(526 days)
Ohmeda and North American Drager Waste Gas Scavenging Interfaces, Dryden SONRA, Gibeck-Dryden CO2 absorber, Ohmeda CO2 absorber
No
The device description focuses on mechanical components like valves, chambers, and filters for gas management, with no mention of AI or ML technologies.
No.
The device is intended for scavenging waste anesthetic gases and providing supplemental oxygen for the healthcare worker's environment, not for diagnosing, treating, or preventing a disease or condition in a patient.
No
The device is intended for scavenging waste anesthetic gases and providing supplemental oxygen. It does not perform any diagnostic functions.
No
The device description clearly details a physical manifold unit with valves, filters, and connections for breathing circuits, masks, and reservoir bags. It is a hardware device for gas scavenging and oxygen delivery.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to scavenge waste anesthetic gases and provide supplemental oxygen to patients during recovery from general anesthesia. This is a direct interaction with the patient's respiratory system and environment, not the examination of specimens derived from the human body.
- Device Description: The device description details a mechanical system for gas flow, pressure regulation, and filtration. It does not describe any components or processes related to analyzing biological samples.
- Lack of IVD Indicators: The document does not mention any of the typical characteristics of an IVD, such as:
- Analysis of biological specimens (blood, urine, tissue, etc.)
- Detection or measurement of analytes
- Diagnostic purposes (identifying a disease or condition)
- Use in a laboratory setting for testing
The device is clearly designed for use in a clinical setting to manage anesthetic gases and provide respiratory support to patients. This falls under the category of a medical device, but not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The SafeCircuit Manifold/Pulmonary Unit, is intended to scavenging of waste anesthetic gases from patients recovery for general anesthesia and provide supplemental oxygen. When used with the SafeCircuit Adhesive mask and a standard breathing circuit. the unit helps to reduce the amount of anesthetic aqents and airborne contaminants released to the work environment of the healthcare worker.
Product codes (comma separated list FDA assigned to the subject device)
Not Found
Device Description
The SafeCircuit ManifoldPulmonary Unit is comprised of a single manifold unit which has been divided into two (2) halves or functional chambers which function to:
- Deliver supplemental oxygen during inhalation and,
- Scavenge the patient's exhaled breath.
The SafeCircuit Manifold / Pulmonary Unit incorporates directional valves similar to the directional valves of the standard CO2 absorber system of anesthesia gas machines and the Dryden disposable CO absorber to establish the inhalation flow of gases.
In addition, as required in the Standard Specification for Anesthetic Equipment - Scavenging Systems for Anesthetic Gases. ASTM 1343-91. there must be a means to relieve excess positive and negative pressures. The SafeCircuit Manifold utilizes relief valves, similar to the Ohmeda Waste Gas unit and the Dryden SONRA, which will -
- "Pop-off" or release any excess positive pressure on the exhalation side into the room should there be excess positive pressures. (Labeled EPPRV)
- Entrain room air, should there be excess negative pressure from the vacuum so that this excess negative pressure is not directed toward the patient circuit. (Labeled ENPRV)
In order to provide safe and effective oxygen delivery / inhalation unit, the use of excess positive and negative pressure relief valves are also incorporated in the inhalation side of the patient circuit. In this case they function to perform when -
- Insufficient or no flow of oxygen occurs then, the patient can entrain room air, 21% oxygen through the excess negative pressure valve. (Labeled INPRV)
- If there is excess oxygen flow, then the excess positive pressure valve will "pop-off" and the excess flow and / or pressure relieved to the outside. (Labeled IPPRV)
The method of connecting the SafeCircuit Manifold to the patient is via a standard breathing circuit which is comprised of two (2) tubes, wye piece to connect to a mask and a reservoir bag to collect excess gases and allow for manual ventilation if required. This circuit would connect to the SafeCircuit Adhesive Mask, approved K950771, to provide an effective seal between the patient's face / airway and the SafeCircuit Manifold. As on the Waste Gas Interface Systems of Ohmeda a scavenging reservoir bag, with 19 / 30 mm fitting, is utilized, the SafeCircuit Manifold/ Pulmonary Unit will also have this overflow (expiratory) reservoir bag. It is intended to utilize a 30 mm fitting for this scavenge reservoir bag as the proposed international, ISO, standard is 30 mm.
