The CPR Mask with Oxygen Port is designed to assist in providing immediate life support (mouth to mask ventilation) to health emergency victims requiring oxygen support (inhalation) or cardiopulmonary resuscitation (CPR) rescue techniques. The CPR Mask with Oxygen Port is intended for prescription use.

The CPR Mask without Oxygen Port is designed to assist in providing immediate life support (mouth to mask ventilation) to health emergency victims requiring cardiopulmonary resuscitation (CPR) rescue techniques. The CPR Mask without Oxygen Port is intended for over-the-counter use.

The Infant CPR Mask without Oxygen Port is designed to provide immediate life support (mouth to mask ventilation) to health emergency victims requiring cardiopulmonary resuscitation (CPR) rescue techniques. The Infant CPR mask is indicated for use on infants with body weight up to 10 kg (22 lbs). The Infant CPR Mask is intended for over-the-counter use.

The Non-Rebreathing Valve is a single-use, non-sterile device intended to be used with a ventilation mask to provide mouth-to-mask ventilation to health emergency victims requiring cardiopulmonary resuscitation (CPR) rescue techniques. It is intended for over-the-counter use.

Device Description

Compower Emergency CPR masks with non-rebreathing valves are designed to assist in providing immediate life support to health emergency victims requiring oxygen support and cardiopulmonary resuscitation rescue techniques. The devices subject to this 510(k) include the following: CPR Mask with Oxygen Port, CPR Mask without Oxygen Port, Infant CPR Mask without Oxygen Port, Non-Rebreathing Valve (15mmOD), Non-Rebreathing Valve (18.5mm).

CPR Mask with Oxygen Port: comprised of an air cushion, foldable mask cover with oxygen port, a non-rebreathing valve and an elastic head strap. Constructed of transparent polyvinyl chloride. Provided non-sterile and is intended for single use only.

CPR Mask without Oxygen Port: comprised of an air cushion, foldable mask cover, a non-rebreathing valve and an elastic head strap. Constructed of transparent polyvinyl chloride. Provided non-sterile and is intended for single use only.

Infant CPR Mask without Oxygen Port: comprised of an air cushion, mask cover and non-rebreathing valve. Constructed of transparent polyvinyl chloride. Provided non-sterile and is intended for single use only.

Non-Rebreathing Valve: a non-sterile, single-use device designed with a rigid styrene-butadiene copolymer housing, a silicone valve plate and polypropylene filter. Compatible for use with 22mm connectors used in standard ventilation masks. Designed with 15mmOD and 18.5mm ports.

AI/ML Overview

Here's a breakdown of the acceptance criteria and study information based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

The document presents performance data primarily in the context of comparison to predicate devices, rather than explicit acceptance criteria with pass/fail values. The "acceptance criteria" are implied by meeting or falling within ranges comparable to the predicate devices and adherence to relevant standards.

Comparison of Compower CPR Mask (with/without Oxygen Port) to KYOLING CPR Mask (Predicate)

Metric	Acceptance Criteria (Implied by Predicate & Standard)	Reported Compower CPR Mask Performance	Reported KYOLING CPR Mask Performance (Predicate)
Inspiratory Resistance Specification	≤0.5 kPa at 50 L/min (from AS 4259)	0.40 - 0.49 kPa at 50 L/min	0.30 - 0.31 kPa at 50 L/min
Expiratory Resistance Specification	≤0.5 kPa at 50 L/min (from AS 4259)	0.20 - 0.30 kPa at 50 L/min	0.31 - 0.32 kPa at 50 L/min
Biocompatibility - Cytotoxicity	Pass (ISO 10993-5)	Pass	Same (Implied by Predicate Comparison)
Biocompatibility - Sensitization	Pass (ISO 10993-10)	Pass	Same (Implied by Predicate Comparison)
Biocompatibility - Irritation	Pass (ISO 10993-10)	Pass	N/A (Not explicitly listed for predicate)
Standards Used	Conformance to ISO 5356-1 and AS 4259-1995	Conformance demonstrated	Conformance demonstrated
Visual Inspection	Implied to meet specifications	Passed	N/A
Dimensional Measurement	Implied to meet specifications	Passed	N/A
Transparency	Implied to meet specifications	Passed	N/A
Function after Contamination/Immersion	Implied to meet specifications	Passed	N/A
Performance After Storage and Aging	Implied to meet specifications	Passed	N/A
Mean Delivered Oxygen Concentration	Implied to meet specifications	Passed	N/A

