(132 days)
Not Found
No
The device description and performance studies focus on mechanical and electrical components, gas delivery, and standard ventilator controls. There is no mention of algorithms, data analysis, or adaptive learning, which are characteristic of AI/ML.
Yes
The device is a ventilator intended to provide ventilation to patients with respiratory distress or insufficiency, which is a therapeutic function.
No
Explanation: The device is described as a ventilator, which is a therapeutic device that assists with breathing. Its intended use is to "provide ventilation to patients who have respiratory distress or insufficiency," which is a treatment function, not a diagnostic one. While it monitors some parameters (like pressure and alarms), these are for operational safety and control of the therapy, not for diagnosing a medical condition.
No
The device description clearly details numerous hardware components including a housing, compressor, oscillator, filter, control module, patient valve and hose assembly, power supply/charger units, and various physical labels and connectors. It is described as a "robust self-contained portable device comprising of the following standard kit parts".
Based on the provided text, the Pneupac compPAC 200HD ventilator is not an In Vitro Diagnostic (IVD) device.
Here's why:
- Intended Use: The intended use is to "provide ventilation to patients who have respiratory ditress or insufficiency." This is a direct medical intervention on a living patient, not a test performed on biological samples outside the body.
- Device Description: The description details a mechanical ventilator that delivers gas to a patient's lungs. It describes components like a compressor, oscillator, filters, patient valve, and controls for ventilation parameters. These are all related to supporting respiration in a living being.
- Lack of IVD Characteristics: The text does not mention any of the typical characteristics of an IVD device, such as:
- Testing of biological samples (blood, urine, tissue, etc.)
- Detection or measurement of analytes
- Diagnostic purposes based on laboratory results
- Reagents or test kits
The device is clearly a life-support medical device used for direct patient care.
N/A
Intended Use / Indications for Use
The Pneupac compPAC 200HD ventilator is a self contained portable gas powered automatic gas ventilator intended to provide ventilation to patients who have respiratory ditress or insufficiency. The comPAC 200HD is suitable for emergency and transport use for adult and paediatric patients greater than 20Kg in situations where convential portable ventilators may not be suitable.
Product codes
BTL
Device Description
The compPAC COM 200HD ventilator is primarily gas powered and is housed in an easily carried, chemically hardened housing is designed to accept the long endurance battery that is used to drive a small compressor, which in turn provides the inflating gas, through an 'oscillator', to the casualty. All ambient air for the ventilation of the casualty passes into the system through a fitter (NATO No: 4240-01-361-1319). About '/3 of the volume is compressed to system uncough in the (cre expansion in an entrainment mixing device, which entrains the other 1/3 by creating a sub-atmospheric pressure It can be operated from a range of power sources Battery! Compressed gass! Mains Electricity (via PS11 power supply/ charger unit) and any d.c. power source, ie: auxiliary aircraft/vehicle electrical source (via CS12 power supply/ charger unit) to provide maximum flexibility of operation in remote areas, in disaster relief.
The compPAC COM 200HD ventilator is a robust self-contained portable device comprising of the following standard kit parts
- Control Module
- Green case variant: Part No 510A2433
- Yellow case variant: Part No 510A2434
- Rubber Boot: Part No 510A2271
- Filter: Part No W194-001
- Patient Valve and Hose assembly: Part No 510A1082
- Oz Auxiliary gas input lead, Schrader probe (BS5682): Part No 510A2600
- Support ramp: Part No 510A2372
- 28 volt open-ended Vehicle Supply lead to compPAC Part No 510A2564
- compPAC C200HD User Manual Part No 504-2055A NUS HD
And the following fitted labels
- Valance Panel Label. Part No 504-228
- Instrument Panel Label: Part No 504-227
- Supplementary O2 Table Label: Part No 504-224
- Battery fitting and removal instruction Label: Part No 504-223
- Alarm Bezel Label (set of 2): Part No 504-222
The module can be used individually as a robust self-contained portable device powered by a NiCad rechargeable battery specified for fitting inside the unit, which will provide approximately (1) hours continuous ventilation. The module weighs 187 lb with the battery installed. The ventilator has a socket to accept an external 24V d c supply from e g. an aircraft or vehicle electrical circuit.
