(269 days)
No
The summary describes a basic automated ventilator with pressure monitoring and alarms. There is no mention of AI or ML in the device description, intended use, or performance studies. The "Mentions AI, DNN, or ML" field is explicitly marked as "Not Found".
Yes
The device is described as providing "short-term ventilatory support to adults during CPR or when Positive-Pressure Ventilation (PPV) is required to manage Acute Respiratory Failure (ARF)" and "automated, controlled positive pressure breaths with ambient air." These functions directly address health conditions and assist in restoring normal physiological function, which aligns with the definition of a therapeutic device.
No
Explanation: The device is described as providing ventilatory support and managing acute respiratory failure, which are treatment functions, not diagnostic. While it monitors airway pressure, this monitoring is for safety and proper operation of the ventilation, not for diagnosing a condition.
No
The device description explicitly states it is a "battery powered compressor" and mentions "hardware components" like pressure monitoring and cut-off mechanisms, indicating it is a physical device with integrated software, not software-only.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens taken from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening.
- Device Function: The SAVe II™ series is a ventilator. Its function is to provide mechanical ventilatory support to patients by delivering positive pressure breaths. It directly interacts with the patient's respiratory system, not with specimens taken from the body.
- Intended Use: The intended use clearly states it's for providing ventilatory support during CPR or for managing Acute Respiratory Failure. This is a therapeutic and life-support function, not a diagnostic one based on analyzing biological samples.
Therefore, the SAVe II™ series falls under the category of a medical device, specifically a ventilator, but not an In Vitro Diagnostic device.
N/A
Intended Use / 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 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.
Product codes (comma separated list FDA assigned to the subject device)
BTL
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
adults that weigh at least 45 kg.
Intended User / Care Setting
It is intended to be used in pre-hospital, field hospitals, and transport environments.
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Impact Instruments - Uni-Vent Model 754 - K931473, AutoMedx - SAVeTM - K071221
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
SAVe™ (K071222
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 868.5925 Powered emergency ventilator.
(a)
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.(b)
Classification. Class II (performance standards).
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. | |
| 1420 Lakeside Parkway, Suite 102 | |
| Flower Mound, Texas 75028 | Tel - 972-586-7500 |
| Fax - 972-408-4177 | |
| Official Contact: | James Evans - President |
| Proprietary or Trade Name: | SA Ve IITM |
| SA Ve IITM Basic | |
| Common/Usual Name: | Powered emergency ventilator |
| Classification Name: | Powered emergency ventilator |
| Procode -- BTL | |
| CFR - 868.5925 | |
| Class 2 | |
| Predicate Devices: | Impact Instruments - Uni-Vent Model 754 - K931473 |
| 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
1
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 | ||
| kilograms | Yes | Yes |
| Should not be used in situations where Positive Pressure | ||
| Ventilation (PPV) is contraindicated. | Yes | Yes |
| Do not use the device for extended periods without | ||
| monitoring blood gases. As duration of use increases, the | ||
| need for close monitoring of CO2 and O2 levels also | ||
| increases. This is especially true for patients over 6' 9". | Yes | Yes |
| Spontaneously breathing patients may not synchronize with | ||
| ventilator. If spontaneously breathing patient has difficulty | ||
| 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.
2
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 | |
| 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. | 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. | ||
| 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 | |
| field hospitals | ||
| transport | pre-hospital | |
| field hospitals | ||
| transport | ||
| Breath Types / Ventilation Modes | ||
| Breath Type | Volume-targeted | |
| Time-cycled | ||
| Pressure limited | Volume-targeted | |
| Time-cycled | ||
| 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% |
3
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).
4
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
K931473) | AutoMedx
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
field hospitals
transport | pre-hospital
field hospitals
transport | pre-hospital
field hospitals
transport |
| Breath Types / Ventilation Modes | | | |
| Breath Type | Volume-targeted
Time-cycled
Pressure limited | Volume-targeted
Time-cycled
Pressure limited | Volume-targeted
Time-cycled
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
K931473) | AutoMedx
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
(K931473) | AutoMedx
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
12 hours using external gas | 5.5 hrs @TV=600,RR=10,PEEP=0 |
| External Power Supply | Input: 100 – 240 VAC / 50 – 60 Hz
Output: 16.8 VDC | Input: 90 – 265 VAC / 47 – 400 Hz
Output: 12 VDC | Input: 100 – 240 VAC / 47 – 63 Hz
Output: 15 VDC |
5
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
ndrations .
Previous in neo which website in the many and Model TS . C. C. (1) . P. P. v. ven Positive Presser Veniliately P.
P. P. resultat manage Acure (A.V.) is incolned i
avironment of Use as aranspor ventilator that on be used in field hopinal, pre-hopid and transport setings which
lenical to the predicate Impact Model 754 (K93) and the subs
7
�
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 (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 |
10
510(k) Summary Page 11 of 12 18-Mar-14
| Features | SAVe II™ Basic | AutoMedx
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-
Segment Displays | Rotary Switch, LEDs |
| Patient Breathing Circuit | Active Breathing Valve | Passive Breathing Valve |
| Oxygen | Low 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) |
| 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
Output: 16.8 VDC | Input: 100 - 240 VAC / 47 - 63 Hz
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.
11
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.
12
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: 21 CFR 868.5925 Regulation Name: Ventilator, Emergency, Powered (Resuscitator) Regulatory Class: II Product Code: BTL Dated: February 14, 2014 Received: February 18, 2014
Dear Mr. Dryden:
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.
Image /page/12/Picture/9 description: The image shows the seal of the Department of Health & Human Services - USA. The seal is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is an abstract image of an eagle.
13
Page 2 - Mr. Dryden
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 801); medical device 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 contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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 (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.
Sincerely yours,
Tejashri Purohit-Sheth, M.D.
Clinical Deputy Director
DAGRID
FOR
Erin I. Keith, M.S. Acting Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
14
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
Form Approved: OMB No. 0910-0120 Expiration Date: December 31, 2013 See PRA Statement on last page.
510(k) Number (if known) K131877
Device Name SA Ve II™ and SA Ve II™ Basic
Indications for Use (Describe)
The SA Ve 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 11™ 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.
Type of Use (Select one or both, as applicable)
🇿 Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.
| FOR FDA USE ONLY | |
|---|---|
| Concurrence of Center for Devices and Radiological Health (CDRH) (Signature) | |
| Anya C. Harry - | |
| S | |
| 2014.03.20 | |
| 14:22:18 -04'00' | |
| FORM FDA 3881 (9/13) | Page 1 of 2 |
| PSC Publishing Services (301) 443-6740 EF |
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