(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 < 87% and at < 50%) | Similar |
| Low / Depleted Battery | Yes | Low Battery / Depleted Battery | Low Battery / Battery Depleted / Battery Exhausted | Similar |
| Other battery warnings | None specified | Not specified | Battery Too Cold / Too Hot | Nuvo Nano includes more specific battery warnings |
| Other system warnings | None specified | Not specified | System Too Cold / Too Hot, Low Input Voltage, Component Fail, Process Fail | Nuvo Nano includes more comprehensive system warnings |
| Technical Fault Alarm / External Power Failure, No Flow Alarm | Technical Fault Alarm / External Power Failure, No Flow Alarm | Component Fail, Process Fail | Similar (different nomenclature but comparable functionality) | |
| Standards Compliance | ||||
| EMC | IEC 60601-1-2, 4th edition | IEC 60601-1-2, 4th edition | IEC 60601-1-2, 4th edition | Identical |
| General Safety | IEC 60601-1 3rd edition | IEC 60601-1 3rd edition | IEC 60601-1 3rd edition | Identical |
| Alarm Systems | IEC 60601-1-8 | IEC 60601-1-8 | IEC 60601-1-8 | Identical |
| Home Healthcare | IEC 60601-1-11 | IEC 60601-1-11 | IEC 60601-1-11 | Identical |
| Biological Evaluation | ISO 10993-1 | ISO 10993-1 | ISO 10993-1 / ISO 10993-10 / ISO 10993-5 | Similar (Nuvo Nano specifies more parts of ISO 10993) |
| Conserving Oxygen | ISO 18779 | ISO 18779 | ISO 18779 | Identical |
| Gas Pathways | Not specified | Not specified | ISO 18562-1 / ISO 18562-2 / ISO 18562-3 | Nuvo Nano specifies these standards |
| Oxygen Conserving Equip | ISO 80601-2-67 | ISO 80601-2-67 | ISO 80601-2-67 | Identical |
| Oxygen Concentrators | ISO 80601-2-69 | ISO 80601-2-69 | ISO 80601-2-69 | Identical |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document primarily describes bench tests and adherence to international standards. It does not refer to 'test sets' in the context of clinical trials with patient data, but rather as test protocols for engineering and safety verification.
- The tests are described as Bench Tests and Biocompatibility Tests.
- Sample size: Not applicable in the context of clinical data for AI, as this is a hardware device. The "sample size" here would refer to the number of devices tested, which is not explicitly stated but implied to be sufficient for compliance with the listed standards.
- Data provenance: Not applicable in the context of clinical data for AI. The data provenance is from the specific testing performed by the manufacturer or contracted labs to demonstrate compliance with the listed ISO and IEC standards. The country of origin of the data is not specified but would be where the manufacturer Nidek Medical Products, Inc. (Birmingham, Alabama, USA) or its testing facilities are located. These tests are prospective, meaning they are performed specifically for the regulatory submission to demonstrate the device's characteristics.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
This information is not applicable as the submission is for a portable oxygen concentrator, not an AI/ML-based diagnostic or imaging device requiring expert ground truth for image interpretation or diagnosis. The "ground truth" for this device is based on objective measurements and compliance with engineering and safety standards.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not applicable as it pertains to clinical data interpretation, typically in AI/ML studies, not hardware device performance testing against engineering standards.
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
This information is not applicable as this is a hardware medical device (portable oxygen concentrator), not an AI-assisted diagnostic tool. No MRMC study was performed or needed.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This information is not applicable as this is a hardware medical device, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The "ground truth" for the Nuvo Nano POC is established by:
- Objective Measurements: Directly measuring physical device parameters such as oxygen concentration, flow rates, trigger sensitivity, sound level, battery performance, dimensions, and weight through standardized testing procedures.
- Compliance with International Standards: Demonstrating adherence to relevant IEC and ISO standards for safety, performance, electromagnetic compatibility, usability, and biocompatibility. These standards define the "ground truth" for acceptable device characteristics.
- Biocompatibility Testing: Evaluating materials in the gas pathway against ISO 10993 standards to ensure they are non-toxic and safe for contact with patients.
8. The sample size for the training set
This information is not applicable as this is a hardware medical device and does not involve AI model training with a "training set."
9. How the ground truth for the training set was established
This information is not applicable as this is a hardware medical device and does not involve AI model training.
