KYOLING CPR Mask with Oxygen Port and Without Oxygen Port

K142764 · Hangzhou Jinlin Medical Appliances Co., Ltd. · CBP · Jul 9, 2015 · Anesthesiology

Device Facts

• Record ID: K142764
• Device Name: KYOLING CPR Mask with Oxygen Port and Without Oxygen Port
• Applicant: Hangzhou Jinlin Medical Appliances Co., Ltd.
• Product Code: CBP · Anesthesiology
• Decision Date: Jul 9, 2015
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 868.5870
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

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 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 resuscitator without oxygen port is for over-the-counter use.

Device Story

Device is a manual CPR mask used in emergency situations to provide mouth-to-mask ventilation. Components include a transparent dome, one-way filtered valve, head strap, and optional oxygen port. Device acts as a physical barrier between rescuer and victim to prevent direct contact while facilitating an airtight seal for simultaneous mouth and nose ventilation. Operated by rescuers (laypeople or professionals) in emergency settings. Output is the delivery of rescue breaths to the victim. Benefits include reduced risk of cross-contamination and improved ventilation efficiency during resuscitation.

Clinical Evidence

Bench testing only. No clinical or animal studies were conducted. Performance testing verified inspiratory and expiratory resistance against AS-4259-1995 standards, with all results <5 cmH2O. Biocompatibility testing performed per ISO 10993-5 and ISO 10993-10.

Technological Characteristics

Materials: PVC (mask), silicone (one-way valve), non-woven (strap). Dimensions: 99.5mm x 122mm. Connectivity: None. Sterilization: Not specified. Standards: ISO 5356-1:2004 (connectors), AS 4259-1995 (resuscitation performance), ISO 10993-5/10 (biocompatibility).

Indications for Use

Indicated for health emergency victims requiring oxygen support or cardiopulmonary resuscitation (CPR) rescue techniques. Prescription version for oxygen support/CPR; OTC version for CPR.

Regulatory Classification

Identification

A nonrebreathing valve is a one-way valve that directs breathing gas flow to the patient and vents exhaled gases into the atmosphere.

Predicate Devices

• MedSource CPR Mask (K081516)
• Genuine First Aid CPR Face Mask without oxygen port (K112126)

Submission Summary (Full Text)

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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 [phone] or [phone] 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 [phone] or [phone] 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)

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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."

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# 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)

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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."

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# 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: [phone]

Fax: [phone]

| Primary Contact Person: | Mike Gu |
|----------------------------|-----------------------------------------------------|
| | Regulatory Affairs Manager |
| | OSMUNDA Medical Device Consulting Co., Ltd |
| | Tel: [phone] |
| | Fax: [phone] |
| 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: <5 cmH2O (at 50 L/min);
- Expiratory resistance: <5 cmH₂O (at 50 L/min)

CPR Mask without Oxygen Port: The physical size for the device is 99.5mm in height * 122mm in length;

- Inspiratory resistance: <5 cmH2O (at 50 L/min);
- Expiratory resistance: <5 cmH2O (at 50 L/min)

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#### V. INDICATIONS FOR USE

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 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 resuscitator without oxygen port is for over-the-counter use.

### VI. COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE PREDICATE DEVICE

The sponsor identified the similarities and differences of the proposed CPR MASK device to the legally marketed predicate MedSource CPR Mask K081516 to which substantial equivalency is claimed.

| Specification | Predicate Device | Proposed Device |
|---------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Manufacturer | MedSource International, LLC | Hangzhou Jinlin Medical Appliances Co., Ltd |
| Device name | MedSource (Brand) CPR Mask | KYOLING CPR Mask With Oxygen Port(Prescription Use) |
| K number | K081516 | -- |
| Indications<br>for Use | The MedSource CPR Mask is designed to<br>assist in providing immediate life support<br>(mouth to mask ventilation) to health<br>emergency victims requiring oxygen<br>support (inhalation) or cardiopulmonary<br>resuscitation (CPR) rescue techniques. | The CPR Mask with Oxygen Port is designed to<br>assist in providing immediate life support (mouth<br>to mask ventilation) to health emergency victims<br>requiring oxygen support (inhalation) or<br>cardiopulmonary resuscitation (CPR) rescue<br>techniques. The CPR Mask with Oxygen Port is for<br>prescription use. |
| Inspiratory<br>Resistance | 2.84-2.87 cmH2O | 3.09-3.17 cmH2O |
| Expiratory<br>Resistance | 2.96-3.01 cmH2O | 3.21-3.26 cmH2O |
| Raw<br>materials | CPR one-way valve: PVC/Silicon valve<br>Face Mask: PVC<br>Strap: Non-Woven | CPR one-way valve: Silicon<br>Face Mask: PVC<br>Strap: Non-Woven |
| Dimensions | Length: 100±3mm<br>Width: 82±3mm | |

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| Standards | ISO 5356-1:2004 Anaesthetic and respiratory equipment -- Conical connectors -- Part 1: Cones<br>and sockets; |
|-----------|-----------------------------------------------------------------------------------------------------------------------|
| | AS 4259-1995 Ancillary devices for expired air resuscitation; |
| | ISO 10993-5:2009 Biological evaluation of medical devices -- Part 5: Tests for in vitro<br>cytotoxicity; |
| | ISO 10993-10:2010 Biological evaluation of medical devices -- Part 10: Tests for irritation and<br>skin sensitization |

Though the Inspiratory Resistance and Expiratory Resistance are slightly different, both the subject and predicate device meet the requirements for AS-4259-1995 Standard.

