REG-00085 Rev 1 Page 1 of 10

Oxus, Inc.

2676 Paldan Drive, Auburn Hills, MI 48326

Document Title:

Dumog Release Non-Filing Justification

Document Number:

REG-00085

Revision 

Level

Revision 

Date

ECO

Number Description of Revision Author

1 7/6/2015 50785 Initial Release N. Schon
REG-00085 Rev 1 Page 2 of 10

Subject: FDA Premarket Notification Non-Filing Justification for the release of Project Dumog.

Part number RS-00500 Portable Oxygen Concentrator (POC) contained in shipping assembly, 

RS-00502. Suffixes may be added to the POC part number to denote branding.

Purpose:

This document describes the Dumog POC as an addition to the existing Oxus POC, RS-00400, family. 

The new device provides an additional oxygen delivery mode, continuous flow, as well as improvements 

to the existing pulse dose delivery mode. The delivery mode is selected through the user interface. The 

new POC to be released by Oxus does not require a separate 510(k) filing from the original POC 510k

according to 21 CFR 807.81 and the FDA guidance document K97-1 “Deciding When to Submit a 510(k) 

for a Change to an Existing Device”, issued on January 10, 1997 by the FDA’s Office of Device 

Evaluation.

Oxus will perform verification and validation activities required through a review of the device 

requirements and risk analysis. Changes will be approved and released through the Oxus change 

management process.

Note: A "device family" is a group of one or more devices manufactured by or for the same manufacturer 

and having the same basic design and performance characteristics related to device safety and 

effectiveness; intended use and function; and device classification and product code.

Device Classification 

510(k) K073242

510(k) Issue Date: January 3, 2008

Trade Name: Portable Oxygen Concentrator

Regulatory Class: 2

Product Code: CAW

Regulatory Number: 870.5440

Modification Summary

The RS-00500 Oxygen Concentrator is similar to the existing RS-00400 except for the following:

• Pulse mode range is extended to 6 LPM.

• Continuous flow will be available for 0.5 – 2 LPM

• Either one or two external batteries may be used.

The changes are addressed in applicable Design History Files, Risk Assessments and Validation 

Protocols. The Verification and Validation activities were performed according to impacted Validation 

Protocols from the master V&V plan.

Modification Intent

The modifications included in RS-00500 will provide the user additional flexibility in the oxygen delivery 

mode as well as the ability to utilize an additional battery. These modifications do not impact the 

performance or safety requirements as demonstrated through Intertek approval of the relevant IEC 

60601-1 3rd Edition testing.

Risk Management
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A risk assessment was performed for the RS-00500 based on ISO 14971:2012. The Hazards and 

Harms are similar to RS-00400 along with the resulting residual risk.

Software

Software changes made to the device didn’t impact or change the software level of concern from the 

original 510(k) submission of “Moderate” based on the FDA guidance document “Guidance for the 

Content of Pre-market Submission for Software Contained in Medical Devices”, issued on May 11, 2005. 

Current software revision is SW-00410 rev 1.08

See Release for detailed changes.

Table 1 Major Level of Concern 

If the answer to any one question below is Yes, the Level of Concern for the 

Software Device is likely to be Major. 

1. Does the Software Device qualify as Blood Establishment Computer 

Software? No

2. Is the Software Device intended to be used in combination with a drug or 

biologic? No

3. Is the Software Device an accessory to a medical device that has a Major 

Level of Concern? No

4. Prior to mitigation of hazards, could a failure of the Software Device result in 

death or serious injury, either to a patient or to a user of the device? No, 

cessation of oxygen can lead to hypoxia, which is a medically

reversible condition

a. Does the Software Device control a life supporting or life sustaining 

function? No

b. Does the Software Device control the delivery of potentially harmful 

energy that could result in death or serious injury, such as radiation 

treatment systems, defibrillators, and ablation generators? No

c. Does the Software Device control the delivery of treatment or therapy 

such that an error or malfunction could result in death or serious 

injury? No, lack of oxygen can lead to hypoxia, which is a 

medically reversible condition. In case of malfunction, patient is 
REG-00085 Rev 1 Page 4 of 10

instructed by the labeling to have an alternative oxygen source.

d. Does the Software Device provide diagnostic information that directly 

drives a decision regarding treatment or therapy, such that if 

misapplied it could result in serious injury or death? No

e. Does the Software Device provide vital signs monitoring and alarms 

for potentially life threatening situations in which medical intervention 

is necessary? No

Table 2 Moderate Level of Concern

If the Software Device is not Major Level of Concern and the answer to any

one question below is Yes, the Level of Concern is likely to be Moderate.

