PRECISION PORTABLE OXYGEN CONCENTRATION MODEL 4150

{0}------------------------------------------------ # K103563 # 510(k) Summary Precision Medical, Inc. Portable Oxygen Concentrator JUL - 1 2011 **Submitter Information** | Submitter | Precision Medical, Inc.<br>300 Held Drive<br>Northampton, Pa.<br>18067 | |--------------------------|----------------------------------------------------------------------------| | FDA registration number: | 2523148 | | Contact | James Parker<br>Quality Assurance Manager | | Tel: | (610)-262-6090 Extensions 228 | | Fax: | (610)-262-6080 | | Preparation Date: | June 29, 2011 | | Device Name | Precision Medical EasyPulse portable oxygen concentrator<br>(Model PM4150) | | Proprietary Name: | Precision Medical EasyPulse portable oxygen concentrator<br>(Model PM4150) | | Common Name: | Portable Oxygen Generator | | Regulation Number: | 21CFR 868.5440 | | Product Code: | CAW<br>Class II Device | #### Predicate Device Equivalence Precision Medical, Inc. is claiming substantial equivalence to the Invacare Flyer Model XPO100 (510K 071928) ## Intended Use The Precision Medical EasyPulse portable oxygen concentrator (model PM4150) is intended to provide supplemental oxygen to persons requiring oxygen therapy. The device can be used in a home, institution, vehicle and for transportable use. {1}------------------------------------------------ ### Description of device The EasyPulse Portable Oxygen Concentrator (POC), model PM4150, was designed to The Lasyl uise I ordain onygen equiring supplemental oxygen. The EasyPulse POC uses provide moonly to patients requiring from the electronic conserving device technology to oxygen concentrator with a lightweight, battery powered oxygen concentrator. The device provide the pation while a nghivoriging on various mobile environments. A nasal can be used in the nome, mistration, xxygen from the device to the patient. The device is not intended to be life supporting or life sustaining. The EasyPulse POC provides pulsed dose delivery to the user through a selection of 5 settings. Setting 1 delivers the lowest amount of oxygen and setting 5 provides the settings. Setting I don't read to rewelvolumes for each setting and oxygen concentration are listed in the device specifications. Oxygen minute volume is controlled electronically are ristou in and conner's breath rate. By monitoring the user's breath rate the bolus by monitoring are about the patient the same amount of oxygen per minute. The EasyPulse POC offers the user multiple options to power the device. The device I he Lasyl uise I OC Offers ion battery, not accessible by the patient, that will provide mendes an meetime minute for outsely setting chosen. Stated battery runtimes are val ying full thires dopendent upon are external AC/DC power supply is included with the Insted in the AC/DC power supply allows the user to power the device from a standard 110 VAC outlet. An external DC/DC automobile adapter is also provided with the 110 VAC outler. The external DC/DC automobile adapter allows the user to power the device from a standard 12V automobile accessory jack. When connected to either the AC/DC power a standard 12 v automobile adapter, the device will default to charging the supply of external DOD C auce is in the OFF position. If the unit is turned on while micrhar battery when the abovee as ice will simultaneously run (provide oxygen) and charge the internal battery. {2}------------------------------------------------ # Specifications of Device r : ・ ・ ・ ・ ・ ・ ・ ・ ・ ・ ・ ・ ・ ・ ・ ・ ・ ・ ・ ・ ・ ・ ・ ・ ・ ・ ・ ・ ・ ・ ・ ・ ・ ・ ・ ・ ・ ・ ・ ・ ・ ・ ・ ・ ・ ・ ・ ・ ・ ・ ・ ・ ・ ・ ・ ・ ・ ・ ・ ・ ・ ・ ・ ・ ・ ・ ・ ・ ・ ・ ・ ・ ・ ・ ・ ・ ・ ・ ・ ・ ・ ・ ・ ・ ・ ・ | Dimensions | Height: 10.1" (25.4 cm)<br>Width: 6.5" (16.5 cm)<br>Depth: 4.5" (11.3 cm) | |-----------------------------------|-------------------------------------------------------------------------------------------------| | Weight | Device: 6.8 lbs (3.08 kg) | | Altitude | Up to 9000 ft (2743 m) | | Storage Temperature | 41°F to 104°F (5°C to 40°C) | | Operating Temperature | -2°F to 140°F (-20°C to 60°C) | | Relative Humidity | Up to 95% Non-Condensing | | Oxygen Concentration | 87% to 95% | | Oxygen Minute Volume | Setting 1: 240 +/-15% cc/min | | | Setting 2: 380 +/-15% cc/min | | | Setting 3: 520 +/-15% cc/min | | | Setting 4: 660 +/-15% cc/min | | | Setting 5: 780 +/-15% cc/min | | Power | AC Power Adapter: 100-240 VAC (1.0 A @ 120 VAC)<br>DC Power Adapter: 11-16 VDC (5.0 A @ 12 VDC) | | Battery Duration<br>(approximate) | Setting 1: 4.5 hrs | | | Setting 2: 3.2 hrs | | | Setting 3: 2.5 hrs | | | Setting 4: 1.8 hrs | | | Setting 5: 1.5 hrs | | Sound (@ Setting 2) | 44 dBA | | Cannula | Maximum 7ft cannula | 4.2 {3}------------------------------------------------ # Predicate Comparison : | Feature/Specification | | Precision Medical | Invacare | |-------------------------------------|--------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Intended Use | | The Precision Medical EasyPulse POC (model<br>PM4150) is intended to provide supplemental<br>oxygen to persons requiring oxygen therapy.