ISO-GARD CLEARAIR MASK
Device Facts
| Record ID | K123176 |
|---|---|
| Device Name | ISO-GARD CLEARAIR MASK |
| Applicant | Teleflexmedical, Inc. |
| Product Code | CBN · Anesthesiology |
| Decision Date | Feb 14, 2013 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 868.5430 |
| Device Class | Class 2 |
| Attributes | Therapeutic |
Indications for Use
The ISO-GARD® ClearAir™ 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® ClearAir™ Mask helps to reduce the amount of anesthetic agents released to the work environment of the healthcare worker.
Device Story
ISO-GARD® ClearAir™ mask is a modified oxygen delivery mask for PACU patients; connects to standard wall oxygen source for supplemental oxygen delivery and institution's regulated vacuum/suction source for scavenging waste anesthetic gases (WAGS). Device features a manifold with oxygen inlet and scavenging outlet; includes foam pad at nose bridge for seal; incorporates one-way flapper/diaphragm valves for excess negative/positive pressure relief. Includes port for ETCO2 monitoring. Used by healthcare workers in hospital/sub-acute PACU settings. Output is oxygen delivery to patient and removal of exhaled anesthetic agents from work environment. Benefits include improved patient oxygenation and reduced occupational exposure to anesthetic agents for healthcare staff.
Clinical Evidence
Bench testing only. Simulated bench study evaluated scavenging and oxygen delivery performance at variable flow rates and vacuum levels, comparing against standard oxygen masks and predicate nasal cannula. Results demonstrated effective WAGS scavenging (no measurable N2O in chamber) and equivalent or superior oxygen delivery performance compared to standard masks. ETCO2 waveform consistency was verified.
Technological Characteristics
Modified oxygen mask with manifold; materials tested per ISO 10993; includes one-way flapper/diaphragm valves for pressure relief; standard oxygen and vacuum tubing connections; integrated ETCO2 sampling port; non-powered, mechanical operation.
Indications for Use
Indicated for patients recovering from general anesthesia in PACU or sub-acute settings requiring supplemental oxygen and waste anesthetic gas scavenging.
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
- Advanced Warming Systems (Apotheus) SafeCircuit (K953269)
- Advanced Warming Systems (Apotheus) Adhesive Face Mask (K950771)
- Teleflex Bi-Flo ETCO2 nasal cannula (K961150)
Submission Summary (Full Text)
{0}------------------------------------------------
# K123176
# 510(k) Summary Page 1 of 11
# FEB 1 4 2013
| Date prepared: | 29-Oct-12 |
|----------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Sponsor: | Teleflex Medical, Inc.<br>2917 Weck Drive<br>P.O. Box 12600<br>Research Triangle Park, NC 27709 |
| Official Contact: | Angela Bouse<br>Senior Regulatory Affairs Specialist<br>Tel: 919-433-4904<br>Fax: 919-433-4996 |
| Proprietary or Trade Name: | ISO- GARD® ClearAir™ mask |
| Common/Usual Name: | Apparatus, gas-scavenging |
| Classification: | Product code - CBN<br>CFR 868.5430 - apparatus, gas-scavenging<br>Class 2 |
| Predicate Devices: | K953269 - Advanced Warming Systems (Apotheus)<br>SafeCircuit Manifold<br>K950771 - Advanced Warming Systems (Apotheus)<br>Adhesive Face Mask<br>K961150 - Teleflex Bi-Flo ETCO2 nasal cannula |
| Device Description: | |
The ISO-GARD® ClearAir™ 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.
The ISO-GARD® ClearAir™ mask is offered in several configurations, the differences being some of the components. Table 1. lists the configurations.
### Technology / Mode of Operation:
The ISO-GARD® ClearAir™ mask is a simple modified oxygen mask which is placed on the patient's face and connected to a standard oxygen source to deliver supplemental oxygen as needed and a separate hose which is connected to a vacuum / suction source to scavenge the patient's exhaled air. The user may adjust the oxygen flow rate and the vacuum rate as needed to deliver the required oxygen and effectively scavenge the WAGS.
