(208 days)
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.
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.
The provided text describes the acceptance criteria and the study that proves the device meets those criteria for the BigEasy™ Non-Rebreathing Valve.
Here's the breakdown of the information requested:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria Category | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Biocompatibility | Meeting ISO 10993-1 requirements for Cytotoxicity, Irritation, and Sensitization. | The BigEasy™ Non-Rebreathing Valve passed all required biocompatibility tests (Cytotoxicity, Irritation, Sensitization) based on ISO10993-1:2009/2010 and the 2013 FDA Guidance Document. |
| Packaging and Assembly / Shipping | Meeting packaging and assembly / shipping requirements. | The BigEasy™ Non-Rebreathing Valve met the packaging and assembly / shipping testing acceptance criteria. |
| Environmental | Meeting environmental requirements for storage and operation. (Specific ranges provided: Operating Temperature: -18°C to 50°C, Storage Temperature: -40°C to 60°C, Storage Relative Humidity: 10% to 95%) | The BigEasy™ Non-Rebreathing Valve met the environmental requirements acceptance criteria. (Specific values: Operating Temperature: -18°C to 50°C, Storage Temperature: -40°C to 60°C, Storage Relative Humidity: 10% to 95% were also listed as specifications). |
| Volatile Organic Compounds (VOCs), Ozone, CO, CO2 and Fine Particle Discharge | Meeting TO-15 standards for VOCs and requirements for the discharge of other gases and particles below the standards' thresholds. | The BigEasy™ Non-Rebreathing Valve met the requirements for VOCs, Ozone, CO, CO2, and Fine Particles. |
| Materials Specifications | Meeting materials specifications requirements. | The BigEasy™ Non-Rebreathing Valve met the materials specifications acceptance criteria. |
| Labeling Verification | Meeting labeling verification requirements. | The BigEasy™ Non-Rebreathing Valve met the labeling verification acceptance criteria. |
| Inlet and Outlet Fittings | Meeting inlet and outlet fitting requirements (Standard 22mm ID for inlet, Standard 22mm OD/15mm ID for outlet). | The BigEasy™ Non-Rebreathing Valve met the fittings acceptance criteria. |
| Resistance to Inhalation and Exhalation | Meeting resistance requirements after and during environmental exposure, vomitus contamination, water submersion, and mechanical displacement. | The BigEasy™ Non-Rebreathing Valve met the resistance criteria. (Specific values: Inspiratory Resistance: 1.9 cm H2O at 50 LPM, Expiratory Resistance: 0.25 cm H2O at 50 LPM were also listed as specifications). |
| Drop Test | Withstanding a drop on a concrete floor from 1 meter. | The BigEasy™ Non-Rebreathing Valve met the drop test requirements. |
| Mean Concentration of Oxygen at 15 LPM and Circuit Backpressure at 30 LPM | Determining the mean oxygen concentration and backpressure during oxygen delivery. | The BigEasy™ Non-Rebreathing Valve met the requirements for oxygen delivery. |
| Assembly and Application | Validation that the device can be assembled and applied according to the Instructions For Use (IFU). | Participants were able to perform the intended actions while following the IFU. |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document does not explicitly state the sample sizes for each specific test or the data provenance (country of origin, retrospective/prospective). The studies are described as "Non-clinical test results" and "Bench Tests," which typically implies laboratory testing rather than human subject data.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
This information is not provided. Given that the tests are primarily "Bench Tests" and "Biocompatibility Testing," they typically involve objective measurements against established standards, rather than expert interpretation for ground truth.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not provided. The tests appear to be objective measurements against predefined standards, thus not requiring an adjudication method by human experts.
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
No MRMC comparative effectiveness study was done. This device is a non-rebreathing valve, which is a physical medical device, not an AI-powered diagnostic tool. The "performance testing" focuses on physical and material properties, not diagnostic accuracy with or without AI.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
A standalone performance evaluation was done, but it was for the physical device itself, not an algorithm. The device was tested independently against various physical, material, and operational standards.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The "ground truth" for the performance tests was based on established industry standards and regulations, such as:
- AS 4259-1995 (Ancillary devices for expired air resuscitation)
- ISO 13544-2:2002 (Respiratory Therapy Equipment – Part 2: Tubing and Connectors)
- ISO 5356-1:2004 (Anaesthetic and Respiratory Equipment – Conical Connectors - Part 1: Cones and Sockets)
- BS EN ISO 10651-4:2009 (Lung Ventilators – Part 4: Particular requirements for operator-powered non-rebreathing valves)
- ISTA-2A:2011 (Packaged-Products weighing 150 lbs (68 kg) or Less)
- ISO 10993-1:2009 COR 1 2010 (Biological Evaluation of Medical Devices – Part 1: Evaluation and Testing within a Risk Management Process)
- FDA Guidance Document (Draft) (Reviewer Guidance on Face Masks and Shield for CPR)
- BS EN ISO 15223-1:2012 (Medical Devices – Symbols to be used with Medical Devices Labels, Labelling and Information to be supplied– Part 1: General Requirements)
- EPA-453/R-98-008B (Method TO-15, Determination Of Volatile Organic Compounds (VOCs) In Air)
8. The sample size for the training set
Not applicable. This is a physical medical device, not an AI algorithm requiring a 'training set.'
9. How the ground truth for the training set was established
Not applicable. There is no training set for this type of device.
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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.
