(91 days)
The Ranfac Fat Aspiration Cannula is intended for use in aesthetic body contouring. If harvested fat is to be re-implanted, the harvested fat is only to be used without any additional manipulation.
The Ranfac Fat Aspiration Cannula consist of silicone coated stainless steel tubing that is closed on the distal end and has fenestrations in the side wall to allow fat to be aspirated into the tubing. There is a Luer Lock compatible handle made of ABS plastic, molded to the cannula.
The provided document is a 510(k) premarket notification for the Ranfac Fat Aspiration Cannula, which is a medical device and not an AI/ML powered device. As such, the information requested in the prompt regarding acceptance criteria and studies for AI/ML device performance (e.g., sample size for test/training sets, expert ground truth, MRMC studies, standalone performance) is not applicable to this document.
The document discusses the substantial equivalence of the Ranfac Fat Aspiration Cannula to a predicate device, the Tulip Disposable Cannulas, based on similarities in:
- Intended use
- Design (sterile, disposable)
- Performance characteristics (e.g., attachment to Luer Lock syringe, available sizes and configurations)
- Cannula configuration (hollow, closed end, side ports)
- Gauge sizes (11Ga., 13Ga., 14Ga.)
- Lengths (10cm, 12cm, 15cm, 20cm, 25cm)
- Sterilization method (Ethylene Oxide)
- Materials (ABS plastic handle, ISO 9626 Stainless Steel cannula with silicone coating)
Performance Testing mentioned (Non-clinical Data):
The document states that performance testing was conducted to demonstrate substantial equivalence in aspiration performance. This involved:
- Aspiration of Distilled Water using both the Ranfac Fat Aspiration Cannula and various Tulip predicate cannulas (Trivisonno Micro Harvester, J.W. Little Harvester, GEMS Carraway Harvester) with 20cc and 30cc syringes.
- Aspiration of Silicone, Dow Corning 200 Fluid using the same comparison setup.
- Aspiration of Pure Glycerin using the same comparison setup.
However, the document DOES NOT provide specific acceptance criteria or quantitative results of these aspiration performance tests that would allow for the completion of the requested table. It only states that the testing was conducted to demonstrate substantial equivalence, implying the results were comparable, but no numerical data or thresholds are given.
Therefore, I cannot populate the table or answer the specific questions about AI/ML performance studies as the provided text pertains to a traditional medical device demonstrating substantial equivalence, not an AI/ML diagnostic or prognostic tool.
§ 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.