1. Is the Software Device an accessory to a medical device that has a 

Moderate Level of Concern? No

2. Prior to mitigation of hazards, could a failure of the Software Device result in 

Minor Injury, either to a patient or to a user of the device? Yes, lack of 

oxygen can lead to Hypoxia

3. Could a malfunction of, or a latent design flaw in, the Software Device lead 

to an erroneous diagnosis or a delay in delivery of appropriate medical care 

that would likely lead to Minor Injury? No

If the answers to all of the questions in Tables 1 and 2 above are No, the Level 

of Concern is Minor.
REG-00085 Rev 1 Page 5 of 10

RS-00500 Documentation

Item Number Item Description

BOM-00502 Dumog Shipping Assembly

DHF-0001092 Dumog System Requirements (SyRS)

DHF-0001099 Dumog Master Verification and Validation Plan

DHF-0001114 Dumog Trace Matrix

DL-00462 Artwork-Keypanel, DuMog

DL-00463 Artwork-Cover, GSE 

DL-00464 DuMog Battery Label

DL-00465 DuMog Product Label

DL-00466 Dumog User Manual (GCE)

DL-00467 DuMog Accessory Guide (components)

DL-00468 Artwork – Tag – Carry Case, DuMog

DL-00469 DuMog Quick Start Guide

DL-00470 Artwork – DuMog Battery Insertion Label

DL-00471 Artwork – Front Cover, ZEN-O

DL-00472 Dumog User Manual (Oxus)

FM-00109 Record Retention Schedule

LB-10857 US OXUS DUMOG OUTER SHIPPER LABEL

LB-10857-D DUMOG OUTER SHIPPER LABEL-DUAL BATT

LB-10857-S DUMOG OUTER SHIPPER LABEL-SINGLE BATT

LB-10865 DEVICE SERIAL NUMBER LABEL

LB-10872 DUMOG SIEVE SERIAL NUMBER

MP-16025 Dumog Label Printing Procedure

MP-16026 Dumog Process Flow Chart

OP-01009 Risk Management

OP-04023 Technical File

QP-00733 Dumog Assembly Quality Plan

RA-00051 Dumog Risk Management Plan

RA-00052 Dumog Risk Management Summary

RA-00053 Hazard Analysis

RA-00054 DFMEA

RA-00055 PFMEA

REG-00072 ISO 13485 Certificate

REG-00079 Dumog Declaration of Conformity (MDD and RoHS2)

REG-00080 Dumog Technical File Part B

REG-00081 Dumog Technical File Part A

REG-00082 Dumog MDD-M5 Essential Requirements

VR-01004 Dumog Environmental Test Report

VR-01005 Dumog Software Black Box Report
REG-00085 Rev 1 Page 6 of 10

Item Number Item Description

VR-01006 Dumog Software White Box Report

VR-01007 Dumog Software Unit Test Report

VR-01008 Dumog Purity and Bolus Test Fixture #2 Verification Report

VR-01009 Dumog Software Black Box Report

VR-01010 Dumog Software White Box Report

VR-01011 Dumog Software Unit Test Report

VR-01012 Validation of Matchbox and Dumog Alarm System

VR-01013 Dumog Systems Alarm Verification Report

VR-01014 Dumog Pneumatic Interface Durability Verification Report

VR-01015 Dumog Packaging Test Verification Report

VR-01016 Dumog Bio-compatibility Verification Report

VR-01017 Dumog Device Specification Verification Report

VR-01018 Dumog Rechargeable Battery Verification Report

VR-01019 Dumog PCA Verification Report

VR-01020 Dumog Breath Detect Verification Report

VR-01021 Dumog Systems Verification Report

VR-01022 Dumog Safety and EMC Verification Report

VR-01023 Dumog Manual Simulated Verification Report

VR-01024 Dumog Labeling Spec Verification Report (includes GUDID)

VR-01025 Dumog Performance Protocol Verification Report

VR-01026 Dumog Software Black Box Report

VR-01027 Dumog Software Unit Test Report

VR-01029 Dumog Rechargeable Battery Verification Report

VR-01030 Dumog IEC 60601-1-2 & RTCA DO-160G Test Report

VR-01031 Dumog IEC 60601-1 Test Report

VR-01032 Dumog Listing Constructional Data Report

VR-01033 Dumog IEC 60601-1-11 Test Report

VR-01034 Dumog IEC 60601-1-6 Test Report

VR-01035 Dumog IEC 62366 Test Report

VR-01036 Dumog IEC 60601-1-8 Test Report

VR-01037 Dumog Environmental Vibration Regression Test Report

VR-01038 ISO 14971 Checklist

VR-01039 Dumog Calibration and Test Fixture Software Verification Report

VR-01040 Dumog Leak Test Fixture Software Verification Report
REG-00085 Rev 1 Page 7 of 10

Non-Filing Justification

Based on FDA guidance document K97-1 “Deciding when to submit a 510(k) for a change to an existing 

device”, the changes made by Oxus, Inc. do not require a new 510(k) submission.