The unit has also incorporated filters at the back of the unit at each excess relief condition port opening to fitter the air released to the environment or entrained when excess positive or negative oressure conditions occur. These filters are to reduce any airborne contaminants, dust, dirt from the air entrained or released during exhalation.
The SafeCircuit Manifold/Pulmonary Unit is designed to be mounted on the wall or on a pole so that the device can be conveniently located next to the patient and various wall outlets - oxygen and vacuum.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
adult and pediatric patients
Intended User / Care Setting
post anesthesia recovery room which may be located in a hospital, outpatient surgery center or equivalent facility where patients are observed and monitored following anesthesia.
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Ohmeda and North American Drager Waste Gas Scavenging Interfaces, Dryden SONRA, Gibeck-Dryden CO2 absorber, Ohmeda CO2 absorber
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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).
0
July 12, 1995
| Advanced Warming Systems, Inc.
3414 - 22nd St.
Lubbock, TX 79410 | Tel - (806) 796-1246
Fax - (806) 793-8030 |
|------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------|
| Official Contact: | Randy Hickle, M.D., President |
| Proprietary or Trade name: | SafeCircuit Manifold / Pulmonary Unit |
| Common / Usual name: | Gas scavenging apparatus |
| Classification name: | Gas scavenging apparatus |
| Intended device: | SafeCircuit Manifold / Pulmonary Unit |
| Predicate devices: | Ohmeda and North American Drager Waste Gas Scavenging
Interfaces; Dryden SONRA, Gibeck-Dryden CO2 absorber,
Ohmeda CO2 absorber |
Device description:
The SafeCircuit ManifoldPulmonary Unit is comprised of a single manifold unit which has been divided into two (2) halves or functional chambers which function to:
- Deliver supplemental oxygen during inhalation and,
-
- Scavenge the patient's exhaled breath.
The SafeCircuit Manifold / Pulmonary Unit incorporates directional valves similar to the directional valves of the standard CO2 absorber system of anesthesia gas machines and the Dryden disposable CO absorber to establish the inhalation flow of gases.
- Scavenge the patient's exhaled breath.
In addition, as required in the Standard Specification for Anesthetic Equipment - Scavenging Systems for Anesthetic Gases. ASTM 1343-91. there must be a means to relieve excess positive and negative pressures. The SafeCircuit Manifold utilizes relief valves, similar to the Ohmeda Waste Gas unit and the Dryden SONRA, which will -
- "Pop-off" or release any excess positive pressure on the exhalation side into the room should there be excess positive pressures. (Labeled EPPRV)
- Entrain room air, should there be excess negative pressure from the vacuum so that this excess negative pressure is not directed toward the patient circuit. (Labeled ENPRV)
1
July 12, 1995
Device description (continued):
In order to provide safe and effective oxygen delivery / inhalation unit, the use of excess positive and negative pressure relief valves are also incorporated in the inhalation side of the patient circuit. In this case they function to perform when -
- Insufficient or no flow of oxygen occurs then, the patient can entrain room air, 21% oxygen through the excess negative pressure valve. (Labeled INPRV)
- If there is excess oxygen flow, then the excess positive pressure valve will "pop-off" and the excess flow and / or pressure relieved to the outside. (Labeled IPPRV)
The method of connecting the SafeCircuit Manifold to the patient is via a standard breathing circuit which is comprised of two (2) tubes, wye piece to connect to a mask and a reservoir bag to collect excess gases and allow for manual ventilation if required. This circuit would connect to the SafeCircuit Adhesive Mask, approved K950771, to provide an effective seal between the patient's face / airway and the SafeCircuit Manifold. As on the Waste Gas Interface Systems of Ohmeda a scavenging reservoir bag, with 19 / 30 mm fitting, is utilized, the SafeCircuit Manifold/ Pulmonary Unit will also have this overflow (expiratory) reservoir bag. It is intended to utilize a 30 mm fitting for this scavenge reservoir bag as the proposed international, ISO, standard is 30 mm.