Comparison of Compower Infant CPR Mask to EMS Child/Infant Mask (Primary Predicate) & Laerdal Paediatric Pocket Mask (Reference)

Metric	Acceptance Criteria (Implied by Predicate/Reference & Standard)	Reported Compower Infant CPR Mask Performance	Reported EMS Child/Infant Mask Performance (Predicate)	Reported Laerdal Paediatric Pocket Mask Performance (Reference)
Inspiratory Resistance Specification	<0.5 kPa at 50 L/min (from AS 4259)	0.46-0.48 kPa at 50 L/min	Not Known	0.32 kPa at 50 L/min
Expiratory Resistance Specification	<0.5 kPa at 50 L/min (from AS 4259)	0.27-0.29 kPa at 50 L/min	Not Known	0.42 kPa at 50 L/min
Dead Space	≤120 ml (AS 4259-1995)	44.4 ml	Not Known	90.5 ml
Biocompatibility - Cytotoxicity	Pass (ISO 10993-5)	Pass	Not Known	Not Known
Biocompatibility - Sensitization	Pass (ISO 10993-10)	Pass	Not Known	Not Known
Biocompatibility - Irritation	Pass (ISO 10993-10)	Pass	Not Known	Not Known
Standards Used	Conformance to ISO 5356-1 and AS 4259-1995	Conformance demonstrated	Conformance to ASTM 920-93 (other not known)	Conformance to ISO 5356-1 and AS 4259-1995

Comparison of Compower Non-Rebreathing Valve to Seal Rite™ Non-Rebreathing Valve (Predicate)

Metric	Acceptance Criteria (Implied by Predicate & Standard)	Reported Compower Non-Rebreathing Valve Performance	Reported Seal Rite™ Non-Rebreathing Valve Performance (Predicate)
Inspiratory Resistance Specification	≤0.5 kPa at 50 L/min (from AS 4259)	15mmOD: 0.46-0.49 kPa; 18.5mm: 0.46-0.48 kPa	0.113 kPa at 50 L/min
Expiratory Resistance Specification	≤0.5 kPa at 50 L/min (from AS 4259)	15mmOD: 0.26-0.30 kPa; 18.5mm: 0.26-0.30 kPa	0.0321 kPa at 50 L/min
Biocompatibility - Cytotoxicity	Pass (ISO 10993-5)	Pass	Pass
Biocompatibility - Sensitization	Pass (ISO 10993-10)	Pass	Pass
Biocompatibility - Irritation	Pass (ISO 10993-10)	Pass	Pass
Standards Used	Conformance to AS 4259-1995 and ISO 5356-1	Conformance demonstrated	Conformance demonstrated

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

The document does not explicitly state the sample size used for the test set for performance testing, nor does it detail the country of origin for the data or whether it was retrospective or prospective. The non-clinical testing was conducted to confirm conformance to specified requirements, implying internal laboratory testing.

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

N/A. This type of information (experts, ground truth for test set, qualifications) is typically relevant for studies involving subjective interpretation (e.g., medical imaging AI). For medical devices like CPR masks and valves, performance is assessed through objective, quantifiable non-clinical tests based on engineering standards.

4. Adjudication Method for the Test Set

N/A. Adjudication methods are typically used in clinical studies or studies requiring expert consensus for ground truth, which is not applicable to the non-clinical testing described for these devices.

5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

N/A. This is a non-AI medical device. MRMC studies are not applicable.

6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done

N/A. This is a non-AI medical device. Standalone algorithm performance is not applicable.

7. The type of ground truth used

For the non-clinical performance and biocompatibility testing, the "ground truth" was established by objective measurements against established international and national standards (ISO 5356-1, AS 4259-1995, ISO 10993 series) and product specifications. This means the device's performance was compared to predefined, quantifiable limits and characteristics outlined in these standards.

8. The sample size for the training set

N/A. There is no "training set" as this is not an AI/ML device. The device design and materials are based on established engineering principles and comparison to existing predicate devices.

9. How the ground truth for the training set was established

N/A. There is no "training set" or corresponding ground truth for this type of device.

