(269 days)
The Ranfac FATS Procedure Pack is used in medical procedures involving the harvesting of autologous adipose tissue. The FATS Procedure Pack is for concentrating adipose tissue harvested with a legally marketed lipoplasty system. The device is intended for use in the following surgical specialties when the concentration of harvested adipose is desired: Neurosurgery, gastrointestinal surgery, urological surgery, plastic & reconstructive surgery, orthopedic surgery, gynecological surgery, thoracic surgery, laparoscopic surgery, arthroscopic surgery.
The Ranfac Fat Aspirate Transfer System (FATS) is designed to allow for sterile processing and transfer of the collected adipose tissue. The device consists of a procedure pack including the following components: two sterile centrifugation syringes, two each 30 mL and 20 mL sterile syringes for adipose tissue aspirate transfer, and other luer fittings as accessories to be used to transfer into and from the centrifugation syringe. Additionally, a non-sterile, reusable centrifugation syringe Containment Vessel is provided as a separate accessory which allows the centrifugation syringe to fit within a commercially available centrifuge.
This document describes a 510(k) premarket notification for the Ranfac Fat Aspiration Transfer Syringe (FATS) Procedure Pack. The purpose of this notification is to demonstrate substantial equivalence to a legally marketed predicate device.
Here's an analysis based on your requested information:
1. Table of Acceptance Criteria and Reported Device Performance
The provided document does not explicitly state quantitative acceptance criteria in a table format for performance metrics like fat viability, purity, or recovery rate. Instead, it mentions that "Design verification tests were performed based on the risk analysis and product requirements, and the results of these tests demonstrate that the Ranfac FATS Procedure Pack is adequately designed for the intended use indicated."
The "Performance Data" section lists the types of tests conducted:
- Fluid transfer into and from the process disposable: This would likely involve ensuring efficient and sterile movement of fluids within the system.
- Centrifugation tests: This would assess the device's ability to withstand centrifugation and effectively separate components.
- Data to support conformance with applicable requirements of ISO 7886-1:1993: This standard relates to sterile hypodermic syringes for single use. Conformance would imply meeting specified dimensional, functional, and material requirements for syringes.
- Simulated use: This testing would mimic the actual surgical procedure to confirm the device performs as expected.
- Biocompatibility testing: Performed in compliance with ANSI/AAMI/ISO 10993-1: 2009, demonstrating that the materials are suitable for contact with human tissue.
2. Sample Size Used for the Test Set and Data Provenance
The document does not specify the sample sizes used for the design verification tests. It mentions "tests" in plural, implying multiple units were tested, but no specific numbers are given.
The data provenance (country of origin, retrospective/prospective) is also not specified. Given this is a 510(k) submission, the tests were likely conducted by the manufacturer (Ranfac Corp., located in Avon, Massachusetts, USA) as part of their product development and regulatory submission process. It's prospective testing for this specific device.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
This information is not applicable and not provided in the document. The performance tests described (fluid transfer, centrifugation, ISO compliance, biocompatibility, simulated use) are objective engineering and material science tests, not assessments requiring expert "ground truth" in a clinical diagnostic sense. There is no mention of experts establishing a ground truth for these tests.
4. Adjudication Method for the Test Set
Not applicable. As noted above, the tests are objective engineering and material science evaluations, not subjective assessments requiring adjudication by experts.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. The document explicitly states under "8. Clinical Data": "Not applicable." This type of study is typically associated with diagnostic imaging devices or algorithms that involve human interpretation and would measure the impact of an AI on human reader performance. This device is a surgical procedure pack, not a diagnostic or interpretation-assistive device.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
This is not applicable as the Ranfac FATS Procedure Pack is a physical medical device (a surgical procedure pack), not a software algorithm. Therefore, "standalone" performance in the context of an algorithm is not a relevant concept for this device. Its performance is evaluated through its physical and functional attributes.
7. The Type of Ground Truth Used
For the engineering and material tests, the "ground truth" would be the established specifications, standards (e.g., ISO 7886-1:1993), and risk analysis requirements that the device is designed to meet. For biocompatibility, the ground truth is defined by the ANSI/AAMI/ISO 10993-1 standard. There is no clinical "ground truth" in terms of pathology or outcomes data presented here, as it's a 510(k) submission for a device based on substantial equivalence, not a clinical trial demonstrating efficacy against a disease outcome.
8. The Sample Size for the Training Set
Not applicable. This device is a physical sterile procedure pack, not an AI/ML algorithm that requires a training set.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as there is no training set for this type of device.
§ 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.