(208 days)
K8337480, K842693
K8337480, K842693
No
The device description and performance studies focus on mechanical and material properties, with no mention of AI or ML.
Yes
The device is described as assisting in providing immediate life support and cardiopulmonary resuscitation (CPR) techniques, which are therapeutic interventions.
No.
The device is a non-rebreathing valve designed for resuscitation to assist in providing life support and ventilation, not to diagnose a condition.
No
The device description clearly outlines a physical, mechanical valve with fittings, silicone valves, and an oxygen inlet port. There is no mention of software components.
Based on the provided information, the BigEasy™ Non-Rebreathing Valve 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 ventilation and CPR rescue techniques. This is a direct intervention on a patient, not a test performed on a sample taken from the body.
- Device Description: The description details a mechanical valve for directing airflow during resuscitation. It does not mention any components or processes related to analyzing biological samples.
- Lack of IVD Indicators: The document does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Detecting or measuring substances in samples
- Providing diagnostic information about a patient's health status
The device is clearly intended for in vivo use (on a living organism) for resuscitation purposes.
N/A
Intended Use / Indications for Use
The BigEasy™ Non-Rebreathing Valve is intended to assist in providing immediate life support (mouth to mask ventilation) to health emergency victims requiring oxygen support or cardiopulmonary resuscitation (CPR) rescue techniques.
Product codes
CBP
Device Description
The BigEasy™ Non-Rebreathing Valve is a resuscitation valve designed for resuscitation using expired air for ventilation. It has fittings on the patient end that will adapt to standard masks (22mm ID) or endotracheal tubes (15mm OD) used for resuscitation. It provides a path for a rescuer to blow expired air into a mask or endotracheal tube through a silicone valve in the device and has a rigid one-way valve that directs exhaled air from the patient away from the rescuer. It also incorporates an oxygen inlet port on the rescuer's side of the valve for the adding of supplemental oxygen without requiring a separate adapter.
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
Adult/pediatric patients greater than 18 months of age.
Intended User / Care Setting
Hospitals and field emergency
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)
Bench Test:
- Packaging and Assembly / Shipping: Verify the device meets packaging and assembly / shipping requirements. Results: Pass.
- Environmental: Verify the device meets environmental requirements. Results: Pass.
- VOC's, Ozone, CO, CO2 and Fine Particle Discharge: Verify that the device meets TO-15 standards for VOC's and requirements for the discharge of other gases and particles below the standards' thresholds. Results: Pass.
- Materials Specifications: Verify the device meets the materials specifications requirements. Results: Pass.
- Labeling Verification: Verify the device meets the labeling verification requirements. Results: Pass.
- Inlet and Outlet Fittings: Verify the device meets the inlet and outlet fitting requirements. Results: Pass.
- Biocompatibility: Verify the device meets the biocompatibility requirements. Results: Pass, based on ISO10993-1:2009/2010 and the 2013 FDA Guidance Document.
- Resistance to inhalation and exhalation after and during environmental exposure, vomitus contamination, water submersion and mechanical displacement: Verify the device meets the inhalation and exhalation resistance requirements. Results: Pass.
- Drop test from 1 meter: Verify that the valve can withstand a drop on a concrete floor. Results: Pass.
- Mean concentration of oxygen at 15 LPM and circuit backpressure at 30 LPM: Determine the mean oxygen concentration and the backpressure during oxygen delivery. Results: Pass.
- Assembly and Application: Validate the device can be assembled and applied according to the IFU. Results: Pass, participants were able to perform the intended actions while following the IFU.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
- Inspiratory Resistance: 1.9 cm H2O at 50 LPM
- Expiratory Resistance: 0.25 cm H2O at 50 LPM
- Expiratory Resistance: 0.7 cm H2O at 50 LPM (for predicate)
- Inspiratory Resistance: 1.85 cm H2O at 50 LPM (for predicate)
- Mean concentration of oxygen at 15 LPM
- Circuit backpressure at 30 LPM
Predicate Device(s)
Respironics Rescue Valve/VentEasy Non-Rebreathing Valve (K8337480 and K842693)
Reference Device(s)
Not Found
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/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is an abstract symbol that resembles a stylized human figure or a group of people. The symbol is composed of three interconnected profiles facing to the right, creating a sense of unity and collaboration.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
March 23, 2015
12th Man Technologies, Inc. Mr. Alex Stenzler President 7245 Garden Grove Blvd., Suite G Garden Grove, CA 92841
Re: K142402
Trade/Device Name: BigEasy™ Non-Rebreathing Valve Regulation Number: 21 CFR 868.5870 Regulation Name: Non-rebreathing valve Regulatory Class: II Product Code: CBP Dated: February 19, 2015 Received: February 23, 2015
Dear Mr. Stenzler:
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.
