The Southmedic OxyArm CO2 is an oxygen delivery device with a headset and oxygen delivery port, which is placed in front of the patient vs. nasal cannula or over their mouth and nose. It also contains a port for taking a sample of expired gases, to measure exhaled end-tidal carbon dioxide. It is connected to a standard oxygen source and the sampling tubing to a standard end-tidal carbon dioxide monitor.

AI/ML Overview

The provided document describes a 510(k) premarket notification for the "OxyArm CO2" device, an oxygen delivery and expired gas sampling mask. The submission focuses on demonstrating substantial equivalence to predicate devices rather than proving specific performance against quantitative acceptance criteria through a dedicated study.

Therefore, many of the requested details, such as specific acceptance criteria, sample sizes for test/training sets, expert qualifications, adjudication methods, or MRMC studies, are not applicable or not present in the provided text because the device's approval is based on equivalence, not novel performance validation requiring such rigorous testing.

Here's an analysis based on the available information:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state quantitative acceptance criteria or detailed performance metrics in the way a novel device might. Instead, it compares attributes of the proposed device to predicate devices to establish substantial equivalence. The "Performance" section within the comparison table implicitly serves as the acceptance criteria, where the proposed device is deemed equivalent if it "Yields comparable CO2 waveforms and values at various flow rates of oxygen" and is "Capable O2 % concentration at various flows."

Attribute	Acceptance Criteria (Implied by Predicate Comparison)	Reported Device Performance (OxyArm CO₂)
CO2 waveforms and values at various oxygen flow rates	Comparable to predicate device (Medsys / Southmedic Capnoxygen mask K971229)	Yes (Yields comparable CO2 waveforms and values at various flow rates)
O2 % concentration capability at various flows	Comparable to predicate devices (Southmedic OxyArm O2 - K001865, Medsys / Southmedic Capnoxygen mask K971229)	Yes (Capable O2 % concentration at various flows)
Intended for single patient, multi-use	Yes	Yes
Prescription	Yes	Yes
Intended population	Any patient requiring oxygen delivery and expired gas sampling	Any patient requiring oxygen delivery and expired gas sampling
Intended Environment of Use	Hospital, Physician Office, sub-acute, Emergency services	Hospital, Physician Office, sub-acute, Emergency services
Delivers oxygen to patient nose and mouth	Yes	Yes
Can measure expired gases	Yes	Yes
Materials (Polyethylene, polypropylene, PVC, no latex)	Comparable to predicate devices	Yes (Polyethylene, polypropylene, PVC; No latex)

2. Sample size used for the test set and the data provenance

The document does not describe a specific clinical or performance test set with a stated sample size. The approval is based on demonstrating substantial equivalence to legally marketed predicate devices through a comparison of attributes and intended use. There is no mention of specific data provenance (country, retrospective/prospective) for a direct device performance study.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Not applicable. No external experts were used to establish ground truth in the context of a performance study for this 510(k) submission. The FDA reviews the provided information and determines substantial equivalence.

4. Adjudication method for the test set

Not applicable. No formal adjudication method involving multiple experts was performed as there was no independent test set demanding such a process.

5. If a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was done, and the effect size of how much human readers improve with AI vs without AI assistance

Not applicable. This device is an oxygen delivery and gas sampling mask, not an AI-powered diagnostic tool. Therefore, an MRMC study or assessment of human reader improvement with AI assistance is irrelevant.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

Not applicable. The OxyArm CO2 is a physical medical device, not an algorithm, so standalone performance in this context is irrelevant.

7. The type of ground truth used

Not applicable in the typical sense of a diagnostic or AI device. The "ground truth" for this 510(k) submission is the established performance and safety profiles of the legally marketed predicate devices. The new device demonstrates that its attributes and performance are comparable to these existing devices, thus inferring its safety and effectiveness.

8. The sample size for the training set

Not applicable. As this is not an AI/machine learning device, there is no training set in that context.

9. How the ground truth for the training set was established

Not applicable. See point 8.

Summary

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JUN 11 2002

K014211

Non-Confidential Summary of Safety and Effectiveness

	Page 1 of 2June 5, 2002
Southmedic, Inc.50 Alliance Blvd.Barrie, Ontario, L4M 5K3Canada	Tel - (705) 726-9383Fax - (705) 728-9537
Official Contact:	Lee McDonald - President
Proprietary or Trade Name:	OxyArm CO2
Common/Usual Name:	Oxygen / Carbon Dioxide Sampling Mask
Classification Name:	Accessory to Analyzer, gas, carbon dioxide, gaseous phase
Device:	Oxygen / Carbon Dioxide Sampling Mask
Predicate Devices:	Medsys / Southmedic - Capnoxygen mask - K971229Southmedic - OxyArm oxygen - K001865Respan Oxygen mask - K942907

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Intended Use:
Indicated Use --	To deliver oxygen to patients in low to medium concentrations andprovide a means to sample expired gases.
Environment of Use --	Hospital, Sub-acute Institutions, Emergency services,Physician offices

