K Number

Validate with FDA (Live)

Device Name

SAFETYMATE TALKING FIRST AID

Manufacturer

SAFETYMATE, INC.

Date Cleared

2011-06-17

(105 days)

Product Code

Regulation Number

Type

Panel

Age Range

All

Reference & Predicate Devices

N/A

Predicate For

N/A

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.

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.

AI/ML Overview

Here's a summary of the acceptance criteria and the study that proves the device meets them, based on the provided text:

Device: SafetyMate® Talking First Aid, SM200 Series

1. Table of Acceptance Criteria and Reported Device Performance:

Acceptance Criteria (Stated Goal)	Reported Device Performance
Device does not impair appropriateness of care.	Clinical usability and human factors studies indicated that the use of a prompting device did not lead subjects to render inappropriate care in a simulated first aid emergency situation. While initial issues were noted, changes were implemented and addressed.
Device does not impair speed to treat (i.e., does not cause significant delays in treatment).	Clinical usability and human factors studies concluded that overall, no significant delays in treatment were noted. While initial issues were noted, changes were implemented and addressed.
Users are able to use the device correctly without prompting from an observer.	Usability studies indicated that 100% of the users were able to use the device correctly without any prompting from the observer.
Compliance with Electromagnetic Compatibility (Emissions)	The device met EN 55014-1, EN 55022, and FCC Part 15 Section 15.109 standards for Electromagnetic Compatibility (Emissions).
Compliance with Electromagnetic Compatibility (Immunity)	The device met EN 55014-2 and EN 61000-4-2 standards for Electromagnetic Compatibility (Immunity).

2. Sample Size Used for the Test Set and Data Provenance:

The document does not explicitly state the specific sample size used for the clinical usability and human factors studies (test set). It is referred to as "users" and "subjects" in the plural, but no number is given.

The provenance of the data (country of origin, retrospective/prospective) is not specified in the provided text. However, given the context of a 510(k) submission to the FDA, it's highly likely to be prospective studies conducted in the USA.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts:

The document does not specify the number of experts used or their qualifications to establish ground truth for the usability and human factors studies. The ground truth for correct first aid procedures would likely be based on established medical guidelines, but the method for assessing subject performance against this ground truth (e.g., observation by medical professionals or trained evaluators) is not detailed.

4. Adjudication Method for the Test Set:

The document does not describe a specific adjudication method (e.g., 2+1, 3+1). It states "Clinical usability and human factors studies were conducted to assess..." and "Conclusions indicated that overall, no significant delays in treatment were noted." This implies an assessment and conclusion were made, but the exact process of reaching consensus on "appropriateness of care" and "speed to treat" is not detailed.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size:

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not explicitly done in the traditional sense of comparing multiple human readers' diagnostic accuracy. The studies focused on human factors and usability of the device for first aid assistance, specifically comparing performance with the device versus without a prompting device to assess delays in treatment and appropriateness of care.

The "effect size" mentioned, while not a standard MRMC metric, indicates that the device did not cause significant delays and did not lead to inappropriate care, with 100% of users able to use the device correctly without prompting.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done:

No, a standalone performance study in the sense of an "algorithm only" without human interaction was not relevant or performed for this device. The SafetyMate® is an interactive, talking first aid guide that by its nature requires human interaction (selection of categories, response to voice prompts) to function. Its performance is inextricable from human-in-the-loop use.

7. The Type of Ground Truth Used:

The ground truth for the clinical usability and human factors studies implicitly relied on established best practices and protocols for first aid and common medical emergencies. The device itself "provides verbal information from established sources" and "reminds the user of important points in the management of identified emergency situations." The studies assessed whether users could correctly follow these established procedures with the device's assistance.

8. The Sample Size for the Training Set:

The document describes non-clinical tests for electromagnetic compatibility (EMC) and clinical usability/human factors studies for performance. It does not mention a "training set" in the context of machine learning. The device is an electronic talking first aid guide, not an AI/ML algorithm that requires a training set in the typical sense.

