(136 days)
For rapid transcervical aspiration of the uterine cavity.
The Berkeley VC-10 Vacuum Curettage System uses aspiration to remove uterine contents through the cervix. The system includes the vacuum pump, collection containers, connection tubing, and patient contacting vacurettes. The vacuum pump is electrically powered and generates suction through vacuum pressure. The vacuum pump console is not provided sterile and is a multi-use device. The patient contacting vacurettes of the VC-10 system are provided as sterile, single use disposable devices.
Similar to the predicate device VC-10, the modified Berkeley VC-10 includes a high capacity. double diaphragm pump and motor, enclosed in a stainless steel cabinet. Collection canisters sit on top of the cabinet, and a large vacuum gauge and vacuum control knob are easily accessed on the top of the cabinet. A vacurette (available in various shapes and sizes) is attached to a collection set (includes a plastic swivel handle with a slip ring to control the vacuum and PVC tubing) and is attached to the patient port of the first collection container. Two accessories, which can be used to collect tissue, include a tissue trap, which is connected to the collection tubing and the collection container, or a gauze sack, which is placed inside the collection container. The modified VC-10 offers the same foot actuator pedal for vacuum supply.
The provided text describes a 510(k) premarket notification for the Berkeley VC-10 Vacuum Curettage System, focusing on a modification to the vacuum pump motor. This type of submission primarily demonstrates substantial equivalence to a predicate device rather than presenting a comprehensive study on diagnostic performance or AI effectiveness.
Therefore, many of the requested elements regarding acceptance criteria for diagnostic accuracy, sample sizes for AI training/testing, expert adjudication, MRMC studies, and ground truth establishment are not applicable or extractable from this document. The document describes acceptance criteria and testing for the functional performance and safety of the device itself, not for its diagnostic or interpretative capabilities.
Here’s what can be extracted based on the provided text, addressing the applicable points:
1. Table of Acceptance Criteria and Reported Device Performance
The document states that "All performance testing passed or met the pre-specified acceptance criteria." However, the exact numerical acceptance criteria are not explicitly stated in the provided text. Only the tests performed and the outcomes are mentioned broadly.
| Test Performed | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Maximum Measured Vacuum Pressure | Not explicitly stated in the document | Passed acceptance criteria |
| Free Flow Rate | Not explicitly stated in the document | Passed acceptance criteria |
| Time to Develop Vacuum | Not explicitly stated in the document | Passed acceptance criteria |
| Time to Reach Full Vacuum | Not explicitly stated in the document | Passed acceptance criteria |
| Time to Evacuate 1L w/ 7mm Curette | Not explicitly stated in the document | Passed acceptance criteria |
| Time to Evacuate 1L w/ 6mm Curette | Not explicitly stated in the document | Passed acceptance criteria |
| Electrical Safety (AAMI/ANSI ES 60601-1:2005/(R) 2012 and A1:2012) | Compliance with standards | Passed |
| EMC (IEC 60601-1-2 Edition 3: 2007-03) | Compliance with standards | Passed |
2. Sample Size Used for the Test Set and Data Provenance
The document does not describe a "test set" in the context of diagnostic accuracy, image analysis, or AI. The testing performed is bench performance testing of the device's physical functions. Therefore, information on sample size and data provenance in this context is not applicable/available.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
As this is not a study assessing diagnostic performance or AI, there were no "experts" establishing a "ground truth" for a test set in that sense. The "ground truth" for functional performance tests would be the established engineering specifications and physical measurements, determined by the device manufacturer's engineers.
4. Adjudication Method for the Test Set
Not applicable, as there is no diagnostic test set or human interpretation being evaluated.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No, an MRMC study was not done. This document does not describe the evaluation of human readers or AI assistance.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) Was Done
Not applicable. The device is a vacuum curettage system, not an AI algorithm. Its performance is entirely "standalone" in the sense that it performs physical actions.
7. The Type of Ground Truth Used
For the functional bench tests, the "ground truth" would be the pre-specified engineering and performance specifications that the device is designed to meet (e.g., specific vacuum pressure levels, flow rates, evacuation times). For electrical safety and EMC, the ground truth is compliance with the referenced international consensus standards (AAMI/ANSI ES 60601-1 and IEC 60601-1-2).
8. The Sample Size for the Training Set
Not applicable. This is not an AI/machine learning device.
9. How the Ground Truth for the Training Set Was Established
Not applicable. This is not an AI/machine learning device.
Summary of the Study and Device Performance:
The study described is a bench performance testing study conducted by the manufacturer (Gyrus ACMI, Inc.) to evaluate the functional and safety performance of the modified Berkeley VC-10 Vacuum Curettage System. The modification involved an upgrade to a 1/2 horsepower vacuum pump motor from a 1/3 horsepower motor.
The study aimed to demonstrate substantial equivalence of the modified device to its predicate (the original Berkeley VC-10) by showing that the technological differences (new motor) do not raise different questions of safety or effectiveness.
Tests performed included:
- Maximum Measured Vacuum Pressure
- Free Flow Rate
- Time to Develop Vacuum
- Time to Reach Full Vacuum
- Time to Evacuate 1L with 7mm Curette
- Time to Evacuate 1L with 6mm Curette
- Electrical Safety (according to AAMI/ANSI ES 60601-1)
- Electromagnetic Compatibility (EMC) (according to IEC 60601-1-2)
All performance testing passed or met the pre-specified acceptance criteria, and the device was found to be in compliance with the relevant electrical safety and EMC standards. This indicates that the modified device functions as intended and safely, maintaining substantial equivalence to the predicate device.
§ 884.5070 Vacuum abortion system.
(a)
Identification. A vacuum abortion system is a device designed to aspirate transcervically the products of conception or menstruation from the uterus by using a cannula connected to a suction source. This device is used for pregnancy termination or menstrual regulation. This type of device may include aspiration cannula, vacuum source, and vacuum controller.(b)
Classification. Class II (performance standards).