PNEUTON MINI VENTILATOR PNEUTON MINI NON-INVASIVE VENTILATION (NIV) KIT ACCESSORY

K121379 · Airon Corporation · CBK · Oct 11, 2012 · Anesthesiology

Device Facts

• Record ID: K121379
• Device Name: PNEUTON MINI VENTILATOR PNEUTON MINI NON-INVASIVE VENTILATION (NIV) KIT ACCESSORY
• Applicant: Airon Corporation
• Product Code: CBK · Anesthesiology
• Decision Date: Oct 11, 2012
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 868.5895
• Device Class: Class 2
• Attributes: Therapeutic, Pediatric

Indications for Use

The pNeuton mini is intended to provide ventilatory support for critically ill patients who require the following general types of ventilatory support: - Positive pressure ventilation delivered invasively (via an ET Tube) or non-invasively (via a mask or nasal prongs) - CMV and IMV mode of ventilation with or without PEEP / CPAP . - Provide oxygen or a mixture of medical air and oxygen . Patient population: Neonates, infants, and children, from 400 g to 25 kg in weight Environments of Use - Inter and intra-hospital patient transport - Air & ground transport Pressurized and non-pressurized aircraft (to 15,000 ft) - Intensive care units (short term use only associated with patient transport) - Emergency Departments - Radiology suites including MRI (MR Conditional 3T) - Operating rooms (short term use only associated with patient transport)

Device Story

pNeuton mini is a small, lightweight, purely pneumatic transport ventilator for neonates to pediatric patients (400g-25kg). It operates on 40-70 psi oxygen and medical air; no electrical power or software. It provides CMV and IMV ventilation modes with adjustable inspiratory/expiratory time, pressure, and 21-100% oxygen concentration. A built-in PEEP/CPAP system provides expiratory positive pressure. Used in pre-hospital, inter/intra-hospital transport, air/ground transport, ICU, ER, OR, and MRI suites (MR Conditional 3T). Operated by physicians, nurses, or respiratory therapists. Clinicians monitor patient status via a mechanical manometer. The device supports patients by providing respiratory assistance during transport or short-term care, reducing work of breathing for spontaneously breathing patients.

Clinical Evidence

No clinical data. Safety and efficacy established through bench testing only. Performance validated against ASTM F1100-90, ISO 10651-3, RTCA DO-160G, and MIL-STD-810F. Testing included 2,200 hours of continuous operation, environmental/mechanical safety (vibration, shock, rapid decompression), and MRI compatibility (3T). Waveform analysis (Pressure/Time, Flow/Time, Volume/Time) confirmed accuracy and precision of breath delivery across clinical simulated conditions.

Technological Characteristics

Purely pneumatic, non-electronic ventilator. Materials in gas pathway identical to predicate K043085. Dimensions: rugged, lightweight form factor. Energy source: 40-70 psi medical air/oxygen. Sensing: mechanical manometer using proximal airway signal. Connectivity: none. Sterilization: not specified (disposable patient circuit). No software or electronic controls.

Indications for Use

Indicated for neonates, infants, and children (400g to 25kg) requiring invasive (ET tube) or non-invasive (mask/nasal prongs) positive pressure ventilation (CMV/IMV) with or without PEEP/CPAP and oxygen/air delivery. Contraindicated for use in the presence of flammable anesthetics.

Regulatory Classification

Identification

A continuous ventilator (respirator) is a device intended to mechanically control or assist patient breathing by delivering a predetermined percentage of oxygen in the breathing gas. Adult, pediatric, and neonatal ventilators are included in this generic type of device.

Predicate Devices

• pNeuton Transport Ventilator model A (K043085)
• BabyPAC 100 Ventilator (K043495)
• Millennium Infant Ventilator (K993167)
• Babi Plus Nasal Cannula System (K110471)

Submission Summary (Full Text)

{0}------------------------------------------------

Image /page/0/Picture/0 description: The image shows the logo for Airon. The logo consists of a stylized graphic to the left of the word "Airon". The graphic appears to be a circle with an abstract design inside, possibly representing a bird or an airplane. The word "Airon" is written in a simple, sans-serif font.

