(125 days)
The Puregraft® 850/PURE System is indicated for use in the harvesting, filtering and transferring of autologous fat tissue for reinjecting back into the same patient for aesthetic body contouring.
The Puregraft® 850/PURE System is a sterile, single use, closed-loop tubing and bag system intended for delivering adipose tissue back to the same patient for cosmetic and reconstructive surgery applications. The Puregraft 850/PURE System consists of collection bags, tubing and syringe adaptors that all have unique connectors and fittings to assure proper assembly. The Puregraft® 850/PURE System is composed of the following components: Puregraft® 850 Bag, Puregraft® 850 Drain Bag, Tissue Access Port Adapter (TAPA), and Luer Lock Syringe Adapter. In addition to the Puregraft® Assemblies described above, the Puregran® 850/PURE System is used in combination with the following Class I hand-held manual instruments provided by Cytori Therapeutics: Easel and Slider.
This document describes the Puregraft® 850/PURE System, a device for harvesting, filtering, and transferring autologous fat tissue. The submission focuses on demonstrating substantial equivalence to a predicate device rather than presenting new clinical study data with specific acceptance criteria and performance metrics in the format requested.
Therefore, much of the requested information cannot be extracted directly from the provided text. The document is a 510(k) summary, which typically focuses on demonstrating equivalence to a previously cleared device, not on presenting novel clinical trial results.
Here's an attempt to address your request based on the available information, with clear notations where information is not present:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (What was measured) | Reported Device Performance (Result) |
|---|---|
| Mechanical Performance (e.g., tensile strength, pressure, drop testing) | "Nonclinical testing was performed on the Puregraft® 850/PURE System and Puregraft® 250/PURE System predicate device that included... bench top testing such as tensile strength, pressure, and drop testing." The tests demonstrated that "the Puregraft® 850/PURE System is substantially equivalent to the Puregraft® 250/PURE System predicate device." Specific numerical acceptance criteria or performance values are not provided. |
| Biological Performance Verification | "Nonclinical testing... included biological performance verification..." Specific biological acceptance criteria (e.g., cell viability, sterility, endotoxin levels post-filtration) or results are not provided. The conclusion is that the new device is "substantially equivalent" to the predicate. |
| Material Composition (DEHP-free, Medical Grade) | "All materials are medical grade and DEHP free." (For Puregraft® 850 Bag and Drain Bag). "The Puregraft® 850/PURE System is fabricated from medical grade, DEHP free materials." This acts as an implicit acceptance criterion, which the device meets. |
| Sterility (Gamma Irradiation) | "The Puregraft® 850/PURE System is sterilized with gamma irradiation." This acts as an implicit acceptance criterion, which the device meets. No specific sterility assurance level (SAL) is mentioned. |
2. Sample Size for Test Set and Data Provenance
- Sample Size for Test Set: Not explicitly stated as a separate "test set" for a clinical study. The nonclinical testing mentioned was "bench top testing" comparing the new device to a predicate. The number of units tested for mechanical and biological verification is not specified.
- Data Provenance: The testing was "nonclinical" and involved "bench top testing." It's internal testing conducted by the manufacturer, Cytori Therapeutics, Inc., based in San Diego, California, USA. It is retrospective in the sense that it's comparing against an existing predicate, but the specific testing conducted for this submission would be prospective for the purpose of demonstrating equivalence.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications
- This information is not applicable and not provided because the study described is a nonclinical, bench-top comparison demonstrating substantial equivalence, not a clinical study involving human outcomes or expert assessment of diagnostic accuracy. There was no "ground truth" established by experts in the context of diagnostic performance.
4. Adjudication Method for the Test Set
- Not applicable and not provided. As it was nonclinical bench testing, there was no need for adjudication by experts.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, and the effect size of how much human readers improve with AI vs without AI assistance
- Not applicable and not provided. This device is a medical instrument for fat tissue processing, not an AI-powered diagnostic or decision-support system involving human readers. Therefore, an MRMC study comparing human performance with and without AI assistance is irrelevant to this submission.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
- Not applicable and not provided. This device is a physical system, not a software algorithm.
7. The Type of Ground Truth Used
- For the nonclinical testing described, the "ground truth" would be engineering specifications and the performance of the predicate device. For example, for tensile strength, the "ground truth" would be a defined breaking point or acceptable range. For biological performance, it would be adherence to established standards or the comparable performance of the predicate device. Specific quantitative metrics for this "ground truth" against which the new device was measured are not detailed in the summary.
8. The Sample Size for the Training Set
- Not applicable and not provided. This is not an AI/ML device that requires a training set.
9. How the Ground Truth for the Training Set Was Established
- Not applicable and not provided. This is not an AI/ML device that requires a training set or ground truth for training.
§ 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.