SAVE II, SAVE II BASIC

K131877 · Automedx, Inc. · BTL · Mar 21, 2014 · Anesthesiology

Device Facts

• Record ID: K131877
• Device Name: SAVE II, SAVE II BASIC
• Applicant: Automedx, Inc.
• Product Code: BTL · Anesthesiology
• Decision Date: Mar 21, 2014
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 868.5925
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The SAVe II™ series are intended to provide short-term ventilatory support to adults during CPR or when Positive-Pressure Ventilation (PPV) is required to manage Acute Respiratory Failure (ARF). The SAVe II™ series are appropriate for adults that weigh at least 45 kg. It is intended to be used in pre-hospital, field hospitals, and transport environments.

Device Story

The SAVe II™ and SAVe II™ Basic are portable, battery-powered emergency ventilators designed for use by first responders in pre-hospital, field hospital, and transport settings. The device uses an internal compressor to deliver volume-targeted, time-cycled, pressure-limited breaths using ambient air or supplemental oxygen. It features an active breathing valve and connects to patients via face mask, supraglottic airway, endotracheal tube, or tracheostomy tube. The device is software-controlled, with settings based on patient height (SAVe II™ allows user adjustment; SAVe II™ Basic has fixed parameters). It monitors airway pressure and provides visual alarms for circuit disconnect, over-pressure, low battery, and high temperature. The device aims to augment manual BVM ventilation, providing automated, controlled positive pressure to improve patient outcomes in emergency scenarios where compressed oxygen may be unavailable.

Clinical Evidence

Bench testing only. Performance testing confirmed the device meets specifications, including durability (2,000 hours), EMC, EMI, electrical safety, and atmospheric pressure testing (simulated 10,000 ft altitude). No clinical data was required or presented.

Technological Characteristics

Battery-powered compressor; volume-targeted, time-cycled, pressure-limited ventilation; membrane panel interface with LEDs and 7-segment displays; lithium-ion battery; standard ventilator circuit; software-controlled; sterilization not specified; materials tested per ISO 10993.

Indications for Use

Indicated for short-term ventilatory support in adults weighing at least 45 kg during CPR or for management of Acute Respiratory Failure (ARF). Contraindicated for patients <45 kg, situations where PPV is contraindicated, or if spontaneous breathing patients cannot synchronize with the device.

Regulatory Classification

Identification

A powered emergency ventilator is a demand valve or inhalator intended to provide emergency respiratory support by means of a face mask or a tube inserted into a patient's airway.

Predicate Devices

• Impact Instruments - Uni-Vent Model 754 (K931473)
• AutoMedx - SAVe™ (K071221)

Submission Summary (Full Text)

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

MAR 2 1 2014

K. 131 8 77

### AutoMedx SAVe II™

510(k) Summary

| 510(k) Summary |
|----------------|
| Page 1 of 12 |

| Date Prepared: | 18-Mar-14 |
|---------------------------------------------------------------------------------|-----------------------------------------------------------------------------------|
| AutoMedx, Inc.<br>1420 Lakeside Parkway, Suite 102<br>Flower Mound, Texas 75028 | Tel - 972-586-7500<br>Fax - 972-408-4177 |
| Official Contact: | James Evans - President |
| Proprietary or Trade Name: | SA Ve IITM<br>SA Ve IITM Basic |
| Common/Usual Name: | Powered emergency ventilator |
| Classification Name: | Powered emergency ventilator<br>Procode -- BTL<br>CFR - 868.5925<br>Class 2 |
| Predicate Devices: | Impact Instruments - Uni-Vent Model 754 - K931473<br>AutoMedx - SA VeTM - K071221 |

### Device Description:

The SAVe II™ and SAVe II™ Basic ventilators are battery powered compressors to deliver automated, controlled positive pressure breaths with ambient air for up to 10 hours. It is designed to augment the capabilities of first responders by supplementing Bag Valve Mask (BVM) manual ventilation delivery with an automated solution that can be rapidly deployed by minimally skilled providers in environments where compressed oxygen is unavailable or ill-advised.

