The paraPAC 200D 'Transport' ventilator is a portable, gas powered, time-cycled ventilator that is designed for ventilation during transportation and emergency ventilation of patients who have respiratory distress or insufficiency.

Device Description

The paraPAC 'Transport' ventilator is a gas powered, time cycled, volume preset, pressure limited ventilator which uses the same technology as existing legally marketed devices. It depends solely on the pressure of the supply gas for its operation. Additionally, it incorporates an integrated electronic pressure alarm unit to alert the user to certain significant changes that may occur in the patient's ventilation. Loss of battery power for the alarm is signalled to the user but will have no effect on the ventilation performance of the paraPAC "Transport" ventilator, nor affect the mechanically operated alarms and protection systems, which operate in an identical manner to the predicate devices.

The paraPAC 'Transport' ventilator consists of a control module and patient circuit comprising the following disposable items: Hose/ Patient Valve/ PEEP Valve/ Exhaust Collector and Mouthpiece.

The module weighs 3.1 kilograms.

The module control panel has the following features:

Adjustable Relief Pressure Control, range 20 to 80 cm H2O. .
Air Mix (45% oxygen) / No Air Mix (100% oxygen) Selector. ●
Inspiratory Time Range 3.0 to 0.5 seconds. .
. Expiratory Time Range 6.0 to 0.5 seconds.
Patient Inflation Pressure Manometer, range -10 to +100 cm H2O. .
Flow Range 0.1 to 1.0 L/sec. .
Ventilation: Off (Spontaneous breathing)/ On (Spontaneous breathing/ Controlled Mandatory . Ventilation).
Supply Gas Failure Alarm A mechanically operated visual alarm gives 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 it shows red, with adequate pressure it shows white. Any visible red indicates that the supply should be changed. In most cases 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) audible warning. In order to conserve the battery, if this audible alarm is ignored for more than 60 seconds the alarm system will ultimately switch itself off.

Electronic alarm 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.
- Breathing detect indicator Flashes Green LED each time a spontaneous breath is . detected.
- Low battery indicator Flashes Yellow LED with audible alarm. .

AI/ML Overview

Here's an analysis of the provided text regarding the acceptance criteria and study for the Pneupac paraPAC 'Transport' model 200D ventilator:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly list quantitative "acceptance criteria" alongside specific numerical "reported device performance" values in a neat table format for the paraPAC 'Transport' 200D. Instead, it describes a more general approach based on compliance with standards and comparison to predicate devices.

However, based on the description, we can infer some criteria and the general performance outcome:

Acceptance Criteria (Inferred)	Reported Device Performance
Compliance with Draft Reviewer's Guidance for Ventilators, July 1995	Passes all tests and met all requirements of the standard.
Compliance with EN794-3 'Lung Ventilators - Part 3 Particular requirements for emergency and transport ventilators' 1999	Passes all tests and met all requirements of the standard.
Compliance with EN60601-1 'Medical Electrical Equipment - Part 1 General requirements for safety': 1990	Passes all tests and met all requirements of the standard.
Compliance with EN 60601-1-2: 1993 (Environmental testing - EMC)	Complied with the guidelines and performed within specifications and functional requirements.
Compliance with EN794-3: 1999 (Environmental testing - Electrical, Mechanical durability, Safety, Temperature/humidity)	Complied with the guidelines and performed within specifications and functional requirements.
Performance of Delivered Tidal Volume, Frequency, Inspiration times, and Expiration time parameters	Within the specified tolerances of the ventilators, deemed same as predicate devices.
Substantial Equivalence to predicate devices (babyPAC and paraPAC 'medic')	The device is substantially equivalent to legally marketed predicate devices.

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

The document does not specify a sample size for the test set in terms of number of devices tested or number of test conditions with specific repetitions. It only states that "Testing was performed to ensure that the paraPAC 'Transport' was safe and would perform within the environment(s) for which it is to be marketed."