OCT 11 2012

### pNeuton mini Ventilator

## 510(k) Summary - K121379 14 September 2012 Page 1 of 8

### Contact Information

G. Eric Gjerde President Airon Corporation 751 North Drive, Unit 6 Melbourne, FL 32934 Tel: [phone] Fax: [phone] email: [e-mail]

### Device Trade Name

pNeuton mini Ventilator

### Device Classification

Continuous Ventilator (21 CFR 868.5895, Product Code CBK)

# Device Class

# Class II

### Predicate Devices

pNeuton Transport Ventilator model A

- manufactured by Airon Corporation .
- 510(k) number K043085 .

#### BabyPAC 100 Ventilator

- manufactured by Smiths Medical International Ltd. .
- 510(k) number K043495 .

#### Millennium Infant Ventilator

- manufactured by Sechrist Industries Inc. .
- 510(k) number K993167 .

#### Babi Plus Nasal Cannula System

- manufactured by A Plus Medical .
- 510(k) number K110471 .

Airon Corporation 751 North Drive, Unit 6 Melbourne, FL 32934 USA tel [phone] fax [phone]

{1}------------------------------------------------

# 510(k) Summary - K121379 14 September 2012 Page 2 of 8

#### Device Description

The pNeuton mini ventilator is a small, lightweight transport ventilator designed for use on patients from neonate to pediatric in size (400 gram to 25 kg). It is a time cycled, flow limited ventilator providing Continuous Mechanical Ventilation (CMV) or Intermittent Mandatory Ventilation (IMV). In these modes of ventilation, an adjustable inspiratory time, expiratory time and pressure is delivered to the patient. The patient is allowed to breath spontaneously between the mandatory breaths with little added work of breathing. A built-in PEEP / CPAP system can be set to provide expiratory positive pressure. The delivered oxygen is adjustable from 21 to 100 percent.

The pNeuton mini ventilator is a pure pneumatic ventilator. Electrical power is not used. The ventilator operates from oxygen and medical grade air input pressures from 40 to 70 psi. The various control systems that manage the time controls, PEEP / CPAP, and safety systems / pneumatic alarms is powered with pure oxygen to maintain stability and accuracy. There are no electronic controls or software in this device.

The device provides ventilation and CPAP support for the care of individuals who require respiratory assistance. The device is a restricted medical device for use by qualified medical personnel under the direction of a physician. The device may be used in prehospital environments, inter and intra-hospital patient transport, air and ground transport, and all areas of the hospital including the MRI (NOT for use in the presence of flammable anesthetics). The mini ventilator has been specifically designed for ruggedness and ease of use.

The pNeuton mini ventilator uses accessories during normal operation. The primary accessory is a patient tubing circuit to attach the device to the patient. The patient circuit is a single-use disposable device. The patient circuit uses the same major component (expiratory valve) included with the predicate pNeuton Ventilator K043085 with smaller diameter hoses.

#### Intended Use

The pNeuton mini is intended to provide ventilatory support for critically ill patients who require the following general types of ventilatory support:

- Positive pressure ventilation delivered invasively (via an ET Tube) or non-. invasively (via a mask or nasal prongs)
- CMV and IMV mode of ventilation with or without PEEP / CPAP .
- Provide oxygen or a mixture of medical air and oxygen .

#### Patient population:

Neonates, infants, and children, from 400 g to 25 kg in weight

Environments of Use

- · Inter and intra-hospital patient transport
Airon Corporation 751 North Drive, Unit 6 Melbourne, FL 32934 USA tel [phone] fax [phone]

{2}------------------------------------------------

### 510(k) Summary - K121379 14 September 2012 Page 3 of 7

- Air & ground transport Pressurized and non-pressurized aircraft (to . 15.000 ft)
- Intensive care units (short term use only associated with patient . transport)
- Emergency Departments .
- Radiology suites including MRI (MR Conditional 3T) .
- Operating rooms (short term use only associated with patient transport) ●

### Substantial Equivalence

The pNeuton mini ventilator shares substantial equivalency with the pNeuton model A Ventilator, the BabyPAC 100 Ventilator and the Millennium Infant Ventilator across the spectrum of patient population for which each was designed.

The pNeuton mini ventilator utilizes many similar components as found in the pNeuton model A Ventilator including an identical timing and pressure control system with patient / gas supply alarms. Due to the requirements of neonatal ventilation a precision air / oxygen blender is used instead of the air entrainment based oxygen mixing of the model A ventilator.

