Seal Rite Non-Rebreathing Valve

K152521 · The Lifeguard Store, Inc. · CBP · Jun 3, 2016 · Anesthesiology

Device Facts

• Record ID: K152521
• Device Name: Seal Rite Non-Rebreathing Valve
• Applicant: The Lifeguard Store, Inc.
• Product Code: CBP · Anesthesiology
• Decision Date: Jun 3, 2016
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 868.5870
• Device Class: Class 2
• Attributes: Therapeutic, Pediatric

Intended Use

The Seal Rite Non-Rebreathing Valve is a single-use, non-sterile device intended to be used with a ventilation mask (without oxygen port) 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 Story

Resuscitation valve for mouth-to-mask ventilation; used in hospitals and field emergency settings by rescuers. Device input: expired air from rescuer. Device output: rescue breaths delivered to patient. Operation: plastic body with silicone inspiratory one-way valve and rigid plastic expiratory one-way valve. During inspiration, rescuer air pressure closes expiratory valve and opens inspiratory valve to patient. During expiration, patient airway pressure closes inspiratory valve and opens expiratory valve, directing exhaled gases away from rescuer through exhaust ports. Protects rescuer from patient contamination. Connects to standard masks via 22 mm ID/15 mm ID fittings.

Clinical Evidence

Bench testing only. Device passed all performance requirements per AS 4259-1995, including ventilation performance, resistance testing (inspiratory/expiratory), dead space measurement, and environmental stress testing (temperature, immersion, contamination). Biocompatibility testing (cytotoxicity, sensitization, irritation) performed per ISO 10993-5, 10993-10, and 10993-12 passed.

Technological Characteristics

Materials: Polycarbonate, silicone. Principle: Mechanical one-way valve system (silicone inspiratory, rigid plastic expiratory). Dimensions: Standard 22 mm ID inlet, 22 mm OD/15 mm ID outlet. Connectivity: Standalone. Sterilization: Non-sterile. Conformance: AS 4259-1995.

Indications for Use

Indicated for adult and pediatric patients >18 months of age requiring mouth-to-mask CPR rescue ventilation.

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

• Respironics Rescue Valve (K833748)

Submission Summary (Full Text)

{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" arranged around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, layered on top of each other to create a sense of depth and unity.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

June 3, 2016

The Lifeguard Store, Inc. % Jennifer J. Hennessy Attorney Quarles & Brady, Llp 33 E Main Street, Suite 900 Madison. Wisconsin 53703

Re: K152521

Trade/Device Name: Seal Rite Non-Rebreathing Valve Regulation Number: 21 CFR 868.5870 Regulation Name: Nonrebreathing Valve Regulatory Class: Class II Product Code: CBP Dated: May 4, 2016 Received: May 5, 2016

Dear Jennifer J. Hennessy:

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 requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in

{1}------------------------------------------------

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 at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/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 at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

Susan Runna DDS, MA

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

{2}------------------------------------------------

## Indications for Use

510(k) Number (if known) K152521

Device Name

Seal Rite Non-Rebreathing Valve

#### Indications for Use (Describe)

The Seal Rite Non-Rebreathing Valve is a single-use, non-sterile device intended to be used with a ventilation mask (without oxygen port) 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)

| <input type="checkbox"/> Prescription Use (Part 21 CFR 801 Subpart D) |
|---------------------------------------------------------------------------------|
| <input checked="" type="checkbox"/> Over-The-Counter Use (21 CFR 801 Subpart C) |

_ | 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 [e-mail]

"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."