This enables the system to be used for extended periods wherever a 24-28V d.c. supply is available. The power requirement is less than 50 watts.
If the Pneupac CS12 (d.c. source only) power supply) battery charger (weight 2.2 lbs) is connected to this socket, simultancous full charging of the internal battery will occar whilst the ventilator is running.
If the Pneupac PSI i (inains or d.c. source) power supply / battery charger (weight. 3.86 lb) is connected to this socket, simultaneous trickle charging of internal battery will occur whilst the ventilator is running When not required as a power supply it can be switched, to fast charge the battery whilst it is in situ inside the ventilator.
Additionally, specifically for aircraft use, an aeromedical EMC filter/ lead assembly (Part No 525-1015) is featured to protect the aircraft from compPAC emissions.
An input gas connector is provided to allow the compPAC ventilator to be connected to a 44 to 87 psig gas supply via a legally registered high pressure regulator (not suppliated with the material battered battered hence not part of this submission) so that it can be operated independently of its its internal battery electrical supply In this way, if oxygen cylinders are available, 100% or 4.5% or allows electrical supply in this way. In usygen cymiders are are This facility also allows connection to air compressor systems.
Alternatively, there is a supplementary oxygen intake connector, in paralied with the filter, enabling 21-45% oxygen to be supplied to the casualty, from e g an oxygen cylinder was a legally registered high pressure regulator (not supplied with the compPAC, hence not part of this registeres ), when the ventilator is operating on its compressor.
Calibrated controls for frequency and minute volume are provided to set the required ventiation pattern. A fixed pressure relief valve is fifted to limit the peak inspiratory pressure to a maximum of 40 cm HzO and provides a pneumatically operated audible high-pressure alarm (an adjustable pressure relief device will also be available in the fittere as a retro-fittable option). In addition an pressure reach device the alarm sounds if the inflation pressure exceeds 40 cm HzO.
Most of the controls and input and output connections are mounted on the from panel, which is deeply shrouded to give maximum protection from chemical "rain".
The ventilator module comrol panel has the following features.
-
Minute Volume Control. This calibrated rotary control knob gives continuous adjustment of the minute volume delivered to the patient over the range 6 to 14 L/min.
-
Frequency Control, This rotary control knob gives continuous adjussment of frequency over the range 10 to 30 breaths per minute
-
I:E ratio is nominally constant at 1. i. 8 throughout the range of frequency
-
Patient Inflation Pressure Manometer, range -10 to +100 cm HpO
-
Oxygen Concentration Control This two-position rovary control in assessed to the eas-후 100% or 45% inspired oxygen concentration when an oxygen supply is connected to the gas-100% or 43% inspired oxygen concentralion withis systed is disabled internally. In the 45% Oz position the driving gas requirement is reduced by 66% and the balance of the In the 45% U position the driving gas requirement arr which is drawn through the fifter canister
-
A mechanically operated visual alarm (labelled 'Supply Gas Failure Alam') gives a . warning that the supply gas has dropped to a pressure at which the ventilator will no longer be warming that the supply gas nas artipped to a pressure it shows red, with adequate its suces the operating to specificated ( red indicates that the supply should be changed In most cases the shows will begin to oscillate from white to parial red as the supply pressure falls to the lower threshold level. The visual indication will be accompanied by an electronically generated medium priority audible warning.
-
Electronic aların bezel indicating
- High Pressure Indicator Flashes Red LED with audible alarm at set relief pressure and with continuous positive pressure
- Normal Cycle Indicator Flashes Green LED every time inflation pressure rises through ♪ 10 cm H2O
- Low Pressure/ Disconnect Indicator Flashes Yellow LED with audible alarm if pressure does not rise through 10 cm H2O within ten seconds.
- Silence button silences audible alarm for 60 seconds. Flashes Orange LED to indicate to * the operator that the audible alarm is silenced.