The data provenance can be inferred as prospective given that the testing was conducted specifically for this new device (paraPAC 'Transport' model 200D) to demonstrate its safety and effectiveness.

The country of origin for the submitter is the United Kingdom (Pneupac Ltd.), suggesting the testing was likely conducted under UK regulatory and manufacturing standards, even though the submission is to the US FDA.

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

This type of information is not applicable to this submission. The "ground truth" for a medical device like a ventilator is established through objective engineering tests against defined performance specifications and regulatory standards, not expert consensus on interpretations of data. There are no human "experts" establishing ground truth in the way described for AI/ML models analyzing medical images, for example.

4. Adjudication Method for the Test Set

This is not applicable as there is no mention of expert interpretation or adjudication panels for the testing of a mechanical ventilator's performance against engineering specifications. The testing involves objective measurements against established technical standards.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done

No, an MRMC comparative effectiveness study was not done. This type of study focuses on the diagnostic performance of human readers, sometimes with and without AI assistance, typically in image interpretation. This document describes the testing of a mechanical ventilator, which is a different domain.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done

This concept is not directly applicable in the context of a mechanical ventilator as described. The "standalone" performance here refers to the device's ability to meet its technical specifications independently, which is what the performance and environmental testing aimed to establish. However, it's not an "algorithm" in the sense of AI/ML. The device's operation is mechanical and electronic, and its performance was tested without human intervention impacting its core function during the tests (though humans operate the device in real-world use).

7. The Type of Ground Truth Used

The ground truth used for the paraPAC 'Transport' 200D was based on objective measurements against established performance specifications and regulatory standards. This includes:

Engineering specifications for parameters like adjustable relief pressure, inspiratory time, expiratory time, flow range, patient inflation pressure, and alarm thresholds.
Compliance with international safety and performance standards (e.g., EN794-3, EN60601-1, EN60601-1-2).
Comparative performance to predicate devices (babyPAC and paraPAC 'medic') for Tidal Volume, Frequency, Inspiration times, and Expiration time, ensuring performance was "within the specified tolerances."

8. The Sample Size for the Training Set

This is not applicable. The paraPAC 'Transport' 200D is a traditional mechanical medical device, not an AI/ML system that utilizes a "training set" of data in the common sense. Its design is based on established engineering principles and technology, not on machine learning from a dataset.

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

This is not applicable for the same reason as Item 8.

Summary

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SEP 2 9 2003

Pneupac

Summary of Safety and Effectiveness

Submitter:	Pneupac Ltd.
Address:	Bramingham Business Park,Enterprise Way, Luton,Bedfordshire, LU2 OAHUnited Kingdom.
Telephone:	(+44) (0) 1582 430000
Contact:	Regulatory Affairs & Quality AssuranceManager
Prepared:	24th October 2002
Proprietary Name:	paraPAC 'Transport' model 200D
Common/ Classification Name:	Gas powered Transport Ventilator withElectronic alarms

New Device Description:

The paraPAC 'Transport' ventilator consists of a control module and patient circuit comprising the following disposable items: Hose/ Patient Valve/ PEEP Valve/ Exhaust Collector and Mouthpiece.

Pneupac Limited. Bramingham Business Park. Enterprise Wav. Luton. Beds. LU3 4BU Tel: +44 (0) 1582 430000 Fax: +44 (0) 1582 430001 e-mail: pneupac a smiths-industries com ww.pneupac.co.uk Section 2 /Page 1

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Pneupac

Summary of Safety and Effectiveness

New Device Description (ctd.):

The module weighs 3.1 kilograms.