Comparison to Predicate Devices:

Attribute	Proposed device –OxyArm CO₂	SouthmedicOxyArm O₂ - K001865	Medsys / SouthmedicCapnoxygen mask K971229
Intended use	To deliver oxygen to patientsand provide a means tosample expired gases	To deliver oxygen topatients	To deliver oxygen to patientsand provide a means to sampleexpired gases

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Non-Confidential Summary of Safety and Effectiveness

Page 2 of 2

5-Jun-02

Attribute	Proposed deviceOxyArm CO₂	SouthmedicOxyArm - O₂- K001865	Medsys / SouthmedicCapnoxygen mask K971229
Intended for single patient, multi-use	Yes	Yes	Yes
Prescription	Yes	Yes	Yes
Intended population	Any patient requiring oxygen delivery and expired gas sampling	Any patient requiring oxygen delivery	Any patient requiring oxygen delivery and expired gas sampling
Intended Environment of Use	Hospital, Physician Office, sub-acute, Emergency services	Same plus Home	Hospital, Physician Office, sub-acute, Emergency services
Design Features
Various sizes	One size fits all	One size fits all	Multiple sizes
Delivers oxygen to patient nose and mouth	Yes	Yes	Yes
Covers patient nose and mouth	No	No	Yes
Can measure expired gases	Yes	No	Yes
Held on patient by	Head set	Head set	Elastic band
Comes into contact with patient's face	No	No	Yes
Materials
Polyethylene, polypropylene, PVC	Yes	Yes	PVC and elastic rubber band for head strap
Contains latex	No	No	Yes
Performance
Yields comparable CO2 waveforms and values at various flow rates of oxygen	Yes	Note applicable	Yes
Capable O2 % concentration at various flows	Yes	Yes	Yes

Differences between Other Legally Marketed Predicate Devices ﺍﻟﻤﻮﺍﺩ ﺍﻟﻤﺪﻳﺮ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﻮﻗﻊ ﺍﻟﻤﺘﻮﻗﻊ ﺍﻟﻤﺘﻮﻗﻊ ﺍﻟﻤﺘﻮﻗﻊ ﺍﻟﻤﺘﻮﻗﻊ ﺍﻟﻤﺘﻮﻗﻊ ﺍﻟﻤﺘﻮﻗﻊ ﺍﻟﻤﺘﻮﻗﻊ ﺍﻟﻤﺘﻮﻗﻊ ﺍﻟﻤﺘﻮﻗﻊ ﺍﻟﻤﺘﻮﻗﻊ ﺍﻟﻤﺘﻮﻗﻊ ﺍﻟﻤﺘﻮﻗﻊ ﺍﻟﻤﺘﻮﻗﻊ ﺍﻟﻤﺘﻮﻗﻊ ﺍﻟﻤﺘﻮﻗﻊ ﺍﻟﻤﺘﻮﻗﻊ ﺍﻟﻤﺘﻮﻗﻊ ﺍﻟﻤﺘﻮﻗﻊ

There are no significant differences between the intended device and the predicates - Medsys Southmedic - Capnoxygen mask - K971229, Southmedic - OxyArm Oxygen - K001865, and Respan Oxygen mask - K942907.

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" around the perimeter. Inside the circle is an abstract image of an eagle with its wings spread, formed by three stylized human profiles facing to the right.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUN 1 1 2002

Southmedic, Inc. Mr. Paul E. Dryden c/o ProMedic Inc. 6329 W. Waterview Court McCordsville. IN 46051-9501

Re: K014211

OxyArm CO2 Regulation Number: 868.1400 Regulation Name: Carbon Dioxide Gas Analyzer Regulatory Class: II (two) Product Code: 73 CCK Dated: March 14, 2002 Received: March 15, 2002

Dear Mr.Dryden:

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.

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

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Page 2 - Mr. Paul E. Dryden

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): good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 21 CFR Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4648. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely yours.

Dakota Tuteh

Dr. Dakota R. Tuteh, Ph.D.

Donna-Bea Tillman, Ph.D. Acting Director Division of Cardiovascular and Respiratory Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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243 - Indications for Use . 、・・・。

Page 1 of 1

510(k) Number:	K014211 (To be assigned)
Device Name:	OxyArm CO2
Intended Use:	To deliver oxygen to patients in low to medium concentrations and provides a means to sample expired gases

Concurrence of CDRH, Office of Device Evaluation (ODE)

Division of Cardiovascular & Respiratory Devices
510(k) Number K04211

Prescription Use ✓
(Per CFR 801.109)

、

Over-the-counter use _________________________________________________________________________________________________________________________________________________________

Regulation Number and Section

§ 868.1400 Carbon dioxide gas analyzer.

(a)
Identification. A carbon dioxide gas analyzer is a device intended to measure the concentration of carbon dioxide in a gas mixture to aid in determining the patient's ventilatory, circulatory, and metabolic status. The device may use techniques such as chemical titration, absorption of infrared radiation, gas chromatography, or mass spectrometry.(b)
Classification. Class II (performance standards).