(86 days)
The ISO-Gard® Mask is intended to scavenge waste anesthetic gases from patients during recovery from general anesthesia and to provide supplemental oxygen.
The ISO-Gard® Mask helps to reduce the amount of anesthetic agents released to the work environment of the healthcare worker.
The ISO-Gard Mask system is an oxygen delivery mask that actively scavenges waste anesthetic gases (WAG) exhaled by patients recovering from surgery in the Post-Anesthetic Care Unit (PACU). Vacuum/suction for scavenging of WAG is provided by the institution's regulated vacuum source. The proposed device allows for the delivery of supplemental / therapeutic oxygen to patients to aid in their recovery while reducing the amount of patient expelled waste anesthetic agents released to the work environment of the healthcare workers. The mask can be used with or without suction / vacuum to function as a standard oxygen mask with an ETCO2 monitoring port.
This document describes the Teleflex Medical, Inc. ISO-Gard Mask (K142138), a gas-scavenging apparatus intended to remove waste anesthetic gases and provide supplemental oxygen to patients recovering from general anesthesia.
Here's an analysis of the provided information regarding acceptance criteria and the supporting studies:
1. Table of Acceptance Criteria and Reported Device Performance:
| Test Name | Test Objective | Acceptance Criteria | Reported Device Performance and Conclusion |
|---|---|---|---|
| Oxygen Delivery with Vacuum Tubing | To evaluate the oxygen delivery performance at variable oxygen flow rates and vacuum levels at standard Tidal Volumes of 500 ml. | The delivered oxygen percentage using the ISO-Gard Mask must be equal to or greater than a standard medium concentration oxygen mask for all vacuum settings and oxygen flow rates. | Not explicitly detailed in the provided text. The overall conclusion states that "Performance test results demonstrate that the proposed device does not raise new questions of safety and effectiveness and because all acceptance criteria has been met, the device can be found substantially equivalent." This implies the device met this criterion. |
| Oxygen Delivery with Vacuum Tubing Removed | To evaluate the oxygen delivery performance with vacuum tubing removed at variable oxygen flow rates. | The delivered oxygen percentage using the ISO-Gard Mask must be equal to or greater than a standard medium concentration oxygen mask for all oxygen flow rates. | Not explicitly detailed in the provided text. The overall conclusion states that "Performance test results demonstrate that the proposed device does not raise new questions of safety and effectiveness and because all acceptance criteria has been met, the device can be found substantially equivalent." This implies the device met this criterion. |
| Strength of Connection | To validate the Oxygen Flow Concentrator to Mask bond strength. | The Oxygen Flow Concentrator will not detach at 30 lpm flow rate and the initial gauge pressure reading will remain the same as the final pressure reading for each tested mask. | Not explicitly detailed in the provided text. The overall conclusion states that "Performance test results demonstrate that the proposed device does not raise new questions of safety and effectiveness and because all acceptance criteria has been met, the device can be found substantially equivalent." This implies the device met this criterion. |
| Biocompatibility Testing: Cytotoxicity | To verify biocompatibility of the new material. Testing was performed based on skin/external communication contact of limited duration (< 24 hours). | Must meet the requirements as outlined in ISO 10993-1. | The text states: "All patient contacting materials are identical to the predicate device except as noted above. All materials are in compliance with ISO 10993-1:2009 and FDA Bluebook Memorandum G95-1 according to their nature and duration of contact. Testing performed is listed in the performance summary table below." This indicates the new material (PVC dye: CV5M664907 Dark Blue) passed due to satisfying ISO 10993-1 requirements. |
| Biocompatibility Testing: Sensitization | To verify biocompatibility of the new material. Testing was performed based on skin/external communication contact of limited duration (< 24 hours). | Must meet the requirements as outlined in ISO 10993-1. | The text states: "All patient contacting materials are identical to the predicate device except as noted above. All materials are in compliance with ISO 10993-1:2009 and FDA Bluebook Memorandum G95-1 according to their nature and duration of contact. Testing performed is listed in the performance summary table below." This indicates the new material (PVC dye: CV5M664907 Dark Blue) passed due to satisfying ISO 10993-1 requirements. |
