(207 days)
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.
The EasyPulse Portable Oxygen Concentrator (POC), model PM4150, was designed to provide supplemental oxygen to patients requiring oxygen therapy. The EasyPulse POC uses electronic conserving device technology to provide the patient with a lightweight, battery powered oxygen concentrator. The device can be used in the home, institution, vehicle and various mobile environments. A nasal cannula is used to channel oxygen 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 highest. Minute volumes for each setting and oxygen concentration are listed in the device specifications. Oxygen minute volume is controlled electronically by monitoring the user's breath rate. By monitoring the user's breath rate the device is able to provide the patient the same amount of oxygen per minute.
The EasyPulse POC offers the user multiple options to power the device. The device includes an internal Lithium-Ion battery, not accessible by the patient, that will provide varying runtimes dependent upon the setting chosen. Stated battery runtimes are listed in the specifications. An external AC/DC power supply is included with the device. The external 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 device. 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 supply or external DC/DC automobile adapter, the device will default to charging the internal battery when the unit is in the OFF position. If the unit is turned on while connected to either of the above, the device will simultaneously run (provide oxygen) and charge the internal battery.
The provided text describes a 510(k) submission for the Precision Medical EasyPulse portable oxygen concentrator (Model PM4150). However, it does not contain information about a study proving the device meets specific acceptance criteria in the manner typically seen for medical imaging or AI-driven diagnostic devices.
Instead, the document focuses on demonstrating substantial equivalence to a predicate device and lists various performance and safety tests conducted to show the device's functionality and adherence to relevant standards. There is no mention of "acceptance criteria" in terms of clinical performance metrics like sensitivity, specificity, or accuracy that would be relevant to an AI-driven device or a device requiring expert review for ground truth.
Therefore, I will interpret "acceptance criteria" as the reported specifications and "study" as the performance testing conducted to verify these specifications, as described in the provided document.
Here's the breakdown of the information based on your request, with explicit statements where requested information is not available in the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
Given that this is a portable oxygen concentrator and not an AI/diagnostic device, the "acceptance criteria" refer to the device's technical specifications and the "reported device performance" are the measurements taken during testing to confirm these specifications.
| Acceptance Criteria (Specification) | Reported Device Performance (Test Result) | Study/Test Performed |
|---|---|---|
| Oxygen Concentration: 87% to 95% | Measured O2 concentration after operating for 1 hour, and over a 9-hour period, confirmed to be within 87% to 95%. | 738-9 Oxygen Concentration, 738-10 Mean Oxygen Concentration |
| Oxygen Minute Volume (Tolerance +/-15%): | 738-11 Bolus Volume | |
| - Setting 1: 240 cc/min | Confirmed as 240 +/-15% cc/min | 738-11 Bolus Volume |
| - Setting 2: 380 cc/min | Confirmed as 380 +/-15% cc/min | 738-11 Bolus Volume |
| - Setting 3: 520 cc/min | Confirmed as 520 +/-15% cc/min | 738-11 Bolus Volume |
| - Setting 4: 660 cc/min | Confirmed as 660 +/-15% cc/min | 738-11 Bolus Volume |
| - Setting 5: 780 cc/min | Confirmed as 780 +/-15% cc/min | 738-11 Bolus Volume |
| Battery Duration (approximate): | Measured battery runtimes for each setting. | 738-14 Sound Level (Listed under this, but likely a typo and refers to battery tests) |
| - Setting 1: 4.5 hrs | Confirmed to meet or exceed 4.5 hrs. | 738-14 (Battery Runtimes) |
| - Setting 2: 3.2 hrs | Confirmed to meet or exceed 3.2 hrs. | 738-14 (Battery Runtimes) |
| - Setting 3: 2.5 hrs | Confirmed to meet or exceed 2.5 hrs. | 738-14 (Battery Runtimes) |
| - Setting 4: 1.8 hrs | Confirmed to meet or exceed 1.8 hrs. | 738-14 (Battery Runtimes) |
| - Setting 5: 1.5 hrs | Confirmed to meet or exceed 1.5 hrs. | 738-14 (Battery Runtimes) |
