The Pneupac VR1 Airmix is a hand-held, portable, time maled, gas powered, flow generator ventilatory resuscitator that is suitable for emergency and transport use and will operate safely in an MRI environment up to 3 Tesla. It is designed for use by qualified medical caregivers, paramedics and other trained personnel for the following conditions: Pneupac VR1 Airmix Ventilatory resuscitator intended for use on adults and children above a bodyweight of 22 lb (10 kg) with either respiratory distress/ insufficiency or no respiratory function and including a control for providing oxygen concentrations of either 100% or 50% nominal.

Device Description

Pneupac VR1 Airmix is intended for emergency resuscitation by medical personnel, paramedics and ambulance technicians inside and outside hospital and for ventilation by medical personnel inside and outside hospital in emergency situations and inter- hospital transport. The Pneupac VR1 Airmix allows two modes of ventilation, automatic and manual. In automatic mode the device cycles in accordance with the setting of the single tidal volume/frequency control that changes the tidal volume and frequency dependently whilst maintaining a constant I:E ratio of 1:2. In manual mode, preset breaths, singly or in a controlled breathing pattern may be selected by use of an omni-directional lever or push button. The tidal volume and rate possible are limited by the position of the single tidal volume/frequency control. The Pneupac VR1 Airmix includes a control for providing oxygen concentrations of either 100% or 50% nominal. The Pneupac VR1 Airmix uses the same technology as existing legally marketed devices and depends solely on the pressure of the supply gas for its operation. The Pneupac VR1 Airmix incorporates a pneumatic high-pressure audible alarm which dumps excess patient pressure according to the in-built relief pressure (40 cmH2O standard, 60cmH2O optional) which operates in an identical manner to the predicate devices. The Pneupac VR1 Airmix consists of a hand-held control module connected to the patient at its outlet via a mask, endotracheal tube or laryngeal mask airway and is used with various patient circuits and accessories comprising the following items; User replaceable patient valve, Oxygen input gas hose assemblies, Breathing filter, Biological breathing filter kit (optional for contaminated atmospheres), Masks, airways and airway adjuncts, Manual suction, Oxygen therapy kits, Oxygen cylinders and regulators, Carrying bag, Breathing circuits, PEEP accessories. The mass of Pneupac VR1 Airmix is 1.001lb, 0.455kg. The Pneupac VR 1 Airmix control module has the following features; Interdependent and continuous control of tidal volume and frequency from 150ml/25bpm to 1050ml/10bpm using a single tidal volume/frequency control, Demand breathing system, Spontaneous breathing under power failure, Audible pressure relief alarm, Integrated, user replaceable patient valve, Automatic or Manual mode selector, Manual mode push button and omni-directional lever, Airmix control for providing oxygen concentrations of either 100% or 50% nominal.

AI/ML Overview

Here's an analysis of the provided 510(k) summary regarding the Pneupac VR1 Airmix device, adhering to your requested format.

It's important to note that this document is a 510(k) summary, which focuses on demonstrating substantial equivalence to a predicate device rather than presenting a comprehensive clinical trial or standalone performance study. Therefore, some of your requested information (e.g., sample sizes for test sets, number of experts for ground truth, MRMC study details) is typically not found in this type of submission.

1. Table of acceptance criteria and the reported device performance

The submission demonstrates the device's performance against established safety and performance standards for ventilators and resuscitators. The acceptance criteria essentially align with meeting the requirements of these standards.

Acceptance Criteria (aligned with standards)	Reported Device Performance
Safety Testing (ASTM F 920-93)	Passed all tests and met all requirements.
Environmental & Performance Testing:
- Operating environment compliance (ETR848 to ASTM F920-93 section 8.2)	Complied
- Storage temperature/humidity (ETR848 to ASTM F920-93 section 8.1)	Complied
- Vibration (ETR835 to MIL-STD 810F section 514.4 & RTCA DO160D section 8 profile C)	Complied
- Altitude (ETR853 to MIL-STD 810F section 500.4, RTCA DO160D section 4.6.2 & Smiths requirements)	Complied
- MRI (ETR 917 to 3 Tesla)	Complied
- IP rating (ETR849 to IEC 529 rating IP5x, IPx5 and Ipx6)	Complied
- Driving sand & dust (ETR849 to RTCA DO160D section 12)	Complied
- Oxygen consumption	Complied
- Mechanical shock (drop) (ETR863 to ASTM F920-93 section A1.5.4 and EN794-3:1998 section 21.102)	Complied
- Rigidity (ETR 921 to EN60601-1:1990)	Complied
- Impact (ETR 919 to EN60601-1:1990)	Complied
- Cleaning & sterilisation (ETR 743 AND ETR 926)	Complied
Overall Performance	Performed within its specifications and functional requirements.
Comparison to Predicate Devices	Demonstrated similarity in performance to Pneupac VR1 (standard) and Oxylog 1000.