Summary

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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food & Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, with the letters "FDA" in a blue square. Next to that is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

November 17, 2017

Xiamen Compower Medical Tech. Co. Ltd. % Lynn Jensen Principal Medical Research Manager, Regulatory Affairs NAMSA 400 Highway 169 South Suite 500 Minneapolis, Minnesota 55426

Re: K171961

Trade/Device Name: CPR Mask with Oxygen Port, CPR Mask without Oxygen Port, Infant CPR Mask without Oxygen Port, Non-Rebreathing Valve (15mmOD), Non-Rebreathing Valve (18.5mm) Regulation Number: 21 CFR 868.5870 Regulation Name: Nonrebreathing Valve Regulatory Class: Class II Product Code: CBP Dated: October 18, 2017 Received: October 19, 2017

Dear Lynn Jensen:

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.

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

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requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device 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 contact the Division of Industry and Consumer Education (DICE) at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevicesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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 Industry and Consumer Education (DICE) at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely,

Tara A. Ryan -S

for

Tina Kiang, Ph D

Tina Kiang, Ph.D. Acting Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control, and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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510(k) Number (if known) K171961

Device Name CPR Mask with Oxygen Port

The CPR Mask with Oxygen Port is designed to assist in providing immediate life support (mouth to mask ventilation) to health emergency victims requiring oxygen support (inhalation) or cardiopulmonary resuscitation (CPR) resue techniques. The CPR Mask with Oxygen Port is intended for prescription use.

Type of Use (Select one or both, as applicable)

Prescription Use (Part 21 CFR 801 Subpart D)

Over-The-Counter Use (21 CFR 801 Subpart C)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2020 See PRA Statement below.

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510(k) Number (if known) K171961

Device Name CPR Mask without Oxygen Port

Type of Use (Select one or both, as applicable)

Prescription Use (Part 21 CFR 801 Subpart D)

Over-The-Counter Use (21 CFR 801 Subpart C)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

*DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW."

Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2020 See PRA Statement below.

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510(k) Number (if known) K171961

Device Name Infant CPR Mask without Oxygen Port

Indications for Use (Describe)

The Infant CPR Mask without Oxygen Port is designed to assist in providing immediate life support (mouth to mask ventilation) to health emergency victims requiring cardiopulmonary resuscitation (CPR) rescue techniques. The Infant CPR Mask is indicated for use on infants with body weight up to 10 kg (22 lbs). The Infant CPR Mask is intended for over-the-counter use.

Type of Use (Select one or both, as applicable)

Prescription Use (Part 21 CFR 801 Subpart D)

Over-The-Counter Use (21 CFR 801 Subpart C)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.

Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

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510(k) Number (if known) K171961

Device Name Non-Rebreathing Valve (15mmOD)

Indications for Use (Describe)

The Non-Rebreathing Valve is a single-use, non-sterile device intended to be used with a ventilation mask to provide mouth-to-mask ventilation to health emergency victims requiring cardiopulmonary resuscitation (CPR) resue techniques. It is intended for over-the-counter use.

Type of Use (Select one or both, as applicable)

] Prescription Use (Part 21 CFR 801 Subpart D)

X Over-The-Counter Use (21 CFR 801 Subpart C)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.

Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

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510(k) Number (if known) K171961

Device Name Non-Rebreathing Valve (18.5mm)

Type of Use (Select one or both, as applicable)

Prescription Use (Part 21 CFR 801 Subpart D)

Over-The-Counter Use (21 CFR 801 Subpart C)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

*DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW."

Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

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510(k) Summary K171961

In accordance with 21 CFR 807.92 the following summary of information is provided:

I. SUBMITTER NAME

Xiamen Compower Medical Tech Co Ltd. 3F, No.16-1 Xianghong Road, Xiang'An Torch Industrial Zone, Xiamen, 361101, China Phone: +86-13306000572 Primary Contact Person: Lynn Jensen - NAMSA Regulatory Affairs Phone: 651-206-6530 Date Submitted: October 18, 2017

II. DEVICE

Name of Device: CPR Mask with Oxygen Port CPR Mask without Oxygen Port Infant CPR Mask without Oxygen Port Non-Rebreathing Valve (15mmOD) Non-Rebreathing Valve (18.5mm) Common/Usual Names: CPR Mask / Non-Rebreathing Valve Classification Name: Non-Rebreathing Valve Regulation Class: II Regulation Number: 868.5870 Product Code: CBP Panel: Anesthesiology

