**Draft Guidance for Industry and FDA Staff**

**Class II Special Controls Guidance Document: Oxygen Pressure
Regulators and Oxygen Conserving Devices**

***Draft Guidance***

**This guidance document is being distributed for comment purposes
only.** []{.mark}

**Document issued on: \[release date of FR Notice\]**

Comments and suggestions regarding this draft document should be
submitted within 90 days of publication in the *Federal Register* of the
notice announcing the availability of the draft guidance. Submit
comments to the Division of Dockets Management (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852.
Electronic comments may be submitted to
<http://ww.fda.gov/dockets/ecomments>. All comments should be identified
with the docket number listed in the notice of availability that
publishes in the *Federal Register*.

For questions regarding this document contact Christy Foreman in the
Office of Compliance at 240-276-0120 or Justin Guay in the Office of
Device Evaluation at 240-276-3700.

![](media/image1.png){width="0.9631944444444445in"
height="1.0763888888888888in"}

**U.S. Department of Health and Human Services**

**Food and Drug Administration**

**Center for Devices and Radiological Health**

**Office of Compliance**

**Preface**

**Additional Copies**

Additional copies are available from the Internet at:
[[http://www.fda.gov/cdrh/\[specific]{.underline}](http://www.fda.gov/cdrh/%5Bspecific)
address\], or to receive this document via your fax machine, call the
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followed by the pound sign (#). Follow the remaining voice prompts to
complete your request. []{.mark}

**Draft Guidance for Industry and FDA Staff**

**Class II Special Controls Guidance Document: Oxygen Pressure
Regulators and Oxygen Conserving Devices**

***This draft guidance, when finalized, will represent the Food and Drug
Administration\'s (FDA\'s) current thinking on this topic. It does not
create or confer any rights for or on any person and does not operate to
bind FDA or the public. You can use an alternative approach if the
approach satisfies the requirements of the applicable statutes and
regulations. If you want to discuss an alternative approach, contact the
FDA staff responsible for implementing this guidance. If you cannot
identify the appropriate FDA staff, call the appropriate number listed
on the title page of this guidance.***

**1. Background**

This draft guidance document was developed as a special control to
support the reclassification of pressure regulators for use with medical
oxygen (pressure greater than 200 psig[^1]) from class I (general
controls) into class II (special controls). This draft guidance was also
developed as a special control for oxygen conserving devices with a
built-in oxygen pressure regulator, already classified into class II as
part of the generic device type noncontinuous ventilators (21 CFR
868.5905). This guidance will be issued in conjunction with a *Federal
Register* notice announcing the proposal to reclassify oxygen pressure
regulators and to designate this document as the special control for
both oxygen pressure regulators and oxygen conserving devices with a
built-in oxygen pressure regulator. This guidance is issued for comment
purposes only. If a final rule is not issued designating this document
as a special control for these device types, this guidance document will
not be issued as a special control.

This guidance document describes a means by which oxygen pressure
regulators and oxygen conserving devices with a built-in oxygen pressure
regulator may comply with the requirement of special controls for class
II devices. Designation of this guidance document as a special control
means that manufacturers should (1) conform to the general controls; (2)
address the specific risks identified in the guidance; and (3) obtain a
substantial equivalence order from FDA before marketing their devices,
unless such devices are exempt from premarket notification requirements.

Section 510(m) of the Federal Food, Drug, and Cosmetic Act (the act)
provides that FDA may exempt a class II device from the premarket
notification requirements of section 510(k) of the act if FDA determines
that premarket notification is not necessary to provide reasonable
assurance of the safety and effectiveness of the device. FDA has
determined that premarket notification is not necessary to provide
reasonable assurance of the safety and effectiveness of oxygen pressure
regulators when the manufacturer meets the American Society of Testing
and Materials (ASTM) standard G175-03 identified in this special
controls guidance. Accordingly, under the proposed rule, oxygen pressure
regulators that meet the ASTM standard would be exempt from premarket
notification requirements (see proposed 21 CFR 868.2750(b)(1)). However,
manufacturers of this device type who use measures other than ASTM
standard G175-03 would be required to submit a premarket notification
establishing that the alternate measures provide equivalent assurances
of safety and effectiveness (sections 510(m) and 513(f), (i) of the
act.).