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Nidek Medical Products, Inc. Olivia Mullen Compliance/ Regulatory Affairs 3949 Valley East Industrial Drive Birmingham, Alabama 35217
Re: K192693
Trade/Device Name: Nuvo Nano Portable Oxygen Concentrator Regulation Number: 21 CFR 868.5440 Regulation Name: Portable Oxygen Generator Regulatory Class: Class II Product Code: CAW Dated: May 1, 2020 Received: May 1, 2020
Dear Olivia Mullen:
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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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.
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
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801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Todd Courtney Assistant Director DHT1C: Division of ENT, Sleep Disordered Breathing, Respiratory and Anesthesia Devices OHT1: Office of Ophthalmic, Anesthesia, Respiratory, ENT and Dental Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K192693
Device Name
Nuvo Nano Portable Oxygen Concentrator
Indications for Use (Describe)
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.
Type of Use (Select one or both, as applicable)
| Prescription Use (Part 21 CFR 801 Subpart D) |
|---|
| Over-The-Counter Use (21 CFR 801 Subpart C) |
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5 510(k) Summary
| 510(k) Summary | This summary of 510(k) safety and effectiveness is made in accordancewith the requirements of 21 CFR 807.92. |
|---|---|
| Submitter | Nidek Medical Products, Inc.3949 Valley East Industrial DriveBirmingham, AL 35217, USAPhone - 205.856.7200Fax - 205.856.0533 |
| Contact Person | Olivia MullenCompliance / Regulatory Affairsomullen@nidekmedical.comPhone - 205.856.7200 ext 220Fax - 205.856.0533 |
| Date Submitted | 07 May 2019 |
| Trade Name | Nuvo Nano Portable Oxygen Concentrator |
| Common Name | Oxygen Concentrator |
| Classification Name | Generator, Oxygen, Portable |
| Regulation Number | 21 CFR 868.5440 |
| Prior PMA Submission | No, there has not been a submission for the Nuvo Nano from NidekMedical Products, Inc. |
| Equivalent LegallyMarketed Device | Respironics SimplyGo Mini Oxygen ConcentratorK111885 |
| Description | The Nuvo Nano Portable Oxygen Concentrator (Nano POC) begins itsoperation with air being pulled into the external air intake filter. Thisfiltered air enters the compressor via a suction resonator and fine filter.Pressurized air then exits the compressor. Next, an electronic valvesystem directs the air into one of two tubes that contain molecularsieve (sieve beds). The molecular sieve adsorbs (physically attracts) thenitrogen from the air as it is pushed through the sieve beds, thisprocess is called pressure swing adsorption (PSA). As one tube isgenerating the product gas, the other is being purged of the adsorbednitrogen. After passing through the oxygen storage tank, the rate ofproduct gas being delivered to the patient is set by a restricting orificeand pulse dose valve based upon detection of a breath. It then passesthrough a fine particle filter and thru a sensor that detects the oxygenconcentration of the product gas before it exits the device through a |
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Description (cont.) 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.
The Nano POC is for prescription use by patients requiring high Intended use 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.
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.
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| Predicate Device | Proposed Device | |
|---|---|---|
| Trade Name | Philips Respironics SimplyGo Mini | Nidek Medical Nuvo Nano |
| Model Number | SimplyGo Mini | 855 |
| 510(k) submitter | Respironics, Inc. | Nidek Medical Products, Inc. |
| 510(k) number | K111885 | K192693 |
| Common Name | Oxygen Concentrator | Oxygen Concentrator |
| Classification Name | Generator, Oxygen, Portable | Generator, Oxygen, Portable |
| FDA Product Code | CAW | CAW |
| Regulation Number | 21 CFR 868.5440 | 21 CFR 868.5440 |
| Intended Use | The Philips Respironics SimplyGo MiniPortable Oxygen Concentrator is forprescription use by patients requiring highconcentrations of oxygen on a supplementalbasis. It is small, portable, and is capable ofcontinuous use in the home, institutional,and travel / mobile environments. | The Nuvo Nano Portable OxygenConcentrator is for prescription use bypatients requiring high concentrations ofoxygen on a supplemental basis. It is small,portable, and is capable of continuous use inthe home, institutional, and travel / mobileenvironments. |
| ComparisonStatement | The proposed device has the same classification information and intendeduse as the predicate device. | |
| General | ||
| Power Supply | Lithium Ion BatteryAC Power (100 to 240 VAC, 50/60Hz)DC Power (12-16 VDC) | Lithium Ion BatteryAC Power (100 to 240 VAC, 50/60Hz) |
| Battery Options | Standard BatteryExtended Battery | Standard Battery |
| Watt-hour Rating | 97.9 Wh (per standard battery) | 99 Wh |
| Battery Duration | Up to 4.5 hours (setting 2 at 20 BPM –standard battery) | Up to 4 hours |
| Battery ChargeTime | 4 hours (max recharge for std battery) | Not more than 4 hours |
| Expected ServiceLife | 5 years – device and accessories | 5 years – Nano System1 year – Molecular Sieve Beds500 cycles - Battery |
