PUREFILL OXYGEN COMPRESSOR

K141967 · Inovo, Inc. · CAW · Nov 7, 2014 · Anesthesiology

Device Facts

• Record ID: K141967
• Device Name: PUREFILL OXYGEN COMPRESSOR
• Applicant: Inovo, Inc.
• Product Code: CAW · Anesthesiology
• Decision Date: Nov 7, 2014
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 868.5440
• Device Class: Class 2
• Attributes: Therapeutic

Indications for Use

The PureFill Oxygen Compressor is indicated to supply pressurized oxygen to fill gas cylinders for the patient's personal ambulatory use. The device is not intended to be life supporting or life sustaining.

Device Story

PureFill Oxygen Compressor accepts low-pressure (14-30 PSIG) oxygen from external oxygen concentrators; utilizes 2-stage positive displacement compression to pressurize oxygen to 2,000 PSIG; fills portable oxygen cylinders for patient ambulatory use. Operated by patients or caregivers in home or sub-acute care settings. Device includes over-pressurization safety mechanism (solid red fault LED and continuous audible alarm at >2,200 PSIG). Does not include internal oxygen concentration monitoring, relying instead on the connected oxygen concentrator's monitoring system. Benefits patients by enabling independent refilling of portable oxygen cylinders, facilitating mobility.

Clinical Evidence

Bench testing only. No clinical data provided. Testing included electrical safety (ES60601-1), EMC (IEC 60601-1-2, EN55011 CISPR 22), altitude, fill rate, oxygen pressure surge, material selection/cleaning, autogenous ignition temperature, and acoustic noise/energy.

Technological Characteristics

2-stage positive displacement compressor; 110W average power consumption; 2,000 PSIG output; 55 dBA sound level. Compatible with oxygen concentrators providing 14-30 PSIG, 2 LPM minimum, and 93±3% oxygen. Materials evaluated for gas pathway/mucosa contact. Standards: ES60601-1, IEC 60601-1-2, IEC 61000-6-3, EN55011 CISPR 22.

Indications for Use

Indicated for patients on supplemental oxygen requiring pressurized oxygen to fill gas cylinders for personal ambulatory use. Not for life support or life sustaining use. Suitable for sub-acute care facilities and home settings.

Regulatory Classification

Identification

A portable oxygen generator is a device that is intended to release oxygen for respiratory therapy by means of either a chemical reaction or physical means (e.g., a molecular sieve).

Predicate Devices

• Gas Transfill (K091191)
• Home Fill II (K003939)

Submission Summary (Full Text)

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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

November 13, 2014

Inovo. Inc. c/o Mr. Paul Dryden President ProMedic. Inc. 24301 Woodsage Drive Bonita Springs, FL 34134

Re: K141967

Trade/Device Name: PureFill Oxygen Compressor Regulation Number: 868.5440 Regulation Name: Portable Oxygen Generator Regulatory Class: II Product Code: CAW Dated: October 08, 2014 Received: October 10, 2014

Dear Mr. Dryden:

This letter corrects our substantially equivalent letter of November 7, 2014

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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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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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 medical device reporting of medical devicerelated adverse events) (21 CFR 803); 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.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801, please contact the Division of Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

Tejashri Purohit-Sheth, M.D.

Tejashri Purohit-Sheth, M.D. Clinical Deputy Director DAGRID/ODE/CDRH FOR

Erin I. Keith, M.S. Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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### DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

# Indications for Use

510(k) Number (if known)

K141967

Device Name

PureFill Oxygen Compressor Indications for Use (Describe)

The PureFill Oxygen Compressor is indicated to supply pressurized oxygen to fill gas cylinders for the patient's personal ambulatory use. The device is not intended to be life supporting or life sustaining.

Environment of use: - Sub-acute care facilities and home settings

XX Prescription Use (Part 21 CFR 801 Subpart D) Over-The-Counter Use (21 CFR 801 Subpart C)

# PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.

# FOR FDA USE ONLY

Page 1 of 2

Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)

FORM FDA 3881 (9/13)

Type of Use (Select one or both, as applicable)

EF PSC Publishing Services [phone]

Form Approved: OMB No. 0910-0120 Expiration Date: December 31, 2013 See PRA Statement on last page.