{1}------------------------------------------------
# 510(k) Summary Page 2 of 11 29-Oct-12
# Table 1: ISO-GARD® ClearAir™ Mask Product Codes
| Product Code | Product Description |
|--------------|------------------------------------------|
| 8011 | ISO-GARD ClearAir Mask, with Tubing |
| 8012 | ISO-GARD ClearAir Mask, 8011 with Filter |
| 8013 | ISO-GARD ClearAir Mask, Wye and Clamps |
| 8014 | ISO-GARD ClearAir Mask, 8013 with Filter |
### Indications for Use:
The ISO-GARD® ClearAir™ 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® ClearAir™ 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.
### Predicate Device Comparison:
The ISO-GARD® ClearAir™ mask is viewed as substantially equivalent to the predicate devices because:
### Indications -
### Scavenging waste anesthetic gases and providing supplemental oxygen
The intended uses are identical and the indications for use of scavenging of waste anesthetic gases from patients recovery from general anesthesia and provide supplement oxygen are identical to the predicate, Advanced Warming Systems (Apotheus) SafeCircuit (K953269) when used with the Advanced Warming Systems (Apotheus) Adhesive face mask (K950771).
### Discussion -
There are no differences in the intended use and indications for use for the ISO-GARD® ClearAir™ mask and the predicate, Advanced Warming Systems (Apotheus) SafeCircuit (K953269) when used with the Advanced Warming Systems (Apotheus) Adhesive face mask (K950771).
### Measuring end-tidal CO2
The indications for use of measuring end-tidal CO2 near the patient's mouth are identical to the predicate Hudson (Teleflex) Bi-Flo ETCO2 Nasal Cannula (K961150).
{2}------------------------------------------------
# 510(k) Summary Page 3 of 11 29-Oct-12
# Discussion -
There are no differences in the indications for use for the ISO-GARD® ClearAir™ mask and the predicate, Hudson (Teleflex) Bi-Flo ETCO2 Nasal Cannula (K961150) for delivering supplemental oxygen and gas sampling.
### Technology -
The use of a face mask which provides a seal to improve gas scavenging while delivering supplemental oxygen and providing a gas sampling port is identical to the predicates, Advanced Warming Systems (Apotheus) SafeCircuit (K953269) when used with the Advanced Warming Systems (Apotheus) Adhesive face mask (K950771) and Hudson (Teleflex) Bi-Flo ETCO2 Nasal Cannula (K961150).
Providing excess positive and negative pressure relief for safety is equivalent to the predicate Advanced Warming Systems (Apotheus) SafeCircuit (K953269).
The source of oxygen and vacuum are identical to the predicate Advanced Warming Systems (Apotheus) SafeCircuit (K953269).
### Discussion -
All the technological characteristics of the proposed device are substantially equivalent to the predicates Advanced Warming Systems (Apotheus) SafeCircuit (K953269) when used with the Advanced Warming Systems (Apotheus) Adhesive face mask (K950771) and Hudson (Teleflex) Bi-Flo ETCO2 Nasal Cannula (K961150) and any difference do not raise any new safety concerns.
### Materials -
The materials are either identified predicates or have been tested per ISO 10993.
### Discussion -
The materials have been determined to be safe for the intended use based upon being identical to existing devices or having been tested per ISO 10993.
### Environment of Use -
The proposed environment of use in the Post-Operative Care Unit ("PACU") is identical to the predicate, Advanced Warming Systems (Apotheus) SafeCircuit (K953269).
### Discussion -
There are no differences in the environments of use for the ISO-GARD® ClearAir™ mask and the predicate, Advanced Warming Systems (Apotheus) SafeCircuit (K953269).
### Patient Population -
Patients recovering from general anesthesia and may need supplemental oxygen is identical to the predicate Advanced Warming Systems (Apotheus) SafeCircuit (K953269).