<br>The Precision Medical POC can be used in a<br>home, institution, vehicle and various mobile<br>environments. | The Invacare XP02 is intended to be used by patients with<br>respiratory disorders who require supplemental oxygen. It<br>supplies a high concentration of supplemental oxygen and is<br>used with a nasal cannula to channel oxygen from the<br>concentrator to the patient. The Invacare XP02 can be used in<br>a home, institution, vehicle and various mobile environments.<br>The Invacare XP02 does not, nor is it intended to sustain or<br>support life. | | Method by which oxygen is released | | Molecular Sieve (mechanical) | Molecular Sieve (mechanical) | | Process by which oxygen is released | | Pressure/Vacuum Swing Absorption | Pressure Swing Absorption | | Sieve Bed Material | | Synthetic Zeolite | Synthetic Zeolite | | Software/Hardware | | Analog & digital electronics w/ microprocessor | Analog & digital electronics w/ microprocessor | | Flow control | | Microprocessor controlled valves | Microprocessor controlled valves | | Weight | | 6.8 lbs w/ internal battery | < 7.0 lbs w/ internal battery | | | Height | 10.0" | 10.0" | | Outside<br>Dimensions | Width | 6.5" | 7.0" | | | Depth | 4.5" | 4.3" | | Oxygen % | | 87% to 95% all flow rates | 87% to 95.6% all flow rates | | Flow Rates | | Pulse Flow (Minute Volume)<br>Tolerance +/-15%<br>Setting 1: 260 cc/min<br>Setting 2: 380 cc/min<br>Setting 3: 520 cc/min<br>Setting 4: 660 cc/min<br>Setting 5: 760 cc/min | Pulse Flow (Minute Volume)<br>Tolerance Not Available<br>Setting 1: 240 cc/min<br>Setting 2: 380 cc/min<br>Setting 3: 480 cc/min<br>Setting 4: 600 cc/min<br>Setting 5: 700 cc/min | | Operating Temperature | | 41 to 104°F (5 to 40°C) All power sources | 41 to 95°F (5 to 35°C) All power sources<br>95 to 104°F (35 to 40°C) continuous use w/ AC or DC adapter<br>95 to 104°F (35 to 40°C) limited use w/ internal battery | | Storage Temperature | | -2 to 140°F (-20 to 60°C) | -2 to 140°F (-20 to 60°C) | | Operating Humidity | | Up to 95% RH non-condensing | Up to 95% RH non-condensing | | Storage Humidity | | Up to 95% RH non-condensing | Up to 95% RH non-condensing | | Operating Altitude | | Up to 9000 ft | Up to 10000 ft | | Sound Level (@ Setting 2) | | 44 dBA | 45 dBA | | Power options | | AC/DC Power supply<br>Input: 100-240 VAC , 50/60 Hz<br>Output: 18 VDC, 60W<br>DC/DC Power supply<br>Input: 11-16 VDC , 50/60 Hz<br>Output: 18 VDC, 60W | AC/DC Power supply<br>Input: 100-240 VAC , 50/60 Hz<br>Output: 18 VDC, 60W<br>DC/DC Power supply<br>Input: 11-16 VDC , 50/60 Hz<br>Output: 18 VDC, 60W | | Battery | | Non-removable<br>Lithium-Ion - 14.4 VDC, 5.0 Ah | Non-removable<br>Lithium-Ion - 14.8 VDC, 5.2 Ah | | System Alarms | | Low Battery Warning<br>Low Battery Alarm<br>No Breath Detect Alarm<br>Excessive Breath Rate Alarm<br>Compressor Alarm (Abnormal Motor Current)<br>Battery Temperature Alarm<br>Motor Temperature Alarm<br>Pressure Alarm<br>Fan Failure Alarm<br>Motor Connection Alarm<br>Battery Connection Alarm<br>Performance Alarm (Monitor system pressures) | Low Battery Warning<br>Low Battery Alarm<br>Battery Discharged Alarm<br>No Breath Detect Alarm<br>Breath Rate Over Capacity Alarm<br>System Too Hot/Cold for Start Alarm<br>System Too Hot/Cold Running Alarm<br>Battery Too Hot/Cold<br>Stuck Button Alarm<br>Operating Alarm (Abnormal Operating Conditions)<br>Compressor Alarm (Abnormal Compressor Conditions)<br>System Alarm (Abnormal System Conditions) | 43 {4}------------------------------------------------ ## Comparison Technology The only significant difference relative to the predicate is the predicate device uses a PSA The only sightincan unforched form. For the Precision Medical POC opted for use of a (ITCSSure Swing Adsorption) og Adsorption) cycle. Both cycle types are proven VI SA ( vacuum 1 result o wing ther devices on the market. Precision Medical felt a technology and used in Tarrous es in reducing complexity of the pneumatic circuit and reducing power consumption. The predicate comparison table shows the EasyPulse POC is similar to the Invacare The predicate comparison acto the wo do use, use similar methods for extracting oxygen AI O2. Dour deviece have similar environmental specifications, similar oxygen purity and provide similar power options. # Summary of Performance Testing | Electromagnetic Compatibility Testing Performed per: | | |---------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------| | EN 60601-1-2:2007 | Medical electrical equipment - Part 1-2: General requirements for safety<br>Collateral standard: Electromagnetic compatibility | | Mechanical and Electrical Safety Testing Performed per: | | | UL 60601-1, 1st Edition 2006-04-26 | Medical electrical Equipment, Part 1: General Requirements for Safety | | CAN/CSA-C22.2 No.601.1-M90, 2005 | Medical electrical Equipment, Part 1: General Requirements for Safety | | IEC 60601-1:1998, A1:1991, A2:1995 | Medical electrical Equipment, Part 1: General Requirements for Safety | | IEC 60068-2-6 | Sinusoidal Vibration | | IEC 60068-2-27 | Shock/Bump | | IEC 60068-2-64 | Random Vibration | | VOC and Particulate Testing Performed per: | | | EPA PM₂.