CPR FACE MASK

{0}------------------------------------------------ # 510(k) SUMMARY KI 8846 12-2261 MAR 1 8 2011 Submitter: Genuine First Aid LLC 600 Cleveland Street Suite 400 Clearwater FL 33755, USA Office: (727) 449 2150 (727) 449 2145 Fax: Contact: Desiree Jacques Contact/Consultant: Gary Lehnus Lehnus & Associates Consulting 150 Cherry Lane Rd East Stroudsburg, PA 18301 USA (570) 620-0198 (570) 620-0199 Trade Name: Genuine First Aid CPR Mask Common Name: Emergency CPR Mask Classification Name: Valve, Non-Rebreathing Product Code: СВР Classification: Class II Panel: Anesthesiology 21CFR 868.5870 Requlatory Classification: Medisource CPR Mask with Oxygen Port - K081516 Predicate Device: #### Device Description: Genuine First Aid CPR Face Mask and oxygen port, made up of medical grade PVC and one-way valve made up 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 with 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) {1}------------------------------------------------ Operation Temperature: -18°C~ 40°C Storage Temperature: -30℃ ~ 50℃ Storage relative humidity: <85% ### Indications For Use: The Genuine First Aid CPR Face (with oxygen port) is single use designed for mouth to mask ventilation to health emergency victims requiring oxygen support (inhalation) or 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. #### Substantial Equivalency Summary | 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 | Oxygen port optional use | Oxygen port optional use | | Oxygen port | standard 6mm nipple | standard 6mm nipple | | 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 | Universal breathing tube | | | One-way filtered valve | One-way filtered valve | | | Head strap | Head strap | | | With or without oxygen port | With or without oxygen port | #### PERFORMANCE TESTING Biocompatibility testing: | Biocompatibility test | ISO10993-1,-5,-10<br>requirement | Testing results | |-----------------------|----------------------------------|-----------------| | vitro cytotoxicity | required | passes | | skin irritation | required | passes | | delayed-type | required | passes | {2}------------------------------------------------ | | | -------------------- | |------------------------------------|----------------------------------------------|------------------------------------------| | <br>nvnersensitivity<br>100 AM And | Property of Children Warrant of the Property | STATUTE OF CONSULTER COLLECTION OF CLAIM | | | | | ## 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 | Device component | Material of<br>construction | Patient /rescuer<br>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 | ## Patient contact components description 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. Some minor modifications were made to the methods | 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 | <5 cmH2O ( at 50 L/min) | 2 cmH2O ( at 50 L/min) | Recognized consensus standards | ISO5356-1:2004 | Anaesthetic and respiratory equipment-Conical<br>connectors - Part1: Cones and sockets | |-----------------|----------------------------------------------------------------------------------------| | ISO10651-4:2002 | Lung ventilators-Part 4: Particular requirements for<br>operator-powered resuscitators | | ISO10993-1:2003 | Biological Evaluation of Medical Device-Part 1:<br>evaluation and testing | {3}------------------------------------------------ Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized depiction of an eagle or bird-like figure with three curved lines representing its wings or feathers. To the left of the emblem, the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular pattern around the emblem. 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 Lehnus & Associates Consulting 150 Cherry Lane Road East Stroudsburg, Pennsylvania 18301 MAR 1 8 201 Re: K102299 Trade/Device Name: Genuine First Aid CPR Face Mask Regulation Number: 21 CFR 868.5870 Regulation Name: Nonbreathing Valve Regulatory Class: II Product Code: CBP Dated: March 11, 2011 Received: March 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. {4}------------------------------------------------ ## 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 (OS) 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/ReportalProblem/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 (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. Sincerely yours, dam L Rosotad for 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 {5}------------------------------------------------ # Indications for Use 510(k) Number (if known): Device Name: _________________________________________________________________________________________________________________________________________________________________ Genuine First Aid CPR Face Mask # Indications For Use: The Genuine First Aid CPR Face (with oxygen port) is single use designed for mouth to mask ventilation to health emergency victims requiring oxygen support (inhalation) or 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.. Prescription Use X (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) Y. Schutte (Division Sign-Off) Division of Anesthesiology, General Hospital Infection Control, Dental Devices 510(k) Number: k102299 Page 1_of _1_