(228 days)
The Origins LipoHarvesting System is used in the aspiration, harvesting, filtering and transferring of autologous tissue. If harvested fat is to be re-implanted, the harvested fat is only to be used without any additional manipulation.
The Origins LipoHarvesting System is used in the aspiration, harvesting, filtering and transferring of adipose autologous tissue for aesthetic body contouring. If harvested fat is to be reimplanted, the harvested fat is only to be used without any additional manipulation.
The Origins LipoHarvesting System consists of a reusable, closed loop tissue collection system comprised of a medical grade canister, a drain port and a lid intended to be used with a standard liposuction aspiration pump to collect fatty tissue for aesthetic body contouring. As the tissue is harvested from the patient, it enters the collection canister via a port in the canister lid. The physician removes unwanted waste materials from the collection system via the drain port at the base. This process leaves fatty tissue that can be transferred to syringes for autologous fat re-injection.
Here's an analysis of the provided text regarding the acceptance criteria and study for the Origins LipoHarvesting System:
Acceptance Criteria and Device Performance for Origins LipoHarvesting System (K120328)
Based on the provided 510(k) summary, the device is a suction lipoplasty system used for harvesting and transferring autologous adipose tissue. The submission focuses on demonstrating substantial equivalence to predicate devices, primarily through technological characteristics and performance testing related to materials and basic functionality, rather than clinical efficacy.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria / Performance Aspect | Reported Device Performance | Comments / Study Details |
|---|---|---|
| Material Biocompatibility | Complies with ISO 10993-1: 2009 | Test results and analyses indicated compliance. |
| Performance - Bench Testing | Complies with predetermined specifications | Tested for performance in accordance with Section 11, Device Description - Performance Specifications. No specific quantitative criteria or results are provided in the summary. |
| Sterilization (by user) | To be validated prior to commercial distribution in accordance with ISO 17665-1: 2006 (Moist heat) | The device is not provided sterile. The user is responsible for sterilization. The validation of this user-performed sterilization process is a pre-market commitment. |
| Absence of Software | No software components | No software testing was applicable. |
| Absence of Electrical Components | No electrical components | No electromagnetic compatibility or electrical safety testing was applicable. |
| Substantial Equivalence | Considered substantially equivalent to predicate devices | Demonstrated through comparison of technological characteristics and performance testing. |
2. Sample Size Used for the Test Set and Data Provenance
The provided summary does not mention any studies involving a "test set" in the context of human or animal data. The performance testing described is limited to bench testing for material biocompatibility and general performance against pre-determined specifications. Therefore, information regarding sample size, country of origin, or retrospective/prospective nature for a test set of data is not applicable/provided.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
As there is no mention of a "test set" involving human or animal data needing a ground truth established by experts, this information is not applicable/provided in the summary. The studies described are primarily engineering and material conformance tests.
4. Adjudication Method for the Test Set
Not applicable, as there is no human or animal test set described.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done, and Effect Size
No MRMC comparative effectiveness study was described or performed. The submission is for a physical device for tissue collection, not an imaging or diagnostic AI-powered device.
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study was Done
Not applicable. The device does not contain an algorithm or software. It is a mechanical system.
7. The Type of Ground Truth Used
For the biocompatibility testing, the "ground truth" would be the standards themselves (ISO 10993-1: 2009). The material properties were tested against the requirements of this standard.
For the bench performance testing, the "ground truth" would be the predetermined specifications for the device's function.
8. The Sample Size for the Training Set
No training set is applicable or mentioned. The device is a physical system, not an AI or machine learning model.
9. How the Ground Truth for the Training Set was Established
Not applicable, as there is no training set.
§ 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.