Predicate Devices

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The description focuses on mechanical scavenging and oxygen delivery, with no mention of AI or ML technologies.

Therapeutic

Yes

The device delivers supplemental oxygen to patients to aid in their recovery, which is a therapeutic function.

Diagnostic

No

Explanation: The device is an oxygen delivery mask that scavenges waste anesthetic gases and can be used for ETCO2 monitoring. Its primary functions are therapeutic (oxygen delivery) and environmental safety (scavenging), not to diagnose a patient's condition. While it has an ETCO2 monitoring port, the device itself does not perform diagnosis; it only facilitates the measurement of exhaled carbon dioxide.

SaMD (Software as a Medical Device)

No

The device description clearly describes a physical oxygen delivery mask system with components for scavenging waste anesthetic gases and delivering supplemental oxygen. It is a hardware device.

IVD (In Vitro Diagnostic)

Based on the provided information, the ISO-Gard® Mask is not an In Vitro Diagnostic (IVD) device.

Here's why:

Intended Use: The intended use is to "scavenge waste anesthetic gases from patients during recovery from general anesthesia and to provide supplemental oxygen." This is a therapeutic and environmental control function, not a diagnostic one.
Device Description: The description focuses on oxygen delivery and waste gas scavenging, which are physical processes applied to the patient and their environment.
Lack of Diagnostic Function: There is no mention of analyzing biological samples (blood, urine, tissue, etc.) or providing information for the diagnosis, monitoring, or treatment of a disease or condition based on such analysis.
Performance Studies: The performance studies evaluate oxygen delivery, scavenging efficiency, and ETCO₂ monitoring (which is a physiological measurement, not an in vitro diagnostic test).

IVD devices are specifically designed to perform tests on samples taken from the human body to provide information for medical purposes. The ISO-Gard® Mask does not fit this definition.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / 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.

Product codes (comma separated list FDA assigned to the subject device)

CBN

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.

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

Adult

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)

Nonclinical Performance Testing Summary:

Test: Oxygen Delivery; Test Objective: To evaluate the oxygen delivery performance at variable oxygen flow rates and vacuum levels at standard Tidal Volumes of 500 ml without the use of N₂O; Acceptance Criteria: The delivered oxygen percentage using the ISO-Gard Mask must be equal to or greater than a standard medium concentration oxygen mask for all vacuum settings
Test: Scavenging; Test Objective: To evaluate the scavenging performance at variable oxygen flow rates and vacuum levels at standard Tidal Volumes of 500 ml with N₂O; Acceptance Criteria: N₂O levels must be lower than with a standard medium concentration oxygen mask
Test: ETCO₂; Test Objective: To evaluate the ETCO₂ performance in simulated conditions; Acceptance Criteria: The traces/waveforms during testing must be distinct and 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.

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Not Found

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.

K123176

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

Regulation Number and Section

§ 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).

Summary

0

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: 919-433-8050 919-433-4996 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.

1

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
Characteristics | Predicate
K123176
ISO-GARD® ClearAir™ Mask | Proposed
ISO-Gard®
Mask |
|--------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------|
| Classification Name | Apparatus, gas scavenging | Same |
| Product Code / CFR | CBN
868.5430

Secondary
CCK – Gaseous-Phase Carbon Dioxide Gas
Analyzer
868.1400 | Same |
| 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.

2

.

3

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.

4

. 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
delivery performance at
variable oxygen flow rates
and vacuum levels at
standard Tidal Volumes of
500 ml without the use of
N₂O	The delivered oxygen
percentage using the ISO-Gard
Mask must be equal to or
greater than a standard
medium concentration oxygen
mask for all vacuum settings
Scavenging	To evaluate the
scavenging performance
at variable oxygen flow
rates and vacuum levels at
standard Tidal Volumes of
500 ml with N₂O	N₂O levels must be lower than
with a standard medium
concentration oxygen mask
ETCO₂	To evaluate the ETCO₂
performance in simulated
conditions	The traces/waveforms during
testing must be distinct and
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.

5

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.

6

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 (800) 638-2041 or (301) 796-7100 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 (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/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

7

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