To support use in emergency situations, the SA Ve II™ is portable and easy to carry. Rapid initial setup is enabled by default ventilator settings based on adult patient's height, ranging from 4'6'' to 6'6" weighing at least 45 kg, organized in a circular-shaped graphic. To mitigate the risk of patient injury, airway pressure is monitored and users are alerted to potentially dangerous low and high pressure situations. Immediate patient injury due to high pressure is avoided by a pressure cut-off that triggers an exhalation if inspiratory pressure exceeds device settings. Rapid troubleshooting is enabled by visual alarm indicators located together at the bottom of the unit that identifies the most likely cause of the triggered alarm.

- . SAVE IITM
- This is a full feature unit and the predicate is the Impact Uni-Vent Model 754 o (K931473)
- o Note the some references have been made to Enhanced SAVe, which is the identical to the SAVe II™
- SAVe II™ Basic .

റ

- This is similar to the SAVe II™ but has fewer options and features. o
- The predicate is the legacy product AutoMedx SAVe (K071221) o

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### 510(k) Summary Page 2 of 12 18-Mar-14

### Indications for Use:

The SAVe II™ series are intended to provide short-term ventilatory support to adults during CPR or when Positive-Pressure Ventilation (PPV) is required to manage Acute Respiratory Failure (ARF). The SAVe IITM series are appropriate for adults that weigh at least 45 kg. It is intended to be used in pre-hospital, field hospitals, and transport environments.

### Contraindications:

| Contraindication | SAVe II™ | SAVe II™ Basic |
|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------|----------------|
| Should not be used on patients weighing less than 45<br>kilograms | Yes | Yes |
| | | |
| Should not be used in situations where Positive Pressure<br>Ventilation (PPV) is contraindicated. | Yes | Yes |
| | | |
| Do not use the device for extended periods without<br>monitoring blood gases. As duration of use increases, the<br>need for close monitoring of CO2 and O2 levels also<br>increases. This is especially true for patients over 6' 9". | Yes | Yes |
| | | |
| | | |
| | | |
| Spontaneously breathing patients may not synchronize with<br>ventilator. If spontaneously breathing patient has difficulty<br>synchronizing with the device, consider discontinuing use. | Yes | Yes |
| | | |
| | | |
| Do not set PEEP above zero (0) when performing CPR. | Yes | N/A* |

*The SA Ve II™ Basic does not have an adjustable PEEP setting, thus is not applicable.

### Technological Characteristics:

The principle of operation for both models is that they use a battery-powered compressor to deliver air to a patient for up to 10 hours on a single charge.

The device is software controlled to deliver ventilation to the patient based upon pre-set parameters, which are based upon height of the adult patient and for the SAVe II™ model may be adjusted by the user.

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### 510(k) Summary Page 3 of 12 18-Mar-14

We use a standard ventilator circuit to connect the SAVe II™ to the patient with the patient connection being face mask, supralaryngeal airway (laryngeal tube), endotracheal tube or tracheostomy tube.

