K Number
K043495
Device Name
BABYPAC
Date Cleared
2005-04-22

(126 days)

Product Code
Regulation Number
868.5925
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The babyPAC 100 is a portable gas powered transport ventilator, suitable for use in an MRI environment up to 3 Testa, which features a battery powered integrated electronic pressure alarm unit. It is designed for use by qualified medical caregivers, paramedics and other trained personnel, for ambulance, hospital, emergency and transport ventilation of patients during respiratory distress or insufficiency. It can be used on neonates and infants up to a bodyweight of 44lb (20 kg).
Device Description
The babyPAC ventilator consists of a control module with a disposable conventional Y patient circuit. The babyPAC ventilator is a pressure generator which depends solely on the pressure of the supply gas for its operation. The babyPAC 100 additionally incorporates an integrated electronic pressure alarm unit which becomes operational during Controlled Mandatory Ventilation. This unit provides a warning of significant changes which may occur in the patient's ventilation. Loss of battery power for the alarm is signaled to the user but will have no effect on the ventilation performance of the babyPAC ventilator, nor affect the mechanically operated alarms and performance on the babyPAC ventilator (K970158) already on the market. The babyPAC 100 portable ventilator is designed for use as an emergency and transport ventilator in ambulances and hospitals, and can be used in an MRI environment up to 3 Teslas. It is intended for transportation and for resuscitation of infants (above approx 11lb [5 kg]) and neonates up to 44 lb (20 kg). The control module of the babyPAC ventilator is rugged by virtue of its thick section structural foam plastic case and the controls for the gauge and internal pneumatics are recessed to minimise the possibilities of damage and inadvertent operation. The babyPAC 100 portable ventilator consists of a control module and the following items: 22mm disposable Polyethylene respirator hose/ 22mm OD female connector and Paediatric 'Y' piece connector The module weighs 8.25 lb (3.75 kilograms) The module control panel has the following features: - Adjustable Relief Pressure Control, range 12 to 80 cm H2O. - Inspiratory Time Control, range 0.25 to 2.0 seconds. - Expiratory Time Control, range 0.25 to 4.0 seconds - Inspiratory Pressure Control, range 12 to 70 cm H2O, with click action warning at and above 40 cm H2O. - PEEP/ CPAP Control, range 0 to 20 cm H2O with click action warning at and above 10 cm H2O. - IMV Control, range Expiratory time 2.5 to 40 seconds with CPAP Pressure level and oxygen concentration as selected. - Patient Inflation Pressure Manometer, range -10 to +100 cm H2O. - Variable Oxygen Concentration, range 45 (approx) to 100% with oxygen only as supply, 21 to 70 % with oxygen and air supplies - Supply Gas Failure Alarm indicators- One for air, the other for oxygen, these mechanically operated visual alarms give a warning that the supply gas has dropped to a pressure at which the ventilator will no longer be operating to specification (< 35 psi). With low pressure they show red, with adequate pressure they show white. Any visible red indicates that the supply should be changed. As the pressure falls the display will begin to oscillate from white to partial red as the supply pressure falls to the lower threshold level. The visual indication will be accompanied by an electronically generated medium priority (to EN 475: 1995) audible warning. - Electronic alarm bezel indicating - High Pressure/ Constant Positive Inflation Pressure Indicator Flashes Red LED with audible alarm at set relief pressure and with continuous positive pressure - Inflation 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 eight seconds - Silence button silences audible alarm for 60 seconds. Flashes Orange LED to indicate to the operator that the audible alarm is silenced. - Single Gas Use Indicator Flashes a Green LED as a burst of 3 flashes every 30 seconds, whenever the ventilator is being used with only a single gas input (ie oxygen or air only). In the event that the single gas fails (ie. where the audible gas failure alarm has activated) the Low Pressure/ Disconnect Indicator will activate together with the audible alarm. - Low battery indicator Flashes Yellow LED with audible alarm.
More Information

Not Found

No
The device description and performance studies focus on mechanical and electronic components, alarms based on fixed thresholds, and comparisons to predicate devices without mention of learning or adaptive algorithms.

Yes
The device is a ventilator used for patients in respiratory distress or insufficiency, directly supporting or restoring a physiological function.

No

The babyPAC 100 is a portable gas-powered transport ventilator designed to provide respiratory support for patients, not to diagnose a condition. While it has an electronic pressure alarm unit that provides warnings of significant changes in the patient's ventilation, these alarms indicate issues with the ventilation process itself, not an underlying medical diagnosis.