The pNeuton mini ventilator shares common modalities with the BabyPAC 100 Ventilator and the Millennium Infant Ventilator with significant overlap in the clinical range of function for their target population. The essential clinical function of each device is significantly similar and mimics each other in the typical frame of use by the health care providers. All are pneumatic based and applicable for the same areas of use.

| Characteristic | pNeuton mini<br>Ventilator | pNeuton A<br>Ventilator | BabyPAC<br>Ventilator | Millennium<br>Ventilator |
|------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------|
| 510(k) number<br>Intended Use –<br>application | Provide continuous or<br>intermittent<br>mechanical<br>ventilation and / or<br>CPAP for neonate to<br>child patients (400 g<br>to 25 kg) via mask,<br>nasal prongs or<br>endo-tracheal tube | K043085<br>Provide continuous or<br>intermittent mechanical<br>ventilation and / or<br>CPAP for pediatric to<br>adult patients via mask<br>or endo-tracheal tube | K043495<br>Provide continuous<br>or intermittent<br>mechanical<br>ventilation and / or<br>CPAP for neonate<br>to child patients up<br>to 20 kg | K993167<br>Provide continuous<br>or intermittent<br>mechanical<br>ventilation and / or<br>CPAP for neonate to<br>pediatric patients up<br>to 50 kg |
| Environments of use | Hospital, pre-hospital<br>and transport<br>environments | Hospital, pre-hospital,<br>transport and sub-<br>acute/alternate site<br>facility environments | Ambulance,<br>hospital,<br>emergency and<br>transport<br>environments | Hospital environment |
| Operation<br>environmental<br>requirements | -15 to 49 °C (5 to 120<br>°F), 15 to 95 percent<br>humidity | -5 to 40 °C (23 to 104<br>°F), 15 to 95 percent<br>humidity | -10 to 40°C (14 to<br>104 °F) | -10 to 40°C (14 to<br>104 °F), 15 to 95 percent<br>humidity |

Airon Corporation 751 North Drive, Unit 6 Melbourne, FL 32934 USA tel [phone] fax [phone]

{3}------------------------------------------------

# 510(k) Summary – K121379 14 September 2012 Page 4 of 8

| Personnel<br>Requirements | Training as physician,<br>nurse, respiratory<br>therapist | Training as physician,<br>nurse, respiratory<br>therapist, EMT | Training as<br>qualified medical<br>caregiver,<br>paramedics and<br>other trained<br>personnel | Training as<br>physician, nurse,<br>respiratory therapist |
|----------------------------------------|-----------------------------------------------------------------------------|--------------------------------------------------------------------------|------------------------------------------------------------------------------------------------|-----------------------------------------------------------|
| Operating principle | Pneumatic driven and<br>controlled with<br>pneumatic alarms | Pneumatic driven and<br>controlled with<br>pneumatic alarms | Pneumatic driven<br>and controlled with<br>electronic alarms | Pneumatic driven<br>and electronically<br>controlled |
| Gas Input(s) | 40 to 70 psi | 40 to 70 psi | 40 to 87 psi | 40 to 60 psi |
| Patient circuit | Tubing with external<br>expiratory valve and<br>proximal pressure<br>line | Tubing with external<br>expiratory valve | Tubing with<br>external attached<br>expiratory valve | Tubing with external<br>attached expiratory<br>valve |
| Enclosure | Rugged, lightweight | Rugged, lightweight | Rugged, lightweight | Single enclosure on<br>stand for hospital use |
| Displays | Manometer | Manometer | Manometer | Electronic screen |
| Safety features | Internal high pressure<br>release, spontaneous<br>breathing safety<br>valve | Internal high pressure<br>release, spontaneous<br>breathing safety valve | None | Internal high<br>pressure release |
| MRI compatibility | MRI Conditional 3T | MRI Conditional 3T | MRI Conditional 3T | None |
| Patient support<br>modes | CMV, IMV, CPAP | CMV, IMV, CPAP | CMV, IMV, CPAP | Assist / Control,<br>SIMV / IMV, CPAP |
| Maximum working<br>pressure limitation | 80 cm H2O | 80 cm H2O | 80 cm H2O | 70 cm H2O |
| Maximum inspiratory | 20 L/min | Mandatory - 36 L/min | 10 L/min | 40 L/min |