III. PREDICATE/REFERENCE DEVICES

Kyoling CPR Mask with Oxygen Port (Prescription Use) K142764 Decision ● Date: July 9, 2015
. Kyoling CPR Mask without Oxygen Port (Over the Counter Use) K142764 -Decision Date: July 9, 2015
Engineered Medical Systems Child/Infant Facemask with Non-Rebreathing ● Valve (Over the Counter Use) K983919 - Decision Date: April 7, 1999 (Primary Predicate)
Laerdal Paediatric Pocket Mask (Model 820050) K023805 Decision Date: ● February 11, 2003 (Reference Device)
Seal Rite™ Non-Rebreathing Valve (Over the Counter Use) K152521 -● Decision Date: June 3, 2016

IV. DEVICE DESCRIPTION

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CPR Mask with Oxygen Port

The CPR Mask with Oxygen Port is comprised of an air cushion, foldable mask cover with oxygen port, a non-rebreathing valve and an elastic head strap. The air cushion is designed to promote an airtight seal with the patient's face and the oxygen port allows for the delivery of supplemental oxygen to the patient. The mask is constructed of transparent polyvinyl chloride and is fitted with a non-rebreathing valve designed for resuscitation and providing a physical barrier between the rescuer and patient. The CPR Mask with Oxygen Port is indicated for prescription use. The device is provided non-sterile and is intended for single use only.

CPR Mask without Oxygen Port

The CPR Mask without Oxygen Port is comprised of an air cushion, foldable mask cover, a non-rebreathing valve and an elastic head strap. The air cushion is designed to promote an airtight seal with the patient's face during use. The mask is constructed of transparent polyvinyl chloride and is fitted with a non-rebreathing valve designed for resuscitation and to provide a physical barrier between the rescuer and patient. The CPR Mask without Oxygen Port is indicated for over the counter use. The device is provided non-sterile and is intended for single use only.

Infant CPR Mask without Oxygen Port

The Infant CPR Mask is comprised of an air cushion, mask cover and non-rebreathing valve. The air cushion is designed to promote an airtight seal with the patient's face during use. The mask is constructed of transparent polyvinyl chloride and is fitted with a non-rebreathing valve designed for resuscitation and to provide a physical barrier between the rescuer and patient. The Infant CPR Mask is indicated for over the counter use. The device is provided non-sterile and is intended for single use only.

Non-Rebreathing Valve

The Non-Rebreathing Valve is a non-sterile, single-use device is designed with a rigid styrene-butadiene copolymer housing, a silicone valve plate and polypropylene filter. The valve is compatible for use with 22mm connectors used in standard ventilation masks. During use, the rescuer blows air into the non-rebreathing valve that is filtered and breathed by the patient. The patient's expiratory breath is directed through an open hole on the side of the valve and is prevented from flowing back to the rescuer by the silicone valve. The Non-Rebreathing Valve is designed with 15mmOD and 18.5mm ports and is indicated for over the counter use.

V. INDICATION FOR USE

CPR Mask with Oxygen Port

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CPR Mask without Oxygen Port

Infant CPR Mask without Oxygen Port

Non-Rebreathing Valve (15mmOD)

Non-Rebreathing Valve (18.5mm)

VI. SUBSTANTIAL EQUIVALENCE

The following information supports the substantial equivalence of Xiamen Compower Medical Tech Co Ltd devices described in this premarket notification as compared to predicate and reference devices cleared for marketing.

