Predicate Devices

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The device description and performance studies focus on the physical design and gas scavenging/delivery capabilities, with no mention of AI or ML.

Therapeutic

Yes
The device is intended to provide "supplemental / therapeutic oxygen to patients to aid in their recovery," which is a therapeutic function.

Diagnostic

No

The device is an oxygen delivery mask designed to scavenge waste anesthetic gases and provide supplemental oxygen; it does not measure, analyze, or interpret physiological signals or provide a diagnosis.

SaMD (Software as a Medical Device)

No

The device description clearly outlines a physical mask system with components like vacuum tubing, an oxygen flow concentrator, and a mask body, indicating it is a hardware device, not software-only.

IVD (In Vitro Diagnostic)

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 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. It does not mention any analysis of biological samples or diagnostic testing.
Performance Studies: The performance studies evaluate oxygen delivery, connection strength, and biocompatibility. These are related to the device's function and safety, not its ability to diagnose a condition.
Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting specific analytes, or providing information for diagnosis, monitoring, or screening of diseases or conditions.

In summary, the ISO-Gard® Mask is a medical device used for patient care and environmental safety, not for in vitro diagnostic purposes.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

The ISO-Gard® Mask is intended to scavenge waste anesthetic gases from patients during recovery from general anesthesia and to provide supplemental oxygen.

The ISO-Gard® Mask helps to reduce the amount of anesthetic agents released to the work environment of the healthcare worker.

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 (WAG) exhaled by patients recovering from surgery in the Post-Anesthetic Care Unit (PACU). Vacuum/suction for scavenging of WAG is provided by the institution's regulated vacuum source. The proposed device allows for the delivery of supplemental / therapeutic oxygen to patients to aid in their recovery while reducing the amount of patient expelled waste anesthetic agents released to the work environment of the healthcare workers. The mask can be used with or without suction / vacuum to function as a standard oxygen mask with an ETCO2 monitoring port.

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

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)

Test: Oxygen Delivery with Vacuum Tubing
Test Objective: To evaluate the oxygen delivery performance at variable oxygen flow rates and vacuum levels at standard Tidal Volumes of 500 ml
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 and oxygen flow rates

Test: Oxygen Delivery with Vacuum Tubing Removed
Test Objective: To evaluate the oxygen delivery performance with vacuum tubing removed at variable oxygen flow rates
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 oxygen flow rates

Test: Strength of Connection
Test Objective: To validate the Oxygen Flow Concentrator to Mask bond strength
Acceptance Criteria: The Oxygen Flow Concentrator will not detach at 30 lpm flow rate and the initial gauge pressure reading will remain the same as the final pressure reading for each tested mask

Test: Biocompatibility Testing • Cytotoxicity per ISO 10993-5 • Sensitization per ISO 10993- 10 • Irritation per ISO 10993-10 Acute Systemic Toxicity per 10993-11
Test Objective: To verify biocompatibility of the new material. Testing was performed based on skin/external communication contact of limited duration (

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

Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized image of three faces in profile, stacked on top of each other. The faces are rendered in a dark color, contrasting with the white background. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the image.

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

October 30, 2014

Teleflex Medical, Inc. Brian Gall Regulatory Affairs Specialist 2917 Weck Drive Research Triangle Park, NC 27709

Re: K142138

Trade/Device Name: ISO-Gard Mask Regulation Number: 868.5430 Regulation Name: Gas-Scavenging Apparatus Regulatory Class: II Product Code: CBN Dated: August 01, 2014 Received: August 05, 2014

Dear Mr. Gall:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food. Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

1

Page 2 - Mr. Gall

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office

You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

of Surveillance and Biometrics/Division of Postmarket Surveillance.

Sincerely yours,

Tejashri Purohit-Sheth, M.D. Tejashri Purohit-Sheth, M.D. Clinical Deputy Director DAGRID/ODE/CDRH

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

FOR

2

Indications for Use

510(k) Number (if known)

K142138

Device Name

ISO-Gard® Mask

Indications for Use (Describe)

The ISO-Gard® Mask is intended to scavenge waste anesthetic gases from patients during recovery from general anesthesia and to provide supplemental oxygen.