### Table 1 - Comparison of the 2 - SAVe II™ Models

| | SAVE II™ | SAVE II™ Basic |
|----------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Indications for Use | The SAVE II™ series are intended to<br>provide short-term ventilatory support<br>to adults during CPR or when Positive-<br>Pressure Ventilation (PPV) is required<br>to manage Acute Respiratory Failure<br>(ARF). The SAVE II™ series are<br>appropriate for adults that weigh at<br>least 45 kg. It is intended to be used in<br>pre-hospital, field hospitals, and<br>transport environments. | The SAVE II™ series are intended to<br>provide short-term ventilatory support<br>to adults during CPR or when<br>Positive-Pressure Ventilation (PPV) is<br>required to manage Acute Respiratory<br>Failure (ARF). The SAVE II™ series<br>are appropriate for adults that weigh at<br>least 45 kg. It is intended to be used in<br>pre-hospital, field hospitals, and<br>transport environments. |
| User Population | Qualified and trained users | Qualified and trained users |
| Patient Population | Adults Patients weighing >45 kg | Adult Patients weighing >45 kg |
| Environment of Use | pre-hospital<br>field hospitals<br>transport | pre-hospital<br>field hospitals<br>transport |
| Breath Types / Ventilation Modes | | |
| Breath Type | Volume-targeted<br>Time-cycled<br>Pressure limited | Volume-targeted<br>Time-cycled<br>Pressure limited |
| Main Ventilation Mode | Assist Control | Assist Control |
| Basic and Advanced User Modes | Yes | No |
| Manual Triggered Breath | Yes | Yes |
| CPR Mode | Yes | No |
| Air Source | Ambient / Oxygen | Ambient / Oxygen |
| Settings | | |
| TV [mL/breath] | 200 – 800 increments of 50 | 300 – 700 increments of 100 |
| RR [br/min] | 8 – 20 | 10 fixed |
| Inspiratory Flow [L/min] | Up to 27 | Up to 27 |
| I:E Ratio | Fixed at 1:3 or 1:2 | Fixed at 1:3 or 1:2 |
| PIP Limit [cmH2O] | 10 – 60 | 30 fixed |
| PEEP [cmH2O] | Internal: 0 – 10 | 0 fixed |
| Supplemental Oxygen (FIO2) | 21 – 100% | 21 – 100% |

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### 510(k) Summary Page 4 of 12 18-Mar-14

| | SAVe IITM | SAVe II™ Basic |
|------------------------------------|-----------------------------------|-----------------------------------|
| Alarms/Indicators | | |
| Start-up Self-Test | Yes | Yes |
| Circuit Disconnect | Yes | Yes |
| Over Pressure / Blockage | Yes | Yes |
| External Power Indicator | Yes | Y cs |
| Low Battery | Yes | Yes |
| Detect Spontaneous Breath | Yes | Yes |
| Device Temperature Too High | Yes | Yes |
| Excessive PEEP ("Breath Stacking") | Yes | Yes |
| I:E Ratio Exceeded | Yes | No |
| Physical Characteristics | | |
| Weight [Ibs] | 2.6 | 2.6 |
| Size | 6.5" x 6.25" x 2.0" (81 in3) | 6.5" x 6.25" x 2.0" (81 in3) |
| Display/User Interface | Membrane Panel, LEDs, and 7- | Membrane Panel, LEDs, and 7- |
| | Segment Displays, | Segment Displays |
| | Increment/Decrement Buttons | |
| Interfaces With | | |
| Patient Breathing Circuit | Active Breathing Valve | Active Breathing Valve |
| Oxygen | Low flow sources | Low flow sources |
| | O2 flow meters | O2 flow meters |
| | O2 concentrators | O2 concentrators |
| EtCO2 Detector | Yes (External) | Yes (External) |
| Power | | |
| Battery | Rechargeable, Lithium Ion | Rechargeable, Lithium Ion |
| Duration per charge | 10 hrs @TV=600,RR=10,PEEP=5 | 10 hrs @TV=600,RR=10,PEEP=0 |
| External Power Supply | Input: 100 - 240 VAC / 50 - 60 Hz | Input: 100 - 240 VAC / 50 - 60 Hz |
| | Output: 16.8 VDC | Output: 16.8 VDC |

### Substantial Equivalence Discussion - SAVe IITM

Table 2 compares the SAVe II™ vs. the predicate Impact Model 754 (K931473). One will note that the predicate has more features than the proposed SA Ve II™ and thus one could consider it a subset of the predicate.

It should be noted that our legacy SAVe™ ventilator (K071221) has many of the equivalent function and features of the SAVe IJ™. The legacy SAVe™ used the Impact Model 754 (K931473) as its predicate when it was reviewed and found substantially equivalent.

In addition, we have included in Table 2 a reference predicate, the SA Ve™ ventilator (K071221).