Oxygen conserving devices with a built-in oxygen pressure regulator
would also be subject to the special controls guidance because of the
incorporation of the oxygen pressure regulator. These devices, however,
would not be exempt from premarket notification requirements regardless
of whether they meet the ASTM G175-03 standard discussed in this
guidance or another measure that provides equivalent assurances of
safety and effectiveness. This is because the oxygen pressure regulator
is just one part of this device and FDA has previously determined that
submission of a 510(k) is necessary to provide reasonable assurance of
the safety and effectiveness of oxygen conserving devices (section
510(m) of the act). However, manufacturers of these devices who follow
the recommendations in the guidance and can certify conformance with
ASTM G175-03 may be able to submit an Abbreviated 510(k) rather than a
Traditional 510(k) submission. Section 3 of this document provides
guidance on submitting Abbreviated 510(k)s.

The ASTM G175 -- 03 standard referenced in this guidance applies to
oxygen regulators used for medical and emergency applications that are
designed and fitted with CGA 870 pin-index adapters and CGA 540 inlet
connections (CGA V-1, Standard for Compressed Gas Cylinder Valve Outlet
and Inlet Connections). Due to the design and location of the oxygen
pressure regulator incorporated into oxygen conserving devices, and due
to the detailed test instructions in the ASTM standard, it may not be
possible to test the built-in oxygen pressure regulator in accordance
with the ASTM standard. In these instances, the ASTM standard should be
used to the extent possible. Regardless of testing procedures, oxygen
conserving devices will not be exempt from premarket notification
requirements and manufacturers of such devices must submit either a
510(k) or, in appropriate cases, an Abbreviated 510(k).

Thus, following the effective date of a final rule reclassifying oxygen
pressure regulators into class II and establishing this guidance as the
special control for oxygen pressure regulators and oxygen conserving
devices with a built-in oxygen regulator, manufacturers of these devices
would need to address the issues covered in this special controls
guidance (section 513(a)(1)(B) of the act). However, such firms would
have the option of either following the recommendations in this guidance
or using an approach other than the ASTM G175-03 standard as long as
they can show their approach provides equivalent assurances of safety
and effectiveness.

FDA\'s guidance documents, including this guidance, do not establish
legally enforceable responsibilities. Instead, guidances describe the
Agency\'s current thinking on a topic and should be viewed only as
recommendations, unless specific regulatory or statutory requirements
are cited. The use of the word *should* in Agency guidances means that
something is suggested or recommended, but not required.

**The Least Burdensome Approach**

This draft guidance document reflects our careful review of what we
believe are the relevant issues related to special controls for oxygen
pressure regulators and oxygen conserving devices, and what we believe
would be the least burdensome way of addressing these issues. If you
have comments on whether there is a less burdensome approach, however,
please submit your comments as indicated on the cover of this document.

**2. Scope**

In a separate document issued in conjunction with this draft guidance,
FDA is proposing to reclassify generic pressure regulators for use with
medical oxygen as class II anesthesiology devices under 21 CFR 868.2750
(oxygen pressure regulator), subject to special controls. An oxygen
pressure regulator is intended to convert oxygen from a high variable
pressure (greater than 200 psig) to a lower, more constant working
pressure. Pressure regulators that are intended to be used with medical
gases other than oxygen under 21 CFR 868.2700 (pressure regulator) are
not subject to the reclassification or special controls.

FDA is also proposing to designate this guidance document as a special
control for oxygen conserving devices with a built-in o o0o xygen
pressure regulator, a device type currently classified into class II
under 21 CFR 868.5905. FDA proposes to define oxygen conserving devices
with a built-in o o0o xygen pressure regulator as \"a device intended to
conserve oxygen delivered to a patient that incorporates a built-in
oxygen pressure regulator.\" Under the proposal, all oxygen conserving
devices would remain in class II under a newly established
identification classification (see proposed 21 CFR 868.5910). However,
only those oxygen conserving devices that incorporate a built-in oxygen
pressure regulator would be subject to special controls.

This special controls guidance document identifies the classification,
product codes, and classification definitions for oxygen pressure
regulators and oxygen conserving devices with a built-in oxygen pressure
regulator. It also identifies the risks to health associated with these
generic device types and serves as the special control that, when
followed and combined with the general controls, will generally address
these risks. In addition, this document offers guidance on how
manufacturers of oxygen conserving devices with a built-in oxygen
pressure regulator that complies with the ASTM G175-03 standard can
prepare and submit an Abbreviated 510(k).

**3. The Content and Format of an Abbreviated 510(k) Submission --
Oxygen Conserving Devices**

This section provides information on submitting an abbreviated 510(k)
for oxygen conserving devices with a built-in oxygen pressure
regulator.[^2] An Abbreviated 510(k) submission must include the
required elements identified in 21 CFR 807.87, including the proposed
labeling for the device sufficient to describe the device, its intended
use, and the directions for its use. In an Abbreviated 510(k), FDA may
consider the contents of a summary report to be appropriate supporting
data within the meaning of 21 CFR 807.87(f) or (g); therefore, we
recommend that you include a summary report. The report should describe
how this special control guidance document was used during the device
development and testing and should briefly describe the methods or tests
used and a summary of the test data or description of the acceptance
criteria applied to address the risks identified in this document, as
well as any additional risks specific to your device. This section
suggests information to fulfill some of the requirements of section
807.87, as well as some other items that we recommend you include in an
Abbreviated 510(k).