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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
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-
- 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
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510(k) Summary
| Submitter's Name | 12th Man Technologies, Inc.7245 Garden Grove Blvd., Suite GGarden Grove, CA 928411.714.705.4576 |
|---|---|
| Registration Number | 3009108174 |
| Contact Name | Alex Stenzler12th Man Technologies, Inc.7245 Garden Grove Blvd., Suite GGarden Grove, CA 92841Telephone: 1.714.705.4576Fax: 1.714.373.0505Email: 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
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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% |
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| Intended Use | The BigEasy™ Non-Rebreathing Valve is intendedto assist in providing immediate life support (mouthto mask ventilation) to health emergency victimsrequiring oxygen support or cardiopulmonaryresuscitation (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 | |
|---|---|
| RespironicsRescue Valve and VentEasyNon-Rebreathing Valve(Predicates) | |
| 12th Man Technologies, Inc.BigEasy™ Non-RebreathingValve | |
| Intended Use | Mouth to mask ventilation |
| Mouth to mask ventilation | |
| 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 | 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 | |
| EnergyUsed/Delivered | Air flow through device usedto deliver inspiratory air andexhaled expiratory air frompatient. |
| Air flow through device usedto deliver inspiratory air andexhaled expiratory air frompatient. | |
| Compatibility | Designed for use withresuscitation masks (ProductCode BSJ) and endotrachealtubes with connectors (ProductCode BTR) |
| Designed for use withresuscitation masks (ProductCode BSJ) and endotrachealtubes with connectors (ProductCode BTR) |
| Substantial Equivalency Summary Comparision Table |
|---|
| --------------------------------------------------- |
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Applicable Standards Met
| Standard orRegulation | StandardOrganization orRegulatory Body | Name of Test Performed | TestResults |
|---|---|---|---|
| AS 4259-1995 | Standards of Australia | Ancillary devices for expired air resuscitation | Pass |
| ISO 13544-2:2002 | InternationalStandards Office | Respiratory Therapy Equipment – Part 2:Tubing and Connectors | Pass |
| ISO 5356-1:2004 | InternationalStandards Office | Anaesthetic and Respiratory Equipment –Conical Connectors - Part 1: Cones andSockets | Pass |
| BS EN ISO10651-4:2009 | InternationalStandards Office | Lung Ventilators – Part 4: Particularrequirements for operator-powered non-rebreathing valves | Pass |
| ISTA-2A:2011 | National Institutefor OccupationalSafety and Health | Packaged-Products weighing 150 lbs (68kg) or Less | Pass |
| ISO 10993-1:2009 COR 12010 | InternationalStandards Office | Biological Evaluation of Medical Devices– Part 1: Evaluation and Testing within aRisk Management Process | Pass |
| FDA GuidanceDocument(Draft) | FDA | Draft Reviewer Guidance on Face Masksand Shield for CPR | Pass |
| BS EN ISO15223-1:2012 | InternationalStandards Office | Medical Devices – Symbols to be usedwith Medical Devices Labels, Labellingand Information to be supplied– Part 1:General Requirements | Pass |
| EPA-453/R-98-008B | EnvironmentalProtectionAgency | Method TO-15, Determination Of VolatileOrganic Compounds (VOCs) In AirCollected In Specially-Prepared CanistersAnd 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 |
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Summary Table of Testing Performed to the Applicable Standards Listed
| Bench Test | Purpose | Pass/FailResults | Justification |
|---|---|---|---|
| Packaging and Assembly /Shipping | To verify the device meets packagingand assembly / shipping requirements | Pass | The BigEasy™ Non-Rebreathing Valve met the packagingand assembly / shipping testing acceptance criteria. |
| Environmental | To verify the device meetsenvironmental requirements | Pass | The BigEasy™ Non-Rebreathing Valve met theenvironmental requirements acceptance criteria. |
| VOC's, Ozone, CO, CO2 and FineParticle Discharge | To verify that the device meets TO-15standards for VOC's and requirementsfor the discharge of other gases andparticles below the standards' thresholds | Pass | The BigEasy™ Non-Rebreathing Valve met therequirements for VOC's, Ozone, CO, CO2, and FineParticles. |
| Materials Specifications | To verify the device meets the materialsspecifications requirements | Pass | The BigEasy™ Non-Rebreathing Valve met the materialsspecifications acceptance criteria. |
| Labeling Verification | To verify the device meets the labelingverification requirements | Pass | The BigEasy™ Non-Rebreathing Valve met the labelingverification acceptance criteria. |
| Inlet and Outlet Fittings | To verify the device meets the inlet andoutlet fitting requirements | Pass | The BigEasy™ Non-Rebreathing Valve met the fittingsacceptance criteria. |
| Biocompatibility | To verify the device meets thebiocompatibility requirements | Pass | Based on ISO10993-1:2009/2010 and the 2013 FDAGuidance Document, the BigEasy™ Non-RebreathingValve meets the biocompatibility acceptance criteria. |
| Resistance to inhalation andexhalation after and duringenvironmental exposure, vomituscontamination, water submersionand mechanical displacement. | To verify the device meets theinhalation and exhalation resistancerequirements | Pass | The BigEasy™ Non-Rebreathing Valve met the resistancecriteria. |
| Drop test from 1 meter | To verify that the valve can withstand adrop on a concrete floor | Pass | The BigEasy™ Non-Rebreathing Valve met the drop testrequirements |
| Mean concentration of oxygen at15 LPM and circuit backpressure at30 LPM | To determine the mean oxygenconcentration and the backpressureduring oxygen delivery | Pass | The BigEasy™ Non-Rebreathing Valve met therequirements for oxygen delivery. |
| Assembly and Application | To validate the device can be assembledand applied according to the IFU | Pass | Participants were able to perform the intended actions whilefollowing the IFU |
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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
§ 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).