| Dimensions | 9.4 in x 8.3 in x 3.6 in (std battery) | 8.3 in x 3.5 in x 6.5 in |
| Weight | 5.0 lbs (std battery) | 4.7 lbs |
| Classification | ||
| IEC Class II Internally PoweredEquipment | IEC Class II Internally PoweredEquipment | |
| Type BF Applied Part | Type BF Applied Part | |
| IP22 | IP22 | |
| ComparisonStatement | The proposed device has similar general specifications as the predicatedevice. |
Predicate Device Comparison
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Predicate Device Comparison
| Predicate Device | Proposed Device | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Technology | Pressure Swing Adsorption (PSA) | Pressure Swing Adsorption (PSA) | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| User Interface | Capacitive Touch Screen | 2.8 inch (7.1 cm) color LCD withmembrane switch controls | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| ComparisonStatement | The proposed device has similar technology to the predicate device. | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| PerformanceSpecifications | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Average OxygenContent | At least 87% at all settings (maximum of96%) | 87% to 96% at all settings | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Inspiratory TriggerSensitivity | ≤ 0.2 cm H2O | ≤ 0.12 cm H2O | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Breathing Frequency | Up to 40 BPM | 10 to 40 breaths per minute | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Flow Control Settingsand Pulse Volumes | 1 2 3 4 5 Breath Rate Pulse Volumes (mL) 15 11.0 22.0 33.0 44.0 55.0 20 11.0 22.0 33.0 44.0 50.0 25 8.8 17.6 26.4 35.2 40.0 30 7.3 14.7 22.0 29.3 33.3 35 6.3 12.6 18.9 25.1 28.6 40 5.5 11.0 16.5 22.0 25.0 per ISO 80601-2-67 | 1 2 3 4 5 Breath Rate Pulse Volumes (ml) 10 21 42 63 84 100 15 14 28 42 58 66.7 20 10.5 21 31.5 42 50 25 8.4 16.8 25.2 33.6 40 30 7 14 21 28 33.3 35 6 12 18 24 28.6 40 5.3 10.5 15.8 21 25 ±15% at Standard Temperature and Pressure, dry (STDP)± 25% over the rated environmental range STDP is 101.3kPa at an operating temperature of 20°C, dry | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Sound Level | 43 dBA typical at setting 249 dBA typical at setting 5 | 49 dBA (on setting 2) | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Altitude Capability | Up to 10,000 ft | 0 to 10,000 ft/3048 m | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Storage Temperature | -4 to 140 F/-20 to 60 C | -4 to 158 F/-20 to 70 C | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| OperatingTemperature | 41 to 95 F/5 to 35 C | 41 to 104 F/5 to 40 C | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Relative Humidity | 15% to 93% | 10% to 90% | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Alarms/Alerts | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| No breath / High Breath Rate | No breath detected | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Low Oxygen Concentration | Low O2 concentration(at < 87% and at < 50%) | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Low Battery / Depleted Battery | Low Battery / Battery Depleted /Battery Exhausted | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Battery Too Cold / Too Hot | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| System Too Cold / Too Hot | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Low Input Voltage |
{7}------------------------------------------------
Predicate Device Comparison
| Alarms/Alerts | Predicate Device | Proposed Device |
|---|---|---|
| Technical Fault Alarm / External PowerFailure | Component Fail(sieve bed, power supply, compressor, valvecheck, cooling fan, breath sensor, oxygensensor) | |
| No Flow Alarm | Process Fail(gas supply, system startup, gas delivery, tankpressure) | |
| ComparisonStatement | The proposed device has similar performance specifications to the predicatedevice. | |
| StandardsCompliance | Predicate Device | Proposed Device |
| EMC | IEC 60601-1-2, 4th edition | IEC 60601-1-2, 4th edition |
| General Safety | IEC 60601-1 3rd edition | IEC 60601-1 3rd edition |
| Alarm Systems | IEC 60601-1-8 | IEC 60601-1-8 |
| Home Healthcare | IEC 60601-1-11 | IEC 60601-1-11 |
| Biological Evaluation | ISO 10993-1 | ISO 10993-1 / ISO 10993-10 /ISO 10993-5 |
| Conserving Oxygen | ISO 18779 | ISO 18779 |
| Gas Pathways | ISO 18562-1 / ISO 18562-2 /ISO 18562-3 | |
| Oxygen ConservingEquip | ISO 80601-2-67 | ISO 80601-2-67 |
| OxygenConcentrators | ISO 80601-2-69 | ISO 80601-2-69 |
| ComparisonStatement | The proposed device has the same standards compliance as the predicate device. |
Technological The Nano POC is technologically equivalent to the referenced legally marketed device. Both devices share five basic components: 1) a motor Characteristics driven compressor which is manufactured by the same supplier and has the same operational characteristics, 2) air separation module comprised of an electronically activated control valve and two air separation columns of adsorbent molecular sieve, 3) a flame retardant thermoplastic enclosure, 4) a human-machine interface (HMI) that controls all functions of the device and 5) rechargeable lithium ion batteries and AC/DC power supply as power sources. Both devices have incorporated the same basic design and the same
technological characteristics, and utilize the same operating principle.