**Coversheet**

> The coversheet should prominently identify the submission as an
> Abbreviated 510(k) and cite the title of this special controls
> guidance document.
>
> **Proposed labeling**
>
> Proposed labeling should be sufficient to describe the device, its
> intended use, and the directions for its use. (Please refer to
> **Section 6. Labeling**.)
>
> **Summary report**
>
> We recommend that the summary report contain:
>
> **Description of the device and its intended use**
>
> We recommend that you describe the performance specifications and,
> when appropriate, include detailed, labeled drawings of the device.
> You should also submit an "indications for use" enclosure.[^3]
>
> **Description of device design requirements**
>
> We recommend that you include a brief description of the device design
> requirements.
>
> **Identification of the risk analysis method**
>
> We recommend that you identify the risk analysis method(s) you used to
> assess the risk profile in general, as well as the specific device's
> design, and the results of this analysis. (Please refer to **Section
> 4** for the risks generally associated with the use of this device
> that FDA has identified.)
>
> **Discussion of the device characteristics**
>
> We recommend that you discuss the device characteristics that address
> the risks identified in this class II special controls guidance
> document (see **Section 4**), as well as any additional risks
> identified in your risk analysis.
>
> **Description of the performance aspects**
>
> We recommend that you include a brief description of the test
> method(s) you have used or intend to use to address each performance
> aspect identified in **Section 5** of this class II special controls
> guidance document. If you follow a suggested test method, you may cite
> the method rather than describing it. If you modify a suggested test
> method, you may cite the method but should provide sufficient
> information to explain the nature of and reason for the modification.
> For each test, you may either (1) briefly present the data resulting
> from the test in clear and concise form, such as a table,
> **[or]{.underline}** (2) describe the acceptance criteria that you
> will apply to your test results.[^4] (See also 21 CFR 820.30, Subpart
> C - Design Controls under the Quality System Regulation.)
>
> **Reliance on standards**
>
> If you choose to rely on a recognized standard for any part of the
> device design or testing, you may include either:

-   a statement that testing will be conducted and will meet specified
    acceptance criteria before the product is marketed; or

-   a declaration of conformity to the standard.[^5]

> Because a declaration of conformity is based on results from testing,
> we believe you cannot properly submit a declaration of conformity
> until you have completed the testing the standard describes. For more
> information, please refer to section 514(c)(1)(B) of the act and the
> FDA guidance, **Use of Standards in Substantial Equivalence
> Determinations; Final Guidance for Industry and FDA** at
> <http://www.fda.gov/cdrh/ode/guidance/1131.html>.

If it is not clear how you have addressed the risks identified by FDA or
additional risks identified through your risk analysis, we may request
additional information about aspects of the device's performance
characteristics. We may also request additional information if we need
it to assess the adequacy of your acceptance criteria. (Under 21 CFR
807.87(l), we may request any additional information that is necessary
to reach a determination regarding substantial equivalence.)

As an alternative to submitting an Abbreviated 510(k), you may submit a
Traditional 510(k) that provides all of the information and data
required under 21 CFR 807.87 and described in this guidance. A
Traditional 510(k) should include all of your methods, data, acceptance
criteria, and conclusions. Manufacturers considering modifications to
their own cleared devices should consider submitting Special
510(k)s.[^6]

**4. Risks to Health**

FDA has identified fires and explosions resulting in injury, burns, or
death as risks to health associated with the use of oxygen pressure
regulators and oxygen conserving devices with a built-in oxygen pressure
regulator. Investigation of adverse event reports involving these
devices indicates that promoted ignition of vulnerable regulators has
occurred with increasing frequency, resulting in incidents of
catastrophic burnout and injury to equipment operators. (The preamble to
the proposed rule, published in the FEDERAL REGISTER in conjunction with
this guidance (72 FR 8652) contains additional information regarding the
regulator fires.) We have identified the major risks in the table below
and the measures that we believe will mitigate these risks.

