(127 days)
Not Found
No
The device description and performance studies focus on the physical scavenging and oxygen delivery functions of the mask, with no mention of AI or ML.
Yes
The device is intended to provide supplemental/therapeutic oxygen to patients as an aid in their recovery, which aligns with the definition of a therapeutic device designed to treat or alleviate a medical condition.
No
Explanation: The device is designed to scavenge waste anesthetic gases and deliver supplemental oxygen, not to diagnose a medical condition. While it has an ETCO2 monitoring port, the device itself is not performing the diagnostic function; it merely provides a port for connection to a separate monitoring device.
No
The device description clearly indicates it is a physical mask system with components for oxygen delivery and waste anesthetic gas scavenging, relying on an external vacuum source. It is not solely software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to scavenge waste anesthetic gases from patients and provide supplemental oxygen. This is a therapeutic and environmental control function, not a diagnostic test performed on samples taken from the body.
- Device Description: The description focuses on oxygen delivery and gas scavenging, not on analyzing biological samples for diagnostic purposes.
- Lack of IVD Characteristics: There is no mention of analyzing blood, urine, tissue, or any other biological sample. The device interacts with the patient's exhaled breath and delivers oxygen.
- Performance Studies: The performance studies focus on scavenging efficiency, oxygen delivery, and ETCO2 monitoring (which is a physiological measurement, not an in vitro diagnostic test).
In summary, the ISO-GARD® ClearAir™ Mask is a medical device used for patient care and environmental control, not for performing diagnostic tests on biological samples.
N/A
Intended Use / 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.
Product codes (comma separated list FDA assigned to the subject device)
CBN, CCK
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Adults
Intended User / Care Setting
Environment of use is - Post-operative Care Units (PACU) in hospital, sub-acute facilities.
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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 |
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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 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 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 Oxygen Flow rate | ||
| 4 lpm | ||
| 6 lpm | 7% | |
| 8 lpm | 11% | |
| 10 lpm | 17% |
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.
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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).
0
K123176
510(k) Summary Page 1 of 11
FEB 1 4 2013
| Date prepared: | 29-Oct-12 |
|---|---|
| Sponsor: | Teleflex Medical, Inc. |
| 2917 Weck Drive | |
| P.O. Box 12600 | |
| Research Triangle Park, NC 27709 | |
| Official Contact: | Angela Bouse |
| Senior Regulatory Affairs Specialist | |
| Tel: 919-433-4904 | |
| Fax: 919-433-4996 | |
| Proprietary or Trade Name: | ISO- GARD® ClearAir™ mask |
| Common/Usual Name: | Apparatus, gas-scavenging |
| Classification: | Product code - CBN |
| CFR 868.5430 - apparatus, gas-scavenging | |
| Class 2 | |
| Predicate Devices: | K953269 - Advanced Warming Systems (Apotheus) |
| SafeCircuit Manifold | |
| K950771 - Advanced Warming Systems (Apotheus) | |
| Adhesive Face Mask | |
| 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
ISO-GARD® ClearAir™ Mask | Predicate
K953269
Advanced Warming Systems
(Apotheus) SafeCircuit | Predicate
K950771
Advanced Warming Systems
(Apotheus) Adhesive Mask |
|------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Classification name
Product Code / CFR | Apparatus, gas scavenging
CBN
868.5430
Secondary
CCK - Gaseous-Phase Carbon Dioxide Gas
Analyzer
868.1400 | Apparatus, gas scavenging
CBN
868.5430 | Mask, gas, anesthetic
BSJ
868.5550 |
| Intended Use | To scavenge waste anesthetic gases and
provide supplemental oxygen | To scavenge waste anesthetic gases and
provide supplemental oxygen | To provide a patient seal when
connected to a breathing circuit and
allow for gases to be delivered to the
patient |
| 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. | To be used to scavenging of wastes
anesthetic gases from patients recovery
from general anesthesia and provide
supplement oxygen | To be used in conjunction with the
SafeCircuit (K953269) manifold to
provide the seal for scavenging of
waste anesthetic gases and delivery of
supplemental oxygen |