{3}------------------------------------------------

# Seal Rite™ Non-Rebreathing Valve 510(k) Summary

| Submitter's Name | The Lifeguard Store, Inc.<br>2012 W. College Ave.<br>Normal, IL 61761<br>Telephone: [phone]<br>Fax: [phone] |
|-----------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Registration Number | 3003197958 |
| Contact Name | Amy Hilten, COO<br>The Lifeguard Store, Inc.<br>2012 W. College Ave.<br>Normal, IL 61761<br>Telephone: [phone]<br>Fax: [phone]<br>Email: [e-mail] |
| Date Prepared | June 2, 2016 |
| Device Trade Name | Seal Rite™ Non-Rebreathing Valve |
| Device Common Name | Non-Rebreathing Valve |
| Classification Name | Valve, Non-Rebreathing |
| Product Code | CBP |
| Device Classification | Class II |
| Panel | Anesthesiology and Respiratory Devices |
| Regulatory Classification | 21 CFR 868.5870 |
| Type of 510(k) Submission | Traditional |
| Legally Marketed Predicate Device | Respironics Rescue Valve (K833748) |

Premarket Notification (510(k)) Number

K152521

{4}------------------------------------------------

### Description

The Seal Rite™ Non-Rebreathing Valve ("Seal Rite Valve") is a resuscitation valve designed for resuscitation using expired air for ventilation. It has fittings on the grooved patient end that will adapt to standard masks (22 mm ID) used for resuscitation. The Seal Rite Valve allows the rescuer to blow air into a mask through its silicone one-way valve and directs the patient's exhaled air away from the rescuer via a rigid one-way valve and multiple exhaust ports. The Seal Rite Valve helps protect the rescuer from potential patient contamination. The Seal Rite Valve does not have an oxygen port.

#### Indications for Use

The Seal Rite Non-Rebreathing Valve is a single-use, non-sterile device intended to be used with a ventilation mask (without oxygen port) to provide mouth-to-mask ventilation to health emergency victims requiring cardiopulmonary resuscitation ("CPR") rescue techniques. It is intended for over-the-counter use.

#### Predicate Device

The Seal Rite Valve is substantially equivalent to the Respironics Rescue Valve (K833748). The Seal Rite Valve and the Rescue Valve are both resuscitation valves utilized for mouth-to-mask emergency resuscitation using expired air from the rescuer through a valve for ventilation of the patient. Both valves direct the patient's exhaled gases away from the rescuer's face via a rigid one-way valve, and both valves have an ISO Standard 15/22 connector that allows use with a standard mask.

Please refer to the Substantial Equivalence Summary Comparison Table below for a summary of the similarities and differences between the subject and predicate devices.

### Description of Operation

The Seal Rite Valve consists of a plastic body with two one-way valves: a silicone inspiratory one-way valve and a rigid, plastic expiratory one-way valve. Rescuers utilizing the Seal Rite Valve place their lips on the open end of the valve and blow expired air into the valve, which is attached to a standard mask, for the purpose of supplying rescue breaths to the patient. When the expired air enters the top of the Seal Rite Valve, the rigid one-way valve moves toward the patient, seals multiple exhaust ports, and the silicone one-way valve opens and provides air from the rescuer to the patient. The rigid, plastic expiratory valve remains closed when the rescuer is providing exhaled air to the patient because the pressure on the rescuer side of the plastic valve is

{5}------------------------------------------------

greater than the pressure inside the patient's airways. When the rescuer stops breathing exhaled air into the Seal Rite Valve, the silicone one-way valve closes and prevents the backflow of exhaled air from the patient to the rescuer. The rigid, plastic one-way valve lifts off of the exhaust ports due to the pressure inside the patient's airways being greater than the atmospheric pressure. The patient's exhaled air passes then through multiple exhaust ports.

#### Technological Characteristics Summary

The Seal Rite Valve is substantially equivalent to the Respironics Rescue Valve (K833748) with respect to intended use, design, principle of operation, technological characteristics and performance and the minor difference in device materials does not raise new questions of safety or effectiveness.