The modifications described above don’t result in any control mechanism change or operating principle

change. The device still uses pressure swing adsorption technology (PSA) using a pneumatic system 

and oxygen delivery is still controlled by software.

Oxus’ Notified Body (British Standards Institution) has approved the RS-00500 to carry the CE mark as 

part of the POC family which includes the RS-00400. The RS-00500 Technical File is identified as REG00083 and controlled per the Oxus Quality Management System OP-05010, Document Control.
REG-00085 Rev 1 Page 8 of 10

Change due to 

recall or corrective 

action

Labeling 

Change

Technology or 

Performance Change

Materials 

change

Documentation

See “510(k) requirements 

for Proposed Fixes to 

Devices Undergoing 

Recall”

Go to Chart A

Go to Chart B

Go to Chart C

No

Yes

No

No

No

Yes

Yes

Yes

Main Flowchart 

When to File a 510(k) after change to 

a legally marketed device
REG-00085 Rev 1 Page 9 of 10

Decision tree based on all inclusive changes listed above:

Chart A: Labeling Changes Yes/No

A1 Does the change affect the indications for use? No

A2 Is it a change in warnings or precautions? No

A3 Does the change add a contraindication? No

A4 Does the change delete a contraindication? No

The IFU for RS-00500 is effectively the same in terms of target population, indications 

for use, contraindications, warning and precautions. There are some updates due to 

IEC60601-1 3rd Edition. These updates would also be applicable to RS-00400.

A5 Is the labeling being revised for clarity to insure safer or more effective use? Yes

The label changes are only to address the specific instructions for the RS-00500 as 

well as documentation pertaining to IEC60601-1 3rd Edition and branding.

Chart B: Technology, Engineering, and Performance Changes

B1 Is it a control mechanism change? No

B2 Is it an operating principle change? No

B3 Is it a change in energy type? No

B4 Is it a change in environmental specifications? No

B5 Is it a change in performance specifications? Yes

The RS-00500 provides the user a continuous flow oxygen delivery option. 

Instructions for this delivery method are provided. In addition, there is an extended 

range in the pulse dose delivery mode. Neither of these changes impact the 

performance requirements of the applicable device safety standards (e.g. ISO 80601-2-

67, ISO 80601-2-69, ISO 8359, ASTM 1464-93)

B6 Is it a change in ergonomics of the patient/user interface? No

Both devices utilize a keypanel for the patient / user interface.

B7 Is it a change in dimensional specifications? Yes

The RS-00500 envelope is slightly bigger than RS-00400. While the weight is also 

slightly more, both devices round to 10lbs without the case.

B8 Is it a change in software or firmware? Yes

B8.1 Does the change affect the indications for use? No

B8.2 Are clinical data necessary to evaluate safety and effectiveness for purposes 

of determining substantial equivalence?

No

B8.3 Do results of design validation raise new issues of safety and effectiveness? No

The Indications for use did not change. Clinical data was not necessary. However, the 

Clinical Evaluation Report was updated to include the RS-00500 as required by the EU 

Medical Device Directive. No safety or effectiveness issues were raised during the 

V&V testing.

B9 Is there a change in packaging or expiration dating? Yes

Neither device requires expiration dating. Packaging was changed to accommodate 

the RS-00500 dimensional changes.

B10 Has there been a change in sterilization? No

B10.1 Has there been a change in performance specification of the device or in the 

sterility assurance level attained as a result of the change in sterilization?

N/A

Neither device is sterile.

Materials Changes

C1 Is the device an in vitro diagnostic product (IVD)? No
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C2 Is this a change in the type of material from which the device is 

manufactured?

No

C2.1 Is the device an implant? No

C2.1.1 (Since the device is an implant) Will the material of the affected part of the 

implant be likely to contact body tissues or fluids?

N/A

C2.1.2 Is there a change in performance specifications? N/A

C2.2 Will the material of the affected part of the (non-implant) device be likely to 

contact body tissues or fluids in vivo?

N/A

C2.2.1 Considering that the material is likely to contact in vivo body tissues or fluids 

and the requirements of ISO 10993-1, is additional testing required?

N/A

C2.3 Is there a change in performance specifications? N/A

C3 Is this a change in the formulation of the material, but not a change in 

material type?

No

C4 Is there a change in the vendor of the raw material from which the device is 

manufactured?

Yes

C4.1 Is the new material being supplied to a specification? Yes

Component vendors have changed due to commercial reasons. However, all 

components and sub-assemblies are purchased to an Oxus specification.