(140 days)
No
The device description and performance studies focus on the physical components and mechanical performance of the CPR masks and valves, with no mention of AI or ML capabilities.
Yes.
The device's intended use is to assist in providing immediate life support (mouth to mask ventilation) and oxygen support, which are therapeutic interventions.
No
The device description and intended use clearly state that these CPR masks are designed to assist in providing immediate life support through ventilation, not to diagnose medical conditions.
No
The device description clearly outlines physical components made of materials like polyvinyl chloride, styrene-butadiene copolymer, silicone, and polypropylene, and the performance studies focus on physical characteristics and functionality of these components. There is no mention of software.
Based on the provided information, no, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use of these devices is to assist in providing immediate life support through mouth-to-mask ventilation and oxygen support. This is a direct intervention on a patient's respiratory system.
- Device Description: The devices are physical masks and valves designed to facilitate breathing and oxygen delivery.
- Lack of Diagnostic Function: There is no mention of the device being used to examine specimens (like blood, urine, or tissue) from the human body to provide information for diagnosis, monitoring, or screening.
IVD devices are specifically designed to perform tests on samples taken from the body to provide diagnostic information. These CPR masks and valves are therapeutic devices used on the body to support a vital function.
N/A
Intended Use / Indications for Use
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) rescue techniques. The CPR Mask with Oxygen Port is intended for prescription use.
CPR Mask without Oxygen Port
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.
Infant CPR Mask without Oxygen Port
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.
Non-Rebreathing Valve (15mmOD)
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.
Non-Rebreathing Valve (18.5mm)
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.
Product codes
CBP
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
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
The Infant CPR mask is indicated for use on infants with body weight up to 10 kg (22 lbs).
Intended User / Care Setting
Not Found
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)
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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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).
0
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
1
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
2
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.
3
510(k) Number (if known) K171961
Device Name CPR Mask without Oxygen Port
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.
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.
4
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.
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."
5
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.
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."
6
510(k) Number (if known) K171961
Device Name Non-Rebreathing Valve (18.5mm)
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.
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."
7
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
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:
8
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
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.
9
CPR Mask without Oxygen Port
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.
Infant CPR Mask without Oxygen Port
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.
Non-Rebreathing Valve (15mmOD)
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.
Non-Rebreathing Valve (18.5mm)
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.
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 Mask
Subject Device | KYOLING CPR Mask
Predicate Device |
|-----------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------|
| Manufacturer | Xiamen Compower Medical
Tech Co Ltd | Hangzhou Jinlin Medical
Appliances 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 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 | Same |
| | Compower CPR Mask | KYOLING CPR Mask |
| | Subject Device | Predicate Device |
| Indications for Use -
Without Oxygen Port | (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. | Same |
| How Provided | Mask (with or without oxygen
port), non-rebreathing valve
and head strap.
Non Sterile | Mask (with or without
oxygen port), universal
breathing tube, non-
rebreathing valve with filter
and head strap.
Non Sterile |
| Inspiratory Resistance
Specification ≤0.5 kPa at
50 L/min | $0.40 - 0.49$ kPa at 50 L/min | $0.30 - 0.31$ kPa at 50 L/min |
| Expiratory Resistance
Specification ≤0.5 kPa at
50 L/min | $0.20 - 0.30$ kPa at 50 L/min | $0.31 - 0.32$ kPa at 50 L/min |
| Device Materials | Face Mask: PVC
Valve Housing: Rigid styrene-
butadiene copolymer (K-resin)
Valve Plate: Silicone
Filter: Polypropylene | Face Mask: PVC
Valve Housing: Rigid plastic
(K-resin)
Valve Plate: Silicone
Filter: Not Known |
| Dimensions | Length: 124 mm
Width: 99 mm | Length: 122 mm
Width: 99 mm |
| Standards Used to
Support Design and
Performance Testing | ISO 5356-1: Anaesthetic and
respiratory equipment- Conical
connectors-Part 1: Cones and
Sockets
AS 4259-1995-Ancillary
devices for expired air
resuscitation | Same |
| Biocompatibility Testing
Conducted | ISO 10993-5 - Cytotoxicity
ISO 10993-10 - Sensitization | Same |
| | Compower CPR Mask
Subject Device | KYOLING CPR Mask
Predicate 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
10
11
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 Infant
CPR Mask
Subject Device | EMS
Child/Infant
Mask
Primary
Predicate | Laerdal Paediatric
Pocket Mask
Reference Device |
|-----------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Manufacturer | Xiamen Compower
Medical Tech Co
LTD | Engineered
Medical Systems
EMS | Laerdal Medical A/S |
| Device Name | Compower Infant
CPR Mask | EMS CPR Mask
Child/Infant | Laerdal Paediatric
Pocket Mask |
| 510(k) Number | K171961 | K983919 | K023805 |
| Product Code | CBP | CBP | CBP |
| FDA Regulatory
Classification | 868.5870 | 868.5870 | 868.5870 |
| Indications for
Use | The Infant CPR
Mask 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 | Indicated to
provide assisted
ventilation to
someone
requiring assisted
ventilation,
breathing or
resuscitation, by
use of a mouth to
mask method.
Patient
population is | Laerdal Paediatric
Pocket Mask is a
device designed for
mouth-to-mask
ventilation of a non-
breathing child or
infant. |
| | Compower Infant
CPR Mask
Subject Device | EMS
Child/Infant
Mask
Primary
Predicate | Laerdal Paediatric
Pocket Mask
Reference Device |
| | use on infants with
body weight up to 10
kg (22 lbs). The
Infant CPR Mask is
intended for over-
the-counter use. | child/infant and
adult. Those with
oxygen port are
prescription
devices and those
without oxygen
port are OTC. | |
| Inspiratory
Resistance
Specification