CPR MICROMASK WITH OXYGEN INLET

K953414 · Plasco, Inc. · CBP · Mar 20, 1996 · Anesthesiology

Device Facts

• Record ID: K953414
• Device Name: CPR MICROMASK WITH OXYGEN INLET
• Applicant: Plasco, Inc.
• Product Code: CBP · Anesthesiology
• Decision Date: Mar 20, 1996
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 868.5870
• Device Class: Class 2
• Attributes: Therapeutic, Pediatric

Intended Use

A device used for mouth-to-mask treatment of respiratory failure.

Device Story

CPR MICROMASK is a pocket-sized, cushioned face mask for mouth-to-mask ventilation. Device features a one-way valve to deliver rescuer's exhaled air to patient while venting expired air and fluids away from rescuer. Includes oxygen inlet for supplemental oxygen delivery. Designed for adults; can be used on infants by rotating mask 180 degrees to accommodate facial contours. Used by trained rescuers in emergency settings to treat respiratory failure. Provides barrier protection between rescuer and patient.

Clinical Evidence

Bench testing only. Performance testing compared subject device to predicate across multiple parameters: flow resistance, transparency, face sealing, barrier effectiveness against vomitus, dead space, temperature effects, misassembly risk, human factors, and supplemental oxygen delivery.

Technological Characteristics

Cushioned face mask with one-way valve and oxygen inlet. Non-sterile. Materials comply with Tripartite Biocompatibility Guidance. Designed for manual operation; no energy source or software.

Indications for Use

Indicated for mouth-to-mask treatment of respiratory failure in adults and infants. Contraindicated for use by persons not trained in basic life saving skills or those with only a basic bystander course.

Regulatory Classification

Identification

A nonrebreathing valve is a one-way valve that directs breathing gas flow to the patient and vents exhaled gases into the atmosphere.

Predicate Devices

• Laerdal Medical Pocket Mask, Cat. No. 83-00-03 (K861401)

Submission Summary (Full Text)

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plasco, inc.
4080 MORRISON DRIVE • GURNEE, ILLINOIS 60031 • 708-662-4400
MAR 20 1996
510(k) SUMMARY

1. Submitted By:
Gary S. Botsford
Plasco, Inc. (Registration No. 1416598)
4080 Morrison Dr.
Gurnee, IL 60031
847-662-4400 Fax: [phone]

2. Date Prepared: 3/19/96

3. Name of Device:
Proprietary Name: CPR MICROMASK™ with Oxygen Inlet
Classification Name: Valve, Non-Rebreathing
Common/Unusual Name: Exhaled-air Pulmonary Resuscitator with Filter

4. Equivalent device:
Laerdal Medical Pocket Mask, Cat. No. 83-00-03 (K861401)

5. Device description:
The configuration of this pocket-sized device is a cushioned face mask used to enclose the patient's nose and mouth. A one-way valve allows the rescuer to provide exhaled air to the patient. The oxygen port will allow oxygen enhancement of the rescuer's exhaled air. Expired air and/or fluids from the patient is vented away from the rescuer due to the one-way valve and an alternate venting route.

The device comes in one size and is designed for adults but can be used on infants. By rotating the mask 180 degrees and placing the nose portion just below the infants' lower lip, the wider portion of the cushion rests on the forehead. The repositioning of the mask and the soft material of the mask cushion allows for a complete seal of the mask cushion to an infant's facial contours.

The device is non-sterile. It normally will be packaged in a polybag which may be placed in a zippered nylon pouch.

This device is not intended for use by persons not trained in basic life saving skills or those with only a basic bystander course.

6. Device use:
A device used for mouth-to-mask treatment of respiratory failure.

7. The CPR MICROMASK with Oxygen Inlet performs the same function and is technologically equivalent to the Laerdal Medical Pocket Mask, Cat. No. 83-00-03.

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plasco, inc.
4080 MORRISON DRIVE • GURNEE, ILLINOIS 60031 • 708-662-4400

510(k) SUMMARY - Page 2

8. Performance Testing:
The CPR MICROMASK with Oxygen Inlet was found equivalent to the Laerdal Medical Pocket Mask for the following:
- FLOW RESISTANCE
- FACE MASK TRANSPARENCY
- FACE SEALING
- EFFECT OF VOMITUS AND BARRIER EFFECTIVENESS
- DEAD SPACE
- EFFECTS OF TEMPERATURE
- POSSIBILITY OF MISASSEMBLY
- HUMAN FACTORS DESIGN AND INSTRUCTIONS
- SUPPLEMENTAL OXYGEN

9. The major patient/rescuer contact components complies with the Tripartite Biocompatibility Guidance for Medical Devices.

MAR-19-1996 15:00 FROM PLASCO INC TO 13014804204 P. 04