- Electrical power indicator Flashes Yellow LED with audible alarm
The CS12 power supply and battery charger designed to power the comply has the The CS12 power supply and Dattery from an aircraft or vehicle 24-28V dc supply has the following controls and features:
The CS12 power supply and battery charger complements the complexe with a nominal 12/24/28 vol The CS12 power supply and battery charged from any source with a nominal 12/24/28 vol.
allows the ventilator's battery to be charged from the second with annoly allows the ventilator's battery to be clarged from any only be operated simultaneously if the supply
D.C. aircraft/ vehicle supply. The ventilator may only be operated simult D.C. aircrato vemere supply. The following controls and features
- DC Outputs protected outputs to power the ventilator and supply a constant current to # charge the +28Vdc battery
- Start Button initiates a battery charging cycle If held for a few seconds, it will also ● terminate any battery charging cycle underway
- POWER Yellow Lamp 'charge only' indicates aircraft/ vehicle supply voltage is only # sufficient (10-22V) to charge the battery
- POWER Green Lamp 'compPAC & charge' indicates aircraft/ vehicle supply voltage is ◆ POWER Green Lamp compt AC of charge its battery simultator and charge its battery simultancously
- CHARGE Yellow Lamp 'Charging' indicates a battery charging cycle is underway
- CHARGE Green Lamp 'Complete' indicates the battery charging cycle has been * successfully completed
The PS11 Dower supply/ charger designed to power the compPAC 200HD ventilator and The ESTI Dower Support Chartery from a Mains (230 or 115 volt nominal AC operation) or d.c. (12 to 30 volt d c ) supply has the following controls and features:
- Line Output In conjunction with the negative common, a -28V dc output for general ↓ Lifte Output = In conjunction with the negarres battle when the appropriate lead is fitted. The output is fully protected against short circuits and overload
- Trickle charge output In conjunction with the negative common, a +28V dc ourput
- I rickle charge output - In complise ventilator This line provides a trickle charge facility for the compPAC's internal battery
- Battery Charge Output In conjunction with the negative common, this is the output used to charge a +28V dc NiCad battery
- On/Off Switch The switch on the from panel of the PS11 selects two different operating modes -
- 28V de & Trickle Clug. ON: This activates the 28V dc Line and Trickle Charge outputs and open circuits the compPAC internal battery
- Output OFF & Charge Battery This activates the Battery Charge output and removes power from the 28V dc Line and Trickle Charge outputs.
Additionally, specifically for aircraft use, an aeromedical EMC filter/ lead assembly (Part No: 525-1015) is featured to protect the aircraft from compPAC emissions.
When the compleAC is operating its imernal compresson, the incoming air is filtered. The specifications of the recommended filter are as follows -
- Fifter efficiency is at least 99.99% efficient against a 0.3um Mass Median Aerodynamic # Diameter aerosol challenge at 32 L/min
- Airflow resistance at 32 Liters per Minute is 10 to 17 mm HzO
- Connector size is 40mm DIN NATO compatible threads
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
Adult and paediatric patients greater than 20Kg
Intended User / Care Setting
Emergency and transport use
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)
Safety testing was conducted in accordance with the Draft Reviewer's Guidance for Ventilators, Safety testing was condicted in accordance Watt Inc. Draft documents for emergency and transport ventilators" 1999 and EN60601-1 "Medical Electrical Equipment - Part 1 General fransport venthators - 1727 and ES (2000)ator and power supply/ charger passes all of these tests and met all requirements of the standards.
Performance testing was performed in accordance with the following standards:
- EN 60601-1-2: 1993
- EN794-3: 1999
- BS EN 61000-3-2: 1995 'Limits for harmonic current emissions (equipment input current S. * 16A per phase)'
- BS EN 61000-4-3: 1997 "Radiated, Radio frequency, Electromagnetic field immunity test
- BS EN 61000-4-4: 1995 Electrical fast transient/ burst immunity test.
- BS EN 61000-4-2: 1995 - Electrostatic discharge immunity test.