| Sound (@ Setting 2): 44 dBA | Measured sound of device while operating, confirmed at 44 dBA. | 738-14 Sound Level |
| Weight: 6.8 lbs (3.08 kg) | Measured overall weight of device. | 738-2 Weight and Dimensions |
| Operating Temperature: 41°F to 104°F | Verified performance at extremes of operating temperature range. | 738-3 Operating Temperature |
| Storage Temperature: -2°F to 140°F | Subjected packaged device to extremes of storage temperature range. | 738-4 Storage Temperature |
| Altitude: Up to 9000 ft | Verified performance at maximum altitude. | 738-5 Barometric Pressure Range |
| Functionality (Basic): | Verified basic functions of test units. | 738-6 Functionality |
| Outlet Temperature: | Measured gas outlet temperature under max operating temperature. | 738-8 Outlet Temperature |
| Bolus Volume: | Measured bolus volume @ setting 5 over 9 hour period. Measured O2 minute volume for each setting, at every breath rate from 15-35 breaths/min. | 738-11 Bolus Volume, 738-12 Basic Performance |
| Internal Battery Charging: | Measured battery runtimes for each setting and battery charge time. | 738-13 Internal Battery Charging |
| Trigger Delay/Sensitivity: | Measured trigger delay and trigger sensitivity. | 738-15 Trigger Delay/Sensitivity |
| Drop Test (Packaging): | Packaging drop test. | 738-16 ISTA Drop Test |
| Electromagnetic Compatibility: | Confirmed compliance with EN 60601-1-2:2007. | Electromagnetic Compatibility Testing |
| Mechanical & Electrical Safety: | Confirmed compliance with UL 60601-1, CAN/CSA-C22.2 No.601.1-M90, IEC 60601-1, IEC 60068-2-6, IEC 60068-2-27, IEC 60068-2-64. | Mechanical and Electrical Safety Testing |
| VOC and Particulate Testing: | Confirmed compliance with EPA PM₂.₅, ASTM D5466, 21 CFR 801.415 (Ozone), EPA NAAQS (Carbon Monoxide), OSHA (Carbon Dioxide). | VOC and Particulate Testing |
2. Sample size used for the test set and the data provenance
- Sample size: Not specified. The document refers to "test units" but does not give a specific number.
- Data provenance: Not explicitly stated, but assumed to be internal testing conducted by Precision Medical, Inc. The nature of the device (a physical medical device) suggests these are laboratory and engineering tests, not involving human patient data in the context of clinical trials to establish efficacy for a diagnosis.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Not applicable / Not provided. The device is a portable oxygen concentrator, not an AI-driven diagnostic tool that would require expert-established ground truth for a test set in the conventional sense (e.g., radiologist review of images). The "ground truth" for this device's performance is derived from physical measurements and adherence to technical specifications and regulatory standards.
4. Adjudication method for the test set
- Not applicable / Not provided. Adjudication methods like 2+1 or 3+1 are typically used in clinical studies involving human interpretation or subjective assessments, often for establishing ground truth in diagnostic tasks. This is not relevant to the described performance testing of an oxygen concentrator.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
- Not applicable / Not provided. An MRMC comparative effectiveness study is exclusively relevant to AI-assisted diagnostic tools and does not apply to a portable oxygen concentrator.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
- Not applicable / Not provided. The device is a physical medical device. There is no "algorithm only" performance reported in the context of diagnostic AI. Its "standalone" performance refers to its ability to meet its technical specifications independently, which is what the listed performance tests address.
7. The type of ground truth used
- The "ground truth" for this device's performance is physical measurement against established engineering specifications and regulatory standards. For example, oxygen concentration is measured by an appropriate sensor, and sound level by a sound level meter. There is no ground truth based on expert consensus or pathology in the context of a diagnostic outcome.
8. The sample size for the training set
- Not applicable / Not provided. This device is a hardware product, not a machine learning model, so there is no training set in the AI sense.
9. How the ground truth for the training set was established
- Not applicable / Not provided. As there is no training set mentioned in the context of AI, this question is not relevant to the provided information.