2. Sample size used for the test set and the data provenance

Sample Size for Test Set: Not specified in the provided 510(k) summary. Performance data appears to be based on engineering verification and validation testing of the device itself rather than clinical patient data.
Data Provenance: The testing was conducted internally by Smiths Medical International Limited (or certified laboratories on their behalf) to comply with recognized international standards (e.g., ASTM, MIL-STD, RTCA, IEC, EN). The country of origin for the data generation would likely be the UK, given the submitter's address. The data is based on the performance of the device itself under various simulated conditions, not retrospective or prospective patient data.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Not applicable in this context. The "ground truth" for this type of device (a ventilator) is its ability to meet engineering specifications and performance standards. This is typically assessed through objective measurements against predefined criteria, not expert consensus on diagnostic images or clinical outcomes.

4. Adjudication method for the test set

Not applicable in this context. Adjudication methods like 2+1 or 3+1 are used for human interpretation tasks (e.g., reading medical images). Here, the device's performance is objectively measured against technical standards.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

No. This device is a medical device (ventilator), not an AI-powered diagnostic tool for human readers. Therefore, an MRMC study and discussions of human reader improvement with AI assistance are irrelevant to this submission.

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

Yes, in a conceptual sense. The "standalone" performance here refers to the device and its components meeting the specified technical and safety standards independently. The performance data presented (e.g., passing ASTM tests, complying with environmental standards) represents the device's inherent capability to function as intended without direct human intervention once configured.

7. The type of ground truth used

The "ground truth" here is defined by the objective, measurable requirements specified in the referenced international standards (e.g., ASTM F 920-93 for minimum performance and safety, MIL-STD, RTCA, IEC, EN for environmental and mechanical tests). The device's performance was compared against these established benchmarks.

8. The sample size for the training set

Not applicable. This device is a mechanical/electrical ventilator, not an AI/ML algorithm that requires a training set of data.

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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K071527

OCT 4 2007

smiths

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

FDA 510k SUBMISSION FILE Pneupac VR1 Air Mix

SECTION 2 510(k) Summary

Smilhs Madical International Limitod - a part of Smiths Group plc. Registered Office: 765 Finchiey Road London UK NW11 8DS Incorporated In England No. 36267

Image /page/0/Picture/12 description: The image contains two distinct elements. On the left, there is a bold number "1" with a degree symbol to its upper right. To the right of this, there is a logo that appears to be a semi-circle with the letters "pvb" inside.

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smiths

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

Summary of Safety and Effectiveness

Submitter:	Smiths Medical International Ltd.
Address:	Bramingham Business Park,Enterprise Way, Luton,Bedfordshire, LU3 4BUUnited Kingdom.
Telephone:	(+44) (0) 1582 430000
Contact:	Senior UK Regulatory Manager
Prepared:	5 th April 2007
Proprietary Name:	Pneupac VR1 Airmix
Common/ Classification Name:	Gas powered Emergency and TransportVentilator
Regulatory Class:	II (two)
Product Code:	BTL
Classification Number:	21 CFR 868.5925
Predicate Device:	Pneupac VR1 Standard (K051322)Oxylog 1000 (K0107093)

Page 15

Smiths Medical International Linited - a part of Smiths Group plc. Registerd Office: 765 Finchley Road London UK NW11 BDS Incorporated in England No. 362047

Image /page/1/Picture/6 description: The image shows the word "PORTEX" in a bold, sans-serif font. The text is positioned at the bottom left of the image. Above the text is a black square.