- BS EN 61000-4-5: 1995 Surge immunity test
t Generic Specification for Special Purpose Aeromedical Equipment - Issue 3, specifically -Generic Specification for Special Part 3 Issue 5, the following parts:
- DRE01 Radiated E Field Emissions
- DRS02 Radiated E Field Susceptibility
- DCE01 Conducted Emissions
- DCS01 Conducted Susceptibility
- DCS02 Conducted Susceptibility
- DCS10 Electrostatic Discharge
Electromagnetic compatibility (EMC), electrical mechanical durability, safety (operator and Flectromagnetic companding (EMC), electrical, and been completed The results demonstrated that the compPAC 200HD ventilator, PSI | Mains' d c Power supply charger and CSI2 d.c. Power. comply/ charger complied with the guidelines and standards and that they performed within their specifications and functional requirements.
Comparison testing of the compPAC model 200HD with its predicate counterparas the compl'AC Comparison testing of the collip AC though 2001 the performance of the delivered Volume and 200 and paral AC, 200 Medic was doile to sach. The tress were performed across the ventilators. These data Frequency paramerers are the same to tack to cach tolerances of the ventilators. These casts of the ventilators. These casts PAC 200 and catire range. All meastiements were within the species to both the compPAC 200 and paraPAC 200 Medic.
Key results: The testing described above indicates that there is no functional difference between the operation The resting described above multierparts the counterparts the compense the compenses it is is not of the compl AC model 200112 with its presency parameters. Based on these results, it is our determination that the device model is safe, effective and performs as well as the legally marketed predicate devices.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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
KO4oo9o
MAY 2 7 2004
Pneupac Ltd.
Bramingham Susiness Park Liferense Was 1 .. 11:4; 2 32 .. 132 .. 152 .. ্রাম Tel - - - 44 |013681 430000 50x - - 44 100 158 1 433001 r folophelucan ny ak www.phalip... It is
Summary of Safety and Effectiveness
| Submitter: | Pneupac Ltd. |
|---|---|
| Address: | Bramingham Business Park. |
| Enterprise Way, Luton, | |
| Bedfordshire, LU3 4BU | |
| United Kingdom. | |
| Telephone: | (+44) (0) 1582 430000 |
| Contact: | Regulatory Affairs & Quality Assurance |
| Manager | |
| Prepared: | 20 th August 2003 |
| Proprietary Name: | compPAC Ventilator Model 200, PS11 |
| Mains or dc Power Supply/ Battery | |
| Charger & CS12 dc Power Supply/ Battery | |
| Charger | |
| Common/ Classification Name: | Powered Ventilator with Power Supply/ |
| Battery Charger | |
| Predicate Devices: | compPAC 200 Powered Emergency Ventilator |
| & PS11 Power Supply/ Battery Charger | |
| (K021841). | |
| ParaPAC Model 200 Medic Emergency | |
| Powered Ventilator (Resuscitator) (K020899). |
New Device Description:
The compPAC COM 200HD ventilator is primarily gas powered and is housed in an easily carried, chemically hardened housing is designed to accept the long endurance battery that is used to drive a small compressor, which in turn provides the inflating gas, through
X. Summary of Safety and Killestjvesses 510/kW COM200FU3
in the present case, it is impossible to continue without additional data.
we cannot proceed for the time being.
1
Summary of Safety and Effectiveness
New Device Description (ctd.):
an 'oscillator', to the casualty. All ambient air for the ventilation of the casualty passes into the system through a fitter (NATO No: 4240-01-361-1319). About '// of the volume is compressed to system uncough in the (cre expansion in an entrainment mixing device, which entrains the other 1/3 by creating a sub-atmospheric pressure It can be operated from a range of power sources Battery! Compressed gass! Mains Electricity (via PS11 power supply/ charger unit) and any d.c. power source, ie: auxiliary aircraft/vehicle electrical source (via CS12 power supply/ charger unit) to provide maximum flexibility of operation in remote areas, in disaster relief.
The compPAC COM 200HD ventilator is a robust self-contained portable device comprising of the following standard kit parts
- Control Module -�
- Green case variant: Part No 510A2433 ◆ ાર
- Yellow case variant: Part No 510A2434 .