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utoMedx SAVe II™

510(k) Summary

## 510(k) Summary

# omparison of Proposed SAVe II™ and Predicate Impact Model 754 (K931473) and Reference – SAVe™ (K071222 Table 2 –

| Features | SAVe IITM | Impact Uni-Vent Model 754<br>K931473) | AutoMedx<br>SAVe™-K071221 |
|--------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Overview | Robust functionality in small form factor, completely self-contained, meant to be used by minimally trained providers. | Robust functionality in large form factor, completely self-contained, meant to be used by trained providers. | Robust functionality in small form factor, completely self-contained, meant to be used by minimally trained providers. |
| Indications for Use | The SAVe IITM series are intended to provide short-term ventilatory support to adults during CPR or when Positive-Pressure Ventilation (PPV) is required to manage Acute Respiratory Failure (ARF). The SAVe IITM series are appropriate for adults that weigh at least 45 kg. It is intended to be used in pre-hospital, field hospitals, and transport environments. | Intended to provide ventilatory support to individuals during CPR or when Positive-Pressure Ventilation (PPV) is required to manage Acute Respiratory Failure (ARF). | Intended to provide short-term ventilatory support to individuals during CPR or when Positive-Pressure Ventilation (PPV) is required to manage Acute Respiratory Failure (ARF). |
| Users Population | Qualified and trained users | Qualified and trained users | Qualified and trained users |
| Patient Population | Adult Patients weighing >45 kg | Adult, Pediatric, Infants | Patients weighing >45 kg |
| Target Environment | pre-hospital<br>field hospitals<br>transport | pre-hospital<br>field hospitals<br>transport | pre-hospital<br>field hospitals<br>transport |
| Breath Types / Ventilation Modes | | | |
| Breath Type | Volume-targeted<br>Time-cycled<br>Pressure limited | Volume-targeted<br>Time-cycled<br>Pressure limited | Volume-targeted<br>Time-cycled<br>Pressure limited |
| Main Ventilation Mode | Assist Control | Assist Control | Assist Control |
| Basic and Advanced User Modes | Yes | Yes | No |
| Manual Triggered Breath | Yes | Yes | No |
| CPR Mode | Yes | Yes | No |
| Features | SAVE IITM | Impact Uni-Vent Model 754<br>K931473) | AutoMedx<br>SAVe™- K071221 |
| Air Source | Ambient / Oxygen | Ambient / Oxygen | Ambient / Oxygen |
| Settings | | | |
| TV [mL/breath] | 200 - 800 increments of 50 | 0 - 3000 | 600 (fixed) |
| RR [br/min] | 8 - 20 | 1 to 150 | 10 (fixed) |
| Inspiratory Flow [L/min] | Up to 27 | Up to 60 | Up to 17 |
| I:E Ratio | Fixed at 1:3 or 1:2 | 1:1 to 1:599 | Fixed at 1:2 |
| PIP Limit [cmH2O] | 10 - 60 | 15 - 100 | 38 |
| PEEP [cmH20] | Internal: 0 - 10 | 0 - 20 | 0 |
| Supplemental Oxygen (FIO2) | 21 - 100% | 21 - 100% | 21 - 60% |
| Alarms/Indicators | | | |
| Startup Self-Test | Yes | Yes | Yes |
| Circuit Disconnect | Yes | Yes | Yes |
| Over Pressure / Blockage | Yes | Yes | Yes |
| External Power Indicator | Yes | Yes | Yes |
| Low Battery | Yes | Yes | Yes |
| Detect Spontaneous Breath | Yes | Yes | Yes |
| Device Temperature Too High | Yes | No | Yes |
| Excessive PEEP ("Breath Stacking") | Yes | Yes | Yes |
| I:E Ratio Exceeded | Yes | Yes | No |
| Technological and Physical Characteristics | | | |
| Source for ventilation | Internal, battery operated compressor | Internal, battery operated compressor | Internal, battery operated compressor |
| Weight [lbs] | 2.6 | 13.0 | 3.1 |
| Display/User Interface | Membrane Panel, LEDs, and 7-Segment Displays, Increment/Decrement Buttons | Rotary Switches, LEDs, Graphic Display | Rotary Switch, LEDs |
| Interfaces With | | | |
| Patient Breathing Circuit | Active Breathing Valve | Active Breathing Valve | Passive Breathing Valve |
| Oxygen | Low flow sources, O2 flow meters, and O2 concentrators | Low & High flow sources, O2 flow meters, and O2 concentrators | Low flow source, O2 flow meter, and O2 concentrator (up to 10 L/min) |
| EtCO2 Detector | Yes (External) | Yes (External) | Yes (External) |
| Features | SAVE IITM | Impact Uni-Vent Model 754<br>(K931473) | AutoMedx<br>SAVETM-K071221 |
| Power | | | |
| Battery | Rechargeable, Lithium Ion | Rechargeable, SLA | Rechargeable, SLA |
| Duration per charge | 10 hrs @TV=600,RR=10,PEEP=5 | 3 hrs using internal pump<br>12 hours using external gas | 5.5 hrs @TV=600,RR=10,PEEP=0 |
| External Power Supply | Input: 100 – 240 VAC / 50 – 60 Hz<br>Output: 16.8 VDC | Input: 90 – 265 VAC / 47 – 400 Hz<br>Output: 12 VDC | Input: 100 – 240 VAC / 47 – 63 Hz<br>Output: 15 VDC |

