GENUINE FIRST AID CPR MASK

K112126 · Genuine First Aid, LLC · CBP · Dec 1, 2011 · Anesthesiology

Device Facts

• Record ID: K112126
• Device Name: GENUINE FIRST AID CPR MASK
• Applicant: Genuine First Aid, LLC
• Product Code: CBP · Anesthesiology
• Decision Date: Dec 1, 2011
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 868.5870
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The CPR mask (without oxygen port) is single use designed for mouth to mask ventilation to health emergency victims requiring cardiopulmonary resuscitation (CPR) rescue techniques of a non-breathing adult. It is also used as a barrier that will direct expired air from the patient away from the user. This device should only be used by persons who have received adequate training.

Device Story

Single-use CPR face mask; facilitates mouth-to-mask ventilation for non-breathing adults. Device acts as physical barrier; one-way valve directs patient's expired air away from rescuer. Components include PVC mask, K-resin/silicone one-way filter valve, and elastic strap. Used in emergency settings by trained personnel. Provides protection against cross-contamination during rescue breathing; ensures airway maintenance via standard 22mm connector. No electronic or software components.

Clinical Evidence

Bench testing only. Performance evaluated for inspiratory and expiratory resistance per ISO 10651-4:2002. Biocompatibility testing conducted per ISO 10993-1, -5, and -10 (cytotoxicity, skin irritation, delayed-type hypersensitivity). All tests passed.

Technological Characteristics

Materials: Medical grade PVC (mask), K-resin/silicone (one-way valve), non-woven (strap). Dimensions: 122mm x 100mm x 90mm. Connector: 22mm ID. Oxygen port: 6mm OD. Resistance: Inspiratory <2 cmH2O, Expiratory 3 cmH2O (at 50 L/min). Single-use, manual operation. Biocompatibility per ISO 10993.

Indications for Use

Indicated for mouth-to-mask ventilation of non-breathing adult victims requiring CPR. Intended for use by trained individuals as a barrier to direct expired air away from the rescuer.

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

• Medisource CPR Mask without Oxygen Port (K081516)
• LIV Medica CPR Face Mask (K052458)

Submission Summary (Full Text)

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K112126

# 510(k) SUMMARY

Nov. 28. 2011

DEC – 1 2011

Submitter: Genuine First Aid LLC 600 Cleveland Street Suite 400 Clearwater FL 33755, USA Office: [phone] Fax: Contact: Desiree Jacques

Contact/Consultant: Gary Lehnus Lehnus & Associates Consulting 150 Cherry Lane Rd East Stroudsburg, PA 18301 USA [phone] [phone]

Trade Name: Genuine First Aid CPR Mask

Common Name: Emergency CPR Mask

Classification Name: Valve, Non-Rebreathing Product Code: CBP Classification: Class II Panel: Anesthesiology Regulatory Classification: 21CFR 868.5870

Predicate Device: Medisource CPR Mask without Oxygen Port - K081516 LIV Medica CPR Face Mask - K052458

### Device Description:

Genuine First Aid CPR Face Mask without oxygen port, is made up of medical grade PVC and one-way valve of medical grade K-resin. The mask is used for mouth-to-mask breathing. There is a shield between the person who gives respiration and the victim.

Single use, CPR mask includes: One-way filter valve PVC mask without oxygen port Elastic Strap Packaged for easy portability and quick access

#### Specifications:

Dimensions: (122mm x 100mm x 90mm) mask connector 22mm ID oxygen port 6mm OD Inspiratory resistance: < < 5 cmH2O ( at 50 L/min ) Expiratory resistance: < < 5 cmH2O (at 50 L/min)

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Operation Temperature: -18°C~ 40°C

Storage Temperature: -30℃ ~ 50℃

Storage relative humidity: <85%

- Indications For Use: The CPR mask (without oxygen port) is single use designed for mouth to mask ventilation to health emergency victims requiring cardiopulmonary resuscitation (CPR) rescue techniques of a nonbreathing adult. It is also used as a barrier that will direct expired air from the patient away from the user. This device should only be used by persons who have received adequate training.