1
Page 2 - Mr. Stenzler
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 Small Manufacturers, International and Consumer Assistance at its tollfree 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 Small Manufacturers, International and Consumer Assistance 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. Division Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
2
-
- Indications for Use Statement
INDICATIONS FOR USE STATEMENT
510(k) Number (if known): K142402 Device Name: BigEasyTM
Indications for Use:
The BigEasy™ Non-Rebreathing Valve is intended to assist in providing immediate life support (mouth to mask ventilation) to health emergency victims requiring oxygen support or cardiopulmonary resuscitation (CPR) rescue techniques.
Prescription Use X AND/OR (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (Part 21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED) ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Concurrence of CDRH, Office of Device Evaluation (ODE)
Page 10 of 268
3
510(k) Summary
| Submitter's Name | 12th Man Technologies, Inc.
7245 Garden Grove Blvd., Suite G
Garden Grove, CA 92841
1.714.705.4576 |
|-----------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Registration Number | 3009108174 |
| Contact Name | Alex Stenzler
12th Man Technologies, Inc.
7245 Garden Grove Blvd., Suite G
Garden Grove, CA 92841
Telephone: 1.714.705.4576
Fax: 1.714.373.0505
Email: alex.stenzler@12thmantec.com |
| Date Prepared | January 11, 2015 |
| Device Trade Name | BigEasyTM Non-Rebreathing Valve |
| Device Common Name | Non-Rebreathing Valve |
| Classification Name | Valve, Non-Rebreathing |
| Product Code | CBP |
| Device Classification | Class II |
| Panel | Anesthesiology |
| Regulatory Classification | 21 CFR 868.5870 |
| 510(k) Submission | Traditional |
| Legally Marketed Equivalent | Respironics Rescue Valve/VentEasy Non-
Rebreathing Valve (K8337480 and K842693) |
Description
The BigEasy™ Non-Rebreathing Valve is a resuscitation valve designed for resuscitation using expired air for ventilation. It has fittings on the patient end that will adapt to standard masks (22mm ID) or endotracheal tubes (15mm OD) used for resuscitation. It provides a path for a rescuer to blow expired air into a mask or endotracheal tube through a silicone valve in the device and has a rigid one-way valve that directs exhaled air from the patient away from the
4
rescuer. It also incorporates an oxygen inlet port on the rescuer's side of the valve for the adding of supplemental oxygen without requiring a separate adapter.
Predicate Device
The design of the BigEasy non-rebreathing valve is substantially equivalent to the Respironics Rescue Valve (K8337480) and Non-Rebreathing Valve (K842693). The predicate devices are resuscitation valves designed for resuscitation using expired air for ventilation. They all have fittings on the patient end that will adapt to standard masks (22mm ID) or endotracheal tubes (15mm OD) used for resuscitation. They all provide a path for a rescuer to blow expired air into a mask or endotracheal tube through a silicone valve in the device and have a rigid one-way valve that directs exhaled air from the patient away from the rescuer.
The only difference between the predicate device and the BigEasy non-rebreathing valve is that the predicate devices have an accessory fitting for adding oxygen during use while the BigEasy non-breathing valve has the oxygen inlet port molded into the valve body.
Description of Operation
The BigEasy non-breathing valve consists of a plastic body housing a silicone inspiratory oneway valve and a rigid plastic expiratory one-way valve. Rescuers using the BigEasy fill their lungs with room air and then seal their mouth/lips on the BigEasy and blow the air from their lungs into the lungs of the patient requiring resuscitation. When the rescuer blows into the device, the rigid plastic valve moves forward toward the patient and seals the expiratory vent holes. A silicone one-way in the rigid plastic valve plate opens and allows the air from the rescuer to be delivered to the patient. The pressure on the rescuer side of the plastic plate valve is equal or greater than the pressure inside the patient's airways, so the plastic exhalation valve remains closed. When the rescuer stops exhaling into the device, the silicone valve closes, preventing a backflow of air from the patient flowing to the rescuer. The rigid plastic valve now lifts off the expiratory vent hole because the pressure inside the patient's airways are greater than atmospheric pressure. The patient can then passively exhale through the vent holes.
