(101 days)
The BRAVO series of Autoclaves are intended to be used in medical and dental practices, hospitals, clinics and other associated facilities to sterilize re-usable medical and dental instruments (including dental handpieces) and medical materials that are heat and moisture resistant and compatible with the steam sterilization process.
The BRAVO series of Autoclaves are not intended nor recommended for the sterilization of fluids, liquids, or pharmaceutical products.
The BRAVO series of Autoclaves are table-top vacuum steam sterilizers designed to process medical and dental instruments to achieve successful sterilization. The units utilize saturated steam at high pressures and temperatures to attain an effective kill of infectious bio-organisms.
BRAVO autoclaves are equipped with either a 17 or 21 litre sterilization chamber and feature an advanced fractionated vacuum system to achieve complete air removal from the sterilization chamber and effective final vacuum drying with an effective final vacuum to minimize the presence of condensation from the finished load.
Instruments are placed onto a sterilization tray which is then inserted into the sterilization chamber and the unit is closed. One of the ten pre-set sterilization cycles is selected and the unit is started. The units are fully automatic for the complete sterilizing cycle.
An exclusive steam generation system, combined with an advanced control system, guarantees optimal thermodynamic parameters during the entire sterilization process.
The devices offer sterilization programs optimized for the effective and fast sterilization of various instruments and materials used in the medical and dental environments. Depending on the preset cycle chosen, the devices will progress through a series of pulses which consist of one to three vacuum draws followed by pressurization to create steam in order to remove any air from the sterilization chamber. They will then maintain the projected sterilization time, vent down to atmospheric conditions and begin a heated vacuum dry cycle that will run for a predetermined period of time depending on the model as well as the cycle selected. The devices then return to atmospheric conditions so that the door can be opened to remove the processed load.
This document describes the BRAVO series of autoclaves (17, 17V, 21V) and formally requests its clearance by the FDA under 510(k) K090265. The submission highlights the device's technological characteristics, intended use, and substantial equivalence to a predicate device (M.O.C.O.M. Millennium series Autoclaves, K050263).
However, the provided text does not contain information about acceptance criteria or a study that proves the device meets specific performance criteria. The document is a 510(k) summary, which typically focuses on demonstrating substantial equivalence to a predicate device rather than presenting detailed performance study results against predefined acceptance criteria.
The tables in the document describe the available sterilization programs, their parameters (temperature, sterilization time, dry time), maximum load, and intended use. These are specifications of the device's functionality rather than acceptance criteria for a performance study.
Therefore, for the information requested regarding acceptance criteria and a study proving their fulfillment, the following can only be inferred as not present in the provided text:
1. Table of Acceptance Criteria and Reported Device Performance:
- Acceptance Criteria: Not explicitly stated in the provided text.
- Reported Device Performance: The document lists the operational parameters for each sterilization cycle (e.g., "134°C (273°F)" for "4 min." sterilization time, "16.5 min" dry time for "134 POROUS/WRAPPED" cycle). These are the designed performance parameters, not measured performance against specific acceptance metrics in a study. The document states that the devices "guarantees stable and homogeneous thermodynamic parameters during the entire sterilization process," but it doesn't provide data to support this claim, nor does it define what "stable and homogeneous" specifically means as an acceptance criterion.
2. Sample Size Used for the Test Set and Data Provenance:
- Sample Size: Not mentioned.
- Data Provenance (e.g., country of origin of the data, retrospective or prospective): Not mentioned.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications:
- Not applicable as no specific performance study with a test set and ground truth is described.
4. Adjudication Method for the Test Set:
- Not applicable.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done:
- No, an MRMC study is not mentioned. This type of study is more relevant for diagnostic devices where human interpretation is involved, not for an autoclave that performs a fixed sterilization cycle.
6. If a Standalone (algorithm only without human-in-the-loop performance) was done:
- While the autoclave operates autonomously, the document does not describe a "standalone performance study" in the context of an algorithm's performance. The device's operation is its standalone performance, and the parameters listed are its functional specifications.
7. The Type of Ground Truth Used:
- Not applicable as no specific performance study requiring ground truth is described. For an autoclave, "ground truth" would typically relate to successful sterilization (e.g., biological indicator kill rates). This information is not provided.
8. The Sample Size for the Training Set:
- Not applicable as this is not a machine learning or algorithm-based device that requires a training set.
9. How the Ground Truth for the Training Set was Established:
- Not applicable.
Summary of what is available from the document:
The provided text focuses on the functional specifications of the BRAVO autoclaves, establishing their intended use and claiming substantial equivalence to a predicate device. It describes the sterilization cycles (temperature, time, load capacity) but does not detail any specific performance studies with acceptance criteria, test sets, or ground truth data. Such information would typically be found in verification and validation reports, which are usually referenced or summarized within a 510(k) submission but are not fully elaborated in this summary.
The document implicitly relies on the fact that an autoclave, operating at specified temperatures and times, under validated conditions (which are not detailed here), is accepted as achieving sterilization. The submission leverages the predicate device's prior clearance and presumably similar technological characteristics and performance metrics.
§ 880.6880 Steam sterilizer.
(a)
Identification. A steam sterilizer (autoclave) is a device that is intended for use by a health care provider to sterilize medical products by means of pressurized steam.(b)
Classification. Class II (performance standards).