Predicate Devices

SafetyMate, SM200 Series

Reference Devices

Exempt

AI/ML (Artificial Intelligence / Machine Learning)

No
The description focuses on providing pre-programmed verbal information based on button selections and voice queries, without mentioning any learning or adaptive capabilities.

Therapeutic

No.
The device provides verbal information and reminders for first aid care, but it does not directly treat or diagnose any medical condition.

Diagnostic

No

The device provides verbal information and guidance for first aid, reinforcing existing knowledge and reminding users of correct steps. It does not perform any assessment, measurement, or analysis of a patient's condition to determine the nature or cause of an illness or injury.

SaMD (Software as a Medical Device)

No

The device description explicitly states it is a "hand-held, interactive talking first aid guide," implying a physical hardware component. The performance studies also refer to it as a "device."

IVD (In Vitro Diagnostic)

Based on the provided information, this device is not an IVD (In Vitro Diagnostic).

Here's why:

IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
SafetyMate's Function: The SafetyMate device provides verbal information and guidance on how to handle common medical emergencies. It does not analyze any biological samples from the user or patient.
Intended Use: The intended use clearly states it provides "verbal information from established sources to refresh how to handle common medical emergencies." This is an educational and guidance function, not a diagnostic one.
Device Description: The description reinforces that it's an "interactive talking first aid guide" that provides "guidance for what to do in case of an emergency."
Lack of IVD Indicators: There is no mention of analyzing samples, detecting biomarkers, or any other activities typically associated with in vitro diagnostics.

Therefore, the SafetyMate Talking First Aid device falls outside the scope of an In Vitro Diagnostic device. It is more accurately described as a medical device providing educational and procedural guidance for emergency situations.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / 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.

Product codes (comma separated list FDA assigned to the subject device)

OVR

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.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

N/A

Indicated Patient Age Range

infant, child, and adult

Intended User / Care Setting

Home or office

Description of the training set, sample size, data source, and annotation protocol

Not Found

Description of the test set, sample size, data source, and annotation protocol

Not Found

Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)

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.
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.

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Not Found

Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.

SafetyMate, SM200 Series

Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.

Exempt

Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).

Not Found

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.

Summary

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
Predicates (510(k) Exempt) | Similar or
Different |
|------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------|
| Product Code | OVR (*the Agency created a
new product code to better
accommodate / define the subject
device) | OHO | Different |
| Product
Classification | 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 Aid
assistance | Supplies to be used | Similar |
| Indications for Use | Intended for use as an
adjunct to first aid /
responder training and
information sources
through utilization of | Intended for use as an
adjunct to first aid offering
the user an external means of
absorbing body fluids in the
management of emergency | Different |
| | voice queries and prompts
which remind the user of
important points in the
management of identified
emergency situations. | situation | |
| Intended
Population | Infant, child and adult | Infant, child and adult | Similar |
| Technological
features - Mode of
Operation | Electronic talking first aid
device. User selects one of
eight first aid categories.
Voice queries prompt
user to select age-
appropriate instructions. | No technological features | Different |
| Design | Electronic audio aid in
performing CPR and
other first aid activities.
Audio beeps proper CPR
cadence with voice
prompt for breaths.
Software controlled.

2

.

・

ﺴﻴ

3

510(k) Pre-Market Notification

SafetyMate, Inc.

8. Discussion of Non-Clinical Tests Performed:

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