Indications for Use:
The BigEasy™ Non-Rebreathing Valve is intended to assist in providing immediate life support (mouth to mask ventilation) to health emergency victims requiring oxygen support or cardiopulmonary resuscitation (CPR) rescue techniques.
| Specifications | Dimensions: 3.1 x 1.7 x 1.7 inches |
|---|---|
| Inlet Connector: Standard 22mm ID | |
| Outlet Connector: Standard 22mm OD/15mm ID | |
| Oxygen Port: Standard for respiratory fittings | |
| Inspiratory Resistance: 1.9 cm H2O at 50 LPM | |
| Expiratory Resistance: 0.25 cm H2O at 50 LPM | |
| Operating Temperature: -18°C to 50°C | |
| Storage Temperature: -40°C to 60°C | |
| Storage Relative Humidity: 10% to 95% |
5
| Intended Use | The BigEasy™ Non-Rebreathing Valve is intended
to assist in providing immediate life support (mouth
to mask ventilation) to health emergency victims
requiring oxygen support or cardiopulmonary
resuscitation (CPR) rescue techniques. |
| -------------- | ----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------- |
|---|
Technology Characteristics Summary
Based on the design, intended use, principle of operation, technological characteristics, Dassed on the design, theirled ass, principle of operation, toomstributions, Inc. BigEasy™ Non-Rebreathing Valve is substantially equivalent to the Respironics Rescue Valve/VentEasy Non-Rebreathing Valve with the SealEasy Oxygen Adapter. The comparison data show similar values for resistance to flow when compared to the legally marketed device and within the requirements of the identified standards.
Non-clinical test results are submitted to confirm product conformance with device requirements and substantial equivalence to predicate device.
| Features | |
|---|---|
| Respironics | |
| Rescue Valve and VentEasy | |
| Non-Rebreathing Valve | |
| (Predicates) | |
| 12th Man Technologies, Inc. | |
| BigEasy™ Non-Rebreathing | |
| Valve | |
| Intended Use | Mouth to mask ventilation |
| Mouth to mask ventilation | |
| Target Population | Adult/pediatric patients greater |
| than 18 months of age. | |
| Adult/pediatric patients greater | |
| than 18 months of age. | |
| Environment of Use | Hospitals and field emergency |
| Hospitals and field emergency | |
| Materials | Thermoplastic, Silicone |
| Thermoplastic, Silicone, TPR | |
| (oxygen port cap) | |
| Oxygen port | Accessory adapter |
| Integrated into the device | |
| Expiratory Resistance | $0.25 cm H_2O$ at 50 LPM |
| $0.7 cm H_2O$ at 50 LPM | |
| Inspiratory Resistance | $1.85 cm H_2O$ at 50 LPM |
| $1.8 cm H_2O$ at 50 LPM | |
| Inlet connector | Standard 22mm ID |
| Standard 22mm ID | |
| Outlet connector | Standard 22mm OD/15mm ID |
| Standard 22mm OD/15mm 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 | |
| Energy | |
| Used/Delivered | Air flow through device used |
| to deliver inspiratory air and | |
| exhaled expiratory air from | |
| patient. | |
| Air flow through device used | |
| to deliver inspiratory air and | |
| exhaled expiratory air from | |
| patient. | |
| Compatibility | Designed for use with |
| resuscitation masks (Product | |
| Code BSJ) and endotracheal | |
| tubes with connectors (Product | |
| Code BTR) | |
| Designed for use with | |
| resuscitation masks (Product | |
| Code BSJ) and endotracheal | |
| tubes with connectors (Product | |
| Code BTR) |
| Substantial Equivalency Summary Comparision Table |
|---|
| --------------------------------------------------- |
6
Applicable Standards Met
| Standard or
Regulation | Standard
Organization or
Regulatory Body | Name of Test Performed | Test
Results |
|-------------------------------------|-------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------|
| AS 4259-1995 | Standards of Australia | Ancillary devices for expired air resuscitation | Pass |
| ISO 13544-
2:2002 | International
Standards Office | Respiratory Therapy Equipment – Part 2:
Tubing and Connectors | Pass |
| ISO 5356-1:2004 | International
Standards Office | Anaesthetic and Respiratory Equipment –
Conical Connectors - Part 1: Cones and
Sockets | Pass |
| BS EN ISO
10651-4:2009 | International
Standards Office | Lung Ventilators – Part 4: Particular