- Rubber Boot: Part No 510A2271 奉
- Filter: Part No W194-001 �
- Patient Valve and Hose assembly: Part No 510A1082 *
- Oz Auxiliary gas input lead, Schrader probe (BS5682): Part No 510A2600 ◆
- Support ramp: Part No 510A2372 春
- 28 volt open-ended Vehicle Supply lead to compPAC Part No 510A2564 ゃ
- compPAC C200HD User Manual Part No 504-2055A NUS HD #
And the following fitted labels
- Valance Panel Label. Part No 504-228 ◆
- Instrument Panel Label: Part No 504-227 �
- Supplementary O2 Table Label: Part No 504-224 �
- Battery fitting and removal instruction Label: Part No 504-223 �
- Alarm Bezel Label (set of 2): Part No 504-222 .
X. Sciencer) of Stately and Effectiveners 510K | COM20EMD
2
Summary of Safety and Effectiveness
New Device Description (ctd.):
The module can be used individually as a robust self-contained portable device powered by a NiCad rechargeable battery specified for fitting inside the unit, which will provide approximately (1) hours continuous ventilation. The module weighs 187 lb with the battery installed. The ventilator has a socket to accept an external 24V d c supply from e g. an aircraft or vehicle electrical circuit
This enables the system to be used for extended periods wherever a 24-28V d.c. supply is available. The power requirement is less than 50 watts
If the Pneupac CS12 (d.c. source only) power supply) battery charger (weight 2.2 lbs) is connected to this socket, simultancous full charging of the internal battery will occar whilst the ventilator is running
If the Pneupac PSI i (inains or d.c. source) power supply / battery charger (weight. 3.86 lb) is connected to this socket, simultaneous trickle charging of internal battery will occur whilst the ventilator is running When not required as a power supply it can be switched, to fast charge the battery whilst it is in situ inside the ventilator
Additionally, specifically for aircraft use, an aeromedical EMC filter/ lead assembly (Part No 525-1015) is featured to protect the aircraft from compPAC emissions
The following diagrams illustrate the optional sources available to drive the compPAC ventilator, the electrical power source options and the battery charging options -
X: Smannary of Safety and Effect/sences: 510(13 COM200HD
Section 2/ Page 3
smiths
3
Summary of Safety and Effectiveness
New Device Description (51d
New Device Description (110.):
Graphical representation of electrical power source inputs, their relevant interfaces / devices and outputs
To run the compPAC
Image /page/3/Figure/5 description: The image shows a diagram of an electrical power source with interfaces, devices, and outputs. The electrical power sources include a battery, 12V dc, 115V ac, 230V ac, and 24-28V dc. The interfaces and devices include PS11 for stationary use only, a dc vehicle cable, and CS12 for vehicle and aircraft use. The output is compPAC operating.
To charge the batters
Image /page/3/Figure/7 description: The image shows a diagram of an electrical power source with interfaces, devices, and outputs. The electrical power sources include 115V ac, 230V ac, 12V dc, and 24-28V dc. The interfaces/devices include PS11 and CS12, and the output is battery charging. PS11 provides a trickle charge while operating, and CS12 provides a standard charge while operating.
X: Summery of Saleny and Effectivenen 510(k) U M200HD
4
Summary of Safety and Effectiveness
New Device Description (ctd.);
An input gas connector is provided to allow the compPAC ventilator to be connected to a 44 to 87 psig gas supply via a legally registered high pressure regulator (not suppliated with the material battered battered hence not part of this submission) so that it can be operated independently of its its internal battery electrical supply In this way, if oxygen cylinders are available, 100% or 4.5% or allows electrical supply in this way. In usygen cymiders are are This facility also allows connection to air compressor systems
Alternatively, there is a supplementary oxygen intake connector, in paralied with the filter, enabling 21-45% oxygen to be supplied to the casualty, from e g an oxygen cylinder was a legally registered high pressure regulator (not supplied with the compPAC, hence not part of this registeres ), when the ventilator is operating on its compressor
Calibrated controls for frequency and minute volume are provided to set the required ventiation pattern. A fixed pressure relief valve is fifted to limit the peak inspiratory pressure to a maximum of 40 cm HzO and provides a pneumatically operated audible high-pressure alarm (an adjustable pressure relief device will also be available in the fittere as a retro-fittable option). In addition an pressure reach device the alarm sounds if the inflation pressure exceeds 40 cm HzO.
