Nuvo Nano Portable Oxygen Concentrator

K192693 · Nidek Medical Products, Inc. · CAW · May 7, 2020 · Anesthesiology

Device Facts

• Record ID: K192693
• Device Name: Nuvo Nano Portable Oxygen Concentrator
• Applicant: Nidek Medical Products, Inc.
• Product Code: CAW · Anesthesiology
• Decision Date: May 7, 2020
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 868.5440
• Device Class: Class 2
• Attributes: Therapeutic

Indications for Use

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.

Device Story

Nuvo Nano Portable Oxygen Concentrator (POC) provides supplemental oxygen via pressure swing adsorption (PSA). Ambient air enters through an intake filter, passes through a compressor, and is directed by an electronic valve system into molecular sieve beds to remove nitrogen. The resulting oxygen-enriched gas passes through a storage tank and is delivered to the patient via a nasal cannula. The device detects patient breath to provide pulsed dose delivery across 5 settings, adjusting bolus volume based on breath rate. Operated by patients in home, institutional, or mobile settings. Powered by a detachable lithium-ion battery or external AC/DC supply. The device features a 2.8-inch color LCD and membrane controls. Output oxygen concentration is 87-96%. Alarms monitor system faults, breath detection, oxygen concentration, and battery status. Benefits include portability and cost-effectiveness compared to bottled oxygen.

Clinical Evidence

Bench testing only. No clinical data. Performance verified against ISO 80601-2-69 (oxygen concentrators), ISO 80601-2-67 (oxygen-conserving equipment), IEC 60601-1 (electrical safety), IEC 60601-1-2 (EMC), IEC 60601-1-8 (alarms), IEC 60601-1-11 (home healthcare), and ISO 10993/18562 (biocompatibility). All tests passed.

Technological Characteristics

Materials: PC + ABS cabinet, PET HMI overlay. Principle: Pressure Swing Adsorption (PSA) with molecular sieve beds. Power: Lithium-ion battery, AC/DC supply (100-240V, 50/60Hz). Form factor: 21.6cm x 8.9cm x 16.5cm, 2.1 kg. Connectivity: Standalone. Sterilization: Not sterile. Software: Embedded control system for breath detection and pulse dose delivery.

Indications for Use

Indicated for patients requiring supplemental high-concentration oxygen. Suitable for home, institutional, and mobile/travel use. Contraindicated for use while smoking.

Regulatory Classification

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).

Predicate Devices

• Respironics SimplyGo Mini Oxygen Concentrator (K111885)

Reference Devices

• Kingon P2 (K190304)

Submission Summary (Full Text)

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Image /page/0/Picture/0 description: The image contains the logos of the Department of Health and Human Services and the Food and Drug Administration (FDA). The Department of Health and Human Services logo is on the left, and the FDA logo is on the right. The FDA logo includes the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.

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 ([e-mail]) or phone [phone] 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)

| <svg height="12" width="12"> <rect fill="white" height="12" stroke="black" stroke-width="1" width="12"></rect> <path d="M2,2 L10,10 M10,2 L2,10" stroke="black" stroke-width="1"></path> </svg> Prescription Use (Part 21 CFR 801 Subpart D) |
|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| <svg height="12" width="12"> <rect fill="white" height="12" stroke="black" stroke-width="1" width="12"></rect> </svg> Over-The-Counter Use (21 CFR 801 Subpart C) |

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Image /page/3/Picture/0 description: The image shows the logo for NIDEK Medical. The word "NIDEK" is written in large, blue, sans-serif font. Below the word "NIDEK" is the word "Medical" written in a smaller, italicized, gray font. There is a horizontal line below the word "NIDEK".

#### 5 510(k) Summary

| 510(k) Summary | This summary of 510(k) safety and effectiveness is made in accordance<br>with the requirements of 21 CFR 807.92. |
|---------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Submitter | Nidek Medical Products, Inc.<br>3949 Valley East Industrial Drive<br>Birmingham, AL 35217, USA<br>Phone - 205.856.7200<br>Fax - 205.856.0533 |
| Contact Person | Olivia Mullen<br>Compliance / Regulatory Affairs<br>[e-mail]<br>Phone - 205.856.7200 ext 220<br>Fax - 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 Nidek<br>Medical Products, Inc. |
| Equivalent Legally<br>Marketed Device | Respironics SimplyGo Mini Oxygen Concentrator<br>K111885 |
| Description | The Nuvo Nano Portable Oxygen Concentrator (Nano POC) begins its<br>operation with air being pulled into the external air intake filter. This<br>filtered air enters the compressor via a suction resonator and fine filter.<br>Pressurized air then exits the compressor. Next, an electronic valve<br>system directs the air into one of two tubes that contain molecular<br>sieve (sieve beds). The molecular sieve adsorbs (physically attracts) the<br>nitrogen from the air as it is pushed through the sieve beds, this<br>process is called pressure swing adsorption (PSA). As one tube is<br>generating the product gas, the other is being purged of the adsorbed<br>nitrogen. After passing through the oxygen storage tank, the rate of<br>product gas being delivered to the patient is set by a restricting orifice<br>and pulse dose valve based upon detection of a breath. It then passes<br>through a fine particle filter and thru a sensor that detects the oxygen<br>concentration 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 Mini<br>Portable Oxygen Concentrator is for<br>prescription use by patients requiring high<br>concentrations of oxygen on a supplemental<br>basis. It is small, portable, and is capable of<br>continuous use in the home, institutional,<br>and travel / mobile environments. | The Nuvo Nano Portable Oxygen<br>Concentrator is for prescription use by<br>patients requiring high concentrations of<br>oxygen on a supplemental basis. It is small,<br>portable, and is capable of continuous use in<br>the home, institutional, and travel / mobile<br>environments. |
| Comparison<br>Statement | The proposed device has the same classification information and intended<br>use as the predicate device. | |
| | | |
| General | | |
| Power Supply | Lithium Ion Battery<br>AC Power (100 to 240 VAC, 50/60Hz)<br>DC Power (12-16 VDC) | Lithium Ion Battery<br>AC Power (100 to 240 VAC, 50/60Hz) |
| Battery Options | Standard Battery<br>Extended 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 –<br>standard battery) | Up to 4 hours |
| Battery Charge<br>Time | 4 hours (max recharge for std battery) | Not more than 4 hours |
| Expected Service<br>Life | 5 years – device and accessories | 5 years – Nano System<br>1 year – Molecular Sieve Beds<br>500 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 Powered<br>Equipment | IEC Class II Internally Powered<br>Equipment |
| | Type BF Applied Part | Type BF Applied Part |
| | IP22 | IP22 |
| Comparison<br>Statement | The proposed device has similar general specifications as the predicate<br>device. | |