The sponsor identified the similarities and differences of the proposed CPR MASK device to the legally marketed predicate Genuine First Aid LLC K112126 to which substantial equivalency is claimed.

| Specification | Predicate Device | Proposed Device |
|---------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Manufacturer | Genuine First Aid LLC | Hangzhou Jinlin Medical Appliances Co., Ltd |
| Device name | Genuine First Aid CPR Face Mask<br>without oxygen port | KYOLING CPR Mask Without Oxygen Port(Over-<br>the-Counter Use) |
| K number | K112126 | -- |
| Indications<br>for Use | The CPR mask (without oxygen port) is<br>single use designed for mouth to mask<br>ventilation to health emergency victims<br>requiring cardiopulmonary resuscitation<br>(CPR) rescue techniques of a<br>nonbreathing adult. It is also used as a<br>barrier that will direct expired air<br>from the patient away from the user. | The CPR Mask without Oxygen Port is designed to<br>assist in providing immediate life support (mouth<br>to mask ventilation) to health emergency victims<br>requiring cardiopulmonary resuscitation (CPR)<br>rescue techniques. The resuscitator without<br>oxygen port is for over-the-counter use. |
| Inspiratory<br>Resistance | 1.94@50L/min | 3.09-3.17 cmH2O |
| Expiratory<br>Resistance | 2.04@50L/min | 3.21-3.26 cmH2O |
| Raw<br>materials | CPR one-way valve: K-Resin, Silicone<br>Face Mask: PVC<br>Strap: Non-Woven | CPR one-way valve: Silicon<br>Face Mask: PVC<br>Strap: Non-Woven |
| Dimensions | Length: 100±3mm<br>Width: 82±3mm | |

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| Standards | ISO 5356-1:2004 Anaesthetic and respiratory equipment -- Conical connectors -- Part 1: Cones<br>and sockets; |
|-----------|-----------------------------------------------------------------------------------------------------------------------|
| | AS 4259-1995 Ancillary devices for expired air resuscitation; |
| | ISO 10993-5:2009 Biological evaluation of medical devices -- Part 5: Tests for in vitro<br>cytotoxicity; |
| | ISO 10993-10:2010 Biological evaluation of medical devices -- Part 10: Tests for irritation and<br>skin sensitization |

Though the Inspiratory Resistance and Expiratory Resistance are slightly different, both the subject and predicate device meet the requirements for AS-4259-1995 Standard.

### VII. PERFORMANCE DATA

The following performance data were provided in support of the substantial equivalence determination.

# Biocompatibility testing:

The biocompatibility evaluation for the KYOLING CPR Mask was conducted in accordance with the FDA Blue Book Memorandum #G95-1 "Use of International Standard ISO-10993, 'Biological Evaluation of Medical Devices Part 1: Evaluation and Testing," May 1, 1995, and International Standard ISO 10993-1 "Biological Evaluation of Medical Devices – Part 1: Evaluation and Testing Within a Risk Management Process," as recognized by FDA. The battery of testing included the following tests:

- . ISO 10993-5: 2009-Cytotoxicity
- ISO 10993-10: 2010-Sensitization
- ISO 10993-10: 2010-Irritation

The cushion and valve is considered surface contacting for duration of less than 24 hours.

# Bench testing:

Expiratory resistance and inspiratory resistance testing was for Kyoling CPR mask with oxygen port done using the test methods described in AS-4259-1995 Ancillary Devices for Expired Air Resuscitations

| Parameters | Standard | Proposed device |
|-----------------------|----------|------------------|
| Inpiratory resistance | <5cmH2O | 3.19~3.24 cm H2O |

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| the country of the country of the country of the country of the country<br>Expiratory resistance | <5cmH30 | 3.31~3.37cmH₂O |
|--------------------------------------------------------------------------------------------------|---------|----------------|
|--------------------------------------------------------------------------------------------------|---------|----------------|

Expiratory resistance and inspiratory resistance testing was for Kyoling CPR mask without oxygen port done using the test methods described in AS-4259-1995 Ancillary Devices for Expired Air Resuscitations

| Parameters | Standard | Proposed device |
|-----------------------|----------|--------------------|
| Inpiratory resistance | <5cmH₂O | 3.19~3.24 cm H₂O |
| Expiratory resistance | <5cmH₂O | 3.31~3.37cmH $₂$ O |

Animal and clinical study:

The subject of this premarket submission, KYOLING CPR Mask, does not require clinical studies to support substantial equivalence.

### VIII. CONCLUSIONS

Hangzhou Jinlin Medical Appliances Co., Ltd considers the Kyoling CPR mask with oxygen port is as safe and effective as the predicate device. It has the same intended use, indications for use, technological characteristics, and principles of operation as those of the predicate device. The minor differences between the Kyoling CPR mask with oxygen port and its predicate device raise no new issues of safety or effectiveness. Thus, the Kyoling CPR mask with oxygen port is substantially equivalent to its predicate device.

Hangzhou Jinlin Medical Appliances Co., Ltd considers the Kyoling CPR mask without oxygen port is as safe and effective as the predicate device. It has the same intended use, indications for use, technological characteristics, and principles of operation as those of the predicate device. The minor differences between the Kyoling CPR mask without oxygen port and its predicate device raise no new issues of safety or effectiveness. Thus, the Kyoling CPR mask without oxygen port is substantially equivalent to its predicate device.