| Maximum working<br>pressure limitation | 80 cm H2O | 80 cm H2O | 80 cm H2O | 70 cm H2O |
|-----------------------------------------------------------|------------------------------|--------------------------------------------------|------------------------------|-----------------|
| Maximum inspiratory<br>flow | 20 L/min | Mandatory - 36 L/min<br>Spontaneous - 140 L/min | 10 L/min | 40 L/min |
| Inspiratory time<br>Control setting:<br>Accuracy: | 0.25 to 2.0 sec<br>± 10% | label as tidal volume<br>0.6 to 2.0 sec<br>± 10% | 0.25 to 2.0 sec<br>± 0.8 sec | 0.1 to 3.0 sec |
| Expiratory time<br>Control setting:<br>Accuracy: | 0.25 to 20.0 sec<br>± 10% | label as resp rate<br>0.6 to 20.0 sec<br>± 10% | 0.25 to 40 sec<br>± 0.8 sec | 0.3 to 30.0 sec |
| Peak patient<br>pressure<br>Control setting:<br>Accuracy: | 15 – 60 cm H2O<br>± 2 cm H2O | 15 – 75 cm H2O<br>± 10% | 10 – 70 cm H2O<br>± 15% | 5 – 70 cm H2O |

・

な

{4}------------------------------------------------

# 510(k) Summary – K121379 14 September 2012 Page 5 of 8

| Flow Rate | | | | |
|-----------------------------|------------------------------------------------|-----------------------------------------|-------------------------------------------------------|--------------------------------------------------------------------------------------------------|
| Control setting: | 6, 8, 10, 15, 20 L/min<br>± 10% | Non adjustable @ 36 | Non adjustable @ 10 | 2 to 32 L/min |
| CPAP | | | | |
| Control setting: | 0 - 20 cm H2O<br>± 2 cm H2O | 0 - 20 cm H2O<br>± 5% | 0 - 20 cm H2O<br>± 15% | 0 - 20 cm H2O |
| Oxygen | | | | |
| Control setting: | 21 to 100%<br>± 3% | 2 choices, 65 or 100<br>± 10% | 21 to 100%<br>± 8% | 21 to 100% |
| Measurements | | | | |
| Pressure sensor<br>type: | Mechanical gauge<br>Use proximal airway signal | Mechanical gauge<br>Use internal signal | Mechanical gauge<br>Use internal signal | Transducer<br>Proximal airway |
| Volume sensor type: | None | None | None | None |
| Monitored<br>parameters | | | | |
| Parameter / range: | Pressure -10 to 80<br>± 2 cm H2O | Pressure -10 to 80<br>± 2 cm H2O | Pressure -10 to 100<br>± 2 cm H2O | Pressure -10 to 70<br>I:E ratio 4:1 to 1:10<br>Resp rate 0 to 150 |
| Alarms | | | | |
| Parameter / range: | High pressure<br>10 - 70 cm H2O | No adjustable alarms | High pressure<br>12 - 80 cm H2O | High pressure<br>5 - 70 cm H2O<br><br>High rate<br>2 to 150 |
| Default setting: | 30 cm H2O | N/A | | |
| Non-adjustable: | Patient disconnect,<br>low gas supply | Patient disconnect, low<br>gas supply | Patient disconnect,<br>low gas supply, low<br>battery | Patient disconnect,<br>low PEEP, apnea,<br>low gas supply, low<br>electrical power, vent<br>inop |
| Battery | | | | |
| Type: | None | None | 3/3.6 volt lithium | None |
| Operating time: | N/A | N/A | 1 year | N/A |
| Materials in gas<br>pathway | Identical to Pneuton<br>ventilator | Cleared in K043085 | | |

The pNeuton mini Ventilator can provide non-invasive and invasive ventilation to the intended patient population. To provide invasive ventilation the Airon patient breathing circuit includes a wye piece with a standard 15 mm ID fitting for connection to an endotracheal tube. To provide non-invasive ventilation (NIV), accessory kits are used to

> Airon Corporation 751 North Drive, Unit 6 Melbourne, FL 32934 USA tel [phone] fax [phone]

{5}------------------------------------------------

## 510(k) Summary - K121379 14 September 2012 Page 6 of 8

replace the wye piece with appropriate tubing and patient interfaces (nasal prongs or mask).

