(112 days)
Aesthetic body contouring. This Infiltration Pump is used to cause a flow of fluid from an IV bag into patient in a manner controlled manually by a health care professional.
The B89055 Vitruvian Infiltration Pump is intended to be used for aesthetic body contouring. Normal use includes general tumescent infiltration. It has a self-adjusting power converter which works with either 100V or 240V currents, and includes a pneumatic foot-switch and selfadjusting tubing guide to prevent tubing slippage during operation. It has a fully adjustable flow rate between 0 mL/min and 475 mL/min.
The Vitruvian Infiltration Pump is a pre-assembled device consisting of:
- Housing: ABS Plastic
- Power Operation: 100-240VAC, 50-60Hz, 1.8-1.0A
- Head: 3 roller peristaltic action
- Control: Knob used to set mL/min
- Display: LED
- Foot Switch: Air Powered ON/OFF
- Power Cord: Yes
The infiltration pump does not contact the patient.
This document is an FDA 510(k) premarket notification for the Vitruvian Infiltration Pump, which is a medical device. The purpose of a 510(k) is to demonstrate that the new device is "substantially equivalent" to a legally marketed predicate device. This process typically relies on comparing indications for use, technological characteristics, and performance data to the predicate device.
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria for the Vitruvian Infiltration Pump are primarily demonstrated through compliance with electrical safety standards and performance testing related to its function, particularly flow rate calibration. The document states compliance with general design and safety standards, and specifically mentions performance testing for flow rate.
| Acceptance Criteria / Standard | Reported Device Performance |
|---|---|
| IEC 60601-1:2005 (+ CORR. 1:2006 + CORR. 2:2007 + A1:2012 /IEC 60601-1: 2012 reprint) - Medical electrical equipment - Part 1: General requirements for basic safety and essential performance | Complies |
| ANSI/AAMI ES60601-1:2005 + A1:2012 + A2:2010, ed. 3.1 | Complies |
| CAN/CSA C22.2 No. 60601-1 Ed. 3 + A1(2014) | Complies |
| EN 60601-1:2006 + A1:2013 (2013) + A11 (2011), + A12 (2014) | Complies |
| IEC 60601-1-2:2007 (3rd Edition) - Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral standard: Electromagnetic compatibility - Requirements and tests | Complies |
| Vitruvian Infiltration Pump Flow Rate Display Calibration | Pass |
It's important to note that for a 510(k), the "acceptance criteria" are typically demonstrating substantial equivalence to a predicate, which often involves showing the new device performs as intended and meets relevant safety standards, rather than defining specific statistical endpoints for a comparative clinical study against a disease state.
2. Sample Size Used for the Test Set and the Data Provenance
The document does not specify a separate "test set" in the context of clinical data for algorithmic performance or diagnostic accuracy. The performance testing mentioned is for the device's functional characteristics (e.g., electrical safety, flow rate calibration). The data provenance for this functional testing is stated as "Performed at Manufacturing Facility." No patient-specific data or country of origin for such data is provided, as it is not a study involving patient outcomes or diagnostic outputs.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts
Not applicable. This is not a study assessing diagnostic accuracy or requiring expert-derived ground truth. The "ground truth" for the performance testing cited (electrical safety, flow rate calibration) would be the established engineering standards and specifications.
4. Adjudication Method for the Test Set
Not applicable. As noted above, this is not a study involving diagnostic accuracy and expert adjudication. The "adjudication" for the performance tests would be whether the device passed or failed the specified standard's requirements.
5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
Not applicable. The Vitruvian Infiltration Pump is an infiltration pump for aesthetic body contouring; it is not an AI-powered diagnostic or interpretive device that would involve human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. The Vitruvian Infiltration Pump is a medical device, not a standalone algorithm.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)
For the performance testing mentioned (IEC standards, flow rate calibration), the ground truth is established by the technical specifications and requirements of those international and national standards. For example, a flow rate calibration would involve comparing the pump's output to accurately measured fluid volumes over time, with the "ground truth" being the true measured flow rate.
8. The sample size for the training set
Not applicable. This is not an AI/ML device that requires a training set of data.
9. How the ground truth for the training set was established
Not applicable. This is not an AI/ML device that requires a training set of data.
§ 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.