| Biocompatibility Testing: Irritation | To verify biocompatibility of the new material. Testing was performed based on skin/external communication contact of limited duration (< 24 hours). | Must meet the requirements as outlined in ISO 10993-1. | The text states: "All patient contacting materials are identical to the predicate device except as noted above. All materials are in compliance with ISO 10993-1:2009 and FDA Bluebook Memorandum G95-1 according to their nature and duration of contact. Testing performed is listed in the performance summary table below." This indicates the new material (PVC dye: CV5M664907 Dark Blue) passed due to satisfying ISO 10993-1 requirements. |
| Biocompatibility Testing: Acute Systemic Toxicity | To verify biocompatibility of the new material. Testing was performed based on skin/external communication contact of limited duration (< 24 hours). | Must meet the requirements as outlined in ISO 10993-11. (Note: The table lists ISO 10993-11, indicating this specific part for acute systemic toxicity). | The text states: "All patient contacting materials are identical to the predicate device except as noted above. All materials are in compliance with ISO 10993-1:2009 and FDA Bluebook Memorandum G95-1 according to their nature and duration of contact. Testing performed is listed in the performance summary table below." This indicates the new material (PVC dye: CV5M664907 Dark Blue) passed due to satisfying ISO 10993-1 or ISO 10993-11 requirements, as appropriate for the specific test. |
2. Sample Size Used for the Test Set and Data Provenance:
The document does not explicitly state the sample sizes used for the oxygen delivery and bond strength tests. However, the biocompatibility testing was performed on the "new material" (PVC dye: CV5M664907 Dark Blue). The provenance of the data for these performance tests is internal to Teleflex Medical, Inc. and is likely based on laboratory testing rather than patient data, given the nature of the device (mask for gas scavenging/oxygen delivery). The study is retrospective in the sense that it evaluates the performance of the device's design.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications:
This information is not applicable as the studies described are performance and biocompatibility tests on a physical device, not related to image interpretation or diagnosis requiring expert ground truth establishment.
4. Adjudication Method for the Test Set:
This information is not applicable for the same reasons as point 3.
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 device is a medical mask, not an AI-powered diagnostic or assistive tool for human readers.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done:
This information is not applicable. The device is a physical medical device, not an algorithm.
7. The Type of Ground Truth Used:
For the oxygen delivery and strength of connection tests, the "ground truth" is based on engineering and performance standards (e.g., maintaining a certain oxygen percentage, not detaching under specific flow rates). For biocompatibility, the "ground truth" is adherence to established international standards (ISO 10993-1 and ISO 10993-11).
8. The Sample Size for the Training Set:
This information is not applicable as there is no mention or implication of a "training set" in the context of this device's performance testing. The device is not based on a machine learning algorithm.
9. How the Ground Truth for the Training Set was Established:
This information is not applicable for the same reasons as point 8.
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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
October 30, 2014
Teleflex Medical, Inc. Brian Gall Regulatory Affairs Specialist 2917 Weck Drive Research Triangle Park, NC 27709
Re: K142138
Trade/Device Name: ISO-Gard Mask Regulation Number: 868.5430 Regulation Name: Gas-Scavenging Apparatus Regulatory Class: II Product Code: CBN Dated: August 01, 2014 Received: August 05, 2014
Dear Mr. Gall:
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. Gall
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
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.
of Surveillance and Biometrics/Division of Postmarket Surveillance.
Sincerely yours,
Tejashri Purohit-Sheth, M.D. Tejashri Purohit-Sheth, M.D. Clinical Deputy Director DAGRID/ODE/CDRH
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
FOR
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Indications for Use
510(k) Number (if known)
K142138
Device Name
ISO-Gard® Mask
Indications for Use (Describe)
The ISO-Gard® Mask is intended to scavenge waste anesthetic gases from patients during recovery from general anesthesia and to provide supplemental oxygen.
The ISO-Gard® Mask helps to reduce the amount of anesthetic agents released to the work environment of the healthcare worker.
Type of Use (Select one or both, as applicable)
2 Prescription Use (Part 21 CFR 801 Subpart D)
_ Over-The-Counter Use (21 CFR 801 Subpart C)
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FOR FDA USE ONLY
Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)
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Teleflex Medical, Inc.