{3}------------------------------------------------
# 510(k) Summary Page 4 of 11 29-Oct-12
# Discussion -
There are no differences in the intended patient population for use for the ISO-GARD® ClearAir™ mask and the predicate, Advanced Warming Systems (Apotheus) SafeCircuit (K953269).
Table 2 is a comparison of the predicates Advanced Warming Systems (Apotheus) SafeCircuit (K953269) and Advanced Warming Systems (Apotheus) Adhesive face mask (K950771), while Table 3 is a comparison of the proposed device to the predicate Hudson (Teleflex) Bi-Flo ETCO2 Nasal Cannula (K961150).
{4}------------------------------------------------
510(k) Summary
Page 5 of 11
29-Oct-12
| Features | Proposed<br>ISO-GARD® ClearAir™ Mask | Predicate<br>K953269<br>Advanced Warming Systems<br>(Apotheus) SafeCircuit | Predicate<br>K950771<br>Advanced Warming Systems<br>(Apotheus) Adhesive Mask |
|------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Classification name<br>Product Code / CFR | Apparatus, gas scavenging<br>CBN<br>868.5430<br>Secondary<br>CCK - Gaseous-Phase Carbon Dioxide Gas<br>Analyzer<br>868.1400 | Apparatus, gas scavenging<br>CBN<br>868.5430 | Mask, gas, anesthetic<br>BSJ<br>868.5550 |
| Intended Use | To scavenge waste anesthetic gases and<br>provide supplemental oxygen | To scavenge waste anesthetic gases and<br>provide supplemental oxygen | To provide a patient seal when<br>connected to a breathing circuit and<br>allow for gases to be delivered to the<br>patient |
| Indications for use | The ISO-GARD® ClearAir™ Mask is<br>intended to be used to scavenge waste<br>anesthetic gases from patients during recovery<br>from general anesthesia and to provide<br>supplemental oxygen. | To be used to scavenging of wastes<br>anesthetic gases from patients recovery<br>from general anesthesia and provide<br>supplement oxygen | To be used in conjunction with the<br>SafeCircuit (K953269) manifold to<br>provide the seal for scavenging of<br>waste anesthetic gases and delivery of<br>supplemental oxygen |
| | The ISO-GARD® ClearAir™ Mask helps to<br>reduce the amount of anesthetic agents<br>released to the work environment of the<br>healthcare worker. | When used with the SafeCircuit Adhesive<br>mask and a standard breathing circuit, the<br>unit helps to reduce the amount of<br>anesthetic agents and airborne<br>contaminants released to the work<br>environment of the healthcare worker. | |
| Features | Proposed<br>ISO-GARD® ClearAir™ Mask | Predicate<br>K953269<br>Advanced Warming Systems<br>(Apotheus) SafeCircuit | Predicate<br>K950771<br>Advanced Warming Systems<br>(Apotheus) Adhesive Mask |
| Environment of Use | Hospital, sub-acute facilities PACU | Hospital, sub-acute facilities PACU | Hospital, sub-acute facilities PACU |
| Patient Population | Patients recovering from general anesthesia<br>and may need supplemental oxygen | Patients recovering from general anesthesia<br>and may need supplemental oxygen | Used with the SafeCircuit manifold |
| Basic components | Adults<br>Mask<br>Oxygen delivery tubing<br>Vacuum (scavenging) tubing<br>Mask Manifold controlling oxygen delivery<br>and scavenging | Pediatrics and Adults<br>Used with Adhesive mask<br>Breathing circuit for oxygen delivery<br>Connects to vacuum for scavenging<br>Manifold with directional valves for<br>controlling oxygen delivery and scavenging | Pediatric and Adults<br>Adhesive mask used with SafeCircuit<br>manifold |
| Design, Features, and Specifications<br>Mask | Flexible oxygen mask with sealing foam | Uses Adhesive mask to seal around the<br>patient's face | Adhesive mask used with SafeCircuit<br>manifold with an adhesive seal |
| Method to hold mask on<br>patient for seal | Elastic band / strap | Head strap plus adhesive seal of mask | Head strap plus adhesive seal of mask |