### 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 with<br>membrane switch controls | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
| Comparison<br>Statement | The proposed device has similar technology to the predicate device. | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
| Performance<br>Specifications | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
| Average Oxygen<br>Content | At least 87% at all settings (maximum of<br>96%) | | 87% to 96% at all settings | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
| Inspiratory Trigger<br>Sensitivity | ≤ 0.2 cm H2O | | ≤ 0.12 cm H2O | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
| Breathing Frequency | Up to 40 BPM | | 10 to 40 breaths per minute | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
| Flow Control Settings<br>and 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)*<br>± 25% over the rated environmental range<br>* STDP is 101.3kPa at an operating temperature of 20°C, dry | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
| | Sound Level | 43 dBA typical at setting 2<br>49 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 | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
| Operating<br>Temperature | 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<br>(at < 87% and at < 50%) | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
| | Low Battery / Depleted Battery | | Low Battery / Battery Depleted /<br>Battery Exhausted | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
| | | | Battery Too Cold / Too Hot | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
| | | | System Too Cold / Too Hot | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
| | | | Low Input Voltage | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |

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### Predicate Device Comparison

| Alarms/Alerts | Predicate Device | Proposed Device |
|----------------------------|----------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------|
| | Technical Fault Alarm / External Power<br>Failure | Component Fail<br>(sieve bed, power supply, compressor, valve<br>check, cooling fan, breath sensor, oxygen<br>sensor) |
| | No Flow Alarm | Process Fail<br>(gas supply, system startup, gas delivery, tank<br>pressure) |
| Comparison<br>Statement | The proposed device has similar performance specifications to the predicate<br>device. | |
| Standards<br>Compliance | 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 /<br>ISO 10993-5 |
| Conserving Oxygen | ISO 18779 | ISO 18779 |
| Gas Pathways | | ISO 18562-1 / ISO 18562-2 /<br>ISO 18562-3 |
| Oxygen Conserving<br>Equip | ISO 80601-2-67 | ISO 80601-2-67 |
| Oxygen<br>Concentrators | ISO 80601-2-69 | ISO 80601-2-69 |
| Comparison<br>Statement | 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.

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| Technological<br>Characteristics<br>(cont.) | Both of them have been tested to the same electrical and electromagnetic<br>safety standards for medical electrical equipment. Both devices are<br>manufactured under a quality system. The differences between the<br>predicate and subject devices, such as size, storage condition, operating<br>conditions, battery duration, alarm settings, and control panel indicators<br>introduce risks mitigated by the performance testing provided in this<br>submission. |
|---------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | 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 Essential<br>Performance of Oxygen<br>Concentrators | ISO 80601-2-69:2014 | R19012 | Pass |
| Basic Safety and Essential<br>Performance of Oxygen-<br>Conserving Equipment | ISO 80601-2-67:2014 | R19020 | Pass |
| Basic Safety and Essential<br>Performance of Medical Electrical<br>Equipment | IEC 60601-1:2006 + A1:2013 | R19013 | Pass |
| Electromagnetic Disturbances –<br>requirements and tests | IEC 60601-1-2:2015 | R19014 | Pass |
| Usability Engineering to Medical<br>Devices | IEC 62366-1:2015 + AC:2016 | R19021 | Pass |
| Alarm Systems in Medical<br>Electrical Equipment | IEC 60601-1-8:2007 | R19015 | Pass |
| Usability | IEC 60601-1-6:2010 | R19020 | Pass |
| Medical Devices used in a Home<br>Healthcare Environment | IEC 60601-1-11:2015 | R19016 | Pass |
| Safety Requirements for lithium<br>batteries used in portable<br>applications | IEC 62133-2:2017 | EA3373IEC | Pass |
| Exposure to RFID Readers | AIM 7351731:2017 | 1909ESU013-U1 | Pass |
| Biocompatibility Tests | | | |
| Biological Evaluation of Breathing<br>Gas Pathways | ISO 18562-1:2017 | R19011 | Pass |
| Emissions of Particulate Matter | ISO 18562-2:2017 | R19011 | Pass |
| Emissions of Volatile Organic<br>Compounds | ISO 18562-3:2017 | R19011 | Pass |
| Biological Evaluation of Medical<br>Devices | 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 |

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| Conclusion | Based on information contained in this 510(k) submission, the Nuvo Nano POC<br>has similar intended use, principle of operation, and technological<br>characteristics as the predicate device identified. Performance testing<br>contained in this submission demonstrates the minor differences between<br>devices do not raise different questions of safety or effectiveness. Therefore,<br>in accordance with the 21 CFR 807, Nidek Medical Products, Inc. concludes<br>that the Nuvo Nano Portable Oxygen Concentrator is substantially equivalent<br>to the referenced predicate device. |
|------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|