(207 days)
510K 071928
Not Found
No
The description focuses on electronic conserving technology and monitoring breath rate to deliver oxygen, with no mention of AI or ML.
Yes
The device is intended to provide supplemental oxygen to persons requiring oxygen therapy, which is a therapeutic intervention.
No
The device is described as an "oxygen concentrator" intended to "provide supplemental oxygen to persons requiring oxygen therapy," which is a therapeutic function, not a diagnostic one. It does not analyze patient data or provide any form of diagnosis.
No
The device description clearly outlines a physical hardware device (portable oxygen concentrator) with electronic components, a battery, and power adapters. The performance studies also include testing for mechanical and electrical safety, indicating it is not software-only.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to "provide supplemental oxygen to persons requiring oxygen therapy." This is a therapeutic purpose, not a diagnostic one.
- Device Description: The description details how the device delivers oxygen to the patient through a nasal cannula. It focuses on the mechanical and electronic aspects of oxygen delivery and conservation.
- Lack of Diagnostic Function: There is no mention of the device being used to test samples (blood, urine, tissue, etc.) or to provide information for the diagnosis of a disease or condition.
- Performance Studies: The performance studies listed focus on safety, electrical compatibility, environmental factors, and the performance of the oxygen delivery itself (concentration, bolus volume, etc.). These are typical for a medical device that provides therapy, not for an IVD.
IVD devices are specifically designed to be used in vitro (outside the body) to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device operates in vivo (within the body) by delivering oxygen directly to the patient.
N/A
Intended Use / 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.
Product codes
CAW
Device Description
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
home, institution, vehicle and for transportable use.
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies
Electromagnetic Compatibility Testing Performed per: EN 60601-1-2:2007 Medical electrical equipment - Part 1-2: General requirements for safety 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 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 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 Packaging drop test
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
510K 071928
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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).
0
K103563
510(k) Summary Precision Medical, Inc. Portable Oxygen Concentrator
JUL - 1 2011
Submitter Information
| Submitter | Precision Medical, Inc.
300 Held Drive
Northampton, Pa.
18067 |
|--------------------------|----------------------------------------------------------------------------|
| FDA registration number: | 2523148 |
| Contact | James Parker
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
(Model PM4150) |
| Proprietary Name: | Precision Medical EasyPulse portable oxygen concentrator
(Model PM4150) |
| Common Name: | Portable Oxygen Generator |
| Regulation Number: | 21CFR 868.5440 |
| Product Code: | CAW
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)
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
3
Predicate Comparison
:
| Feature/Specification | Precision Medical | Invacare | |
|---|---|---|---|
| Intended Use | The Precision Medical EasyPulse POC (model | ||
| PM4150) is intended to provide supplemental | |||
| oxygen to persons requiring oxygen therapy. | |||
| The Precision Medical POC can be used in a | |||
| home, institution, vehicle and various mobile | |||
| environments. | The Invacare XP02 is intended to be used by patients with | ||
| respiratory disorders who require supplemental oxygen. It | |||
| supplies a high concentration of supplemental oxygen and is | |||
| used with a nasal cannula to channel oxygen from the | |||
| concentrator to the patient. The Invacare XP02 can be used in | |||
| a home, institution, vehicle and various mobile environments. | |||
| The Invacare XP02 does not, nor is it intended to sustain or | |||
| 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 |