REG - 00 085 Rev 1 Page 1 of 10 

# Oxus, Inc. 2676 Paldan Drive, Auburn Hills, MI 48326 Document Ti tle: **Dumog Release N**  **on -**  **Filing Justification**

Document Number: **REG -** **00 0**  **85**

**Revision Level**  **Revision**

**Date ECO** 

**Number Description of Revision**  **Au thor**  1 7/6/2015 50785 Initial Release N. SchonREG - 00 085 Rev 1 Page 2 of 10

**Subject:** FDA Premarket Notifi cation Non - Filing Justification for the release of Project Dumog

.

Part n um ber 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 m ode. The delivery mo de 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 W hen to Submit a 510(k) for a Change to an Existing Device”, issued on January 10, 1997 by the FDA’s Office of De vice 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 ma nagem ent 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 cod e. **Device Classification** 510(k) K073242 510(k) Issue Date: January 3, 2008 Trade Name: Portable Oxygen Concentrator Regulatory Class: 2 Product Code: CA

W Regulatory Number: 870. 5440 **Modification Summary** The RS - 00500 Oxygen Concentrator is similar to the existing RS - 0040 0 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 His tory 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 mo de 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 60 601 - 1 3 rd Edition testing. **Risk Management**REG - 00 085 Rev 1 Page 3 of 10

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) subm ission of **“M oderate”**  based on the FDA guidance document “Guidance for the Content of Pre - ma rk et Submission for Software Contained in Medi cal 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 Softw**  **are 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 res ult in death or serious injury, either to a patient or to a user of the device? **No, cessation of oxy** **gen can lead to hy poxia, 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 hy poxia,**  **wh ich is a**  **medically**

**rev ersible condition. In case of malfunction, pat**  **ient is**REG - 00 085 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 d eath? **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 belo** **w 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 oxy** **gen 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 - 00 085 Rev 1 Page 5 of 10

**RS -**  **00500 Documentation Item Number**  **Item Description** BOM - 00502 Dumog Shipping Assembly DHF - 000 1092 Dumog System Requirements (SyRS) DHF - 000 1099 Dumog Master Verification and Validation Plan DHF - 000 1114 Dumog Trace Matrix DL - 00462 Artwork- Ke yp anel, 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 G uide (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 ReportREG - 00 085 Rev 1 Page 6 of 10 **Item Number Item Description**  VR- 01006 Dumog Software W hite 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 W hite 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 ReportREG - 00 085 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 n o t require a new 510(k) submission. The mo difications described above don’t result in any control mechanism change or operating principle change. The device still uses pressure swing adsorption techno log y (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 REG 00083 and controlled per the Oxus Quality Management System OP - 05010, Document Control.REG - 00 085 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 - 00 085 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 3 rd**  **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 3 rd**  **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, A STM 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 Me**  **dical 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**REG - 00 085 Rev 1 Page 10 of 10

C2 Is this a change in the type of material from which the device is

ma nufactured? **No** C2.1 Is the device an implant? **No** C2.1.1 (Since the device is an implant) Wi ll the m aterial of the affected part of the

im plant be likely to contact body tissues or fluids? **N/A** C2.1.2 Is there a change in performance specifications? **N/A** C2.2 Wi ll the m aterial of the affected part of the (non - im plant) 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

ma terial type? **No** C4 Is there a change in the vendor of the raw material from which the device is

ma nufactured? **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.**