(224 days)
The Nuvo Nano Portable Oxygen Concentrator is for prescription use by patients requiring high concentrations of oxygen on a supplemental basis. It is small, portable, and is capable of continuous use in the home, institutional, and travel / mobile environments.
The Nuvo Nano Portable Oxygen Concentrator (Nano POC) begins its operation with air being pulled into the external air intake filter. This filtered air enters the compressor via a suction resonator and fine filter. Pressurized air then exits the compressor. Next, an electronic valve system directs the air into one of two tubes that contain molecular sieve (sieve beds). The molecular sieve adsorbs (physically attracts) the nitrogen from the air as it is pushed through the sieve beds, this process is called pressure swing adsorption (PSA). As one tube is generating the product gas, the other is being purged of the adsorbed nitrogen. After passing through the oxygen storage tank, the rate of product gas being delivered to the patient is set by a restricting orifice and pulse dose valve based upon detection of a breath. It then passes through a fine particle filter and thru a sensor that detects the oxygen concentration of the product gas before it exits the device through a fire-resistant outlet. Once the product gas leaves the device, it travels to the patient via oxygen tubing and a cannula inserted in the nose. The Nano POC offers the user multiple options to power the device; a detachable lithium ion battery, replaceable by the patient, and an external AC/DC power supply. The device will charge the lithium ion battery when the battery and power supply are both attached. The device operates from 100V to 240V and at 50/60Hz. The device is approximately 8.3″ wide by 3.5″ deep by 6.5″ high (21.6cm x 8.9cm x 16.5cm). The device weighs about 4.7 pounds (2.1 kg) including the battery. The device provides an intermittent supply of oxygen enriched gas at a concentration between 87% and 96% to patients requiring longterm oxygen therapy without the higher cost of bottled oxygen. The device produces a product pressure of less than 170 kPa (25 psig) and flow is set by a controller that delivers pulsed flow rates nominally equivalent to continuous flow rates of 1 to 5 LPM. The device provides pulsed dose delivery of oxygen to the user through a selection of 5 settings; setting 1 delivering the least and setting 5 delivering the greatest amount of oxygen enriched product gas. Oxygen pulse volume per minute is controlled electronically by monitoring the user's breath rate and therefore adjusting bolus volume to deliver the same amount of oxygen per minute to the user. The device does not contain, nor does it produce, any latex, phthalates, harmful chemicals, animal tissue, blood components, or radioactive materials that the user or patient could physically contact. The user has short term surface contact with the device (PC + ABS cabinet and PET HMI overlay), but the nasal cannula has contact with the face for the duration of the treatment. The product gas also has prolonged contact with the respiratory airways. The device is not invasive nor implanted. The device is not life supporting, life sustaining, sterile, or radioactive. The device does not incorporate a medical substance, animal tissue or blood component. The device is reusable and should be used as often as prescribed, for the duration prescribed. Smoking cigarettes while undergoing treatment, especially during treatment, is a contraindication to the intended purpose of the device. Nidek Medical Products, Inc. warns against the use of oil or grease, using the device around an open flame, and using the device without a prescription from a doctor.
The provided text describes the acceptance criteria and the studies performed for the Nidek Medical Products, Inc. Nuvo Nano Portable Oxygen Concentrator (POC).
1. Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria Category | Specific Metric (as per Predicate) | Predicate Device Performance (Philips Respironics SimplyGo Mini) | Proposed Device Performance (Nuvo Nano) | Outcome |
|---|---|---|---|---|
| General | ||||
| Power Supply | Lithium Ion Battery, AC (100-240V, 50/60Hz), DC (12-16V) | Lithium Ion Battery, AC (100-240V, 50/60Hz), DC (12-16V) | Lithium Ion Battery, AC (100-240V, 50/60Hz) | Similar (DC power supply not specified for Nuvo Nano but common for portable devices) |
| Battery Options | Standard Battery, Extended Battery | Standard Battery, Extended Battery | Standard Battery | Similar (Nuvo Nano has only standard battery) |
| Watt-hour Rating | 97.9 Wh (per standard battery) | 97.9 Wh (per standard battery) | 99 Wh | Similar |
| Battery Duration | Up to 4.5 hours (setting 2 at 20 BPM – standard battery) | Up to 4.5 hours (setting 2 at 20 BPM – standard battery) | Up to 4 hours | Similar |
| Battery Charge Time | 4 hours (max recharge for std battery) | 4 hours (max recharge for std battery) | Not more than 4 hours | Similar |
| Expected Service Life | 5 years – device and accessories | 5 years – device and accessories | 5 years – Nano System, 1 year – Molecular Sieve Beds, 500 cycles - Battery | Similar (specific component lifespan included) |
| Dimensions | 9.4 in x 8.3 in x 3.6 in (std battery) | 9.4 in x 8.3 in x 3.6 in (std battery) | 8.3 in x 3.5 in x 6.5 in | Similar (different dimensions but both portable) |
| Weight | 5.0 lbs (std battery) | 5.0 lbs (std battery) | 4.7 lbs | Similar (slightly lighter) |
| Classification | IEC Class II Internally Powered Equipment, Type BF Applied Part, IP22 | IEC Class II Internally Powered Equipment, Type BF Applied Part, IP22 | IEC Class II Internally Powered Equipment, Type BF Applied Part, IP22 | Identical |
| Technology | ||||
| Core Technology | Pressure Swing Adsorption (PSA) | Pressure Swing Adsorption (PSA) | Pressure Swing Adsorption (PSA) | Identical |
| User Interface | Capacitive Touch Screen | Capacitive Touch Screen | 2.8 inch (7.1 cm) color LCD with membrane switch controls | Similar (different interface type) |
| Performance Specifications | ||||
| Average Oxygen Content | At least 87% (maximum 96%) | At least 87% (maximum 96%) | 87% to 96% at all settings | Identical |
| Inspiratory Trigger Sensitivity | ≤ 0.2 cm H2O | ≤ 0.2 cm H2O | ≤ 0.12 cm H2O | Similar (Nuvo Nano more sensitive) |
| Breathing Frequency | Up to 40 BPM | Up to 40 BPM | 10 to 40 breaths per minute | Identical |
| Flow Control Settings and Pulse Volumes | Per ISO 80601-2-67 (detailed table provided) | Specific pulse volumes per breath rate (detailed table provided) | Specific pulse volumes per breath rate (detailed table provided) | Similar (different pulse volume values but same principle and range of settings 1-5) |
| Sound Level | 43 dBA typical at setting 2, 49 dBA typical at setting 5 | 43 dBA typical at setting 2, 49 dBA typical at setting 5 | 49 dBA (on setting 2) | Similar (Nuvo Nano reports 49 dBA at setting 2, predicate 43 dBA at setting 2, 49 dBA at setting 5) |
| Altitude Capability | Up to 10,000 ft | Up to 10,000 ft | 0 to 10,000 ft/3048 m | Identical |
| Storage Temperature | -4 to 140 F / -20 to 60 C | -4 to 140 F / -20 to 60 C | -4 to 158 F / -20 to 70 C | Similar (wider range for Nuvo Nano) |
| Operating Temperature | 41 to 95 F / 5 to 35 C | 41 to 95 F / 5 to 35 C | 41 to 104 F / 5 to 40 C | Similar (wider range for Nuvo Nano) |
| Relative Humidity | 15% to 93% | 15% to 93% | 10% to 90% | Similar |
| Alarms/Alerts | ||||
| No breath / High Breath Rate | Yes | No breath / High Breath Rate | No breath detected | Similar |
| Low Oxygen Concentration | Yes | Low Oxygen Concentration | Low O2 concentration (at |
§ 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).