IlliBCI®

Delter® Bivona® GRASEBY®

Lwallace®

Pneubac®

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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 Pneupac VR1 Airmix allows two modes of ventilation, automatic and manual. In automatic mode the device cycles in accordance with the setting of the single tidal volume/frequency control that changes the tidal volume and frequency dependently whilst maintaining a constant I:E ratio of 1:2. In manual mode, preset breaths, singly or in a controlled breathing pattern may be selected by use of an omni-directional lever or push button. The tidal volume and rate possible are limited by the position of the single tidal volume/frequency control.

The Pneupac VR1 Airmix includes a control for providing oxygen concentrations of either 100% or 50% nominal.

The Pneupac VR1 Airmix uses the same technology as existing legally marketed devices and depends solely on the pressure of the supply gas for its operation.

The Pneupac VR1 Airmix incorporates a pneumatic high-pressure audible alarm which dumps excess patient pressure according to the in-built relief pressure (40 cmH2O standard, 60cmH2O optional) which operates in an identical manner to the predicate devices.

The Pneupac VR1 Airmix consists of a hand-held control module connected to the patient at its outlet via a mask, endotracheal tube or laryngeal mask airway and is used with various patient circuits and accessories comprising the following items;

User replaceable patient valve .
. Oxygen input gas hose assemblies
Breathing filter .
Biological breathing filter kit (optional for contaminated atmospheres) .
Masks, airways and airway adjuncts .
Manual suction .
Oxygen therapy kits .
Oxygen cylinders and regulators ●
Carrying bag .
Breathing circuits .
PEEP accessories

Page 16

Smiths Medical International Limited - a part of Smiths Group plc. Registered Office: 765 Finchley Road London UK NW11 8DS Incorporated in England No. 362847

LRA° Daltor° Rivanna° GRACERV° Wallace° Pe

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50

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 (ctd.):

The specifications for the recommended, optional biological breathing filter are as follows;

Filter efficiency at least 99.99% efficient against a 0.3micron mass median aerodynamic . diameter aerosol challenge at 32 l/min.
Airflow resistance at 32 1/min. is 10-17 mm H2O .
Connector size 40mm DIN NATO compatible threads .

The mass of Pneupac VR1 Airmix is 1.001lb, 0.455kg

The Pneupac VR 1 Airmix control module has the following features;

Interdependent and continuous control of tidal volume and frequency from 150ml/25bpm to . 1050ml/10bpm using a single tidal volume/frequency control
Demand breathing system .
Spontaneous breathing under power failure .
Audible pressure relief alarm .
Integrated, user replaceable patient valve .
Automatic or Manual mode selector .
Manual mode push button and omni-directional lever .
Airmix control for providing oxygen concentrations of either 100% or 50% nominal .

Page 17

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

Image /page/3/Picture/21 description: The image contains two distinct symbols. The first symbol is the number "1" with a degree symbol in the upper right corner. The second symbol is a circle with the letters "pvb" inside of it, with a line going across the top of the circle.

Image /page/3/Picture/22 description: The image shows a logo or emblem with a dark, solid shape at the top, possibly a square or rectangle. Below this shape, there is text that reads "PARTY" in a bold, sans-serif font. The text is white, contrasting with the dark background, making it stand out.

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smith

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

Intended Use:

The Pneupac VR1 Airmix is a hand-held, portable, time cycled, gas powered, flow generator ventilatory resuscitator that is suitable for emergency and transport use and will operate safely in an MRI environment up to 3 Tesla.

It is designed for use by qualified medical caregivers, paramedics and other trained personnel for the following conditions:

Pneupac VR1 Airmix Ventilatory resuscitator intended for use on adults and children above a . bodyweight of 22 lb (10 kg) with either respiratory distress/ insufficiency or no respiratory function and including a control for providing oxygen concentrations of either 100% or 50% nominal.

Performance data:

Testing was performed to ensure that the Pneupac VR1 Airmix was safe and would perform within the environment(s) for which it is to be marketed.

Safety testing was conducted in accordance with:

ASTM F 920-93 'Minimum Performance and Safety Requirements for Resuscitators Intended for Use With Humans'.

The resuscitator passed all of these tests and met all requirements of the standards.

