SAFECIRCUIT MANIFOLD/PULMONARY UNIT

K953269 · Advanced Warming Systems, Inc. · CBN · Dec 20, 1996 · Anesthesiology

Device Facts

• Record ID: K953269
• Device Name: SAFECIRCUIT MANIFOLD/PULMONARY UNIT
• Applicant: Advanced Warming Systems, Inc.
• Product Code: CBN · Anesthesiology
• Decision Date: Dec 20, 1996
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 868.5430
• Device Class: Class 2
• Attributes: Therapeutic, Pediatric

Intended Use

The SafeCircuit Manifold/Pulmonary Unit, is intended to be used 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 agents and airborne contaminants released to the work environment of the healthcare worker.

Device Story

SafeCircuit Manifold/Pulmonary Unit functions as a gas scavenging apparatus and supplemental oxygen delivery system. Device connects to patient via standard breathing circuit and SafeCircuit Adhesive mask; utilizes reservoir bags for gas collection and manual ventilation. Manifold contains two functional chambers: one for oxygen delivery, one for scavenging exhaled breath. Incorporates directional valves to manage gas flow and relief valves to regulate pressure: positive pressure relief valves (IPPRV/EPPRV) release excess pressure; negative pressure relief valves (INPRV/ENPRV) entrain room air to prevent vacuum-induced negative pressure. Filters at relief ports reduce airborne contaminants. Device is wall or pole-mounted in recovery settings. Healthcare providers use the system to minimize anesthetic gas exposure to staff while supporting patient respiration post-anesthesia.

Clinical Evidence

Bench testing only. Device performance was validated against ASTM 1343-91 (scavenging systems) and ASTM 1054-87 (anesthetic equipment fittings) standards. Testing confirmed pressure relief valve functionality (positive/negative pressure limits), leakage rates (<100ml/min), and flow characteristics. No clinical data provided.

Technological Characteristics

Materials: ABS, PC, PP, PS, metal, and silicone rubber (SR). Sensing/Actuation: Mechanical directional and pressure relief valves. Energy: None (passive pneumatic). Connectivity: None. Form factor: Wall/pole-mounted manifold. Standards: ASTM 1343-91 (scavenging), ASTM 1054-87 (fittings), ISO 30mm fitting standard. Sterilization: Provided non-sterile.

Indications for Use

Indicated for adult and pediatric patients recovering from general anesthesia in post-anesthesia recovery rooms within hospitals, outpatient surgery centers, or equivalent facilities.

Regulatory Classification

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.

Predicate Devices

• Ohmeda Waste Gas Scavenging Interface
• North American Drager Waste Gas Scavenging Interface
• Dryden SONRA
• Gibeck-Dryden CO2 absorber

Submission Summary (Full Text)

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K953269

# Non-confidential Summary of Safety and Effectiveness

July 12, 1995


Advanced Warming Systems, Inc.
3414 - 22nd St.
Lubbock, TX 79410

Tel - [phone]
Fax - [phone]

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 Manifold/Pulmonary Unit is comprised of a single manifold unit which has been divided into two (2) halves or functional chambers which function to:

1) Deliver supplemental oxygen during inhalation and,
2) 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 CO₂ absorber to establish the inhalation / exhalation 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 -

1. "Pop-off" or release any excess positive pressure on the exhalation side into the room should there be excess positive pressures. (Labeled EPPRV)
2. 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)

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Non-confidential Summary of Safety and Effectiveness
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 -

1. Insufficient or no flow of oxygen occurs then, the patient can entrain room air, 21% oxygen through the excess negative pressure valve. (Labeled INPRV)
2. 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 filter the air released to the environment or entrained when excess positive or negative pressure 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 be used 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 agents 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.

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# Non-confidential Summary of Safety and Effectiveness

July 12, 1995

| Attribute | SafeCircuit Manifold | North American Drager Waste Gas Interface | Ohmeda Waste Gas Interface | Dryden SONRA | Gibeck-Dryden CO_{2} 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 |

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page 6 of 117
# Non-confidential Summary of Safety and Effectiveness

July 12, 1995

| Attribute | SafeCircuit Manifold | North American Drager Waste Gas Interface | Ohmeda Waste Gas Interface | Dryden SONRA | Glbeck-Dryden CO_{2} 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 |

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page 7 of 117
# Non-confidential Summary of Safety and Effectiveness

July 12, 1995

| Attribute | SafeCircuit
Manifold | North American
Drager | Ohmeda
Waste Gas | Dryden
SONRA | Gibeck-Dryden
CO_{2} absorber |
| --- | --- | --- | --- | --- | --- |
| | | Waste Gas
Interface | Interface | | |
| Housing / body | ABS, PC, PP
PS, metal | ABS, metal | metal | PC,PS | PS,PC,ABS |
| Performance Standards | | | | | |
| 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 < 0.5 cm | Yes | Yes | Yes | Yes | N/A |
| 5.3.2 Positive pressure ambient | Yes | Yes | Yes | Yes | N/A |
| 5.3.3 Positive w/ flush | Not applicable - no flush capabilities in intended environment | | | | |
| 5.3.4 Positive pressure occluded < 10 cm | Yes | Yes | Yes | Yes | N/A |
| 5.3.5 Positive, occluded, flush | Not applicable - no flush capabilities in intended environment | | | | |
| 5.4 Leakage < 100ml/min | Yes | Yes | Yes | Yes | N/A |
| ISO 8835.3.2 draft 30 mm | Yes | No | No | No | No |