ISO-GARD MASK

K142138 · Teleflexmedical, Inc. · CBN · Oct 30, 2014 · Anesthesiology

Device Facts

• Record ID: K142138
• Device Name: ISO-GARD MASK
• Applicant: Teleflexmedical, Inc.
• Product Code: CBN · Anesthesiology
• Decision Date: Oct 30, 2014
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 868.5430
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

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.

Device Story

ISO-Gard Mask is an oxygen delivery mask for post-anesthesia care unit (PACU) patients. Device connects to institutional wall oxygen and regulated vacuum sources. Mask features a divided manifold to separate oxygen delivery from waste anesthetic gas (WAG) scavenging. Includes entrainment valves to manage excess negative or positive pressure and an ETCO2 monitoring port. Used by healthcare workers in hospital or sub-acute settings. By scavenging exhaled anesthetic gases, the device reduces occupational exposure for staff while providing therapeutic oxygen to the patient. Output is the delivery of oxygen and the removal of waste gases; healthcare providers monitor patient recovery and ETCO2 levels via the integrated port.

Clinical Evidence

Bench testing only. Evaluated oxygen delivery performance at variable flow rates and vacuum levels compared to standard medium concentration oxygen masks. Validated bond strength of oxygen flow concentrator. Biocompatibility testing performed per ISO 10993-5, -10, and -11 for limited duration skin/external contact.

Technological Characteristics

Flexible PVC mask with foam seal and elastic strap. Divided manifold (polystyrene) separates oxygen inlet and scavenging outlet. Includes polyisoprene one-way inhalation valves and ETCO2 sampling port (female luer lock). Materials include PVC, polystyrene, polyisoprene, polypropylene, and polyester. Compliant with ISO 10993-1:2009. Non-powered, passive scavenging system.

Indications for Use

Indicated for patients recovering from general anesthesia in the PACU who require supplemental oxygen. No contraindications.

Regulatory Classification

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.

Predicate Devices

• ISO-GARD ClearAir Mask (K132729)

Submission Summary (Full Text)

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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 [phone] or [phone] 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 [phone] or [phone] 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)

#### PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.

#### FOR FDA USE ONLY

Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)

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."

Teleflex Medical, Inc.

Page 006.2

Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below.

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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: [phone] Fax: [phone]

## 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:

| Comparative<br>Characteristics | Predicate<br>K132729<br>ISO-GARD® Mask | Proposed<br>ISO-Gard®<br>Mask |
|-----------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------|
| Classification Name | Apparatus, gas scavenging | Same |
| Product Code / CFR | CBN<br>868.5430<br><br>Secondary<br>CCK - Gaseous-Phase Carbon Dioxide Gas<br>Analyzer<br>868.1400 | Same |
| Indications for Use | The ISO-GARD® ClearAir™ Mask is intended<br>to be used to scavenge waste anesthetic gases<br>from patients during recovery<br>from general anesthesia and to provide<br>supplemental oxygen.<br><br>The ISO-GARD® ClearAir™ Mask helps to<br>reduce the amount of anesthetic agents released to<br>the 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 anesthesia<br>and may need supplemental oxygen | Same |
| | Adults | |
| Contraindications | None | Same |
| Basic Components | Mask<br>Oxygen delivery tubing<br>Vacuum (scavenging) tubing<br>Mask Manifold controlling oxygen delivery<br>and scavenging | Same |
| Design, Features, and Specifications | | |
| Mask | Flexible oxygen mask with sealing foam | Same |
| Method to hold mask<br>on patient for seal | Elastic band / strap | Same |
| Tubing to deliver<br>oxygen | Standard oxygen tubing | Same |
| Connects to ETCO2<br>monitor | Yes | Same |
| Connector to<br>sampling line | Standard female luer lock | Same |
| Method of separating<br>gas flows | Divided manifold for separating vacuum and<br>oxygen delivery and then a separate<br>sampling port | Same |
| Safety features | | |
| Excess negative<br>pressure | Contains entrainment valves if the negative<br>pressure from vacuum is too great<br>Valves are one-way flapper/diaphragm<br>valves that open with minimal negative<br>pressure or flow | Same |
| Excess positive<br>pressure | Contains entrainment valves if patient's<br>inhalation is greater than the supply of the<br>oxygen | Same |
| Method to assist in<br>sealing | Foam pad around bridge of nose to assist in<br>sealing of the mask | Same |
| Method to separate<br>oxygen delivery from<br>scavenging | Mask manifold body is a divided adapter<br>which has an oxygen inlet and a scavenging<br>outlet | Same |
| Oxygen source | Wall oxygen | Same |
| Vacuum source | Wall vacuum | Same |
| Port for sampling<br>end tidal CO2 | Port connector on exhalation side of Mask<br>Manifold adapter | Same |
| Typical oxygen<br>delivered flow rates | Up to 10 lpm | Same |
| Oxygen at various<br>Oxygen flow<br>rates and Vacuum<br>setting | Delivered oxygen equal or greater than oxygen<br>concentration mask | Same |
| Mask sizes | Adult | Same |
| Performance<br>Standards | None | Same |
| Shelf Life | 1 year shelf-life | Same |
| Patient Contacting Materials | | |
| Mask | PVC | Same |
| Star-Lumen Oxygen<br>Tube | PVC | Same |
| Connector, Star-<br>Lumen Oxygen Tube | PVC | Same |
| Gasketing Foam<br>w/Adhesive | Natural ester foam with acrylic pressure sensitive<br>adhesive | Same |
| Tethered Cap | Thermoplastic Elastomer | Same |
| One-way inhalation<br>valves | Polyisoprene | Same |
| One-way Valve Body | Polystyrene, Trans Blue | Same |
| Oxygen Delivery<br>Port Adaptor | Polypropylene | Same |
| White Elastic Strap | White Polyester/<br>Polyisoprene | Same |
| Mask Manifold | Polystyrene | Same |
| Suction/Exhalation<br>Port | Polystyrene | Same |
| Oxygen Port<br>Concentrator | PVC,HOSE END GRADE,VM 1760 CLEAR 0001<br>Dye: 07001-57 | PVC: Same<br>Dye:<br>CV5M664907<br>Dark 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 with<br>Vacuum Tubing | To evaluate the oxygen<br>delivery performance at<br>variable oxygen flow rates<br>and vacuum levels at<br>standard Tidal Volumes of<br>500 ml | The delivered oxygen<br>percentage using the ISO-Gard<br>Mask must be equal to or<br>greater than a standard<br>medium concentration oxygen<br>mask for all vacuum settings<br>and oxygen flow rates |
| Oxygen Delivery with<br>Vacuum Tubing<br>Removed | To evaluate the oxygen<br>delivery performance with<br>vacuum tubing removed at<br>variable oxygen flow rates | The delivered oxygen<br>percentage using the ISO-Gard<br>Mask must be equal to or<br>greater than a standard<br>medium concentration oxygen<br>mask for all oxygen flow rates |
| Strength of Connection | To validate the Oxygen<br>Flow Concentrator to<br>Mask bond strength | The Oxygen Flow<br>Concentrator will not detach<br>at 30 lpm flow rate and the<br>initial gauge pressure reading<br>will remain the same as the<br>final pressure reading for each<br>tested mask |
| Biocompatibility<br>Testing<br>• Cytotoxicity per<br>ISO 10993-5<br>• Sensitization<br>per ISO 10993-<br>10 | To verify biocompatibility<br>of the new material.<br>Testing was performed<br>based on skin/external<br>communication contact of<br>limited duration<br>(< 24 hours) | Must meet the requirements as<br>outlined 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.