| Features | Medisource | Genuine First Aid CPR mask |
|------------------------|-------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------|
| Configuration | One piece | One piece |
| Use | Single | Single |
| Size | Adult | Adult |
| Material | PVC、silicone、Non-Woven | PVC、silicone、Non-Woven |
| Intended Use | Mouth to mask ventilation | mouth to mask ventilation |
| Ventilation | manual | manual |
| Oxygen port | None | None |
| Connector | Standard 22 mm | Standard 22 mm |
| Expiratory resistance | 1.94 cmH2O ( at 50 L/min) | 3 cmH2O ( at 50 L/min) |
| Inspiratory resistance | 2.04 cmH2O (at 50 L/min) | 2 cmH2O ( at 50 L/min) |
| Includes | Universal breathing tube<br>One-way filtered valve<br>Head strap<br>With or without oxygen port | Universal breathing tube<br>One-way filtered valve<br>Head strap<br>With or without oxygen port |

### Substantial Equivalency Summary

### PERFORMANCE TESTING

Biocompatibility testing:

| Biocompatibility test | ISO10993-1,-5,-10<br>requirement | Testing results |
|----------------------------------|----------------------------------|-----------------|
| vitro cytotoxicity | required | passes |
| skin irritation | required | passes |
| delayed-type<br>hypersensitivity | required | passes |

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Conclusion:

.

The potential for causing irritation is remote for the follow reasons:

- . The raw material and mask have been tested beyond the requirements of ISO10993 for skin contact.
- . The time of contact and percentage of body exposure is very low.
- The injection molding process does not significantly alter the raw material . characteristics

| Patient contact components description | | | |
|----------------------------------------|--------------------------|--------------------------|--------------|
| Device component | Material of construction | Patient /rescuer contact | Contact time |
| One way valve | K-resin/silicone | mouth (rescuer) | 3-60minutes |
| Face mask | PVC | Skin(Patient) | 3-60minutes |
| Elastic strap | Non-woven | Hair<br>/skin(Patient) | 3-60minutes |

Expiratory resistance and Inspiratory resistance performance testing was done using the test methods described in ISO10651-4:2002, Lung ventilators-Part 4: Particular requirements for operator-powered resuscitators.

| Device tested | Standard requirement | Genuine First Aid CPR mask |
|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------|----------------------------|
| Expiratory resistance | <5 cmH2O ( at 50 L/min) | 3 cmH2O ( at 50 L/min) |
| Inspiratory resistance<br>------------------------------------------------------------------------------------------------------------------------------------------------------------------------------<br>------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ | <5 cmH2O ( at 50 L/min) | 2 cmH2O ( at 50 L/min) |

## CONCLUSIONS:

The Genuine First Aid CPR mask without oxygen port is as safe and effective as the predicate device. It has the same or similar intended use, indications for use, technological characteristics, and principles of operation as those of the predicate device. The minor differences between the Genuine First Aid CPR mask with oxygen port and its predicate device raise no new issues of safety or effectiveness. Thus, the Genuine First Aid CPR mask without oxygen port is substantially equivalent to its predicate device.

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Public Health Service

DEC - 1 2011

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002

Genuine First Aid LLC C/O Mr. Gary Lehnus Official Correspondent Lehnus & Associates Consulting 482 Cherry Lane Road East Stroudsburg, Pennsylvania 18301

Re: K112126

Trade/Device Name: Genuine First Aid OTC CPR Face Mask Regulation Number: 21 CFR 868.5870 Regulation Name: Nonrebreathing Valve Regulatory Class: II Product Code: CBP Dated: November 10, 2011 Received: November 16, 2011

Dear Mr. Lehnus:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

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Page 2 – Mr. Lehnus

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices /ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely yours,

Arthman D. Martin

Anthony D. Watson, B.S., M.S., M.B.A. Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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# Indications for Use

· · 510(k) Number (if known):

Device Name: ____ Genuine First Aid OTC CPR Face Mask

## Indications For Use:

The CPR mask (without oxygen port) is single use designed for mouth to mask ventilation to health emergency victims requiring cardiopulmonary resuscitation (CPR) rescue techniques of a non-breathing adult. It is also used as a barrier that will (vect expired air from the patient away from the user. This device should only be used hy persons who have received adequate training.

Prescription Use (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use × (21 CFR 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (OIVD)

L. Schultheis

(Division Sign-Off) (Division Sign-On)
Division of Anesthesiology, General Hospital
Division of Anesthesiology, General Devices Division of Anton, Dental Devices

510(k) Number: K112126

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