	Compower CPR MaskSubject Device	KYOLING CPR MaskPredicate Device
Manufacturer	Xiamen Compower MedicalTech Co Ltd	Hangzhou Jinlin MedicalAppliances Co. Ltd
Device Name	Compower CPR Mask	KYOLING CPR Mask
510(k) Number	K171961	K142764
Product Code	CBP	CBP
FDA Classification	868.5870	868.5870
Indications for Use -With Oxygen Port	The CPR Mask with OxygenPort is designed to assist inproviding immediate lifesupport (mouth to maskventilation) to healthemergency victims requiringoxygen support (inhalation) orcardiopulmonary resuscitation	Same
	Compower CPR Mask	KYOLING CPR Mask
	Subject Device	Predicate Device
Indications for Use -Without Oxygen Port	(CPR) rescue techniques. TheCPR Mask with Oxygen Port isintended for prescription use.The CPR Mask withoutOxygen Port is designed toassist in providing immediatelife support (mouth to maskventilation) to healthemergency victims requiringcardiopulmonary resuscitation(CPR) rescue techniques. TheCPR Mask without OxygenPort is intended for over-the-counter use.	Same
How Provided	Mask (with or without oxygenport), non-rebreathing valveand head strap.Non Sterile	Mask (with or withoutoxygen port), universalbreathing tube, non-rebreathing valve with filterand head strap.Non Sterile
Inspiratory ResistanceSpecification ≤0.5 kPa at50 L/min	$0.40 - 0.49$ kPa at 50 L/min	$0.30 - 0.31$ kPa at 50 L/min
Expiratory ResistanceSpecification ≤0.5 kPa at50 L/min	$0.20 - 0.30$ kPa at 50 L/min	$0.31 - 0.32$ kPa at 50 L/min
Device Materials	Face Mask: PVCValve Housing: Rigid styrene-butadiene copolymer (K-resin)Valve Plate: SiliconeFilter: Polypropylene	Face Mask: PVCValve Housing: Rigid plastic(K-resin)Valve Plate: SiliconeFilter: Not Known
Dimensions	Length: 124 mmWidth: 99 mm	Length: 122 mmWidth: 99 mm
Standards Used toSupport Design andPerformance Testing	ISO 5356-1: Anaesthetic andrespiratory equipment- Conicalconnectors-Part 1: Cones andSocketsAS 4259-1995-Ancillarydevices for expired airresuscitation	Same
Biocompatibility TestingConducted	ISO 10993-5 - CytotoxicityISO 10993-10 - Sensitization	Same
	Compower CPR MaskSubject Device	KYOLING CPR MaskPredicate Device
	ISO 10993-10 - Irritation
How Used	Single Use	Single Use
How Packaged	Hard or Soft Carrying Case	Hard Carrying Case

Comparison of Subiect and Predicate CPR Mask With and Without Oxygen Port

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There were no significant differences noted between the Compower CPR Mask with and without Oxygen Port and the corresponding predicate devices that would raise new issues of safety and efficacy of the Compower CPR masks for their intended use. The subject devices have the same indications for use and the same or similar technological characteristics, principles of operation, components, material composition, performance compliance and biological safety compliance as the predicate devices.

The inspiratory resistance and expiratory resistance values are not the same between the subject and predicate devices. The differences can be explained due to slightly different design features of the non-rebreathing valves. These differences do not raise new issues of safety and efficacy as inspiratory and expiratory requirements of AS 4259 were met by all the subject and predicate devices.

The Compower CPR Masks with and without Oxygen Port are substantially equivalent to the predicate Kyoling CPR Masks with and without Oxygen Port.