Page 006.2
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510(k) SUMMARY
Name, Address, Phone and Fax Number of Applicant
Teleflex Medical, Incorporated 2917 Weck Drive Research Triangle Park, NC 27709 USA Phone: 919-433-8050 Fax: 919-433-4996
Contact Person
Brian Gall Regulatory Affairs Specialist
Date Prepared
August 1, 2014
Device Name
| Trade Name: | ISO-Gard® Mask |
|---|---|
| Classification Name: | Apparatus, gas-scavenging |
| Product Code: | CBN |
| Regulation Number: | 868.5430 |
| Classification: | II |
| Classification Panel: | Anesthesiology |
Predicate Device
This submission demonstrates substantial equivalence to the predicate device ISO-GARD ClearAir Mask - K132729
Device Description
The ISO-Gard Mask system is an oxygen delivery mask that actively scavenges waste anesthetic gases (WAG) exhaled by patients recovering from surgery in the Post-Anesthetic Care Unit (PACU). Vacuum/suction for scavenging of WAG is provided by the institution's regulated vacuum source. The proposed device allows for the delivery of supplemental / therapeutic oxygen to patients to aid in their recovery while reducing the amount of patient expelled waste anesthetic agents released to the work environment of the healthcare workers. The mask can be used with or without suction / vacuum to function as a standard oxygen mask with an ETCO2 monitoring port.
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Indications for Use
The ISO-Gard® Mask is intended to be used to scavenge waste anesthetic gases from patients during recovery from general anesthesia and to provide supplemental oxygen.
The ISO-Gard® Mask helps to reduce the amount of anesthetic agents released to the work environment of the healthcare worker.
Patient Population
Patients recovering from general anesthesia in the PACU.
Environments of use
The environment of use is - Post-operative Care Units (PACU) in hospital, sub-acute facilities.
Contraindications
None
Substantial Equivalence
The proposed device is substantially equivalent to the predicate devices:
| ComparativeCharacteristics | PredicateK132729ISO-GARD® Mask | ProposedISO-Gard®Mask |
|---|---|---|
| Classification Name | Apparatus, gas scavenging | Same |
| Product Code / CFR | CBN868.5430SecondaryCCK - Gaseous-Phase Carbon Dioxide GasAnalyzer868.1400 | Same |
| Indications for Use | The ISO-GARD® ClearAir™ Mask is intendedto be used to scavenge waste anesthetic gasesfrom patients during recoveryfrom general anesthesia and to providesupplemental oxygen.The ISO-GARD® ClearAir™ Mask helps toreduce the amount of anesthetic agents released tothe work environment of the healthcare worker. | Same |
| Trade Name | ISO-Gard® Mask | Same |
| Environment of Use | Hospital, sub-acute facilities PACU | Same |
| Patient Population | Patients recovering from general anesthesiaand may need supplemental oxygen | Same |
| Adults | ||
| Contraindications | None | Same |
| Basic Components | MaskOxygen delivery tubingVacuum (scavenging) tubingMask Manifold controlling oxygen deliveryand scavenging | Same |
| Design, Features, and Specifications | ||
| Mask | Flexible oxygen mask with sealing foam | Same |
| Method to hold maskon patient for seal | Elastic band / strap | Same |
| Tubing to deliveroxygen | Standard oxygen tubing | Same |
| Connects to ETCO2monitor | Yes | Same |
| Connector tosampling line | Standard female luer lock | Same |
| Method of separatinggas flows | Divided manifold for separating vacuum andoxygen delivery and then a separatesampling port | Same |
| Safety features | ||
| Excess negativepressure | Contains entrainment valves if the negativepressure from vacuum is too greatValves are one-way flapper/diaphragmvalves that open with minimal negativepressure or flow | Same |
| Excess positivepressure | Contains entrainment valves if patient'sinhalation is greater than the supply of theoxygen | Same |
| Method to assist insealing | Foam pad around bridge of nose to assist insealing of the mask | Same |
| Method to separateoxygen delivery fromscavenging | Mask manifold body is a divided adapterwhich has an oxygen inlet and a scavengingoutlet | Same |
| Oxygen source | Wall oxygen | Same |
| Vacuum source | Wall vacuum | Same |
| Port for samplingend tidal CO2 | Port connector on exhalation side of MaskManifold adapter | Same |
| Typical oxygendelivered flow rates | Up to 10 lpm | Same |