| Tubing to deliver<br>oxygen | Standard oxygen tubing | Breathing circuit tubing 22 mm | Standard oxygen tubing |
| 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. | Incorporates excess negative pressure relief<br>valves in case of excess vacuum | N/A |
| Excess positive pressure | Contains entrainment valves if patient's<br>inhalation is greater than the supply of the<br>oxygen | Incorporates excess positive pressure relief<br>valves if patient inhalation exceeds the<br>available supply of gas | N/A |
| Features | Proposed<br>ISO-GARD® ClearAir™ Mask | Predicate<br>K953269<br>Advanced Warming Systems<br>(Apotheus) SafeCircuit | Predicate<br>K950771<br>Advanced Warming Systems<br>(Apotheus) Adhesive Mask |
| Method to assist in sealing | Foam pad around bridge of nose to assist in sealing of the mask | Adhesive along the edges of the mask to permit a tight seal between the patient's face and the mask | N/A |
| Method to separate oxygen delivery from scavenging | Mask manifold body is a divided adapter which has an oxygen inlet and a scavenging outlet | Directional valves in the SafeCircuit manifold direct oxygen to the patient which a scavenging from the manifold | N/A |
| Oxygen source | Wall oxygen | Wall oxygen | Wall oxygen |
| Vacuum source | Wall vacuum | Wall vacuum | N/A |
| For sampling end-tidal CO2 | Port connector on exhalation side of Mask<br>Manifold adapter | Not offered at the time | See BiFlo nasal cannula (K961150) |
| Typical oxygen delivered flow rates | Up to 10 lpm | Not specified by could be up to 10 lpm | Up to 10 lpm |
| Specifications delivered oxygen at various Oxygen flow and Vacuum rate | 4 lpm O2 @ 30 mm Hg = 23% O2<br>10 lpm O2 @ 30 mm Hg = 44% O2<br><br>4 lpm O2 @ 50 mm Hg = 22% O2<br>10 lpm O2 @ 50 mm Hg = 43% O2 | Not specified but equivalent | N/A |
| Sizes | 1 | 3 | 3 |
| Materials | Materials are identical to already cleared devices or have been tested per ISO 10993 | Biocompatible materials | Biocompatible materials |
| Performance Standards | None | None | None |
'
·
{5}------------------------------------------------
510(k) Summary
:
:
:
. .
:
.
.
·
.
incorporates excess pos
valves if patient inhalati
available supply of gas
{6}------------------------------------------------
'510(k) Summary
:
:
.
.
1
:
{7}------------------------------------------------
# . 510(k) Summary
29-Oct-12
# Table 3 - Predicate Device Comparison Table – Teleflex Bi-Flo ETCO2 Nasal cannula (K961150)
| Features | Proposed<br>ISO-GARD® ClearAir™ Mask | Predicate<br>K961150<br>Teleflex |
|-------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Classification name | Apparatus, gas scavenging | Bi-Flo ETCO₂ Nasal Cannula<br>Gaseous-Phase Carbon Dioxide Gas Analyzer |
| Product Code / CFR | CBN<br>868.5430 | |
| | Secondary<br>CCK - Gaseous-Phase Carbon Dioxide Gas<br>Analyzer<br>868.1400 | CCK - Gaseous-Phase Carbon Dioxide Gas<br>Analyzer<br>868.1400 |
| Intended Use | To scavenge waste anesthetic gases and<br>provide supplemental oxygen and be able to<br>sample for ET CO2 | To provide supplemental oxygen and be<br>able to sample for ET CO2 |
| Indications for use | The ISO-GARD® ClearAir™ Mask is<br>intended to be used to scavenge waste<br>anesthetic gases from patients during recovery<br>from general anesthesia and to provide<br>supplemental oxygen. [To provide<br>supplemental oxygen and be able to sample for<br>ET CO2] | The Hudson RCI Gas Sampling Oxygen<br>Nasal Cannula is an adjunct to oxygen<br>therapy with its primary function being that<br>of delivering low flow oxygen to a patient<br>while providing a means to sample expired<br>gas. It is intended for use in patients<br>requiring oxygen therapy to improve blood<br>oxygen levels while monitoring expired gas |