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# 510(k) Summary Page 1 of 5
8-Oct-14

| Inovo, Inc.<br>401 Leonard Blvd. North<br>Lehigh Acres, FL 33971 | Telephone: [phone] | |
|------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--|
| Official Contact: | Ed Brantley, Manager of Engineering | |
| Proprietary or Trade Name: | PureFill Oxygen Compressor | |
| Common/Usual Name: | Oxygen Compressor | |
| Classification Name: | Portable oxygen generator<br>CAW – 868.5440 | |
| Predicate Devices: | Gas Transfill – K091191<br>Home Fill II – K003939 | |
| Device Description: | The PureFill Oxygen Compressor is designed to accept low<br>pressure (14-30 PSIG) oxygen from existing oxygen<br>concentrators and pressurize the oxygen to 2,000 PSIG to fill<br>patient's portable oxygen cylinders. | |
| Indications for Use: | The PureFill Oxygen Compressor is indicated to supply<br>pressurized oxygen to fill gas cylinders for the patient's personal<br>ambulatory use. The device is not intended to be life supporting<br>or life sustaining. | |
| Patient Population: | Patients on supplemental oxygen. | |
| Environment of Use: | Sub-acute care facilities and home settings. | |
| Contraindications: | None | |

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# 510(k) Summary Page 2 of 5
8-Oct-14

| | Predicate Device | Predicate Device | Proposed Device |
|--------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Model Name: | Gas Transfill | Venture IOH 200 Home<br>Fill II Complete Home<br>Oxygen System | PureFill Oxygen<br>Compressor |
| 510(k) Number | K091191 | K003939 | |
| Indications | The intended use of the Gas<br>Transfill System is to<br>provide supplemental<br>oxygen to patients and to<br>supply pressurized oxygen to<br>fill gas cylinders for the<br>patient's personal ambulatory<br>use.<br><br>The device is not intended to<br>be life supporting nor life<br>sustaining.<br><br>The Transfill System is<br>comprised of a high pressure<br>oxygen compressor and an<br>external oxygen<br>concentrator. The oxygen<br>concentrator provides up to<br>2LPM of gaseous oxygen to<br>the high pressure oxygen<br>compressor for filling<br>medical oxygen cylinders. | The intended function and<br>use of the Invacare Model<br>IOH 200 Complete Home<br>Oxygen System is to provide<br>supplemental oxygen to<br>patients and to supply<br>pressurized oxygen to fill gas<br>cylinders for the patient's<br>personal ambulatory use. | The PureFill Oxygen<br>Compressor is indicated to<br>supply pressurized oxygen to<br>fill gas cylinders for the<br>patient's personal ambulatory<br>use.<br><br>The device is not intended to<br>be life supporting or life<br>sustaining.<br><br>Environment of use: - Sub-<br>acute care facilities and<br>home settings |
| Environment of Use | Home | Home | Sub-acute care facilities and<br>home settings |
| Patient Population | Patients on supplemental<br>oxygen | Patients on supplemental<br>oxygen | Patients on supplemental<br>oxygen |

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# 510(k) Summary Page 3 of 5
8-Oct-14

# Specifications / Features

| | Gas Transfill<br>K091191 | Home Fill II<br>K003939 | Proposed<br>PureFill |
|---------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------|
| Dimensions (l x w x h) | 9" x 20" x 25.5" | 16" x 15" x 16" | 23" x 8in x 12in |
| Weight | 45 lbs | 33 lbs | 33 lbs |
| Sound Level | 44 dBA | Unknown | 55 dBA |
| Power Consumption | 110W | 140W | 110W average |
| Cylinder type | 2,000 and 3,000 PSI | 2,000 PSI | 2,000 PSI |
| Typical filling time | M6* (2,000 PSI)<br>1 hr 5 min | M6 (2,000 PSI)<br>1 to 2 hours and 45 minutes | M4 (2,00 PSI)<br>55 min<br>M6 (2,000 PSI),<br>90 min<br>M9 (2,000 PSI)<br>135 min<br>Typical at 22 psi input<br>pressure |
| OCD/Regulator type | CGA-870 connection | Unknown | CGA-870 Connection |
| Delivers Oxygen to<br>patient while filling | Yes | Unknown | Yes |
| Input Pressure | Not published | 14-21 psi | 14-30 psig |
| Input flow | Not published | 2 LPM minimum | 2 LPM minimum |
| Compatible<br>Concentrators | EverFlo, EverFlo Q,<br>Millennium<br>M600 and M605 series, and<br>M10 | Invacare Platinum 5, 10, XL,<br>and Perfecto2. | Any concentrator that<br>provides: 14-30 PSIG<br>2 LPM Minimum<br>93±3% oxygen |
| Supply Oxygen<br>Concentration | EverFlo<br>93% (+/- 3%) (5 LPM)<br>Millennium M600/605<br>92% (+/- 4%) 5LPM, 94% (+/-<br>2%) 2LPM<br>Millennium M10<br>92 +/- 4% @ 8-10 LPM<br>94 +/- 2% @ 3-7 LPM<br>92 +/- 4% @ 1-2 LPM | Invacare Platinum 5<br>All 5LXO2/5LX models<br>87% to 95.6% at 0.5-5 LPM<br>Invacare Platinum 10<br>87% to 95.6% at 2-10 LPM<br>Invacare Perfecto2<br>87% to 95.6% for flows<br>ranging at 0.5 to 5 LPM | Any concentrator that<br>provides: 14-30 PSIG<br>2 LPM Minimum<br>93±3% oxygen |
| Oxygen Concentration | 93% (+/- 3%) | >90% | 93±3% |