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AutoMedx SAVe II™

### 510(k) Summary

## 510(k) Summary

:

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

## itoMedx SAVe III

510(k) Summa

## 0(k) Summar
Page 7 of 12
18-Mar-14

## cussion of Substantial Equivalence and Any Differen

he SA Ve II™ is viewed as substantially equivalent to the predicate, Impact Model 754 (K931473) device

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�

### 510(k) Summary Page 8 of 12 18-Mar-14

### Patient Population -

The SAVe IITM is intended for adult patients greater than 45 kg.

Discussion - The predicate Impact Model 754 (K931473) is used for pediatrics to adult and the reference predicate AutoMedx SAVe™ (K071221) for patients greater than 45 kg, the proposed SAVe II™ is within the patient population of the predicates and thus can be considered substantially equivalent.

### Technology -

### Principle of Operation -

The Save II™ is a battery powered ventilator with an internal compressor which generates the positive pressure to be delivered. It primary gas source is ambient air but supplemental oxygen may be used. It is has integrated software and electronics which control the functions and alarms. The user interface is a membrane panel with LEDs. The patient interface is a standard ventilator circuit that can connect to the patient via a face mask, supraglottic airway, endotracheal tube, or tracheostomy tube.

Discussion - The SAVe II™ and the predicate Impact Model 754 (K931473) as well as the reference predicate AutoMedx SAVe™ (K071221) have the identical operating and technological characteristics and modes of operation. The User Interface of the SAVe II™ is a membrane panel vs. rotary switches for the predicate, which is easier to use and does not pose any new safety concerns.

### Alarms -

The SAVe II™ has full complement of alarms expected for a ventilator. These include – circuit disconnect, over pressure / blockage, external power indicator, low battery, detect spontaneous breathing Excessive PEEP, I:E Ratio limits, device temperature too high.

Discussion - The SAVe II™ and the predicate have the same set of alarms, except the SAVe II™ has a device high temperature alarm which for the proposed environment of use is a safety feature.

### Materials -

The materials in the gas pathway are identical to the reference predicates, AutoMedx SAVe™ and Impact Model 754, and / or have been tested per VOC and PM3 s.

G95-1 and ISO 10993 would suggest the level of patient contact as:

- External Communicating (indirect gas pathway) .
- Tissue contact ●
- . Limited duration (< 24 hours)

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### 510(k) Summary Page 9 of 12 18-Mar-14

### Non-clinical Testing -

### Bench Testing -

We have performed a complete set of performance testing to the device specifications and confirmed that the device meets it performance requirements. We also performed comparative bench testing to the predicate.

In addition, we performed durability testing up to 2,000 hours, EMC, EMI, electrical safety, mechanical and environmental testing and Atmospheric Pressure Testing at both 10.15 psia (700 hPa) and 15.95 psia (1100 hPa). The latter represents a simulated altitude of 10,000 feet.

Discussion - We performed a full complement of bench tests that demonstrated that the SAVe II™ met its performance requirements and specifications. It can be considered substantially equivalent to the predicates having undergone similar or identical testing as the predicates.

