ISO-GARD MASK

K132729 · Teleflexmedical, Inc. · CBN · Jan 9, 2014 · Anesthesiology

Device Facts

• Record ID: K132729
• Device Name: ISO-GARD MASK
• Applicant: Teleflexmedical, Inc.
• Product Code: CBN · Anesthesiology
• Decision Date: Jan 9, 2014
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 868.5430
• Device Class: Class 2
• Attributes: Therapeutic

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.

Device Story

ISO-Gard Mask is an oxygen delivery mask for patients recovering from general anesthesia in the PACU. It connects to an institutional regulated vacuum source to actively scavenge exhaled waste anesthetic gases (WAGS), reducing exposure to healthcare workers. The device also delivers supplemental oxygen and includes an ETCO2 monitoring port. It features a divided manifold to separate oxygen delivery from scavenging, and entrainment valves to manage excess negative or positive pressure. The mask is secured to the patient via an elastic strap and includes a foam bridge pad for sealing. Healthcare providers use the mask to aid patient recovery while maintaining a safer work environment. The device is a passive/active hybrid system; it functions as a standard oxygen mask with or without vacuum suction.

Clinical Evidence

Bench testing only. Testing evaluated oxygen delivery performance at variable flow rates and vacuum levels, scavenging performance (N2O levels) compared to a standard medium concentration mask, and ETCO2 waveform consistency. Results demonstrated that the device meets performance requirements and is equivalent to the predicate.

Technological Characteristics

Oxygen delivery mask with integrated scavenging manifold. Materials: PVC (mask, tubing), natural ester foam with acrylic adhesive, thermoplastic elastomer, polyisoprene (valves), polystyrene, polypropylene, polyester. Features: divided manifold for gas separation, one-way flapper/diaphragm entrainment valves for pressure regulation, ETCO2 sampling port (female luer lock). Connectivity: connects to wall oxygen and wall vacuum. Form factor: adult size, elastic strap fixation. Shelf life: 1 year.

Indications for Use

Indicated for patients recovering from general anesthesia in the PACU to scavenge waste anesthetic gases and provide supplemental oxygen.

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 (K123176)

Submission Summary (Full Text)

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# K132729

510(k) Submission Tab 007 - Section 011 - 510(k) Summary ISO-Gard® Mask

JAN - 9 2014

## 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:

## Contact Person

Angela Bouse Senior Regulatory Affairs Specialist

## Date Prepared

December 11, 2013

## 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 - K123176

## Device Description

The ISO-Gard Mask system is an oxygen delivery mask that actively scavenges waste anesthetic gases (WAGS) exhaled by patients recovering from surgery in the Post-Anesthetic Care Unit (PACU). Vacuum/suction for scavenging of WAGS 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 1SO-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>K123176<br>ISO-GARD® ClearAir™ 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® ClearAir™ Mask | ISO-Gard® Mask |
| Environment of Use | Hospital, sub-acute facilities PACU | Same |
| Patient Population | Patients recovering from general anesthesia | Same |
| | and may need supplemental oxygen<br>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 on patient for seal | Elastic band / strap | Same |
| Tubing to deliver oxygen | Standard oxygen tubing | Same |
| Connects to ETCO2 monitor | Yes | Same |
| Connector to sampling line | Standard female luer lock | Same |
| Method of separating gas flows | Divided manifold for separating vacuum and oxygen delivery and then a separate sampling port | Same |
| Safety features | | |
| Excess negative pressure | Contains entrainment valves if the negative pressure from vacuum is too great<br>Valves are one-way flapper/diaphragm valves that open with minimal negative pressure or flow | Same |
| Excess positive pressure | Contains entrainment valves if patient's inhalation is greater than the supply of the oxygen | Same |
| Method to assist in sealing | Foam pad around bridge of nose to assist in sealing of the mask | Same |
| Method to separate oxygen delivery from scavenging | Mask manifold body is a divided adapter which has an oxygen inlet and a scavenging outlet | Same |
| Oxygen source | Wall oxygen | Same |
| Vacuum source | Wall vacuum | Same |
| Port for sampling end tidal CO2 | Port connector on exhalation side of Mask Manifold adapter | Same |
| Typical oxygen delivered flow rates | Up to 10 lpm | Same |
| Oxygen at various Oxygen flow rates and Vacuum setting | Delivered oxygen equal or greater than oxygen concentration mask | Same |
| Mask sizes | Adult | Same |
| Performance | None | Same |
| Standards | | Same |
| Shelf Life | No shelf life | 1 year shelf life |
| 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 | Same |

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.

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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, materials, and construction. The proposed change is to add a one year shelf life to the ISO-Gard Mask labeling.

#### . Indications for Use -

The indications for use are identical to the predicate.

#### Technology and construction -●

The proposed device design, drawings, components, accessories, materials, packaging and product configurations remain unchanged. The proposed change is to add a one year shelf life to the ISO-Gard Mask labeling.

### 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.

#### . Performance Testing

## Nonclinical Performance Testing Summary

| Test | Test Objective | Acceptance Criteria |
|-----------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Oxygen Delivery | 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 without the use of<br>N₂O | 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 |
| Scavenging | To evaluate the<br>scavenging performance<br>at variable oxygen flow<br>rates and vacuum levels at<br>standard Tidal Volumes of<br>500 ml with N₂O | N₂O levels must be lower than<br>with a standard medium<br>concentration oxygen mask |
| ETCO₂ | To evaluate the ETCO₂<br>performance in simulated<br>conditions | The traces/waveforms during<br>testing must be distinct and<br>generated consistently |

## 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 an acceptance criteria has been met, the device can be found substantially equivalent.

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### DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/5/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three stripes forming its wing and body. The eagle is positioned to the right of a circular border containing the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA".

Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

January 9, 2014

Teleflex Medical, Inc. Angela Bouse Senior Regulatory Affairs Specialist 2917 Weck Drive Research Triangle Park, NC 27709

Re: K132729

Trade Name: ISO-Gard® Mask Regulation Number: 21 CFR 868.5430 Regulation Name: Gas-scavenging apparatus Regulatory Class: Class II Product Code: CBN Dated: December 11, 2013 Received: December 12, 2013

Dear Ms. Bouse:

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 - Ms. Bouse

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 (2) 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/ResourcesforYou/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 [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours.

Image /page/6/Picture/8 description: The image contains a signature and some text. The text includes the name "Tejashri Purohit-Sheth, M.D.", followed by the title "Clinical Deputy Director". The acronym "DAGRID" is also present. The word "FOR" is at the bottom right.

Erin Keith, M.S. Acting Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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## Indications for Use Statement

Page I of I

510(k) Number:

(To be assigned)

Device Name:

ISO-Gard® Mask

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.

Prescription Use XX (Part 21 CFR 801 Subpart D) or

Over-the-counter use (21 CFR 807 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

K132729

Nayan J. Patel 2014.01.07 15:25:50 05'00'

Teleflex Medical, Inc