(287 days)
No reference devices were used in this submission.
No
The device description and performance studies focus on the physical properties and function of a CPR mask, with no mention of AI or ML technologies.
Yes
Explanation: The device is used to assist in providing immediate life support (mouth to mouth or CPR rescue techniques) to emergency victims, which directly addresses a health condition (lack of oxygen/blood flow) and restores a function in the body. This aligns with the definition of a therapeutic device.
No
The CPR Mask is designed to assist in providing immediate life support (resuscitation), not to diagnose a condition.
No
The device description clearly outlines physical components made of PVC and K-resin, indicating it is a hardware device, not software-only.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to assist in providing immediate life support through mouth-to-mask breathing and CPR. This is a direct intervention on a patient's body to support vital functions.
- Device Description: The description details a physical barrier and a one-way valve for ventilation. It does not mention any components or processes related to testing samples of human origin (like blood, urine, tissue, etc.) outside of the body to provide information about a physiological state, health, or disease.
- Lack of IVD Characteristics: There is no mention of analyzing samples, detecting analytes, or providing diagnostic information. The device's function is purely mechanical and supportive.
IVD devices are used to perform tests on samples taken from the human body to diagnose, monitor, or screen for diseases or conditions. This CPR mask does not perform any such testing.
N/A
Intended Use / Indications for Use
The CPR Mask with Oxygen Port is designed to assist in providing immediate life support (mouth to health emergency victims requiring oxygen support (inhalation) or cardiopulmonary resuscitation (CPR) rescue techniques. The CPR Mask with Oxygen Port is for prescription use.
The CPR Mask without Oxygen Port is designed to assist in providing immediate life support (mouth to health emergency victims requiring cardiopulmonary resuscitation (CPR) resuscitator without oxygen port is for overthe-counter use.
Product codes (comma separated list FDA assigned to the subject device)
CBP
Device Description
The KYOLING CPR mask is used during cardiopulmonary resuscitation procedures, which are used in emergency situations to supply oxygen and produce blood flow in the heart and lungs.
The CPR mask is made of PVC and one-way valve made of medical grade K-resin, the mask is used for mouth-to-mask breathing, it provides a physical barrier between the rescuer and victim, eliminating direct contact of the rescuer's lips with the unknown subject; and also it promotes an airtight seal to the face allowing ventilation through both the mouth and nose simultaneously. The KYOLING CPR Mask includes transparent dome, universal breathing tube, one-way filtered valve, head strap, and with Oxygen Port or without Oxygen Port.
Specification
CPR Mask with Oxygen Port: The physical size for the device is 99.5mm in height* 122mm in length;
- Inspiratory resistance:
§ 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/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol featuring three stylized human profiles facing to the right, stacked on top of each other.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
July 9, 2015
Hangzhou Jinlin Medical Appliances Co., Ltd. c/o Mr. Mike Gu Regulatory Affairs Manager OSMUNDA Medical Device Consulting Co., Ltd No.9, 16th Ave. Hangzhou Economic and Technological Development Zone, Hangzhou, Zhejiang Province 310018. CHINA
Re: K142764
Trade/Device Name: KYOLING CPR Mask with Oxygen Port, KYOLING CPR Mask without Oxygen Port Regulation Number: 21 CFR 868.5870 Regulation Name: Non-Rebreathing Valve Regulatory Class: II Product Code: CBP Dated: June 1, 2015 Received: June 8, 2015
Dear Mr. Gu:
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. Mike Gu
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 (QS) 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 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. 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 Industry and Consumer Education 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 yours,
Tejashri Purohit-Sheth, M.D.
Tejashri Purohit-Sheth, M.D. Clinical Deputy Director DAGRID/ODE/CDRH FOR
Erin I. Keith, M.S. 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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Indications for Use
510(k) Number (if known) K142764
Device Name
KYOLING CPR Mask With Oxygen Port
Indications for Use (Describe)
The CPR Mask with Oxygen Port is designed to assist in providing immediate life support (mouth to health emergency victims requiring oxygen support (inhalation) or cardiopulmonary resuscitation (CPR) rescue techniques. The CPR Mask with Oxygen Port is for prescription use.
Type of Use (Select one or both, as applicable)
X Prescription Use (Part 21 CFR 801 Subpart D)
_ Over-The-Counter Use (21 CFR 801 Subpart C)
PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.
FOR FDA USE ONLY
Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)
3
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."
4
Indications for Use
510(k) Number (if known) K142764
Device Name
KYOLING CPR Mask Without Oxygen Port
Indications for Use (Describe)
The CPR Mask without Oxygen Port is designed to assist in providing immediate life support (mouth to health emergency victims requiring cardiopulmonary resuscitation (CPR) resuscitator without oxygen port is for overthe-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)
PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.
FOR FDA USE ONLY
Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)
5
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) Summary
In accordance with 21 CFR 807.92 the following summary of information is provided:
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Hangzhou Jinlin Medical Appliances Co., Ltd.
No.9, 16th Ave. Hangzhou Economic and Technological
Development Zone, 310018, Hangzhou, Zhejiang Province, China
Phone: +86-571-86911905
Fax: +86-571-86840897
| Primary Contact Person: | Mike Gu |
|---|---|
| Regulatory Affairs Manager | |
| OSMUNDA Medical Device Consulting Co., Ltd | |
| Tel: (+86) 20-6232 1333 | |
| Fax: (+86) 20-8633 0253 | |
| Secondary Contact Person: | Ms. Lydia HE |
| Hangzhou Jinlin Medical Appliances Co., Ltd | |
| Date Prepared: | June 01, 2015 |
| II. DEVICE | |
| Device trade name: | KYOLING CPR Mask With Oxygen Port(Prescription Use) |
| KYOLING CPR Mask Without Oxygen Port(OTC Use) | |
| Common/Usual Name: | Emergency CPR Mask |
| Classification Names | Valve, Non-Rebreathing |
| Regulation classification: | 21 CFR 868.5870 |
| Panel: | Anesthesiology |
| Regulation Class: | II |
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СВР Product Code:
III. Prescription Use: PREDICATE DEVICE
Brand MedSource CPR Mask, MedSource International, LLC, K081516
OTC Use:
Genuine First Aid CPR Face Mask without oxygen port,, Genuine First Aid LLC, K112126
These predicates have not been subject to a design-related recall.
No reference devices were used in this submission.
IV. DEVICE DESCRIPTION
The KYOLING CPR mask is used during cardiopulmonary resuscitation procedures, which are used in emergency situations to supply oxygen and produce blood flow in the heart and lungs.
The CPR mask is made of PVC and one-way valve made of medical grade K-resin, the mask is used for mouth-to-mask breathing, it provides a physical barrier between the rescuer and victim, eliminating direct contact of the rescuer's lips with the unknown subject; and also it promotes an airtight seal to the face allowing ventilation through both the mouth and nose simultaneously. The KYOLING CPR Mask includes transparent dome, universal breathing tube, one-way filtered valve, head strap, and with Oxygen Port or without Oxygen Port.
Specification
CPR Mask with Oxygen Port: The physical size for the device is 99.5mm in height* 122mm in length;
- Inspiratory resistance: