BABYPAC by SMITHS MEDICAL INTERNATIONAL LTD., LUTON

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.

AI/ML Overview

Here's an analysis of the provided text to extract the requested information about acceptance criteria and the study proving device performance:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria Category	Specific Acceptance Criteria	Reported Device Performance
Safety Testing	Compliance with EN794-3 (Lung Ventilators - Part 3 Particular requirements for emergency and transport ventilators) 1999	"The ventilator passes all of these tests and met all requirements of the standards."
	Compliance with EN60601-1 (Medical Electrical Equipment - Part 1 General requirements for safety) 1990	"The ventilator passes all of these tests and met all requirements of the standards."
Environmental Testing	Compliance with EN 60601-1-2: 1993	"The results demonstrated that the babyPAC 100 complied with the guidelines and standards and that they performed within their specifications and functional requirements."
	Compliance with EN794-3: 1999	"The results demonstrated that the babyPAC 100 complied with the guidelines and standards and that they performed within their specifications and functional requirements."
Performance (Functional Equivalence to Predicate K970158)	Delivered Tidal Volume, Frequency, Inspiration times, and Expiration time parameters are the same as the predicate (babyPAC K970158).	"All measurements were within the specified tolerances of the ventilators," indicating "no functional difference."
Performance (Functional Equivalence to Predicate K020899)	Safe for use in an MRI environment up to 3 Teslas, and the performance of the electronic integrated alarms system is the same as the predicate (paraPAC 'medic' P200 K020899).	"No functional difference... for safe use in an MRI environment up to 3 Teslas and operation of the integrated electronic alarms."

2. Sample Size Used for the Test Set and Data Provenance

The document does not explicitly state a 'sample size' in terms of patient data or a specific number of devices tested for each parameter. The testing described is typically design verification and validation testing rather than a clinical trial with a patient test set.

Test Set Sample Size: Not explicitly stated in terms of patient numbers or specific device units. The wording suggests testing of the ventilator's entire range and across its parameters.
Data Provenance: The document does not specify the country of origin of the data. Given the "Submitter" and "Address" information (Smiths Medical International Ltd., UK), it is highly probable the testing was conducted in the UK or a region complying with the cited European standards (EN). The data is part of a submission for regulatory clearance (510(k)), implying it is prospective with respect to the regulatory approval process, but the detailed testing itself would have been retrospective if conducted on existing manufactured units as part of the product development lifecycle.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

This type of information (experts for ground truth determination) is not applicable or provided in this document. The "ground truth" for the device's performance is established by direct measurement against engineering specifications and regulatory standards, not by expert consensus on clinical data. The tests refer to objective measurements (e.g., Tidal Volume, Frequency, alarm activation) against defined tolerances and compliance with standards.

4. Adjudication Method for the Test Set

Not applicable. This is not a study involving human interpretation where adjudication would be necessary. Performance is measured against objective technical standards and predicate device performance.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No, an MRMC comparative effectiveness study was not done. This device is a ventilator, and the testing focuses on its engineering performance and safety compliance, not on human interpretation of medical images or data where MRMC studies are typically employed.

6. Standalone Performance Study (Algorithm Only Without Human-in-the-Loop Performance)

Yes, a standalone performance study was done. The entire "Performance Data" section describes the device's performance in isolation (e.g., meeting EN standards, comparison of physical output parameters like tidal volume). The device itself is not an "algorithm" in the modern AI sense, but its functional performance was tested standalone without human intervention affecting the measurement of its core parameters. The electronic alarm unit's operation was also tested standalone in its comparison to the predicate.

7. Type of Ground Truth Used

The ground truth used is primarily based on:

Engineering Specifications and Tolerances: For parameters like Tidal Volume, Frequency, Inspiration/Expiration times, relief pressure, PEEP/CPAP, etc.
Regulatory and International Standards: E.g., EN794-3, EN60601-1, EN60601-1-2. Compliance with these standards forms the ground truth for safety and environmental performance.
Predicate Device Performance: For demonstrating substantial equivalence, the performance of the babyPAC (K970158) and paraPAC 'medic' P200 (K020899) served as the established ground truth for comparison.

8. Sample Size for the Training Set

Not applicable. This device is a medical ventilator, not an AI/ML algorithm that requires a "training set" in the computational sense. The design and validation are based on engineering principles and regulatory testing, not statistical learning from a dataset.

9. How the Ground Truth for the Training Set Was Established

Not applicable, as there is no training set for this type of device.

Summary

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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 OAHUnited 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 Transportpressure generator type Ventilator withElectronic alarms
Regulatory Class:	II (two)
Product Code:	BTL
Classification Number:	21 CFR 868.5925
Predicate Devices:	babyPAC Gas Powered Emergency andTransport pressure generator typeVentilator (K970158)paraPAC 'medic' Gas Powered EmergencyVentilator with integrated electronicalarms (K020899)

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

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Pneupac®

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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. �

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

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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 (< 35 psi). With low pressure they show red, with adequate pressure they show white. Any visible red indicates that the supply should be while adoquate pressure the showated to the particular supply gas indicated on the indicator changed. Laon moreater as a coses 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
- audiolo atam andicator 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.
- the operations 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 seconds, whene event that the single gas fails (ie. where the audible gas failure alarm has an only). In the event that the bitgs is being used) the Low Pressure/ Disconnect Indicator will activate together with the audible alarm.
- Low battery indicator Flashes Yellow LED with audible alarm. .

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vaistered Office: 765 Finchley Road London UK NW11 8DS Incorpora

GRASEBY

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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

Intended 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).

Performance Data:

The design of this ventilator uses currently available technology found in many legally marketed ventilators. Testing was performed to ensure that the babyPAC 100 was safe and would perform within the environment(s) for which it is to be marketed.

Safety testing was conducted in accordance with EN794-3 'Lung Ventilators - Part 3 Particular is wirements for emergency and transport ventilators' 1999 and EN60601-1 'Medical Electrical

Equipment - Part 1 General requirements for safety': 1990. The ventilator passes all of these tests and met all requirements of the standards

Environmental testing was performed in accordance with EN 60601-1-2: 1993 and EN794-3: 1999.

Electromagnetic compatibility (EMC), electrical, mechanical durability, safety (operator and patient), and temperature/ humidity testing has been completed. The results demonstrated that the babyPAC 100 complied with the guidelines and standards and that they performed within their specifications and functional requirements.

Comparison testing of the babyPAC 100 with its predicate counterpart the babyPAC (K970158) was done to show that the performance of the delivered Tidal Volume, Frequency, Inspiration times and Expiration time parameters are the same for each. The tests were performed across the ventilator's entire range. All measurements were within the specified tolerances of the ventilators. These data support substantial equivalence of the predicate babyPAC (K970158) to the babyPAC 100. Additionally, comparison testing of the babyPAC 100 with its other predicate counterpart, the paraPAC 'medic' P200 (K020899) was done to show that the ventilator was safe for use in an MRI environment up to 3 Teslas and that the performance of the electronic integrated alarms system is the same for each.

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Sraithe Medical international Limited- & part of Smiths Group pic. Registered Office: 765 Finchley Road London UK NW11 8DS Incorporated in England No.30204/

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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

The testing described above indicates that there is no functional difference between the operation The testing described doove marcates that counterpart the babyPAC for delivered Tidal Volume, of the bady. It 100 will its precises and Expiration time parameters, and no functional difference requency, inspiration of the babyPAC 100 with its other predicate counterpart, the paraPAC "medic' (K020899) for safe use in an MRI environment up to 3 Teslas and operation of the integrated electronic alarms. Based on athese results, it is our determination that the device model is safe, effective and performs as well as the legally marketed predicate devices.

This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807 92.

Respectfully
Colin Walters
Colin Walters
Senior UK Regulatory Manager

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Smiths Medical International Limited, a part of Smiths Group plc. Registered Office: 765 Finchley Road London UK NW11 8DS Incorporated in England no. 36847

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Public Health Service

APR 2 2 2005

ﺒ

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Smiths Medical International, Limited C/O Mr. Donald Alexander Vice President Regulatory Affairs Smiths Medical P.M., Incorporated N7 W22025 Johnson Drive Waukesha, Wisconsin 53186

Re: K043495

Trade/Device Name: babyPAC 100 Regulation Number: 868.5925 Regulation Name: Powered Emergency Ventilator Regulatory Class: II Product Code: BTL Dated: February 20, 2005 Received: April 6, 2005

Dear Mr. Alexander:

We have reviewed your Section 510(k) premarket notification of intent to market the device we have roved 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 mendments, or to devices that have been reclassified in accordance with the provisions of / Including, or to are read Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general approval uppliedion (the Act. The general controls provisions of the Act include controls provisions of a ... ... ... ... ... ... .. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 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 may be subject to such additional controls. Existing major regulations affecting (1 Mrs), it may of subject to tax of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

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Page 2 - Mr. Alexander

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. or the ret of any 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 and fisting (21 CF rate on the quality systems (QS) regulation (21 CFR Part 820); and if requirences as bet form in nodict 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) This reter 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), rr Jose contact the Office of Compliance at (240) 276-0115. 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/industry/support/index.html.

Sincerely yours,

Jenette Y. Michau Omd.

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

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510(k) Submission Ref: K043495 – Attachment # 17a

Indications for Use

510(k) Number (if known): K043495

Device Name: babyPAC 100

Indications For Use: The babyPAC 100 is a portable gas powered transport Indications For Use. The babyr AC Too is a portune to 3 Testa, which features a
ventilator, suitable for use in an MRI environment up to 3 Testa, which featured for use b ventilator, suitable for use in anniti enwonent up to this designed for use by
battery powered integrated electronic pressure alarm unit. It is designed for battery powered integrated elections proceded ther trained personnel, for qualified medical caregivers, paramours and transport ventilation of patients during
ambulance, hospital, emergency and transmand on pennates and infants ambulance, hospital, emergency and transport vehilation of i
respiratory distress or insufficiency. It can be used on neonates and infants up to a bodyweight of 44lb (20 kg).

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

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

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

(Concurrence of CDRH, Office of Device Evaluation (ODE)

Que Suleom

(Civision Sign-Off) (Civision Oigh Sthesiology, General Hospital, Intection Control, Dental Devices K043495

510(k) Number:

X: Indications For Use FDA 510(k) document babyPAC 100

Section 1/Page 3

Regulation Number and Section

§ 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).