	Compower InfantCPR MaskSubject Device	EMSChild/InfantMaskPrimaryPredicate	Laerdal PaediatricPocket MaskReference Device
Manufacturer	Xiamen CompowerMedical Tech CoLTD	EngineeredMedical SystemsEMS	Laerdal Medical A/S
Device Name	Compower InfantCPR Mask	EMS CPR MaskChild/Infant	Laerdal PaediatricPocket Mask
510(k) Number	K171961	K983919	K023805
Product Code	CBP	CBP	CBP
FDA RegulatoryClassification	868.5870	868.5870	868.5870
Indications forUse	The Infant CPRMask is designed toprovide immediatelife support (mouthto mask ventilation)to health emergencyvictims requiringcardiopulmonaryresuscitation (CPR)rescue techniques.The Infant CPRmask is indicated for	Indicated toprovide assistedventilation tosomeonerequiring assistedventilation,breathing orresuscitation, byuse of a mouth tomask method.Patientpopulation is	Laerdal PaediatricPocket Mask is adevice designed formouth-to-maskventilation of a non-breathing child orinfant.
	Compower InfantCPR MaskSubject Device	EMSChild/InfantMaskPrimaryPredicate	Laerdal PaediatricPocket MaskReference Device
	use on infants withbody weight up to 10kg (22 lbs). TheInfant CPR Mask isintended for over-the-counter use.	child/infant andadult. Those withoxygen port areprescriptiondevices and thosewithout oxygenport are OTC.
InspiratoryResistanceSpecification<0.5 kPa at50 L/min	0.46-0.48 kPa at 50L/min	Not Known	0.32 kPa at 50 L/min
ExpiratoryResistanceSpecification<0.5 kPa at50 L/min	0.27-0.29 kPa at 50L/min	Not known	0.42 kPa at 50 L/min
Design	Transparent maskwith non-rebreathingvalve without oxygenport	-Transparent maskwith non-rebreathing valvewith and withoutoxygen port-Optional flextube extension	Transparent maskwith non-rebreathingvalve
Dimensions	Length: 80 mm (3.2")Width: 63 mm (2.5")Height: 86 mm (3.4")	Not Known	Circular: 102 mm (4")Height: 76 mm (3")
Dead Space(AS 4259-1995Specification ≤120 ml)	44.4 ml	Not Known	90.5 ml
DeviceMaterials	Face Mask: PVCValve Housing: Rigidstyrene-butadienecopolymer (K-resin)	Face Mask: PVCValve Housing:K-Resin	Face Mask: SiliconeValve Housing:Rigid Polycarbonate
	Valve Plate: SiliconeFilter Media:Polypropylene	Valve Plate:Synthetic RubberFilter Media:3M Filtrate
	Compower InfantCPR MaskSubject Device	EMSChild/InfantMaskPrimaryPredicate	Laerdal PaediatricPocket MaskReference Device
Standards Usedto SupportDesign andPerformanceTesting	ISO 5356-1:Anaesthetic andrespiratoryequipment- Conicalconnectors-Part 1:Cones and SocketsAS 4259-1995-Ancillary devices forexpired airresuscitation	ASTM 920-93Other standardsnot known.	ISO 5356-1:Anaesthetic andrespiratoryequipment- Conicalconnectors-Part 1:Cones and SocketsAS 4259-1995-Ancillary devices forexpired airresuscitation
BiocompatibilityTestingConducted	ISO 10993-5 -CytotoxicityISO 10993-10 -SensitizationISO 10993-10 -Irritation	Not Known	Not Known
How Used	Single Use	Single Use	Single Use
How Packaged	Cloth (Nylon) Bag	Clam Shell/ PolyBag	Cloth Bag
How Provided	Non Sterile	Non Sterile	Non-Sterile

Comparison of Subject and Predicate/Reference Infant CPR Mask

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The Compower Infant CPR Mask (subject device) and the EMS Child/Infant CPR mask without oxygen port (primary predicate device) are transparent molded CPR masks with non-rebreathing valves intended for over the counter use. The Compower Infant CPR Mask has the same intended use as the EMS Child/Infant CPR Mask but specifies a more limited indication for use with infants up to 10 kg.

The Compower Infant CPR Mask with Non-Rebreathing Valve has the same intended use, same or similar materials, technological characteristics, principles of operation and components as compared to the primary predicate EMS Child/Infant CPR Mask with Non-Rebreathing Valve. The subject device also demonstrates similar performance characteristics to the Laerdal Pediatric Pocket Mask reference device.

The inspiratory resistance and expiratory resistance values are not the same between the subject and reference device. The differences can be explained due to slightly different design features of the non-rebreathing valves. These differences do not raise new issues of safety and efficacy as inspiratory and expiratory requirements of AS 4259 were met by the subject and reference device.

There were no significant differences noted between the Compower Infant CPR Mask with Non-Rebreathing Valve and the EMS Child/Infant CPR Mask with Non

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Rebreathing Valve that raise new issues of safety and efficacy of the subject device for its intended use. The Compower Infant CPR Mask with Non-Rebreathing Valve is substantially equivalent to the EMS Child/Infant CPR mask with Non-Rebreathing Valve.