| | The ISO-GARD® ClearAir™ Mask helps to<br>reduce the amount of anesthetic agents<br>released to the work environment of the<br>healthcare worker. | to determine ventilator rate. |
| Environment of Use | Hospital, sub-acute facilities PACU | Hospital, sub-acute facilities no limitation<br>of specific locations of use |
| Patient Population | Patients recovering from general anesthesia<br>and may need supplemental oxygen<br>Adults | Patient requiring supplemental oxygen and<br>the ability to sample for ET CO2 |
| Design, Features and Specifications | | Pediatrics and Adults |
| Connects to ETCO2<br>monitor | Yes | Yes |
| Connector to sampling<br>line | Standard female luer lock | Standard female luer lock |
| Method of separating<br>gas flows | Divided manifold for separating vacuum and<br>oxygen delivery and then a separate<br>sampling port | Divided cannula for oxygen and gas<br>sampling |
| Performance standard | None | None |
| Materials | ISO 10993 tested or identical to predicates | Biocompatible materials |
·
{8}------------------------------------------------
# 510(k) Summary Page 9 of 11 29-Oct-12
# Non-clinical Performance Testing Summary:
## Materials - Biocompatibility:
The materials were tested per ISO 10993 - cytotoxicity, sensitization, and irritation as surface contact, skin, limited duration or external communicating, tissue contact, limited duration.
### Discussion -
The biocompatibility testing demonstrated that the materials meet the requirements of ISO 10993.
### Performance Testing:
A simulation bench set-up was developed and validated to perform design and final product validation testing. The simulated bench testing is designed to evaluate measure and confirm the design performance of the ISO-GARD® ClearAir™ mask.
### Pass / Fail criteria:
There is no pass / fail criteria for the ISO-GARD® ClearAir™ mask. The testing performed is for disclosure only.
The tests performed are summarized in Table 4 below.
## Table 4 - Validation / Performance Testing Summary
| General Description |
|---------------------------------------------------------------------------------------------------------------------------------------------------|
| Scavenging and Oxygen Delivery performance at variable oxygen flow rates and Vacuum levels at standard Tidal Volumes of 500 ml |
| Scavenging and Oxygen Delivery performance at variable oxygen flow rates and Vacuum levels at Tidal Volumes outside 500 ml |
| Intentional leak - Scavenging and Oxygen Delivery performance at variable oxygen flow rates and Vacuum levels at standard Tidal Volumes of 500 ml |
| Performance when the vacuum source is a suction canister vs. wall vacuum |
| Performance of oxygen delivery without the use of N₂O |
| Evaluate simulation set-up to see the build-up of WAGS when no vacuum is applied |
| Characterize the oxygen delivery performance of medium concentration oxygen masks without N2O present |
| ET CO2 performance in simulated conditions |
| Comparative ET CO₂ performance of the predicate nasal cannula |
{9}------------------------------------------------
# 510(k) Summary Page 10 of 11 29-Oct-12
# Summary of Non-clinical Test Results
# Table 5 - Delivered Oxygen % at various O2 Flow and Vacuum rates (Tidal Volume of 500 ml) - Part 1
| Vacuum | | | |
|---------------------|----------|----------|----------|
| Oxygen Flow<br>rate | 30 mm Hg | 40 mm Hg | 50 mm Hg |
| 4 lpm | 23% | 21% | 22% |
| 6 lpm | 32% | 31% | 31% |
| 8 lpm | 38% | 38% | 38% |
| 10 lpm | 44% | 44% | 43% |
### Discussion:
The delivered oxygen % for the ISO-GARD® ClearAir™ mask was equal to or greater than a standard medium concentration oxygen mask for all vacuum settings, see Table 7.
Therefore the proposed device can deliver oxygen % equivalent to other oxygen mask while scavenging.
