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.

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

AI/ML Overview

This document describes the performance testing of the Genuine First Aid CPR Mask.

1. Table of Acceptance Criteria and Reported Device Performance

Performance Metric	Acceptance Criteria	Reported Device Performance
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)
In vitro cytotoxicity	Required (passes ISO10993-1,-5,-10)	Passes
Skin irritation	Required (passes ISO10993-1,-5,-10)	Passes
Delayed-type hypersensitivity	Required (passes ISO10993-1,-5,-10)	Passes

2. Sample Size and Data Provenance for Test Set

The provided document does not specify a distinct "test set" in the context of a typical AI/software device evaluation. The performance metrics listed (expiratory and inspiratory resistance) refer to a single device (the Genuine First Aid CPR mask) being tested against established industry standards. Biocompatibility testing results are also presented for the device.

There is no information on:

The sample size used for the resistance and biocompatibility tests.
The country of origin of the data.
Whether the data was retrospective or prospective.

3. Number of Experts and Qualifications for Ground Truth Establishment (Test Set)

Not applicable. This device is a physical medical device (CPR mask), not an AI or software device that requires expert-established ground truth for a test set. The performance is assessed against recognized engineering and biological standards.

4. Adjudication Method for Test Set

Not applicable. As noted above, this is a physical device, not an AI/software device requiring an adjudication process for ground truth.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

Not applicable. This device is a CPR mask and not an AI or imaging device for which MRMC studies are typically conducted to assess the impact of AI assistance on human readers.

6. Standalone Performance

Yes, standalone performance was done. The document directly reports the performance of the Genuine First Aid CPR mask for expiratory and inspiratory resistance, and biocompatibility in isolation, without involving human users for comparative analysis in these specific tests.

7. Type of Ground Truth Used

The "ground truth" for the performance criteria is based on:

Established industry standards: Specifically, ISO10651-4:2002 for lung ventilators (for resistance measurements) and ISO10993-1, -5, -10 for biological evaluation of medical devices (for biocompatibility). These international standards define the acceptable limits for the device's physical and biological properties.

8. Sample Size for Training Set

Not applicable. This is a physical medical device, not an AI/machine learning algorithm, and therefore does not have a "training set" in the sense of data used to train a model.

9. How Ground Truth for Training Set was Established

Not applicable. As this device does not involve an AI/machine learning model, there is no training set or associated ground truth establishment process.

Summary

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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:

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)

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Operation Temperature: -18°C~ 40°C

Storage Temperature: -30℃ ~ 50℃

Storage relative humidity: <85%

Indications For Use:

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,-10requirement	Testing results
vitro cytotoxicity	required	passes
skin irritation	required	passes
delayed-type	required	passes

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		--------------------
nvnersensitivity100 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 ofconstruction	Patient /rescuercontact	Contact time
One way valve	K-resin/silicone	mouth (rescuer)	3-60minutes
Face mask	PVC	Skin(Patient)	3-60minutes
Elastic strap	Non-woven	Hair/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-Conicalconnectors - Part1: Cones and sockets
ISO10651-4:2002	Lung ventilators-Part 4: Particular requirements foroperator-powered resuscitators
ISO10993-1:2003	Biological Evaluation of Medical Device-Part 1:evaluation and testing

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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.

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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 (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

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Indications for Use

510(k) Number (if known):

Device Name: _________________________________________________________________________________________________________________________________________________________________ Genuine First Aid CPR Face Mask

Indications For Use:

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

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Regulation Number and Section

§ 868.5870 Nonrebreathing valve.

(a)
Identification. A nonrebreathing valve is a one-way valve that directs breathing gas flow to the patient and vents exhaled gases into the atmosphere.(b)
Classification. Class II (performance standards).