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 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.

AI/ML Overview

The provided text is a 510(k) summary for the Seal Rite Non-Rebreathing Valve (K152521). It describes the device, its intended use, and the testing conducted to establish its substantial equivalence to a predicate device.

Here's an analysis of the acceptance criteria and study information based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The device was tested to ensure conformance with the FDA Recognized AS 4259-1995 standard ("Ancillary devices for expired air resuscitation") and passed all testing requirements. The table below summarizes the key performance parameters tested and the reported results. The explicit acceptance criteria (e.g., maximum allowable resistance values per the standard) are not fully detailed in the provided text, but the text states that the device "passed all testing requirements" and "performs as intended and meets the requirements of the AS 4259-1995 standard." I've extracted specific quantitative performance values where available and indicated "Pass" for qualitative tests.

Acceptance Criteria (Implied by standard AS 4259-1995)	Reported Device Performance (Seal Rite™ Non-Rebreathing Valve)	Predicate Device Performance (Respironics Rescue Valve)
Biocompatibility:
Meet Cytotoxicity requirements (ISO 10993-5)	Pass	Not explicitly stated for predicate in this document
Meet Irritation requirements (ISO 10993-10)	Pass	Not explicitly stated for predicate in this document
Meet Sensitization requirements (ISO 10993-12)	Pass	Not explicitly stated for predicate in this document
Bench Testing (Functional Performance/Conformity to AS 4259-1995):
Ventilation Performance requirements	Pass	Not explicitly stated for predicate in this document
Expiratory Resistance for the Patient requirements	Pass	Not explicitly stated for predicate in this document
Expiratory Resistance for the Rescuer requirements	Pass	Not explicitly stated for predicate in this document
Inspiratory Resistance for a Spontaneously Breathing Patient requirements	Pass	Not explicitly stated for predicate in this document
Function After Contamination with Stomach Contents requirements	Pass	Not explicitly stated for predicate in this document
Function After Immersion in Water requirements	Pass	Not explicitly stated for predicate in this document
Measurement of Dead Space requirements	Pass	Not explicitly stated for predicate in this document
Resistance to Disengagement of Parts requirements	Pass	Not explicitly stated for predicate in this document
High and Low Storage Conditions requirements	Pass	Not explicitly stated for predicate in this document
High Temperature Operation requirements	Pass	Not explicitly stated for predicate in this document
Low Temperature Operation requirements	Pass	Not explicitly stated for predicate in this document
Attempted Displacement of Valve by Finger, Function After Dropping, Function After Potentially Deforming Weight requirements	Pass	Not explicitly stated for predicate in this document
Conformance of Connectors requirements	Pass	Not explicitly stated for predicate in this document
ISTA Procedure 2A Shipping Testing requirements	Pass	Not explicitly stated for predicate in this document
Expiratory Resistance at 50 LPM	0.327 cm H2O (0.0321 kPa)	0.25 cm H2O at 50 LPM (per K142402 510(k) Summary)
Inspiratory Resistance at 50 LPM	1.15 cm H2O (0.113 kPa)	1.85 cm H2O at 50 LPM (per 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

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

The document does not explicitly state the sample sizes for the non-clinical tests (biocompatibility and bench testing). It mentions that the testing was conducted according to recognized standards (FDA Blue Book Memo G95-1, ISO 10993 series, AS 4259-1995, ISTA Procedure 2A). Typically, these standards specify the number of samples required for each test. The data provenance is implied to be from laboratory testing as mandated by these standards, not from human subjects or real-world use. It is retrospective in the sense that the testing was performed to support the 510(k) submission.

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

This information is not applicable as the evaluation relies on a non-clinical, benchtop and laboratory testing against established engineering and biocompatibility standards, not on expert interpretation of medical data.

4. Adjudication Method for the Test Set

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

This information is not applicable. The Seal Rite Non-Rebreathing Valve is a mechanical medical device, not an AI or imaging diagnostic tool. Therefore, an MRMC study with human readers (or AI assistance) would not be relevant.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

This information is not applicable as the device is a mechanical non-rebreathing valve, not an algorithm or AI system. The performance evaluated is the standalone performance of the physical device according to engineering and biocompatibility standards.

7. The Type of Ground Truth Used

The "ground truth" for this device's performance is based on established engineering standards and biocompatibility standards. Specifically:

AS 4259-1995: "Ancillary devices for expired air resuscitation"
FDA Blue Book Memo G95-1: Guidance for biocompatibility testing.
ISO 10993-5: Biocompatibility testing (Cytotoxicity)
ISO 10993-10: Biocompatibility testing (Irritation)
ISO 10993-12: Biocompatibility testing (Sensitization)
ISTA Procedure 2A: Shipping testing.

These standards define the acceptable performance parameters and test methods for such devices.

8. The Sample Size for the Training Set

This information is not applicable. The device is a mechanical non-rebreathing valve, not a machine learning model. Therefore, there is no "training set."

9. How the Ground Truth for the Training Set Was Established

This information is not applicable as there is no training set for this type of device.

Summary

{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 (800) 638-2041 or (301) 796-7100 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 (800) 638-2041 or (301) 796-7100 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)

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)

_ | 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."

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

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

Submitter's Name	The Lifeguard Store, Inc.2012 W. College Ave.Normal, IL 61761Telephone: (309) 451-5858Fax: (309) 451-5959
Registration Number	3003197958
Contact Name	Amy Hilten, COOThe Lifeguard Store, Inc.2012 W. College Ave.Normal, IL 61761Telephone: (309) 451-5858Fax: (309) 451-5959Email: amy@thelifeguardstore.com
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

Indications for 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-RebreathingValve (K152521)	Respironics Rescue Valve(Predicate Device -- K833748)
Intended Use	Mouth-to-mask ventilation	Mouth-to-mask ventilation
Product Code	CBP	CBP
Target Population	Adult/pediatric patients greaterthan 18 months of age	Adult/pediatric patients greaterthan 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 standalonevalve; option available only withaccessory adapter cleared underK842693
Expiratory Resistance	0.327 cm H2O (0.0321 kPa) at 50LPM	0.25 cm H2O at 50 LPM (perK142402 510(k) Summary)
InspiratoryResistance	1.15 cm H2O (0.113 kPa) at 50LPM	1.85 cm H2O at 50 LPM (perK142402 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 ofOperation	Air flow through device used todeliver inspiratory air andexhaled expiratory air frompatient	Air flow through device used todeliver inspiratory air and exhaledexpiratory air from patient
Compatibility	Designed for use with standardresuscitation masks	Designed for use with standardresuscitation 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 aSpontaneously Breathing Patient	Pass
Function After Contamination withStomach 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 byFinger, Function After Dropping,Function After Potentially DeformingWeight	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.

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).