OXYARM CO2

K014211 · Southmedic, Inc. · CCK · Jun 11, 2002 · Anesthesiology

Device Facts

• Record ID: K014211
• Device Name: OXYARM CO2
• Applicant: Southmedic, Inc.
• Product Code: CCK · Anesthesiology
• Decision Date: Jun 11, 2002
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 868.1400
• Device Class: Class 2
• Attributes: Therapeutic

Indications for Use

To deliver oxygen to patients in low to medium concentrations and provide a means to sample expired gases.

Device Story

OxyArm CO2 is an oxygen delivery and gas sampling headset. Device features an oxygen delivery port positioned in front of patient's nose and mouth, plus a dedicated port for sampling expired gases for end-tidal CO2 monitoring. Device connects to standard oxygen source and external CO2 monitor via sampling tubing. Used in hospitals, sub-acute institutions, emergency services, and physician offices. Operated by healthcare professionals. Unlike traditional masks, device does not cover nose or mouth and does not contact patient's face, potentially increasing patient comfort. Output allows clinicians to monitor patient respiratory status via CO2 waveforms and values while simultaneously providing oxygen therapy.

Clinical Evidence

Bench testing only. Performance data confirmed the device yields comparable CO2 waveforms and values at various oxygen flow rates and is capable of delivering required O2 concentrations.

Technological Characteristics

Materials: Polyethylene, polypropylene, PVC. No latex. Design: Headset-based, non-contact, one-size-fits-all. Connectivity: Connects to standard oxygen source and external CO2 monitor. Energy source: None (passive delivery/sampling).

Indications for Use

Indicated for any patient requiring oxygen delivery and expired gas sampling. Prescription use only.

Regulatory Classification

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.

Predicate Devices

• Medsys / Southmedic - Capnoxygen mask (K971229)
• Southmedic - OxyArm oxygen (K001865)
• Respan Oxygen mask (K942907)

Submission Summary (Full Text)

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JUN 11 2002

K014211

# Non-Confidential Summary of Safety and Effectiveness

| | Page 1 of 2<br>June 5, 2002 |
|-----------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------|
| Southmedic, Inc.<br>50 Alliance Blvd.<br>Barrie, Ontario, L4M 5K3<br>Canada | Tel - [phone]<br>Fax - [phone] |
| 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 - K971229<br>Southmedic - OxyArm oxygen - K001865<br>Respan Oxygen mask - K942907 |

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|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------|------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
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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.

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

Comparison to Predicate Devices:

| Attribute | Proposed device –<br>OxyArm CO₂ | Southmedic<br>OxyArm O₂ - K001865 | Medsys / Southmedic<br>Capnoxygen mask K971229 |
|--------------|---------------------------------------------------------------------------------|-----------------------------------|---------------------------------------------------------------------------------|
| Intended use | To deliver oxygen to patients<br>and provide a means to<br>sample expired gases | To deliver oxygen to<br>patients | To deliver oxygen to patients<br>and provide a means to sample<br>expired gases |

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# Non-Confidential Summary of Safety and Effectiveness

Page 2 of 2

### 5-Jun-02

| Attribute | Proposed device<br>OxyArm CO₂ | Southmedic<br>OxyArm - O₂- K001865 | Medsys / Southmedic<br>Capnoxygen 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 [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. 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 [phone] or [phone] 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)

or

、

Over-the-counter use _________________________________________________________________________________________________________________________________________________________