{8}------------------------------------------------
| TechnologicalCharacteristics(cont.) | Both of them have been tested to the same electrical and electromagneticsafety standards for medical electrical equipment. Both devices aremanufactured under a quality system. The differences between thepredicate and subject devices, such as size, storage condition, operatingconditions, battery duration, alarm settings, and control panel indicatorsintroduce risks mitigated by the performance testing provided in thissubmission. |
|---|---|
| Additionally, the Nano POC uses identical materials in the gas pathway as |
those found in the Kingon P2 (K190304), therefore the methods used to determine biocompatibility are applicable to the Nano POC.
| Performance Data | |||
|---|---|---|---|
| Bench Tests | Standard | Report | Results |
| Basic Safety and EssentialPerformance of OxygenConcentrators | ISO 80601-2-69:2014 | R19012 | Pass |
| Basic Safety and EssentialPerformance of Oxygen-Conserving Equipment | ISO 80601-2-67:2014 | R19020 | Pass |
| Basic Safety and EssentialPerformance of Medical ElectricalEquipment | IEC 60601-1:2006 + A1:2013 | R19013 | Pass |
| Electromagnetic Disturbances –requirements and tests | IEC 60601-1-2:2015 | R19014 | Pass |
| Usability Engineering to MedicalDevices | IEC 62366-1:2015 + AC:2016 | R19021 | Pass |
| Alarm Systems in MedicalElectrical Equipment | IEC 60601-1-8:2007 | R19015 | Pass |
| Usability | IEC 60601-1-6:2010 | R19020 | Pass |
| Medical Devices used in a HomeHealthcare Environment | IEC 60601-1-11:2015 | R19016 | Pass |
| Safety Requirements for lithiumbatteries used in portableapplications | IEC 62133-2:2017 | EA3373IEC | Pass |
| Exposure to RFID Readers | AIM 7351731:2017 | 1909ESU013-U1 | Pass |
| Biocompatibility Tests | |||
| Biological Evaluation of BreathingGas Pathways | ISO 18562-1:2017 | R19011 | Pass |
| Emissions of Particulate Matter | ISO 18562-2:2017 | R19011 | Pass |
| Emissions of Volatile OrganicCompounds | ISO 18562-3:2017 | R19011 | Pass |
| Biological Evaluation of MedicalDevices | ISO 10993-1:2009 + AC:2010 | R19011 | Pass |
| Cytotoxicity Tests | ISO 10993-5:2009 | R19011 | Pass |
| Skin Sensitization / Irritation Tests | ISO 10993-10:2010 | R19011 | Pass |
{9}------------------------------------------------
| Conclusion | Based on information contained in this 510(k) submission, the Nuvo Nano POChas similar intended use, principle of operation, and technologicalcharacteristics as the predicate device identified. Performance testingcontained in this submission demonstrates the minor differences betweendevices do not raise different questions of safety or effectiveness. Therefore,in accordance with the 21 CFR 807, Nidek Medical Products, Inc. concludesthat the Nuvo Nano Portable Oxygen Concentrator is substantially equivalentto the referenced predicate device. |
|---|
§ 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).