### Substantial Equivalence Conclusion -

The sponsor has demonstrated through performance testing, comparison of design and features, and nonclinical testing that the proposed device and predicate can be found to be substantially equivalent.

### Substantial Equivalence Discussion - SAVe II™ - Basic

Table 3 compares the SAVe II™ Basic vs. the predicate AutoMedx SAVe™ (K071221).

Much of the testing that is presented in this submission has been performed on the SAVe [[™ which has more functions and features than the SA Ve II™ Basic: but the entire unit is identical. The only differences, as outlined in Table 1 above, are that some features / functions are removed in the Basic model, making it closer in function to our predicate SAVeTM (K071211).

### Discussion of Substantial Equivalence and Any Differences

The SAVe II™ Basic is viewed as substantially equivalent to the predicate AutoMedx SAVe™ (K071221) device because:

### Indications -

The proposed indications for use which are to provide short-term ventilatory support to adults during CPR or when Positive-Pressure Ventilation (PPV) is required to manage Acute Respiratory Failure (ARF) is identical to the predicate AutoMedx SAVe™ (K071221).

Discussion - The SAVe II™ Basic is identical to the predicate AutoMedx SAVe™ (K071221).

### Environment of Use -

The proposed environments of use as a transport ventilator that can be used in field hospitals as well as pre-hospital and transport settings is identical to the predicate AutoMedx SA Ve™ (K071221).

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### 510(k) Summary Page 10 of 12 18-Mar-14

Discussion - The environments for use are identical to the predicate AutoMedx SAVe™ (K071221) thus the SAVe II™ basic can be found to be substantially equivalent.

### Patient Population -

The SAVe II™ Basic is intended for adult patients greater than 45 kg. Discussion - The predicate AutoMedx SA Ve™ (K071221) was cleared for patients greater than 45 kg, the proposed SA Ve II™ Basic fits within the predicate Impact Model 754 (K931473) and thus can be considered substantially equivalent.

| | Table 3 - Comparison of Proposed SAVe IITM Basic and Predicate AutoMedx SAVe™ K071221) | |
|--|----------------------------------------------------------------------------------------|--|
|--|----------------------------------------------------------------------------------------|--|

| Features | SAVe II™ Basic | AutoMedx<br>SAVe™ - K071221 |
|-------------------------------|--------------------------------------------|--------------------------------------|
| Indications for Use | The SAVe II™ series are intended to | Intended to provide short-term |
| | provide short-term ventilatory support to | ventilatory support to individuals |
| | adults during CPR or when Positive- | during CPR or when Positive-Pressure |
| | Pressure Ventilation (PPV) is required to | Ventilation (PPV) is required to |
| | manage Acute Respiratory Failure | manage Acute Respiratory Failure |
| | (ARF). The SAVe IITM series are | (ARF). |
| | appropriate for adults that weigh at least | |
| | 45 kg. It is intended to be used in pre- | |
| | hospital. field hospitals, and transport | |
| | environments. | |
| Users Population | Qualified and trained users | Qualified and trained users |
| Patient Population | Adult patients weighing >45 kg | Patients weighing >45 kg |
| Target Environment | pre-hospital | pre-hospital |
| | field hospitals | field hospitals |
| | hospital transport | transport |
| Breath Type | Volume-targeted | Volume-targeted |
| | Time-cycled | Time-cycled |
| | Pressure limited | Pressure limited |
| Main Ventilation Mode | Assist Control | Assist Control |
| Basic and Advanced User Modes | No | No |
| Manual Triggered Breath | No | No |
| CPR Mode | No | No |
| Air Source | Ambient / Oxygen | Ambient / Oxygen |
| TV mL/breath | 300 - 700 increments of 100 | 600 (fixed) |
| RR br/min | 10 fixed | 10 (fixed) |
| Inspiratory Flow L/min] | Up to 27 | Up to 17 |
| I:E Ratio | Fixed at 1:3 or 1:2 | Fixed at 1:2 |
| PIP Limit [cmH2O] | 30 fixed | 38 |
| PEEP cmH2O | 0 fixed | 0 |
| Supplemental Oxygen (FIO2) | 21 - 100% | 21 - 60% |
| Startup Self-Test | Yes | Yes |
| Circuit Disconnect | Yes | Yes |
| Over Pressure / Blockage | Yes | Yes |
| External Power Indicator | Yes | Yes |
| Low Battery | Yes | Yes |
| Detect Spontaneous Breath | Yes | Yes |