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K103563
510(k) Summary Precision Medical, Inc. Portable Oxygen Concentrator
JUL - 1 2011
Submitter Information
| Submitter | Precision Medical, Inc.300 Held DriveNorthampton, Pa.18067 |
|---|---|
| FDA registration number: | 2523148 |
| Contact | James ParkerQuality 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(Model PM4150) |
| Proprietary Name: | Precision Medical EasyPulse portable oxygen concentrator(Model PM4150) |
| Common Name: | Portable Oxygen Generator |
| Regulation Number: | 21CFR 868.5440 |
| Product Code: | CAWClass 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.
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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.
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Specifications of Device
r
: ・ ・ ・ ・ ・ ・ ・ ・ ・ ・ ・ ・ ・ ・ ・ ・ ・ ・ ・ ・ ・ ・ ・ ・ ・ ・ ・ ・ ・ ・ ・ ・ ・ ・ ・ ・ ・ ・ ・ ・ ・ ・ ・ ・ ・ ・ ・ ・ ・ ・ ・ ・ ・ ・ ・ ・ ・ ・ ・ ・ ・ ・ ・ ・ ・ ・ ・ ・ ・ ・ ・ ・ ・ ・ ・ ・ ・ ・ ・ ・ ・ ・ ・ ・ ・ ・
| Dimensions | Height: 10.1" (25.4 cm)Width: 6.5" (16.5 cm)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)DC Power Adapter: 11-16 VDC (5.0 A @ 12 VDC) |
| Battery Duration(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
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Predicate Comparison
:
| Feature/Specification | Precision Medical | Invacare | |
|---|---|---|---|
| Intended Use | The Precision Medical EasyPulse POC (modelPM4150) is intended to provide supplementaloxygen to persons requiring oxygen therapy.The Precision Medical POC can be used in ahome, institution, vehicle and various mobileenvironments. | The Invacare XP02 is intended to be used by patients withrespiratory disorders who require supplemental oxygen. Itsupplies a high concentration of supplemental oxygen and isused with a nasal cannula to channel oxygen from theconcentrator to the patient. The Invacare XP02 can be used ina home, institution, vehicle and various mobile environments.The Invacare XP02 does not, nor is it intended to sustain orsupport 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" | |
| OutsideDimensions | 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)Tolerance +/-15%Setting 1: 260 cc/minSetting 2: 380 cc/minSetting 3: 520 cc/minSetting 4: 660 cc/minSetting 5: 760 cc/min | Pulse Flow (Minute Volume)Tolerance Not AvailableSetting 1: 240 cc/minSetting 2: 380 cc/minSetting 3: 480 cc/minSetting 4: 600 cc/minSetting 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 sources95 to 104°F (35 to 40°C) continuous use w/ AC or DC adapter95 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 supplyInput: 100-240 VAC , 50/60 HzOutput: 18 VDC, 60WDC/DC Power supplyInput: 11-16 VDC , 50/60 HzOutput: 18 VDC, 60W | AC/DC Power supplyInput: 100-240 VAC , 50/60 HzOutput: 18 VDC, 60WDC/DC Power supplyInput: 11-16 VDC , 50/60 HzOutput: 18 VDC, 60W | |
| Battery | Non-removableLithium-Ion - 14.4 VDC, 5.0 Ah | Non-removableLithium-Ion - 14.8 VDC, 5.2 Ah | |
| System Alarms | Low Battery WarningLow Battery AlarmNo Breath Detect AlarmExcessive Breath Rate AlarmCompressor Alarm (Abnormal Motor Current)Battery Temperature AlarmMotor Temperature AlarmPressure AlarmFan Failure AlarmMotor Connection AlarmBattery Connection AlarmPerformance Alarm (Monitor system pressures) | Low Battery WarningLow Battery AlarmBattery Discharged AlarmNo Breath Detect AlarmBreath Rate Over Capacity AlarmSystem Too Hot/Cold for Start AlarmSystem Too Hot/Cold Running AlarmBattery Too Hot/ColdStuck Button AlarmOperating Alarm (Abnormal Operating Conditions)Compressor Alarm (Abnormal Compressor Conditions)System Alarm (Abnormal System Conditions) |
43
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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 safetyCollateral 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 Chemicalsin 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 from15-35 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 sensitivityPackaging drop test |
4.4.
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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.
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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.
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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
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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
§ 868.5440 Portable oxygen generator.
(a)
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).(b)
Classification. Class II (performance standards).