Most of the controls and input and output connections are mounted on the from panel, which is deeply shrouded to give maximum protection from chemical "rain"
The ventilator module comrol panel has the following features.
- Minute Volume Control. This calibrated rotary control knob gives continuous adjustment of � the minute volume delivered to the patient over the range 6 to 14 L/min.
- Frequency Control, This rotary control knob gives continuous adjussment of frequency over 兼 the range 10 to 30 breaths per minute
- I:E ratio is nominally constant at 1. i. 8 throughout the range of frequency *
X Summery of Satiety and Ellectricess 5100 - COM200800
Section 2/ Page 5
smiths · · Seat · ist finishing Bricked in
5
Summary of Safety and Effectiveness
New Device Description (ctd.):
- Patient Inflation Pressure Manometer, range -10 to +100 cm HpO �
- Oxygen Concentration Control This two-position rovary control in assessed to the eas-후 100% or 45% inspired oxygen concentration when an oxygen supply is connected to the gas-100% or 43% inspired oxygen concentralion withis systed is disabled internally. In the 45% Oz position the driving gas requirement is reduced by 66% and the balance of the In the 45% U position the driving gas requirement arr which is drawn through the fifter canister
- A mechanically operated visual alarm (labelled 'Supply Gas Failure Alam') gives a . warning that the supply gas has dropped to a pressure at which the ventilator will no longer be warming that the supply gas nas artipped to a pressure it shows red, with adequate its suces the operating to specificated ( red indicates that the supply should be changed In most cases the shows will begin to oscillate from white to parial red as the supply pressure falls to the lower threshold level
The visual indication will be accompanied by an electronically generated medium priority audible warning
- Electronic aların bezel indicating *
- High Pressure Indicator Flashes Red LED with audible alarm at set relief pressure and 要 with continuous positive pressure
- Normal Cycle Indicator Flashes Green LED every time inflation pressure rises through ♪ 10 cm H2O
- Low Pressure/ Disconnect Indicator Flashes Yellow LED with audible alarm if pressure � does not rise through 10 cm H2O within ten seconds.
- Silence button silences audible alarm for 60 seconds. Flashes Orange LED to indicate to * the operator that the audible alarm is silenced.
- Electrical power indicator Flashes Yellow LED with audible alarm �
K Surners of Subery and Effectiveness (100) COM200HD
6
Summary of Safety and Effectiveness
The CS12 power supply and battery charger designed to power the comply has the The CS12 power supply and Dattery from an aircraft or vehicle 24-28V dc supply has the following controls and features:
The CS12 power supply and battery charger complements the complexe with a nominal 12/24/28 vol The CS12 power supply and battery charged from any source with a nominal 12/24/28 vol.
allows the ventilator's battery to be charged from the second with annoly allows the ventilator's battery to be clarged from any only be operated simultaneously if the supply
D.C. aircraft/ vehicle supply. The ventilator may only be operated simult D.C. aircrato vemere supply. The following controls and features
- DC Outputs protected outputs to power the ventilator and supply a constant current to # charge the +28Vdc battery
- Start Button initiates a battery charging cycle If held for a few seconds, it will also ● terminate any battery charging cycle underway
- POWER Yellow Lamp 'charge only' indicates aircraft/ vehicle supply voltage is only # sufficient (10-22V) to charge the battery
- POWER Green Lamp 'compPAC & charge' indicates aircraft/ vehicle supply voltage is ◆ POWER Green Lamp compt AC of charge its battery simultator and charge its battery simultancously
- CHARGE Yellow Lamp 'Charging' indicates a battery charging cycle is underway �
- CHARGE Green Lamp 'Complete' indicates the battery charging cycle has been * successfully completed
X. Summery of Safety and Effectiversism 510(k) LOM200HD
Section 2/ Page 7
smiths Coments Shallerys of a port of the series famise
7
Summary of Safety and Effectiveness
The PS11 Dower supply/ charger designed to power the compPAC 200HD ventilator and The ESTI Dower Support Chartery from a Mains (230 or 115 volt nominal AC operation) or d.c. (12 to 30 volt d c ) supply has the following controls and features
- Line Output In conjunction with the negative common, a -28V dc output for general ↓ Lifte Output = In conjunction with the negarres battle when the appropriate lead is fitted. The output is fully protected against short circuits and overload
- Trickle charge output In conjunction with the negative common, a +28V dc ourput 章 I rickle charge output - In complise ventilator This line provides a trickle charge facility for the compPAC's internal battery
- Battery Charge Output In conjunction with the negative common, this is the output used to � charge a +28V dc NiCad battery
- On/Off Switch The switch on the from panel of the PS11 selects two different operating . modes -
- 28V de & Trickle Clug. ON: This activates the 28V dc Line and Trickle Charge outputs and � open circuits the compPAC internal battery
- Output OFF & Charge Battery This activates the Battery Charge output and removes power . from the 28V dc Line and Trickle Charge outputs.
