SAFETYMATE TALKING FIRST AID

{0}------------------------------------------------ 510(k) Pre-Market Notification SafetyMate, Inc. # EXHIBIT C # 510(k) Summary JUN 1 7 2011 SafetyMate, Inc. 1633 Monrovia Ave. Costa Mesa, California 92627 This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR §807.92. The assigned 510(k) number is: K110625. ### Submitter's Identification: | Submitter's name: | SafetyMate, Inc. | |-------------------------|------------------------------| | Address: | 1633 Monrovia Avenue | | | Costa Mesa, California 92627 | | Phone: | 949.722.1121 | | Fax: | 949.764.1774 | | Name of contact person: | Sharon Cohen, Ph.D. | | | Vice President | | | sharon@safetymate.com | | Phone: | 949.722.1121 | | Date Summary Prepared: | June 15, 2011 | #### 2. Name of the Device: Name of device: Classification name: New Product Code: Class: Regulation Number: Definition: Kit, first aid, talking OVR 1 878.4014 The device provides verbal instructions pertaining to various first aid and common medical emergencies. The device does not contain any drug or supporting device that could be applied to the patient. #### 3. Common or Usual Name: SafetyMate Talking First Aid #### 4. Predicate Device Information: The legally marketed device to which we are claiming equivalence [807.92(a)(3)]: SafetyMate, SM200 Series {1}------------------------------------------------ | Reference # | Device Name | Applicant | |-------------|------------------------------|-----------| | Exempt | 510(k) Exempt First Aid Kits | | | | Without Drugs | | ### 5. Device Description: SafetyMate® Talking First Aid, SM200 Series is a hand-held, interactive talking first aid guide for adult, child or infant emergencies. It includes eight themed first aid categories including CPR/Unconscious, Choking/Breathing, Allergic Reaction, Bleeding, Burns, Falls/Bone Injury, Poison/Bites/Stings, and Seizures. Besides providing guidance for what to do in case of an emergency, SafetyMate also highlights what not to do to prevent further injury. SafetyMate is designed to reinforce and remind users of the correct steps and procedures to provide established first aid care. #### 6. Intended Use: SafetyMate® Talking First Aid, SM200 Series is an electronic device intended for use to provide verbal information from established sources to refresh how to handle common medical emergencies through utilization of button options, voice queries and prompts which remind the user of important points in the management of identified emergency situations for infant, child, and adult emergencies. #### Comparison to Predicate Device: 7. ### Table #1 | Subject Area | SafetyMate, SM200 Series | First Aid Kit Without Drug<br>Predicates (510(k) Exempt) | Similar or<br>Different | |------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------| | Product Code | OVR (*the Agency created a<br>new product code to better<br>accommodate / define the subject<br>device) | OHO | Different | | Product<br>Classification | Class I | Class I | Similar | | Classification Name | Kit, talking, first aid | Non-Resorbable gauze<br>/sponge for external Use | Different | | Proprietary Name | SafetyMate, SM200 Series | First Aid Kit Without Drug | | | Intended Use | Talking First Aid<br>assistance | Supplies to be used | Similar | | Indications for Use | Intended for use as an<br>adjunct to first aid /<br>responder training and<br>information sources<br>through utilization of | Intended for use as an<br>adjunct to first aid offering<br>the user an external means of<br>absorbing body fluids in the<br>management of emergency | Different | | | voice queries and prompts<br>which remind the user of<br>important points in the<br>management of identified<br>emergency situations. | situation | | | Intended<br>Population | Infant, child and adult | Infant, child and adult | Similar | | Technological<br>features - Mode of<br>Operation | Electronic talking first aid<br>device. User selects one of<br>eight first aid categories.<br>Voice queries prompt<br>user to select age-<br>appropriate instructions. | No technological features | Different | | Design | Electronic audio aid in<br>performing CPR and<br>other first aid activities.<br>Audio beeps proper CPR<br>cadence with voice<br>prompt for breaths.<br>Software controlled.<br><br>Has eight user selection<br>buttons which guide the<br>user through the proper<br>first aid steps with audio<br>instructions. Voice queries<br>prompt user to select age<br>category. | Porous material used to soak<br>up liquid/bodily fluids.