The Seal Rite Valve was tested to ensure conformance with the FDA Recognized AS 4259-1995 standard ("Ancillary devices for expired air resuscitation") and passed all testing requirements.

| Features | Seal Rite™ Non-Rebreathing<br>Valve (K152521) | Respironics Rescue Valve<br>(Predicate Device -- K833748) |
|---------------------------|-----------------------------------------------------------|------------------------------------------------------------------------------------------------------------------|
| Intended Use | Mouth-to-mask ventilation | Mouth-to-mask ventilation |
| Product Code | CBP | CBP |
| Target Population | Adult/pediatric patients greater<br>than 18 months of age | Adult/pediatric patients greater<br>than 18 months of age |
| Environment of Use | Hospitals and field emergency | Hospitals and field emergency |
| Materials | Polycarbonate, silicone | Thermoplastic, silicone |
| Oxygen Port | Not available | Not available with standalone<br>valve; option available only with<br>accessory adapter cleared under<br>K842693 |
| Expiratory Resistance | 0.327 cm H2O (0.0321 kPa) at 50<br>LPM | 0.25 cm H2O at 50 LPM (per<br>K142402 510(k) Summary) |
| Inspiratory<br>Resistance | 1.15 cm H2O (0.113 kPa) at 50<br>LPM | 1.85 cm H2O at 50 LPM (per<br>K142402 510(k) Summary) |
| Inlet Connector | Standard 22 mm ID | Standard 22 mm ID |
| Outlet Connector | Standard 22 mm OD/15 mm ID | Standard 22 mm OD/15 mm ID |
| Sterile | No | No |
| Reusable | No - single patient use device | No - single patient use device |
| Duration of Use | Less than 24 hours | Less than 24 hours |

#### Substantial Equivalence Summary Comparison Table

{6}------------------------------------------------

| Principle of<br>Operation | Air flow through device used to<br>deliver inspiratory air and<br>exhaled expiratory air from<br>patient | Air flow through device used to<br>deliver inspiratory air and exhaled<br>expiratory air from patient |
|---------------------------|----------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------|
| Compatibility | Designed for use with standard<br>resuscitation masks | Designed for use with standard<br>resuscitation masks |

### Performance Testing

As described below, a comprehensive battery of non-clinical tests was submitted to confirm product conformance with device requirements, including the FDA recognized AS 4259-1995 standard. These studies demonstrate that the Seal Rite™ Non-Rebreathing Valve is biocompatible, performs as intended and meets the requirements of the AS 4259-1995 standard and is therefore as safe and effective as the predicate device, the Rescue Valve.

## Biocompatibility Testing

The biocompatibility testing was conducted in accordance with FDA Blue Book Memo G95-1. Testing was conducted for cytotoxicity, sensitization and irritation per ISO 10993-5, 10993-10 and 10993-12.

| Test | Test Results |
|---------------|--------------|
| Cytotoxicity | Pass |
| Irritation | Pass |
| Sensitization | Pass |

### Bench Testing

| Test | |
|-----------------------------------------------------------------|------|
| Ventilation Performance | Pass |
| Expiratory Resistance for the Patient | Pass |
| Expiratory Resistance for the Rescuer | Pass |
| Inspiratory Resistance for a<br>Spontaneously Breathing Patient | Pass |
| Function After Contamination with<br>Stomach Contents | Pass |

{7}------------------------------------------------

| Function After Immersion in Water | Pass |
|--------------------------------------------------------------------------------------------------------------------------|------|
| Measurement of Dead Space | Pass |
| Resistance to Disengagement of Parts | Pass |
| High and Low Storage Conditions | Pass |
| High Temperature Operation | Pass |
| Low Temperature Operation | Pass |
| Attempted Displacement of Valve by<br>Finger, Function After Dropping,<br>Function After Potentially Deforming<br>Weight | Pass |
| Conformance of Connectors | Pass |
| ISTA Procedure 2A Shipping Testing | Pass |

In summary, the Seal Rite Valve is substantially equivalent to the predicate Respironics Rescue Valve with respect to intended use, technological characteristics and performance.