Aircraft Power Supply Lead:
Additionally, specifically for aircraft use, an aeromedical EMC filter/ lead assembly (Part No: 525-1015) is featured to protect the aircraft from compPAC emissions.
X Summary of Safety and Effect/temess 510 k | COM200f1)
Section 2/ Page 8
smiths Simming sessent is - 8 , so t to the fymilians for a
8
Summary of Safety and Effectiveness
Filter:
When the compleAC is operating its imernal compresson, the incoming air is filtered. The specifications of the recommended filter are as follows -
- Fifter efficiency is at least 99.99% efficient against a 0.3um Mass Median Aerodynamic # Diameter aerosol challenge at 32 L/min
- Airflow resistance at 32 Liters per Minute is 10 to 17 mm HzO .
- Connector size is 40mm DIN NATO compatible threads �
Intended Use:
The Pheupac compPAC 200HD ventilator is a self contained portable gas powered aumanie I he Pheapac Compt AC 200112 ventilation to patients who have respiratory distress or insufficiency. venthator measured to provice venences and transport use for adult and pediatric patients I he compt AC 2001D is sunable for chergency and mable ventilators may not be suitable.
Performance Data:
The design of this ventilator uses currently available technology found in many legally marketed I de design of this ventuator these carrence that the compPAC 200HD PSII Power supply! ventuators Testing Was performics to casure were safe and would perform within the environment(s) for which they are to be marketed.
Safety testing was conducted in accordance with the Draft Reviewer's Guidance for Ventilators, Salery testing was condicted in accordance Watt Inc. Drainents for emergency and transport ventilators" 1999 and EN60601-1 "Medical Electrical Equipment - Part 1 General fransport venthators - 1727 and ES (2000)ator and power supply/ charger passes all of these tests and met all requirements of the standards
and met an requirement was performed in accordance with the following standards -
- EN 60601-1-2: 1993 *
- EN794-3: 1999 を
- BS EN 61000-3-2: 1995 'Limits for harmonic current emissions (equipment input current S. * 16A per phase)'
- BS EN 61000-4-3: 1997 "Radiated, Radio frequency, Electromagnetic field immunity test
X: Summary of Safety and Effectiveress 510(x) COM200HD
9
Summary of Safety and Effectiveness
Performance Data (ctd.):
- BS EN 61000-4-4: 1995 Electrical fast transient/ burst immunity test.
- ◆ BS EN 61000-4-2: 1995 - Electrostatic discharge immunity test. ●
- BS EN 61000-4-5: 1995 Surge immunity test
t Generic Specification for Special Purpose Aeromedical Equipment - Issue 3, specifically -Generic Specification for Special Part 3 Issue 5, the following parts
- DRE01 Radiated E Field Emissions .
- DRS02 Radiated E Field Susceptibility .