| | The ISO-GARD® ClearAir™ Mask helps to
reduce the amount of anesthetic agents
released to the work environment of the
healthcare worker. | When used with the SafeCircuit Adhesive
mask and a standard breathing circuit, the
unit helps to reduce the amount of
anesthetic agents and airborne
contaminants released to the work
environment of the healthcare worker. | |
| Features | Proposed
ISO-GARD® ClearAir™ Mask | Predicate
K953269
Advanced Warming Systems
(Apotheus) SafeCircuit | Predicate
K950771
Advanced Warming Systems
(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
and may need supplemental oxygen | Patients recovering from general anesthesia
and may need supplemental oxygen | Used with the SafeCircuit manifold |
| Basic components | Adults
Mask
Oxygen delivery tubing
Vacuum (scavenging) tubing
Mask Manifold controlling oxygen delivery
and scavenging | Pediatrics and Adults
Used with Adhesive mask
Breathing circuit for oxygen delivery
Connects to vacuum for scavenging
Manifold with directional valves for
controlling oxygen delivery and scavenging | Pediatric and Adults
Adhesive mask used with SafeCircuit
manifold |
| Design, Features, and Specifications
Mask | Flexible oxygen mask with sealing foam | Uses Adhesive mask to seal around the
patient's face | Adhesive mask used with SafeCircuit
manifold with an adhesive seal |
| Method to hold mask on
patient for seal | Elastic band / strap | Head strap plus adhesive seal of mask | Head strap plus adhesive seal of mask |
| Tubing to deliver
oxygen | Standard oxygen tubing | Breathing circuit tubing 22 mm | Standard oxygen tubing |
| Excess negative
pressure | Contains entrainment valves if the negative
pressure from vacuum is too great
Valves are one-way flapper/diaphragm
valves that open with minimal negative
pressure or flow. | Incorporates excess negative pressure relief
valves in case of excess vacuum | N/A |
| Excess positive pressure | Contains entrainment valves if patient's
inhalation is greater than the supply of the
oxygen | Incorporates excess positive pressure relief
valves if patient inhalation exceeds the
available supply of gas | N/A |
| Features | Proposed
ISO-GARD® ClearAir™ Mask | Predicate
K953269
Advanced Warming Systems
(Apotheus) SafeCircuit | Predicate
K950771
Advanced Warming Systems
(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
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
10 lpm O2 @ 30 mm Hg = 44% O2
4 lpm O2 @ 50 mm Hg = 22% O2
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
ISO-GARD® ClearAir™ Mask | Predicate
K961150
Teleflex |
|-------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Classification name | Apparatus, gas scavenging | Bi-Flo ETCO₂ Nasal Cannula
Gaseous-Phase Carbon Dioxide Gas Analyzer |
| Product Code / CFR | CBN
868.5430 | |
| | Secondary
CCK - Gaseous-Phase Carbon Dioxide Gas
Analyzer
868.1400 | CCK - Gaseous-Phase Carbon Dioxide Gas
Analyzer
868.1400 |
| Intended Use | To scavenge waste anesthetic gases and
provide supplemental oxygen and be able to
sample for ET CO2 | To provide supplemental oxygen and be
able to sample for ET CO2 |
| 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. [To provide
supplemental oxygen and be able to sample for
ET CO2] | The Hudson RCI Gas Sampling Oxygen
Nasal Cannula is an adjunct to oxygen
therapy with its primary function being that
of delivering low flow oxygen to a patient
while providing a means to sample expired
gas. It is intended for use in patients
requiring oxygen therapy to improve blood
oxygen levels while monitoring expired gas |
| | The ISO-GARD® ClearAir™ Mask helps to
reduce the amount of anesthetic agents
released to the work environment of the
healthcare worker. | to determine ventilator rate. |
| Environment of Use | Hospital, sub-acute facilities PACU | Hospital, sub-acute facilities no limitation
of specific locations of use |
| Patient Population | Patients recovering from general anesthesia
and may need supplemental oxygen
Adults | Patient requiring supplemental oxygen and
the ability to sample for ET CO2 |
| Design, Features and Specifications | | Pediatrics and Adults |
| Connects to ETCO2
monitor | Yes | Yes |
| Connector to sampling
line | Standard female luer lock | Standard female luer lock |
| Method of separating
gas flows | Divided manifold for separating vacuum and
oxygen delivery and then a separate
sampling port | Divided cannula for oxygen and gas
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 | |||
| 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 | |||
| 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 | ||
| 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