9. How the Ground Truth for the Training Set Was Established:

As there is no mention of a "training set" for an AI/ML algorithm, this question is not applicable. The information provided by the device (first aid instructions) is stated to be from "established sources."

Summary

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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

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Reference #	Device Name	Applicant
Exempt	510(k) Exempt First Aid Kits
	Without Drugs

5. Device Description:

6. Intended Use:

Comparison to Predicate Device: 7.

Table #1

Subject Area	SafetyMate, SM200 Series	First Aid Kit Without DrugPredicates (510(k) Exempt)	Similar orDifferent
Product Code	OVR (*the Agency created anew product code to betteraccommodate / define the subjectdevice)	OHO	Different
ProductClassification	Class I	Class I	Similar
Classification Name	Kit, talking, first aid	Non-Resorbable gauze/sponge for external Use	Different
Proprietary Name	SafetyMate, SM200 Series	First Aid Kit Without Drug
Intended Use	Talking First Aidassistance	Supplies to be used	Similar
Indications for Use	Intended for use as anadjunct to first aid /responder training andinformation sourcesthrough utilization of	Intended for use as anadjunct to first aid offeringthe user an external means ofabsorbing body fluids in themanagement of emergency	Different
	voice queries and promptswhich remind the user ofimportant points in themanagement of identifiedemergency situations.	situation
IntendedPopulation	Infant, child and adult	Infant, child and adult	Similar
Technologicalfeatures - Mode ofOperation	Electronic talking first aiddevice. User selects one ofeight first aid categories.Voice queries promptuser to select age-appropriate instructions.	No technological features	Different
Design	Electronic audio aid inperforming CPR andother first aid activities.Audio beeps proper CPRcadence with voiceprompt for breaths.Software controlled.Has eight user selectionbuttons which guide theuser through the properfirst aid steps with audioinstructions. Voice queriesprompt user to select agecategory.	Porous material used to soakup liquid/bodily fluids.Not software controlled.	Different
Materials:	Plastic body with eightbutton selections. Batterypowered.	Porous material. Not batterypowered.	Different
Performance	First aid assistant devicewith eight major first aidarcas.	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 isgushing	Different
Human Factors	Designed for ease of use	Designed for ease of use	Similar
EnergyUsed/Delivered	Electrical none delivered	Electrical none delivered	Similar
Compatibility withthe environmentand other devices	Standard luer connectionsto administration devices	N/A	Different
Where used	Home or office	Home or office	Similar
Standards met	See Section I -- CDRHPremarket ReviewSubmission Cover Sheet	Unknown
Electrical Safety	See Exhibit J	Unknown
Thermal safety	N/A	N/A
Radiation safety	N/A	N/A

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・

ﺴﻴ

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510(k) Pre-Market Notification

SafetyMate, Inc.

8. Discussion of Non-Clinical Tests Performed:

SM202	Standard	Title
SM202	EN 55014-1EN 55022	Electromagnetic compatibility –Requirements for householdappliances and similar apparatus –Part 1 Emissions
SM202	EN 55014-2EN 61000-4-2	Electromagnetic compatibility –Requirements for householdappliances and similar apparatus –Part 2 Immunity
SM202	FCC Part 15Section 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:

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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.

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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.

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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

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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:

Prescription Use (Pet 21 CFR 801 Subpart D)

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

Regulation Number and Section

§ 878.4014 Nonresorbable gauze/sponge for external use.

(a)
Identification. A nonresorbable gauze/sponge for external use is a sterile or nonsterile device intended for medical purposes, such as to be placed directly on a patient's wound to absorb exudate. It consists of a strip, piece, or pad made from open woven or nonwoven mesh cotton cellulose or a simple chemical derivative of cellulose. This classification does not include a nonresorbable gauze/sponge for external use that contains added drugs such as antimicrobial agents, added biologics such as growth factors, or is composed of materials derived from animal sources.(b)
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in part 807, subpart E of this chapter subject to the limitations in § 878.9.