There was no measurable No o detected in the chamber, supporting effective scavenging at the patient.
| | Vacuum | | |
|---------------------|----------|----------|----------|
| Oxygen Flow<br>rate | 30 mm Hg | 40 mm Hg | 50 mm Hg |
| 4 lpm | 34% | 27% | 28% |
| 6 lpm | 37% | 31% | 30% |
| 8 lpm | 37% | 35% | 33% |
| 10 lpm | 40% | 36% | 35% |
# Table 6 - Delivered Oxygen % with no N2O - Part 5
# Discussion:
The delivered oxygen % for the ISO-GARD® ClearAir™ mask without N20 was greater than a standard oxygen mask at all flow rates and vacuum, see Table 8.
| | Table 7 - Standard Oxygen Mask Delivered Oxygen % with N20 - Part 6 | |
|----------------------------------------|---------------------------------------------------------------------|--|
| % Delivered Oxygen<br>Oxygen Flow rate | | |
| 4 lpm | રેજે | |
| 6 lpm | 7% | |
| 8 lpm | 11% | |
| 10 lpm | 17% | |
{10}------------------------------------------------
# 510(k) Summary Page 11 of 11 29-Oct-12
## Discussion:
The delivered oxygen % for the standard oxygen mask at all flow rates can be compared with Table 8 while N2O built up in the test chamber.
| Oxygen Flow rate | Delivered Oxygen % |
|------------------|--------------------|
| 4 lpm | 25% |
| 6 lpm | 26% |
| 8 lpm | 29% |
| 10 lpm | 32% |
| Table 8 - Delivered Oxygen % with no N2O with Standard Oxygen Mask - Part 7 | | | |
|-----------------------------------------------------------------------------|--|--|--|
|-----------------------------------------------------------------------------|--|--|--|
## Discussion:
The delivered oxygen % for the standard oxygen mask at all flow rates without N2O is less than the performance of the ISO-GARD® ClearAir™ mask under the same conditions, see Table 5.
# End-tidal CO2 tracing and waveform with ISO-GARD™ ClearAir™ mask - Part 8
### Discussion:
The tracings and waveform were more consistent that compared to the predicate Bi-Flo nasal sampling cannula.
# Substantial Equivalence Conclusion -
The sponsor has demonstrated through performance testing, design features, and non-clinical testing that the proposed device and predicates have been found to substantially equivalent.
{11}------------------------------------------------
Image /page/11/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 tail. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged in a circular fashion around the eagle.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
February 14, 2013
Ms. Angela Bouse Senior Regulatory Affairs Specialist Teleflex Medical, Incorporated 2917 Weck Drive PO Box 12600 RESEARCH TRIANGLE PARK NC 27709
Re: K123176
Trade/Device Name: ISO-GARD® ClearAir™ Mask Regulation Number: 21 CFR 868.5430 Regulation Name: Gas-Scavenging Apparatus Regulatory Class: II Product Code: CBN Dated: January 16, 2013 Received: January 17, 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.
{12}------------------------------------------------
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 (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 go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. 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/MedicalDeyices/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,
Image /page/12/Picture/6 description: The image shows the name "Kwame O. Ulmer" in a bold, sans-serif font. The letters are black, and the name is centered in the image. There is a design behind the name that looks like a stylized logo or emblem. The design is made up of horizontal lines and geometric shapes.
Anthony D. Watson, B.S., M.S., M.B.A. Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control and Dental Devices
Office of Device Evaluation
Center for Devices and Radiological Health
Enclosure
{13}------------------------------------------------
# Indications for Use Statement
510(k) Number:
p123176 (To be assigned)
Device Name:
ISO-GARD® ClearAir™ Mask
Indications for Use:
The ISO-GARD® ClearAir™ 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® ClearAir™ 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)
Over-the-counter use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
or
Concurrence of CDRH, Office of Device Evaluation (ODE)
Lester W. Schult 2013.02.15 15 15:07 00"
(Division Sign-Off) Division of Anesthestology, General Hospital Infaction Control, Dental Devices
K123176 510(k) Number:
Teleflex Medical, Inc
PDF Page 17 of 311
Page 4.2