Two NIV kits are available for use with the Airon patient breathing circuit. One NIV kit is called the NIC CK CPAP Kit. This is the same device as the Babi Plus Infant Nasal Cannula System cleared under K110471 by A Plus Medical.

The other NIV kit is called the NIC FM CPAP Kit. The NIC FM CPAP Kit is substantially equivalent in the indications for use, environment of use, patient population, material and function to the A Plus Medical Nasal Cannula Kit (K110471). The NIC FM CPAP Kit includes both nasal pronos and nasal masks while the A Plus Medical Nasal Cannula Kit only has nasal prongs. The addition of the nasal mask, which is Class 1 exempt under 21 CFR 868.5580 and Product Classification BYG – Oxygen mask, allows for the patient interface pressure points to be switched from inside of the nares (prongs) to outside (mask). . The essential clinical function of each device is significantly similar and mimics each other in the typical frame of use by the health care providers

| Characteristic | NIC FM CPAP Kit | Babi Plus Nasal<br>Cannula System |
|----------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 510(k) number | | K110471 |
| Intended Use -<br>application | Single patient use device<br>intended for use with neonates,<br>infants and children under 10 Kg<br>requiring a non-invasive nasal<br>interface during intermittent or<br>continuous gas flow therapy | Single patient use device<br>intended for use with neonates,<br>infants and children under 10 Kg<br>requiring a nasal prong interface<br>during intermittent or continuous<br>gas flow therapy |
| Environments of use | Hospital critical care unit | Hospital critical care unit |
| Connection to Airon<br>patient circuit | 10 mm male connectors in kit fit<br>10 mm female connectors in<br>patient circuit. Length of tubing<br>to patient interface is 10 mm. | 10 mm male connectors in kit fit<br>10 mm female connectors in<br>patient circuit. Length of tubing<br>to patient interface is 10 mm. |
| Patient interfaces | 6 sizes of nasal prongs and 4<br>sizes of nasal mask | 8 sizes of nasal prongs |
| Inspiratory flow<br>resistance | 1.0 to 1.7 cm H2O | 1.1 to 1.3 cm H2O |
| Expiratory flow<br>resistance | 1.2 to 1.4 cm H2O | 1.2 to 1.4 cm H2O |
| Materials in gas<br>pathway | Silicone, K-resin, Polypropylene | Silicone, K-resin, Ethyl Vinyl<br>Acetate (EVA) tubing, Polyvinyl<br>chloride (DEHP, DAP free) |

Airon Corporation 751 North Drive, Unit 6 Melbourne, FL 32934 USA tel [phone] fax [phone]

{6}------------------------------------------------

# 510(k) Summary - K121379 14 September 2012 Page 7 of 8

### Summary of Non-Clinical Testing and Validation

The performance of the pNeuton mini ventilator has been comprehensively tested. All functions as listed in the specifications have been validated. The device meets all test requirements as identified in the FDA Draft Reviewer Guidance for Ventilators (April, 1995).

The pNeuton mini ventilator complies with the following voluntary standards:

- ASTM: F1100 90 Ventilators Intended for Use in Critical Care .
- ISO: 10651-3: 1997 Lung Ventilators for Medical Use- Particular requirements . for emergency and transport ventilators
- RTCA DO-160G Environmental Conditions and Test Procedures for Airborne . Equipment, as applicable
- MIL-STD-810F Environmental Engineering Considerations and Laboratory . · Tests, as applicable
- CGA V-5:2008 Diameter-Index Safety System (Noninterchangeable Low ● Pressure Connections for Medical Gas Applications)
- ASTM F2052 06e1 Standard Test Method for Measurement of Magnetically . Induced Displacement Force on Medical Devices in the Magnetic Resonance Environment
- ASTM F2119 07 Standard Test Method for Evaluation of MR Image Artifacts . from Passive Implants

Specific non-clinical tests included:

- Specification verification and waveform tests. Following the requirements of . ASTM F1100 90, all operational functions were tested to meet required specifications. This included operation at the extremes of input gas pressures as specified. Waveform tests using Pressure / Time, Flow / Time and Volume / Time graphics showed that the accuracy and precision of breath delivery meets or exceeds specifications during four different clinical simulated conditions.
- Reliability and endurance tests. Tests were performed to demonstrate reliability . of performance during the entire device lifetime, under conditions comparable to the clinical environment as specified. Following the requirements of ASTM F1100 90. the device operated continuously for 2,200 hours at two different clinical simulated conditions. In addition, reliability tests were performed for an additional 240 hours at the extremes of environmental conditions which may be encountered during clinical use of this transport ventilator. Following these tests operation was verified using specification verification and waveform tests as described above.
- Environmental and mechanical safety. The device was tested and passed the . environmental / mechanical safety tests identified in the following standards:
- RTCA DO-160G, section 4, Altitude and Overpressure tests using Category o A2

Airon Corporation 751 North Drive, Unit 6 Melbourne, FL 32934 USA tel [phone] fax [phone]

{7}------------------------------------------------

## 510(k) Summary - K121379 14 September 2012 Page 8 of 8

- RTCA DO-160G, section 4 & 5, Temperature Variation tests of Procedure o 5.3.1 using Category A4
- RTCA DO-160G, section 6, Humidity tests using Category A o
- RTCA DO-160G, section 8, Robust Vibrations Tests for Category R o
- RTCA DO-160G, section 10, Spray Proof Test using Procedure 10.3.3 O
- ISO 10651-3: 1997, section 21.6c}, Bump test in accordance with IEC 68-2-O 29, test Eb
- MIL-STD-810F, section 500.4, Procedure III, Rapid decompression o
- MIL-STD-810F, section 514.5, Procedure I, Jet Aircraft Random Vibration O Test
- Testing for MRI environments. All tests were performed according to ASTM . F2052 - 06e1 and ASTM F2119 - 07 using a 3 Tesla scanner. There was no induced displacement force, performance variance or artifact generated in the scans. The pNeuton mini ventilator is not intended for implant so the assessment of magnetic field interactions for this product specifically involved evaluations of translational attraction and function in relation to exposure to a 3 Tesla MR system only.

Clinical testing was not performed on this device. Safety and efficacy were established through non-clinical testing and risk analysis. The pNeuton mini ventilator performs as intended according to its performance specification and is substantially equivalent to the predicate devices.

> Airon Corporation 751 North Drive, Unit 6 Melbourne, FL 32934 USA tel [phone] fax [phone]

{8}------------------------------------------------

# DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/8/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized depiction of an eagle or bird-like figure with three curved lines representing its wings or body. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged in a circular fashion around the emblem.

#### Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002

OCT 1 1 2012

Airon Corporation
G. Eric Gjerde
President & CEO
751 North Drive, Unit 6
Melborne, Fl 32934

Re: K121379

Trade/Device Name: pNeuton mini Ventilator Regulation Number: 21 CFR 868.5895 Regulation Name: Continuous Ventilator Regulatory Class: II Product Code: CBK Dated: September 17, 2012 Received: September 18, 2012

Dear Mr. Gjerde :

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. 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

{9}------------------------------------------------

Page 2 - Mr. Gjerde

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 [phone] or [phone] or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

Nh for

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

{10}------------------------------------------------

## Indications For Use

510(k) Number: K121379

Device Name: pNeuton mini Ventilator

Indications For Use: The pNeuton mini is intended to provide ventilatory support for critically ill patients who require the following general types of ventilatory support:

- Positive pressure ventilation delivered invasively (via an ET Tube) or non-. invasively (via a mask or nasal prongs)
- CMV and IMV mode of ventilation with or without PEEP / CPAP .
- Provide oxygen or a mixture of medical air and oxygen .

Patient population:

Neonates, infants, and children, from 400 g to.25 kg in weight

Environments of Use

- Inter and intra-hospital patient transport .
- Air & ground transport Pressurized and non-pressurized aircraft (to 15,000 ft) .
- Intensive care units (short term use only associated with patient transport)
- Emergency Departments
- Radiology suites including MRI (MR Conditional 3T)
- Operating rooms (short term use only associated with patient transport)

Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use (Part 21 CFR 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Z. Schullk

(Division Sign-Off) Division of Anesthesiology, General Hospital Infection Control, Dental Devices

510(k) Number: icl 21379