<br>Not software controlled. | Different | | Materials: | Plastic body with eight<br>button selections. Battery<br>powered. | Porous material. Not battery<br>powered. | Different | | Performance | First aid assistant device<br>with eight major first aid<br>arcas. | First aid assistant materials. | Different | | Specifications | Hand held device | Hand held product(s) | Different | | Mechanical Safety | None | None | Similar | | Chemical Safety | N/A | N/A | Similar | | Anatomical Sites | N/A | Wherever bodily fluid is<br>gushing | Different | | Human Factors | Designed for ease of use | Designed for ease of use | Similar | | Energy<br>Used/Delivered | Electrical none delivered | Electrical none delivered | Similar | | Compatibility with<br>the environment<br>and other devices | Standard luer connections<br>to administration devices | N/A | Different | | Where used | Home or office | Home or office | Similar | | Standards met | See Section I -- CDRH<br>Premarket Review<br>Submission Cover Sheet | Unknown | | | Electrical Safety | See Exhibit J | Unknown | | | Thermal safety | N/A | N/A | | | Radiation safety | N/A | N/A | | {2}------------------------------------------------ . ・ ﺴﻴ {3}------------------------------------------------ # 510(k) Pre-Market Notification SafetyMate, Inc. # 8. Discussion of Non-Clinical Tests Performed: | SM202 | Standard | Title | |-------|-------------------------------|-------------------------------------------------------------------------------------------------------------------------| | SM202 | EN 55014-1<br>EN 55022 | Electromagnetic compatibility –<br>Requirements for household<br>appliances and similar apparatus –<br>Part 1 Emissions | | SM202 | EN 55014-2<br>EN 61000-4-2 | Electromagnetic compatibility –<br>Requirements for household<br>appliances and similar apparatus –<br>Part 2 Immunity | | SM202 | FCC Part 15<br>Section 15.109 | Radiated Emission | ### Table #2 ### 9. Discussion of Clinical Tests Performed: Clinical usability and human factors studies were conducted to assess if SafetyMate Talking First Aid Device impairs appropriateness of care and/or speed to treat. Conclusions indicated that overall, no significant delays in treatment were noted. While there were a few instances in which changes to the protocols needed to be made to address points of confusion, either over word choice or clarity of instructions, those changes have been implemented and the issues have been answered. #### 10. Conclusions: {4}------------------------------------------------ Based on the design, technology, performance, functional testing, and intended use, the SafetyMate, SM200 series is substantially equivalent to the devices currently marketed under the Federal Food, Drug and Cosmetic Act. Usability studies indicate that 100% of the users were able to use the device correctly without any prompting from the observer. The human factors study addressed two questions: first, whether the use of an audio prompting device (in this case, a SafetyMate Talking First Aid device), in a simulated first aid emergency situation, caused a delay in treatment when compared to the same situation without a prompting device; and second, whether the use of a prompting device lead the subjects to render inappropriate care, in a simulated first aid emergency situation. While there were a few instances in which changes to the protocols needed to be made, those changes have been implemented and the issues have been answered. {5}------------------------------------------------ ## DEPARTMENT OF HEALTH & HUMAN SERVICES Image /page/5/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized image of an eagle or other bird with outstretched wings. The bird is facing to the right. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the bird. ### Public Health Service Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002 Sharon Cohen Ph.D Vice President SafetyMate, Incorporated 1633 Monrovia Avenue Costa Mesa, California 92627 ## JUN 1 7 2011 Re: K110625 Trade/Device Name: SafetyMate® Talking First Aid, SM200 Series Regulation Number: 21 CFR 878.4014 Regulation Name: Nonresorbable Gauze/Sponge for External use Regulatory Class: I Product Code: OVR Dated: May 10, 2011 Received: May 12, 2011 Dear Dr. Cohen: 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. {6}------------------------------------------------ ### Page 2- Dr. Cohen 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/AboutlFDA/CentersOffices/CDRH/CDRHOffices/ ucm 1 15809.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 (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. Sincerely vours. Antony D. Austin 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 {7}------------------------------------------------ ### Exhibit E ### Indications for Use Page __ 1__ of__ 1_ 510(k) Number (if known): K110625 SafetyMate® Talking First Aid, SM200 Series Device Name: Indications For Use: SafetyMate® Talking First Aid, SM200 Series is an electronic device intended for use to provide verbal information from established sources to refresh how to handle common medical emergencies through utilization of button options, voice queries and prompts which remind the user of important points in the management of identified emergency situations for infant, child, and adult emergencies. Prescription Use (Pet 21 CFR 801 Subpart D) OR Over-The Counter Use X (21 CFR 807 Subpart C) # (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE) NAT 6115/2011 "Weifing Gm for RZC. 6/1/2011 (Division Sign-Off) Division of Anesthesiology, General Hospital Infection Control, Dental Devices 510(k) Number: K110625