	Compower Non-RebreathingValve	Seal Rite™ Non-RebreathingValve
	Subject Device	Predicate Device
Manufacturer	Xiamen Compower MedicalTech Co Ltd	The Lifeguard Store, Inc.
Device Name	Compower Non-RebreathingValve	Seal Rite™ Non-RebreathingValve
510(k) Number	K171961	K152521
Indications for Use	The Non-Rebreathing Valveis a single-use, non-steriledevice intended to be usedwith a ventilation mask toprovide mouth-to-maskventilation to healthemergency victims requiringcardiopulmonaryresuscitation (CPR) rescuetechniques. It is intended forover the counter use.	The Seal Rite Non-Rebreathing Valve is a single-use, non-sterile deviceintended to be used with aventilation mask (withoutoxygen port) to providemouth-to-mask ventilation tohealth emergency victimsrequiring cardiopulmonaryresuscitation ("CPR") rescuetechniques. It is intended forover the counter use.
Inspiratory ResistanceSpecification ≤0.5 kPaat 50 L/min	15mmOD:0.46-0.49 kPa at 50 L/min18.5 mm:0.46-0.48 kPa at 50 L/min	0.113 kPa at 50 L/min
Expiratory ResistanceSpecification ≤0.5 kPaat 50 L/min	15mmOD:0.26-0.30 kPa at 50 L/min18.5mm:0.26-0.30 kPa at 50L/min	0.0321 kPa at 50 L/min
Device Materials	Valve Housing: Rigidstyrene-butadiene copolymerValve Plate: SiliconeFilter: Polypropylene	Valve Housing:PolycarbonateValve Plate: SiliconeFilter: Not Described
Dimensions of PatientPort	15mmOD18.5mm	15mmOD
Dimension of Port thatConnects to the Mask	22 mm	22 mm
Sterile/Non-Sterile	Non-Sterile	Non-Sterile
Use	Single Use	Single Use
Compatibility	Designed for use withstandard resuscitation masks	Designed for use withstandard resuscitation masks
	Compower Non-RebreathingValveSubject Device	Seal Rite™ Non-RebreathingValvePredicate Device
Standards Used toSupport Design andPerformance Testing	AS 4259-1995ISO 5356-1ISO 10993-5 - CytotoxicityISO 10993-10 - SensitizationISO 10993-10 - Irritation	AS 4259-1995ISO 5356-1ISO 10993-5 - CytotoxicityISO 10993-10 - SensitizationISO 10993-10 - Irritation

Comparison of Subject and Predicate Non-Rebreathing Valve

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The Compower Non-Rebreathing Valve has the same indications for use, technological characteristics, principles of operation, material types, performance compliance and biological safety compliance as compared to the predicate device.

The inspiratory resistance and expiratory resistance values are not the same between the subject and predicate devices. The differences can be explained due to slightly different design features of the non-rebreathing valves such as specific filtration media and the design of the exhalation ports. These differences do not raise new issues of safety and efficacy as inspiratory and expiratory requirements of AS 4259 were met by the subject and predicate devices.

There were no significant differences noted between the Compower Non-Rebreathing Valves and the Seal Rite™ Non-Rebreathing Valve that raise new issues of safety and efficacy of the subject device for its intended use. The Compower Non-Rebreathing Valve is substantially equivalent to the predicate Seal Rite™ Non-Rebreathing Valve.

VII. PERFORMANCE DATA

Non-clinical testing was conducted to confirm the conformance of the subject devices to specified requirements. Standards referenced for designing and testing were ISO 5356-1 and AS-4259-1995. Applicable testing was performed on each device model including:

Visual Inspection ●
Dimensional Measurement ●
Transparency ●
Expiratory resistance of Non-Rebreathing Valve ●
Inspiratory resistance of Non-Rebreathing Valve
Dead Space
Tensile Testing
Function after Contamination with Stomach Contents
Function after Immersion in Water
Performance After Storage and Aging ●
. Mean Delivered Oxygen Concentration (Performed for CPR Mask with Oxygen Port Only)

All testing performed passed acceptance criteria demonstrating compliance to relevant standards and supporting the use of the devices for their intended uses.

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VIII. BIOCOMPATIBILITY

Biological safety testing was conducted according to Guidance for Industry and Food and Drug Administration Staff - Use of International Standard ISO 10993-1, "Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process" June 16, 2016. All testing passed acceptance criteria when tested according to ISO 10993 requirements.

Test	Standard	Results
Cytotoxicity	ISO 10993- 5	Pass
Irritation	ISO 10993-10	Pass
Sensitization	ISO 10993-10	Pass

IX. CONCLUSION

The Xiamen Compower Medical Tech Co Ltd. CPR Masks with Non-Rebreathing Valves are substantially equivalent to the predicate devices in respect to intended use, technological characteristics and performance.

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).