization Process Validation (ISO 11135-1) | SAL of 10^-6 (Note: text states 10^-9 in one place, and 10^-6 in the comparison table.) |
| 5-year Shelf Life Validation (ASTM F1980) | Shelf life of five years established via accelerated aging |
| Biocompatibility (ISO 10993 series) | Biocompatible for materials in the fluid path (Cytotoxicity, Sensitization, Intracutaneous Reactivity, Acute Systemic Toxicity, LAL bacterial endotoxin test) |
| Pre-assembly Washing Process Validation | Validation performed on device spheres and sieves |
2. Sample size used for the test set and the data provenance:
- For non-clinical tests (sterility, shelf-life, biocompatibility, patency/leakage), the sample sizes are not explicitly stated. These are typically performed on a representative number of devices or materials according to the respective standards.
- Data provenance: Not applicable in the context of device performance related to its intended use as no clinical performance studies are presented. The non-clinical tests are conducted by the manufacturer as part of the device validation.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable, as no clinical performance or ground truth for diagnostic accuracy is being established in this document. The "ground truth" for non-clinical tests is defined by the standards and validated methodologies for those tests.
4. Adjudication method for the test set:
- Not applicable, as no clinical performance or ground truth for diagnostic accuracy is being established.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done:
- No, an MRMC comparative effectiveness study was not done. The document does not describe any clinical studies comparing the device's effectiveness.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- This device is a mechanical processing system, not an algorithm. Therefore, "standalone performance" in the context of an algorithm is not applicable. The device's "performance" is described as user-controlled.
7. The type of ground truth used:
- For the non-clinical tests, the "ground truth" is based on established scientific and regulatory standards (e.g., ISO, ASTM) for demonstrating sterility, biocompatibility, and physical integrity. There is no clinical or pathology-based ground truth related to the device's efficacy on tissue processing outcomes discussed.
8. The sample size for the training set:
- Not applicable, as this is not an AI/algorithm-based device and no training set is mentioned or implied.
9. How the ground truth for the training set was established:
- Not applicable.
§ 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.