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### 510(k) Summary Page 11 of 12 18-Mar-14

| Features | SAVe II™ Basic | AutoMedx<br>SAVe™ - K071221 |
|------------------------------------|-----------------------------------------------------------|-------------------------------------------------------------------------|
| Device Temperature Too High | Yes | Yes |
| Excessive PEEP ("Breath Stacking") | Yes | Yes |
| I:E Ratio Exceeded | No | No |
| Source for ventilation | Internal, battery operated compressor | Internal, battery operated compressor |
| Weight [Ibs] | 2.6 | 3.1 |
| Display/User Interface | Membrane Panel, LEDs, and 7-<br>Segment Displays | Rotary Switch, LEDs |
| Patient Breathing Circuit | Active Breathing Valve | Passive Breathing Valve |
| Oxygen | Low flow sources, O2 flow meters, and<br>O2 concentrators | Low flow source, O2 flow meter, and<br>O2 concentrator (up to 10 L/min) |
| EtCO2 Detector | Yes (External) | Yes (External) |
| Battery | Rechargeable, Lithium Ion | Rechargeable, Lithium Ion |
| Duration per charge | 10 hrs @TV=600,RR=10,PEEP=0 | 5.5 hrs @TV=600,RR=10,PEEP=0 |
| External Power Supply | Input: 100 - 240 VAC / 50 - 60 Hz<br>Output: 16.8 VDC | Input: 100 - 240 VAC / 47 - 63 Hz<br>Output: 15 VDC |

### Technology -

### Principle of Operation -

The Save II™ Basic is a battery powered ventilator with an internal compressor which generates the positive pressure to be delivered. It primary gas source is ambient air but supplemental oxygen may be used. It is has integrated software and electronics which control the functions and alarms. The user interface is a membrane panel with LEDs. The patient interface is a standard ventilator circuit that can connect to the patient via a face mask, supraglottic airway, endotracheal tube, or tracheostomy tube. Discussion - The SAVe II™ Basic and the predicate AutoMedx SAVe™ (K071221) have the identical operating and technological characteristics and modes of operation. The User Interface of the SA Ve II™ Basic is a membrane panel which is identical to the predicate.

### Alarms -

The SAVe II™ Basic has full complement of alarms expected for a ventilator. These include - circuit disconnect, over pressure / blockage, external power indicator, low battery, detect spontaneous breathing Excessive PEEP, and device temperature too high.

Discussion - The SAVe II™ Basic and the predicate have the same set of alarms.

### Non-clinical Testing -

### Bench Testing -

We have performed a complete set of performance testing to the device specifications and confirmed that the device meets it performance requirements.

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### 510(k) Summary Page 12 of 12 18-Mar-14

In addition, we performed durability testing up to 2,000 hours, EMC, EMI, electrical safety, mechanical and environmental testing and Atmospheric Pressure Testing at both 10.15 psia (700 hPa) and 15.95 psia (1100 hPa). The latter represents a simulated altitude of 10,000 feet.

Discussion - We performed a full complement of bench tests that demonstrated that the SA Ve IITM which would include the SA Ve II™ Basic, met its performance requirements and specifications. It can be considered substantially equivalent to the predicates having undergone similar or identical testing as the predicates.

### Substantial Equivalence Conclusion -

The sponsor has demonstrated through performance testing, comparison of design and features, and nonclinical testing that the proposed device and predicate can be found to substantially equivalent.

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Public Health Service

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

March 21, 2014

AutoMedx, Incorporated C/O Mr. Paul Dryden Regulatory Consultant 1420 Lakeside Parkway, Suite 102 Flower Mound, Texas 75028

Re: K131877 Trade/Device Name: SAVe IITM SAVe II™ Basic Regulation Number: 2…