(395 days)
The MINISCAV™ waste gas evacuation apparatus is intended to remove patients' exhaled waste gases during procedures where analgesia is administered to a patient via inspiration of mixtures oxide and oxygen from a nitrous oxide / oxygen delivery device. Not intended for use with flammable anesthetic gases.
This device is intended for professional use only in healthcare facilities, clinics, and physician and dentist offices.
The MINISCAV™ is a small, portable, vacuum pump that generates a constant vacuum that can be connected via a standard flexible vacuum hose to nitrous oxide / oxygen delivery equipment. The vacuum hose is connected to the "vacuum / suction" nipple on exemplary equipment.
The MINISCAVIM is a diaphragm hermetically sealed pump with a fixed vacuum flow rate. The inlet line is connected to a flowmeter exhaust port of the nitrous oxide / oxygen delivery equipment which has an exhaust port for scavenging gases.
Here's an analysis of the acceptance criteria and study information for the MINISCAV™ device, based on the provided document:
The document describes a 510(k) premarket notification for the MINISCAV™ waste gas evacuation apparatus. This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than providing extensive clinical efficacy studies in the same way a PMA would. Therefore, the "study" mentioned here refers primarily to the non-clinical testing performed to show the device meets its performance specifications and is as safe and effective as the predicate.
1. Table of Acceptance Criteria and Reported Device Performance
The document doesn't explicitly state "acceptance criteria" in a tabulated format for each performance aspect. Instead, it describes various tests and what they demonstrated. I've extracted the implied criteria and the reported performance from the "Non-Clinical Testing Summary" and "Technology, Construction, Performance" sections.
| Acceptance Criteria Category | Specific Criterion / Requirement | Reported Device Performance |
|---|---|---|
| Electrical Safety | Compliance with AAMI/ANSI/ES60601-1 standard. | Demonstrated compliance with AAMI/ANSI/ES60601-1. |
| Electromagnetic Compatibility (EMC) | Compliance with IEC 60601-1-2 standard. | Demonstrated compliance with IEC 60601-1-2. |
| Durability - Continuous Running | Maintain specifications for at least 10,000 hours of continuous running. | Continuous running demonstrated the vacuum pump stays within its specifications for at least 10,000 hours. |
| Durability - Real-time Unit Life | Meet performance specifications after 2 years of use. | Real-time testing of the complete unit supports that the device meets its performance specifications after 2 years use. |
| Vacuum and Flow - Constant Vacuum | Provide a constant vacuum of |
§ 868.5430 Gas-scavenging apparatus.
(a)
Identification. A gas-scavenging apparatus is a device intended to collect excess anesthetic, analgesic, or trace gases or vapors from a patient's breathing system, ventilator, or extracorporeal pump-oxygenator, and to conduct these gases out of the area by means of an exhaust system.(b)
Classification. Class II (performance standards).