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# 510(k) Summary Page 4 of 5 8-Oct-14

### Indicators (alarms)

| Alarm / Alert | Gas Transfill | HomeFill II | Propose<br>PureFill |
|------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------|
| O2 Concentration | Continuous Green and<br>Yellow with Flashing Red =<br>the device has detected a<br>possible oxygen purity fault<br>(purity is less than 90%) and<br>the oxygen within the<br>cylinder is less than 90%.<br>System continues to fill | Yellow Light = O2 from<br>concentrator is < 90% (any<br>time after three minute<br>warmup)<br><br>Cylinder filling stops, will<br>restart when O2 >90% | No oxygen alarm. Relies on<br>concentrator oxygen<br>monitoring system |
| Over<br>Pressurization | Not known | Not known | Solid Red FAULT LED and<br>Continuous Audible Alarm.<br>Shut off power to motor.<br>Patient cannot restart unit.<br>Contact your provider<br>> 2200 psig |

# Substantial Equivalence Rationale

The Drive Inovo PureFill Oxygen Compressor is viewed as substantially equivalent to the predicate devices because:

Indications - The PureFill Oxygen Compressor is indicated to supply pressurized oxygen to fill gas cylinders for the patient's personal ambulatory use. The device is not intended to be life supporting or life sustaining.

This is identical to the predicate - Gas Transfill - K091191, which is intended to provide supplemental oxygen to patients and to supply pressurized oxygen to fill gas cylinders for the patient's personal ambulatory use. The device is not intended to be life supporting nor life sustaining.

This is identical to the predicate - Home Fill II - K003939, which is intended to function and use of the Invacare Model IOH 200 Complete Home Oxygen System is to provide supplemental oxygen to patients and to supply pressurized oxygen to fill gas cylinders for the patient's personal ambulatory use.

Technology - The PureFill Oxygen Compressor is a 2-Stage Positive Displacement compressor designed to accept low pressure (14-30 PSIG) oxygen from existing oxygen concentrators and pressurize the oxygen to 2,000 PSIG. The high pressure oxygen is used to fill portable oxygen cylinders which are for patients' personal ambulatory use only.

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# 510(k) Summary Page 5 of 5 8-Oct-14

Environment of Use - The PureFill Oxygen Compressor is designed to be used in sub-acute care facilities and home setting. This is identical to the predicates.

Patient Population - Population is defined not by age but by patients on supplemental oxygen. This is identical to predicate - Home Fill II - K003939 and Gas Transfill - K091191.

Performance Specifications - The PureFill has similar specifications to the predicate for pressurization, fill rate and time, ability to connect to several different concentrators with minimum output requirements. The performance specifications are substantially equivalent to the predicates -Home Fill II - K003939 and Gas Transfill - K091191.

# Non-clinical Testing

We performed a number of non-clinical tests to demonstrate the safety and efficacy of the PureFill. These tests included:

Materials - The materials utilized are common materials. G95-1 and ISO 10993-1 would categorize the PureFill Oxygen Compressor as:

- External communicating (indirect / gas pathway)
- Mucosa contact
- Permanent duration (> 30 days) .

However, mechanical, pressure generating devices often have materials which cannot be tested by the above listed tests. We performed the following tests:

- VOC
- . PM25
- Ozone, CO, and CO2 ●

Performance Testing - We performed equivalent bench testing, including ES60601-1, IEC 60601-1-2, IEC 61000-6-3, EN55011 CISPR 22, Altitude, Fill rate, Oxygen Pressure Surge Testing, Material Selection and Cleaning of Components, Autogenous Ignition Temperature Test, Acoustic Noise, Audible Acoustic Energy. The PureFill Oxygen Compressor performed as intended in each test. These tests were equivalent to the testing required of the predicates.

# Substantial Equivalence Conclusion -

The sponsor has demonstrated through performance testing, design and features, and non-clinical testing that the proposed device and predicate have been found to be substantially equivalent.