No

The device description clearly outlines a physical ventilator with mechanical and electronic components, including a control module, patient circuit, pressure gauge, and various physical controls and indicators. While it includes an "integrated electronic pressure alarm unit," this is part of a larger hardware system, not a standalone software device.

Based on the provided text, 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, or tissue) to provide information about a person's health.
  • Device Function: The babyPAC 100 is a ventilator. Its function is to assist or control breathing by delivering gas to the patient's lungs. It does not analyze biological specimens.
  • Intended Use: The intended use clearly states it's for "ventilation of patients during respiratory distress or insufficiency." This is a direct medical intervention, not a diagnostic test performed on a sample.

The description focuses on the mechanical and electronic aspects of delivering air to the patient, not on analyzing any biological material.

N/A

Intended Use / Indications for Use

The babyPAC 100 is a portable gas powered transport ventilator, suitable for use in an MRI environment up to 3 Tesla, which features a battery powered integrated electronic pressure alarm unit. It is designed for use by qualified medical caregivers, paramedics and other trained personnel, for ambulance, hospital, emergency and transport ventilation of patients during respiratory distress or insufficiency. It can be used on neonates and infants up to a bodyweight of 44lb (20 kg).

Product codes (comma separated list FDA assigned to the subject device)

BTL

Device Description

The babyPAC ventilator consists of a control module with a disposable conventional Y patient circuit. The babyPAC ventilator is a gas generator which depends solely on the pressure of the supply gas for its operation. The babyPAC 100 additionally incorporates an integrated electronic pressure alarm unit which becomes operational during Controlled Mandatory Ventilation. This alarm unit provides a warning of significant changes which may occur in the patient's ventilation. Loss of battery power for the alarm is signaled to the user but will have no effect on the ventilation performance of the babyPAC ventilator, nor affect the mechanically operated alarms and performance of the babyPAC ventilator (K970158) already on the market.

The babyPAC 100 portable ventilator is designed for use as an emergency and transport ventilator in ambulances and hospitals, and can be used in an MRI environment up to 3 Teslas. It is intended for transportation and resuscitation of infants (above approx 11lb [5 kg]) and neonates up to 44 lb (20 kg).

The control module of the babyPAC ventilator is rugged by virtue of its thick section structural foam plastic case and the Mountings for the gauge and internal pneumatics and controls are recessed to minimise the possibilities of damage and inadvertent operation.

The babyPAC 100 portable ventilator consists of a control module and the following items: 22mm disposable Polyethylene respirator hose/ 22mm OD female connector and Paediatric 'Y' piece connector

The module weighs 8.25 lb (3.75 kilograms)

The module control panel has the following features:

  • Adjustable Relief Pressure Control, range 12 to 80 cm H2O.
  • Inspiratory Time Control, range 0.25 to 2.0 seconds.
  • Expiratory Time Control, range 0.25 to 4.0 seconds
  • Inspiratory Pressure Control, range 12 to 70 cm H2O, with click action warning at and above 40 cm H2O.
  • PEEP/ CPAP Control, range 0 to 20 cm H2O with click action warning at and above 10 cm H2O.
  • IMV Control, range Expiratory time 2.5 to 40 seconds with CPAP Pressure level and oxygen concentration as selected.
  • Patient Inflation Pressure Manometer, range -10 to +100 cm H2O.
  • Variable Oxygen Concentration, range 45 (approx) to 100% with oxygen only as supply, 21-70 % with oxygen and air supplies
  • Supply Gas Failure Alarm indicators- One for air, the other for oxygen, these mechanically operated visual alarms give a warning that the supply gas has dropped to a pressure at which the ventilator will no longer be operating to specification (

§ 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

Image /page/0/Picture/1 description: The image contains two lines of text. The first line reads 'Ko43495' in a handwritten style. The second line reads 'smiths' in a sans-serif font, with each letter clearly defined.