The module control panel has the following features:

Adjustable Relief Pressure Control, range 20 to 80 cm H2O. .
Air Mix (45% oxygen) / No Air Mix (100% oxygen) Selector. ●
Inspiratory Time Range 3.0 to 0.5 seconds. .
. Expiratory Time Range 6.0 to 0.5 seconds.
Patient Inflation Pressure Manometer, range -10 to +100 cm H2O. .
Flow Range 0.1 to 1.0 L/sec. .
Ventilation: Off (Spontaneous breathing)/ On (Spontaneous breathing/ Controlled Mandatory . Ventilation).
Supply Gas Failure Alarm A mechanically operated visual alarm gives 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 it shows red, with adequate pressure it shows white. Any visible red indicates that the supply should be changed. In most cases the display will begin to oscillate from white to partial red as the supply pressure falls to the lower threshold level.

Electronic alarm 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.
- Breathing detect indicator Flashes Green LED each time a spontaneous breath is . detected.
- Low battery indicator Flashes Yellow LED with audible alarm. .

Pneupac Limited. Bramingham Business Park. Enterprise Wav. Luton. Beds. LU3 4BU Tel: +44 (0) 1582 430000 Fax: +44 (0) 1582 430001 e-mail: pneupac a smiths-industries.com www.pneupac.co.uk

Section 2 /Page 2

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Pneupac

Summary of Safety and Effectiveness

Intended Use:

Performance Data:

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

Safety testing was conducted in accordance with the Draft Reviewer's Guidance for Ventilators, July 1995, EN794-3 'Lung Ventilators - Part 3 Particular requirements 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

Performance Data (ctd.):

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 paraPAC "Transport' complied with the guidelines and that they performed within their specifications and functional requirements.

Comparison testing of the paraPAC 'Transport' with its respective predicate counterparts: the babyPAC and paraPAC 'medic' 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 paraPAC

Pneupac Limited. Bramingham Business Park. Enterprise Wav. Luton. Beds. LU3 4BU Tel: +44 (0) 1582 430000 Fax: +44 (0) 1582 430001 e-mail: pneupac a smiths-industries.com ww.pncupac.co.uk Section 2 /Page 3

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Pneupac

Summary of Safety and Effectiveness

'Transport' to the babyPAC and paraPAC 'medic' with integrated electronic alarms.

The testing described above indicates that there is no functional difference between the operation of the paraPAC 'Transport' with its predicate counterparts the babyPAC and paraPAC 'medic' with integrated electronic alarms for delivered Tidal Volume, Frequency, Inspiration times and Expiration time parameters. Based on these results, it is our determination that the device models are safe, effective and perform as well as the legally marketed predicate device(s).

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
Regulatory Affairs and Quality Assurance Manager

Pneupac Limited. Bramingham Business Park. Enterprise Wav. Luton. Beds. LU3 4BU Tel: +44 (0) 1582 430000 Fax: +44 (0) 1582 430001 e-mail: pneupac a smiths-industries.com ww.pneupac.co.uk Section 2 /Page 4

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/4/Picture/1 description: The image shows the logo for the Department of Health & Human Services (HHS). The logo features a stylized eagle with three lines forming its body and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle. The logo is black and white.

Public Health Service

SEP 2 9 2003

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Pneupac, Limited. C/O Mr. Donald Alexander Vice President of Regulatory Affairs BCI Incorporated N7 W22025 Johnson Road Waukesha, Wisconsin 53186-1856

Re: K030803

Trade/Device Name: paraPAC 'Transport' Model V 200D Regulation Number: 21 CFR 868.5925 Regulation Name: Emergency Powered Ventilator (Resuscitator) Regulatory Class: II Product Code: BTL Dated: July 8, 2003 Received: July 9, 2003

Dear Mr. Alexander:

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.

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 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.

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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. 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); 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. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained 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 yours,

Susan Palmer

Susan Runner, DDS, MA Interim 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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Indications For Use

510(k) Number (if Known): __ K030 8 03

Device Name: paraPAC 200D 'Transport' Emergency & Transport gas powered Ventilator

Indications For Use:

Intended Use:

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

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

Prescription Use
(Per 21 CFR 801.109)

Over The Counter Use

Bohn

(Division Sign-Off) Division of Anesthesiciogy, General Hospital, Infection Control, Denial Devices

510(k) Number: K030803

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).