requirements for operator-powered non-
rebreathing valves | Pass |
| ISTA-2A:2011 | National Institute
for Occupational
Safety and Health | Packaged-Products weighing 150 lbs (68
kg) or Less | Pass |
| ISO 10993-
1:2009 COR 1
2010 | International
Standards Office | Biological Evaluation of Medical Devices
– Part 1: Evaluation and Testing within a
Risk Management Process | Pass |
| FDA Guidance
Document
(Draft) | FDA | Draft Reviewer Guidance on Face Masks
and Shield for CPR | Pass |
| BS EN ISO
15223-1:2012 | International
Standards Office | Medical Devices – Symbols to be used
with Medical Devices Labels, Labelling
and Information to be supplied– Part 1:
General Requirements | Pass |
| EPA-453/R-98-
008B | Environmental
Protection
Agency | Method TO-15, Determination Of Volatile
Organic Compounds (VOCs) In Air
Collected In Specially-Prepared Canisters
And Analyzed By Gas Chromatography/
Mass Spectrometry (GC/MS) | Pass |
Performance Testing
Biocompatibility testing
| Biocompatibility Test | ISO 10993-1 Requirement | Test Results |
|---|---|---|
| Cytotoxicity | Required | Passes |
| Irritation | Required | Passes |
| Sensitization | Required | Passes |
7
Summary Table of Testing Performed to the Applicable Standards Listed
| Bench Test | Purpose | Pass/Fail
Results | Justification |
|-------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Packaging and Assembly /
Shipping | To verify the device meets packaging
and assembly / shipping requirements | Pass | The BigEasy™ Non-Rebreathing Valve met the packaging
and assembly / shipping testing acceptance criteria. |
| Environmental | To verify the device meets
environmental requirements | Pass | The BigEasy™ Non-Rebreathing Valve met the
environmental requirements acceptance criteria. |
| VOC's, Ozone, CO, CO2 and Fine
Particle Discharge | To verify that the device meets TO-15
standards for VOC's and requirements
for the discharge of other gases and
particles below the standards' thresholds | Pass | The BigEasy™ Non-Rebreathing Valve met the
requirements for VOC's, Ozone, CO, CO2, and Fine
Particles. |
| Materials Specifications | To verify the device meets the materials
specifications requirements | Pass | The BigEasy™ Non-Rebreathing Valve met the materials
specifications acceptance criteria. |
| Labeling Verification | To verify the device meets the labeling
verification requirements | Pass | The BigEasy™ Non-Rebreathing Valve met the labeling
verification acceptance criteria. |
| Inlet and Outlet Fittings | To verify the device meets the inlet and
outlet fitting requirements | Pass | The BigEasy™ Non-Rebreathing Valve met the fittings
acceptance criteria. |
| Biocompatibility | To verify the device meets the
biocompatibility requirements | Pass | Based on ISO10993-1:2009/2010 and the 2013 FDA
Guidance Document, the BigEasy™ Non-Rebreathing
Valve meets the biocompatibility acceptance criteria. |
| Resistance to inhalation and
exhalation after and during
environmental exposure, vomitus
contamination, water submersion
and mechanical displacement. | To verify the device meets the
inhalation and exhalation resistance
requirements | Pass | The BigEasy™ Non-Rebreathing Valve met the resistance
criteria. |
| Drop test from 1 meter | To verify that the valve can withstand a
drop on a concrete floor | Pass | The BigEasy™ Non-Rebreathing Valve met the drop test
requirements |
| Mean concentration of oxygen at
15 LPM and circuit backpressure at
30 LPM | To determine the mean oxygen
concentration and the backpressure
during oxygen delivery | Pass | The BigEasy™ Non-Rebreathing Valve met the
requirements for oxygen delivery. |
| Assembly and Application | To validate the device can be assembled
and applied according to the IFU | Pass | Participants were able to perform the intended actions while
following the IFU |
8
Substantial Equivalence
12th Man Technologies, Inc. has demonstrated that the proposed device (BigEasy Non-Rebreathing Valve) is as safe and as effective as the predicate device. It is considered to be substantially equivalent to the currently marketed predicate device which has been previously reviewed for market clearance by the FDA.
Premarket Notification [510(k)] Number