| Oxygen at variousOxygen flowrates and Vacuumsetting | Delivered oxygen equal or greater than oxygenconcentration mask | Same |
| Mask sizes | Adult | Same |
| PerformanceStandards | None | Same |
| Shelf Life | 1 year shelf-life | Same |
| Patient Contacting Materials | ||
| Mask | PVC | Same |
| Star-Lumen OxygenTube | PVC | Same |
| Connector, Star-Lumen Oxygen Tube | PVC | Same |
| Gasketing Foamw/Adhesive | Natural ester foam with acrylic pressure sensitiveadhesive | Same |
| Tethered Cap | Thermoplastic Elastomer | Same |
| One-way inhalationvalves | Polyisoprene | Same |
| One-way Valve Body | Polystyrene, Trans Blue | Same |
| Oxygen DeliveryPort Adaptor | Polypropylene | Same |
| White Elastic Strap | White Polyester/Polyisoprene | Same |
| Mask Manifold | Polystyrene | Same |
| Suction/ExhalationPort | Polystyrene | Same |
| Oxygen PortConcentrator | PVC,HOSE END GRADE,VM 1760 CLEAR 0001Dye: 07001-57 | PVC: SameDye:CV5M664907Dark Blue |
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Comparison to Predicate Device
The proposed ISO-Gard Mask is substantially equivalent to the predicate device with respect to indications for use, technology, labeling, and construction. The proposed material change to the ISO-Gard Mask does not introduce any new issues of safety and effectiveness.
-
Indications for Use -
The indications for use are identical to the predicate. -
Technology and construction -● The proposed device design, drawings, components, accessories, shelf-life, packaging, labeling, and product configurations remain unchanged.
-
Environment of use -
The environment of use is identical to the predicate.
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● Patient Population -
The patient population is identical to the predicate.
● Materials -
All patient contacting materials are identical to the predicate device except as noted above. All materials are in compliance with ISO 10993-1:2009 and FDA Bluebook Memorandum G95-1 according to their nature and duration of contact. Testing performed is listed in the performance summary table below.
Performance Testing -●
A brief summary of tests relied upon to demonstrate substantial equivalence to the predicate can be found in the table below:
| Test | Test Objective | Acceptance Criteria |
|---|---|---|
| Oxygen Delivery withVacuum Tubing | To evaluate the oxygendelivery performance atvariable oxygen flow ratesand vacuum levels atstandard Tidal Volumes of500 ml | The delivered oxygenpercentage using the ISO-GardMask must be equal to orgreater than a standardmedium concentration oxygenmask for all vacuum settingsand oxygen flow rates |
| Oxygen Delivery withVacuum TubingRemoved | To evaluate the oxygendelivery performance withvacuum tubing removed atvariable oxygen flow rates | The delivered oxygenpercentage using the ISO-GardMask must be equal to orgreater than a standardmedium concentration oxygenmask for all oxygen flow rates |
| Strength of Connection | To validate the OxygenFlow Concentrator toMask bond strength | The Oxygen FlowConcentrator will not detachat 30 lpm flow rate and theinitial gauge pressure readingwill remain the same as thefinal pressure reading for eachtested mask |
| BiocompatibilityTesting• Cytotoxicity perISO 10993-5• Sensitizationper ISO 10993-10 | To verify biocompatibilityof the new material.Testing was performedbased on skin/externalcommunication contact oflimited duration(< 24 hours) | Must meet the requirements asoutlined in ISO 10993-1 |
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| Irritation per ISO 10993-10 Acute Systemic Toxicity per 10993-11 | ||
|---|---|---|
| ------------------------------------------------------------------ | -- | -- |
Conclusion
The ISO-Gard Mask has the same indications for use, technological characteristics, and constructions as the predicate. Performance test results demonstrate that the proposed device does not raise new questions of safety and effectiveness and because all acceptance criteria has been met, the device can be found substantially equivalent.
§ 868.5430 Gas-scavenging apparatus.
(a)
Identification. A gas-scavenging apparatus is a device intended to collect excess anesthetic, analgesic, or trace gases or vapors from a patient's breathing system, ventilator, or extracorporeal pump-oxygenator, and to conduct these gases out of the area by means of an exhaust system.(b)
Classification. Class II (performance standards).