Environmental and performance testing was performed in accordance with;

Operating environment compliance, ETR848 to ASTM F920-93 section 8.2 and Smiths input . requirements
. Storage temperature/humidity, ETR848 to ASTM F920-93 section 8.1 and Smiths input requirements
Vibration, ETR835 to MIL-STD 810F section 514.4 and RTCA DO160D section 8 profile C .
Altitude, ETR853 to ML-STD 810F section 500.4, RTCA DO160D section 4.6.2 10,000ft to . 20,000ft and Smiths input requirements
MRI, ETR 917 to 3 Tesla ●

Deltec®

IP rating, ETR849 to IEC 529 rating IP5x, IPx5 and Ipx6 .
Driving sand & dust, ETR849 to RTCA DO160D section 12 ●
Oxygen consumption

Page 18

GRASEBY®

765 Finchley Road London UK NW11 8DS In

Bivona®

1®
VF I

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smit

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

Performance data (ctd.):

Mechanical shock (drop), ETR863 to ASTM F920-93 section A1.5.4 and EN794-3:1998 . section 21.102
Rigidity, ETR 921 to EN60601-1:1990 .
Impact, ETR 919 to EN60601-1:1990 .
Cleaning & sterilisation, ETR 743 AND ETR 926 .

The results demonstrated that the Pneupac VR1 Airmix complied with the guidelines and standards and that it performed within its specifications and functional requirements.

A comparison table was constructed to show the similarity in performance between Pneupac VR1 Airmix and the predicate devices Pneupac VR1 (standard) and Oxylog 1000.

Based on these results, it is our determination that the device model(s) are safe, effective and perform as well as the legally marketed predicate device.

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 Senior UK Regulatory Manager

Page 19

e: 765 Finchiev Road London UK NW11 8DS Inc

Image /page/5/Picture/16 description: The image shows a series of brand names in a horizontal arrangement. The brands listed are Bivona, GRASEBY, wallace, and Pneupac. Each brand name is followed by the registered trademark symbol. The text is in bold font.

Image /page/5/Picture/17 description: The image shows a logo with the letters 'pvb' inside a circle. The circle and letters are black, set against a white background. The logo appears to be a trademarked symbol, indicated by the '®' symbol in the upper right corner.

Image /page/5/Picture/18 description: The image shows a logo with the word "PORTEX" in a bold, sans-serif font. The letters are black, and they are positioned below a solid black rectangle. The rectangle is wider than the word "PORTEX", and it appears to be a design element that emphasizes the brand name.

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Image /page/6/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with its wings spread, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES. USA" arranged in a circular pattern around the eagle. The eagle is black, and the text is also black. The logo is simple and recognizable.

ood and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Smiths Medical International Limited C/O Mr. Donald Alexander Vice President Regulatory Affairs Smiths Medical MDPM, Incorporated North 7 W22025 Johnson Drive Waukesha, Wisconsin 53186

2007

Re: K071527

Trade/Device Name: Pneupac VR1 Airmix Regulation Number: 21 CFR 868.5925 Regulation Name: Powered Emergency Ventilator Regulatory Class: II Product Code: BTL Dated: September 20, 2007 Received: September 26, 2007

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 (OS) 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 (240) 276-0120. 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 vours.

Clues

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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Indications for Use

510(k) Number (if known):_____________________________________________________________________________________________________________________________________________________

Device Name: Pneupac VR1 Airmix

Indications For Use: The Pneupac VR1 Airmix is a hand-held, portable, time maled, gas powered, flow generator ventilatory resuscitator that is suitable for emergency and transport use and will operate safely in an MRI environment up to 3 Tesla.

o Toola.
It is designed for use by qualified medical caregivers, paramedics and other trained personnel for the following conditions:

Pneupac VR1 Airmix Ventilatory resuscitator intended for use on adults and . children above a bodyweight of 22 lb (10 kg) with either respiratory distress/ insufficiency or no respiratory function and including a control for providing oxygen concentrations of either 100% or 50% nominal.
Prescription Use_ X (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 ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------

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

Mat Nhat

(Division Sign-Uri) Division of Anesthesiology, General Hospital Infection Control, Dental Devices

K671527 510(k) Number: _______________________________________________________________________________________________________________________________________________________________

H: IFU FDA $10(k) document VR1 Airmix iss 1 Section 1/Page 13

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).