The ISO-Gard® Mask helps to reduce the amount of anesthetic agents released to the work environment of the healthcare worker.

Type of Use (Select one or both, as applicable)

2 Prescription Use (Part 21 CFR 801 Subpart D)

_ Over-The-Counter Use (21 CFR 801 Subpart C)

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

FOR FDA USE ONLY

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

This section applies only to requirements of the Paperwork Reduction Act of 1995.

DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

Teleflex Medical, Inc.

Page 006.2

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

3

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 Fax: 919-433-4996

Contact Person

Brian Gall Regulatory Affairs Specialist

Date Prepared

August 1, 2014

Device Name

Trade Name:	ISO-Gard® Mask
Classification Name:	Apparatus, gas-scavenging
Product Code:	CBN
Regulation Number:	868.5430
Classification:	II
Classification Panel:	Anesthesiology

Predicate Device

This submission demonstrates substantial equivalence to the predicate device ISO-GARD ClearAir Mask - K132729

Device Description

The ISO-Gard Mask system is an oxygen delivery mask that actively scavenges waste anesthetic gases (WAG) exhaled by patients recovering from surgery in the Post-Anesthetic Care Unit (PACU). Vacuum/suction for scavenging of WAG is provided by the institution's regulated vacuum source. The proposed device allows for the delivery of supplemental / therapeutic oxygen to patients to aid in their recovery while reducing the amount of patient expelled waste anesthetic agents released to the work environment of the healthcare workers. The mask can be used with or without suction / vacuum to function as a standard oxygen mask with an ETCO2 monitoring port.

4

Indications for Use

The ISO-Gard® Mask is intended to be used to scavenge waste anesthetic gases from patients during recovery from general anesthesia and to provide supplemental oxygen.

The ISO-Gard® Mask helps to reduce the amount of anesthetic agents released to the work environment of the healthcare worker.

Patient Population

Patients recovering from general anesthesia in the PACU.

Environments of use

The environment of use is - Post-operative Care Units (PACU) in hospital, sub-acute facilities.

Contraindications

None

Substantial Equivalence

The proposed device is substantially equivalent to the predicate devices:

| Comparative
Characteristics | Predicate
K132729
ISO-GARD® 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.

5

6

Comparison to Predicate Device

The proposed ISO-Gard Mask is substantially equivalent to the predicate device with respect to indications for use, technology, labeling, and construction. The proposed material change to the ISO-Gard Mask does not introduce any new issues of safety and effectiveness.

Indications for Use -
The indications for use are identical to the predicate.
Technology and construction -● The proposed device design, drawings, components, accessories, shelf-life, packaging, labeling, and product configurations remain unchanged.
Environment of use -

The environment of use is identical to the predicate.

7

● Patient Population -

The patient population is identical to the predicate.

● Materials -

All patient contacting materials are identical to the predicate device except as noted above. All materials are in compliance with ISO 10993-1:2009 and FDA Bluebook Memorandum G95-1 according to their nature and duration of contact. Testing performed is listed in the performance summary table below.

Performance Testing -●

A brief summary of tests relied upon to demonstrate substantial equivalence to the predicate can be found in the table below:

Test	Test Objective	Acceptance Criteria
Oxygen Delivery with
Vacuum Tubing	To evaluate the oxygen
delivery performance at
variable oxygen flow rates
and vacuum levels at
standard Tidal Volumes of
500 ml	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
and oxygen flow rates
Oxygen Delivery with
Vacuum Tubing
Removed	To evaluate the oxygen
delivery performance with
vacuum tubing removed at
variable oxygen flow rates	The delivered oxygen
percentage using the ISO-Gard
Mask must be equal to or
greater than a standard
medium concentration oxygen
mask for all oxygen flow rates
Strength of Connection	To validate the Oxygen
Flow Concentrator to
Mask bond strength	The Oxygen Flow
Concentrator will not detach
at 30 lpm flow rate and the
initial gauge pressure reading
will remain the same as the
final pressure reading for each
tested mask
Biocompatibility
Testing
• Cytotoxicity per
ISO 10993-5
• Sensitization
per ISO 10993-
10	To verify biocompatibility
of the new material.
Testing was performed
based on skin/external
communication contact of
limited duration
(