- DCE01 Conducted Emissions �
- DCS01 Conducted Susceptibility ◆
- DCS02 Conducted Susceptibility 章
- DCS10 Electrostatic Discharge 泰
Electromagnetic compatibility (EMC), electrical mechanical durability, safety (operator and Flectromagnetic companding (EMC), electrical, and been completed The results demonstrated that the compPAC 200HD ventilator, PSI | Mains' d c Power supply charger and CSI2 d.c. Power . comply/ charger complied with the guidelines and standards and that they performed within their specifications and functional requirements.
Comparison testing of the compPAC model 200HD with its predicate counterparas the compl'AC Comparison testing of the collip AC though 2001 the performance of the delivered Volume and 200 and paral AC, 200 Medic was doile to sach. The tress were performed across the ventilators. These data Frequency paramerers are the same to tack to cach tolerances of the ventilators. These casts of the ventilators. These casts PAC 200 and catire range. All meastiements were within the species to both the compPAC 200 and paraPAC 200 Medic
The testing described above indicates that there is no functional difference between the operation The resting described above multierparts the counterparts the compense the compenses it is is not of the compl AC model 200112 with its presency parameters. Based on these results, it is our determination that the device model is safe, effective and performs as well as the legally marketed
Surnmary of Safety and Effectiveness 5100 : COM200HO
Scotion 2/ Page 10
smiths
10
Summary of Safety and Effectiveness
Performance Data (cid.):
predicate devices.
This summary of 510(k) safety and effectiveness information is being submitted in accordance
s and consisted on 2017 4 1969 wel 31 CER 807 92 This summary of 570(K) safery and enver. In CFR 807.92 with the requirements of SMDA 1990 and 21 CFR 807.92
Respectfully, Frankalo Colin Walters Comi Walter."
Regulatory Affairs and Quality Assurance Manager
X: Summery of Safety and leffectiveress 510(8 ) COM200) ID
Section 2/ Page 11
smiths 20: Sau Area
11
Image /page/11/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular and contains the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol that resembles an eagle or bird in flight, composed of three curved lines.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAY 27 2004
Pneupac Limited C/O Mr. Donald J. Alexander Vice President of Regulatory Affairs BCI International N7 W22025 Johnson Road Waukesha, Wisconsin 53186-1856
Re: K040090
Trade Name: compPAC 200HD with PS11 and CS12 Power Supplies Regulation Number: 21 CFR 868.5925 Regulation Name: Emergency Powcred Ventilator (Resuscitator) Regulatory Class: II Product Code: BTL Dated: April 28, 2004 Received: May 3, 2004
Dear Mr. Alexander:
We have reviewed your Section 510(k) premarket notification of intent to market the device we nave reviewed your we determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for use stated in the encreations of the enactment date of the Medical Device Amendments, or to commerce proc to rial 2011-11-11) in accordance with the provisions of the Federal Food, Drug, ucvices that have been require approval of a premarket approval application (PMA). and coometic for ( res) ( res) ( res) ( = ) = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = 1 ou may, increrery initions of the Act include requirements for annual registration, listing of general obliable provision practice, labeling, and prohibitions against misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it If your device is clashines tontrols. Existing major regulations affecting your device can may be subject to sater added to the 21, Parts 800 to 898. In addition, FDA may be found in the over ments concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean r lease of actives and i promination that your device complics with other requirements of the Act that 1 1971 has made a and regulations administered by other Federal agencies. You must
12
Page 2 – Mr. Donald J. Alexander
comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); 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. This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at (301) 594-4646. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html.
Sincerely vours,
Chiu Lin, Ph.D.
Chiu Lin, Ph.D. Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
13
Indications for Use
510(k) Number (if known): K040090
Device Name: compPAC 200HD Emergency Powered Ventilator, PS11 Power Supply/Charger & CS12 Power Supply/Charger
Indications for Use:
The Pneupac compPAC 200HD ventilator is a self contained portable gas powered automatic gas ventilator intended to provide ventilation to patients who have respiratory ditress or insufficiency. The comPAC 200HD is suitable for emergency and transport use for adult and paediatric patients greater than 20Kg in situations where convential portable ventilators may not be suitable
Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR
Over- The- Counter Use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Ci Suin
(Division Sign Off)
Division of Anesthesiology, General Hospital,
Infection Control, Dental Devices
510(k)