The unit has also incorporated filters at the back of the unit at each excess relief condition port opening to fitter the air released to the environment or entrained when excess positive or negative oressure conditions occur. These filters are to reduce any airborne contaminants, dust, dirt from the air entrained or released during exhalation.
The SafeCircuit Manifold/Pulmonary Unit is designed to be mounted on the wall or on a pole so that the device can be conveniently located next to the patient and various wall outlets - oxygen and vacuum.
Intended use:
The SafeCircuit Manifold/Pulmonary Unit, is intended to scavenging of waste anesthetic gases from patients recovery for general anesthesia and provide supplemental oxygen. When used with the SafeCircuit Adhesive mask and a standard breathing circuit. the unit helps to reduce the amount of anesthetic aqents and airborne contaminants released to the work environment of the healthcare worker.
Indicated population and environment:
The SafeCircuit Manifold/Pulmonary Unit, is indicated for use with adult and pediatric patients recovering from general anesthesia. The environment is in the post anesthesia recovery room which may be located in a hospital, outpatient surgery center or equivalent facility where patients are observed and monitored following anesthesia.
2
July 12, 1995
| Attribute | SafeCircuit
Manifold | North American
Drager
Waste Gas
Interface | Ohmeda
Waste Gas
Interface | Dryden
SONRA | Gibeck-Dryden
CO2 absorber |
|----------------------------------------------------------------------------|---------------------------------------------------------------|----------------------------------------------------|----------------------------------|-----------------|-------------------------------|
| Use | | | | | |
| Scavenging waste
anesthetic gases | Yes | Yes | Yes | Yes | N/A |
| Delivers gases like
oxygen to patients | Yes | N/A | N/A | Yes | Yes |
| Indicated for adult / pediatric
patients | Yes | Yes | Yes | Yes | Yes |
| Indicated for extended use | Yes | Yes | Yes | Yes | No |
| Design | | | | | |
| Directional flow valves
inhalation / exhalation | Yes | No | No | Yes | Yes |
| Excess positive pressure
reliefs | Yes | Yes | Yes | Yes | N/A |
| Excess negative pressure
reliefs | Yes | Yes | Yes | Yes | N/A |
| Can entrain room air
during inhalation | Yes | N/A | N/A | Yes | N/A |
| Attribute | SafeCircuit Manifold | North American Drager
Waste Gas Interface | Ohmeda
Waste Gas Interface | Dryden SONRA | Gibeck-Dryden CO2 absorber |
| Can entrain room air to satisfy
excess negative pressure from
vacuum | Yes | Yes | Yes | Yes | N/A |
| Has patient inhalation reservoir
bag | Yes | N/A | N/A | Yes | Yes |
| Has overflow gas scavenging
(exhalation) reservoir bag | Yes | Yes | Yes | Yes | N/A |
| Connects to vacuum for
scavenging | Yes | Yes | Yes | Yes | No |
| Patient circuit fittings 22 mm | Yes | N/A | N/A | Yes | Yes |
| Scavenging fittings 19 /30 mm | Yes | Yes | Yes | Yes | Yes |
| Requires periodic maintenance | Yes | Yes | Yes | Yes | N/A |
| Provided non-sterile | Yes | Yes | Yes | Yes | Yes |
| Has filters at excess pressure
relief port openings | Yes | No | No | No | N/A |
| Materials | | | | | |
| Directional valves | SR, PE, PP | N/A | PE, PP | SR | SR |
| Attribute | SafeCircuit
Manifold | North American
Drager
Waste Gas
Interface | Ohmeda
Waste Gas
Interface | Dryden
SONRA | Gibeck-Dryden
CO2 absorber |
| Housing / body | ABS, PC, PP
PS, metal | ABS, metal | metal | PC,PS | PS,PC,ABS |
| 22 mm / 15 mm
ASTM 1054-87 | Yes | Yes | Yes | Yes | Yes |
| ASTM Scavenging
1343-91 | Yes | Yes | Yes | Yes | N/A |
| 5.3.1 Normal negative
pressure