APR 2 2 2005

Smiths Medical International Limited Bramingham Business Park Enterprise Way Luton LU3 4EU UK Tel: +44 (0)1582 430000 Fax: +44 (0)1582 430001 www.smiths-medical.com

Summary of Safety and Effectiveness

Submitter:Smiths Medical International Ltd.
Address:Bramingham Business Park,
Enterprise Way, Luton,
Bedfordshire, LU2 OAH
United Kingdom.
Telephone:(+44) (0) 1582 430000
Contact:Senior UK Regulatory Manager
Prepared:15 th March 2005
Proprietary Name:babyPAC 100
Common/ Classification Name:Gas powered Emergency and Transport
pressure generator type Ventilator with
Electronic alarms
Regulatory Class:II (two)
Product Code:BTL
Classification Number:21 CFR 868.5925
Predicate Devices:babyPAC Gas Powered Emergency and
Transport pressure generator type
Ventilator (K970158)
paraPAC 'medic' Gas Powered Emergency
Ventilator with integrated electronic
alarms (K020899)

Page I

a part of Smiths Group plc. Registered Office: 765-Finchley Road London UK NW11 8DS Incorporated in England No. 362647 ariths Me

Image /page/0/Picture/8 description: The image shows a logo with the word "PORTYX" in a bold, sans-serif font. The letters are white and stand out against a dark, solid background. The logo appears to be a stylized design, possibly representing a company or brand name.

Image /page/0/Picture/11 description: The image contains two distinct elements. On the left, there is a simple vertical line with a dot at the top. To the right of this line, there is a circular logo with the letters 'pvb' inscribed within it. The letters are in a sans-serif font and are arranged in a slightly curved manner to fit the circular shape.

Pneupac®

1

Smiths Medical International Limited Bramingham Business Park Enterprise Way Luton LU3 4BU UK Tel: +44 (0)1582 430000 Fax: +44 (0)1582 430001 www.smiths-medical.com

New Device Description:

The babyPAC ventilator consists of a control module with a disposable conventional Y patient The baby AC venthator consisted or a care generator which depends solely on the pressure of the supply gas for its operation. The babyPAC 100 additionally incorporates an integrated electronic pressure alarm unit which becomes operational during Controlled Mandaty electronic pressure analy. "This "Which "Coventes in significant changes which may occur in the patient's ventilation. Loss of

battery power for the alarm is signaled to the user but will have no effect on the venilation performance of the babyPAC ventilator, nor affect the mechanically operated alarms and performance on the baby? AC - vehicate babyPAC (K970158) already on the market.

The babyPAC 100 portable ventilator is designed for use as an emergency and transport ventilator in ambulances and hospitals, and can be used in an MRI environment up to 3 Testas (a) is no In anoutations and nosplans, and og transportation and for resuscitation of infants (above approx 111b [5 kg]) and neonates up to 44 lb (20 kg),

The control module of the babyPAC ventilator is rugged by virtue of its thick section structural The Control module of the ouby Fre Tourings for the gauge and internal pneumatics and lean prastic case and the are recessed to minimise the possibilities of damage and inadvertent operation.

The babyPAC 100 portable ventilator consists of a control module and the following items: 22mm disposable Polyethylene respirator hose/ 22mm OD female connector and Paediatric 'Y' piece connector

The module weighs 8.25 lb (3.75 kilograms)

The module control panel has the following features:

  • Adjustable Relief Pressure Control, range 12 to 80 cm H2O. .
  • Inspiratory Time Control, range 0.25 to 2.0 seconds. .
  • Expiratory Time Control, range 0.25 to 4.0 seconds �
  • Inspiratory Pressure Control, range 12 to 70 cm H2O, with click action warning at and above . 40 cm H2O.
  • 40 cm 110.
    PEEP/ CPAP Control, range 0 to 20 cm H2O with click action warning at and above 10 cm . H-O.
  • IMV Control, range Expiratory time 2.5 to 40 seconds with CPAP Pressure level and oxygen t concentration as selected.
  • Patient Inflation Pressure Manometer, range -10 to +100 cm H2O. �

Page 2

Jo Dic. Begistered Office: 765 Finchley Road London UK NW11 8DS

Image /page/1/Picture/20 description: The image shows a logo with the word "PORTEX" in a bold, sans-serif font. The text is white and set against a black background. The letters are tightly spaced, giving the logo a compact appearance.

2

Smiths Medical International Limited Bramingham Business Park Enterprise Way Luton LU3 4BU UK Te': +44 (0)1582 430000 Fax: +44 (0)1582 430001 www.smiths-medical.com

New Device Description (ctd.):

  • Variable Oxygen Concentration, range 45 (approx) to 100% with oxygen only as supply, 21 10 . 70 % with oxygen and air supplies
    Supply Gas Failure Alarm indicators- One for air, the other for oxygen, these mechanically . operated visual alarms give a warning that the supply gas has dropped to a pressure at which the ventilator will no longer be operating to specification (