  -----------------------------------------------------------------------
  **Identified Risk**                 **Recommended Mitigation Measures**
  ----------------------------------- -----------------------------------
  Fire or explosion due to rapid      Section 5: Oxygen pressure shock
  pressurization (adiabatic           test
  compression)                        

  Fire or explosion due to an         Section 5: Promoted ignition test
  ignition mechanism                  
  -----------------------------------------------------------------------

**5. Recommended Mitigation Measures**

FDA believes that conformance with this special controls guidance
document, when combined with the general controls of the act, will
provide reasonable assurance of the safety and effectiveness of oxygen
pressure regulators and oxygen conserving devices that incorporate an
oxygen pressure regulator. In response to the reported fires, ASTM
developed a consensus standard that is intended to evaluate regulators
for ignition sensitivity and fault tolerance. The standard provides an
evaluation tool for determining the fault tolerance of pressure
regulators intended for use with medical oxygen for medical and
emergency a pplications through an oxygen pressure shock test and a
promoted ignition test. Fault tolerance is defined a as:

1\. the probability of ignition as evaluated by rapid pressurization
testing, and

2\. the consequence of ignition as evaluated by forced ignition testing.

Preventing fires associated with the use of oxygen pressure regulators
requires careful attention to materials selection and established design
practice. In addition to using established design practices and careful
materials selection, we recommend that manufacturers who intend to
market an oxygen pressure regulator or oxygen conserving device that
includes a built-in oxygen pressure regulator evaluate the selection of
materials and the design of the device by testing device\'s ignition
sensitivity and fault tolerance measures through use of the ASTM
standard designated ASTM G175 -- 03, Standard Test Method for Evaluating
the Ignition Sensitivity and Fault Tolerance of Oxygen Regulators Used
for Medical and Emergency Applications. This standard is available from:

ASTM

100 Barr Harbor Drive

West Conshohocken,

Pennsylvania, USA 19428-2959

[www.astm.org](http://www.astm.org/)

We also recommend that device designs that are modified after initial
testing to the standard be retested if those modifications or changes
are in the high-pressure section of the regulator.

# 6. Labeling[^7]

As prescription devices under [21 CFR
801.109](http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?FR=801.109),
oxygen pressure regulators and oxygen conserving devices are exempt from
the requirement to have adequate directions for lay use. Nevertheless,
we recommend that you provide sufficient directions for use, including
routine maintenance instructions. We also recommend that you identify
the ignition sensitivity and fault tolerances of your device permanently
on the device itself. The proposed rule would require that devices that
conform with ASTM G175-03 bear a permanently affixed label stating
"Conforms with ASTM G175-03." (Proposed 21 CFR 868.2750(b)(2) and
868.5910(b)(3)).

# 7. Limitations of Exemption from Premarket Notification 

Under the proposed rule issued in conjunction with this guidance, oxygen
pressure regulators that meet ASTM standard G175-03 would generally be
exempt from premarket notification \[510(k)\] requirements. However, the
exemption from 510(k) requirements for this generic type of device would
apply only to the extent that the particular device at issue has the
existing or reasonably foreseeable characteristics of other devices
within that generic type that currently are, or have been, in commercial
distribution. Where this is not the case, manufacturers of such devices
may still need to submit a premarket notification to FDA before
commercially distributing their device. (See 21 CFR § 868.9
\--Limitations of exemption from section 510(k)).

[^1]: ANSI/CGA E-7 -- 1992 American National Standard for Medical Gas
    Regulators and Flowmeters.

[^2]: As noted earlier, under the proposed rule, oxygen pressure
    regulators that meet the ASTM standard would be exempt from
    premarket notification (see proposed 21 CFR 868.2750(b)(1)), subject
    to the limitations on exemption in 21 CFR § 868.9 (see also
    **Section 7** of this draft guidance).

[^3]: Refer to <http://www.fda.gov/cdrh/ode/indicate.html> for the
    recommended format.

[^4]: If FDA makes a substantial equivalence determination based on
    acceptance criteria, the subject device should be tested and shown
    to meet these acceptance criteria before being introduced into
    interstate commerce. If the finished device does not meet the
    acceptance criteria and, thus, differs from the device described in
    the cleared 510(k), FDA recommends that submitters apply the same
    criteria used to assess modifications to legally marketed devices
    (21 CFR 807.81(a)(3)) to determine whether marketing of the finished
    device requires clearance of a new 510(k).

[^5]: See Required Elements for a Declaration of Conformity to a
    Recognized Standard (Screening Checklist for All Premarket
    Notification \[510(k)\] Submissions),
    http://www.fda.gov/cdrh/ode/reqrecstand.html.

[^6]:
    ##  For more information about submitting Special 510(k)s, refer to The New 510(k) Paradigm - Alternate Approaches to Demonstrating Substantial Equivalence in Premarket Notifications - Final Guidance

    at http://www.fda.gov/cdrh/ode/parad510.html

[^7]: Final labeling must comply with the requirements of 21 CFR Part
    801 before a device is introduced into interstate commerce.