₅ | Particulate Matter | | ASTM D5466 | Standard Test Method for Determination of Volatile Organic Chemicals<br>in Atmospheres (Canister Sampling Methodology) | | 21 CFR 801.415 | Ozone Levels | | EPA NAAQS - Carbon Monoxide | Carbon Monoxide Levels | | OSHA Permissible Exposure Limits | Carbon Dioxide Levels | | Performance Testing: | | | 738-2 Weight and Dimensions | Measure overall weight and size of device | | 738-3 Operating Temperature | Verify performance at extremes of operating temperature range | | 738-4 Storage Temperature | Subject packaged device to extremes of storage temperature range | | 738-5 Barometric Pressure Range | Verify performance at maximum altitude | | 738-6 Functionality | Verify basic functions of test units | | 738-8 Outlet Temperature | Measure gas outlet temperature under max operating temperature | | 738-9 Oxygen Concentration | Measure O2 concentration after operating for 1 hour | | 738-10 Mean Oxygen Concentration | Measure O2 concentration over 9 hour period | | 738-11 Bolus Volume | Measure O2 minute volume for each setting, at every breath rate from<br>15-35 breaths/min | | 738-12 Basic Performance | Measure bolus volume @ setting 5 over 9 hour period | | 738-13 Internal Battery Charging | Measure O2 concentration and bolus volume for each setting | | 738-14 Sound Level | Measure battery runtimes for each setting and battery charge time | | 738-15 Trigger Delay/Sensitivity | Measure sound of device while operating | | 738-16 ISTA Drop Test | Measure trigger delay and trigger sensitivity<br>Packaging drop test | 4.4. {5}------------------------------------------------ ## Conclusions In Summary, Precision Medical, Inc. has demonstrated that the Precision Medical, Inc. III Sulminary, I recision Modical, the nas actively to the combined testing and analysis of results provides assurance that the device meets the specifications and is safe and effective for the intended use. {6}------------------------------------------------ Image /page/6/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three tail feathers, representing the three levels of government: federal, state, and local. The eagle is enclosed in a circle with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002 Precision Medical Inc. C/O Mr. James Parker Quality Assurance Manager 300 Held Drive Northhamption, Pennsylvania 18067 JUL - 1 2011 Re: K103563 Trade/Device Name: Precision Medical Easy Pulse Portable Oxygen Concentrator (Model PM4150) Regulation Number: 21 CFR 868.5440 Regulation Name: Portable Oxygen Concentrator Regulatory Class: II Product Code: CAW Dated: June 27, 2011 Received: June 28, 2011 Dear Mr. Parker: 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 ffor 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. {7}------------------------------------------------ Page 2 -- Mr. Parker 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 (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) 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 go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. 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 Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. Sincerely yours. Antion O.n Anthony D. Watson, B.S., M.S., M.B.A. Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation · Center for Devices and Radiological Health Enclosure {8}------------------------------------------------ #### Portable oxygen concentrator 510K 103563 ## 510 (k) number (if known) K103563 Device Name: Precision Medical EasyPulse portable oxygen concentrator (Model PM4150) #### Indications for use: The Precision Medical EasyPulse portable oxygen concentrator (model PM4150) is intended to provide supplemental oxygen to persons requiring oxygen therapy. The device can be used in a home, institution, vehicle, and for transportable use. (Please do not write below this line- continue on another page if needed) Concurrence of CDRH, office of device Evaluation (ODE) Prescription Use: X Or (Per 21 CFR 80 Over the counter use (Optional Format 1-2-9) (Division Sign-Oil) Division of Anesthesiology, General Hospital Infection Control, Dental Devices 510(k) Number: K115663